,nct_id,organization,title,status,summary,conditions,study_type,study_design,interventions,eligibility,study_pop,sex,samplingMethod,primary_endpoint,secondary_endpoint 0,NCT00726128,"{'fullName': 'Zimmer Biomet', 'class': 'INDUSTRY'}",Patient Outcomes Evaluation of the EBI Vuelock™ Anterior Cervical Plate System,COMPLETED,To prospectively collect radiographic and outcome data on patients who are having cervical spine fusion surgery with the VueLock™ Anterior Cervical Plate System,"['Trauma', 'Tumor', 'Pseudarthrosis', 'Scoliosis', 'Degenerative Disc Disease']",OBSERVATIONAL,"{'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'DEVICE', 'name': 'VueLock™ Anterior Cervical Plate', 'description': 'Implanted in subjects having an ACDF (Anterior cervical discectomy and fusion)', 'armGroupLabels': ['VueLock™ Anterior Cervical Plate Group']}]","Inclusion Criteria: 1. The patient will undergo anterior cervical fusion with the VueLock™ Anterior Cervical Plate System for treatment of degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma, tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusion. 2. The patient must be available for follow-up during the study. 3. The patient must be skeletally mature (epiphyses closed). Exclusion Criteria: 1. Patients with other pathology at the involved spinal level, e.g., osteomyelitis, Paget's disease, pathologic fracture, etc. 2. Patients with a disease entity or condition that totally precludes the possibility of bony fusion such as known active cancer, etc. 3. Pregnant or nursing females. 4. Patients who in the opinion of the investigator would be psychologically unwilling or unable to understand or complete the protocol, especially those unwilling or unstable to participate in the follow-up.",Subjects from multiple centers with disease of the cervical spine,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Proportion of Patients with radiographic fusion', 'timeFrame': '24 Months'}]","[{'measure': 'Neck Disability Index and Short Form Health Survey (SF-36) scores, change from baseline', 'timeFrame': '24 Month'}]" 1,NCT02482428,"{'fullName': 'Novartis', 'class': 'INDUSTRY'}",Efficacy and Tolerability of Topical LFX453 for External Genital Warts,COMPLETED,"The LFX453X2202 study tested the investigational drug LFX453 against placebo for safety, tolerability, and efficacy in treating genital warts in circumcised men, in parallel with an additional open label arm using imiquimod 5%. During the study the patients received either LFX453, placebo or active comparator and the tolerability and safety was assessed continuously through local tolerability assessments and adverse event recorded. Efficacy was clinical evaluations and lesion count. During the study biopsies were taken for analysis of pharmacokinetics and biomarkers. Blood samples were taken for safety, pharmacokinetics (PK), and biomarkers.",['External Genital Warts'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}","[{'type': 'DRUG', 'name': 'Investigational Treatment', 'description': 'Applied twice daily for up to 12 weeks', 'armGroupLabels': ['LFX453 0.1% NMC', 'LLFX453 0.15% LCC', 'Vehicle to LCC', 'Vehicle to NMC']}, {'type': 'DRUG', 'name': 'Aldara', 'description': 'Applied 3 times a week for 16 weeks', 'armGroupLabels': ['Aldara'], 'otherNames': ['imiquimod']}]","Inclusion Criteria: * Signed informed consent * Circumcised male 18-60 years * Clinical diagnosis of external genital warts * Agree to remain abstinent or to use condoms during intercourse for the duration of the study * Agree to digital photographs of treated area Exclusion Criteria: * Any treatment of genital warts within one month of treatment start * HPV vaccination * presence of warts larger than 200 mm2 * Genital herpes within one month of treatment start * History of Bowenoid papulosis * significant illness within 2 weeks of treatment start * use of other investigational drugs * known hypersensitivity to study drugs or constituents * history of ECG abnormalities * History of significant heart conditions * Impaired renal function * Abnormal liver function * History of immunodeficiency disease * Drug or alcohol abuse * Immunosuppressive therapies * Malignancies in the past 5 years * hypertrophic scarring",NA,MALE,NA,"[{'measure': 'Complete Clearance of Disease at Week 14', 'description': 'Number of participants achieving complete clearance of genital warts at Week 14', 'timeFrame': 'Week 14'}, {'measure': 'Number of Adverse Events (AE)/Serious Adverse Events (SAE) as a Measure of Safety and Tolerability up to 30 Weeks', 'description': 'Number of participants with at least one AE/SAE in the category up to 30 weeks', 'timeFrame': '30 weeks'}]","[{'measure': 'Number of Participants That Had Partial Clearance Rate of at Least 75 Percent Reduction in External Genital Wart (EGW)s Count at End of Treatment (EOT) Week 12 or 16', 'description': 'Number of Participants that had partial clearance rate of at least 75 percent reduction in External Genital Wart (EGW)s count at end of treatment (EOT) Week 12 or 16', 'timeFrame': 'End of Treatment (EOT) Week 12 or Week 16'}]" 2,NCT01222728,"{'fullName': 'National Institutes of Health Clinical Center (CC)', 'class': 'NIH'}",Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients,COMPLETED,"Background: * Neurofibromatosis type II (NF2) is associated with tumors of the nerves, brain, and spinal cord. Most people with NF2 develop vestibular schwannomas, or tumors on the hearing and balance nerves. As they grow, vestibular schwannomas can cause hearing loss and balance problems. If they grow very large they can cause more serious problems, such as seizures, loss of eyesight, weakness, speech problems, and problems with the sense of touch. More research is needed into NF2 because researchers do not completely understand why these tumors occur or what makes them grow over time. * Currently, tumor size is measured with magnetic resonance imaging (MRI) scans. However, MRI scans cannot predict how fast a tumor will grow. By using positron emission tomography (PET) scanning, researchers hope to be able to predict sudden growth spurts of tumors associated with NF2 and develop better treatment methods for this type of cancer. Objectives: \- To use magnetic resonance imaging and positron emission tomography to better understand the growth of brain tumors in people with neurofibromatosis type II. Eligibility: \- Individuals between 18 and 50 years of age who have been diagnosed with NF2 and have at least three untreated intracranial tumors. Design: * This study requires an initial set of outpatient visits to the NIH Clinical Center that will last 7 to 10 days. * Participants will have a physical and neurological examination and blood tests at the first visit. Participants will then have the following imaging studies to examine the tumors: * MRI scans of the brain * PET scans of the brain, combined with a computed tomography (CT) scan. The PET scans will be performed on separate days. Different contrast agents will be used for both scans, so researchers will inform participants if they need to fast or follow other procedures before having the scan. * After the initial imaging studies, participants will have additional MRI scans every 6 months for 2 years to track tumor growth.","['Neoplasms', 'Nervous System Disease', 'Vestibular Disease']",OBSERVATIONAL,{'timePerspective': 'PROSPECTIVE'},NA,"* INCLUSION CRITERIA: * Clinical diagnosis of NF2 by established clinical criteria or genetic testing. * Age 18 to 50. * A minimum of 3 intracranial tumors (meningiomas and/or VSs) measuring = or \> 1cm in size, including: 1. At least one unoperated VS \> 1 cm in size AND 2. At least one unoperated meningioma \> 1 cm in size * No pregnancy or intent to become pregnant, with proper use of contraception for the duration of the study. * Normal liver enzymes: tests should be completed within 14 days before injection of the radiopharmaceutical; SGOT, SGPT \<5x ULN; bilirubin less than or equal to 2x ULN * If prior radiation therapy to the tumor: \>2 years must have passed after radiotherapy administration and tumor must demonstrate growth after radiotherapy (signifying a viable tumor for study is present) * If prior chemotherapy: must have completed chemotherapy \>6 months prior to enrollment to allow washout of chemotherapeutic agent EXCLUSION CRITERIA: * Clinically unstable condition that precludes serial clinical and imaging evaluation (i.e. Class 3 congestive heart failure, severe chronic renal insufficiency, severe chronic obstructive pulmonary disease). * Contraindication to MRI scanning, including pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pump, or shrapnel fragments * Severe chronic renal insufficiency (glomerular filtration rate \< 30 mL/min/1.73 m2), hepatorenal syndrome or post-liver transplantation.",NA,ALL,NA,"[{'measure': 'To determine whether FDG and/or FLT uptake correlate with growth rate of meningiomas and Vestibular Schwannomas (VSs) in NF2 patients, and can be used to predict their future growth pattern.'}]","[{'measure': 'To characterize glucose metabolism and cellular proliferative activity in meningiomas and VSs in NF2 patients, using FDG and FLT PET/CT imaging. To determine the degree to which glucose metabolism and cell proliferation are coupled in meningioma...'}]" 3,NCT01031628,"{'fullName': 'Sarcoma Alliance for Research through Collaboration', 'class': 'OTHER'}",Study of Dose Escalation Versus no Dose Escalation of Imatinib in Metastatic Gastrointestinal Stromal Tumors (GIST) Patients,TERMINATED,The purpose of this study is to determine if escalating the dose of imatinib to keep the drug blood level at ≥ 1100 ng/ml leads to better outcomes for patients.,['Gastrointestinal Stromal Tumors'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Imatinib mesylate', 'description': '400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops', 'armGroupLabels': ['Arm A', 'Arm C'], 'otherNames': ['Gleevec', 'Glivec']}, {'type': 'DRUG', 'name': 'Imatinib mesylate', 'description': '600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops', 'armGroupLabels': ['Arm B'], 'otherNames': ['Gleevec', 'Glivec']}, {'type': 'DRUG', 'name': 'Imatinib mesylate', 'description': '400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops', 'armGroupLabels': ['Arm D'], 'otherNames': ['Gleevec', 'Glivec']}]","Inclusion Criteria: * Age ≥ 18 years * Unresectable and/or metastatic GIST * Currently receiving imatinib 400 mg per day for a minimum of 4 weeks prior to registration, and for no more than 6 months prior to registration. This must be the first time that the patient has been treated for metastatic and/or unresectable GIST * For patients who received imatinib following surgery at the time of an initial diagnosis of GIST, there must be a 6 month interval between completion of imatinib and the diagnosis of metastatic GIST * Good physical functioning (ECOG Performance Status of 0 or 1) * Generally, good function of organ such as liver and kidneys Exclusion Criteria: * Disease progression during adjuvant therapy with imatinib (adjuvant treatment is treatment that is given after surgery for GIST) * Known intolerance of imatinib at a dose of 400 mg/day or higher * Prior systemic therapy for advanced GIST with imatinib or those who have been on imatinib for longer than 6 months for unresectable and/or metastatic disease * Major surgery within 2 weeks prior to Day 1 of study or who have not yet recovered from prior surgery * Use of coumadin derivatives (i.e. warfarin, acenocoumarol, phenprocoumon) * Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation \< 2 weeks or who have not recovered from side effects of this therapy",NA,ALL,NA,"[{'measure': 'Evaluation of Lesions for Progression or Response Via RECIST Criteria', 'timeFrame': 'Every 3 months'}]",NA 4,NCT06766565,"{'fullName': 'Fuzhou General Hospital', 'class': 'OTHER'}","QYJD Compound Preparation Promotes Rapid Postoperative Recovery in Early-stage NSCLC Patients by Regulating Tissue Microecology: a Prospective, Randomized Controlled, Open-label, Phase I Clinical Study With Predefined Future Exploration",COMPLETED,"QYJD compound preparation has the efficacy of clearing heat and removing toxins, dispelling blood stasis and relieving pain, etc. investigators aimed to explore the effect of expelling blood stasis and removing toxins compound preparation on the microecological changes of lungs of patients with early stage non-small cell lung cancer (NSCLC) by using metagenomics next-generation sequencing (mNGS) technology to carry out a prospective phase I clinical study. The aim of the study was to investigate the effect of the expelling stasis and detoxifying compound preparation on the microecology of lungs of patients with early-stage non-small cell lung cancer (NSCLC), and to conduct a prospective phase I clinical study to provide new ideas for promoting the postoperative rehabilitation of early-stage NSCLC.",['NSCLC'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'QYJD Compound Preparation', 'description': 'The intervention group was treated with 2 capsules (g) of expelling stasis and QYJD compound preparation orally for 4 days before thoracoscopic radical surgery for lung cancer, 3 times a day. The blank control group had no oral drug treatment before surgery.', 'armGroupLabels': ['QYJD Compound Preparation intervention group']}]","Study Population Patients diagnosed with early-stage non-small cell lung cancer in accordance with the Primary Lung Cancer Diagnosis and Treatment Guidelines (2022 Edition) issued by the National Health and Health Commission and the TNM staging criteria of the 8th edition of the International Association for the Study of Lung Cancer (IASLC). Inclusion criteria: 1. Patients with (a) no contraindications to surgery, early stage NSCLC diagnosed by postoperative pathology, and clinical stage I-IIIA; (b) aged 18-80 years old, with KPS score ≥60; (c) with expected survival of more than 3 months; (d) with no history of smoking; (e) with no previous underlying lung diseases such as bronchiectasis, bronchial asthma, or COPD; (f) without neoadjuvant chemotherapy; (g) with no previous treatment with neoadjuvant chemotherapy; (h) with no previous treatment with neoadjuvant chemotherapy; (i) with no previous treatment with bronchodilatation, bronchial asthma, or COPD; (j) with no previous treatment with neoadjuvant chemotherapy. (f) No neoadjuvant chemotherapy; (g) No history of other systemic malignancies; (h) Sufficient fresh tumor tissue specimens are available. 2. Participants are willing to participate in this study and comply with the study plan; 3. Participants or legally authorized representatives were able to provide written informed consent approved by the ethical review board managing the site. Exclusion Criteria: 1. the presence of malignant tumors or metastatic foci in other parts of the body; 2. the combination of other organic diseases; 3. psychiatric disorders or communication disorders; 4. lung infections, systemic hematologic diseases, immune system diseases; 5. bronchodilatation, bronchial asthma, or chronic obstructive pulmonary disease and other underlying lung diseases; 6. within the past month, there are antibiotics, immunosuppressive drugs, hormones, probiotics, as well as any those who have taken antibiotics, immunosuppressants, hormones, probiotics, and any form of traditional Chinese medicine or proprietary Chinese medicine within the past month; 7. Those who have a history of smoking; 8. Those who have a history of occupational or environmental exposure to dust, mines, or asbestos.",NA,ALL,NA,"[{'measure': 'Rapid rehabilitation indexes', 'description': 'the number of days of postoperative chest drain retention', 'timeFrame': '15 days'}, {'measure': 'Rapid rehabilitation indexes', 'description': 'postoperative pain VAS scores', 'timeFrame': '1 week'}, {'measure': 'Rapid rehabilitation indexes', 'description': 'six-minute walking experiments', 'timeFrame': '7 day'}, {'measure': 'Laboratory indicators of inflammation', 'description': 'including white blood cell count, neutrophil count, lymphocyte count, platelet count, NLR, PLR', 'timeFrame': 'through study completion, an average of 1 year'}]",NA 5,NCT01417065,"{'fullName': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}",Temsirolimus In Phase 0,COMPLETED,"The goal of this clinical research trial is to study the effects of the FDA-approved drug, temsirolimus, using a new type of clinical study design called a ""Phase 0."" This type of study may be able to predict if a drug can affect cancer and may be able to prevent potentially useful study drugs from being discarded before they are fully tested. The purpose of the study is not to treat the cancer, but to help improve general cancer treatment knowledge.",['Advanced Cancer'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Temsirolimus', 'description': 'Starting dose will be 0.02 mg intravenous administered once on Day 1 over 60 minutes.', 'armGroupLabels': ['Temsirolimus'], 'otherNames': ['CCI-779', 'Torisel']}]","Inclusion Criteria: 1. Patients with advanced or metastatic cancer, preferably with tumor easily accessible for biopsy. 2. Patients should be at least four weeks or 5 half lives from the last day of chemotherapy, antibody or other biological therapy, whichever is shorter. 3. Patients should preferably be undergoing screening for 2007-0668, 2008-0384, 2008-0425, and 2008-0827 (currently active Phase I trials involving temsirolimus). However, patients may also be allowed on protocol if they are undergoing screening for any study. Exclusion Criteria: 1. Pregnant or lactating women. 2. Patients with a known hypersensitivity to any of the components or metabolites of the drug products. 3. Patients with a known bleeding diathesis which would prevent safely obtaining a biopsy if a biopsy is indicated. 4. Patients who are less than 18 years of age.",NA,ALL,NA,"[{'measure': ""Participants' Pharmacodynamic (PD) Responses"", 'description': 'PD response, significant S6 Kinase 1 (S6K1) inhibition, is defined at both the patient level and the dose level, 1) as compared with baseline, at least 50% reductions of S6K1 after treatment (biological criterion); 2) differences in log transformed S6K1 activity between post-treatment and baseline should be greater than threshold of 1.8 times standard deviation (SD) of baseline, which yields a 90% statistical confidence that it is not due to chance variation (statistical criterion).', 'timeFrame': 'Blood drawn at 4 hours (+/- 2 hours) after study drug'}]",NA 6,NCT01433965,"{'fullName': 'University of California, Davis', 'class': 'OTHER'}",Study of Lenalidomide in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome,COMPLETED,The purpose of this study is to determine whether lenalidomide can stop the growth of leukemia stem cells and can be used to prevent the return of leukemia cells after a transplant.,"['Acute Myeloid Leukemia', 'Myelodysplastic Syndrome']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Lenalidomide', 'description': 'Lenalidomide will be taken orally once a day for 21 days continuously in 28 day cycles. The dose of the lenalidomide administered to each patient will be based on the group that the patient is enrolled. The dose cycles will be 21 days of a 28 day cycle.', 'armGroupLabels': ['Phase I Dose Escalation'], 'otherNames': ['REVLIMID', 'CC-5013']}]","Inclusion Criteria: * Understand and voluntarily sign an informed consent form * Age greater than or equal to 18 and less than or equal to 65 years * Able to adhere to the study visit schedule and other protocol requirements. * High risk acute myelogenous leukemia or high risk myelodysplastic syndrome status post allogeneic bone marrow transplant * ECOG performance status of less than or equal to 2 * Disease free of other malignancies beside the AML or MDS for ≥ 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma ""in situ"" of the cervix or breast. * All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®. * Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for Cycle 1 (prescriptions must be filled within 7 days as required by RevAssist) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. * Between 6 months to 8 months post transplant * Laboratory tests: * Neutrophil count of ≥ 1.5 x 109/L * Platelet count ≥ 50 x 109/L * Calculated creatinine clearance ≥ 60ml/min by Cockcroft-Gault formula * Total bilirubin ≤1.5 x upper limit of normal * AST (SGOT) and ALT (SGPT) ≤ 3 x upper limit of normal Patients are eligible to start on this protocol if they are between 6 months to 10 months post transplant. Exclusion Criteria: * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form * Pregnant or breast feeding females (Lactating females must agree not to breast feed while taking lenalidomide) * Any level of acute graft versus host disease * Active, uncontrolled infection are not eligible for this study * Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study * Use of any other experimental drug or therapy within 28 days of baseline. * Known hypersensitivity to thalidomide * Development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drug * Known sero-positive for active viral infection with HI, hepatitis B virus (HBV) or hepatitis C virus (HCV) * Mixed chimerism (at 6 months post transplant will not be started on the protocol * Active AML or MDS at the time of the study are not eligible for this protocol * Not able to swallow the lenalidomide capsule as a whole are excluded from this study * Impaired gastrointestinal absorption",NA,ALL,NA,"[{'measure': 'Maximum-tolerated dose as assessed by NCI CTCAE, Version 4.0 and Graft versus Host Disease Staging', 'description': 'All patients will be followed closely and evaluated for toxicity. For grade III-IV non hematological toxicity or grade IV hematological toxicity associated with lenalidomide will be held until the toxicity resolves and then will be started at a lower dose; Patients who develop grade II to IV GVHD on study will stop lenalidomide', 'timeFrame': '4 week cycle; the expected time frame is 24 weeks (or 6 cycles)'}]","[{'measure': 'Disease relapse', 'description': 'Percentage of patients with relapse from all the patients who received the transplant.', 'timeFrame': 'One year'}, {'measure': 'Disease-free survival', 'description': 'Percentage of patients who are alive and remain in remission at one year after infusion of stem cells', 'timeFrame': 'One year'}, {'measure': 'Incidence of Graft versus Host disease', 'description': 'The percentage of pathologically confirmed cases of acute and/or chronic Graft versus Host disease at one year post transplant', 'timeFrame': 'One year'}]" 7,NCT04755465,"{'fullName': 'Acibadem University', 'class': 'OTHER'}",Effects of NMES and Exercise in Hematological Cancer,COMPLETED,"Physical activity levels of adult hematologic cancer patients are deficient. The resulting physical inactivity causes fatigue, muscle loss, and deterioration in physical performance values. However, physical exercise programs still play a minor role in treating hematological malignancies. In addition, there are no reliable data in the literature regarding risk factors, feasibility, and exercise results in individuals with hematological malignancies. Although it is known that the use of corticosteroids, which are among the drugs given during chemotherapy, causes muscle weakness, there are no physical exercise programs performed with this patient group in the literature. The current study aims to compare the effects of resistance exercise and resistance exercise combined with neuromuscular electrical stimulation on muscle strength, functional lower extremity strength, and mobility in hematological cancer patients during chemotherapy.","['Hematologic Malignancy', 'Muscle Weakness']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}","[{'type': 'DEVICE', 'name': 'Neuromuscular Electrical Stimulation', 'description': 'Neuromuscular Electrical Stimulation (NMES) is based on the principle of creating a contraction by stimulating the nerve fibers innervating the related muscle in the healthy muscle and the muscle fibers in the denervated muscle with electrical current. The electric currents used in stimulation of muscles and nerves perform this function by changing the electrical potential of cell membranes.\n\nIt is contraindicated in pregnancy, presence of pacemaker, severe heart disease, epilepsy, fracture, dementia and impaired consciousness. We prevent contraindicated situations by excluding volunteer participants with these characteristics.', 'armGroupLabels': ['NMES Training Group']}, {'type': 'OTHER', 'name': 'Structured Exercise', 'description': ""Warm-up exercise, main training program and cool down exercise. Main training consists of resistance exercises to be applied with resistance bands of different resistance or with the patient's own body weight. Our prescribed training protocol includes 4-6 different exercises for each limb (bench press with resistance band, upper extremity proprioceptive neuromuscular facilitation exercises, biceps/triceps curl, leg press, knee extension, 4-way hip motion, mini squat). Intensity, sets, and number of repetitions will be adapted to a target score between 12 and 14 using the Borg scale. It will be applied as low intensity, long-term passive stretching exercises to the pectoral, hamstring, and gastrosoleus muscle groups. Patients will perform 1 set of 10 repetitions of each resistance exercise determined by their level of fatigue. Resistance will be increased every three visits. If the patient complains of excessive fatigue, the resistance will be reduced to the previous level."", 'armGroupLabels': ['NMES Training Group', 'Resistance Exercise Group']}]","Inclusion Criteria: * Diagnosed with hematological cancer, * ≥ 18 years old * ECOG Performance Status to be between 1-3 * Hemoglobin; 8-10gr / dl and over * Receiving platelet support related to thrombocytopenia and/or having a platelet value of 20.000 mm3 or more * Leukocyte (WBC) count being 3000 μL and above * Giving written consent to participate in the study Exclusion Criteria: * Comorbidities that cause fatigue (eg multiple sclerosis, Parkinson's disease, heart failure) * Presence of previously diagnosed heart disease * Using a pacemaker * Rapid deterioration of the general condition (sudden uncontrolled weight loss, confused consciousness, high C reactive protein (CRP) values) * Brain metastasis or femoral bone metastasis * Having dementia or psychotic condition * Being depressed and /or taking medication to treat depression * Presence of epilepsy * Presence of neuropathy * Having sensory defects in the NMES application area * Denying NMES application",NA,ALL,NA,"[{'measure': 'Muscle Strength Evaluation', 'description': ""Participants' muscle strength measurements will be made using a digital hand dynamometer (J Tech Commander Muscle Tester). The patients will be seated in the appropriate position and the dynamometer will be placed in the dominant leg to give resistance to the muscle to be evaluated. While patients press the dynamometer as hard as possible for three seconds, the evaluator will give resistance to prevent any movement to provide an isometric contraction. Following the familiarization test, patients will perform three trials with standardized verbal encouragement and the highest strength (kilogram, kg) sustained for over half a second will be recorded."", 'timeFrame': 'Change from Baseline Muscle Strength through study completion, an average of 6 weeks'}, {'measure': 'Functional Muscle Strength Evaluation', 'description': 'Lower extremity functional strength will be evaluated using the ""Sit and Stand for 30 sec"" test. The patient will be instructed to stand up and sit back and forth from a standardized chair as quickly as possible in 30 seconds without using his arms. Participants will be able to use their hands to help them stand as needed, and standardized verbal encouragement will be provided to continue sitting and standing throughout the test.', 'timeFrame': 'Change from Baseline Functional Muscle Strength through study completion, an average of 6 weeks'}]","[{'measure': 'Anthropometric Assessment', 'description': 'Thigh circumference measurement will be made from the middle of the thigh over the Quadriceps muscle. By marking the inguinal region and the proximal part of the patella, the midpoint between the two points will be found. All measurements will be made on the right side and by the same physiotherapist.', 'timeFrame': 'Baseline and Immediately after completion of study, an average of 6 weeks'}, {'measure': 'Mobility Assessment', 'description': '""Timed Up-Go Test"" will be applied before and after treatment to evaluate the patient\'s mobility and functional exercise capacity. The time taken to complete the task is strongly correlated with the level of functional mobility. In other words, the longer the person completes the task, the more dependent he is on daily life activities.', 'timeFrame': 'Baseline and Immediately after completion of study, an average of 6 weeks'}, {'measure': 'The Brief Fatigue Scale', 'description': 'The Brief Fatigue Scale will be used to assess cancer-related fatigue in our study. This scale is one of the standard tests used to evaluate fatigue in cancer patients. Evaluates the level of fatigue in the last 24 hours and the effect of fatigue on daily activities (general activity, mood, walking ability, work life, relationships with other people, joy of life)', 'timeFrame': 'Baseline and Immediately after completion of study, an average of 6 weeks'}, {'measure': 'European Cancer Research and Treatment Organization Quality of Life Questionnaire', 'description': 'The assessment of quality of life will be carried out using the European Cancer Research and Treatment Organization Quality of Life Questionnaire Version 3.0. The scale consists of three subsections: general health status scale, functional scale, and symptom scale, and includes a total of 30 questions.', 'timeFrame': 'Baseline and Immediately after completion of study, an average of 6 weeks'}]" 8,NCT07035600,"{'fullName': 'Sahlgrenska University Hospital', 'class': 'OTHER'}",Walking and Sitting Difficulties After Rectal Cancer Surgery,NOT_YET_RECRUITING,"Earlier studies have shown that many patients (up to 30%) who have had a major surgery for rectal cancer, called a rectum amputation (where the entire rectum and anus are removed and the person gets a permanent stoma), still have trouble sitting and walking three years after the surgery. These problems are then seen as long-term or chronic. WASA is a randomized multicenter international study that will test a way to reduce these problems. It will start in fall 2025 and go on for 3.5 years. About 300 patients will take part. The patients will be randomly divided into two groups. One group will get guided online training twice a week, specially made for their needs. The other group will get information about the World Health Organization's (WHO) general advice on physical activity. The idea is that special training during the first year after surgery will reduce problems with walking and sitting. If the hypothesis can be confirmed, it could lead to an easy and low-cost way to help many rectal cancer patients feel and function better.","['Rectal Cancer Patients', 'Rectal Cancer Surgery', 'Rectal Cancer, Radiotherapy', 'Rectal Cancer']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, interventional, controlled mtrial', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'PROCEDURE', 'name': 'Targeted leaderled training program', 'description': 'Training program:\n\nAfter inclusion and consent the patients are instructed through an online group training program consisting of specific training of levator, abdominal, quadriceps (all portions), and gluteal muscles as well as endurance training. They are given information about WHO recommendations about physical activity. The patients are asked to sign up for two specific training occasions per week where no group will be larger than 10 patients. Group based exercise sessions consist of 45-minute supervised online zoom exercise sessions. Apart from the supervised sessions patients are encouraged to perform one functional training session, unsupervised, as well as follow the WHO recommendation for aerobic exercise', 'armGroupLabels': ['Training intervention arm']}, {'type': 'PROCEDURE', 'name': 'Control arm with WHO recommendation on physical activity', 'description': 'Training will be in accordance with WHO recommendations of 30 min aerobic physical activity five times per week (150 min per week) plus strength sessions twice weekly. The patients will be individually adviced on how to perform the training at inclusion in the trial. This is considered standard care and will not include any on-line supervision, but will include a coaching/reminder by a phone call from a research nurse/short message service (by choice of the patient) at regular intervals before and after surgery', 'armGroupLabels': ['Control arm']}]","Inclusion Criteria: * Patients with rectal cancer to be treated with/without neoadjuvant (chemo)radiation and abdominoperineal excision with or without mesh (APE/ELAPE) Informed consent Able to read and understand Swedish or Danish Exclusion Criteria: * Patients with rectal cancer to be operated by extended abdominoperineal excision (ELAPE) requiring musculocutaneous or muscular flaps to be operated by Hartmann's procedure to be operated by anterior resection (low or high) participation in other randomized trials in conflict with the protocol and endpoints of the WASA trial Not understanding Swedish or Danish Patients reporting habit of physical activity exceeding the WHO-recommendations (150 min + two strength sessions) at baseline.",NA,ALL,NA,"[{'measure': 'Can a specific physical online training program decrease sitting and walking difficulties 12 months after abdominoperineal excision for rectal cancer compared with standard care (self-administered aerobic training according to WHO recommendations only)?', 'description': 'Patient reported sitting and walking difficulties by validated questions in questionnaire with items from ""no difficulties"" to ""severe difficulties"".', 'timeFrame': '12 months'}]","[{'measure': 'Self-reported problems with sitting and/or walking and physical activity', 'description': 'Patient reported sitting and walking difficulties by validated question in questionnaire at 6 and 24 months with items from ""no difficulties"" to ""severe difficulties""', 'timeFrame': '6 and 24 months'}, {'measure': 'Objective tests', 'description': 'Balance test as time in seconds standing on one leg, measured by a research nurse', 'timeFrame': 'baseline, 6, 12 and 24 months'}, {'measure': 'Pain', 'description': 'Pain, as reported by patient using validated instrument, Body Pain Inventory - Short Form (BPI-SF) included in questionnaire. Scored 0 (no pain) -10 (worst) on up to seven items.', 'timeFrame': '6, 12 and 24 months'}, {'measure': 'Comprehensive Complication Index (CCI)', 'description': 'Postoperative complications classified by CCI. Each complications is graded by Clavien-Dindo system and added into a score from 0 (no complications) to 100 (death).', 'timeFrame': 'Within 30 and 90 days of abdominoperineal excision surgery'}, {'measure': 'Re-admissions', 'description': 'Readmissions retrieved from hospital records, number of occasion', 'timeFrame': 'Within 12 and 24 months of abdominoperineal excision surgery'}, {'measure': 'Parastomal hernia', 'description': 'Retrieved by clinical record form, at clinical examination and radiology', 'timeFrame': '12 months after abdominoperineal excision surgery'}, {'measure': 'Length of hospital stay', 'description': 'Total length of hospital stay in days, retrieved from hospital records', 'timeFrame': 'within 12 months and 24 months of abdominoperineal excision surgery'}, {'measure': 'Mortality', 'description': 'Retrieved from the Swedish/Danish National Cause of Death Register, date and cause of death', 'timeFrame': '30 days, 1, 2 and 5 years'}, {'measure': 'Health economic analysis', 'description': 'Using data collected in the trial adding registered clinical costs, from health care cost-register in Sweden (KKP-register) with sensitivity analyses.', 'timeFrame': '24 months after abdominoperineal excision surgery'}, {'measure': 'Perineal hernia', 'description': 'Diagnosed through CT/MRI of the pelvic region', 'timeFrame': '12 months after abdominoperineal excision surgery'}, {'measure': 'Biomarkers', 'description': 'Blood sample analyzed for markers for inflammation, such as inflammatory proteins', 'timeFrame': 'Baseline, 4 weeks and 12 months'}, {'measure': 'Faecal sample', 'description': 'Analysis of kalprotectin and microbiome in faeces', 'timeFrame': 'baseline, 4 weeks and 12 months'}, {'measure': 'Cognition', 'description': 'Measured by specific questions on memory function in SF 36 instrument, items ranging from ""no (problems)"" to ""more than 3 times per day""', 'timeFrame': 'baseline, 6,12 and 24 months after abdominoperineal excision surgery'}, {'measure': 'Fatigue', 'description': 'Measured by specific questions in SF 36', 'timeFrame': '6, 12 and 24 months'}, {'measure': 'Activities of daily life', 'description': 'Measured by specific questions in EQ5D with items raning from ""no (problems)"" to ""cannot perform activity""', 'timeFrame': 'baseline, 6,12 and 24 months'}, {'measure': 'Bodily functions', 'description': 'Measured by validated questions in questionnaire, no score involved. Items ranging from ""no problem"" to ""problem at least 1 time per day""', 'timeFrame': 'baseline, 6, 12 and 24 months'}, {'measure': 'Quality of life', 'description': 'Quality of life as reported by patient validated question in questionnaire: ""How would you describe your quality of life during the last month"" answered in a 7 point Likert scale from ""worst possible"" to ""best possible""', 'timeFrame': '6,12 and 24 months'}, {'measure': 'Muscle thickness', 'description': 'Diagnosed through CT/MRI of the buttocks/pelvic region', 'timeFrame': '12 months'}, {'measure': 'Fibrosis in pelvic region', 'description': 'diagnosed through CT/MRI of the pelvic region', 'timeFrame': '12 months'}, {'measure': 'Degree pf physical activity', 'description': 'PAtient reported by specific question (Saltin-Grimby) in questionnaire', 'timeFrame': '6,12 and 24 months'}, {'measure': 'Health economic analysis', 'description': 'comparison of intervention vs control by costs of intervention (one group), costs of hospital care, costs of sick-leave, using health economic models and sensitivity analsyes', 'timeFrame': '24 months'}, {'measure': 'Microbiota', 'description': 'determined in faecal sample', 'timeFrame': '6 months'}, {'measure': 'From sitting to standing', 'description': 'Number of times rising from sitting to standing position during 30 seconds, measured by a research nurse', 'timeFrame': 'baseline, 6, 12 and 24 months'}, {'measure': 'Walk test', 'description': 'Time to walk 10 meters, measured by a research nurse', 'timeFrame': 'baseline, 6, 12 and 24 months'}, {'measure': 'Grip strength', 'description': 'Hand grip strength tested by dynamometer, measured in kg by a research nurse', 'timeFrame': 'baseline, 6 and 12 months'}, {'measure': 'Reoperation', 'description': 'Retrieved from hospital records and described by type of procedure', 'timeFrame': 'Within 12 and 24 months after abdoinomperineal escision surgery'}]" 9,NCT04249167,"{'fullName': 'Mayo Clinic', 'class': 'OTHER'}","Cryoablation, Atezolizumab/Nab-paclitaxel for Locally Advanced or Metastatic Triple Negative Breast Cancer",WITHDRAWN,"This early phase I trial studies the side effects and feasibility of cryoablation, atezolizumab, and nab-paclitaxel in treating patients with triple negative breast cancer that has spread to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Cryosurgery, also known as cryoablation or cryotherapy, kills tumor cells by freezing them. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cryoablation, atezolizumab and nab-paclitaxel may improve response to the disease.","['Anatomic Stage III Breast Cancer AJCC v8', 'Anatomic Stage IIIA Breast Cancer AJCC v8', 'Anatomic Stage IIIB Breast Cancer AJCC v8', 'Anatomic Stage IIIC Breast Cancer AJCC v8', 'Anatomic Stage IV Breast Cancer AJCC v8', 'Locally Advanced Breast Carcinoma', 'Metastatic Triple-Negative Breast Carcinoma', 'Prognostic Stage III Breast Cancer AJCC v8', 'Prognostic Stage IIIA Breast Cancer AJCC v8', 'Prognostic Stage IIIB Breast Cancer AJCC v8', 'Prognostic Stage IIIC Breast Cancer AJCC v8', 'Prognostic Stage IV Breast Cancer AJCC v8']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Atezolizumab', 'description': 'Given IV', 'armGroupLabels': ['Treatment (cryoablation, atezolizumab, nab-paclitaxel)'], 'otherNames': ['MPDL 3280A', 'MPDL 328OA', 'MPDL-3280A', 'MPDL3280A', 'MPDL328OA', 'RG7446', 'RO5541267', 'Tecentriq']}, {'type': 'PROCEDURE', 'name': 'Cryosurgery', 'description': 'Undergo cryoablation of the primary tumor', 'armGroupLabels': ['Treatment (cryoablation, atezolizumab, nab-paclitaxel)'], 'otherNames': ['Ablation, Cryo', 'Cryoablation', 'cryosurgical ablation']}, {'type': 'DRUG', 'name': 'Nab-paclitaxel', 'description': 'Given IV', 'armGroupLabels': ['Treatment (cryoablation, atezolizumab, nab-paclitaxel)'], 'otherNames': ['ABI 007', 'ABI-007', 'Abraxane', 'Albumin-bound Paclitaxel', 'Albumin-Stabilized Nanoparticle Paclitaxel', 'Nanoparticle Albumin-bound Paclitaxel', 'Nanoparticle Paclitaxel', 'Paclitaxel Albumin', 'paclitaxel albumin-stabilized nanoparticle formulation', 'Protein-bound Paclitaxel']}]","Inclusion Criteria: * Locally advanced or metastatic PD-L1 positive TNBC (TNBC is defined as estrogen receptor \[ER\] \< 10%, progesterone receptor \[PR\] \< 10%, and HER2 non-amplified; and PD-L1 positive is defined as \>= 1%.) * Presents with primary breast tumor lesion amenable to cryoablation * Have at least one additional distant lesion feasible for biopsies * Agreeable to start on atezolizumab and nab-paclitaxel as per standard of care * Patients with locally advanced disease must be ineligible for curative surgery for any reason, including but not limited to comorbid status precluding surgery due to safety, unresectability, or patient refusal * Patient may have received prior systemic chemotherapy regimens Exclusion Criteria: * History of autoimmune disease * History of human immunodeficiency virus (HIV) * Previous immune checkpoint targeting therapies * No primary breast lesion amenable for cryoablation due to size (greater than 5 cm) or location (proximity of \< 0.5 cm to the skin or nipple-areola complex) * Pregnancy",NA,FEMALE,NA,"[{'measure': 'Safety and Feasibility of cryoablation with systemic atezolizumab/nab-paclitaxel', 'description': ""All adverse events will be reported by grade using frequencies and relative frequencies, and rates will be estimated using a 90% confidence interval obtained using Jeffrey's prior method."", 'timeFrame': '5 years'}]","[{'measure': 'Abscopal response in the distant non-cryoablated site(s)', 'description': ""Will be assessed by using digital spatial profiling. Each immune response will be treated as a continuous variable, and will be summarized using frequencies and relative frequencies. The overall immune response rate will be estimated using a 90% confidence interval obtained using Jeffrey's prior method."", 'timeFrame': '5 years'}, {'measure': 'Systemic effector cell and cytokine responses', 'description': ""Each immune response will be treated as a continuous variable, and will be summarized using frequencies and relative frequencies. The overall immune response rate will be estimated using a 90% confidence interval obtained using Jeffrey's prior method."", 'timeFrame': 'At baseline, after cryoablation, and after atezolizumab and nab-paclitaxel'}, {'measure': 'Overall survival', 'description': 'Will be summarized using standard Kaplan-Meier methods. OS defined as Time from cryoablation until death due to any cause or last follow-up', 'timeFrame': 'Assessed up to 5 years'}, {'measure': 'Disease-specific survival', 'description': 'Will be summarized using standard Kaplan-Meier methods. OS defined as Time from cryoablation until death due to breast cancer', 'timeFrame': 'Time from cryoablation until death due to breast cancer or last follow-up, assessed up to 5 years'}, {'measure': 'Progression-free survival', 'description': 'Will be summarized using standard Kaplan-Meier methods.', 'timeFrame': 'Time from cryoablation to tumor growth as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria, assessed up to 5 years'}]" 10,NCT00445900,"{'fullName': 'Mayo Clinic', 'class': 'OTHER'}","Thalidomide, Prednisone, and Cyclophosphamide in Treating Patients With Myelofibrosis and Myeloid Metaplasia",COMPLETED,"RATIONALE: Giving thalidomide together with prednisone and cyclophosphamide may lessen symptoms caused by myelofibrosis and myeloid metaplasia. PURPOSE: This phase II trial is studying the side effects and how well giving thalidomide together with prednisone and cyclophosphamide works in treating patients with myelofibrosis and myeloid metaplasia.","['Chronic Myeloproliferative Disorders', 'Secondary Myelofibrosis']",INTERVENTIONAL,"{'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'cyclophosphamide'}, {'type': 'DRUG', 'name': 'prednisone'}, {'type': 'DRUG', 'name': 'thalidomide'}, {'type': 'OTHER', 'name': 'immunohistochemistry staining method'}, {'type': 'OTHER', 'name': 'laboratory biomarker analysis'}, {'type': 'PROCEDURE', 'name': 'biopsy'}]","DISEASE CHARACTERISTICS: * Histologically confirmed myelofibrosis with myeloid metaplasia (MMM) of any of the following subtypes: * Agnogenic myeloid metaplasia * Post-polycythemic myeloid metaplasia * Post-thrombocythemic myeloid metaplasia * Must have 1 of the following MMM-related conditions: * Anemia, defined as hemoglobin \< 10 g/dL * Iron deficiency must be excluded as cause * Thrombocytopenia, defined as platelet count \< 100,000/mm³ * Palpable hepatomegaly or splenomegaly * No evidence of myelofibrosis-associated conditions in the bone marrow, including any of the following: * Metastatic carcinoma * Lymphoma * Myelodysplasia * Hairy cell leukemia * Mast cell disease * Acute leukemia (including M7 type) * Acute myelofibrosis * No chromosomal translocation t(9:22) or bcr-abl as determined by bone marrow chromosome analysis or peripheral blood fluorescent in situ hybridization (FISH) analysis PATIENT CHARACTERISTICS: * ECOG performance status 0-3 * Absolute neutrophil count ≥ 750/mm³ * Bilirubin ≤ 2 times upper limit of normal (ULN), unless elevation due to MMM * AST ≤ 5 times ULN, unless elevation due to MMM * Creatinine ≤ 2.5 mg/dL * No uncontrolled infection, including tuberculosis * No known history of positive purified protein derivative (PPD) untreated by isoniazid therapy * Positive PPD with normal chest X-ray and completion of full-course isoniazid therapy allowed * No federal medical center inmates or other incarcerated patients * No peripheral neuropathy ≥ grade 2 * No comorbid condition in which the use of study therapy is felt to be potentially harmful * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use 2 forms of effective contraception PRIOR CONCURRENT THERAPY: * No chemotherapy (e.g., hydroxyurea, myelosuppressive therapy) within the past 14 days * Prior splenectomy for MMM allowed * No concurrent hematopoietic growth factors",NA,ALL,NA,"[{'measure': 'Confirmed response, defined as a complete or partial response in ≥ 1 of 3 response categories (i.e., anemia, thrombocytopenia, or splenomegaly or hepatomegaly)'}]","[{'measure': 'Constitutional symptom status and bone marrow morphology'}, {'measure': 'Overall survival'}, {'measure': 'Progression-free survival'}, {'measure': 'Time to progression'}, {'measure': 'Duration of response'}, {'measure': 'Toxicity as measured by NCI CTC v 2.0'}]" 11,NCT02853500,"{'fullName': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}",Effect of Surefire Infusion Device on Tumor Response to Regional Intra-arterial Therapy for Primary Liver Malignancies,WITHDRAWN,"This research study is studying the TriNav (""TriSalus"") for increasing delivery of chemotherapeutic agents delivered trans-arterially to intermediate stage Hepatocellular Carcinoma (""HCC"") (Barcelona Clinic Liver Cancer (BCLC) class B; locally advanced, liver restricted disease patients. The names of the study interventions involved in this study are: -Trans-arterial chemoembolization (""TACE"") with or without the utilization of Surefire",['Liver Cancer'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DEVICE', 'name': 'TriNav', 'description': 'TriNav is a modified microcatheter with an expandable cone at its tip to prevent retrograde reflux of flow and change flow dynamics downstream.', 'armGroupLabels': ['TACE Procedure With TriNav']}, {'type': 'DEVICE', 'name': 'Traditional Delivery', 'description': 'Low profile tubing microcatheter for easier access to more peripheral/distal vascular branches for precise targeted delivery of medications.', 'armGroupLabels': ['TACE Procedure Traditional Delivery']}, {'type': 'DRUG', 'name': 'Doxorubicin', 'description': 'Medication used in cancer chemotherapy, including intraarterial delivery for liver malignancies.', 'armGroupLabels': ['TACE Procedure Traditional Delivery', 'TACE Procedure With TriNav'], 'otherNames': ['Adriamycin']}]","Inclusion Criteria: * Unresectable HCC, defined by imaging criteria or cytohistologic assessment. TACE as a preferred method of treatment is determined by a multidisciplinary Brigham and Women's Hospital / Dana Farber Cancer Institute (BWH/DFCI) Liver Tumor Board. * Intermediate stage HCC (BCLC class B), not eligible for curative treatment, but with Child-Pugh A or B. Additionally, tumor cannot involve greater than 50% of the entire liver. * Prior systemic chemotherapy is allowable. * Age 18-75 years. The pediatrics population is not included as this disease has very low prevalence in that population. * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 (Karnofsky ≥60%, see Appendix A) * Life expectancy of greater than at least 12 months. * Participants must have normal organ and marrow function as defined below: * leukocytes ≥3,000/mcL * absolute neutrophil count ≥1,500/mcL * platelets ≥60,000/mcL * total bilirubin within normal institutional limits * Aspartate Aminotransferase (AST)/Alanine Aminotransferase (ALT) ≤2.5 × institutional upper limit of normal * creatinine within normal institutional limits or, * creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal. * No previous regional treatment (includes surgery, radiation or liver-directed arterial or ablative therapy). * Main tumor size \> 1 cm * The effects of the study arm on the developing human fetus are unknown, however they are no different than for those in the control group. In addition, because significant radiation will be delivered during the procedure, a positive pregnancy test will exclude patients from the study in addition to excluding them from receiving standard therapy. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Participants who have had prior local regional therapy including radiation therapy, trans-arterial therapy, or ablative therapy. * A hypovascular tumor (defined as a tumor with all its parts less contrast-enhanced than the non-tumorous liver parenchyma on arterial phase computed tomography scans). * Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. * Evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy. * Severe underlying cardiac or renal diseases. * Color Doppler ultrasonography showing portal vein tumor thrombosis with complete main portal vein obstruction without cavernous transformation; or obstructive jaundice. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Human Immunodeficiency Virus (HIV)-positive patients are NOT excluded from the study. * Patients who cannot undergo MRI evaluation/examination (eg. pacemaker or other metallic implant) * History of allergic reactions attributed to agents used in study (i.e. doxorubicin, epirubicin, MRI contrast agents or iodinated contrast agents). * Pregnant women are excluded from this study because the chemotherapy utilized within the chemoembolic agent is teratogenic agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with chemoembolic agent, breastfeeding should be discontinued if the mother is treated with chemoembolic agent. These potential risks may also apply to other agents used in this study as well as from the radiation associated with the angiographic procedure.",NA,ALL,NA,"[{'measure': 'Capillary permeability (Ktrans) calculated by software that analyzes enhancement on post-contrast MRI.', 'description': 'Ktrans represents a calculated metric that represents a measure of capillary permeability obtained during dynamic contrast enhanced MRI; it represents an absolute value of tracer concentration within the tissue of interest. It is calculated by measuring the accumulation of contrast agent on post-contrast MR images within a given tissue over time and comparing it to a baseline contrast-filled structure such as a blood vessel. The measurement represents accumulation of contrast for a given tissue, as determined by the investigator.\n\nNormality of the distribution will be tested using Shapiro-Wilk test. To compare Ktrans, the investigators will apply t-test or Wilcoxon rank sum test as appropriate.', 'timeFrame': '2 years'}]","[{'measure': 'Extravascular extracellular volume fraction (ve) calculated by software that analyzes enhancement on post-contrast MRI.', 'description': 'Calculation of this value allows for more detailed analysis of contrast-enhancement of the tissue of interest. It represents an absolute value of tracer concentration within the tissue of interest, similar to Ktrans.', 'timeFrame': '2 years'}, {'measure': 'Rate constant (kep)', 'description': 'Calculation of this value allows for more detailed analysis of contrast-enhancement of the tissue of interest. It represents a derived value (kep = ktrans/ve) and is dependent upon ktrans and ve.', 'timeFrame': '2 years'}, {'measure': 'Plasma volume (vp) calculated by software that analyzes enhancement on post-contrast MRI.', 'description': 'Calculation of this value allows for more detailed analysis of contrast-enhancement of the tissue of interest. It represents an absolute value of tracer concentration within the plasma and allows for more accurate measurement of tissue permeability.', 'timeFrame': '2 years'}, {'measure': 'Time To Tumor Progression', 'timeFrame': '2 years'}]" 12,NCT02825836,"{'fullName': 'Telios Pharma, Inc.', 'class': 'INDUSTRY'}","Phase I/II, FIH, Dose Escalation Trial of TL-895 and Expansion of TL-895 Monotherapy and Combination Therapy With Navtemadlin in Tx-Naïve and R/R CLL/SLL Subjects",UNKNOWN,"The purpose of this research study is to determine the safety and tolerability of TL-895. There are 2 parts of this study. Part 1 tested increasing doses of TL-895 to identify the recommended safe dose for participants with relapsed/refractory (R/R) B cell malignancies who failed at least 1 but no more than 3 prior therapies. Part 1 of this study is no longer enrolling participants. Arms 1 \& 2 of Part 2 of this study will test different doses of TL-895 in participants with R/R CLL or SLL who have failed at least 1 prior therapy. Arms 1 \& 2 of Part 2 of this study is randomized (like the flip of a coin) to receive a specific treatment dose. If someone participates in arms 1 or 2 of Part 2, the dose they receive will be either 100mg twice a day or 150mg twice a day. Arms 3 and 4 of Part 2 of this study will test the 150mg and 100mg BID dose of TL-895, respectively in treatment naïve participants with CLL/SLL. Arms 5 and 6 of Part 2 will test 150mg TL-895 BID in combination with 240 mg navtemadlin QD in participants with relapsed/refractory and treatment naïve without 17p(del). Arm 7 will test 150mg TL-895 in combination with 240 mg navtemadlin QD in participants with relapsed/refractory CLL/SLL with 17p(del). Every participant in this study will receive TL-895.","['Relapsed/Refractory B Cell Malignancies', 'Mantle Cell Lymphoma and Diffuse Large B Cell Lymphoma', 'Chronic Lymphocytic Leukemia', 'Small Lymphocytic Lymphoma', 'Treatment-Naive B Cell Malignancies']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'TL-895', 'description': 'TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.', 'armGroupLabels': ['TL-895 100 mg BID in R/R Participants', 'TL-895 100 mg BID in Treatment Naïve Participants', 'TL-895 150 mg BID & navtemadlin 240mg QD in R/R Participants with 17p(del)', 'TL-895 150 mg BID & navtemadlin 240mg QD in R/R Participants without 17p(del)', 'TL-895 150 mg BID & navtemadlin 240mg QD in Treatment Naïve Participants without 17p(del)', 'TL-895 150 mg BID in R/R Participants', 'TL-895 150 mg BID in Treatment Naïve Participants', 'TL-895 300 mg BID in R/R Participants', 'TL-895 300 mg QD in R/R Participants', 'TL-895 600 mg QD in R/R Participants', 'TL-895 80/160 mg QD in R/R Participants', 'TL-895 900 mg QD in R/R Participants']}, {'type': 'DRUG', 'name': 'Navtemadlin', 'description': 'Navtemadlin is an experimental MDM2 anticancer drug taken by mouth.', 'armGroupLabels': ['TL-895 150 mg BID & navtemadlin 240mg QD in R/R Participants with 17p(del)', 'TL-895 150 mg BID & navtemadlin 240mg QD in R/R Participants without 17p(del)', 'TL-895 150 mg BID & navtemadlin 240mg QD in Treatment Naïve Participants without 17p(del)']}]","Inclusion Criteria * Relapsed/refractory CLL or relapsed/refractory SLL (Arms 1, 2, 5, and 7) * Treatment naïve CLL or SLL (Arm 3, 4, and 6) * ECOG performance status of ≤ 2 * Adequate hematologic, hepatic, and renal functions Exclusion Criteria * Prior treatment with any BTK or PI3K inhibitors * History of major organ transplant * Women who are pregnant or breastfeeding",NA,ALL,NA,"[{'measure': 'Part 1 (Dose Escalation): DLTs (Dose Limiting Toxicities) during Cycle 1', 'description': 'DLT is defined as any of the adverse event (AEs) of a certain grade or above, related to drug.', 'timeFrame': 'Baseline up to the end of cycle 1 (28 days)'}, {'measure': 'Part 2 (Dose Expansion): Overall Response Rate (ORR)', 'description': 'The proportion of subjects achieving CR, CRi, nodular partial response (nPR), partial response (PR), or PR with lymphocytosis (PR-L) at any time while on the study based on iwCLL response criteria (2), as assessed by investigators', 'timeFrame': 'Baseline up to end of study (2 years after last patient enrolled)'}]","[{'measure': 'Part 1 (Dose Escalation): Best Overall Response (BOR)/Progression Free Survival (PFS)', 'description': 'Defined by the length of time during the treatment of the disease, that a participant lives with the disease but it does not get worse based on investigator assessments', 'timeFrame': 'Baseline up to 6 months on treatment'}, {'measure': 'Part 2 (Dose Expansion): Overall CR/CRi rate', 'description': 'The proportion of subjects achieving CR/CRi based on iwCLL response criteria', 'timeFrame': 'Baseline up to end of study (2 years after last patient enrolled)'}, {'measure': 'Part 2: Duration of Clinical Response (DOR)', 'description': 'Time from initial response to disease progression or death from any cause', 'timeFrame': 'Baseline up to end of study (2 years after last patient enrolled)'}, {'measure': 'Part 2: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)', 'description': 'Incidence, nature, severity of treatment-emergent adverse events (TEAEs), and deaths, including cause of death, from screening up to the end of study visit of participants with CLL/SLL who have failed at least 1 line of therapy', 'timeFrame': 'Baseline up to end of study (2 years after last patient enrolled)'}, {'measure': 'Part 2: Assessment of Safety and Tolerability via Clinical Measurements', 'description': 'Assessments including but not limited to clinical laboratory measurements, ECGs, vital signs, and ECOG performance', 'timeFrame': 'Baseline up to end of study (2 years after last patient enrolled)'}]" 13,NCT06547736,"{'fullName': 'Fudan University', 'class': 'OTHER'}",Exploratory Platform Research on Precision Therapy of Advanced Pancreatic Cancer,RECRUITING,"The study is being conducted to evaluate the safety, tolerability and efficacy of ADC drugs monotherapy or combination therapy with HRS-4642 or immunotherapy in subjects with locally advanced or metastatic pancreatic cancer.",['Pancreatic Cancer'],INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'SHR-A2102 or/and HRS-4642', 'description': 'Drug: SHR-A2102 SHR-A2102 will be administrated per dose level in which the patients are assigned.\n\nDrug: HRS-4642 HRS-4642 will be administrated per dose level in which the patients are assigned.', 'armGroupLabels': ['Arm A']}, {'type': 'DRUG', 'name': 'SHR-A1904 or/and HRS-4642', 'description': 'Drug: SHR-A1904 SHR-A1904 will be administrated per dose level in which the patients are assigned.\n\nDrug: HRS-4642 HRS-4642 will be administrated per dose level in which the patients are assigned.', 'armGroupLabels': ['Arm B']}, {'type': 'DRUG', 'name': 'SHR-A1811 or/and HRS-4642', 'description': 'Drug: SHR-A1811 SHR-A1811 will be administrated per dose level in which the patients are assigned.\n\nDrug: HRS-4642 HRS-4642 will be administrated per dose level in which the patients are assigned.', 'armGroupLabels': ['Arm C']}, {'type': 'DRUG', 'name': 'SHR-A2102, HRS4642 and Adebrelimab', 'description': 'Drug: SHR-A2102 SHR-A2102 will be administrated per dose level in which the patients are assigned.\n\nDrug: HRS-4642 HRS-4642 will be administrated per dose level in which the patients are assigned.\n\nDrug: Adebrelimab Adebrelimab will be administrated per dose level in which the patients are assigned.', 'armGroupLabels': ['Arm D']}]","Inclusion Criteria: 1. Patients volunteered to participate in this study and signed informed consent; 2. Age: ≥18 and ≤75 years old, male or female; 3. Advanced (metastatic or unresectable) pancreatic cancer; and subjects must have at least one measurable lesion as defined by RECIST v1.1; 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; 5. Life expectancy ≥ 12 weeks; 6. Adequate marrow and organ function; 7. Female participants of childbearing age must undergo a pregnancy test within one week before the start of the study medication, and the result is negative. They are willing to use a medically recognized and efficient contraceptive method during the study period and within three months after the last administration of the study medication; For male participants whose partners are women of childbearing age, they should agree to use effective methods of contraception during the study period and within 6 months after the last study administration; Exclusion Criteria: 1. Known to be allergic to the investigational drug or any of its components; 2. Systemic antitumor therapy was received 4 weeks before the start of the study, and palliative radiotherapy was completed within 14 days before the first dose; 3. Have other active malignancies within 5 years; 4. Accompanied by untreated or active central nervous system (CNS) metastases; 5. Failure to recover toxicity and/or complications from previous interventions to NCI-CTCAE ≤ Level 1 or the levels specified by inclusion and exclusion criteria; 6. With interstitial lung disease, non-infectious pneumonia, severe and uncontrolled internal medicine diseases, acute infections, recent history of major surgery (within 28 days or not yet recovered from side effects); 7. With gastrointestinal obstruction or symptoms and signs of gastrointestinal obstruction within 6 months before the start of treatment, but if surgical treatment has been performed and the obstruction is completely relieved, screening can be conducted; 8. Within 6 months prior to entering the study, patients with severe cardiovascular and cerebrovascular thromboembolism; 9. With congenital or acquired immune deficiency, such as people infected with HIV, active hepatitis B (defined as hepatitis B virus surface antigen \[HBsAg\] in screening period is positive and HBV-DNA detection value ≥ 10000 copies/ml \[2000 IU/ml\] or active hepatitis C (defined as hepatitis C virus antibody \[HCV Ab\] in screening period is positive and HCV RNA is positive); 10. With active pulmonary tuberculosis infection within one year prior to enrollment, or those with a history of active pulmonary tuberculosis infection more than one year ago but without formal treatment; 11. Participated in other clinical studies or whose first medication is less than 4 weeks after the end of the previous clinical study (last medication), or whose study drug has a half-life of 5, whichever is shorter; 12. High risk of pancreatitis, serum amylase and/or lipase concentrations ≥ 3 times ULN, will be evaluated by the researchers; 13. Uncontrollable mental illnesses and other known factors that affect the completion of research procedures, such as alcohol, drug or substance abuse, criminal detention, etc; 14. Having undergone major surgeries other than diagnosis or biopsy within 28 days prior to the first administration; Experiencing traumatic minor surgery (biopsy, endoscopic examination, and drainage surgery) within 7 days prior to the first administration; 15. Other situations that researchers believe should not be included.",NA,ALL,NA,"[{'measure': 'Recommended phase II dose (RP2D)', 'description': 'RP2D will be determined on the basis of evaluation on safety and efficacy data in dose escalation stages.', 'timeFrame': 'Approximately 12 months'}, {'measure': 'Objective Response Rate (ORR)', 'description': 'Evaluated by RECIST v1.1.', 'timeFrame': 'Up to approximately 12 months]'}]","[{'measure': 'Disease Control Rate (DCR)', 'description': 'Evaluated by RECIST v1.1.', 'timeFrame': 'Up to approximately 12 months'}, {'measure': 'Duration of Response (DOR)', 'description': 'Evaluated by RECIST v1.1.', 'timeFrame': 'Up to approximately 12 months'}, {'measure': 'Progression Free Survival (PFS)', 'description': 'Time from the date of enrollment to of disease progression, or death of any cause, or date of lost follow-up, whichever comes first, otherwise subject data were censored at time last known disease free.', 'timeFrame': 'Up to approximately 12 months'}, {'measure': 'Overall survival (OS)', 'description': 'Time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive.', 'timeFrame': 'Up to approximately 12 months'}, {'measure': 'Adverse events (AEs)', 'description': 'AEs are assessed by NCI-CTCAE v5.0', 'timeFrame': 'From the first drug administration to within 90 days for the last ADC durgs dose'}]" 14,NCT02970136,"{'fullName': 'University of Miami', 'class': 'OTHER'}",Increasing Uptake of Evidence-Based Screening Services Through CHW-led Multi-modality Intervention,COMPLETED,"The purpose of this research study is to determine the best way to increase screening for cervical cancer, colorectal cancer, HIV, and Hepatitis C among under screened Hispanic, Haitian and African-American individuals in Hialeah, South Dade, and Little Haiti. The investigator will compare home testing led by a community health worker (CHW) versus clinic testing guided by a CHW. Community Health Workers are people who have undergone several weeks of community outreach and health education training. During the study period the participant will continue to receive all of their regular medical care from their regular health care providers. If the participant does not have a health care provider, the Community Health Workers would be able to help in referring the participant for care at a local health care clinic located in their community.","['Human Papillomavirus', 'Human Immunodeficiency Virus', 'Hepatitis C', 'ColoRectal Cancer']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SCREENING', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}","[{'type': 'DEVICE', 'name': 'OraQuick Swab', 'description': 'OraQuick for oral fluid HIV antibody testing', 'armGroupLabels': ['Home Based Screening']}, {'type': 'DEVICE', 'name': 'Fecal Immunochemical Test', 'description': 'Fecal Immunochemical stool test specific for human hemoglobin', 'armGroupLabels': ['Home Based Screening']}, {'type': 'DEVICE', 'name': 'OraQuick Fingerstick', 'description': 'Patients will be tested for Hepatitis C infection using a fingerstick', 'armGroupLabels': ['Home Based Screening']}, {'type': 'OTHER', 'name': 'Standard Screening Tests', 'description': 'Patients will be navigated to a local health center for standard screening tests', 'armGroupLabels': ['Clinic Based Screening']}, {'type': 'DEVICE', 'name': 'HPV Self-Sampling Test', 'description': 'Patients will be using swab to check for HPV infection', 'armGroupLabels': ['Home Based Screening']}, {'type': 'OTHER', 'name': 'Home Based Screening Tests', 'description': 'Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests', 'armGroupLabels': ['Home Based Screening']}]","Inclusion Criteria: 1. live in one of the three target communities 2. self-identify as Haitian, Hispanic and/or Black. 3. be 50-64 years old 4. need at least one of the four recommended screening services as per US Preventive Service Task Force 121 guidelines as follows: never having had a HIV test b) never having had a Hepatitis C Virus (HCV) test c) not having a Pap smear in the last three years d) not having had a colonoscopy in last 10 years and/or stool-based test in the last year. Exclusion Criteria: 1. plan to move out of the community during the next six months; 2. current or prior enrollment (5 five years) in any research study that involved screening for these conditions. 3. Are adults unable to consent 4. Are individuals who are not yet adults (infants, children, teenagers) 5. Pregnant women 6. Prisoners",NA,ALL,NA,"[{'measure': 'Percentage of Participants Who Are Screened for All Conditions', 'description': 'As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, Human Papilloma Virus (HPV) and Fecal Immunochemical Testing (FIT). Male participants are to be screened on 3 conditions: HIV, Hepatitis C Virus (HCV) and FIT.', 'timeFrame': 'Baseline'}]","[{'measure': 'Change in Percentage of Participants Completing Screening Test From Baseline to 6 Months', 'description': 'As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, HPV and FIT. Male participants are to be screened on 3 conditions: HIV, HCV and FIT.', 'timeFrame': 'Baseline, Up to 6 months'}, {'measure': 'Median Number of Screenings Completed', 'description': 'As evaluated by participant self report and completed sampling kits. Female participants are to be screened on 4 conditions: HIV, HCV, HPV and FIT. Male participants are to be screened on 3 conditions: HIV, HCV and FIT.', 'timeFrame': 'At baseline and at 6 months'}]" 15,NCT05827471,"{'fullName': 'Qianfoshan Hospital', 'class': 'OTHER'}",Clinical Study of QSOX1 as a Biomarker for Colon Cancer,NOT_YET_RECRUITING,The goal of this observational study is to determine whether the secreted protein QSOX1 can be used as a molecular marker for early rapid diagnosis and accurate treatment of colon cancer.,['Colon Cancer'],OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'OTHER'}","[{'type': 'DIAGNOSTIC_TEST', 'name': 'Diagnosis of colon cancer', 'description': 'Clinical diagnosis results', 'armGroupLabels': ['Control group', 'Tumor group']}]","Inclusion Criteria: * Colon cancer was confirmed by colonoscopic pathology. * No local or systemic treatment was performed before operation. * Complete clinical data. Exclusion Criteria: * Combined with benign diseases of colon, such as ulcerative colitis, colon adenoma and colon polyp. * Other tumors other than colon cancer.",The patients diagnosed with colon cancer for the first time admitted to the First Affiliated Hospital of Shandong First Medical University.,ALL,PROBABILITY_SAMPLE,"[{'measure': 'Detection of RNA for early rapid diagnosis of colon cancer.', 'description': 'RT-PCR was used to detect the RNA levels of QSOX1 in the tumor and control groups.', 'timeFrame': '6 months'}, {'measure': 'Detection of protein for early rapid diagnosis of colon cancer.', 'description': 'Western blotting was used to detect the protein levels of QSOX1 in the tumor and control groups.', 'timeFrame': '6 months'}]",NA 16,NCT06227871,"{'fullName': 'Kern Medical Center', 'class': 'OTHER'}",A Retrospective Analysis of Pancreatic Injuries and Treatment Outcomes,COMPLETED,"The goal of this observational study is to compare the presentation, treatment, and outcomes in patients suffering traumatic pancreatic injuries from blunt or penetrating trauma. The questions this study aims to answer are: 1. Does a statistically significant association exist between pancreatic injury grade and the following individual factors: * Mortality * Morbidity * Injury severity score 2. Is there an association between post-operative pancreatic complications and operation-specific intervention? 3. Does pancreatic injury score correlate with certain intra-abdominal organ injuries? Participants meeting criteria are greater than 18 years old, with no history of pancreatic surgery who were hospitalized at Kern Medical Center after presenting to the institution's emergency department as tier 1 or 2 trauma activations following blunt or penetrating abdominal injury and were diagnosed with pancreatic injury during the same hospitalization.","['Pancreatic Trauma', 'Pancreatic Duct Injury', 'Pancreas Necrosis', 'Pancreas Cyst', 'Pancreas; Fistula', 'Pancreas Abscess', 'Intra-Abdominal Abscess', 'Anastomotic Leak', 'Pancreas Injury']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}","[{'type': 'PROCEDURE', 'name': 'Exploratory laparotomy', 'description': 'Exploratory laparotomy with interventions addressing pancreatic injuries Grade 1-5 including pancreatic interventions including subtotal pancreatectomy, distal pancreatectomy, pancreatic ligation, pyloric diversion, or simple drainage of the pancreas.', 'armGroupLabels': ['Blunt intra-abdominal injury', 'Penetrating intra-abdominal injury']}]","Inclusion Criteria: * Hospitalized at Kern Medical Center after presenting to the institution's emergency department as a tier 1 and 2 trauma activation * Hospitalized following blunt or penetrating abdominal injury * Diagnosed with traumatic pancreatic injury during same admission Exclusion Criteria: * history of pancreatic surgery * Iatrogenic pancreatic injuries","Patient's greater than 18 years old, with no history of pancreatic surgery who were hospitalized at Kern Medical Center from November 1st, 2019 to March 1st, 2023 after presenting to the institution's emergency department as tier 1 and 2 trauma activations following blunt or penetrating abdominal injury and were diagnosed with pancreatic injury during the same hospitalization.",ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Complication occurrence', 'description': 'Complications including wound dehiscence, pancreatic duct leak, pancreatic pseudocyst, pancreatic fistula formation, pancreatic necrosis, intra-abdominal abscess, traumatic pancreatitis, anastomotic leak', 'timeFrame': 'Up to 12 weeks postoperatively'}]","[{'measure': 'Associated intra-abdominal injuries', 'description': 'concomitant intra-abdominal injuries including pancreatic duck, diaphragm, stomach, liver, kidney, Major vasculature, spleen, duodenum, small bowel, colon, ureter', 'timeFrame': 'within 48 hours of admission'}]" 17,NCT05397171,"{'fullName': 'AstraZeneca', 'class': 'INDUSTRY'}",A First-in-human Study to Evaluate the Safety and Tolerability of AZD8853 in Participants With Selected Advanced/Metastatic Solid Tumours,TERMINATED,"A Phase I/IIa First-in-human, Open-label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD8853 in Participants with Selected Advanced/Metastatic Solid Tumours.","['Urinary Bladder Neoplasms', 'Colorectal Cancer', 'Carcinoma, Non-Small-Cell Lung']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Substudy 1:\n\n* Part A: Part A is an AZD8853 monotherapy dose escalation which may enroll up to 45 participants.\n* Part B: Dose escalation will be followed by Part B, where up to 40 participants will be enrolled to doses determined to be safe during Part A. Additionally, a sub-set of participants will also receive an investigational radiopharmaceutical, Zirconium-89 crefmirlimab berdoxam, to evaluate the presence of CD8+ T cells in and around cancerous tumours.\n* Part C: Part C is an efficacy expansion where up to 80 participants may be enrolled based on doses and indications recommended during Part B.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'AZD8853', 'description': 'Monotherapy given until progressive disease or upon meeting other discontinuation criteria.', 'armGroupLabels': ['Substudy 1 - Parts A, B, and C']}, {'type': 'DRUG', 'name': 'Zirconium-89 crefmirlimab berdoxam', 'description': 'CD8+ T cell tracer for positron emission tomography (PET) at two time points in addition to monotherapy AZD8853', 'armGroupLabels': ['Substudy 1 - Parts B1 and B2 with CD8+ PET'], 'otherNames': ['89-Zr-Df-IAB22M2C, 89-Zr-Df-crefmirlimab']}]","\*Key Inclusion Criteria\* All Substudies: 1. At least one measurable target lesions per RECIST 1.1. 2. Eastern Cooperative Group (ECOG) of 0-1. 3. Life expectancy of ≥ 12 weeks 4. Adequate organ and marrow function as defined in the protocol Substudy 1: 1. Histologically or cytologically confirmed locally advanced, unresectable or metastatic NSCLC, MSS-CRC, or UC. 2. Documented progression from previous therapy 3. NSCLC: 3.a. At least 1 line of systemic therapy in the advanced / metastatic setting 3.b.Must have received anti-PD-1/anti-PD-L1 agent with or without chemotherapy 3.c. Part B and C: Documented no sensitizing EGFR mutations or ALK fusions/rearrangements 4\. MSS-CRC: 4.a. At least 2 prior lines of systemic therapy in the advanced / metastatic setting, including specific therapies defined in the protocol 5\. UC: 5.a. At least 1 prior line of systemic therapy in the advanced / metastatic setting, including either a platinum-containing regimen and/or an anti-PD-1 or anti-PD-L1 drug 6. Provision of archival tissue or unstained slides 7. Part B: Willing to provide mandatory biposies at screening and on study 8. Part B-CD8+ PET: At least 1 non-liver lesion suitable for PET imaging \*Key Exclusion Criteria\* All Substudies: 1. Unresolved toxicities ≥ Grade 2 per CTCAE 5.0 from prior therapy, with some exceptions defined in the protocol 2. Symptomatic CNS metastases or leptomeningeal disease 3. Active or ongoing infections, or uncontrolled intercurrent illness as defined in the protocol 4. Active or prior documented autoimmune or inflammatory disorder 5. Body weight loss of \> 10% within 30 days of screening visit 6. Type 2 diabetes requiring management by metformin, where metformin cannot be switched to another treatment at least 7 days prior to starting study treatment Substudy 1: 1. Must not have had a toxicity from a checkpoint inhibitor that lead to permanent discontinuation of immunotherapy 2. Participants with brain metastases, unless treated, asymptomatic, stable, and not requiring treatment",NA,ALL,NA,"[{'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'description': 'The safety and tolerability of AZD8853 in participants with selected advanced/metastatic solid tumors was assessed.\n\nAs per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, severity scale ranged from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event.\n\nThis outcome measure was assessed only for substudy 1 Part A.', 'timeFrame': 'From Day 1 up to 90 (±7 days) days after the last dose of AZD8853 (1 Year)'}, {'measure': 'Number of Participants With Dose Limiting Toxicity (DLT)', 'description': 'DLTs (in dose escalation Parts only) of AZD8853 in participants with selected advanced/metastatic solid tumors was assessed. The DLTs are specific adverse events defined as grade 3 (severe), grade 4 (life-threatening), and grade 5 (death) as per NCI-CTCAE version 5.0 non-hematological toxicity or hematological toxicity. This outcome measure was assessed only for substudy 1 Part A.', 'timeFrame': 'From Cycle 1 Day 1 to end of Cycle 1 (21 days)'}]","[{'measure': 'Objective Response Rate (ORR)', 'description': 'ORR was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR). This outcome measure was assessed only for substudy 1 Part A.', 'timeFrame': 'First dose until progression of disease (PD) or last evaluable assessment in the absence of progression (1 Year)'}, {'measure': 'Disease Control Rate (DCR) at 15 Weeks', 'description': 'Disease control was defined as a best overall response (BOR) of confirmed CR or PR or having stable disease (SD) (without subsequent cancer therapy) maintained for greater than or equal to (\\>=) 14 weeks (study week 15) from first IP. Disease control rate at study week 15 weeks (DCR-15) was defined as the percentage of participants who had disease control at study week 15 weeks. This outcome measure was assessed only for substudy 1 Part A.', 'timeFrame': '15 weeks'}, {'measure': 'Duration of Response (DOR)', 'description': 'The DOR was defined as the time from the date of first documented response (which was subsequently confirmed) until the date of documented progression or death in the absence of disease progression. This outcome measure was assessed only for substudy 1 Part A.', 'timeFrame': 'First documented response until date of first documented disease progression or study end (1 Year)'}, {'measure': 'Progression Free Survival (PFS)', 'description': 'The PFS was defined as the time from the start of study intervention until the date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the participant withdraws from study intervention or received another anti-cancer therapy prior to progression.\n\nThis outcome measure was assessed only for substudy 1 Part A.', 'timeFrame': 'First dose until documented disease progression or study end (1 Year)'}, {'measure': 'Percentage Change From Baseline in Tumor Size', 'description': 'Tumor size was the sum of the longest diameters (or short axis measurements for lymph nodes) of the target lesions (TLs). Percentage change in tumor size was determined for participants with measurable disease at baseline. Baseline for Response evaluation criteria in solid tumors (RECIST) version 1.1 was defined as the last evaluable assessment prior to first IP dose. This outcome measure was assessed only for substudy 1 Part A.', 'timeFrame': 'Baseline (pre-treatment) up to Week 6 and Week 15'}, {'measure': 'Overall Survival (OS)', 'description': 'Overall survival was defined as the time from the start of treatment until death due to any cause.\n\nThis outcome measure was assessed only for substudy 1 Part A.', 'timeFrame': 'First dose until study end (1 Year)'}, {'measure': 'Percentage Change in Circulating Tumor Deoxyribonucleic Acid (ctDNA) Levels From Baseline', 'description': 'Change in ctDNA is defined as the percentage change in ctDNA from baseline to each timepoint for the safety population. This outcome measure was assessed only for substudy 1 Part A.', 'timeFrame': 'Baseline (pre-treatment), Day 8 of Cycle 1, Days 1 and 8 of Cycle 2, Day 1 of Cycles 3, 4, 5, 7 (each cycle is equal to 21 days)'}, {'measure': 'Maximum Observed Concentration (Cmax) of AZD8853', 'description': 'The pharmacokinetic (PK) (Cmax) of AZD8853 in serum when administered in participants with selected advanced/metastatic solid tumors were assessed. This outcome measure was assessed only for substudy 1 Part A.', 'timeFrame': '0 hour, 15 minutes, 2 hours, 6 hours, 24 hours, 168 hours and 336 hours post EOI of Cycle 1 (each cycle equals to 21 days)'}, {'measure': 'Area Under the Plasma Concentration-time Curve From Zero to the Last Quantifiable Concentration (AUClast) of AZD8853', 'description': 'The PK (AUClast) of AZD8853 in serum when administered in participants with selected advanced/metastatic solid tumors were assessed. This outcome measure was assessed only for substudy 1 Part A.', 'timeFrame': '0 hour, 15 minutes, 2 hours, 6 hours, 24 hours, 168 hours and 336 hours post EOI of Cycle 1 (each cycle equals to 21 days)'}, {'measure': 'Partial Area Under the Plasma Concentration-time Curve From Time 0 to 504 Hours Post Dose (AUC[0-504 Hours]) of AZD8853', 'description': 'The PK (AUC\\[t1-t2\\]) of AZD8853 in serum when administered in participants with selected advanced/metastatic solid tumors were assessed. This outcome measure was assessed only for substudy 1 Part A.', 'timeFrame': '0 hour, 15 minutes, 2 hours, 6 hours, 24 hours, 168 hours and 336 hours post EOI of Cycle 1 (each cycle equals to 21 days)'}, {'measure': 'Area Under the Plasma Concentration-time Curve From Zero to Infinity (AUCinf) of AZD8853', 'description': 'The PK (AUCinf) of AZD8853 in serum when administered in participants with selected advanced/metastatic solid tumors were assessed. This outcome measure was assessed only for substudy 1 Part A.', 'timeFrame': '0 hour, 15 minutes, 2 hours, 6 hours, 24 hours, 168 hours and 336 hours post EOI of Cycle 1 (each cycle equals to 21 days)'}, {'measure': 'Number of Participants With Positive Anti-drug Antibody (ADA) of AZD8853', 'description': 'The immunogenicity of AZD8853 in participants with selected advanced/metastatic solid tumors were assessed. This outcome measure was assessed only for substudy 1 Part A.', 'timeFrame': 'From Day 1 up to 90 (±7 days) days after the last dose of AZD8853 (1 year)'}, {'measure': 'Percentage Change From Baseline in Circulating Growth Differentiation Factor 15 (GDF15) Serum Levels', 'description': 'The pharmacodynamics (PD) activity of AZD8853 by assessment of candidate biomarkers in participants with selected advanced/metastatic solid tumors were assessed. This outcome measure was assessed only for substudy1 Part A.\n\nEnd of infusion= EOI; End of treatment= EOT', 'timeFrame': '0 hours post EOI of Cycle 1 Day 1, Day 1 (Pre-dose) of Cycles 2 and 3 (each cycle equals to 21 days) and 90-days post EOT of 90 days follow-up'}]" 18,NCT00958971,"{'fullName': 'Novartis', 'class': 'INDUSTRY'}",Safety and Efficacy of TKI258 in FGFR1 Amplified and Non-amplified Metastatic HER2 Negative Breast Cancer,COMPLETED,The purpose of this trial is to determine the efficacy and safety profile of TKI258 in 3 groups of patients with metastatic HER2 negative breast cancer (BC) stratified by FGFR1 and hormone receptor (HR) status.,['Metastatic Breast Cancer'],INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'TKI258', 'description': 'All participants received a singly daily oral dose of 500 mg dovitinib on a 5 days on/2 days off schedule in 28 cycles.', 'armGroupLabels': ['TKI258 - Negative', 'TKI258 - Positive', 'TKI258 Non-interpretable'], 'otherNames': ['Dovitinib']}]","Inclusion Criteria: 1. Female presenting with metastatic breast cancer. 2. Tumor must have been tested by FISH/CISH for FGFR1 amplification. 3. HER2 and HR status must have been determined. 4. Patients must have HER2 negative breast cancer. 5. Patients must have a documented disease progression as define by RECIST at baseline. 6. Patients with HR+ disease: * Must have received at least one prior endocrine therapy in the metastatic setting. * Must have received no more than three lines of chemotherapy in the metastatic setting. 7. Patients with HR- disease must have received at least one and no more than three lines of chemotherapy in metastatic setting. Exclusion Criteria: 1. Patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases. 2. Impaired cardiac function or clinically significant cardiac diseases, including any of the following: * History or presence of serious uncontrolled ventricular arrhythmias or presence of atrial fibrillation. * Clinically significant resting bradycardia (\< 50 beats per minute). * LVEF assessed by 2-D echocardiogram (ECHO) or Multiple gated acquisition scanning (MUGA)\< 45%. 3. Any of the following within 6 months prior to study entry: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE). 4. Uncontrolled hypertension defined by a SBP \> 150mm Hg and/or DBP \> 100mm Hg, with or without anti-hypertensive medication. Other protocol-defined inclusion/exclusion criteria may apply",NA,FEMALE,NA,"[{'measure': 'Complete responses (CR) or partial response (PR) defined according to RECIST', 'timeFrame': 'Every 8 weeks'}]","[{'measure': 'Clinical Benefit (CR, PR and SD ≥ 24 weeks after start of study treatment), PFS', 'timeFrame': 'Every 8 weeks'}, {'measure': 'Safety and tolerability of TKI258 treatment assessed by frequency and severity of Adverse Events.', 'timeFrame': 'Monthly'}, {'measure': 'Pharmacokinetic: plasma concentrations and PK parameters (e.g. Cmax, Tmax, AUC0-t)', 'timeFrame': 'Study Day 1, 5 , 26, 52, 78'}]" 19,NCT04152044,"{'fullName': ""St. James's Hospital, Ireland"", 'class': 'OTHER'}",Obesity and Liver Function in Oesophageal Cancer,UNKNOWN,There is an established link between sarcopenia and outcomes in oesophageal cancer. There is scant reports in the literature regarding the influences of different obesity in different compartments.,"['Obesity', 'Liver Function']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}","[{'type': 'OTHER', 'name': 'Observation of different types of obesity and liver pathology in patients undergoing and oesophagectomy', 'description': 'Patinets undergoing surgery', 'armGroupLabels': ['Liver biopsy, Visceral and subcutaneous obesity']}]","Inclusion Criteria: * Those undergoing oesophagectomy Exclusion Criteria: * patients who only had chemotherapy/chemoradiotherapy without surgery",oesophageal cancer patients,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Overall Survival', 'timeFrame': '1 year'}, {'measure': 'Disease free survival', 'timeFrame': '1 year'}]",NA 20,NCT06324344,"{'fullName': 'Baylor College of Medicine', 'class': 'OTHER'}",Transcutaneous Electrical Nerve Stimulation (TENS) for Chemotherapy Induced Peripheral Neuropathy (CIPN),TERMINATED,"The purpose of this pilot study is to examine the acceptability and proof of concept effectiveness of a wireless Transcutaneous Electrical Nerve Stimulation (TENS) technology to address Chemotherapy Induced Peripheral Neuropathy (CIPN). Participants, who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned with ratio of 1:1 into two groups. The patients and clinicians will be blinded for group allocation. One group will utilize TENS high-dose devices (Intervention group, IG); the other group will utilize low-dose TENS devices (Placebo group, PG). The baseline measurements will be performed, and the patients will take the programmed device home for a duration of 8 weeks. Then, the patients will come back after four weeks (4W) and after 8 weeks (8W) for outcome assessment. The primary outcome will be pain. Secondary outcomes include: nerve conduction and velocity, vibration perception threshold, quality of life. Exploratory outcomes include gait assessment (gait speed, stride length, double stance, and gait steadiness), and balance.","['Chemotherapy-induced Peripheral Neuropathy', 'Pain', 'Neuropathy']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants who satisfy the inclusion and exclusion criteria and sign the informed consent form will be randomly assigned into two groups in a 1:1 ratio. One group will utilize high-dose TENS therapy (Intervention group, AG); the other group will utilize low-dose TENS devices (Placebo group, PG).\n\nBoth groups will receive their respective devices at the initial visit (Baseline) and will be asked to return in 4 weeks and 8 weeks for follow-up assessment.\n\nThroughout this 8-week period the participants may receive follow-up phone calls assessing their compliance. All subjects will keep their active device after completion of the 8-week study.', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Double', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}","[{'type': 'DEVICE', 'name': 'High-Dose TENS', 'description': 'high-dose TENS device delivers 1 hour of TENS therapy per session.', 'armGroupLabels': ['Intervention Group'], 'otherNames': ['High Dose TENS', 'Active']}, {'type': 'DEVICE', 'name': 'Low-Dose TENS', 'description': 'low-dose TENS device delivers 6 minutes of TENS therapy per session.', 'armGroupLabels': ['Placebo Group'], 'otherNames': ['Placebo']}]","Inclusion Criteria: * Adults ≥ 18 years old willing and able to participate in study. * Able to use an app via smart phone. * Patients with Chemotherapy Induced Peripheral Neuropathy (CIPN) grades II and III. * Have undergone chemotherapy with a drug known to cause neurotoxicity. * Have finished chemotherapy ≥1 month, and still experiences CIPN. Exclusion Criteria: * Pregnancy or Lactation. * Nerve Block a week prior to enrollment. * Peripheral Sensory Neuropathy Grade I and IV. * Patients applying ointments to the lower extremities. * Patients with electrical implanted devices such as pacemakers. * Patients with lower extremity wounds/history of minor/major amputation. * Planning to undergo any type of chemotherapy in the next 3 months. * Neuropathy derived from uncontrolled Diabetes Mellitus.",NA,ALL,NA,"[{'measure': 'Change in Pain Level at 8 Weeks From Baseline', 'description': 'Pain was assessed using Item 9 of the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3), which ranges from 1 (""not at all"" experiencing pain) to 4 (""very much"" experiencing pain). The percentage change from baseline to week 8 was reported, with negative values indicating a reduction in pain and positive values indicating an increase in pain.', 'timeFrame': 'baseline and 8 weeks'}]","[{'measure': 'Vibration Perception Threshold at 8 Weeks', 'description': ""Change in Vibration Perception Threshold (VPT) will be assessed using the Neuro Touch device (Yostra Labs, Bengaluru, Karnataka, India). Measurements will be taken on the big toe of the participants' left and right feet to determine the minimum vibration intensity required to perceive sensation. VPT values range from 0 to 50 volts, with higher values indicating greater numbness."", 'timeFrame': 'week 8'}, {'measure': 'Quality of Life at 8 Weeks', 'description': ""Quality of Life will be assessed using the European Organization for Research and Treatment in Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQC 30 ). It consists of 30 items divided into three main subscales: functional, symptom, and global health. Each subscale provides a comprehensive view of the patient's health and well-being.\n\nThe Functional Scale measures physical, role, emotional, cognitive, and social functioning, with scores ranging from 0 to 100; higher scores indicate better functioning. The Symptom Scale evaluates cancer-related symptoms like fatigue, pain, and nausea, where higher scores (0-100) indicate greater symptom severity.\n\nThe Global Health Scale assesses overall quality of life and general health, also scored from 0 to 100, with higher scores reflecting better health and well-being. These subscales provide critical insights for evaluating the impact of cancer and its treatment on patients."", 'timeFrame': 'week 8'}]" 21,NCT03949764,"{'fullName': 'University of Kentucky', 'class': 'OTHER'}",The Kentucky Viral Hepatitis Treatment Study,COMPLETED,"The overarching goal of the Kentucky Viral Hepatitis Treatment Project (KeY Treat) is to increase hepatitis C virus (HCV) treatment access and delivery in a rural Appalachian community, which is in the midst of the opioid/hepatitis C (HCV) syndemic. KeY Treat is a clinical research study seeking to determine whether removing barriers (cost, insurance, specialist, abstinence) associated with accessing direct-acting antivirals (DAAs) for the treatment of HCV will impact health in Perry County, Kentucky.","['Hepatitis C', 'Opioid-Related Disorders', 'Injection Drug Use']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Sofosbuvir/velpatasvir (Epclusa®)', 'description': 'The protocol is intended to follow best practices/standard of care for the treatment of HCV, with additional allowances for the investigators to apply rigorous scientific practices for the research aspects of the study. While the treatment of HCV is fairly straightforward, less is known about treating active drug users and RNA-positive individuals in rural areas. We propose eight visits, including intake, four treatment-related visits, and three visits to determine re-infection (6- and 12-months post-SVR). Because determination of medication adherence and long-term reinfection rates are not part of standard clinical practice, the rural protocol developed at the conclusion of KeY Treat will be streamlined based on findings, consisting of five or fewer clinical contacts. The drug used for treatment is Epclusa®, a 12-week, once per day, pan-genotypic DAA with a favorable side effect profile. Vosevi® will also be available in cases where participants are non-responsive or are re-infected.', 'armGroupLabels': ['HCV Positive Study Participants']}]","Inclusion Criteria: * RNA positive for HCV * Perry County residency (verified via ID card showing local address, lease, utility bill, etc.) * 18 years of age or older Exclusion Criteria: * Individuals who are unable to provide consent (to be determined by local study staff in conjunction with our psychiatrist, Dr. Lofwall, a Co-I on the study) * Individuals under 18 years of age (study drugs not FDA-approved for those \<18) * Pregnant women (unable to participate during duration of pregnancy, but encouraged to return following delivery)",NA,ALL,NA,"[{'measure': 'Treatment Uptake', 'description': 'Defined as receiving the first dose of medication, to be measured by number of pills left and viral load.', 'timeFrame': 'Visits 1-5, 1 to 12 weeks post-baseline'}, {'measure': 'Treatment Completion', 'description': 'Defined as receiving all doses of medication, to be measured by number of pills left and viral load.', 'timeFrame': 'Visit 6, 24 weeks post-baseline'}, {'measure': 'Sustained Virologic Response (SVR)', 'description': 'Defined as undetectable viral RNA at the 12-week post-completion blood draw (SVR-12).', 'timeFrame': 'Visit 7, 50 weeks post-baseline'}, {'measure': 'Re-infection', 'description': 'Defined as the presence of viral RNA at either the 6- or 12-month follow-up after achieving SVR.', 'timeFrame': 'Visit 8, 102 weeks post-baseline'}]","[{'measure': 'Prevalence of HCV', 'description': 'Prevalence of HCV in study population, measured by viral load.', 'timeFrame': 'Visit 8, 102 weeks post-baseline'}, {'measure': 'Incidence of HCV', 'description': 'Incidence of HCV in study population, measured by viral load and new cases.', 'timeFrame': 'Visit 8, 102 weeks post-baseline'}]" 22,NCT05457309,"{'fullName': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}",Construction and Effect Evaluation of Malignant Fungating Wounds Care Regimen for Breast Cancer Patients,UNKNOWN,"Patients with breast cancer malignant fungating wounds have six specific symptoms caused by wounds: malodor, pain, massive exudate, bleeding, infection, and pruritus. Malignant fungating wounds cause patients' physical condition and social function to be severely restricted, and the cost of wound dressing change further increases financial pressure, which leads to low self-identity, complex and variable emotions, and low quality of life. Therefore, the care of patients with malignant fungating wounds focuses on symptom management with the aim of improving the quality of life. There are scarce well-defined wound symptom management programs for this group, and most focus on wound management while ignoring the impact on the patient's body and mind. This study will construct malignant fungating wounds care regimen for breast cancer patients in order to improve the quality of life.",['Malignant Fungating Wound'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'PROCEDURE', 'name': 'malignant fungating wounds care regimen', 'description': ""1\\) Preliminary construction of regimen: The researchers summarized the literatures and guidelines about malignant fungating wounds care, and then formed a preliminary draft of the regimen.2) Expert consultation: Experts in malignant fungating wound care, breast cancer and rehabilitation were consulted by email, and the researchers revised the protocol according to the experts' comments, and the final draft was determined after multiple rounds of consultation with experts. 3) Pre-experiment: The researchers investigated the enrolled patients to assess the feasibility of the protocol, and adjusted the content based on the feedback.4) Final Determining: including health records establishment, the intervention time, implementers, location, method and frequency. A wound care team was formed, interventions were carried out in terms of somatic care, wound home care, psychological support, and rehabilitation guidance, and the enrolled patients would be regularly followed by the researchers."", 'armGroupLabels': ['malignant fungating wounds care regimen']}]","Inclusion Criteria: * Age greater than or equal to 18 years old with pathologically confirmed diagnosis of breast cancer. * Tumor metastasis in the chest wall or other sites and rupture to form a malignant fungating wound with a wound area of at least 10cm2 or more. * Knowing of the cancer diagnosis. ④ Capable and willing to receive follow-up. * Informed consent and voluntary participation. Exclusion Criteria: * Patients with mental illness or cognitive impairment and language expression deficiency. * Patients with extensive metastasis of cancer throughout the body to the chest, shoulders, back, arms, etc. and whose treatment was ineffective. * Patients at the end stage of death. * Patients who refused to participate in this study. Withdrawal criteria: * Patients who developed serious complications during the study and were unable to continue the study. * Patients who died during the study. ③Patients who requested withdrawal on their own during the study.",NA,ALL,NA,"[{'measure': 'Change from Baseline in Wound Size at day 42', 'description': 'described by ""healing, improvement, maintenance, deterioration"", where ""wound healing"" refers to 100% epithelialization of the wound, ""wound improvement"" refers to reduction of the wound area, ""wound maintenance"" refers to no change in the wound area, and ""wound deterioration"" refers to an increase in the wound area.', 'timeFrame': 'Baseline and day 42'}]","[{'measure': 'Change from Baseline in Wound symptoms at day 42', 'description': 'measured using the scale named ""Toronto Symptom Assessment System for Wound(TSAS-W)""; the minimum and maximum values are 0 and 100 respectively, and higher scores mean a worse wound symptom reported by patients.', 'timeFrame': 'Baseline and day 42'}, {'measure': 'Change from Baseline in Quality of life in breast cancer patients at day 42', 'description': 'measured using the scale named ""Quality of Life instruments for Cancer Patients-Breast Cancer(QLICP-BR)"". There are 37 items, and 5\\~10 and 27\\~32 are positive entries, and the rest are reverse entries. Using Likert 5-level scoring method, the total score is 36\\~180 points. The higher the total score, the better the quality of life. Only 35 items were used in this study.', 'timeFrame': 'Baseline and day 42'}, {'measure': 'Change from Baseline in Social support at day 42', 'description': 'measured using the scale named ""Social Support Rate Scale(SSRS)"".The scale includes 10 items and 3 dimensions, with a total score of 11-59. The higher the total score, the better the social support.', 'timeFrame': 'Baseline and day 42'}, {'measure': 'Change from Baseline in Anxiety at day 42', 'description': 'measured using the scale named ""Self-rating Anxiety Scale(SAS)"". SAS scale includes 20 items. If it is a positive scoring question, it will be rated as rough score 1, 2, 3 and 4 in turn; Reverse scoring questions (those with \\* sign) will be rated as 4, 3, 2, 1 points. Add the scores of 20 items to get the rough score (x). Multiply the rough score by 1.25 and take the integer part to get the standard score (y). According to the results of the Chinese norm, the cut-off value of SAS standard deviation is 50 points, of which 50 \\~ 59 points are mild anxiety, 60 \\~ 69 points are moderate anxiety, and more than 70 points are severe anxiety.', 'timeFrame': 'Baseline and day 42'}, {'measure': 'Change from Baseline in Depression at day 42', 'description': 'measured using the scale named ""Self-rating Depression Scale(SDS)"". SDS scale includes 20 items and 10 positive scoring questions, which are rated as rough scores of 1, 2, 3 and 4 in turn; 10 reverse scoring questions (those with \\* sign) will be rated as 4, 3, 2, 1 points. Add the scores of 20 items to get the rough score (x). Multiply the rough score by 1.25 and take the integer part to get the standard score (y). According to the results of the Chinese norm, the cut-off value of SDS standard score is 53 points, of which 53-62 points are mild depression, 63-72 points are moderate depression, and more than 73 points are severe depression.', 'timeFrame': 'Baseline and day 42'}, {'measure': 'Change from Baseline in Stigma at day 42', 'description': 'measured using the scale named ""Stigma Scale for Chronic Illness 8-item version(SSCI-8items)"". The scale is developed on the basis of the 24 item stigma scale for chronic illness (SSCI), with a total of 8 items, of which 3 items are from internal shame, 5 items are from external shame, and all items are positive. The five options of the scale are: No, little, sometimes, often, always, and assigned 1, 2, 3, 4, and 5 points respectively, with a total score of 8 to 40 points. The higher the score, the higher the level of shame.', 'timeFrame': 'Baseline and day 42'}]" 23,NCT04821609,"{'fullName': 'Pontificia Universidad Catolica de Chile', 'class': 'OTHER'}",Supervised Resistance TRaining amONG Women at Risk of Breast Cancer Related Lymphedema,UNKNOWN,"Breast cancer (BC) is the most common neoplasm in Chile, and its medical treatment leads to high survival. One-third of survivors will develop BC-related lymphedema. Lymphedema is a chronic condition characterized by increased volume in the ipsilateral arm to surgery. A higher volume is associated with decreased physical functionality and quality of life. Recent studies suggest that resistance training could control arm volume through increased muscle mass development, improving physical functionality and quality of life for patients. To our knowledge, there is no study that has analyzed the effect of a resistance training program among women at risk of BC-related lymphedema on arm volume and quality of life. The purpose of this study is to determine the effect of resistance training on the arm volume and quality of life among women with adjuvant chemotherapy and high risk of BC-related lymphedema compared to a control group with regular physical therapy management, which does not include resistance training. This is a randomized controlled study. It will be held at the Complejo Asistencial Dr. Sotero del Río, which receives all patients from the South East Metropolitan Health Service. Participants: 106 women receiving adjuvant chemotherapy for BC who have undergone axillary lymph node dissection or with obesity will be recruited. The difference in volume between the arms will be evaluated with optoelectric equipment. Quality of life with The European Organization for Research and Treatment in Cancer Quality of Life C-30 (EORTC QLQ-C30) and the European Organization for Research and Treatment of Breast Cancer-Specific Quality of Life Questionnaire BR23 (EORTC QLQ-BR23) questionnaires, both validated in Chile; the handgrip with a dynamometer; and physical functionality with the six-minute walk test. Volunteers will be randomly assigned to the resistance training group or control group. The resistance training group will consist of twice a week supervised sessions, for 12 weeks. The exercises will be for arms and legs, self-loading type, and with external weights. The control group will follow the usual physical therapy management, which does not include resistance training. Subsequently, volunteers will be evaluated at the third and sixth months after completion of the 12 weeks resistance training program.","['Breast Cancer', 'Physical Activity', 'Lymphedema of Upper Arm']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}","[{'type': 'BEHAVIORAL', 'name': 'Resistance Training', 'description': 'The resistance training will be for arms and legs, self-loading type, and external weights.', 'armGroupLabels': ['Resistance training group']}]","Inclusion Criteria: * Newly diagnosed with stage I-III breast cancer, histologically confirmed. * Patients scheduled to receive adjuvant post-operative chemotherapy. * Partial or total mastectomy with axillary node dissection. * Partial or total mastectomy with sentinel node dissection with body mass index between 30.0 and 39.9 kg/m2. * Approval of their treating physician to participate in sub-maximal physiological fitness testing and a low to moderate progressive resistance exercise program. Exclusion Criteria: * Inter-limb volume difference greater than 200 ml or 10%. * Previous antineoplastic treatment (chemotherapy, radiotherapy, or endocrine therapy). * Breast cancer stage IV * Unable to participate in an exercise program related to other medical problems. * Be identified as vigorous exercise behavior related to American College of Sports Medicine recommendations. * Body mass index lower than 18.5 kg/m2 or greater than 40 kg/m2. * Pregnancy. * Fluency and understanding of the Spanish language.",NA,FEMALE,NA,"[{'measure': 'Change from Baseline in Arms lymphedema Volume on the Perometer System at 3, 6 and 9 months.', 'description': 'Perometer is considered the gold standard for determining lymphedema volume in research. Is a valid and reliable tool in volume measurement. It determines volume values expressed in milliliters and percentage. A value of 200 mL or 10% difference between one arm and the other is considered significant.', 'timeFrame': 'Baseline, 3, 6 and 9 months.'}, {'measure': 'Change from Baseline in Health-related quality of life on questionnaire: The European Organization for Research and Treatment in Cancer (EORTC) Quality of Life C-30 (QLQ-C30) and breast cancer-specific module QLQ-BR23 at 3, 6, and 9 months.', 'description': 'The QLQ C-30 and specific module QLQ-BR23 are self-administered and validated questionnaires to assess health-related quality of life in patients with breast cancer. Both had been validated in Spanish language and on Chilean population. QLQ-C30 comprises 30 items to assess physical, role, emotional, cognitive, and social functioning. The QLQ-BR23 is a breast-specific module that comprises 23 questions to assess body image, sexual functioning, sexual enjoyment, future perspective, systemic therapy side effects. All scores were linearly transformed to a 0 to 100 scale. A high functional score represents a high or healthy level of functioning. A high QOL is defined by a high score for global health status or QOL. High symptom scores or items represent more severe symptoms or problems.', 'timeFrame': 'Baseline, 3, 6 and 9 months.'}]","[{'measure': 'Change from Baseline in Hand grip strength on Hydraulic Hand Dynamometer at 3, 6 and 9 months.', 'description': 'Dynamometer assess the maximal voluntary grip strength (measured in kilograms). Each subject will perform six trials, three in each arm, with an alternating bilateral sequence. The results will be based on the best punctuation of the three trials, respectively. There are normative values in percentiles for healthy Chilean women.', 'timeFrame': 'Baseline, 3, 6, and 9 months.'}, {'measure': 'Change from Baseline in Physical Fitness Six minute walk test at 3, 6 and 9 months.', 'description': 'Six minute walk test is a functional test of sub-maximum cardiorespiratory capacity. Valid and reliable in adults with cancer. Result are expressed in meters. A change of 20-30 meters is considered significant.', 'timeFrame': 'Baseline and 3, 6 and 9 months.'}]" 24,NCT01409499,"{'fullName': 'Sun Yat-sen University', 'class': 'OTHER'}",Palliative Treatments for Patients With Advanced Hepatocellular Carcinoma (HCC),COMPLETED,"The standard treatment choice for advanced hepatocellular carcinoma (HCC) is sorafenib, and its efficacy is limited. More active treatments were performed in patients with advanced HCC in China, which include radical hepatectomy or TACE. The study is to investigate whether the active treatment will profit survival of patients, and to evaluate the safety.","['Hepatectomy', 'Hepatocellular Carcinoma', 'Sorafenib']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'PROCEDURE', 'name': 'hepatic resection', 'description': 'palliative hepatectomy followed by sorafenib', 'armGroupLabels': ['A, surgery'], 'otherNames': ['Group A (hepatectomy)']}, {'type': 'PROCEDURE', 'name': 'transcatheter hepatic arterial chemoembolization', 'description': 'TACE followed by sorafenib', 'armGroupLabels': ['B, TACE'], 'otherNames': ['Group B (TACE)']}, {'type': 'DRUG', 'name': 'sorafenib', 'description': 'sorafenib monotherapy, 400mg Bid, continuously', 'armGroupLabels': ['C, sorafenib'], 'otherNames': ['Group C (sorafenib)']}]","Inclusion Criteria: * Male or female patients \> 18 years of age. * Diagnosed to have advanced HCC (BCLC C stage). * Patients who have a life expectancy of at least 12 weeks. * Patients whose primary tumor can be resected. Definition of resectable in this study: * Tumor number \<=2. * If number of tumors \>= 3, then all tumors were located in the same lobe. * Without tumor invasion of the main trunk of the portal vein, or hepatic duct, or caval vein. * Hepatocellular carcinoma with histological diagnose or clinical diagnose according to AASLD. * No major post-operative complication. * Patients who have an ECOG PS of 0, or 1. * Cirrhotic status of Child-Pugh class A only. * The following laboratory parameters: Platelet count \> 60 x 109/L Hemoglobin \> 8.5 g/dL Albumin \> 3.5 g/dL Total bilirubin \< 25μmol/L Alanine transaminase (ALT) and AST \< 2.5 x upper limit of normal Serum creatinine \<1.5 x the upper limit of normal Prothrombin time (PT)\<3 seconds above control. • Patients who give written informed consent. Exclusion Criteria: * Previous or concurrent cancer that is distinct in primary site or histology from HCC. * History of cardiac disease. * Active clinically serious infections (\> grade 2 National Cancer Institute \[NCI\]-Common Terminology Criteria for Adverse Events \[CTCAE\] version 3.0) * Known history of human immunodeficiency virus (HIV) infection * Known Central Nervous System tumors including metastatic brain disease. * Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * History of organ allograft. * Known or suspected allergy to the investigational agent or any agent given in association with this trial. * Pregnant or breast-feeding patients. * Any condition that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study. * Excluded therapies and medications, previous and concomitant: Systemic chemotherapy and target drug other than sorafenib. Antiviral treatment is allowed. * Radiotherapy except for which done for bone metastases palliatively.",NA,ALL,NA,"[{'measure': 'Overall survival (OS)', 'description': 'defined as the time from the first treatment to death', 'timeFrame': 'anticipate 6-12 months'}]","[{'measure': 'Progression Free Survival (PFS)', 'description': 'defined as the time from the first treatment to the first progression disease is confirmed by radiological methods', 'timeFrame': 'anticipate 3-6 months'}, {'measure': 'AEs and SAEs', 'description': 'according to CTC AE 3.0', 'timeFrame': 'anticipate 6-12 months'}, {'measure': 'cost of treatments', 'description': 'to compare costs of different treatments', 'timeFrame': '3 months in average'}]" 25,NCT03769532,"{'fullName': 'Technische Universität Dresden', 'class': 'OTHER'}",MRD-guided Treatment in NPM1mut AML Patients,TERMINATED,Evaluation the safety and efficacy of Pembrolizumab (PEM) when administered in combination with standard Azacitidine (AZA) in nucleophosmin (NPM1) mutated AML patients with molecular relapse defined by the presence of measurable residual disease (MRD).,['Acute Myeloid Leukemia'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Pembrolizumab', 'description': 'Pembrolizumab (IMP): 200mg i.v. (fixed dose), every 3 weeks (Q3W), 8 doses', 'armGroupLabels': ['Pembrolizumab + Azacitidine'], 'otherNames': ['PEM', 'Keytruda®']}, {'type': 'DRUG', 'name': 'Azacitidine', 'description': 'Azacitidine (SOC): 75 mg/m2 s.c., day 1-7 every 4 weeks (Q4W), 6 cycles', 'armGroupLabels': ['Pembrolizumab + Azacitidine'], 'otherNames': ['AZA', 'Vidaza®']}]","Inclusion Criteria: * Signed informed consent * Age ≥18 years * Patients with NPM1mut AML in complete morphologic remission after conventional chemotherapy (anthracycline ± cytarabine based) * Detectable measurable residual disease (MRD) indicating imminent hematological relapse (NPM1mut MRD ratio \>1%, confirmed by central lab) * Patients who are not eligible for immediate allogeneic hematopoietic stem cell transplantation * Patients who are not eligible to undergo alternative intensive treatment * Intended AZA therapy for molecular relapse * Eastern cooperative oncology Group (ECOG) performance status of 0 or 1 * Demonstrate adequate organ function as defined by protocol, all labs should be performed within the screening period. * Negative pregnancy test in women of childbearing potential (negative urine or serum pregnancy within 3 days prior to receiving study treatment). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. * Female subjects of childbearing potential (Section 5.9.2) must be willing to use an adequate method of contraception as outlined in Section 5.9.2 - Contraception, for the course of the study through 120 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. * Male subjects with procreative capacity (Section 5.9.2) must agree to use an adequate method of contraception as outlined in Section 5.9.2- Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. Exclusion Criteria: * Prior allogeneic hematopoietic stem cell transplantation * Treatment with any investigational drug within 4 weeks to study therapy or less than 5 half-lives preceding the first dose of trial medication, whichever is longer. * Anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study day 1 or no recovering (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. * Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or no recovering (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. * Prior treatment with an anti-programmed cell death protein (anti PD-1, anti PD-L1 or anti PD-L2 agent). * Known hypersensitivity to any of the drugs within this study, their constituents or to drugs with similar chemical structure. * Receiving immunosuppressive therapy within 7 days prior to the first dose of trial medication. * Known history of active Bacillus Tuberculosis (TB). * Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. * Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability. * Autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). * Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. * Known history of, or any evidence of active, non-infectious pneumonitis. * Liver cirrhosis or malignant liver tumor. * Known severe congestive heart failure, incidence of clinically unstable cardiac or pulmonary disease. * Active infection requiring systemic therapy. * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. * Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment * Known Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). * Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., Hepatitis C virus (HCV) RNA \[qualitative\] is detected). * Live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.",NA,ALL,NA,"[{'measure': 'Proportion of event-free patients', 'description': 'Events are:\n\n* First hematological relapse after start of combined therapy\n* Death from any cause\n* AML-treatment other than Pembrolizumab and Azacitidine or hypomethylating agents only', 'timeFrame': 'after 24 weeks of combination treatment (i.e. after up to 6 cycles of AZA for 7 days every 4 weeks and up to 8 PEM infusions every 3 weeks)'}]","[{'measure': 'Overall survival (OS)', 'description': 'Overall survival is defined as the number of days between date of first visit (AZA) and date of death from any cause.', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Proportion of event-free patients', 'description': 'For this endpoint apply the same definitions as for the primary endpoint.', 'timeFrame': 'after 12 weeks of combined therapy'}, {'measure': 'Treatment-related mortality', 'description': 'Any death without preceding hematologic relapse is considered to be treatment related.', 'timeFrame': 'during 24 weeks of combined therapy'}, {'measure': 'Course of MRD-burden measured as quantitative NPM1/Abelson murine leukemia viral oncogene homolog 1 (ABL) ratio', 'description': 'The NPM1/ABL-ratio will be log-transformed with base 10. With the log transformation a near normal distributed variable will be derived to be able to use parametric methods for analysis. Values below limit of detection (LOD) will be substituted by LOD/2 before log-transformation.', 'timeFrame': 'through study completion, an average of 1 year'}]" 26,NCT02872532,"{'fullName': 'Mayo Clinic', 'class': 'OTHER'}",Testicular Tissue Cryopreservation in Children,RECRUITING,"This protocol is being designed to offer testicular tissue cryopreservation to male pediatric patients (0-17 years of age) with fertility threatening medical diagnoses or facing surgery, chemotherapy or radiation therapy that may cause loss of reproductive potential.","['Cancer', 'Cancer-Related Condition', 'Infertility']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'PROCEDURE', 'name': 'Testicular tissue cryopreservation', 'description': 'Testicular tissue will be removed', 'armGroupLabels': ['Testicular tissue']}]","Inclusion Criteria: (All inclusion criteria must be met.) * Be male 0-17 years of age * Meet at least one of the following four conditions: * Be scheduled to undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy with risk of causing permanent and complete loss of subsequent testicular function. Risk categories based on treatment regimens are indicated below. Investigators will utilize three sources to calculate risk: 1. ""Fertile Hope - Risks of Azoospermia"" brochure that details typical agents and treatment regimens in each risk category, 2. The Summed Alkylating Agent dose score (Green et al., 2009) or 3. The Cyclophosphamide Equivalent Dose method (Green et al., 2014). Because of the complexity of many treatment regimens, patient risk categorization will be at the discretion of the investigators. * High Risk * \>= 80% risk of prolonged azoospermia, Fertile Hope Brochure * Summed alkylating agent dose score \>= 3 * Cyclophosphamide equivalent dose \>= 7,500mg/m\^2 * Intermediate risk (21-79% risk of prolonged azoospermia, Fertile Hope) * Low Risk ( =\< 20% risk of prolonged azoospermia, Fertile Hope) * Eligibility is limited to patients in the High risk category and/or intermediate risk after discussion with pediatric oncology, fertility preservation team, and the patient/family * Or, have a medical condition or malignancy that requires removal of all or part of one or both testicles * Or, have a medical condition (genetic or autoimmune) that results in decline in fertility (e.g. Klinefelter syndrome) * Or, have a newly diagnosed or recurrent disease affecting fertility. Those who were not enrolled at the time of initial diagnosis (i.e. patients with recurrent disease) are eligible if they have not previous received therapy that is viewed as likely to result in complete and permanent loss of testicular function * Have two testicles if undergoing elective removal of a testicle for fertility preservation only. Note: removal of both testicles will limit fertility preservation options. Or have 1 testicle but limited potential for future fertility due to underlying condition, malignancy, prior surgery or previous torsion and no other fertility preservation methods are available except for testicular tissue cryopreservation * Sign an approved informed consent and authorization permitting the release of personal health information. The patient and/or the patient's legally authorized guardian must acknowledge in writing that consent for specimen collection has been obtained, in accordance with institutional policies approved by the United States (U.S.) Department of Health and Human Services * Consent for serum screening tests for infectious diseases to be performed at the time of testicular tissue harvesting. The immediate testing will include but not be limited to testing for Hepatitis B, Hepatitis C, and human immunodeficiency virus (HIV) * Undergo a full history and physical examination and obtain standard pre-operative clearance (based on the most recent American College of Cardiology/ American Heart Association \[ACC/AHA\] Guideline for Perioperative Cardiovascular Evaluation for Noncardiac Surgery) as determined by their primary surgeon * Note: In cases of torsion of testicles or other medical conditions that result in impairment of testicular function, patients can be consented and included in the study, if during the testicular surgery the provider finds that the patient still has viable tissue that can be cryopreserved. Exclusion Criteria: (Any exclusion criteria will disqualify.) * Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent. * Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery. * Previous recipients of gonadotoxic chemotherapy or radiation therapy thought to have resulted in impairment of testicular function.",NA,MALE,NA,"[{'measure': 'Number of pregnancies and live births after transplantation of cryopreserved testicular tissue', 'timeFrame': '10-20 years'}]",NA 27,NCT02482532,"{'fullName': 'University of Kansas Medical Center', 'class': 'OTHER'}","Vaccine Enriched, Autologous, Activated T-Cells Directed to Tumor in Patients With Relapsed/Refractory Melanoma",COMPLETED,The researchers will investigate if modified T-cells from a patients own system can be utilized to find and destroy metastatic melanoma tumor and thus improve patient outcomes.,['Melanoma'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'tvs-CTL Vaccine', 'description': 'autologous, 14g2a.zeta chimeric receptor transduced, activated T-cells, enriched for vaccine specific cytotoxic T-lymphocytes (tvs-CTL)', 'armGroupLabels': ['tvs-CTL Vaccine']}]","Inclusion Criteria: * Metastatic, surgically unresectable melanoma or newly diagnosed melanoma of any stage, where the patient is unable to receive or complete standard therapy * Life expectancy of at least 12 weeks. * Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2 * Laboratory Values * absolute neutrophil count \> 500 microliters (mcL) * platelet \> 50,000 mcL * serum aspartate aminotransferase (AST) \< 5 x institutional upper limit of normal (IULN) * total bilirubin \< 3 x IULN * serum creatinine \< 3 x IULN * Pulse oximetry of \> 95% on room air. * Must have recovered from the toxic effects of all prior chemotherapy Exclusion Criteria: * Patients with rapidly progressive disease. * Patient is currently receiving any investigational drugs * Current cardiomegaly or bilateral pulmonary infiltrates on chest radiograph, pulmonary metastatic lesions are allowed * Patients must not have tumor in a location where enlargement could cause airway obstruction * Patient is pregnant or lactating * History of hypersensitivity reactions to murine protein-containing products. * Currently receiving immunosuppressive drugs such as corticosteroids (excluding topical treatment), tacrolimus or cyclosporin * Received any tumor vaccines within previous six weeks * Known hypersensitivity to rat monoclonal antibodies * History of severe allergic reaction to Hepatitis B vaccine, Polio vaccine or Tetanus, Diphtheria, Pertussis vaccine (DTP, Tdap, DT or Td). * Allergy to baker's yeast or other components of the vaccines. * History of allergy to the antibiotics Neomycin, Streptomycin or Polymyxin B * History of coma, long/multiple seizures within 7 days after DTP or Tdap, unless a cause other than the vaccine was indicated. * Melanoma involvement of the central nervous system * Chemotherapy given within the last 28 days * Presence of human anti-mouse antibody (HAMA) prior to enrollment (only patients who have received prior therapy with murine antibodies)",NA,ALL,NA,"[{'measure': 'Measurement of infusion related adverse events to evaluate the safety of infused T-cells', 'description': 'To evaluate the safety of autologous, receptor-transduced, activated T-cells, enriched for vaccine-specific cytotoxic T-lymphocytes (tvs-CTL)', 'timeFrame': '4 weeks'}, {'measure': 'PCR measurement of retroviral construct to measure persistence of infused T-cells', 'description': 'To evaluate how long the infused T-cells remain in the blood stream', 'timeFrame': '4 weeks'}, {'measure': 'Measurement of replication competent retrovirus to evaluate the safety of infused T-cells', 'description': 'To evaluate the safety of autologous, receptor-transduced, activated T-cells, enriched for vaccine-specific cytotoxic T-lymphocytes (tvs-CTL)', 'timeFrame': '4 weeks'}]","[{'measure': 'PCR measurement of retroviral construct to measure the expansion of infused T-cells', 'description': 'To determine the expansion of infused tvs-CTL in response to repeat vaccination with previously administered vaccines', 'timeFrame': '12 months'}, {'measure': 'PCR measurement of retroviral construct to compare frequency of peripheral tvs-CTL population pre-infusion vs post-revaccination', 'description': 'To compare the frequency of tvs-CTL in the peripheral blood, after revaccination, to the frequency noted in the prior study of autologous activated, CAR-transduced T-cells infused in patients with relapsed, refractory Stage IV melanoma', 'timeFrame': '12 months'}, {'measure': 'Imaging studies to measure tumor response', 'description': 'Evaluate tumor response to infusion of tvs-CTL and repeat vaccination post-infusion.', 'timeFrame': '10 weeks'}]" 28,NCT05717998,"{'fullName': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}",Imaging and Blood-Based Biomarkers for the Evaluation of Early Signs of Myocardial Injury After Thoracic Radiation Therapy,ACTIVE_NOT_RECRUITING,This study assesses for early signs of damage to the heart following chest radiation therapy using both imaging (cardiac magnetic resonance imaging and cardiac positron emission tomography) and changes in blood biomarkers. This study determines if any changes in the heart muscle can be detected either during the course of radiation therapy or shortly thereafter using specialized imaging techniques or blood tests. Cardiac magnetic resonance imaging may be used to help provide information about changes in the heart structure and function following radiation therapy. Positron emission tomography looks at differences in how the heart takes up radioactive sugar which is injected into the vein to assess changes in heart function following radiation therapy. This study may help identify patients at risk of heart issues following radiation therapy to the chest and ultimately help in the development of more effective and safe treatments for cancer in the future.,"['Lung Non-Small Cell Carcinoma', 'GastroEsophageal Cancer', 'Esophagus Cancer']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'PROCEDURE', 'name': 'Biospecimen Collection', 'description': 'Undergo blood sample collection', 'armGroupLabels': ['Ancillary-correlative (CMR, PET/CT, biospecimen collection)'], 'otherNames': ['Biological Sample Collection']}, {'type': 'PROCEDURE', 'name': 'Computed Tomography', 'description': 'Undergo cardiac PET/CT', 'armGroupLabels': ['Ancillary-correlative (CMR, PET/CT, biospecimen collection)'], 'otherNames': ['CAT', 'CAT Scan', 'Computerized Axial Tomography', 'Computerized Tomography', 'CT', 'CT Scan', 'tomography']}, {'type': 'PROCEDURE', 'name': 'Magnetic Resonance Imaging of the Heart', 'description': 'Undergo CMR', 'armGroupLabels': ['Ancillary-correlative (CMR, PET/CT, biospecimen collection)'], 'otherNames': ['Cardiac MRI', 'Heart MRI']}, {'type': 'PROCEDURE', 'name': 'Positron Emission Tomography', 'description': 'Undergo cardiac PET/CT', 'armGroupLabels': ['Ancillary-correlative (CMR, PET/CT, biospecimen collection)'], 'otherNames': ['Medical Imaging, Positron Emission Tomography', 'PET', 'PET Scan', 'Positron Emission Tomography Scan', 'Positron-Emission Tomography', 'proton magnetic resonance spectroscopic imaging']}]","Inclusion Criteria: * Patients who have been evaluated by a radiation oncologist and have been felt to be suitable to undergo thoracic RT for histologically confirmed NSCLC with a dose range of 60-70 Gy at 1.8-2 Gy per fraction OR histologically confirmed clinical stage I-IVA (AJCC 8th ed) middle or thoracic esophageal or gastroesophageal cancer (squamous cell carcinoma or adenocarcinoma) with a planned dose range of 41.4-60 Gy at 1.8-2 Gy per fraction as part of treatment of their malignancy * Concurrent chemotherapy is permitted * For NSCLC patients, both concurrent and/or adjuvant immunotherapy is permitted * Patients participating in other research studies are eligible as long as participation in this study does not interfere with activities required in the other studies * Patients with no contra-indications to magnetic resonance (MR) or PET imaging as stated in the section exclusion criteria * For the delayed enhancement and the T1 contrast mapping portions of the study, the patient must have an adequate baseline renal function defined as an estimated glomerular filtration rate (eGFR) \> 30 ml/min per the Ohio State Institutional Guidelines. Of note, if the patient's eGFR is =\< 30 ml/min, the patient would still be eligible for enrollment, but only the strain-encoded (SENC) imaging and T2 mapping non-contrast sequences would be obtained. The dynamic contrast-enhanced (DCE) and T1 mapping sequences, which require intravenous (IV) contrast, would not be included * Patients with moderate to end-stage renal disease, or who are at high-risk of nephrogenic systemic fibrosis (e.g. hepatorenal syndrome, liver transplant, acute renal failure, chronic kidney disease, and iron overload conditions) would still be eligible for enrollment, but only the non-contrast SENC and T2 mapping imaging sequences would be obtained. The DCE and T1 mapping sequences, which require IV contrast, would not be included * Age \>= 18 years old * Within 4 weeks of study entry: patients must have vital signs, history/physical examination, and kidney function test (eGFR) * Ability to provide written informed consent obtained prior to participation in the study and any study specific procedures being performed * Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 14 days of the study entry. Urine human chorionic gonadotropin (HCG) is an acceptable pregnancy assessment Exclusion Criteria: * Subjects who are breast-feeding, or have a positive pregnancy test will be excluded from the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately * Medical contraindications to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, known contrast allergy to Gadolinium contrast, pregnancy, nursing mothers, weight greater than 350 pounds) * Subjects with advanced renal disease (eGFR \< 45 mL/min/1.72m\^2) - exclusion from receipt of contrast, but may still be enrolled for basic CMR imaging (left ventricular ejection \[LVEF\], strain, T2, etc) * Medical contraindications to PET imaging (e.g. pregnancy, nursing mothers, weight greater than 420 pounds - scanner limit) * Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other condition that could prevent compliance with study procedures or providing informed consent * Subjects who are prisoners",Patients suitable to undergo thoracic RT for histologically confirmed non-small cell lung cancer (NSCLC) OR histologically confirmed clinical stage I-IVA (American Joint Committee on Cancer \[AJCC\] 8th edition \[ed\]) middle or thoracic esophageal or gastroesophageal cancer (squamous cell carcinoma or adenocarcinoma) at Ohio State University Comprehensive Cancer Center,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Changes in extracellular volume (ECV)', 'description': 'To identify the presence of cardiac fibrosis as assessed by cardiac magnetic resonance-derived ECV during and shortly after RT.', 'timeFrame': 'Baseline up to 6 months post-radiation therapy (RT)'}, {'measure': 'Changes in myocardial T2', 'description': 'To identify the presence of cardiac magnetic resonance-derived cardiac inflammation using T2 mapping during and shortly after RT.', 'timeFrame': 'Baseline up to 6 months post-RT'}, {'measure': 'Changes in myocardial metabolism', 'description': 'To identify changes in myocardial metabolism measured as standardized uptake value (SUV) max during and shortly after RT using myocardial PET.', 'timeFrame': 'Baseline up to 6 months post-RT'}]","[{'measure': 'Blood-based biomarkers', 'description': 'Biomarkers including serum troponin, N-terminal Pro Brain-type Natriuretic Peptide (NT-proBNP), C-reactive protein, carboxy-terminal propeptide of procollagen type I (PICP), and amino-terminal propeptide of procollagen type I (PINP) will be measured.', 'timeFrame': 'Baseline up 6 to months post-RT'}]" 29,NCT00394498,"{'fullName': 'University of Ottawa', 'class': 'OTHER'}",Stem Cell Mobilization by G-CSF Post Myocardial Infarction to Promote Myocyte Repair,UNKNOWN,"Eighty-six patients with heart attacks will be identified at our hospital. Post heart attack we will assess heart function, blood flow to the heart, and heart cell function. We will assess these parameters using nuclear cardiology scans that are used in everyday cardiology practice. The patients will then be divided into 2 groups. One group will receive a medication called G-CSF and the other group will receive a placebo. We will give this drug (1-2ml) for 4 days beneath the skin. We will take the patients blood during this time and measure how the drug affected their blood. The patients will all have the nuclear cardiology tests again in 6 weeks and 6 months to see how their heart is functioning. As well, they will have a six month angiogram. All the patients will otherwise receive optimal care from their Cardiologist. They will be seen at 6, 12, 24, and 52 weeks to assess them clinically. This study will test the effects of G-CSF on the heart function of patients who have had a heart attack. It is a medication that that has been shown in an animal model to improve heart function after a heart attack. It is a medication that has been used for many years to treat patients with cancers and to increase the number of cells donated by healthy bone marrow donors. It has no serious side effects. It works by increasing the number of a person's own stem cells in the blood. Stem cells are special cells that are present in our bodies that have the ability to form new cells. It had been thought that the heart could not make new cells after it has been damaged. Other investigators have shown that this might not be the case. It is now thought that after an injury, stem cells from the bone marrow can transform into cells of the injured tissue. Therefore, we are trying to increase the number of stem cells in the circulation with G-CSF so as to increase repair in the heart after it has been damaged. This strategy has never been tried in human beings and if successful could greatly reduce death and suffering from heart disease.",['Myocardial Infarction'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE'}}","[{'type': 'DRUG', 'name': 'Granulocyte Colony Stimulating Factor'}]","Inclusion Criteria: 1. Large anterior wall ST elevation AMI defined by: Post AMI LVEF less than 45% as assessed by echocardiography. It is standard practice at our institution to obtain echocardiograms on such patients before day 4 post AMI. 2. Age between 40 -75 years 3. Angiographically patent infarct related artery (IRA) with TIMI 3 flow with no significant stenosis (\>70% diameter stenosis in non-intervened upon arteries or \>30% in arteries that had PTCA), no dissection or visible thrombus, and considered at low risk for re-occlusion by the Cardiologist performing the coronary angiography. In patients who have undergone PTCA, this assessment will be none on a post PTCA angiogram. This will be the majority of patients. 4. Eligible for treatment with G-CSF within the 5 days Post AMI. Exclusion Criteria: 1. Prior STEMI 2. Patients with regional wall motion abnormalities in the non-infarct region 3. Prior CABG or need for CABG 4. Patients with significant valve disease; defined as stenosis or regurgitation graded as greater than moderate (2+). 5. Patients with clinically apparent, concurrent infection, requiring intravenous antibiotics 6. Patients who are or could be pregnant 7. Patients with another etiology of LV dysfunction (known/suspected non ischemic cardiomyopathy, previous anthracycline therapy, known ethanol abuse (greater than 6 oz. ethanol/day on a regular basis).",NA,ALL,NA,[{'measure': '6 month Left ventricular ejection fraction'}],"[{'measure': '6 week left ventricular ejection fraction'}, {'measure': '6 week myocardial FDG-PET uptake'}, {'measure': '6 week myocardial Ammonia-PET perfusion'}, {'measure': '6 week/month left ventricular diastolic volume'}, {'measure': '6 week/month left ventricular systolic volume'}]" 30,NCT00310063,"{'fullName': 'Wake Forest University Health Sciences', 'class': 'OTHER'}",Acupressure in Preventing Nausea and Vomiting in Young Cancer Patients Receiving Chemotherapy,COMPLETED,"RATIONALE: Using acupressure wrist bands to press and stimulate nerves at an acupressure point on the inside of the wrist may help control nausea and vomiting caused by chemotherapy. PURPOSE: This randomized clinical trial is studying how well acupressure works in preventing nausea and vomiting in young cancer patients receiving chemotherapy.","['Nausea and Vomiting', 'Unspecified Childhood Solid Tumor, Protocol Specific']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'PROCEDURE', 'name': 'acupressure therapy', 'description': 'Acupressure wristband', 'armGroupLabels': ['Arm I']}, {'type': 'PROCEDURE', 'name': 'sham intervention', 'description': 'Sham wristband', 'armGroupLabels': ['Arm II']}]","DISEASE CHARACTERISTICS: * Patients must receive in-patient primary oncology care at least monthly at Brenner Children's Hospital * Patients may have any type of cancer * Must be receiving at least 1 of the following chemotherapy agents as an inpatient: * An alkylating agent (e.g., cisplatin, cyclophosphamide, or ifosfamide) * An antitumor antibiotic (e.g., doxorubicin, daunomycin, dactinomycin, or mitoxantrone) * High-dose cytarabine PATIENT CHARACTERISTICS: * Patient's primary caregiver must speak English PRIOR CONCURRENT THERAPY: * See Disease Characteristics",NA,ALL,NA,"[{'measure': 'reduction of chemotherapy related nausea', 'description': 'assessment by questionaire of nausea during patient chemo', 'timeFrame': '6 months'}]",NA 31,NCT01110863,"{'fullName': 'Northwell Health', 'class': 'OTHER'}",Characterization of Proliferating Compartment in B-Cell Patients and in Healthy Aging Subjects,COMPLETED,"By ingesting a non-radioactive and non-toxic compound ""heavy water"" for 6 weeks, the DNA of newly developed cells in the body of subjects with B-cell chronic lymphocytic leukemia can be labeled and followed by performing routine blood draws at specified time intervals. By using mass spectrometric analysis we can measure how quickly new B-CLL cells are generated in the bone marrow and how quickly they leave the blood, a measure of cell turnover. This will help us to better understand the unique characteristics of this disease process.",['Chronic Lymphocytic Leukemia'],OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}",NA,"Inclusion Criteria: * 18 years of age, * Patients must be willing to contribute the required amount of blood without compromising their well being, * Participants must be willing to be contacted in the future. Exclusion Criteria: * Pregnancy, * Patients who are known to be anemic, with a hemoglobin \< 8, * Patients who are known to be infected with HIV.",Chronic Lymphocytic Luekemia,ALL,PROBABILITY_SAMPLE,"[{'measure': 'Characterization of the Proliferating Compartment in B-CLL Patients and in Healthy Aging Subjects', 'description': 'B-CLL is a dx of accumulation rather than proliferation. Evidence for various forms of clonal evolution suggests that B-CLL clones may be more dynamic than previously assumed. A non-radioactive, stable isotopic labeling method to measure B-CLL cell kinetics in vivo. Subjects drank an aliquot of 2H2O daily for 84 days, and 2H incorporation into the deoxyribose moiety of DNA of their newly divided B-CLL cells, measured by gc/ms, during the labeling period. Birth rates were calculated from the kinetic profiles. Death rates were defined as the difference between calculated birth and growth rates.', 'timeFrame': '1 year'}]",NA 32,NCT03420963,"{'fullName': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}","Donor Natural Killer Cells, Cyclophosphamide, and Etoposide in Treating Children and Young Adults With Relapsed or Refractory Solid Tumors",TERMINATED,"This phase I trial studies the side effects and best dose of cord blood-derived expanded allogeneic natural killer cells (donor natural killer \[NK\] cells) and how well they work when given together with cyclophosphamide and etoposide in treating children and young adults with solid tumors that have come back (relapsed) or that do not respond to treatment (refractory). NK cells, white blood cells important to the immune system, are donated/collected from cord blood collected at birth from healthy babies and grown in the lab. Drugs used in chemotherapy, such as cyclophosphamide and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving NK cells together with cyclophosphamide and etoposide may work better in treating children and young adults with solid tumors.","['Recurrent Cutaneous Melanoma', 'Recurrent Lip and Oral Cavity Carcinoma', 'Recurrent Malignant Endocrine Neoplasm', 'Recurrent Malignant Female Reproductive System Neoplasm', 'Recurrent Malignant Male Reproductive System Neoplasm', 'Recurrent Malignant Mesothelioma', 'Recurrent Malignant Neoplasm of Multiple Primary Sites', 'Recurrent Malignant Oral Neoplasm', 'Recurrent Malignant Pharyngeal Neoplasm', 'Recurrent Malignant Skin Neoplasm', 'Recurrent Malignant Soft Tissue Neoplasm', 'Recurrent Malignant Solid Neoplasm', 'Recurrent Malignant Thyroid Gland Neoplasm', 'Recurrent Malignant Urinary System Neoplasm', 'Refractory Cutaneous Melanoma', 'Refractory Malignant Bone Neoplasm', 'Refractory Malignant Endocrine Neoplasm', 'Refractory Malignant Female Reproductive System Neoplasm', 'Refractory Malignant Male Reproductive System Neoplasm', 'Refractory Malignant Mesothelioma', 'Refractory Malignant Neoplasm of Multiple Primary Sites', 'Refractory Malignant Oral Neoplasm', 'Refractory Malignant Pharyngeal Neoplasm', 'Refractory Malignant Skin Neoplasm', 'Refractory Malignant Soft Tissue Neoplasm', 'Refractory Malignant Solid Neoplasm', 'Refractory Malignant Thyroid Gland Neoplasm', 'Refractory Malignant Urinary System Neoplasm']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'Cord Blood-derived Expanded Allogeneic Natural Killer Cells', 'description': 'Given IV', 'armGroupLabels': ['Treatment (cyclophosphamide, etoposide, NK cells)'], 'otherNames': ['Allogeneic CB-derived Ex vivo-expanded NK Cells', 'CB-derived Expanded Allogeneic NK Cells', 'UCB-derived Expanded Allogeneic NK Cells', 'Umbilical Cord Blood-derived Expanded Allogeneic Natural Killer Cells']}, {'type': 'DRUG', 'name': 'Cyclophosphamide', 'description': 'Given IV', 'armGroupLabels': ['Treatment (cyclophosphamide, etoposide, NK cells)'], 'otherNames': ['(-)-Cyclophosphamide', '2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate', 'Carloxan', 'Ciclofosfamida', 'Ciclofosfamide', 'Cicloxal', 'Clafen', 'Claphene', 'CP monohydrate', 'CTX', 'CYCLO-cell', 'Cycloblastin', 'Cycloblastine', 'Cyclophospham', 'Cyclophosphamid monohydrate', 'Cyclophosphamide Monohydrate', 'Cyclophosphamidum', 'Cyclophosphan', 'Cyclophosphane', 'Cyclophosphanum', 'Cyclostin', 'Cyclostine', 'Cytophosphan', 'Cytophosphane', 'Cytoxan', 'Fosfaseron', 'Genoxal', 'Genuxal', 'Ledoxina', 'Mitoxan', 'Neosar', 'Revimmune', 'Syklofosfamid', 'WR- 138719']}, {'type': 'DRUG', 'name': 'Etoposide', 'description': 'Given IV', 'armGroupLabels': ['Treatment (cyclophosphamide, etoposide, NK cells)'], 'otherNames': ['Demethyl Epipodophyllotoxin Ethylidine Glucoside', 'EPEG', 'Lastet', 'Toposar', 'Vepesid', 'VP 16', 'VP 16-213', 'VP-16', 'VP-16-213', 'VP16']}]","Inclusion Criteria: * SCREENING: Patients with relapsed or refractory solid tumors and without known curative therapy or therapy proven to proven to prolong survival with acceptable quality of life. * SCREENING: Patients older than 21 years must have a solid tumor considered by study doctor to be of the childhood cancer type. * SCREENING: Performance level as measured by Karnofsky \>= 60% for patients \> 16 years of age or Lansky \>= 60% for patients =\< 16 years of age. * SCREENING: Documentation of measurable or evaluable non-measurable disease. * SCREENING: At least one documented histological verification of solid tumor diagnosis. Can be from original diagnosis or more recent. * ENROLLMENT: Patient must have fully recovered (i.e. returned to baseline) from the clinically significant acute treatment-related toxicities of all prior treatments prior to beginning treatment on this protocol with exceptions of cytopenias resulting from persistent disease, hearing loss and alopecia. * ENROLLMENT: Performance level as measured by Karnofsky \>= 60% for patients \> 16 years of age or Lansky \>= 60% for patients =\< 16 years of age. * ENROLLMENT: Creatinine clearance \>= 60 mL/min/1.73m\^2 (calculated by 24 hour \[h\] urine collection or nuclear glomerular filtration rate \[GFR\] scan if 24 h collection is not possible) or a serum creatinine based on age and gender as follows: * Age, maximum serum creatinine (mg/dL): * 1 month to \< 6 months, male 0.4, female 0.4; * 6 months to \< 1 year, male 0.5, female 0.5; * 1 to \< 2 years, male 0.6, female 0.6; * 2 to \< 6 years, male 0.8, female 0.8; * 6 to \< 10 years, male 1, female 1; * 10 to \< 13 years, male 1.2, female 1.2; * 13 to \< 16 years, male 1.5, female 1.4; * \>= 16 years, male 1.7, female 1.4. * ENROLLMENT: Adequate liver function, defined as: total bilirubin =\< 2 mg/dl * ENROLLMENT: Adequate liver function, as defined as serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 2.5 x upper limit of normal (ULN) for age (unless Gilbert's disease or abnormal liver function due to primary disease). * ENROLLMENT: Evidence of adequate bone marrow function (defined by absolute neutrophil count \>= 750), unless patient has documented tumor metastasis to the bone marrow or other condition that results in cytopenia without abnormal marrow function. * ENROLLMENT: Evidence of adequate bone marrow function (defined by platelets \>= 50,000), unless patient has documented tumor metastasis to the bone marrow or other condition that results in cytopenia without abnormal marrow function. * ENROLLMENT: Pulmonary symptoms controlled by medication and pulse oximetry \>= 92% on room air. * ENROLLMENT: Sexually active males and females of childbearing potential must agree to use a form of contraception considered effective and medically acceptable by the investigator. (Non-childbearing potential defined as pre-menarche, greater than one year post-menopausal or surgically sterilized). * ENROLLMENT: Confirmation that a cord blood donor which is matched with the recipient at a 4, 5, or 6/6 human leukocyte antigen (HLA) class I (serological) and HLA class II (molecular) antigens. * ENROLLMENT: Signed informed consent and if applicable pediatric assent. Exclusion Criteria: * SCREENING: Primary tumors of the central nervous system. * SCREENING: Chronic corticosteroid dependence that is unable to be weaned to discontinue. * SCREENING: Determined by study doctor that patient is unlikely to meet inclusion criteria after screening. * ENROLLMENT: Uncontrolled arrhythmias or uncontrolled symptoms of cardiac disease noted by screening history and physical. Patients with known cardiac dysfunction should have an ejection fraction (EF) \> 40% documented by echocardiogram (ECHO). * ENROLLMENT: Patients where the burden of pulmonary metastasis, location, or bulkiness of disease may cause high morbidity if localized swelling such as causing uncontrolled symptoms, oxygen dependence, or location near a major bronchi as determined by investigator. * ENROLLMENT: Pregnant females. * ENROLLMENT: Any uncontrolled systemic infection.",NA,ALL,NA,"[{'measure': 'Incidence of adverse events', 'description': 'Since toxicity is the primary outcome, patients with non-measurable disease (who are still evaluable) will be included in the analysis and in these cases standard methods for categorizing response of non-measurable disease will be used. Toxicity rate will be estimated separately by dose and cohort along with a 95% confidence interval. Adverse events will be tabulated for all the patients separately by dose levels.', 'timeFrame': 'Up to 30 days after the NK cell infusion'}, {'measure': 'Maximum tolerated dose and/or recommended phase 2 dose of cord blood-derived expanded allogeneic natural killer (NK) cells following chemotherapy', 'description': 'Primary analyses in this phase I trial are descriptive and exploratory. Toxicity rate will be estimated separately by dose and cohort along with a 95% confidence interval. Adverse events will be tabulated for all the patients separately by dose levels.', 'timeFrame': 'Up to 30 days after the NK cell infusion'}]","[{'measure': 'Response rate per immune-related therapy trials Response Evaluation Criteria in Solid Tumors (irRECIST)', 'description': 'Complete response and partial response will be estimated separately by dose and cohort along with a 95% confidence interval. Correlation of NK cell persistence, phenotype, and function with overall response will be estimated using two-sample t-test/Wilcoxon sum-rank test and analysis of variance (ANOVA)/Kruskal-Wallis test as appropriate.', 'timeFrame': 'Up to 30 days after the NK cell infusion'}, {'measure': 'NK cell persistence, phenotype, and function', 'description': 'Correlation of NK cell persistence, phenotype, and function with overall response will be estimated using two-sample t-test/Wilcoxon sum-rank test and ANOVA/Kruskal-Wallis test as appropriate.', 'timeFrame': 'Up to 30 days after the NK cell infusion'}, {'measure': 'Overall survival (OS)', 'description': 'The Kaplan-Meier method will be used to estimate the distribution of OS. The description statistics of rate of OS may be analyzed separately by different tumor types and response/stable patients. Cox proportional hazards regression analysis may also be conducted to model the association between OS and factors of interest.', 'timeFrame': 'Up to 30 days after the NK cell infusion'}, {'measure': 'Time to progression (TTP)', 'description': 'The Kaplan-Meier method will be used to estimate the distribution of TTP. The description statistics of rate of TTP may be analyzed separately by different tumor types and response/stable patients. Cox proportional hazards regression analysis may also be conducted to model the association between TTP and factors of interest.', 'timeFrame': 'Up to 30 days after the NK cell infusion'}]" 33,NCT00005863,"{'fullName': 'National Cancer Institute (NCI)', 'class': 'NIH'}",Combination Chemotherapy With or Without Filgrastim and/or Tretinoin in Treating Patients With Acute Myeloid Leukemia,COMPLETED,"RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. It is not yet known whether combination chemotherapy with filgrastim and/or tretinoin is more effective than combination chemotherapy alone for acute myeloid leukemia. PURPOSE: This randomized phase III trial is studying combination chemotherapy with filgrastim and/or tretinoin to see how well they work compared to combination chemotherapy alone in treating patients with acute myeloid leukemia.","['Leukemia', 'Myelodysplastic Syndromes', 'Myelodysplastic/Myeloproliferative Neoplasms']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}","[{'type': 'BIOLOGICAL', 'name': 'filgrastim'}, {'type': 'DRUG', 'name': 'cytarabine'}, {'type': 'DRUG', 'name': 'daunorubicin hydrochloride'}, {'type': 'DRUG', 'name': 'etoposide'}, {'type': 'DRUG', 'name': 'fludarabine phosphate'}, {'type': 'DRUG', 'name': 'tretinoin'}]","DISEASE CHARACTERISTICS: * Diagnosis of acute myeloid leukemia (AML) including de novo or secondary AML, or a preexisting myelodysplastic syndrome * Overt resistant disease with more than 15% bone marrow blasts after induction course * Primary refractory disease * Failure to achieve first complete remission after at least 2 induction courses * Relapse from first remission with more than 5% bone marrow blasts * Complete or partial remission following 1 induction course with adverse cytogenetic abnormalities at diagnosis * No acute promyelocytic leukemia * No chronic myeloid leukemia in blast transformation * No prior relapse from a second or greater remission PATIENT CHARACTERISTICS: Age: * Any age Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Creatinine clearance at least 30 mL/min Other: * No other active malignancy * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified",NA,ALL,NA,NA,NA 34,NCT04509063,"{'fullName': 'University of Aarhus', 'class': 'OTHER'}",Investigating Public Enthusiasm for Mammography Screening in Denmark,COMPLETED,"Based on an American study by Scherer et al., it is hypothesized that some women will make irrational choices regarding their participation in mammography screening. Therefore, the aim is to estimate the prevalence of Danish women having an irrational preference for mammography screening even when it confers no benefits, but only harms.","['Breast Neoplasm Female', 'Mammography Screening', 'Decision Making', 'Information Seeking Behavior']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Self administered questionnaire', 'whoMasked': ['INVESTIGATOR']}}","[{'type': 'BEHAVIORAL', 'name': 'Information about hypothetical mammography screening without benefits', 'description': 'We will present an online questionnaire with two types of information on the harms of screening. Then we will compare the prevalence of irrational decisions in the two arms.', 'armGroupLabels': ['Detailed information about screening harms', 'Non-detailed information about screening harms']}]","Inclusion Criteria: * Residence: Central Denmark Region Exclusion Criteria: \-",NA,FEMALE,NA,"[{'measure': 'Irrational preference', 'description': 'Willingness to participate in mammography screening with no benefits on morbidity or mortality, only harms. Investigated by sending out questionnaire once to all women.', 'timeFrame': 'The outcome is assessed when women answer the questionnaire which is sent out at the same time to all women. The invited women will have 2 months to answer the questionnaire (it should only take around 15 minutes to answer). Planned from November 2020.'}]",NA 35,NCT03827993,"{'fullName': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}",Improving Sexual Health in Gynecologic Cancer Patients,TERMINATED,This study seeks to find out if an early intervention of providing directed sexual health education and treatment for gynecologic cancer patients will improve patient outcomes as compared to routine clinic visits.,['Gynecologic Cancer'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BEHAVIORAL', 'name': 'dedicated sexual health clinic appointment', 'description': 'Intervention will consist of a dedicated sexual health clinic appointment with a physician provider focused on sexual health in this population. This provider will perform a focused history and physical, and will then determine need for appropriate treatment and management, which may consist of recommendations for medications, psychosocial counseling, physical therapy, and/or dilator use, but are not required.', 'armGroupLabels': ['Dedicated sexual health clinic appointment']}]","Inclusion Criteria: * Able to consent * Screening positive for sexual health dysfunction as per baseline FSFI * Diagnosed with any gynecologic malignancy It is acceptable to have received treatment prior to or during enrollment, including prior surgery, chemotherapy, radiation, hormonal therapy, or clinical trial. Exclusion Criteria: * Unable to speak English * Patients unable to consent",NA,FEMALE,NA,"[{'measure': 'Change in sexual dysfunction as measured by FSFI', 'description': 'Change in sexual function as measured by FSFI, a 19-question, standardized scale of female sexual function, validated in cancer survivors as compared to start of study.', 'timeFrame': 'At 3, 6, 9, and 12 months from start of treatment'}]","[{'measure': 'Change in sexual distress as measured by FSDS', 'description': 'Change in sexual distress score as measured by FSDS, a 13-question, validated questionnaire assessing sexually related personal distress in women with female sexual dysfunction. This questionnaire will be used for follow up visits to help assess the level of distress participants are enduring related to their sexual dysfunction.', 'timeFrame': 'At 3, 6, 9, and 12 months from start of treatment'}, {'measure': 'Change in psychologic distress as measured by Kessler K10 Scale', 'description': ""Change in psychologic distress as measured by Kessler K10 Scale, a 10-question, validated questionnaire assessing psychological distress. This survey will be used at follow up visits to help determine baseline psychological distress unrelated to sexual distress for a more global picture of the participants' coping throughout their illness. Scores range from 10 to 50 with higher scores indicating worse distress symptoms."", 'timeFrame': 'At 3, 6, 9, and 12 months from start of treatment'}, {'measure': 'Change in clinical assessment of vaginal symptoms as measured by VAS', 'description': 'Change in vaginal symptoms as measured by VAS, a 4-item validated clinical measure of vaginal health, with scores ranging from 0-12 and higher scores indicating worse symptoms.', 'timeFrame': 'At 3, 6, 9, and 12 months from start of treatment'}, {'measure': 'Change in clinical assessment of vulvar symptoms as measured by VuAS', 'description': 'Change in vulvar symptoms as measured by VAS, a 4-item validated clinical measure of vulvar health with scores ranging from 0-12 and higher scores indicating worse symptoms.', 'timeFrame': 'At 3, 6, 9, and 12 months from start of treatment'}]" 36,NCT03764293,"{'fullName': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}",A Study to Evaluate SHR-1210 in Combination With Apatinib as First-Line Therapy in Patients With Advanced HCC,COMPLETED,"This is a randomized, open-label, international, multi-center, phase III trial to evaluate the efficacy and safety of SHR-1210 plus apatinib mesylate versus sorafenib as first-line therapy in patients with advanced HCC.",['Locally Advanced or Metastatic and Unresectable HCC'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'SHR-1210', 'description': 'Subjects receive SHR-1210 intravenously, Dosage form: lyophilised powder, Strength: 200 mg /vial', 'armGroupLabels': ['SHR-1210'], 'otherNames': ['Camrelizumab']}, {'type': 'DRUG', 'name': 'Apatinib', 'description': 'Subjects receive Apatinib orally, Dosage form: tablet, Strength: 250 mg/tablet', 'armGroupLabels': ['SHR-1210'], 'otherNames': ['Rivoceranib']}, {'type': 'DRUG', 'name': 'Sorafenib', 'description': 'Subjects receive Sorafenib orally, Dosage form: tablet, Strength: 0.2 g/tablet', 'armGroupLabels': ['Control']}]","Inclusion Criteria: * Histopathologically or cytologically confirmed advanced HCC * No previous systematic treatment for HCC * Have at least one measurable lesion (in accordance with RECIST v1.1) * BCLC stage B or C, and not suitable for surgical or local therapy, or has progressed following surgical and/or local therapy * ECOG-PS score 0 or 1 * Child-Pugh Class: Grade A * Life Expectancy of at least 12 weeks * Subjects with HBV infection: HBV DNA\<500 IU/ml or \< 2500 copy/mL, and have received anti-HBV therapy for at least 14 days prior to enrollment in the study * Subjects with HCV-RNA(+) must receive antiviral therapy * Adequate organ function Exclusion Criteria: * Known hepatocholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and lamellar cell carcinoma; other active malignant tumor except HCC within 5 years or simultaneously * Moderate-to-severe ascites with clinical symptoms * History of gastrointestinal hemorrhage within 6 months prior to the start of study treatment or clear tendency of gastrointestinal hemorrhage * Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess within 6 months prior to the start of study treatment * Known genetic or acquired hemorrhage or thrombotic tendency * Thrombosis or thromboembolic event within 6 months prior to the start of study treatment * Cardiac clinical symptom or disease that is not well controlled * Hypertension that can not be well controlled through antihypertensive drugs * Factors to affect oral administration * History of hepatic encephalopathy * Previous or current presence of metastasis to central nervous system * HIV infection * Combined hepatitis B and hepatitis C co-infection * Be ready for or previously received organ or allogenic bone marrow transplantation * Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity * Active known, or suspected autoimmune disease * Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of first administration of study treatment * Use of potent CYP3A4 inducers or inhibitors within 2 weeks prior to the signature of ICF * Known history of serious allergy to any monoclonal antibody or targeted anti-angiogenic drug * Severe infection within 4 weeks prior to the start of study treatment * Palliative radiotherapy for non-target lesions to control symptoms is allowed, but it must be completed at least 2 weeks prior to the start of study treatment * Treatment of other investigational product(s) within 28 days prior to the start of study treatment",NA,ALL,NA,"[{'measure': 'Overall Survival (OS)', 'description': 'OS was defined as the time from randomization to death from any cause.', 'timeFrame': 'Up to approximately 3 years'}, {'measure': 'Progression-free Survival (PFS) Evaluated by the Blinded Independent Review Committee (BIRC) Based on RECIST v1.1', 'description': 'PFS was defined as the time from randomization to the first occurrence of progressive disease (PD) by tumor image evaluation or death from any cause whichever occurs first as determined by BIRC according to RECIST v1.1. PD: at least a 20% increase in the sum of diameters of target lesions and the sum of diameters must also demonstrate an absolute increase of \\>/= 5 millimeters (mm), or a measurable increase in a non-target lesion, or the appearance of new lesions.', 'timeFrame': 'Up to approximately 3 years'}]","[{'measure': 'Objective Response Rate (ORR)', 'description': 'ORR defined as the percentage of subjects with complete response (CR) or partial response (PR) evaluated by the BIRC or investigator based on RECIST v1.1. CR: disappearance of all target lesions. PR: At least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. Overall Response (OR)=CR+PR.', 'timeFrame': 'Up to approximately 3 years'}, {'measure': 'Disease Control Rate (DCR)', 'description': 'DCR defined as the percentage of subjects with complete response, partial response or stable disease (SD) ≥ 8 weeks evaluated by the BIRC or investigator based on RECIST v1.1. Complete response (CR) was defined as Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.', 'timeFrame': 'Up to approximately 3 years'}, {'measure': 'Duration of Response (DOR)', 'description': 'DOR defined as time from the date of first record of objective response (CR or PR) to the first occurrence of radiological progression or death, whichever comes first, evaluated by the BIRC or investigator based on RECIST v1.1. Complete response (CR) was defined as Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameter of TL, taking as reference the baseline sum of diameters.', 'timeFrame': 'Up to approximately 3 years'}]" 37,NCT06414421,"{'fullName': 'Cukurova University', 'class': 'OTHER'}","The Effect of TENS on Pain, Complications and Comfort in Patients Who Had Prostate Biopsy With Transrectal Ultrasound",COMPLETED,"Prostate cancer is one of the most common types of malignancy in men. Transrectal Ultrasound Guided Prostate Biopsy (TRUSG-PBx) is considered the gold standard method. The present, Transrectal ultrasound guided prostate biopsy is considered the gold standard method in the diagnosis of prostate cancer. During the process, patients experience severe discomfort and pain, although anesthetics and analgesics are used. In addition to pharmacological methods, non-pharmacological methods are also used in the control of pain caused by diagnosis and treatment interventions. Transcutaneous Electrical Nerve Stimulation (TENS) is among the non-pharmacological methods and it is the most widely used electroanalgesia method. In this randomized controlled intervention research, the effect of TENS application will be evaluated on pain, complications and comfort level during and after the procedure in patients who underwent Transrectal Ultrasound-Guided Prostate Biopsy. Thanks to this research, it is thought that the pain level and complications will decrease and the comfort level will increase in patients who undergo TENS application. The research will be carried out in Çukurova University Faculty of Medicine Balcalı Application and Research Hospital Urology Outpatient Clinic. The sample of the research will create volunteer patients, providing research criteria and made prostate biopsy in Urology Outpatient Clinic. Patients consisting of 2 groups as control and experimental (TENS applied) will be determined by randomization. In the power analysis calculated with statistical support, confidence interval of 95%, alpha value 0.05, beta value calculated with 80% power, a total of 80 patients will be included in the control and experimental group, including 40 patients each. The data will be collected by ""Personal Information Form"", ""Pain Assessment Form"", ""TRUSG-PBx Complication Follow-up Form"", ""Perianesthesia Comfort Scale Form"". The data obtained will be analyzed in SPSS (Statisticial Package for the Social Sciences) package program. In this context, our research, a comparison will be made by evaluating the effect of TENS application on pain, complications and comfort, in patients who underwent transrectal ultrasound-guided prostate biopsy. These results, non-pharmacological methods will make great contributions to improving patient outcomes in diagnostic interventions. Keywords: Pain, Nurse, Comfort, Prostate Biopsy and Complications, Transcutaneous Electrical Nerve Stimulation (TENS).",['Prostate Cancer XXX'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study was conducted as a two-group randomized controlled intervention study to determine the effect of TENS application on pain, complications and comfort in patients undergoing transrectal ultrasound-guided prostate biopsy (TRUSG-PBx).', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'OTHER', 'name': 'Transcuten Electriacal Nerve Stimulation', 'description': 'In TENS group patients, 4 electrodes of the TENS device were placed 3-5 minutes before the biopsy procedure, and the application was started and TENS was applied throughout the procedure. continued. TENS was applied again for 30 minutes 2 hours after the procedure.', 'armGroupLabels': ['TENS']}]","Inclusion Criteria: * • Able to communicate, * Those who are over 40 years old, * Being literate, * No previous history of chronic pain, * Not addicted to alcohol or drugs, * Without bleeding diathesis and active urinary tract infection, * Having no cognitive impairment, neurological or psychiatric disease, * Do not have any inflammatory rheumatological, neurological or cognitive disease, * No contraindications for electrotherapy (pacemaker, arrhythmia, epilepsy, dermatological diseases), * Not using chronic opioids, antidepressants or psychoactive drugs, * Those who have not had TENS application before, * No skin lesions in the electrode connection areas, * No significant anorectal disease (wound, fistula, fissure, hemorrhoids, etc.), * As a result of the evaluation by the physician, there is no harm in applying TENS, * Patients who voluntarily agreed to participate in the research were included. Exclusion Criteria: * Lidocaine gel was applied to the anal area and rectum before the biopsy, or a different anesthetic method was used (IV, IM, rectal anesthetic/analgesic drug application or general anesthesia, etc.), * Coming for prostate biopsy followed by Foley catheter, * Patients who did not agree to participate in the research were not included in the sample.",NA,MALE,NA,"[{'measure': 'Pain Scale (Numerical pain scale)', 'description': 'The scale used in the first part of this form, which is intended to evaluate pain severity, is the Numerical Pain Scale (NPS). On this scale, it starts with absence of pain (0) and reaches the level of unbearable pain (10).According to the determined measurement times of the patients \\[T1: At the beginning of the biopsy/while the ultrasound probe is being placed (NPS-1), T2: During the biopsy/5 minutes after the ultrasound probe is placed (NPS-2), T3: At the end of the biopsy/while the ultrasound probe is being removed (NPS-3). , T4: 1 hour after the end of the biopsy (NPS-4), T5: 2 hours after the end of the biopsy (NPS-5), T6: 2.5 hours after the end of the biopsy (NPS-6), T7: During the first urination after the biopsy (NPS-6). -7), T8: 6 hours after the end of the biopsy (NPS-8), T9: 24 hours after the end of the biopsy (NPS-9)\\]. The second part of the pain evaluation form includes information about the analgesic medication used in the first 6 and 24 hours.', 'timeFrame': 'The first 24 hours: NPS 1, 2, 3, 4, 5, 6, 7, 8, 9'}]","[{'measure': 'Complication (TRUSG-PBx Complication Monitoring Form)', 'description': 'Comparison of complications of patients according to time Prepared by the researchers in line with the literature, the first part of TKIF, prepared by the researchers in line with the literature, aims to determine bleeding during biopsy (rectal bleeding, bleeding from the urethra) and bleeding in the first urine after biopsy, and the second part / after discharge (at home) aims to determine complications that may develop after biopsy. 6 items are included (hematuria, hematospermia, rectal bleeding, dysuria, anal pain, urinary retention).', 'timeFrame': 'Hematuria, hematospermia, rectal bleeding, urinary retention, dysuria, anal pain seen in the first 24 hours and 1 week'}]" 38,NCT05027321,"{'fullName': 'Hospital St. Joseph, Marseille, France', 'class': 'OTHER'}","Efficacy of Preparation in Self-Hypnosis by Anchoring Versus Conversational Hypnosis, Used Alone or Combined, in Patients Undergoing Breast Macrobiopsies",RECRUITING,"The incidence of breast cancer and its mortality are reduced thanks in particular to early detection. Often performed after a screening test, stereotactic macrobiopsies are used to characterize abnormalities detected on mammography. This anxiety-inducing and painful examination leads to significant physiological and psychological modifications for these women who logically apprehend the realization of this act. Faced with this observation, investigators wondered what could be done to improve the experience of the patients during this examination. Investigators were interested in hypnosis because its effectiveness as a complementary practice has been validated by numerous studies with benefits on pain and stress management. However, today, there are no convincing results confirming which hypnosis method would be the best to manage patients' anxiety and pain during this examination.",['Breast Neoplasm Female'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BEHAVIORAL', 'name': 'Preparation in Self-Hypnosis by anchoring', 'description': 'Preparation in Self-Hypnosis by anchoring just before examination', 'armGroupLabels': ['Preparation in Self-Hypnosis by anchoring']}, {'type': 'BEHAVIORAL', 'name': 'Conversational Hypnosis', 'description': 'Conversational Hypnosis during examination', 'armGroupLabels': ['Conversational Hypnosis']}, {'type': 'BEHAVIORAL', 'name': 'Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis', 'description': 'Preparation in Self-Hypnosis by anchoring just before examination combied with Conversational Hypnosis during examination', 'armGroupLabels': ['Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis']}]","Inclusion Criteria: * aged 18 or over, * referred to the medical imaging department of Saint-Joseph hospital for breast macrobiopsy, * naive of any hypnosis, * having given free, informed and written consent, * being affiliated to a social security scheme or beneficiary of such scheme Exclusion Criteria: * having a major hearing loss, * suffering from identified mental or psychotic disorders, * not understanding the French language, * having already had hypnosis practices, * having an ongoing pregnancy, * being the subject of a safeguard measure",NA,FEMALE,NA,"[{'measure': 'change in anxiety score', 'description': 'Score (from 20 to 80) measured on the State-Trait Anxiety Inventory for state anxiety (STAI-Y1), how respondent feels right now, at this moment.\n\nTotal scores can be categorized into five levels:\n\n1. \\> 65 (very high),\n2. from 56 to 65 (high),\n3. from 46 to 55 (medium),\n4. from 36 to 45 (low),\n5. \\< 35 (very low). Higher scores mean a worse outcome.', 'timeFrame': 'baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days'}]","[{'measure': 'change in anxiety score', 'description': 'measured on anxiety visual analog scale from 0 (not at all anxious) to 8 (extremely anxious)', 'timeFrame': 'baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days'}, {'measure': 'change in pain score', 'description': 'measured on pain visual analog scale from 0 (no pain) to 10 (worst pain)', 'timeFrame': 'baseline (pre-intervention, during the intervention, immediatly after the intervetion) and at 8 days'}, {'measure': 'patient examination experience', 'description': 'measured on satisfaction visual analog scale from 0 (poor experience quality) to 10 (very good experience quality)', 'timeFrame': 'baseline (immediately after the intervention)'}, {'measure': 'staff examination experience', 'description': 'measured on satisfaction visual analog scale from 0 (poor experience quality) to 10 (very good experience quality)', 'timeFrame': 'baseline (immediately after the intervention)'}, {'measure': 'anxiety score', 'description': 'STAI-Y2 (score from 20 to 80 measured on the STAI for trait anxiety), how respondent generally feel\n\nTotal scores can be categorized into five levels:\n\n1. \\> 65 (very high),\n2. from 56 to 65 (high),\n3. from 46 to 55 (medium),\n4. from 36 to 45 (low),\n5. \\< 35 (very low). Higher scores mean a worse outcome.', 'timeFrame': 'baseline (pre-intervention)'}, {'measure': 'Amount of nesthetic administered to the patiet during the procedure', 'description': 'mL', 'timeFrame': 'baseline (immediately after the intervention)'}, {'measure': 'Examination duration', 'description': 'minutes', 'timeFrame': 'baseline (immediately after the intervention)'}, {'measure': 'AE/SAE reporting', 'timeFrame': 'baseline (during the intervention, immediatly after the intervetion) and at 8 days'}]" 39,NCT05534321,"{'fullName': 'Baptist Health South Florida', 'class': 'OTHER'}",Prophylactic Radiotherapy of MInimally Symptomatic Spinal Disease,RECRUITING,"Early palliative care has been shown to improve the quality of life and even survival for patients with metastatic cancer. More and more supportive oncology teams in cancer centers now advocate for early integration of radiation therapy (RT) in a patient's palliative management course. While multiple randomized studies have evaluated the efficacy of different RT regimens in the treatment of symptomatic bone lesions, few studies have examined the impact of early, upfront RT for asymptomatic or minimally symptomatic (non- opioid dependent) spine metastases and its efficacy in preventing skeletal-related events (SREs). Since the pathophysiology of spinal metastatic disease is distinct from other bony metastatic disease, the proposed trial seeks to understand whether it is beneficial to patients with minimally symptomatic disease to undergo upfront RT to reduce the risks of SREs and their sequelae, including hospitalizations.",['Spine Metastases'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'RADIATION', 'name': 'Prophylactic Radiotherapy', 'description': 'Radiation therapy will be delivered according to department standards. For this protocol, total dose and dose fractionation may be delivered at the discretion of the treating radiation oncologist according to department standards. All techniques including conventional, three-dimensional conformal radiation therapy (3D-CRT), intensity-modulated radiation therapy (IMRT), and stereotactic radiosurgery/stereotactic body radiation therapy (SRS/SBRT) techniques may be used. Image guidance at the time of treatment delivery to verify patient positioning may be chosen at the discretion of the treating radiation oncologist according to department standards.', 'armGroupLabels': ['Prophylactic Radiation Therapy']}, {'type': 'DRUG', 'name': 'Standard of care systemic therapy', 'description': 'Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating medical oncologist. Patients may receive systemic therapy concurrently and there are no restrictions on initiation of systemic agents after radiotherapy including immunotherapy and hormonal therapy, the timing of which will be determined by a consensus between the treating medical and radiation oncologists.', 'armGroupLabels': ['Standard of Care Systemic Therapy or Surveillance']}]","Inclusion Criteria: 1. Histologically-confirmed solid tumor malignancy with greater than 5 sites of metastatic disease detected on cross-sectional imaging. 2. Has high-risk bone metastases that are asymptomatic or minimally symptomatic (not requiring opioids). High risk metastases are defined as: 1. Bulkiest sites of spinal osseous disease ≥ 2cm, 2. Disease at junctional levels, including the thoracic apex (Occiput to C2, C7-T1, T12-L2, and L5- S1) 3. Disease with posterior element involvement, including interspinous, unilateral, or bilateral facet joints. 4. Vertebral body compression deformity \> 50%. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2. 4. Age ≥ 18 years. 5. Able to provide informed consent. 6. Patients at reproductive potential must agree to practice an effective contraceptive method. Women of childbearing potential must not be pregnant or lactating. Exclusion Criteria: 1. Previous RT to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances. 2. Serious medical co-morbidities precluding RT. 3. Pregnant or lactating women. 4. Target lesion(s) is/are complicated bone metastases that include clinical or radiological evidence of spinal cord compression or impending pathological fracture. 5. Leptomeningeal disease. 6. Patients whose entry to the trial will cause unacceptable clinical delays in their planned management.",NA,ALL,NA,"[{'measure': 'Number of patients who have skeletal-related events (SREs)', 'description': 'Number of skeletal related events (SREs), which will be defined as pathological fractures, spinal cord compression, or interventions (palliative RT, interventional procedures, or spine surgery)', 'timeFrame': '1 year'}]","[{'measure': 'Number of skeletal-related event (SRE) hospitalizations', 'description': 'Number of hospitalizations attributed to skeletal-related events (SREs)', 'timeFrame': '1 year'}, {'measure': 'Pain-related quality of life', 'description': 'Pain-related quality of life using the Brief Pain Inventory (BPI) form. The BPI is a 17-item patient self-rating scale assessing demographic data, use of medications, as well as the sensory and reactive components of pain. The scale is from 0-10, and there are breakpoints between scores of 4 and 5 and between 6 and 7, indicating that mild pain correlates with scores of 1-4, moderate pain with 5-6, and severe pain with scores of 7-10.', 'timeFrame': '3 months, 6 months, and 12 months, optionally within 1 week of a skeletal-related event (SRE)'}, {'measure': 'Health care utilities and quality of life', 'description': 'Health care utilities and quality of life using the EuroQol Group EQ-5D-5L form and FACT-G questionnaires. It has been developed to generate a generic cardinal index of health, thus giving it considerable potential for future use in economic evaluation. The EQ-5D-5L is a two-part, patient-completed questionnaire. The first part consists of 5 items covering 5 dimensions including: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on 3 levels including: 1=no problems; 2= moderate problems; and 3=extreme problems. The second component is the visual analog scale, where the participant rates their own overall health on a scale of 0 (worst health) to 100 (best health).', 'timeFrame': '3 months, 6 months, and 12 months, optionally within 1 week of a skeletal-related event (SRE)'}, {'measure': 'Pain-free survival (PFS)', 'description': 'Pain-free survival (PFS) is defined as the time from study entry to until the start of opioid use or until death.', 'timeFrame': 'Until 1 year'}, {'measure': 'Overall survival (OS)', 'description': 'Overall survival (OS) is defined as the time from study entry until death.', 'timeFrame': 'Until 1 year'}, {'measure': 'Adverse event frequency and severity', 'description': 'Evaluate CTCAE v5 toxicity events in the upfront RT arm by tabulating all toxicities and summarizing the CTCAE v5 scores.', 'timeFrame': '3 months, 6 months, and 12 months'}]" 40,NCT03410121,"{'fullName': 'Center Eugene Marquis', 'class': 'OTHER'}",Comparison of Humeral or Thoracic Implantation of an Central Veinous Access by an Implantable Venous Access Device in Patients With Solid Tumors Requiring Chemotherapy,COMPLETED,"The aim of this study is to compare the humeral and thoracic implantation of a central venous access by an implantable device in patients with solids tumors who require intravenous chemotherapy. This is a monocentric randomized study. 572 patients will be recruited for 2 years. They will be randomized either in the thoracic implantation, either in the humeral implantation Due to the 1:3 randomization, 143 patients will be randomized in the humeral arm and 429 into the thoracic one. Number of complications related to the implantable device, medico-economic analysis as well as patient satisfaction will be assessed. Every patients with solid tumor requiring medical device implantation for intravenous chemotherapy treatment will be eligible. Both humeral and thoracic implantation of medical device are standard procedures. The randomization in a specific arm is the study procedure and is considered as an interventional study in France.","['Solid Tumor, Adult', 'Chemotherapy Treatment', 'Advanced or Metastasis Stage']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DEVICE', 'name': 'IPolysite ® Mini série 3108 or Polysite ® Standard, série 4108.', 'description': 'Implantation of intravenous medical device in thoracic location', 'armGroupLabels': ['Standard 1 : Thoracic location']}, {'type': 'DEVICE', 'name': 'Vital Port®Minititanium', 'description': 'Implantation of intravenous medical device in humeral location', 'armGroupLabels': ['Standard 2 : Humeral location']}]","Inclusion Criteria: * Patients with solid tumors at an Advanced or metastasis stage requiring placement of implantable catheter for intravenous chemotherapy treatment * Older than 18 years * Express signed consent Exclusion Criteria: * Life expectancy less than 12 months assessed by investigator * Infection or uncontrolled suspected infection * Medical contraindication to port implantation by catheter in thoracic or humeral location * Pregnant or lactating women * Abnormal coagulation * Immunosuppressed patients (for example known hepatitis B or C, or known positive Human Immunodeficiency Virus due to the spreading risk) * Patient not affiliated to the French social security * Access time to the humeral or thoracic port placement higher than 15 days (from the randomization theoretical date) * Protected Adult or adult deprived of liberty",NA,ALL,NA,"[{'measure': 'Number of complications related to Implantable Venous Access Device', 'description': 'Number of complications that will be recorded by medical oncologist', 'timeFrame': '3 months after medical device placement'}]",NA 41,NCT02820506,"{'fullName': 'University of Southern Denmark', 'class': 'OTHER'}",Sentinel Node Mapping in Women With Endometrial and Cervical Cancer,UNKNOWN,The aim of the study is to evaluate the feasibility of applying the SLN mapping technique in combination with FDG-PET/CT imaging in women with high-risk histology endometrial cancer and in patients with cervical cancer tumour size 2-4 cm.,"['Uterine Cervical Neoplasms', 'Uterine Neoplasms']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Endometrial cancer, Diagnostic; Assessing the safety of the SLN mapping algorithm. Inclusion is defined by a power calculation: Assuming the true incidence of metastasis is 20% and the sensitivity of the SLN mapping algorithm is 96%. To obtain the conclusion that NPV is larger than 94% using a 95% two-sided exact Clopper-Pearson confidence interval, then 150 women with sentinel lymph node mapping, a FDG/PET-CT and Pelvic- and paraaortic lymph node dissection are needed.\n\nCervical cancer: Study is diagnostic and primarily explorative.', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'PROCEDURE', 'name': 'SLN mapping and removal of PET-positive lymph nodes', 'description': 'Sentinel node mapping will be performed, followed by systematic removal og PET/CT positive lymph nodes', 'armGroupLabels': ['Cervical cancer tumor size 2-4 cm', 'High risk endometrial cancer']}]","Inclusion Criteria: * Study IIA: Patients with cervical cancer, FIGO IB1, tumor size 2-4 cm * Study IIB: Patients with high risk endometrial cancer, presumed FIGO I, type 1 histology grade 3 Endometrioid adenocarcinoma or type 2 histology (serous-, clearcel-, carcinosarcoma or undifferentiated adenocarcinoma. Exclusion Criteria: * Prior PL * Known allergy towards ICG and/or iodine (ICG contains 5% sodium iodine) * Women included in other studies affecting outcome-measures of the present study",NA,FEMALE,NA,"[{'measure': 'Sensitivity', 'description': 'Sensitivity of sentinel lymph node mapping compared to the sensitivity of sentinel lymph node mapping combined with removal of PET-positive lymph nodes', 'timeFrame': '2 years'}, {'measure': 'Negative predictive value', 'description': 'Negative predictive value of sentinel lymph node mapping algorithm, and a sentinel lymph node mapping algorithm including removal of PET-positive lymph nodes', 'timeFrame': '2 years'}]","[{'measure': 'Specificity', 'description': 'Specificity of sentinel lymph node mapping compared to the combination of sentinel lymph node mapping and removal of PET-positive lymph nodes', 'timeFrame': '2 years'}, {'measure': 'Positive predictive value', 'description': 'Positive predictive value of sentinel lymph node mapping compared to the combination of sentinel lymph node mapping and removal of PET-positive lymph nodes', 'timeFrame': '2 years'}, {'measure': 'Prevalence of lymph node metastasis', 'description': 'Prevalence of lymph node metastasis in the pelvis and paraaortic area', 'timeFrame': '2 years'}, {'measure': 'Incidence of lymphedema', 'description': 'Using patient reported outcome measures', 'timeFrame': '3 years'}, {'measure': 'Severity of lymphedema', 'description': 'Using patient reported outcome measures', 'timeFrame': '3 years'}, {'measure': 'Quality of life rate', 'description': 'Using patient reported outcome measures', 'timeFrame': '3 years'}]" 42,NCT07377006,"{'fullName': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}",Decision Support Tool to Enhance Germline Genetic Testing for Patients With Prostate Cancer,NOT_YET_RECRUITING,"This clinical trial identifies factors associated with completing genetic testing, aids in the development of a decision support tool, and tests how well the decision support tool works to enhance germline genetic testing in patients with prostate cancer. Germline genetic testing is a guideline-recommended standard of care for many patients with prostate cancer. Completing genetic testing can enable the use of targeted therapies, offers access to novel clinical trials, provides valuable information, and can help identify at risk family members. The decision support tool may educate patients and assist in the decision to engage with germline genetic testing.",['Prostate Carcinoma'],INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BEHAVIORAL', 'name': 'Behavioral Intervention', 'description': 'View decision support tool', 'armGroupLabels': ['Group 2 (Draft decision support tool, cognitive interview)', 'Group 3 (Decision tool)'], 'otherNames': ['Behavior Conditioning Therapy', 'Behavior Modification', 'Behavior or Life Style Modifications', 'Behavior Therapy', 'Behavioral', 'Behavioral Interventions', 'Behavioral Modification', 'Behavioral Therapy', 'Behavioral Treatment', 'Behavioral Treatments']}, {'type': 'PROCEDURE', 'name': 'Biospecimen Collection', 'description': 'Undergo blood sample collection', 'armGroupLabels': ['Group 3 (Decision tool)'], 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection']}, {'type': 'OTHER', 'name': 'Electronic Health Record Review', 'description': 'Ancillary studies', 'armGroupLabels': ['Group 1 (Qualitative interview)']}, {'type': 'OTHER', 'name': 'Genetic Counseling', 'description': 'Meet with genetic counselor', 'armGroupLabels': ['Group 3 (Decision tool)']}, {'type': 'OTHER', 'name': 'Genetic Testing', 'description': 'Undergo standard of care genetic testing', 'armGroupLabels': ['Group 3 (Decision tool)'], 'otherNames': ['Genetic Analysis', 'Genetic Examination', 'Genetic Test']}, {'type': 'OTHER', 'name': 'Interview', 'description': 'Complete qualitative interview', 'armGroupLabels': ['Group 1 (Qualitative interview)']}, {'type': 'OTHER', 'name': 'Interview', 'description': 'Complete cognitive interview', 'armGroupLabels': ['Group 2 (Draft decision support tool, cognitive interview)']}, {'type': 'OTHER', 'name': 'Survey Administration', 'description': 'Ancillary studies', 'armGroupLabels': ['Group 3 (Decision tool)']}]","Inclusion Criteria: * Diagnosed prostate cancer patients receiving care at Lyndon B. Johnson (LBJ) Hospital * Were recommended for germline genetic testing by their oncology provider * Can provide informed consent * Can communicate in English or Spanish Exclusion Criteria: * Prostate cancer patients receiving care at LBJ who are unable to participate due to a serious psychological or cognitive condition",NA,MALE,NA,"[{'measure': 'Safety and Adverse Events (AEs)', 'description': 'Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0', 'timeFrame': 'Through study completion; an average of 1 year'}]",NA 43,NCT03705806,"{'fullName': 'University Health Network, Toronto', 'class': 'OTHER'}",Palliative Thoracic ImmunoRT,ACTIVE_NOT_RECRUITING,The trial is designed as a prospective observational single arm study investigating stage IV non-small cell lung cancer patients who are routinely treated with a PD-1 inhibitor for indications approved by Health Canada. All patients who are selected will be referred for palliative thoracic radiotherapy and treated with a standard dose prescription of 30 Gy in 10 fractions.,"['Lung Cancer, Nonsmall Cell', 'Lung Cancer']",OBSERVATIONAL,"{'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'RADIATION', 'name': 'Radiation combined with immunotherapy', 'description': 'The trial is designed as a prospective observational single arm study investigating stage IV non-small cell lung cancer patients who are routinely treated with a PD-1 inhibitor for indications approved by Health Canada. All patients who are selected will be referred for palliative thoracic radiotherapy and treated with a standard dose prescription of 30 Gy in 10 fractions.'}]","Inclusion Criteria: 1. Pathologically confirmed AJCC 7th/8th edition Stage IV adenocarcinoma or squamous cell carcinoma not eligible for curative treatment. 2. Indication and suitability to receive palliative radiotherapy to the thorax (30Gy/10). 3. Receiving or planned to receive nivolumab or pembrolizumab 4. Prior history of systemic chemotherapy is permitted given a washout period of 4 weeks 5. Age 18 or older 6. ECOG Performance Status 0-2 7. Life expectancy greater than 3 months 8. Able and willing to provide informed consent 9. Able to complete patient reported outcome questionnaires Exclusion Criteria: 1. Contraindications to radiotherapy, including a history of SLE, systemic scleroderma, IPF, ataxia telangiectasia 2. Previous history of thoracic radiotherapy with an overlapping field 3. Previous history of checkpoint inhibitor related pneumonitis or esophagitis 4. Pregnancy",This study will include a population of patients with metastatic NSCLC on first or second line immunotherapy who have an indication for palliative thoracic radiation,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Rate of Radiation related toxicities', 'description': 'rates of radiation-related toxicities in the combination of immunotherapy and palliative thoracic radiotherapy using CTCAE v5.0 grading', 'timeFrame': 'up to 24 months'}, {'measure': 'Patient Report Outcome', 'description': 'FACT-E', 'timeFrame': 'up to 12 months'}, {'measure': 'Patient experience and anxiety related to Quality of Life', 'description': 'EQ-5D', 'timeFrame': 'up to 12 months'}]","[{'measure': 'Rate of Survival', 'timeFrame': '1 year'}, {'measure': 'Rate of Survival', 'timeFrame': '2 year'}, {'measure': 'Rate of Disease Recurrence', 'description': 'Patients will be followed for up to two years following the completion of their radiotherapy. They will undergo CT surveillance imaging as standard by routine immunotherapy protocol with a minimum of 3 scans at the 3, 6 and 12 month mark. Local and distant recurrence will be determined primarily by CTCAE with CT scans as per ir-RECIST v1.0 criteria.', 'timeFrame': '3, 6, 12 months'}]" 44,NCT05746806,"{'fullName': 'Insel Gruppe AG, University Hospital Bern', 'class': 'OTHER'}",Trial of Ultrahypofractionated Focal Salvage Radiotherapy for Isolated Prostate Bed Recurrence After Radical Prostatectomy,ACTIVE_NOT_RECRUITING,The main objective of the trial is to explore the efficacy and safety of combining short-term androgen deprivation therapy (ADT) over 6 months to focal ultrahypofractionated salvage radiotherapy (SRT) delivered in 5 fractions to the site of local recurrence within the prostate bed after radical prostatectomy where multiparametric magnetic resonance imaging (mpMRI) and prostate-specific membrane antigen (PSMA) PET/CT are used to precisely identify the local recurrence and compare it to previously published literature.,['Recurrent Prostate Cancer'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'RADIATION', 'name': 'Ultrahypofractionated salvage radiotherapy to a local recurrence after radical prostatectomy', 'description': 'Ultrahypofractioned radiotherapy for patients with isolated local recurrence after radical prostatectomy in 5 fractions', 'armGroupLabels': ['Single arm']}, {'type': 'DRUG', 'name': 'Androgen deprivation therapy', 'description': 'In combination to the radiotherapy a short term androgen deprivation drug for 6 months will be applied.\n\nThe preferred drug concept used is:\n\n\\- LHRH(Luteinizing hormone releasing hormone)-agonist with 3-month subcutaneous depot injection (e.g. Pamorelin® LA (Triptorelin) 11.25mg s.c.) in combination with nonsteroidal antiandrogen (e.g. Bicalutamide 50mg/day) as flare protection at least 5 days before and max. 15 days after first LHRH-injection\n\nAlternatively the following oral drug concept can be used, if the patient rejects injections:\n\n\\- GnRH (gonadotropin-releasing hormone)-antagonist with tablet intake for 6 months (e.g. Orgovyx® Tablets 120mg; first day 360mg, after second day 120mg per day)', 'armGroupLabels': ['Single arm']}]","Inclusion Criteria: 1. Written informed consent according to ICH/GCP (International Council for Harmonisation/Good Clinical Practice) regulations before registration and prior to any trial specific procedures 2. Age ≥ 18 years at time of registration 3. WHO performance status 0-1 4. Lymph node negative adenocarcinoma of the prostate treated with radical prostatectomy (RP) at least 6 months before trial.Tumor stage pT2a-3b, R0-1, pN0 or cN0. according to the Union for International Cancer Control (UICC) TNM 2009. 5. Evidence of measurable local recurrence at the prostate bed detected by PSMA PET/CT and mpMRI within the last 3 months. In case of unclear local recurrence, a biopsy confirmation is recommended. 6. Patient must have non-metastatic (N0, M0) disease, as defined by a lack of nodal or distant metastases seen on PSMA PET/CT scan 7. Patients must have non-castrate levels of serum testosterone (≥50 ng/dL). 8. Patients must not have previously received hormonal therapy (LHRH agonists, antiandrogen, or both, or bilateral orchiectomy). 9. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial Exclusion Criteria: 1. Persistent PSA (\> 0.4 ng/mL) 4 to 20 weeks after RP 2. Previous hematologic or primary solid malignancy within 3 years prior registration with the exception of curatively treated localized non-melanoma skin cancer 3. Usage of products known to affect PSA levels within 4 weeks prior to start of trial treatment phase including any form of androgen suppression agents and androgen deprivation therapy 4. Bilateral hip prosthesis 5. Severe or active co-morbidity likely to impact on the advisability of SRT 6. Treatment with any experimental drug or participation within a clinical trial within 30 days prior to registration (exception: concurrent participation in the biobank studies is allowed)",NA,MALE,NA,"[{'measure': 'Biochemical relapsefree survival', 'description': 'The initial prostate specific antigen (PSA) at time of registration will be the starting point. Freedom from biochemical progression is counted from the day of registration to the day of either first recorded biochemical progression as defined below, clinical progression or death due to clinical progression.\n\nBiochemical relapsefree survival measured with PSA (prostate specific antigen) lab testing at 1, 3, 6, 12, 18 and 24 months after radiotherapy. The duration of biochemical relapsefree survival is measured and documented in months for each patient.\n\nA biochemical recurrence is defined by any confirmed PSA rise above 0.20 ng/mL with a confirmatory rise at least 2 weeks later. For those patients whose PSA does not drop below 0.20 ng/mL at time of first response assessment at 3 months are considered as non-responders to treatment and are considered to have a biochemical recurrence in case a second measurement at least 2 weeks later confirms a rising PSA above this level.', 'timeFrame': '2 years'}]","[{'measure': 'Acute side effects of grade 3 or higher', 'description': 'Standard acquisition of therapy related acute side effects of grade 3 or higher according to NCI CTCAE v5.0 at radiotherapy end and at 1 and 3 months after radiotherapy will be assessed. The side effects are recorded with the corresponding grade according to the NCI CTCAE v5.0 scale at the measured points of time.\n\nSpecial attention shall be given to diarrhea, fecal incontinence, proctitis, rectal hemorrhage, rectal pain, hematuria, urinary frequency, urinary urgency, urinary retention, urinary incontinence, cystitis non-infective and erectile dysfunction.', 'timeFrame': '90 days'}, {'measure': 'Clinical progression-free survival', 'description': 'Clinical progression-free survival is defined as time between registration and the appearance of a new recurrence (any N1 or M1) as suggested by PET-CT, symptoms related to progressive prostate cancer (PC), or death due to any cause.\n\nThe duration of clinical progression-free survival is measured and documented in months for each patient.\n\nDefinition of recurrence:\n\n* A local recurrence is defined as the appearance of evidence of a recurrence within the prostate bed. Confirmation of the recurrence by biopsy is recommended, whenever possible.\n* A regional nodal recurrence is defined as a radiographic (PET-CT) evidence of a lymphadenopathy in the pelvis in a patient without the diagnosis of hematologic/lymphatic disorder\n* Distant recurrence is defined as the appearance of distant metastases (M1a, M1b, M1c) outside the pelvis.', 'timeFrame': '2 years'}, {'measure': 'Metastasis-free survival', 'description': 'Metastasis-free survival is defined as time between registration and the appearance of a metastatic recurrence (any M1) as suggested by PET-CT or death due to any cause. The duration of metastasis-free survival is measured and documented in months for each patient.\n\nPatients without any of the events of interest (including those with biochemical relapse only) are censored at the date of the last follow-up. Second cancers are not considered events in terms of this endpoint. In case of biochemical progression, re-staging will be made with PET-CT imaging preferably with the same tracer used before registration. In case of negative PET findings at biochemical relapse, a new PET imaging should be repeated on a 6-monthly basis or earlier in case clinically indicated.', 'timeFrame': '2 years'}, {'measure': 'Late side effects', 'description': 'Standard acquisition of therapy related late side effects according to NCI CTCAE v5.0 at 6, 12, 18 and 24 months after radiotherapy. The side effects are recorded with the corresponding grade according to the NCI CTCAE v5.0 scale at the measured points of time.\n\nSpecial attention shall be given to diarrhea, fecal incontinence, proctitis, rectal hemorrhage, rectal pain, hematuria, urinary frequency, urinary urgency, urinary retention, urinary incontinence, cystitis non-infective and erectile dysfunction.', 'timeFrame': 'After 90 days up to 2 years (after acute side effects, see outcome 2)'}, {'measure': 'Quality of life (EORTC Quality of life questionnaire C-30 version 3)', 'description': 'All patients registered into this trial are to complete QoL questionnaires at registration and at 1, 3, 6, 12, 18, 24 months after radiotherapy. A longitudinal design is used. Patients are asked to complete the EORTC Quality of life questionnaire C-30 version 3. The resulting score will be documented at each point of time.', 'timeFrame': '2 years'}, {'measure': 'Quality of life ( EORTC Quality of life PR25)', 'description': 'All patients registered into this trial are to complete QoL questionnaires at registration and at 1, 3, 6, 12, 18, 24 months after radiotherapy. A longitudinal design is used. Patients are asked to complete the EORTC Quality of life questionnaire PR25 prostate cancer module. The resulting score will be documented at each point of time.', 'timeFrame': '2 years'}]" 45,NCT06605404,"{'fullName': 'Paradigm Health', 'class': 'INDUSTRY'}",Pan-tumor MRD Study,RECRUITING,"The purpose of this observational study is to collect clinical information, blood, and tumor tissue samples from participants diagnosed with stage I, stage II, or operable stage III cancer in select solid tumors. The information collected will be used to develop tests to better understand cancer, for example, to improve cancer detection and to assess the risk of cancer coming back. Participants will receive routine standard of care from their doctor and their involvement is expected to last for approximately five and a half (5.5) years.","['Muscle Invasive Bladder Urothelial Carcinoma', 'Esophageal Cancer', 'Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma', 'Melanoma (Skin Cancer)', 'NSCLC (Non-small Cell Lung Cancer)', 'Pancreatic (Exocrine Only)', 'Mix of Solid Tumors (MOST)']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'DIAGNOSTIC_TEST', 'name': 'blood and tissue samples', 'description': 'routine standard of care', 'armGroupLabels': ['Esophageal', 'Gastric and Gastroesophageal Junction (GEJ)', 'Melanoma', 'Mix of Solid Tumors (MOST)', 'Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC)', 'Non-small cell lung (NSCLC)', 'Pancreatic (exocrine only)']}, {'type': 'OTHER', 'name': 'blood and tissue samples', 'description': 'Routine standard of care', 'armGroupLabels': ['Esophageal', 'Gastric and Gastroesophageal Junction (GEJ)', 'Melanoma', 'Mix of Solid Tumors (MOST)', 'Muscle Invasive Urothelial Carcinoma of the Bladder (MIBC)', 'Non-small cell lung (NSCLC)', 'Pancreatic (exocrine only)']}]","Eligibility Criteria: 1. Age 18 years or older. 2. Confirmed histological or cytological diagnosis of a malignant solid tumor that is either specified in one of the pre-defined tumor cohorts or meets the enrollment criteria for the Mix of Solid Tumors (MOST) cohort (Table 1). 3. Eligible for curative intent therapy, with surgical resection of cancer planned. a. If surgical resection has occurred, enrollment should occur within 3 months of surgical resection and before initiation of adjuvant therapy. 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2. 5. No systemic therapy for current cancer diagnosis administered before enrollment. 6. Willing and able to comply with required study procedures, including blood sample collection and primary tumor tissue submission from diagnostic biopsy or surgical excision. 7. Has completed all therapy (including endocrine therapy) 3 or more years ago for any previous invasive solid organ malignancy (with exception of nonmelanoma skin cancers) or hematologic malignancy. Individuals with a prior history of noninvasive (in situ) carcinomas may participate if they have received definitive treatment (no washout period required). 8. No concurrent diagnosis of another invasive cancer, except for nonmelanoma skin cancers. 9. No prior allogeneic hematopoietic stem cell transplant. 10. Able and willing to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for the release of personal health information. Cohort Specific Criteria 11. Muscle-invasive urothelial carcinoma of the bladder and Melanoma Cohorts: Stage II or operable III cancer: 12. Esophageal, Gastric/GEJ, and NSCLC Cohorts: Stage I, II, or operable III cancer. 13. Pancreatic Cohort: Stage I, II or operable III cancer, exocrine only disease. 14. MOST cohort: Stage II or operable stage III solid tumor diagnosis that meets eligibility criteria and is not included in the other cohorts. The following tumor types are excluded: 1. Central nervous system (CNS) malignancies 2. Colorectal cancer 3. Breast cancer 4. Squamous cell skin cancer 5. Basal cell carcinoma 6. Gastrointestinal stromal tumors (GIST) 7. Thyroid cancer 8. Uveal melanoma 9. Low or intermediate grade neuroendocrine tumors ■ Eligible tumor types: High-grade neuroendocrine tumors, including neuroendocrine carcinomas, Merkel cell carcinomas, and small cell lung cancer are permissible 10. Hematologic cancers including multiple myeloma or other plasma cell dyscrasias, Hodgkin\'s lymphoma, non-Hodgkin\'s lymphoma, acute or chronic leukemias including chronic lymphocytic leukemia / small lymphocytic leukemia","Study participants diagnosed with stage I, stage II, or operable stage III cancer in select solid tumors",ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Blood and tissue biospecimen registry', 'description': 'To establish a blood and tissue biospecimen resource in participants with operable solid tumors, with clinical, lab, radiographic, and pathology annotation for the discovery, development, and validation of MRD assays.', 'timeFrame': 'Observation from enrollment to 5.5 years after enrollment'}]",NA 46,NCT02504333,"{'fullName': 'Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)', 'class': 'OTHER'}",Phase I/II Study of Nab-paclitaxel and Gemcitabine Followed by AG-mFOLFOX in Patients With Metastatic Pancreatic Adenocarcinoma,COMPLETED,"The purpose of this study is to assess the safety and efficacy of nab-paclitaxel (Abraxane) and gemcitabine followed by modified FOLFOX (AG-mFOLFOX) in patients with previously untreated, metastatic pancreatic adenocarcinoma",['Metastatic Pancreatic Adenocarcinoma'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'nab-paclitaxel', 'description': 'Day 1-8-15: Intravenous, 125 mg/m2 over 30 minutes', 'armGroupLabels': ['AG']}, {'type': 'DRUG', 'name': 'gemcitabine', 'description': 'Day 1-8-15: Intravenous, 1.000 mg/m2 over 30 minutes', 'armGroupLabels': ['AG']}, {'type': 'DRUG', 'name': 'm-FOLFOX', 'description': 'Day 28 according to the dose levels stablished in Phase I', 'armGroupLabels': ['AG-mFOLFOX']}, {'type': 'DRUG', 'name': 'nab-paclitaxel', 'description': 'Day 1-8-15: Intravenous 30 minutes according to the dose levels stablished in Phase I', 'armGroupLabels': ['AG-mFOLFOX']}, {'type': 'DRUG', 'name': 'gemcitabine', 'description': 'Day 1-8-15: Intravenous 30 minutes according to the dose levels stablished in Phase I', 'armGroupLabels': ['AG-mFOLFOX']}]","Inclusion Criteria: 1. Histologically and/or cytologically confirmed pancreatic adenocarcinoma 2. Stage IV disease (metastatic only) 3. No prior systemic therapy for their diagnosis (except in adjuvant/neoadjuvant setting\>six months previously) 4. ECOG performance status of 0-1 5. At least 18 years of age 6. Evidence of either or both of the following RECIST-defined measurable disease (lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20mm using conventional techniques or ≥10 mm with spiral CT scan) 7. Female patients must be either surgically sterile or postmenopausal, or if of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment and agree to use effective barrier contraception during the period of therapy. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the investigator. 8. Adequate bone marrow function: * ANC ≥ 1500/uL * platelet count ≥ 100,000/uL * hemoglobin ≥ 9.0 g/dL 9. Adequate hepatic function: * Total bilirubin ≤ 1.5 X ULN * AST (SGOT) ≤ 2.5 X ULN * ALT (SGPT) ≤ 2.5 X ULN 10. Adequate renal function as determined by either: \- Calculated or measured creatinine clearance ≥ 40 mL/min (for calculated creatinine clearance, Cockroft-Gault equation will be used). 11. Ability to understand the nature of this study protocol and give written informed consent. 12. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: 1. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that, in the opinion of the investigator, renders the subject at high risk from treatment complications or might affect the interpretation of the results of the study. 2. Presence of central nervous system or brain metastases. 3. Life expectancy \< 12 weeks 4. Pregnancy (positive pregnancy test) or lactation. 5. Pre-existing sensory neuropathy \> grade 1. 6. Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months. 7. Major surgery and/or radiotherapy within 4 weeks of the start of study treatment, without complete recovery. 8. Prior malignancy except for adequately treated basal cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other form of cancer from which the patient has been disease-free for 5 years.",NA,ALL,NA,"[{'measure': 'Dose-limiting toxicity for the AG-mFOLFOX combination', 'description': 'Primary outcome phase I.', 'timeFrame': '12 weeks'}, {'measure': 'Rate of overall survival al 12 months', 'description': 'Primary outcome phase II', 'timeFrame': '12 weeks'}]","[{'measure': 'Rate of overall survival at 6 months', 'timeFrame': '54 months'}, {'measure': 'Rate of overall survival at 24 months', 'timeFrame': '54 months'}, {'measure': 'Time to tumor progression', 'timeFrame': '54 months'}, {'measure': 'Progression free survival', 'timeFrame': '54 months'}, {'measure': 'Overall Survival', 'timeFrame': '54 months'}, {'measure': 'Objective radiographic response', 'description': 'Secondary outcome Phase I and Phase II', 'timeFrame': '54 months'}, {'measure': 'CA 19-9 biomarker response', 'timeFrame': '54 months'}, {'measure': 'Safety profile of this combination (AG-mFOLFOX) using NCI-CTCAE v.4 criteria', 'description': 'Secondary outcome Phase I and Phase II', 'timeFrame': '54 months'}, {'measure': 'To assess the Quality of Life of the patients through the EORTC QLQ-C30/PAN26 and EORTC QLQ-CIPN20 questionnaires', 'description': 'Secondary outcome Phase I and Phase II', 'timeFrame': '54 months'}]" 47,NCT05568433,"{'fullName': 'Iuliu Hatieganu University of Medicine and Pharmacy', 'class': 'OTHER'}",New Biomarkers in the Intracystic Liquid of Inflammatory and Non-inflammatory Pancreatic Cysts,COMPLETED,"Due to the advances made in the field of the imaging techniques and their common use, pancreatic cysts are more and more incidentally found. Pancreatic pseudocysts can be misdiagnosed as cystic neoplasms, in particular when there is no clinical history of acute or chronic pancreatitis. Pancreatic cystic neoplasms on the other hand are rare, but are difficult to diagnose accurately. Neutrophil gelatinase-associated lipocalin (NGAL) , interleukin 1 Beta (IL1beta) and High Mobility Group AT-Hook 2 (HmgA2) are molecules implicated in the process of inflammation and tumour development. The diagnostic value of their concentration in pancreatic cysts is not established yet. Study aim to asses the significance of NGAL,IL1Beta and HMGA2 concentration in cystic fluid obtained by endoscopic ultrasound (EUS) with EUS-guided fine-needle aspiration (EUS-FNA) and serum level for discriminating between inflammatory and non-inflammatory pancreatic cyst.",['Pancreatic Cyst'],OBSERVATIONAL,"{'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'DIAGNOSTIC_TEST', 'name': 'Endoscopic ultrasound fine needle aspiration (EUS-FNA)', 'description': 'Patients with pancreatic cysts who underwent endoscopic ultrasound and endoscopic fine needle aspiration for diagnostic and therapeutic purpose. A sample of the cyst fluid and frozen serum was collected from the patients and stored at minus 80 degrees.', 'otherNames': ['ELISA measurements of cystic fluid']}]","Inclusion Criteria: * patients aged 18-90 years with an unclear specific diagnosis of pancreatic cysts * pancreatic cyst \>15mm on CT or MRI * patients with pseudocysts with indication for drainage Exclusion Criteria: * refusal to participate * platelet level \< 50000/mm3 and International normalized ratio (INR \>1.5) * duodenal stenosis * severe chronic pancreatitis * history of pancreatic cancer or major upper abdominal surgery * congestive heart failure * the liquid sample \< 1ml;","Consecutive patients aged 18-90 years diagnosed with an unclear specific diagnosis of pancreatic cysts \>15mm on Computer tomography scan (CT) or Magnetic resonance imaging (MRI) and patients with pseudocysts with indication for drainage , admitted to our hospital (the Regional Institute of Gastroenterology and Hepatology in Cluj-Napoca, Romania)",ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Role of the cyst fluid concentrations of the specific biomarkers for differentiation the pancreatic cystic lesions', 'description': 'Measurement the cyst fluid concentration of NGAL, IL1beta, HMGA2, expressed in nanograms/dl', 'timeFrame': 'through study completion, an average of 1 year'}]","[{'measure': 'The Correlation between cyst fluid concentration and serum level of the specific biomarkers', 'description': 'coefficient of correlation between the two values', 'timeFrame': 'through study completion, an average of 1 year'}]" 48,NCT04957433,"{'fullName': 'Royal Marsden NHS Foundation Trust', 'class': 'OTHER'}",'Lung Health Check' Biomarker Study,UNKNOWN,"CT screening of lung cancer offers an opportunity to diagnose early stage lung cancers which is associated with better prognosis - indeterminate results delay diagnosis whilst interval imaging is awaited to assess risk of cancer. This study will allow us to examine the potential of blood-based biomarkers to augment CT screening for lung cancer. Hypotheses 1. Blood and sputum samples can be collected in patients attending lung health checks as part of the Lung Health Check pilot in West London at fixed and mobile scanners and safely transported for processing and storage in preparation for biomarker development. 2. The biomarkers will help to identify cohorts of 1. High-risk patients in whom CT surveillance should be conducted more readily/frequently and diagnostic procedures performed earlier. 2. Low-risk patients who might need reduced surveillance intensity. 3. Patients with interstitial lung abnormalities that share similar biomarker characteristics to patients with clinically significant interstitial lung disease","['Lung Cancer', 'Cancer']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}","[{'type': 'DIAGNOSTIC_TEST', 'name': 'Blood Specimen', 'description': 'Blood and Sputum Specimen Samples', 'armGroupLabels': ['Cohort A', 'Cohort B (Nodule Suveillance)', 'Cohort C (Incident Scan)', 'Cohort D'], 'otherNames': ['Sputum Specimen']}]","Inclusion Criteria: * Patients invited to participate in the Royal Marsden (RM) Partners Lung Health Check pilot study who undergo one or more CT scans: * Between the age of 55-75 years of age; and * Current smokers or ex-smokers who have quit after the age of 40. Exclusion Criteria: * Patients excluded from the Lung Health Check: * On the palliative care register; * Any active malignancy undergoing treatment * Daily activity levels equivalent to performance score 3 or 4; and * Unable to consent to Lung Health Check Biomarker Study","Patients who had been identified using two lung cancer risk calculators, the modified Liverpool Lung Project (LLPv2) and the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) to be at high risk for lung cancer and recruited to The Lung Health Check (TLHC) pilot taking place in West London.",ALL,PROBABILITY_SAMPLE,"[{'measure': 'Feasibility of the primary objective to collate a lung health check biobank', 'description': 'The feasibility of the primary objective to collate a lung health check biobank will be reported as a percentage after the final participant recruited has donated both a baseline sample and also their final specimen (or on the same date should they decline to do so). The primary end point of the project will be considered feasible if consent to a blood test, collection and storage can be achieved in at least 50% of the 1000 patients approached for the biomarker study who undertake an LDCT scan.', 'timeFrame': '2 Years'}]","[{'measure': 'Confirming if a lung cancer genomics panel differs between participants who receive a diagnosis of lung cancer at the time of the baseline scan and those who do not', 'description': 'The first secondary end point will be met if, a lung cancer genomics panel on sputum/peripheral blood samples taken at the time of the baseline LDCT screening scans differs between participants who receive a diagnosis of lung cancer at the time of the baseline scan (or associated biopsy) and those whom do not.', 'timeFrame': '2 Years'}, {'measure': 'Confirming if a lung cancer genomics panel (taken at baseline LDCT screening scans) differs between those who receive a diagnosis of lung cancer and those who do not after completion of follow-up imaging', 'description': 'An additional secondary end point will be met if a lung cancer genomics panel on sputum or peripheral blood samples taken at baseline LDCT screening scans differs between patients who receive a diagnosis of lung cancer after completion of follow-up imaging (or two years, whichever occurs sooner) and those whom do not.', 'timeFrame': '2 years'}, {'measure': 'Confirming if peripheral blood telomere length can determine those who have interstitial lung abnormalities at those who do not, and who is at higher risk of developing overt pulmonary fibrosis', 'description': 'An additional secondary endpoint will be met if peripheral blood telomere length differs between those with interstitial lung abnormality and without and can predict those at higher risk of developing overt pulmonary fibrosis', 'timeFrame': '2 years'}]" 49,NCT05600933,"{'fullName': 'National Institutes of Health Clinical Center (CC)', 'class': 'NIH'}",Prospective Procurement of Tumor Tissue to Identify Novel Therapeutic Targets and Study the Tumor Microenvironment,ENROLLING_BY_INVITATION,"Background: Many advances have been made in cancer treatments, but more research is needed. Comparing samples of cancerous tissue to samples of normal, noncancerous tissues may help find differences between them. These differences may help researchers find new ways to treat cancer. Objective: To collect tissues and blood samples from people with known or suspected cancer. The samples will be used to help identify new targets for cancer treatments. Eligibility: People aged 18 years and older with a known or suspected cancer that requires surgery or biopsy. Design: Participants will be screened. They will answer questions about their health. They can do this on the phone or in person. Researchers will collect information from participants medical records. Data may include information about any prior or current cancers. Data about other medical conditions may also be collected. Participants will have blood drawn. Some of the blood will be tested for HIV and hepatitis B and C. Some of the blood will be used for genetic research. Participants will have tissue samples collected during surgeries or biopsies. These are procedures the participants would have had as part of their standard care. No new procedures will be done just for this study. Researchers may also seek out samples from prior procedures the participant had done. Participants will remain in the study for 6 months. They may have blood drawn again. Researchers may also collect tissue samples from any procedures performed during that time.","['Solid Tumors', 'Hematologic Malignancy', 'Gastrointestinal Cancer', 'Liver Cancer', 'Pancreatic Cancer', 'Melanoma', 'Pre-Malignancy', 'Lung Cancer']",OBSERVATIONAL,"{'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}",NA,"* INCLUSION CRITERIA: * Age \>= 18 years * Willing to undergo serologic testing for HIV, hepatitis B and C * Participants who have a known or suspected cancer that requires surgery or biopsy as a part of the standard of care diagnosis, treatment and/or follow up. Note: Participants will not be enrolled exclusively for the procurement of tissue samples. -Able and willing to sign an informed consent document.","Subjects from both sexes and all racial/ethnic groups who are undergoing diagnostic or therapeutic interventions for premalignant, primary or metastatic solid tumors or hematologic malignancies",ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'To collect biologic samples from participants undergoing diagnostic or therapeutic interventions for premalignant, primary or metastatic solid tumors and hematologic malignancies', 'description': 'To collect biologic samples from participants undergoing diagnostic or therapeutic interventions for known or suspected cancer for the purpose of identifying novel molecular and biologic therapeutic targets and studying the intratumoral immune landscape.', 'timeFrame': 'At time of surgery or biopsy'}]","[{'measure': 'To collect detailed history, demographic, treatment data, and perioperative findings.', 'description': 'To collect detailed history, demographic, treatment data, and perioperative findings in order to categorize specimens.', 'timeFrame': 'At time of consent'}]" 50,NCT03623152,"{'fullName': 'Chinese University of Hong Kong', 'class': 'OTHER'}",Colorectal Neoplasia and Microbiota: Does Left Equal Right?,UNKNOWN,"Many studies, including our own, have shown that colorectal cancer (CRC) is related to changes in the microbiome of the colon. However, there are limitations in most studies and questions remained unanswered. Some early data showing that the microbiome in the left vs right colon are different. The aim of this study is to investigate the microbiome (including bacteriome, virome, and fungome) of adenoma/CRC comparing the left (distal to splenic flexure) vs right side (proximal to splenic flexure) of the colon.",['Colo-rectal Cancer'],OBSERVATIONAL,"{'observationalModel': 'CASE_ONLY', 'timePerspective': 'CROSS_SECTIONAL'}",NA,"Inclusion Criteria: 1. \>18 years of age, with the informed consent of the study-specific colonoscopy examination method and samples collection 2. have an indication for a scheduled colonoscopy, either as an investigation of colorectal symptom or as part of a CRC screening 3. for those who are known to have either adenoma or CRC, colonoscopy is arranged for endoscopic submucosal dissection (ESD) or endoscopic mucosectomy (EMR) Exclusion Criteria: a. known history of coagulopathy b. recently on antithrombotics or antiplatelets c. recently on antibiotics, prebiotics, probiotics and symbiotics d. anticipated prolonged standard colonoscopy procedure at endoscopist's discretion e. consent cannot be obtained \-",Patients have scheduled colonoscopy,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Descriptive statistics will be used for demographics data', 'description': 'Since the sample size is small, non-parametric chi-square test or Mann-Whitney tests will be used for the comparison of the clinical data between the cases with adenoma or CRC on the right and left side colon.', 'timeFrame': 'All biological samples will be stored for a maximum of 10 years'}]",NA 51,NCT06959433,"{'fullName': 'Ankara University', 'class': 'OTHER'}",Lu-177 PSMA Treatment in Cell Renal Carcinoma,NOT_YET_RECRUITING,"Summary Renal Cell Carcinoma (RCC) consists of 2% of all malignencies. RCCs are generally divided to histopathological subtypes as clear cell and non-clear cell variants. Clear cell variant responsible for the 75-80% of all RCCs. It is reported that 20-30% of RCCs are metastatic at the diagnosis and 5 years survival is approximately is 10-20% in this group of patients. Moreover, 60% of patients who are not metastatic at the diagnosis, develop metastates within 2-3 years. 2nd and 3th line effective treatment option in metastatic RCCs patients has been a subject of interest. PSMA (protatate specific membrane antigen) with the other name glutamate carboxypeptidase, is a transmembrane protein and overexpresses in prostate adenocarcinomas and neoangiogenesis spots of endothelium of other several tumor types. It infronts as a target for theranostic consept for mainly prostate cancer in nuclear medicine. As a radionuclide treatment option, Lu-177 PSMA treatment is proved as safe and effective treatment option in castration resistant prostata cancer patients. After its widely use in prostate cancer, it is reported that PSMA molecule can be used for imaging of RCC patients and PSMA uptake is higher than 18F-FDG. For this reason, Lu-177 PSMA treatment can be a systemic treatment option in RCC patients who have progress afer 1st cycle treatment. In this study we aimed to safety and efficacy of Lu-177 PSMA treatment in metastatic RCC patients as systemic radionuclide treatment option.",['Metastatic Renal Cancer'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'a single arm will be included patients with metastatic RCC treated with Lu-177 PSMA', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Lu-177 PSMA-617', 'description': 'Included patients will receive 4 cycles of 7.4GBq Lu-177 PSMa therapy every 6 weeks. If any toxicity develops after the first cycle, dose reduction will be performed for the other cycles. At 1. And 4. Cycles of therapy, whole body planar and SPECT/CT imaging will be performed at 4. And 24. Hours and any time at 4-7.days of injection. On these images , kindey, liver and salivary gland doses will be calculated. Mean tumor dose will also be calculated by measurinf the tumoral uptake. In the follow up, patients will be controlled at 9. And 24. Weeks and every 12 months then after.', 'armGroupLabels': ['Lu-PSMA treatment arm']}]","Inclusion Criteria: * Age \>18 * Progression after at least 2 lines of systemic therapy or existence of a contraindication to systemic therapies * At least 3 years of life expectancy * ECOG performance status ≤ 2 * Ability to sign informed consent Exclusion Criteria: * Age\<18 * Not having received any systemic therapies * History of a secondary malignancy * ECOG performance status \> 2 * Any contraindication for radionuclide therapy (pregnancy, lactation, organ disfunction, metastatic lesions with a risk of compression * Previous history of any radionuclide therapies * Inability to sign informed consent",NA,ALL,NA,"[{'measure': 'toxicity analysis', 'description': 'Therapy associated toxicity will be evaluated according to CTCAE V5.0 criteria.', 'timeFrame': '1-36 months'}]","[{'measure': 'efficacy analysis', 'description': 'Therapy response will be evaluated according to RECIST 1.1 criteria', 'timeFrame': '1-36 months'}]" 52,NCT02930252,"{'fullName': 'Azienda USL 1 Imperiese', 'class': 'OTHER'}",Covered Versus Uncovered SEMS for Palliation of Malignant Biliary Strictures.,COMPLETED,The purpose of this study is to compare the duration of stent patency of a covered vs. an uncovered biliary self-expandable metal stents (SEMS) placed to relieve biliary obstruction in patients with inoperable extrahepatic malignant biliary obstruction.,['Biliary Cancer'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}","[{'type': 'DEVICE', 'name': 'Niti-S Biliary ComVi Stent', 'description': 'Endoscopic placement of biliary fully covered metal stents', 'armGroupLabels': ['Niti-S Biliary ComVi Stent'], 'otherNames': ['Fully Covered biliary stent']}, {'type': 'DEVICE', 'name': 'Niti-S stent (D type)', 'description': 'Endoscopic placement of biliary uncovered metal stent', 'armGroupLabels': ['Niti-S Stent (D-type)'], 'otherNames': ['Uncovered biliary stent']}]","Inclusion Criteria: * Malignant obstructive disease at the level of the extrahepatic bile duct (CBD) * Serum bilirubin \>50 micromol/L * Inoperability due to a poor medical condition and/or unresectable disease * ≥ 18 years of age * Willing and able to comply with study procedures and provide written informed consent Exclusion Criteria: * Benign obstruction of the CBD * Malignancy involving intrahepatic ducts or duodenum * Prior gastric bypass or Billroth type I or type II gastric resection * Prior biliary surgery * World Health Organization (WHO) performance score of 4 (100% of time in bed) * international normalized ratio (INR)\> 1.5 * Life expectancy of \< 90 days",NA,ALL,NA,"[{'measure': 'To compare the duration of stent patency of a covered vs. an uncovered biliary SEMS placed to relieve biliary obstruction in patients with inoperable extrahepatic malignant biliary obstruction.', 'description': 'The Kaplan-Meier method will be used to estimate stent patency in each group and the log-rank test will be used for an unadjusted comparison between groups. Then a Cox proportional hazard model will be constructed to compare time to stent occlusion adjusted for important potential confounders. Stent patency will be calculated in days and will represent the interval between the time of stent insertion and the time of its replacement or the death of the patient with concomitant cholangitis.', 'timeFrame': 'minimum follow-up: 4 months'}, {'measure': 'To evaluate complication rates of covered vs. uncovered biliary SEMS in patients with inoperable extrahepatic malignant biliary obstruction', 'description': 'Relationships between complication rates and stent type will be examined by the chi-square or the exact Fisher tests. Logistic regression will be used to compare stent complication rates adjusted for important potential confounders.', 'timeFrame': 'minimum follow-up: 4 months'}]","[{'measure': 'To evaluate the quality of life before and after intervention with covered vs. uncovered biliary SEMS in patients with inoperable extrahepatic malignant biliary obstruction.', 'description': ""Health-related quality of life (HRQL) will be evaluated by a paired t-test to determine the impact of stent placement (i.e. compare baseline HRQL and month 3 HRQL) by Student's t -test to compare the differences in HRQL at baseline and 3 months between study groups. Linear regression models will be constructed to assess HQRL while adjusting for factors other than stent type."", 'timeFrame': '3 months'}, {'measure': 'To evaluate the survival of patients treated with covered vs. uncovered biliary SEMS for the management of inoperable extrahepatic malignant biliary obstruction.', 'description': 'For all analyses the Statistical Package for Social Sciences software (SPSS, Inc. for Windows will be used.', 'timeFrame': 'until death'}, {'measure': 'To evaluate the cost-effectiveness of covered and uncovered biliary SEMS in patients with inoperable extrahepatic malignant biliary obstruction', 'description': 'Total direct costs for each study group will be compared and cost effectiveness modelled.\n\nFor all analyses the Statistical Package for Social Sciences software (SPSS, Inc. for Windows) will be used.', 'timeFrame': 'until death'}, {'measure': 'To determine the predictors of survival in patients in patients with inoperable extrahepatic malignant biliary obstruction managed with SEMS.', 'description': 'For all analyses the Statistical Package for Social Sciences software (SPSS, Inc. for Windows will be used.', 'timeFrame': 'minimum follow-up: 4 months'}]" 53,NCT06384352,"{'fullName': 'MediLink Therapeutics (Suzhou) Co., Ltd.', 'class': 'INDUSTRY'}","Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Advanced Solid Tumors",RECRUITING,"This is a multicenter, open-label, Phase 1 study. The study will enroll subjects with advanced solid tumors. It consists of six parts. Objectives for Dose-Escalation Parts (Part 1 and Part 4) To evaluate the safety and tolerability of YL211 as monotherapy in patients with selected advanced solid tumors (Part 1) and in combination with pembrolizumab in patients with second or third line locally advanced unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) (Part 4) To determine the maximum tolerated dose (MTD) and select the recommended expansion dose(s) (RED(s)) of YL211 as monotherapy in patients with advanced solid tumors (Part 1) and in combination with pembrolizumab in patients with second line locally advanced unresectable or metastatic non-squamous NSCLC (Part 4) Objectives for Backfill Enrollment Parts (Part 2 and Part 5) To better estimate and characterize the safety and efficacy of YL211 as monotherapy in patients with metastatic colorectal cancer (mCRC) or locally advanced unresectable or metastatic NSCLC (Part 2) and in combination with pembrolizumab in patients with previously untreated locally advanced unresectable or metastatic non-squamous NSCLC (Part 5) To select the RED(s) of YL211 as monotherapy in patients with metastatic colorectal cancer (mCRC) or locally advanced unresectable or metastatic NSCLC (Part 2) and in combination with pembrolizumab in patients with previously untreated locally advanced unresectable or metastatic non-squamous NSCLC (Part 5) Objectives for the Dose-Expansion Parts (Part 3 and Part 6) To further characterize the safety and efficacy of YL211 as monotherapy (Part 3) in patients with locally advanced unresectable or metastatic non-squamous or squamous NSCLC and in combination with pembrolizumab in patients with previously untreated locally advanced unresectable or metastatic non- squamous NSCLC (Part 6) To compare the clinical activity of YL211 in combination with pembrolizumab against pembrolizumab, pemetrexed, and platinum-based chemotherapy (cisplatin or carboplatin) in participants with previously untreated advanced unresectable or metastatic non-squamous NSCLC (Part 6)",['Advanced Solid Tumors'],INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'YL211', 'description': 'Patients will be treated with YL211 intravenous (IV) infusion only.', 'armGroupLabels': ['Part 1', 'Part 2', 'Part 3']}, {'type': 'DRUG', 'name': 'YL211+Pembrolizumab', 'description': 'Patients will be treated with YL211 and Pembro by infusion.', 'armGroupLabels': ['Part 4', 'Part 5']}, {'type': 'DRUG', 'name': 'YL211 + Pembro or Pembro+ Pemetrexed + (Carboplatin or Cisplatin)', 'description': 'participants will receive therapy YL211 + Pembro or Pembro+ Pemetrexed + (Carboplatin or Cisplatin) by infusion.(Part 6)', 'armGroupLabels': ['Part 6']}]","Inclusion Criteria: 1. Informed of the trial before the start of the trial and voluntarily sign their name and date on the ICF. 2. Aged ≥18 years. 3. Be able and willing to comply with protocol visits and procedures. 4. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 5. Adequate organ and bone marrow function. For Part 1: History of an advanced solid tumors (including locally advanced unresectable or metastatic NSCLC, metastatic colorectal carcinoma (mCRC), advanced gastric adenocarcinoma (GAC)/ gastroesophageal junction adenocarcinoma (GEJA), pancreatic ductal adenocarcinoma (PDAC), hepatocellular carcinoma (HCC), intrahepatic biliary tract cancer (ih-BTC), and head and neck squamous cell carcinoma (HNSCC) who failed currently available standard therapies and are not amenable to surgical resection, or for whom no available standard therapy or no other approved therapeutic options that have demonstrated clinical benefit. For Part 2: For patients with CRC: History of histologically or cytologically confirmed diagnosis of metastatic CRC and at least 2 prior regimens of standard treatment For patients with NSCLC: History of histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic NSCLC and no more than 2 lines of prior cytotoxic systemic therapy in the locally advanced or metastatic setting. For Part 3: History of histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic non-squamous (Part 3A) or squamous (Part 3B) NSCLC and no more than 2 lines of prior systemic therapy For Part 4: History of histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic non-squamous NSCLC who have progressed on or after 1 or 2 prior lines of systemic therapy For Part 5 and Part 6 Histologically or cytologically documented locally advanced unresectable or metastatic non-squamous NSCLC that is not eligible for curative surgery and/or definitive chemoradiotherapy and no prior systemic treatment for advanced unresectable or metastatic NSCLC Exclusion Criteria: 1. Prior treatment with an agent targeting c-MET (including antibody, ADC, chimeric antigen receptor T cell \[CAR-T\], and other drugs) with the exception of prior treatment with MET-targeted TKIs which are allowed. 2. Previously received an ADC consisting of a TopoI 3. Received continuous systemic steroids therapy for more than 28 days or require long-term (≥ 28 days) use of systemic steroids therapy within 28 days before the first administration, or have other acquired or congenital immune deficiency diseases. (Note: The protocol lists specific situational exceptions immediately following this clause). 4. A history of leptomeningeal carcinomatosis or carcinomatous meningitis 5. Brain metastasis, except for the following situations: Participants with asymptomatic brain metastasis who do not require immediate local or systemic treatment (such as mannitol or steroids, surgery, or radiotherapy) are allowed to be enrolled If the participant's brain metastasis is treated and the condition of the metastasis is stable (brain imaging examination at least 2 weeks before the first administration shows that the lesion is stable, there is no evidence of new or original brain metastasis enlargement, there are no new neurological symptoms, and immediate local or systemic treatment is not required), admission is allowed 6. Clinically significant concomitant pulmonary disease, including but not limited to: A history of drug-induced pneumonitis A history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that requires steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening",NA,ALL,NA,"[{'measure': 'Nature and frequency of adverse events (AEs) with severity determined according to NCI CTCAE v5.0 (Part 1 and Part 4)', 'description': ""AE's"", 'timeFrame': 'Approximately within 36 months'}, {'measure': 'Nature and frequency of dose-limiting toxicities (DLTs) (Part 1 and Part 4)', 'description': 'DLTs', 'timeFrame': 'Approximately within 36 months'}, {'measure': 'Nature and frequency of AEs with severity, physical examination findings (including ECOG PS), vital sign measurements, standard clinical laboratory parameters, SpO2 measurements, ECG parameters, and ECHO findings (Part 2 and Part 5)', 'description': 'Safety', 'timeFrame': 'Approximately within 36 months'}, {'measure': 'ORR assessed using RECIST version 1.1 (Part 2 and Part 5)', 'description': 'Efficacy', 'timeFrame': 'Approximately within 36 months'}, {'measure': 'PFS using RECIST version 1.1 defined as the time interval of randomization to the date of first documentation of PD or death due to any cause, whichever occurs first (Part 3 and Part 6)', 'description': 'Efficacy', 'timeFrame': 'approximately 36 months'}, {'measure': 'Nature and frequency of AEs with severity, physical examination findings (including ECOG PS), vital sign measurements, standard clinical laboratory parameters, SpO2 measurements, ECG parameters, and ECHO findings (Part 3 and Part 6)', 'description': 'Safety', 'timeFrame': 'approximately within 36 months'}]","[{'measure': 'physical examination findings (including Eastern Cooperative Oncology Group performance status; ECOG PS), vital sign measurements, standard clinical laboratory parameters, SpO2 measurements, ECG parameters, and ECHO findings (Part 1 and Part 4)', 'description': 'other safety endpoints', 'timeFrame': 'Approximately within 36 months'}, {'measure': 'PK enpoints (Part 1 and Part 4)', 'description': 'Pharmacokinetic endpoints: for each participant will be estimated using standard non-compartmental methods. Descriptive statistics will be provided for all serum concentration data and PK parameter values, with a break down by dose level/cohort as appropriate. PK parameters of YL211-ADC, YL211-TAb, unconjugated payload YL0010014, metabolite YL0010034 and if applicable, other potential metabolite(s), include but not limited to area under the curve (AUC), maximum concentration (Cmax), trough concentration (Ctrough), time of maximum observed concentration (Tmax), clearance (CL), volume of distribution (Vd), and half-life time (t1/2)', 'timeFrame': 'Approximately within 36 months'}, {'measure': 'Incidence of anti-YL211 antibody (ADA) (Part 1 and Part 4)', 'description': 'ADA', 'timeFrame': 'Approximately within 36 months'}, {'measure': 'Efficacy endpoints (Part 1 and Part 4)', 'description': 'Tumor response will be evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Efficacy variables include objective response rate (ORR, the sum of complete response \\[CR\\] rate and partial response \\[PR\\] rate), disease control rate (DCR, the sum of CR rate, PR rate, and stable disease \\[SD\\] rate), duration of response (DoR), duration of SD, time to response (TTR), and progression free survival (PFS), overall survival (OS), percent change in target lesion, time on therapy of the most recent prior regimen the participant received and that of YL211. The efficacy variable(s) will be also evaluated at 18 weeks after Day 1 of Cycle 1.', 'timeFrame': 'approximately 36 months'}, {'measure': 'PK parameters of YL211-ADC, YL211-TAb, unconjugated payload YL0010014, and if applicable, potential metabolite(s), including but not limited to AUC, Cmax, Ctrough, Tmax, CL, Vd, and t1/2 (Part 2 and Part 5)', 'description': 'PK', 'timeFrame': 'approximately 36 months'}, {'measure': 'DCR, DoR, TTR, PFS, OS, and best tumor response assessed using RECIST version 1.1 (Part 2 and Part 5)', 'timeFrame': 'approximately 36mo'}, {'measure': 'Incidence of ADA (Part 2 and Part 5)', 'timeFrame': 'approximately 36mo'}, {'measure': 'c-MET protein expression level in tumor tissues and its relationship with efficacy endpoints (Part 5)', 'timeFrame': 'approximately 36mo'}, {'measure': 'Plasma or serum concentration of YL211-ADC, YL211-TAb, unconjugated payload YL0010014, and if applicable, potential metabolite(s), at specified time points (Part 3 and Part 6)', 'timeFrame': 'approximately 36mo'}, {'measure': 'Incidence of ADA (Part 3 and Part 6)', 'timeFrame': 'approximately 36mo'}, {'measure': 'ORR, DCR, DoR, TTR, OS, and best tumor response assessed using RECIST version 1.1 (Part 3 and Part 6)', 'timeFrame': 'approximately 36mo'}, {'measure': 'c-MET protein expression level in tumor tissues and its relationship with efficacy endpoints (Part 3 and Part 6)', 'timeFrame': 'Approximately 36mo'}]" 54,NCT04196452,"{'fullName': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}",A Retrospective Observational Study on the Long-term Effects of Ipilimumab-treated Pediatric Participants in the Dutch Melanoma Treatment Registry (DMTR),ACTIVE_NOT_RECRUITING,"This is an observational, national, retrospective study consisting of pediatric patients with advanced (spread or unremoveable) melanoma identified in the DMTR in the Netherlands",['Melanoma'],OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}","[{'type': 'DRUG', 'name': 'Ipilimumab', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Arm A: participants 12 to under 18', 'Arm B: participants under 12']}]","For more information regarding Bristol-Myers Squibb Clinical Trials, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Less than 18 years of age at first dose of monotherapy Ipilimumab used for treatment of advanced melanoma * Histological or cytological confirmation of advanced (unresectable or metastatic) melanoma Exclusion Criteria: -Participation in a clinical trial within the past 4 weeks prior to first dose with ipilimumab or concurrently Other inclusion/exclusion criteria apply",The study population includes participants who are under 18 years old who are diagnosed with advanced (unresectable or metastatic) melanoma who have been treated with ipilimumab and enrolled in the DMTR,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Frequency of Adverse Events (AEs) Grades 3-4', 'timeFrame': 'up to 10 years'}]","[{'measure': 'Baseline assessment of population demographics', 'timeFrame': 'up to 10 years'}, {'measure': 'Baseline assessment of comorbidities', 'timeFrame': 'up to 10 years'}, {'measure': 'Baseline assessment of disease characteristics', 'timeFrame': 'up to 10 years'}, {'measure': 'Baseline assessment of treatment history', 'timeFrame': 'up to 10 years'}, {'measure': 'Assessment of ipilimumab dose exposure', 'timeFrame': 'up to 10 years'}, {'measure': 'Assessment of changes in ipilumamb treatment: dose interruptions/discontinuations', 'timeFrame': 'up to 10 years'}, {'measure': 'Assessment of Ipilimumab dose frequency', 'timeFrame': 'up to 10 years'}, {'measure': 'Assessment of ipilimumab treatment duration', 'timeFrame': 'up to 10 years'}, {'measure': 'Assessment of ipilimumab number of infusions', 'timeFrame': 'up to 10 years'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'up to 10 years'}, {'measure': 'Time to progression (TTP)', 'timeFrame': 'up to 10 years'}, {'measure': 'Assessment of physical growth and development', 'timeFrame': 'up to 10 years'}]" 55,NCT07371247,"{'fullName': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}",Based on ctDNA-MRD Guided Adjuvant Treatment Escalation After Definitive Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: a Study on Safety and Efficacy,ENROLLING_BY_INVITATION,"Numerous studies have confirmed that ctDNA-MRD detection technology based on peripheral blood can identify minimal residual disease (MRD) following surgery and other curative treatments, indicating a higher risk of recurrence. Multiple exploratory studies in esophageal cancer have demonstrated that patients who are ctDNA-MRD positive after definitive chemoradiotherapy (dCRT) exhibit poorer progression-free survival (PFS) and a higher risk of recurrence. Furthermore, the recent NEXUS-1 translational study confirmed that 66.7% of unresectable patients achieved the goal of conversion surgery after receiving definitive chemoradiotherapy combined with immunotherapy. Notably, patients who were ctDNA-MRD positive after chemoradiotherapy had a significantly worse prognosis. These findings suggest that ctDNA-MRD status after chemoradiotherapy has prognostic stratification value and that consolidative immunotherapy is effective. Based on these previous discoveries, this study aims to investigate the safety and efficacy of an escalated treatment strategy involving immunotherapy combined with chemotherapy for high-risk populations after definitive chemoradiotherapy for esophageal cancer, guided by personalized MRD detection results.","['Esophageal Cancer', 'MRD', 'ctDNA']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Step-up therapy', 'description': 'Patients receive step-up therapy, consisting of 4 cycles of immunotherapy combined with intravenous chemotherapy, followed by immunotherapy plus oral chemotherapy for 6 months. MRD testing is repeated after the completion of immunotherapy combined with intravenous chemotherapy.', 'armGroupLabels': ['MRD-positive groups']}, {'type': 'DRUG', 'name': 'Standard treatment Routine treatment', 'description': 'Patients receive 2 cycles of consolidative intravenous chemotherapy and then proceed to routine follow-up. MRD testing is repeated after the completion of chemotherapy.', 'armGroupLabels': ['MRD-negative groups']}]","* Inclusion Criteria 1. Histologically confirmed locally advanced esophageal squamous cell carcinoma (ESCC), with clinical stage Ⅱ-Ⅳ unresectable disease (including unresectable cases, patients with surgical contraindications, or those who refuse surgery). According to the 8th edition AJCC staging system, the pretreatment clinical stage is defined as: cT1N2-3M0, cT2-4bN0-3M0; M1 disease is limited to non-regional lymph node metastases, excluding distant organ metastases. 2. No prior systemic therapy administered for the disease, and planned to receive definitive chemoradiotherapy (dCRT). 3. Having undergone 1021-gene large panel testing on tissue samples. 4. Aged 18-80 years old. 5. Expected overall survival ≥ 6 months. 6. ECOG performance status 0-1. 7. Normal blood biochemical parameters, with normal liver and kidney function. 8. Able to understand the study protocol, voluntarily participate in the study, and sign the informed consent form. 9. Good compliance, able to cooperate with specimen collection at all designated time points and provide relevant clinical data. * Exclusion Criteria 1. Have participated in other clinical trials within 3 months prior to enrollment. 2. Have a history of other malignant tumors within 3 years prior to the diagnosis of esophageal cancer. 3. Have a history of severe mental illness. 4. Patients who are unable to understand the study protocol and thus cannot cooperate, or who refuse to sign the informed consent form. 5. Have contraindications to chemoradiotherapy. 6. Have a history of autoimmune diseases.",NA,ALL,NA,"[{'measure': 'PFS', 'timeFrame': '1 year after enrollment'}]",NA 56,NCT05861349,"{'fullName': 'Jagiellonian University', 'class': 'OTHER'}",Median Nerve Stenosis in Carpal Tunnel Syndrome,COMPLETED,"The goal of this observational study is to test the new kind of ultrasound-based measurements in patients with carpal tunnel syndrome. The main questions it aims to answer are: * Do the measurements of the size of the median nerve at the point where it is maximally compressed accurately diagnose carpal tunnel syndrome? * May these measurements accurately tell how severe is the carpal tunnel syndrome? Participants will be asked to: * Undergo conduction studies of median and ulnar nerve. * Undergo ultrasound of the median nerve. * Fill out the Boston carpal tunnel questionnaire and a demographic questionnaire. Researchers will compare the group of patients with carpal tunnel syndrome with healthy volunteers to see if respective measurements differ significantly between groups.",['Carpal Tunnel Syndrome'],OBSERVATIONAL,"{'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'DIAGNOSTIC_TEST', 'name': 'Nerve conduction study', 'description': 'Nerve conduction study of median and ulnar nerve together with sensory comparative methods on the affected side (sides).', 'armGroupLabels': ['Healthy controls', 'Patients with CTS']}, {'type': 'DIAGNOSTIC_TEST', 'name': 'Ultrasound', 'description': 'Ultrasound of the median nerve on the affected side (sides).', 'armGroupLabels': ['Healthy controls', 'Patients with CTS']}]","Inclusion Criteria: * Symptoms of CTS * Electrophysiologic and/or ultrasonographic confirmation of CTS diagnosis Exclusion Criteria: * Psychiatric or cognitive conditions with may disturb participation in the study * Peripheral neuropathy in history * Fractures and severe trauma in the area of the wrist in history","Participants will be recruited from the patients referred to the EMG Laboratory of the Department of Neurology at Jagiellonian University Medical College for verification of clinical diagnosis of CTS. After NCS and/or US confirms the CTS, the patient will be asked if she/he would like to take part in the study. Healthy controls will be recruited from the patients referred for verification of clinical diagnosis of tetany, after EMG reveals weak tetany or does not confirm it.",ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Difference in the diameter of median nerve in the site of its maximal compression', 'description': 'Difference in the diameter of median nerve in the site of its maximal compression between patients with CTS and healthy controls.', 'timeFrame': 'Through study completion, an average of 1 year.'}, {'measure': 'Difference in the cross-sectional area of median nerve in the site of its maximal compression', 'description': 'Difference in the cross-sectional area of median nerve in the site of its maximal compression between patients with CTS and healthy controls.', 'timeFrame': 'Through study completion, an average of 1 year.'}, {'measure': 'Difference in the echogenicity of median nerve in the site of its maximal compression', 'description': 'Difference in the echogenicity of median nerve in the site of its maximal compression between patients with CTS and healthy controls.', 'timeFrame': 'Through study completion, an average of 1 year.'}]","[{'measure': 'Correlation of the diameter of median nerve in the site of its maximal compression with BCTQ score', 'description': 'Correlation of the diameter of median nerve in the site of its maximal compression with BCTQ score in patients with CTS.', 'timeFrame': 'Through study completion, an average of 1 year.'}, {'measure': 'Correlation of the cross-sectional area of median nerve in the site of its maximal compression with BCTQ score', 'description': 'Correlation of the cross-sectional area of median nerve in the site of its maximal compression with BCTQ score in patients with CTS.', 'timeFrame': 'Through study completion, an average of 1 year.'}, {'measure': 'Correlation of echogenicity of median nerve in the site of its maximal compression with BCTQ score', 'description': 'Correlation of echogenicity of median nerve in the site of its maximal compression with BCTQ score in patients with CTS.', 'timeFrame': 'Through study completion, an average of 1 year.'}, {'measure': 'Correlation of the diameter of median nerve in the site of its maximal compression with CTS electrophysiological severity grade', 'description': 'Correlation of the diameter of median nerve in the site of its maximal compression with CTS electrophysiological severity grade in patients with CTS.', 'timeFrame': 'Through study completion, an average of 1 year.'}, {'measure': 'Correlation of the cross-sectional area of median nerve in the site of its maximal compression with CTS electrophysiological severity grade', 'description': 'Correlation of the cross-sectional area of median nerve in the site of its maximal compression with CTS electrophysiological severity grade in patients with CTS.', 'timeFrame': 'Through study completion, an average of 1 year.'}, {'measure': 'Correlation of echogenicity of median nerve in the site of its maximal compression with CTS electrophysiological severity grade', 'description': 'Correlation of echogenicity of median nerve in the site of its maximal compression with CTS electrophysiological severity grade in patients with CTS.', 'timeFrame': 'Through study completion, an average of 1 year.'}]" 57,NCT01815749,"{'fullName': 'City of Hope Medical Center', 'class': 'OTHER'}",Genetically Modified T-cell Infusion Following Peripheral Blood Stem Cell Transplant in Treating Patients With Recurrent or High-Risk Non-Hodgkin Lymphoma,ACTIVE_NOT_RECRUITING,"This phase I trial studies the side effects and best dose of genetically modified T-cells following peripheral blood stem cell transplant in treating patients with recurrent or high-risk non-Hodgkin lymphoma. Giving chemotherapy before a stem cell transplant helps stop the growth of cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Removing the T cells from the donor cells before transplant may stop this from happening. Giving an infusion of the donor's T cells (donor lymphocyte infusion) later may help the patient's immune system see any remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect)","['Adult Grade III Lymphomatoid Granulomatosis', 'Cutaneous B-cell Non-Hodgkin Lymphoma', 'Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue', 'Intraocular Lymphoma', 'Nodal Marginal Zone B-cell Lymphoma', 'Post-transplant Lymphoproliferative Disorder', 'Recurrent Adult Burkitt Lymphoma', 'Recurrent Adult Diffuse Large Cell Lymphoma', 'Recurrent Adult Diffuse Mixed Cell Lymphoma', 'Recurrent Adult Diffuse Small Cleaved Cell Lymphoma', 'Recurrent Adult Grade III Lymphomatoid Granulomatosis', 'Recurrent Adult Immunoblastic Large Cell Lymphoma', 'Recurrent Adult Lymphoblastic Lymphoma', 'Recurrent Grade 1 Follicular Lymphoma', 'Recurrent Grade 2 Follicular Lymphoma', 'Recurrent Grade 3 Follicular Lymphoma', 'Recurrent Mantle Cell Lymphoma', 'Recurrent Marginal Zone Lymphoma', 'Recurrent Small Lymphocytic Lymphoma', 'Refractory Hairy Cell Leukemia', 'Small Intestine Lymphoma', 'Splenic Marginal Zone Lymphoma', 'Testicular Lymphoma', 'Waldenström Macroglobulinemia']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T cells', 'description': 'Given IV', 'armGroupLabels': ['Treatment (genetically modified T cell infusion)'], 'otherNames': ['CD19-CAR-specific/truncated EGFR lentiviral vector-transduced autologous T cells']}, {'type': 'PROCEDURE', 'name': 'autologous hematopoietic stem cell transplantation', 'description': 'Undergo autologous hematopoietic stem cell transplantation', 'armGroupLabels': ['Treatment (genetically modified T cell infusion)']}, {'type': 'OTHER', 'name': 'laboratory biomarker analysis', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (genetically modified T cell infusion)']}]","Inclusion Criteria: * Research participants enrolled are patients with an indication to be considered for HSCT, who are diagnosed with intermediate grade B-cell NHL (e.g., DLBCL, MCL or transformed NHL), and that have either recurrence/progression following prior therapy, or verification of high-risk disease in first remission * Karnofsky performance status of \>= 70% and a life expectancy \>= 16 weeks at time of enrollment * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately * City of Hope (COH) pathology review confirms that research participant's diagnostic material is consistent with the history of intermediate grade B-cell NHL (e.g., DLBCL, MCL or transformed NHL) * Negative serum pregnancy test for women of childbearing potential * Research participant has an indication to be considered for autologous stem cell transplantation * All patients must have the ability to understand and the willingness to sign a written informed consent ELIGIBILITY TO UNDERGO AUTOLOGOUS MYELOABLATIVE TRANSPLANTATION WITH HEMATOPOETIC PROGENITOR CELL (HPC)A RESCUE * Research participant meets all standard clinical parameters for candidates of autologous transplant as described in the current COH Hematopoietic Cell Transplant Standard Operating Policies, Procedures and Protocols * Patient Evaluation \& Selection or Deferral for hematopoietic cell transplantation (HCT) * Research participant is scheduled to receive a standard chemotherapy-based conditioning regimen, such as cyclophosphamide, carmustine, etoposide (CBV) or carmustine, etoposide, cytarabine, melphalan (BEAM) * Research participant has a cryopreserved unselected HPCA product of at least 3 x 10\^6/kg CD34+ cells * Research participant does not have evidence of disease progression after salvage therapy ELIGIBILITY CRITERIA AT TIME OF INFUSION OF GENETICALLY MODIFIED AUTOLOGOUS T CELLS * Research participant has a released cryopreserved T cell product * Research participant has undergone an autologous HPC(A) procedure * Not requiring supplemental oxygen or mechanical ventilation, oxygen saturation of 90% or higher on room air * Not requiring pressor support, not having symptomatic cardiac arrhythmias * Lack of acute renal failure/requirement for dialysis, as evidenced by creatinine \< 1.6 - Total bilirubin =\< 5.0 * Research participant without clinically significant encephalopathy/new focal deficits * No clinical evidence of uncontrolled active infections process Exclusion Criteria: * Research participants with any uncontrolled illness including ongoing or active infection; research participants with known active hepatitis B or C infection; research participants who are human immunodeficiency virus (HIV) seropositive based on testing performed within 4 weeks of enrollment; research participants with any signs of symptoms of active infection, positive blood cultures or radiological evidence of infections * Research participants receiving any other investigational agents, or concurrent biological, chemotherapy or radiation therapy * History of allergic reactions attributed to compounds of similar chemical or biologic composition to cetuximab * Research participants with known brain metastases (central nervous system \[CNS\] involvement or parenchymal or leptomeningeal involvement) * Research participants with presence of other malignancy or history of prior malignancy within 5 years of study entry; although patients treated with curative intent within 5 year are eligible; this exclusion rule does not apply to non-melanoma skin tumors and in-situ cervical cancer * Failure of research participant to understand the basic elements of the protocol and/or the risks/benefits of participating in this phase I/II study; a legal guardian may substitute for the research participant * History of allogeneic HSCT or prior autologous HSCT * Any standard contraindications to myeloablative HSCT per standard of care practices at COH * Dependence on corticosteroids * Active autoimmune disease requiring systemic immunosuppressive therapy * Research participants will be excluded, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study",NA,ALL,NA,"[{'measure': 'Adverse events attributed to Tcm adoptive transfer as reported using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0', 'description': 'Tables will be created to summarize all toxicities and side effects by dose, course, organ, and severity.', 'timeFrame': 'Up to 15 years'}, {'measure': 'MTD of CD19-CAR-specific/truncated EGFR lentiviral vector-transduced autologous T cells based on dose limiting toxicities', 'description': 'Graded according to the NCI CTCAE version 4.0.', 'timeFrame': 'Up to day 28'}]","[{'measure': 'Engraftment of the transferred T cell products', 'description': 'Rates and associated 95% confidence limits will be estimated.', 'timeFrame': 'Up to 21 days'}, {'measure': 'CD19+ B cell precursors in the peripheral blood as a surrogate for the in vivo effector function of transferred CD19-specific T cells', 'description': 'Rates and associated 95% confidence limits will be estimated.', 'timeFrame': 'Up to 28 days'}]" 58,NCT00039338,"{'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}",Chemotherapy Followed By Surgery Vs Radiotherapy Plus Chemotherapy in Patients With Stage IB or II Cervical Cancer,UNKNOWN,"RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery. Radiation therapy uses high-energy x-rays to kill tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. It is not yet known whether chemotherapy is more effective followed by surgery or combined with radiation therapy in treating cervical cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy followed by radical hysterectomy with that of chemotherapy plus radiation therapy in treating patients who have stage IB or stage II cervical cancer.",['Cervical Cancer'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'PROCEDURE', 'name': 'conventional surgery', 'description': 'Radial hysterectomy', 'armGroupLabels': ['Chemotherapy followed by surgery']}, {'type': 'PROCEDURE', 'name': 'neoadjuvant chemotherapy', 'description': 'Experimental arm: minimal cumulative cisplatin dose of 225 mg/m2. Comparator arm: cumulative cisplatin dose of 200-240 mg/m2.', 'armGroupLabels': ['Chemotherapy followed by surgery', 'Radio-chemotherapy']}, {'type': 'RADIATION', 'name': 'brachytherapy', 'description': 'Brachytherapy at the end of external radiation. Minimal total dose (external with or without external boost + brachytherapy) of 75 Gy EQD2 to point A. Overall treatment less than 50 days.', 'armGroupLabels': ['Radio-chemotherapy']}, {'type': 'RADIATION', 'name': 'radiation therapy', 'description': 'Between 45-50 Gy, in fractions of 1.8 to 2 Gy.', 'armGroupLabels': ['Radio-chemotherapy']}, {'type': 'DRUG', 'name': 'cisplatin', 'description': 'Minimal cumulative 225 mg/m2 (experimental arm). Cumulative 200-240 mg/m2 (comparator arm).', 'armGroupLabels': ['Chemotherapy followed by surgery', 'Radio-chemotherapy']}]","DISEASE CHARACTERISTICS: * Histologically confirmed cervical cancer, including the following subtypes: * Squamous cell carcinoma * Adenosquamous cell carcinoma * Adenocarcinoma (excluding small cell, clear cell, and other rare variants of the classical adenocarcinoma) * FIGO stage IB2, IIA (greater than 4 cm), or IIB PATIENT CHARACTERISTICS: Age: * 18 to 75 Performance status: * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin less than 1.46 mg/dL Renal: * Creatinine clearance greater than 60 mL/min Other: * No other prior or concurrent malignancy except adequately treated basal cell skin cancer * No psychological, familial, sociological, or geographical condition that would preclude study * Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy Surgery: * Not specified Other: * No other concurrent anticancer agent",NA,FEMALE,NA,"[{'measure': 'Overall survival at 5 years', 'timeFrame': '5 years'}]",NA 59,NCT04503538,"{'fullName': 'Wake Forest University Health Sciences', 'class': 'OTHER'}",Telemedicine for Early Detection of Cytokine Release Syndrome and Neurotoxicity,WITHDRAWN,"The purpose of this research is to replace one of participants' outpatient chimeric antigen receptor T-cell (CAR-T) therapy follow up visits with a virtual or ""telemedicine"" visit. The telemedicine visit will use an electronic tablet with a camera and a microphone that allows participants to communicate with their physicians and nurses. Participants will be provided with the necessary equipment to complete these visits.","['Large B-cell Lymphoma', 'Diffuse Large B Cell Lymphoma', 'Primary Mediastinal Large B Cell Lymphoma', 'High-grade B-cell Lymphoma', 'Follicular Lymphoma']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'OTHER', 'name': 'Telemedicine visit', 'description': 'Participants will be provided with a Wifi-and cellular enabled electronic tablet. Additionally, participants will receive a kit that contains a thermometer, a blood pressure monitoring cuff, and a pulse oximeter (to measure oxygen saturation level). Participants will attend an educational session to learn how the telemedicine visit works. Caregivers should attend with participants and will be trained to take temperatures, blood pressures, and oxygen saturation levels. Participants will also be asked to complete a test telehealth visit.', 'armGroupLabels': ['CAR-T cell therapy and Telemedicine']}]","Inclusion Criteria: * Patients must have histologically confirmed relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from of follicular lymphoma * Age ≥ 18 years * ECOG or Karnofsky performance status of ≤ 2 * Patients must have a caregiver(s) with them 24 hours a day for the first 30 days after CAR-T cell infusion * Patients must stay within a 30-minute distance from the cancer center * Patients must have access to wifi network or a cellular network * Patients and caregiver(s) participating in patient's care must attend the education session for outpatient CAR-T and demonstrate competency to collect vital signs with equipment provided * Must have the ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative). Exclusion Criteria: * Patients who have acute lymphoblastic leukemia/lymphoma * Patients who have a high tumor burden (\> 10 cm largest mass) have a high risk of CRS who will receive CAR-T as an inpatient * Patient or caregiver unable to understand and follow English language * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.",NA,ALL,NA,"[{'measure': 'Number of Successfully Completed Telemedicine Visits', 'description': 'To determine feasibility of telemedicine for outpatient cytokine release syndrome and neurotoxicity assessment. Investigators will consider telemedicine feasible in this population if at least 13 of the 15 patients successfully complete 80% of telemedicine visits. A visit will be considered successful if all measurements are recorded OR if the visit is interrupted because the participant needs to come into the CAR-T unit for assessment. If a patient is admitted, then the 80% benchmark will be calculated based on the number of days the patient was outpatient at 11 pm. The proportion meeting the 80% benchmark will be reported along with an exact 95% confidence interval.', 'timeFrame': '3 years'}]","[{'measure': 'Number of Times a Telemedicine Visit Triggered Action', 'description': 'To determine how many times a telemedicine visit triggered an inpatient admission or outpatient observation status', 'timeFrame': '3 years'}, {'measure': 'Number of Patients to Have Cytokine Release Syndrome', 'description': 'Descriptive statistics will be used to characterize the number of cases of cytokine release syndrome based on telemedicine visits.', 'timeFrame': '3 years'}, {'measure': 'Number of Patients to Have Neurotoxicity', 'description': 'Descriptive statistics will be used to characterize the number neurotoxicities reported based on telemedicine visits.', 'timeFrame': '3 years'}]" 60,NCT02848638,"{'fullName': 'University of Washington', 'class': 'OTHER'}",Pair Production PET Imaging to Detect Particle Distribution in Patients Undergoing Yttrium-90 Radioembolization,COMPLETED,"The primary goal of the study is to see if the PET/CT will be able to determine the precise location of the Y-90 particles within the liver and within the tumors. We hope to use this information in order to see if these particles distribute evenly throughout large tumors or if the particles go into the tumor which is located in the portal vein. The secondary goals are threefold. First correlate the distribution of Y90 particles (as demonstrated by PET/CT) with the degree of dead-tumor tissue. Second, see if there is a difference in the Y90 particle's distribution when a low particle load (1-3 million particles) is used compared to when a high particle load (6-8 million particles) is used. Lastly, compare the sensitivity of standard imaging ( bremsstrahlung imaging) currently being used for the Yttrium-90 angioembolization procedure to the sensitivity of the pair production PET research imaging.","['Carcinoma, Hepatocellular']",OBSERVATIONAL,"{'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}",NA,"Inclusion Criteria: 1. UWMC patients over 18 years of age 2. Presence of hepatocellular carcinoma greater than 5 cm OR presence of tumor-associated portal vein thrombosis. 3. Currently undergoing treatment with Yttrium-90 Radioembolization 4. Able to sign informed consent Exclusion Criteria: 1. Patients who are not undergoing treatment with Yttrium-90 Radioembolization 2. Patients unable to provide informed consent","Patients (18-85 years old), who have hepatocellular carcinoma with tumors that are greater than 5 cm or have tumor-associated portal vein thrombosis. The patients are currently undergoing treatment with Yttrium-90 Radioembolization, as part of their clinical care.",ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Degree and distribution of Y90 particle uptake', 'description': 'To use pair production PET/CT in order to determine the degree and distribution of Y90 particle uptake in patients with large (\\>5cm) liver tumors or patients with tumor-associated portal vein thrombosis.', 'timeFrame': 'Within one year of Enrollment completion'}]",NA 61,NCT01120158,"{'fullName': 'Hellenic Oncology Research Group', 'class': 'OTHER'}",Paclitaxel Plus Bevacizumab for Older Patients With Breast Cancer,TERMINATED,"This study will evaluate the efficacy, safety and effect on quality of life of weekly paclitaxel plus bevacizumab as first line treatment in elderly patients (≥ 70 years old) with metastatic breast cancer. Furthermore, the efficacy of the combination therapy will be correlated with the functional status of patients according to the comprehensive geriatric assessment.",['Breast Cancer'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Bevacizumab', 'description': 'Bevacizumab (IV) 10 mg/kg on day 1 and day 15. Treatment repeats every 28 days. Therapy will continue until maximum response, disease progression or unacceptable toxicity.', 'armGroupLabels': ['1'], 'otherNames': ['Avastin']}, {'type': 'DRUG', 'name': 'Paclitaxel', 'description': 'Paclitaxel (IV) 120 mg/m2,on day 1 and day 15. Treatment repeats every 28 days Therapy will continue until maximum response, disease progression or unacceptable toxicity.', 'armGroupLabels': ['1'], 'otherNames': ['Taxoprol', 'Paxene', 'Taxol', 'Ovapac']}]","Inclusion Criteria: * Histologically or cytologically confirmed metastatic breast adenocarcinoma * No previous therapy (other than hormonal therapy) for metastatic disease is accepted * Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions) * Performance status (WHO) 0-2 * Adequate liver (serum bilirubin \<1.5 times the upper normal limit, AST and ALT \<2.5 times the upper normal limit in the absence of demonstrable liver metastases, or \<5 times the upper normal limit in the presence of liver metastases) * adequate renal function (serum creatinine \<1.5 times the upper normal limit) * bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) * No radiation of measurable disease (except brain metastases) * No progressive brain metastases according to clinical or radiological criteria * No brain metastases without prior radiation therapy * Written informed consent Exclusion Criteria: * Active infection * History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias) * History of stroke * Anticoagulation therapy (except of low dose aspirin \<325mg) * Other invasive malignancy except non-melanoma skin cancer * Psychiatric illness or social situation that would preclude study compliance * Pregnant or lactating women",NA,FEMALE,NA,"[{'measure': 'Overall Response Rate', 'timeFrame': 'Objective responses confirmed by CT or MRI every 3 months'}]","[{'measure': 'Toxicity profile', 'timeFrame': 'Toxicity assessment every month'}, {'measure': 'Time to Tumor Progression', 'timeFrame': '1-year'}, {'measure': 'Overall Survival', 'timeFrame': '1 year'}]" 62,NCT04257058,"{'fullName': 'Emory University', 'class': 'OTHER'}",Education Tools to Support Pediatric Survivor Care,COMPLETED,"This study aims to evaluate the impact of electronic educational materials on adolescent and young adult (AYA) survivors' knowledge about late effects, perceived benefits, self-efficacy, and intentions to engage in lifelong survivor care.","['Cancer', 'Pediatric Cancer']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BEHAVIORAL', 'name': 'Electronic educational material', 'description': 'Electronic media via email', 'armGroupLabels': ['Electronic educational material']}]","Inclusion Criteria: * Patients must be 18-25 years of age, * Diagnosed with cancer at ≤ 18 years of age, * ≥ 2 years since the last cancer treatment, * seen at least once in the Aflac Cancer Survivor Program (CSP) in the past 2 years or transitioned out of the Aflac CSP to adult survivor care since 2013. Exclusion Criteria: * Patients will be excluded from participation in the study if the participant is non-English speaking. * Young adult survivors who are cognitively impaired and unable to complete the questionnaires. * Participants that do not consent to the recording of their interviews.",NA,ALL,NA,"[{'measure': 'Survivor Care Knowledge Scale', 'description': ""Knowledge was assessed at baseline and 2 weeks post-intervention, with the Survivor Care Knowledge scale, that includes 15-item multiple-choice quiz to assess participants' knowledge of the content covered in the electronic educational materials previously provided. Total score ranges from 0-15. Higher score is associated with better outcome."", 'timeFrame': 'Baseline, 2 weeks post-intervention'}]","[{'measure': 'Benefits for Survivor Care', 'description': '5-item study adapted Champion Benefits Scale for Mammography Screening. Total score ranges from 5-25. Lower score equals fewer perceived benefits of survivor care.', 'timeFrame': 'Baseline, 2 weeks post-intervention'}, {'measure': 'Barriers for Survivor Care', 'description': '11-item study adapted Champion Barriers Scale for Mammography Screening. Total score ranges from 11-55. Lower score equals fewer perceived barriers to survivor care.', 'timeFrame': 'Baseline, 2 weeks post-intervention'}, {'measure': 'Perceived Susceptibility for Late Effects', 'description': '3-item study adapted Champion Susceptibility Scale for Mammography Screening. Total score ranges from 3-15. Lower score equals less susceptibility to late effects of treatment.', 'timeFrame': 'Baseline, 2 weeks post-intervention'}, {'measure': 'Intentions for Survivor Care', 'description': ""2-item study adapted Ajzen's Theory of Planned Behavior- Intentions. Total score ranges from 2-14. Lower score equals greater intention to engage in long-term follow-up care."", 'timeFrame': 'Baseline, 2 weeks post-intervention'}, {'measure': 'Change in Perceived Health Competence Scale (PHCS)', 'description': '8-item Perceived Health Competence Scale (PHCS). Total score ranges from 8-40. Lower score equals lower perceived health competence.', 'timeFrame': 'Baseline, 2 weeks post-intervention'}]" 63,NCT05377658,"{'fullName': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}",AK104 With Chemotherapy as Neoadjuvant and Adjuvant Therapy for Resectable Non-small Cell Lung Cancer,RECRUITING,"AK104, a tetravalent bispecific antibody targeting PD-1 and CTLA-4, is designed to retain the efficacy benefit of combination of PD-1 and CTLA-4 and improve on the safety profile of the combination therapy. The aim of this study is to evaluate the efficacy and safety of AK104 with chemotherapy as neoadjuvant and adjuvant therapy for patients with resectable stage II-IIIA NSCLC.",['Non-small Cell Lung Cancer'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'AK104', 'description': '10 mg/kg via intravenous infusion on Day 1 of each 21-day cycle.', 'armGroupLabels': ['AK104+albumin-bound paclitaxel+carboplatin'], 'otherNames': ['Cadonilimab']}, {'type': 'DRUG', 'name': 'Albumin-Bound Paclitaxel', 'description': '260mg/m\\^2 via intravenous infusion on Day 1 of each 21-day cycle.', 'armGroupLabels': ['AK104+albumin-bound paclitaxel+carboplatin']}, {'type': 'DRUG', 'name': 'Carboplatin', 'description': 'AUC 5 mg/mL/min via intravenous infusion on Day 1 of each 21-day cycle.', 'armGroupLabels': ['AK104+albumin-bound paclitaxel+carboplatin']}]","Key Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 2. Have previously untreated and pathologically confirmed resectable Stage II-IIIA NSCLC. 3. Have at least one measurable lesion per RECIST 1.1 assessed by investigator. 4. Have adequate organ function. Key Exclusion Criteria: 1. Mixed NSCLC and small cell lung cancer histology. 2. Patients with other active malignancies within 3 years prior to enrollment. 3. Known active autoimmune diseases. 4. Use of immunosuppressive agents within 14 days prior to the first dose of study treatment. 5. Presence of other uncontrolled serious medical conditions.",NA,ALL,NA,"[{'measure': 'Pathological Complete Response (pCR) Rate', 'description': 'defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.', 'timeFrame': 'At time of surgery'}]","[{'measure': 'Major Pathological Response (MPR) Rate', 'description': 'defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.', 'timeFrame': 'At time of surgery'}, {'measure': 'Incidence of Surgical Complications', 'description': 'defined as ≥ grade 3 or severe intraoperative and perioperative complications.', 'timeFrame': 'Up to approximately 30 days following surgery'}, {'measure': 'Complete (R0) Resection Rate', 'description': 'defined as the percentage of participants achieving complete surgical resection following completion of neoadjuvant therapy.', 'timeFrame': 'After surgery (approximately 7 weeks)'}, {'measure': 'Objective Response Rate (ORR)', 'description': 'defined as the percentage of participants having complete response or partial response to protocol treatment. Objective response will be measured by RECIST 1.1.', 'timeFrame': 'At the end of 3 cycles of neoadjuvant therapy (each cycle is 21 days)'}, {'measure': 'Event Free Survival (EFS)', 'description': 'defined as the time from the first dose of study drug to disease progression per RECIST 1.1 that precludes surgery, local or distant recurrence, or death due to any cause, whichever occurs first.', 'timeFrame': 'Up to approximately 5 years'}, {'measure': 'Adverse Events (AEs)', 'timeFrame': 'From the first dose of neoadjuvant treatment until 90 days after the last dose of adjuvant treatment'}]" 64,NCT00897455,"{'fullName': 'National Cancer Institute (NCI)', 'class': 'NIH'}",Studying Breast Cancer Risk in Women Who Are BRCA1/BRCA2 Mutation Carriers,UNKNOWN,"RATIONALE: Studying samples of DNA in the laboratory from women who are BRCA1/BRCA2 mutation carriers may help doctors learn more about cancer and identify biomarkers related to cancer. PURPOSE: This research study is looking at breast cancer risk in women who are BRCA1/BRCA2 mutation carriers.","['brca1 Mutation Carrier', 'brca2 Mutation Carrier', 'Breast Cancer']",OBSERVATIONAL,NA,"[{'type': 'GENETIC', 'name': 'DNA analysis'}, {'type': 'GENETIC', 'name': 'mutation analysis'}, {'type': 'GENETIC', 'name': 'polymorphism analysis'}, {'type': 'OTHER', 'name': 'laboratory biomarker analysis'}, {'type': 'PROCEDURE', 'name': 'evaluation of cancer risk factors'}]","DISEASE CHARACTERISTICS: * Known positive BRCA1/BRCA2 mutation carrier * With or without a personal history of breast cancer prior to enrollment in clinical trial GOG-0199 * Currently enrolled in clinical trial GOG-0199 AND meets the following criteria: * Completed baseline questionnaire (BQ-199) * Provided information on prior breast cancer history, including date of diagnosis * Provided complete data from the DNA analysis on the genetic variants of interest * Signed an approved informed consent and authorization permitting release of personal health information * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics",NA,FEMALE,NA,[{'measure': 'Identification of potential genetic modifiers of breast cancer risk'}],NA 65,NCT00424255,"{'fullName': 'GlaxoSmithKline', 'class': 'INDUSTRY'}",Study Of Adjuvant Lapatinib In High-Risk Head And Neck Cancer Subjects After Surgery,COMPLETED,"This is a randomised, double-blind, placebo-controlled, multicentre, global Phase III trial comparing the efficacy of adjuvant oral lapatinib versus placebo in high-risk subjects with head and neck cancer following surgery. Lapatinib or placebo will be administered post-operatively in combination with chemoradiotherapy followed by maintenance with lapatinib or placebo for 1 year. The primary goal is to determine if lapatinib is effective at reducing the recurrence of the disease in these high-risk patients.","['Neoplasms, Head and Neck']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}","[{'type': 'DRUG', 'name': 'Lapatinib', 'description': 'Dual ErbB1/2 inhibitor', 'armGroupLabels': ['Lapatinib+Chemoradiation']}, {'type': 'RADIATION', 'name': 'Chemoradiation', 'description': 'Radiation plus platinum based chemotherapy', 'armGroupLabels': ['Placebo+Chemoradiation']}, {'type': 'OTHER', 'name': 'Placebo', 'description': 'Placebo', 'armGroupLabels': ['Placebo+Chemoradiation']}]","Inclusion Criteria: * Willing and able to sign a written informed consent. * Histologically confirmed diagnosis of SCCHN of one of the following sites: oral cavity, oropharynx, hypopharynx and larynx. * Pathological Stage II, III or IVa (according to AJCC cancer staging criteria \[Green, 2002\]) with no evidence of gross residual disease, and at least one of the following high risk factors by pathology: * Extracapsular extension of nodal disease * Positive resection margin (5 mm or less) * Primary surgery with a curative intent completed within 4-6 weeks (and no later than 7 weeks) prior to randomization. The extent of surgical resection will follow accepted criteria for adequate excision \[Helliwell, 2005\]. Surgical margins are divided into 'mucosal' and 'deep', and for each category the resection margin (R) is classified as: * Clear : (R0) \> 5mm. * Close: (R1) 1 - 5mm. * Involved: (R2) \<1mm * Complete recovery from the surgical procedure allowing for appropriate radiotherapy. Radiation therapy is required to start as soon as adequate healing has occurred. This is normally around 4-6 weeks but no later than 9 weeks after surgery. * Adequate tumour specimen from archived or resected tissue must be available for IHC evaluation of ErbB1 expression levels in a central laboratory and subsequent biomarker analysis. * Male or female, between 18 and 70 years of age \[Bourhis, 2006\]. Criteria for female subjects or female partners of male subjects: Non-child-bearing potential (i.e., a woman with functioning ovaries who has a current documented tubal ligation or hysterectomy or a woman who is menopausal); or Child-bearing potential (i.e. a woman with functioning ovaries and no documented impairment of oviductal or uterine function that would cause sterility. This category includes women with oligomenorrhoea (even severe), women who are perimenopausal and young women who have begun to menstruate), who have a negative serum pregnancy test at screening, and agree to one of the following: Complete abstinence from intercourse from the time of the screening pregnancy test until 28 days after the final dose of test article; or Consistent and correct use of one of the following acceptable methods of birth control: Male partner who is sterile prior to the female subject's entry into the study and is the sole sexual partner for that female subject; or Oral contraceptives (either combined or progestogen only), or Injectable progestogen-only contraceptives or Implants of levonorgestrel, or Any intrauterine device with a documented failure rate of less than 1% per year; or Barrier methods (e.g. condoms, diaphragms, caps) only if used in combination with one of the above acceptable methods. * ECOG performance status 0, 1 or 2 * Adequate haematology, renal and hepatic function Absolute neutrophil count ≥ 1,500/μL, platelets ≥ 100,000/μL Haemoglobin ≥ 9 gm/dL (5mmol/L) Calculated creatinine clearance ≥60 ml/min as determined by the modified method of Cockcroft and Gault. Aspartate (AST) and alanine transaminase (ALT) less than 3 times the upper limit of the normal range (ULN). Total bilirubin ≤ 2.0 mg/dL * Left ventricular ejection fraction (LVEF) above the lower limits of the institutional normal range as measured by ECHO (if ECHO cannot be performed or if the Investigator feels it is not conclusive to evaluate LVEF, then a MUGA scan should be performed). * Able to swallow and retain tablets whole or swallow a suspension of tablets dissolved in water at study inclusion. The use of feeding tube is optional. If necessary, the suspension may be administered via percutaneous endoscopic gastrostomy (PEG), percutaneous jejunostomy tube (J- Tube), or a nasogastric tube (NG or Dobhoff type tube). * Life expectancy of at least 6 months in the best judgement of the investigator * Current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment). Exclusion Criteria: * Nasopharyngeal, paranasal sinuses or nasal cavity tumours * Head and neck cancer with histology other than squamous cell carcinoma. * Evidence of distant metastases or gross post-operative residual disease. * Evidence of second primary tumour. * Any prior or current anticancer treatment of any kind - except the primary surgical resection. This will include but is not limited to: prior tyrosine kinase inhibitors, prior neoadjuvant therapy, prior radiotherapy or use of any investigational agent. * Concurrent treatment with an investigational agent or participation in another clinical trial. * Concurrent use of CYP3A4 inducers or inhibitors while on lapatinib/placebo. A standard 3 to 5 day course of dexamethasone for the prevention of cisplatin induced nausea and vomiting is permitted. In addition glucocorticoid daily doses (oral) 1.5mg dexamethasone (or equivalent) are allowed. * Subjects with known history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure; * Pregnant or lactating females * History of another malignancy within the last 5 years, with the exception of completely resected basal or squamous cell skin cancer, or successfully treated in-situ carcinoma. History of non-invasive lesion or in-situ carcinoma, that was successfully treated with surgery, photodynamics or laser, will be permitted; * Peripheral neuropathy ≥ grade 2 * Mal-absorption syndrome, disease significantly affecting GI function, or major resection of the stomach or bowel, that could affect absorption of lapatinib. * History of allergic reactions to relevant diuretics or anti-emetics (e.g 5-HT3 antagonists) to be administered with cisplatin chemotherapy * History of allergic reactions attributed to compounds of similar chemical composition (quinazolines) to lapatinib * The investigator considers the subject unfit for the study as a result of the medical interview, physical examinations, or screening investigations",NA,ALL,NA,"[{'measure': 'Disease Free Survival (DFS)', 'description': 'DFS is defined as the time from randomization until the earliest date of disease recurrence (evidence of local, regional, or distant disease progression, second primary tumor) or death due to any cause. Disease recurrence was based on the assessments from the blinded, independent reviewer (radiological and clinical). Participants who initiated alternative anti-cancer therapy prior to disease recurrence or death were treated as censored at the last assessment prior to the time of this initiation. For participants whose disease did not recur or who did not die, DFS was censored at the time of the last independently assessed radiological scan (where initiation of alternative anti-cancer therapy had not commenced). Participants who missed two or more consecutive disease assessments were censored at the last assessment prior to the missed assessments. Participants considered to have malignant disease at Baseline were censored at the time of randomization.', 'timeFrame': 'From randomization until the earliest date of disease recurrence or death due to any cause (average of 101 study weeks)'}]","[{'measure': 'Overall Survival (OS)', 'description': 'OS is defined as the time from randomization until death due to any cause. For participants who did not die, the time to death was censored at the time of last visit/contact.', 'timeFrame': 'From randomization until death due to any cause (average of 131 study weeks)'}, {'measure': 'Disease Specific Survival (DSS)', 'description': 'DSS is defined as the time from randomization until death due to head and neck cancer. Participants whose death was not related to the disease under study were treated as competing risks at the time death occured. Participants who were alive were censored at the time of their last visit.', 'timeFrame': 'From randomization until death due to head and neck cancer (average of 131 study weeks)'}, {'measure': 'Time to Locoregional Recurrence (TTLR)', 'description': 'TTLR is defined as the time from randomization until the first occurrence that local and/or regional recurrence is documented or the date of censor. Local relapse is defined as recurrent cancer in the primary tumor bed not clearly attributable to a second primary neoplasm. Regional relapse is defined as recurrent cancer in the neck not clearly attributable to a second primary neoplasm. All other events prior to locoregional recurrence were treated as competing risks at the time they occured. All other participants were treated as censored at the time of their last disease assessment. Participants with malignant disease at Baseline according to the independent review were censored at the time of randomization for the analysis of independently reviewed data.', 'timeFrame': 'From randomization until thefirst occurrence that local and/or regional recurrence is documented or the date of censor (average of 101 study weeks)'}, {'measure': 'Time to Distant Relapse (TTDR)', 'description': 'TTDR is defined as the time from randomization until the first occurrence that distant relapse is documented. Distant relapse is defined as clear evidence of distant metastases (lung, bone, brain, etc.). Metastasis is defined as the spread of a cancer from one organ or part to another non-adjacent organ or part. All other events prior to a distant relapse were treated as competing risks at the time they occured. All other participants were treated as censored at the time of their last disease assessment. Participants with malignant disease at Baseline according to the independent review were censored at the time of randomization for the analysis of independently reviewed data.', 'timeFrame': 'From randomization until the first documented occurrence that distant relapse is documented (average of 101 study weeks)'}, {'measure': 'Number of Participants With a Second Primary Tumor', 'description': 'Participants who developed a second primary tumor at the time of the first recurrence or within 28 days of the first recurrence were measured. The criteria for a second primary tumor are as follows: a distinct lesion separated from the primary tumor site by \\>2 centimeters of normal epithelium; or a new cancer with different histology; or any cancer, regardless of site, occurring \\>=3 years after initial treatment. Participants with baseline disease were included in the denominator when calculating the percentage.', 'timeFrame': 'From randomization until development of second primary tumor or within 28 days of first recurrence (average of 101 study weeks)'}, {'measure': 'Extent of Exposure', 'description': 'Extent of exposure is defined as the duration of treatment administered during the study. The mean duration of treatment is calculated as the number of days between the start of treatment and the end of treatment inclusive (i.e., treatment stop date minus treatment start date + 1). Participants were counted in a treatment phase (monotherapy, chemoradiotherapy, and maintenance) if they had received any dose in that phase. Participants randomized to placebo who received \\>=1 dose of lapatinib in error were included in the lapatinib arm.', 'timeFrame': 'From randomization until end of 1year maintenance treatment (average of 63 study weeks)'}, {'measure': 'Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE)', 'description': 'An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of non-serious AEs occurring at a frequency threshold of 5% and SAEs.', 'timeFrame': 'From the first dose of lapatinib/placebo until 5 days after the last dose (average of 141 study weeks)'}, {'measure': 'Number of Participants With the Indicated Chemistry Toxicities by Maximum Toxicity Grade (G3 and G4) at the Worst-case On-therapy Visit', 'description': 'Data are summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 (NCI CTC version 3.0) toxicity grades. Data are reported as the number of participants who had a grade 3 (G3) or grade 4 (G4) toxicity for the indicated chemistry parameters, where G3 indicates a severe toxicity and G4 indicates a life-threatening toxicity. Clinical chemistry parameters included: albumin, alkaline phosphatase (AP), alanine amino transferase (ALT), aspartate amino transeferase (AST), total bilirubin (TB), calcium, carbon dioxide content/bicarbonate (CO2/HCO3), creatinine, glucose, potassium, and sodium. The worst-case on-therapy visit includes any scheduled or unscheduled post-Baseline visit.', 'timeFrame': 'From Baseline (within 8 weeks prior to randomization [Day 1]) until the end of the maintenance period/early withdrawal (up to Study Week 64)'}, {'measure': 'Number of Participants With the Indicated Hematological Toxicities by Maximum Toxicity Grade (G3 and G4) at the Worst-case On-therapy Visit', 'description': 'Data are summarized using the NCI CTC version 3.0 toxicity grades. Data are reported as the number of participants who had a grade 3 (G3) or grade 4 (G4) toxicity for the indicated hematological parameters, where G3 indicates a severe toxicity and G4 indicates a life-threatening toxicity. The worst-case on-therapy visit includes any scheduled or unscheduled post-Baseline visit. Hematology parameter included: hemoglobin, total neutrophils (TN), platelet count (PC), and White Blood Cell (WBC) count.', 'timeFrame': 'From Baseline (within 8 weeks prior torandomization [Day 1]) until the end of the maintenance period/early withdrawal (up to Study Week 64)'}, {'measure': 'Number of Participants With On-therapy and Follow-up Late Radiation Morbidity Events', 'description': 'Late radiation morbidity event data are summarized as the number of participants with late radiation morbidity events per system organ class (SOC). Late radiation effects are defined as those that first occur 90 days or more after the initiation of radiation therapy.', 'timeFrame': 'From 180 days after completion of radiation until the last follow-up/withdrawal visit (average of 64 study weeks)'}, {'measure': 'Change From Baseline in Blood Pressure at the Indicated Time Points', 'description': 'Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of CRT, MW 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, and at the time of withdrawal from IP. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.', 'timeFrame': 'Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of chemoradiotherapy (CRT), Maintenance Week (MW) 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, Withdrawal from investigational product (IP; up to Study Week 64)'}, {'measure': 'Change From Baseline in Heart Rate at the Indicated Time Points', 'description': 'Heart rate (HR) was measured at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of CRT, MW 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, and at the time of withdrawal from IP. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.', 'timeFrame': 'Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of chemoradiotherapy (CRT), Maintenance Week (MW) 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, Withdrawal from IP (up to Study Week 64)'}, {'measure': 'Change From Baseline in Body Temperature at the Indicated Time Points', 'description': 'Body temperature was measured at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of CRT, MW 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, and at the time of withdrawal from IP. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.', 'timeFrame': 'Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of chemoradiotherapy (CRT), Maintenance Week (MW) 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, Withdrawal from IP (up to Study Week 64)'}, {'measure': 'Change From Baseline in Body Weight at the Indicated Time Points', 'description': 'Body weight was measured at Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of CRT, MW 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, and at the time of withdrawal from IP. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.', 'timeFrame': 'Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, End of chemoradiotherapy (CRT), Maintenance Week (MW) 8, MW 16, MW 24, MW 32, MW 40, MW 48, MW 56, Withdrawal from IP (up to Study Week 64)'}, {'measure': 'Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings at the Indicated Time Points', 'description': 'A 12-lead ECG was recorded at Baseline, at the end of the CRT, at Maintenance Week 56, at withdrawal from IP, and at anytime post-baseline. Data are presented as clinically significant (CS) or not clinically significant (NCS) abnormal findings. The study investigator determined if an abnormal ECG finding was CS or NCS.', 'timeFrame': 'Baseline (BL; within 8 weeks prior to randomization [Day 1]), End of CRT, Maintenance Week 56, Withdrawal from IP, and at any time Post-Baseline (up to Study Week 64)'}, {'measure': 'Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value', 'description': ""The Eastern Cooperative Oncology Group (ECOG) performance status scales and grades/criteria are used by doctors and researchers to assess how a participant's disease is progressing, to assess how the disease affects the daily living abilities of the participant, and to determine appropriate treatment and prognosis. Grade 0, fully active, able to carry on all pre-disease performance without restriction. Grade 1, restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. Grade 2, ambulatory and capable of all selfcare, but unable to carry out any work activities; up and about more than 50% of waking hours. Grade 3, capable of only limited selfcare; confined to bed or chair more than 50% of waking hours. Grade 4, completely disabled; cannot carry on any selfcare; totally confined to bed or chair. Grade 5, dead."", 'timeFrame': 'From Baseline (BL; within 8 weeks prior to randomization [Day 1]) until the end of the maintenance period/early withdrawal (up to Study Week 64)'}, {'measure': 'Change From Baseline in Quality of Life Status as Assessed by the Functional Assessement of Cancer Therapy-Head and Neck (FACT-H&N) Questionnaire', 'description': 'Change from Baseline in quality of life status was assessed using the FACT-H\\&N questionnaire, which is designed to measure multidimensional quality of life in participants with head and neck cancer. Change from Baseline was analyzed using parametric analysis of covariance (with the Baseline value as a covariate). The FACT-H\\&N questionnaire contains 39 items (27 general questions and 12 head and neck cancer-specific items) covering 4 dimensions and 1 subscale: physical well-being, social/family well-being, emotional well-being, functional well-being, and a head and neck cancer subscale. Possible subscale scores range from 0 to 36. Higher scores represent better quality of life. Data were adjusted for participant-reported quality of life scores at Baseline.', 'timeFrame': 'From randomization until the last follow-up/withdrawal visit (up to 62 study weeks)'}, {'measure': 'Change From Baseline in Quality of Life Status as Assessed by the EuroQol-5D (EQ-5D) Scale', 'description': 'Change from Baseline in quality of life status was assessed using the EQ-5D scale, a 5-item health status measure and a visual analog rating scale. Change from Baseline was analyzed using parametric analysis of covariance (with the Baseline value as a covariate). The EQ-5D is a generic measure of self-reported health outcomes that is applicable to a wide range of health conditions and treatments. The EQ-5D covers health status in 5 domains (3 questions each): mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each item is scored as follows: 1, no problems; 2, some moderate problems; 3, extreme problems. The possible EQ-5D index utility values range from 0.594 to 1, and the thermometer score ranges from 0 to 100. Higher scores represent better quality of life. Data were adjusted for participant-reported quality of life scores at Baseline.', 'timeFrame': 'From randomization until the last follow-up/withdrawal visit (up to 62 study weeks)'}, {'measure': 'Number of Participants With the Indicated Biomarker Expression Status', 'description': 'Biomarkers (which influence clinical response) assessed from tumor tissues included P16, Human Papilloma virus (HPV), and Epidermal Growth Factor Receptor (EGFR)/Epidermal Growth Factor Receptor 1 (ErbB1). Biomarker expression is presented as positive, negative, or unknown. Participants in the ErbB1-positive category include those with results of positive or strongly positive.', 'timeFrame': 'Baseline (BL; within 8 weeks prior to randomization [Day 1]) (up to Study Week 1)'}, {'measure': 'Number of Participants With the Indicated Worst-case On-therapy Left Ventricular Ejection Fraction (LVEF) Change From Baseline', 'description': 'LVEF is the measurement of how much blood is being pumped out of the left ventricle of the heart with each contraction. LVEF was assessed using echocardiogram (ECHO: a test of the action of the heart using ultrasound waves to produce a visual display, for the diagnosis or monitoring of heart disease ) and multigated acqusition scans (MUGA scan: a noninvasive diagnostic test used to evaluate the pumping function of the ventricles). Data from the ECHO and MUGA scans were combined, and the absolute change from Baseline (Abs) data are presented according to the following categories: No change or any increase, 0-\\<10% decrease, 10-19% decrease, \\>=20% decrease, \\>=10% decrease and \\>=the Lower Limit of Normal (LLN), \\>=10% decrease and below LLN, \\>=20% decrease and \\>=LLN, or \\>=20% decrease and below LLN. The relative percent change from Baseline (Rel) data are presented according to the following categories: \\>=20% decrease and \\>=LLN and \\>=20% decrease and below LLN.', 'timeFrame': 'From the end of the CRT until the last follow-up visit (average of 141 study weeks)'}]" 66,NCT02086526,"{'fullName': 'Mayo Clinic', 'class': 'OTHER'}",Targeting Pathways in Polycystic Ovary Syndrome (PCOS) Using Metformin (MET),COMPLETED,The investigator's global hypothesis is that women with Polycystic Ovary Syndrome (PCOS) can be separated into subtypes based on their response to metformin. The investigators propose here to use both targeted and non-targeted metabolomic approach to identify pathways associated with metformin's effect on insulin sensitivity and endothelial function. This pilot project will be the foundation for developing tailored therapeutic approaches to Polycystic Ovary Syndrome and identifying novel drug targets.,['Polycystic Ovary Syndrome'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Metformin', 'description': 'Approximately 37 patients will start metformin therapy 3 months after their visit 2. All other patients will receive metformin therapy at their visit 2.', 'armGroupLabels': ['Delayed Start Metformin', 'Metformin'], 'otherNames': ['Glucophage, Glucophage XR, Glumetza, Fortamet, Riomet']}]","Inclusion Criteria: * Body mass index (BMI) greater than or equal to 25 * Polycystic Ovary Syndrome criteria of both oligomenorrhea (\<9 menses per year) and androgen excess \[clinical hirsutism (Ferriman-Gallway score \>8 or severe acne) or elevated testosterone\]. * Taking no medications for the treatment of insulin resistance. Exclusion Criteria: * Diagnosis of Cushing's syndrome * Untreated hypo/hyperthyroidism * Elevated prolactin * Congenital adrenal hyperplasia * Renal insufficiency (creatinine \> 1.5) * Diabetes * Medications that can significantly affect endothelial function * Pregnancy * Breast Feeding * Taking oral contraceptives * Currently smoking",NA,FEMALE,NA,"[{'measure': 'Change in Insulin Sensitivity (SI) after 3 Months of Metformin Therapy', 'description': 'Insulin sensitivity will be calculated using an oral glucose minimal model. Insulin under the curve will be calculated geometrically with the trapezoidal rule.', 'timeFrame': 'Baseline, 3 months'}]","[{'measure': 'Change in Peripheral Flow-Mediated Vasodilatation after 3 Months of Metformin Therapy', 'description': 'The ratio of Peripheral Digital Arterial Tonometry (PAT) signal after cuff release compared with baseline is calculated through a computer algorithm normalizing for baseline measurements and indexing to measurements in the contra-lateral arm. The calculated ratio reflects the reactive hyperemia index (RHI).', 'timeFrame': 'baseline, 3 months'}]" 67,NCT03642626,"{'fullName': 'Masonic Cancer Center, University of Minnesota', 'class': 'OTHER'}",MT2017-45: CAR-T Cell Therapy for Heme Malignancies,ACTIVE_NOT_RECRUITING,"This is a phase II study of FDA-approved CAR-T products for patients with hematologic malignancies. Patients will be assigned to Arm A and B based on age and diagnosis. Overall remission rate, safety events and other endpoints will be calculated for Arm A and B separately.","['Acute Lymphoblastic Leukemia', 'Large B-cell Lymphoma']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'KYMRIAH', 'description': 'FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells', 'armGroupLabels': ['ARM A: Refractory/relapsed B-cell acute lymphoblastic leukemia (ALL)', 'ARM C: Kymriah for Refractory diffuse large B cell lymphoma (DLBCL)'], 'otherNames': ['tisagenlecleucel']}, {'type': 'DRUG', 'name': 'YESCARTA', 'description': 'CD19-directed genetically modified autologous T cell immunotherapy', 'armGroupLabels': ['ARM B: Yescarta for Refractory diffuse large B cell lymphoma (DLBCL)']}, {'type': 'DRUG', 'name': 'Fludarabine 30mg/m2 4 doses', 'description': '30 mg/m2 IV daily for 4 doses', 'armGroupLabels': ['ARM A: Refractory/relapsed B-cell acute lymphoblastic leukemia (ALL)']}, {'type': 'DRUG', 'name': 'Cyclophosphamide 500 mg/m2; 2 doses', 'description': '500 mg/m2 IV daily for 2 doses starting with the first dose of fludarabine', 'armGroupLabels': ['ARM A: Refractory/relapsed B-cell acute lymphoblastic leukemia (ALL)']}, {'type': 'DRUG', 'name': 'Fludarabine 30mg/m2 3 doses', 'description': '30 mg/m2 IV daily for 3 doses', 'armGroupLabels': ['ARM B: Yescarta for Refractory diffuse large B cell lymphoma (DLBCL)', 'Arm D: Tecartus CAR-T product for Mantle Cell Leukemia (MCL)', 'Arm E: Breyanzi for relapsed or refractory large B-cell lymphoma (RLBCL)', 'Arm F: Abecma for relapsed or refractory multiple myeloma']}, {'type': 'DRUG', 'name': 'Cyclophosphamide 500 mg/m2; 3 doses', 'description': '500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine', 'armGroupLabels': ['ARM B: Yescarta for Refractory diffuse large B cell lymphoma (DLBCL)', 'Arm D: Tecartus CAR-T product for Mantle Cell Leukemia (MCL)', 'Arm E: Breyanzi for relapsed or refractory large B-cell lymphoma (RLBCL)', 'Arm F: Abecma for relapsed or refractory multiple myeloma']}, {'type': 'DRUG', 'name': 'Fludarabine 25mg/m2 3 days', 'description': '25 mg/m2 i.v. daily for 3 days', 'armGroupLabels': ['ARM C: Kymriah for Refractory diffuse large B cell lymphoma (DLBCL)', 'Arm G: Tecartus B-cell acute lymphoblastic leukemia (ALL)']}, {'type': 'DRUG', 'name': 'Cyclophosphamide 250 mg/m2; 3 days', 'description': '250 mg/m2 IV daily for 3 days starting with the first dose of fludarabine', 'armGroupLabels': ['ARM C: Kymriah for Refractory diffuse large B cell lymphoma (DLBCL)']}, {'type': 'DRUG', 'name': 'Tecartus', 'description': 'TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells', 'armGroupLabels': ['Arm D: Tecartus CAR-T product for Mantle Cell Leukemia (MCL)', 'Arm G: Tecartus B-cell acute lymphoblastic leukemia (ALL)'], 'otherNames': ['Brexucabtagene Autoleucel']}, {'type': 'DRUG', 'name': 'Abecma, Intravenous Suspension', 'description': 'Infuse ABECMA 2 days after completion of lymphodepleting chemotherapy.', 'armGroupLabels': ['Arm F: Abecma for relapsed or refractory multiple myeloma']}, {'type': 'DRUG', 'name': 'Cyclophosphamide 900 mg/m2; 1 day', 'description': 'Administer cyclophosphamide 900 mg/m2 over 60 minutes on the second day before infusion of TECARTUS', 'armGroupLabels': ['Arm G: Tecartus B-cell acute lymphoblastic leukemia (ALL)']}, {'type': 'DRUG', 'name': 'Breyanzi Injectable Product', 'description': 'Infuse BREYANZI 2 to 7 days after completion of lymphodepleting chemotherapy.', 'armGroupLabels': ['Arm E: Breyanzi for relapsed or refractory large B-cell lymphoma (RLBCL)']}]","ARM A (Kymriah) and Arm G (Tecartus) :Refractory/relapsed B-cell acute lymphoblastic leukemia expressing CD19 Inclusion Criteria: * Age and Disease Status * Must be age 0-25 years (for Arm A Kymriah) or \>18 years (Arm G Tecartus) * Disease status: Relapsed and refractory pediatric B-cell ALL defined by one of these: * Primary induction failure with no complete remission after ≥2 cycles of induction chemotherapy, or * Patients with persistent minimal residual disease (MRD \>0.01% by flow cytometry or persistent by cytogenetic or molecular assays) after ≥2 cycles of consolidation chemotherapy, or * Patients in 2nd or greater relapse of B-ALL or * Patients with persistent CNS leukemia, or * Down Syndrome or other congenital diseases assuming that they fit the criteria for second or greater relapse or refractory leukemia, or * Patients with Ph+ ALL are eligible if theywho have failed or are intolerant to two lines of TKI assuming they fit the criteria for second or greater relapse or are considered refractory. * Performance Status \* Arm A: Karnofsky (age ≥16 years) or Lansky (age \< 16 years) performance status ≥ 50% at screening; Arm G: ECOG 0, 1 or 2 * Organ Function * Renal function defined as: * A serum creatinine of ≤1.5 x ULN OR * eGFR ≥ 50 mL/min/1.73 m2 * Liver function defined as: \*\* ALT ≤ 5 times the ULN for age (unless due to disease) \*\* Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN * Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 \> 91% on room air * Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA * Other Inclusion Criteria * Life expectancy ≥12 weeks * Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment. * Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures. Exclusion Criteria: * Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. * Patients with Burkitt's lymphoma/leukemia (i.e. patients with mature B-cell ALL, leukemia with B-cell \[sIg positive and kappa or lambda restricted positivity\] ALL, with FAB L3 morphology and /or a MYC translocation) * CNS 2A * CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma. * Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis. * Uncontrolled active hepatitis B or hepatitis C * Active HIV infection * Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion) * Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion * Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion * Intolerance to the excipients of the CAR-T cell product * Any immunosuppressive medication must be stopped ≥ 2 weeks prior to enrollment. * Patient has taken one of the prohibited concomitant medications within the timeframe outlined in section 6.1 ARM B: Yescarta for Relapsed or Refractory diffuse large B cell lymphoma Inclusion Criteria: * Age and Disease Status * Adult patients (age ≥ 18 years)Patients must be ≥18 years of age * One of the following histologies and expression of CD19 by tumor cells: \*\* diffuse large B-cell lymphoma (DLBCL) not otherwise specified, or \*\* primary mediastinal large B-cell lymphoma, or \*\* high grade B-cell lymphoma, or \*\* DLBCL arising from follicular lymphoma * Disease status: \*\* Chemotherapy refractory disease after ≥2 lines of chemotherapy, or \*\* Relapsed with no remission after ≥1 lines of salvage chemotherapy, or \*\* Relapsed following autologous HCT (and failed at least 2 prior lines of therapy including high dose chemotherapy). If salvage therapy is given post autoHCT, the subject must have no response or relapse after the last line of therapy * Measurable disease at time of apheresis: Nodal lesions or extranodal lesion * ECOG performance status 0-2 * ALC \>/=100/uL at screening (prior to apheresis) * Renal function defined as: \*\* A serum creatinine of ≤1.5 x ULN OR \*\* eGFR ≥ 50 mL/min/1.73 m2 * Liver function defined as: * ALT ≤ 5 times the ULN for age (unless due to disease) * Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN * Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 \> 91% on room air * Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA * Adequate bone marrow reserve (unless marrow infiltrated by disease) defined as : * Absolute neutrophil count (ANC) \> 1.000/mm3 (only for NHL) * Platelets ≥ 50.000/mm3 (transfusion support can be provided) * Hemoglobin \>8.0 mg/dl (transfusion support can be provided) * Life expectancy ≥12 weeks * Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment. * Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures. Exclusion Criteria: * Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. * Active CNS involvement by malignancy (no evidence of disease in CSF by flow cytometry) CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma. * Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis. * Uncontrolled active hepatitis B or hepatitis C * Active HIV infection (controlled HIV is permissible) * Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion) * Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion * Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion * Intolerance to the excipients of the CAR-T cell product * Any immunosuppressive medication must be stopped ≥ 2 weeks prior to apheresis. * Patient has taken one of the prohibited concomitant medications within the timeframe. ARM C: Kymriah for rRelapsed or rRefractory diffuse large B cell lymphoma Inclusion Criteria: * Age and Disease Status * Adult patients (age ≥ 18 years) * with relapsed or refractory (r/r) large B-cell lymphoma, including * diffuse large B-cell lymphoma (DLBCL) not otherwise specified, * high grade B-cell lymphoma * and DLBCL arising from follicular lymphoma. * Disease status: * after two or more lines of systemic therapy or * relapse after autologous HCT * Performance Status * ECOG performance status 0-2 * ALC \>/=100/uL at screening (prior to apheresis) * Organ Function * Renal function defined as: * A serum creatinine of ≤1.5 x ULN OR * eGFR ≥ 50 mL/min/1.73 m\^2 * Liver function defined as: * ALT ≤ 5 times the ULN for age (unless due to disease) * Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN * Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 \> 91% on room air * Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA * Adequate bone marrow reserve (unless marrow infiltrated by disease) defined as : * Absolute neutrophil count (ANC) \> 1.000/mm3 (only for NHL) * Platelets ≥ 50.000/mm3 (transfusion support can be provided) * Hemoglobin \>8.0 mg/dl (transfusion support can be provided) * Other Inclusion Criteria * Life expectancy ≥12 weeks * Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment. * Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures. Exclusion Criteria: * Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. * Active CNS involvement by malignancy (no evidence of disease in CSF by flow cytometry) CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma. * Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis. * Uncontrolled active hepatitis B or hepatitis C * Active or inactive HIV infection * Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion) * Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion * Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion * Intolerance to the excipients of the CAR-T cell product * Any immunosuppressive medication must be stopped ≥ 2 weeks prior to apheresis. * Patient has taken one of the prohibited concomitant medications within the timeframe ARM D: Tecartus (Brexucabtagene Autoleucel) for relapsed or refractory mantle cell lymphoma Inclusion Criteria: * Age and Disease Status \* with relapsed or refractory (r/r) mantle cell lymphoma, including * prior anthracycline or Bendamustine containing therapy * prior Rituximab or other CD20 directed antibody (or inability to treat with CD20 MoAb) * not a candidate or relapse after autologous HCT * active disease at enrollment * Performance Status \*ECOG performance status 0-1 * Organ Function * Renal function defined as: * A serum creatinine of ≤1.5 x ULN OR * eGFR ≥ 50 mL/min/1.73 m2 * Liver function defined as: * ALT ≤ 5 times the ULN for age (unless due to disease) * Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN * Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 \> 91% on room air * Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA * Adequate bone marrow reserve (unless marrow infiltrated by disease) defined as: * Absolute neutrophil count (ANC) \> 1,000/mm\^3 (only for NHL) * Platelets ≥ 50,000/mm\^3 (transfusion support can be provided) * Hemoglobin \>8.0 mg/dl (transfusion support can be provided) Other Inclusion Criteria: * Life expectancy ≥12 weeks * Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment. See section 4.5 for definitions of child bearing potential and section 4.6 for definitions of adequate birth control. * Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures. Exclusion Criteria: * Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. * Active CNS involvement by malignancy (no evidence of disease in CSF by flow cytometry) CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma. * Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis. * Uncontrolled active hepatitis B or hepatitis C * Active HIV infection * Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion) * Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion * Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion * Intolerance to the excipients of the CAR-T cell product * Any immunosuppressive medication must be stopped ≥ 2 weeks prior to apheresis (steroids must be stopped \>72 hours prior to apheresis). * Patient has taken one of the prohibited concomitant medications within the timeframe ARM E: Breyanzi ""lisocabtagene maraleucel"" for relapsed or refractory large B-cell lymphoma Inclusion Criteria: * Age and Disease Status * Adult patients (age ≥ 18 years) * with relapsed or refractory disease after two or more lines of systemic therapy, including * diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), * high-grade B-cell lymphoma, * primary mediastinal large B-cell lymphoma, * follicular lymphoma grade 3B * Performance Status \*ECOG performance status 0-2 * Organ Function * Renal function defined as: * A serum creatinine of ≤1.5 x ULN OR * eGFR ≥ 30 mL/min/1.73 m2 * Liver function defined as: * ALT ≤ 5 times the ULN for age (unless due to disease) * Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN * Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 \> 91% on room air * Hemodynamically stable and LVEF ≥ 40% confirmed by echocardiogram or MUGA * Adequate bone marrow reserve (unless marrow infiltrated by disease) defined as: * Absolute neutrophil count (ANC) \> 1,000/mm\^3 (only for NHL) * Platelets ≥ 50,000/mm\^3 (transfusion support can be provided) * Hemoglobin \>8.0 mg/dl (transfusion support can be provided) Other Inclusion Criteria: * Life expectancy ≥12 weeks * Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment. See section 4.5 for definitions of child bearing potential and section 4.6 for definitions of adequate birth control. * Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures. Exclusion Criteria: * Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. * Active CNS involvement by malignancy (no evidence of disease in CSF by flow cytometry) CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma. * Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis. * Uncontrolled active hepatitis B or hepatitis C * Active HIV infection * Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion) * Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion * Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion * Intolerance to the excipients of the CAR-T cell product * Any immunosuppressive medication must be stopped ≥ 2 weeks prior to apheresis (steroids must be stopped \>72 hours prior to apheresis). * Patient has taken one of the prohibited concomitant medications within the timeframe ARM F: Abecma ""Idecabtagene Vicleucel"" for relapsed or refractory multiple myeloma Inclusion Criteria: * Age and Disease Status * Adult patients (age ≥ 18 years) * Relapsed (progression after prior partial or complete remission) or refractory multiple myeloma * Evidence of active disease (medullary or extramedullary) * Prior therapy (Failure or intolerance to) with an immunomodulatory agent, a proteasome inhibitor, and an antiCD38 monoclonal antibody * Performance Status \*ECOG performance status 0-1 * Organ Function * Renal function defined as: * A serum creatinine of ≤2 x ULN OR * eGFR ≥ 50 mL/min/1.73 m2 * Liver function defined as: * ALT ≤ 5 times the ULN for age (unless due to disease) * Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert syndrome; may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN * Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation SpO2 \> 91% on room air * Hemodynamically stable and LVEF ≥ 45% confirmed by echocardiogram or MUGA * Adequate bone marrow reserve (unless marrow infiltrated by disease) defined as: * Absolute neutrophil count (ANC) \> 1,000/mm\^3 (only for NHL) * Platelets ≥ 50,000/mm\^3 (transfusion support can be provided) * Hemoglobin \>8.0 mg/dl (transfusion support can be provided) Other Inclusion Criteria: * Life expectancy ≥12 weeks * Women of child bearing potential and sexually active males with partners of child bearing potential must agree to use adequate birth control for the duration of treatment. See section 4.5 for definitions of child bearing potential and section 4.6 for definitions of adequate birth control. * Written voluntary consent (adults) or parental/guardian consent (minors or adults with diminished capacity) prior to the performance of any research related tests or procedures. Exclusion Criteria: * Pregnant or breastfeeding - Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. * Active CNS involvement by malignancy (no evidence of disease in CSF by flow cytometry) CAR-T is not indicated for the treatment of patients with primary central nervous system lymphoma. * Presence of Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD). All GVHD medication must be stopped 2 weeks prior to apheresis. * Uncontrolled active hepatitis B or hepatitis C * Active HIV infection * Uncontrolled acute life threatening bacterial, viral or fungal infection (e.g. blood culture positive ≤ 72 hours prior to infusion) * Unstable angina and/or myocardial infarction within 1 month prior to CAR-T infusion * Investigational medicinal product within the last 7 days prior to apheresis or CAR-T infusion * Intolerance to the excipients of the CAR-T cell product * Any immunosuppressive medication must be stopped ≥ 2 weeks prior to apheresis (steroids must be stopped \>72 hours prior to apheresis). * Patient has taken one of the prohibited concomitant medications within the timeframe",NA,ALL,NA,"[{'measure': 'Arms B & C&D& E&F: Overall Response Rate (ORR)', 'description': 'ORR defined by complete response + partial response by Lugano', 'timeFrame': 'Day 100'}, {'measure': 'Arm A & E: MRD-negative CR (or CRi)', 'description': 'Percentage of patients with MRD-negative Complete Response CR (or CRi)', 'timeFrame': 'Day 28'}]","[{'measure': 'Percentage of Patients Developing Grade 3 or 4 ICANS', 'description': 'Percentage of patients developing grade 3 or 4 ICANS', 'timeFrame': 'Day 28'}, {'measure': 'Treatment Related Mortality (TRM)', 'description': 'Incidence of treatment related mortality (in absence of disease relapse/progression)', 'timeFrame': 'Day 28'}, {'measure': 'Treatment Related Mortality (TRM)', 'description': 'Incidence of treatment related mortality (in absence of disease relapse/progression)', 'timeFrame': 'Day 100'}, {'measure': 'Treatment Related Mortality (TRM)', 'description': 'Incidence of treatment related mortality (in absence of disease relapse/progression)', 'timeFrame': '1 Year'}, {'measure': 'Relapse-free Survival (RFS)', 'description': 'Incidence of Relapse-free Survival (RFS)', 'timeFrame': '1 year'}, {'measure': 'Event-Free Survival (EFS)', 'description': 'Incidence of event-free survival (EFS) from the date of the CAR-T infusion through 1 year post treatment', 'timeFrame': '1 Year post treatment'}, {'measure': 'Overall Survival (OS)', 'description': 'Incidence of Overall Survival (OS) from the date of the CAR-T infusion through the date of patient death for any reason.', 'timeFrame': '1 year'}, {'measure': 'Overall Toxicity', 'description': 'Percentage of patients with grade 3 or 4 targeted toxicity of CRS and/or neurotoxicity', 'timeFrame': 'Day 28'}]" 68,NCT02436226,"{'fullName': 'Mansoura University', 'class': 'OTHER'}",Use of Low Dose of HCG During Ovulation Induction With CC in Women With CC Resistant PCOS,COMPLETED,The purpose of this study is to evaluate the effect of administration of low dose of human chorionic gonadotropin (HCG) after use of clomiphene citrate (CC) for induction of ovulation in infertile women having CC resistant polycystic ovarian syndrome (PCOS).,"['Infertility', 'Polycystic Ovarian Syndrome']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Clomiphene citrate and Human chorionic gonadotropin (HCG)', 'description': 'Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle) and HCG (200 IU/day SC from day 7 of cycle)', 'armGroupLabels': ['Clomiphene citrate-HCG group'], 'otherNames': ['Clomid and Choriomon']}, {'type': 'DRUG', 'name': 'Clomiphene citrate', 'description': 'Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle)', 'armGroupLabels': ['Clomiphene citrate group'], 'otherNames': ['Clomid']}]","Inclusion Criteria: * Infertile lean women with PCOS as defined by the Rotterdam criteria. * CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles). Exclusion Criteria: * Age \< 20 or \> 35 years. * Presence of any infertility factor other than anovulatory PCOS. * Previous history of ovarian surgery or surgical removal of one ovary. * Previous exposure to cytotoxic drugs or pelvic irradiation. * Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months. * Metabolic or hormonal abnormalities.",NA,FEMALE,NA,"[{'measure': 'Ovulation rate', 'description': 'Number of ovulatory cycles divided by the number of stimulation cycles', 'timeFrame': '3 months'}]","[{'measure': 'Number of ovarian follicles ≥ 18 mm on day of triggering of oocyte maturation', 'description': 'Number of ovarian follicles ≥ 18 mm by TVS on day of triggering of oocyte maturation', 'timeFrame': '3 months'}, {'measure': 'Endometrial thickness on day of triggering of oocyte maturation', 'description': 'Endometrial thickness by Transvaginal sonography (TVS) scan on day of triggering of oocyte maturation', 'timeFrame': '3 months'}, {'measure': 'Clinical pregnancy rate', 'description': 'Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 6-8 weeks gestational age) divided by the number of women', 'timeFrame': '6-8 weeks gestational age'}, {'measure': 'Incidence of early ovarian hyperstimulation syndrome (OHSS)', 'description': 'Incidence of OHSS within 9 days of final triggering of oocyte maturation', 'timeFrame': 'Within 9 days of final triggering of oocyte maturation'}]" 69,NCT00339378,"{'fullName': 'National Institutes of Health Clinical Center (CC)', 'class': 'NIH'}",Incidence and Mortality of Childhood Cancer Among Children of Farmer Pesticide Applications,COMPLETED,"Previous studies have estabished pesticide exposure as a possible risk factor for childhood cancer. The Agricultural Health Study (AHS), a prospective cohort study of pesticide exposure among 51,000 pesticide applicators in North Carolina and Iowa, provides an opportunity to study childhood cancer incidence and mortality among the children of pesticide applicators. Name and dates of birth for 21,985 children were previously provided by adult participants in the AHS. The current study seeks to identify cases of cancer among these children through record linkage to state cancer and death registries. Cancer incidence and mortality within the cohort will be compared with national data through standardized incidence and mortality ratios. A limited case-cohort comparison of pesticide exposures will also be performed. Approximately 44 cases of childhood cancer are expected to be identified. No follow-up or contact with cases is anticipated. It is anticipated that the study results will provide insight into the relationship of pesticide and other farm exposures to the pathogenesis of childhood cancer.",['Pesticide Exposure'],OBSERVATIONAL,NA,NA,"* INCLUSION CRITERIA: Subjects will be included in the study if they are children of private pesticide applicators who participated in the AHS, and were born between 1975 and 1996. EXCLUSION CRITERIA: Subjects with age greater than 19 years during this period will be excluded as the outcome under study is childhood cancer.",NA,ALL,NA,NA,NA 70,NCT07368478,"{'fullName': 'Biocity Biopharmaceutics Co., Ltd.', 'class': 'INDUSTRY'}","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC2027 in Patients With Advanced Solid Malignancies",RECRUITING,"This is a phase Ia/Ib, open-label, dose escalation and dose expansion study designed to evaluate the safety, tolerability, PK, and preliminary anticancer activity of BC2027 in patients with advanced solid Malignanciesr",['Advanced Solid Malignancies'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'BC2027 for Injection', 'description': 'Drug: BC2027 for Injection (lyophilized powder, 20 mg/vial) Administration: Administered via intravenous (IV) infusion, with dosing and frequency determined according to Phase Ia (dose escalation) and Phase Ib (dose expansion) study design.', 'armGroupLabels': ['BC2027 treatment group']}]","Inclusion Criteria: 1. Provide written informed consent. 2. Be at least 18 years old. 3. Have an Eastern Cooperative Group (ECOG) performance status (PS) of 0 or 1. 4. Have a life-expectancy of at least 3 months based on the Investigator's assessment. 5. Patients with advanced solid tumors confirmed by histology or cytology, who have failed standard therapy, have no available standard therapy, or are intolerant to standard therapy. 6. Phase 1a (dose escalation, Part 1) a. Have an advanced solid malignancy confirmed by histologic or cytologic examination that is known to express GPC3 including, but not limited to, HCC, NSCLC (particularly squamous cell NSCLC), sarcoma (undifferentiated), ovarian clear cell adenocarcinoma (OCCC), esophageal squamous cell carcinoma (ESCC). 7. Must provide either a previously archived tumor tissue sample or a fresh core or excisional biopsy from a site that was not irradiated. There must be at least 3-5 unstained sections. A formalin-fixed, paraffin-embedded (FFPE) tissue block is preferred to slides, and fresh biopsies are preferred over archival tissue. If archival tissue cannot be provided and a fresh biopsy cannot be obtained in Part 1, an exemption may be provided by the Sponsor. 8. Must have adequate organ function within 7 days prior to the start of study treatment as defined below: Hematological\* ANC ≥1,500/μL or ≥1.5×109/L Platelets ≥100,000/μL or ≥100×109/L (For HCC patients, PLTs ≥75×109/L) Hemoglobin ≥9.0 g/dL Kidney Function Creatinine clearance (CrCl)\*\* ≥50 mL/min Liver Function Total Bilirubin (TBIL) ≤1.5×ULN, or direct bilirubin ≤ULN (patients with total bilirubin level \>1.5×ULN). AST (SGOT) and ALT (SGPT) ≤2.5×ULN (≤5×ULN in patients with liver metastases) Coagulation International Normalized Ratio (INR), Prothrombin Time (PT), and activated partial thromboplastin time (aPTT) :INR≤1.5; PT and aPTT ≤1.5×ULN or within a therapeutic range if on an anticoagulant. \* Blood transfusion or growth factor support is not allowed within 14 days prior to blood sampling. \*\* CrCl should be calculated according to institutional standards. 9. Must have at least one measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (In the dose escalation part of the study (Part 1), patients without measurable lesions may be enrolled if they have evaluable disease and are approved by the sponsor). Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. 10. Must agree to use highly effective contraceptive measures if patient is a man or woman of childbearing potential. Highly effective contraceptive measures include measures like hormonal contraceptives, intrauterine devices, vasectomy, or tubal ligation, and others (Section 5.3), from the time of signing the informed consent until 6 months after the last dose of the study drug. Women of childbearing potential (WCBP) must have a negative blood or urine pregnancy test within 7 days prior to the first dose of study drug. Female patients with surgically sterile or are postmenopausal for at least 12 months without an alternative medical cause are also allowed. Additional Inclusion Criteria for Part 2 In addition to fulfilling the inclusion for Part 1, patients enrolling in cohorts in Part 2/Phase Ib must have: 1. Cohort 1 (NSCLC Cohort) 1. Positive expression of GPC3 confirmed by immunohistochemistry (IHC) assay, or with existing prior IHC test report documenting GPC3 positivity. 2. Patients with non-small cell lung cancer (NSCLC) who have failed no more than 3 prior lines of systemic antineoplastic therapy. 2. Cohort 2 (HCC Cohort) 1. IHC evidence of GPC3 expression on archival tumor or a fresh biopsy unless biopsy is not feasible or safe and with approval of the Sponsor. 2. The subject has received treatment with 1 prior regimen in the first line advanced setting consisting of an appropriate monoclonal antibody (mAb) targeting PD-1 or PD-L1 with an appropriate mAb targeting CTLA-4 and/or an appropriate tyrosine kinase inhibitor (TKI) or mAb targeting vascular endothelial growth factor (VEGF, e.g., bevacizumab). The subject must have progressed, demonstrated intolerance, or refused such treatment. If a subject had refused treatment, the reasons for such must be documented in the records and case report form (CRF). 3. The patient must have Barcelona Clinic Liver Cancer (BCLC) stage B or C HCC (See Appendix 1), not amenable to locoregional therapy or refractory to locoregional therapy likely to result in reasonable clinical benefit, and not amenable to a curative treatment approach. 4. The subject has a Child-Pugh A score (See Appendix 2) within 7 days of study drug treatment. 3. Cohort 3 (Advanced GPC3 expressing solid cancer). 1. GPC3 positivity confirmed by IHC assay, or documented in prior IHC reports. 2. Patients excluding Cohort 1 and Cohort 2 with failure of ≤ 2 prior lines of systemic antineoplastic therapy. Exclusion Criteria: Patients who meet any of the exclusion criteria must not be enrolled in the study. 1. Prior treatment with GPC3-targeted ADC. 2. Prior treatment with systemic anticancer treatment, including investigational agents, within a period that is less than five half-lives or 2 weeks before the start of treatment, whichever is shorter. 3. Known hypersensitivity or delayed hypersensitivity reactions to the same class and/or any component of BC2027. 4. Treatment with strong CYP3A4 inhibitors or inducers, and P-gp inhibitors within 14 days or 5 half-lives whichever is shorter, before the first dose. 5. For patients with advanced NSCLC: a. Positive for driver oncogenes: including EGFR mutation, ALK gene fusion, ROS1 gene fusion, KRAS-G12C mutation, c-MET (exon 14 skipping, MET amplification and overexpression), HER2 mutation, RET gene fusion, etc. For HCC patients: 1. Received local hepatic therapy including, but not limited to, surgery, radiotherapy, hepatic arterial embolization (TAE), hepatic arterial chemoembolization (TACE), hepatic arterial perfusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection) within 4 weeks prior to initiation of the study drug. 2. History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy (eg, no lactulose, rifaximin, etc if used for purposes of hepatic encephalopathy) 3. The patient has main portal vein thrombosis ((i.e. thrombosis in the main trunk of the portal vein, with or without blood flow) on baseline imaging.) 4. Documented gastrointestinal bleeding within past 6 months or at high risk of gastrointestinal bleeding per investigator's clinical judgement, due to esophageal varices, active gastric or duodenal ulcers. 6. Active and severe viral infections meeting the following criteria: 1. Known HIV seropositivity. 2. Known active hepatitis B (Screening for hepatitis B is not required for non-HCC patients): * For HCC patients: HBV DNA \> 2000 IU/mL. (For patients with positive hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibodies (anti-HBcAb) with detectable HBV DNA (≥10 IU/mL)\], patients with the following conditions may be enrolled: patients who have received antiviral therapy and had sufficient suppression of viral replication before enrollment (HBV DNA ≤ 2000 IU/ml), and patients must continue to receive antiviral therapy during the study and for 6 months after the last dose.) * For other solid malignancies patients: HBsAg positive and HBV-DNA titer \> 500 IU/mL or \> 2500 copies/mL. 3. Known active hepatitis C : * For HCC patients: Co-infection of HBV and HCV. (The following conditions are allowed for inclusion: positive HCV RNA test or positive HCV antibody, and patients complying with local medical practice for treatment.) 7. Severe immunodeficiency requiring systemic corticosteroid therapy at a prednisone-equivalent dose (\>10 mg/day), or any other systemic immunosuppressive therapy, unless approved by the sponsor. 8. A history of allogeneic tissue or solid organ transplantation. 9. A history of radiation pneumonitis, or receipt of radiotherapy within 2 weeks prior to the initiation of study treatment. Note: Patients must have recovered from radiation-related toxicities and must not be receiving corticosteroid treatment. A 1-week washout period is permitted for palliative radiotherapy (≤ 2 weeks of radiotherapy) for non-central nervous system (non-CNS) diseases. 10. Unstable central nervous system (CNS) metastases and/or carcinomatous meningitis. For patients with previously treated brain metastases who have achieved radiological stability (i.e., no evidence of disease progression on repeated imaging examinations for at least 4 weeks, as documented in imaging obtained during screening; and no requirement for corticosteroid treatment for at least 14 days prior to the first dose), routine brain imaging is not required during screening. 11. Uncontrolled pleural effusion, ascites, or pericardial effusion at the time of screening. 12. A history of interstitial lung disease (ILD) or drug-related interstitial lung disease, or any evidence of clinically active interstitial lung disease. 13. Clinically significant cardiovascular disease, including but not limited to: * Congestive heart failure (CHF) of New York Heart Association (NYHA) functional class III or higher, or left ventricular ejection fraction (LVEF) \< 50%. * Unstable angina pectoris or myocardial infarction occurring within 6 months prior to enrollment. * Severe cardiac arrhythmias, including but not limited to complete left bundle branch block, atrioventricular block of second degree or higher, and ventricular tachycardia (including frequent ventricular premature beats). * Clinically uncontrolled hypertension, defined as systolic blood pressure (SBP) ≥ 160 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg despite anti-hypertensive medication use. 14. Clinically significant electrocardiogram (ECG) abnormalities, including any of the following: * Markedly prolonged QT/QTc interval on screening ECG (i.e., repeated measurements demonstrating a QTc interval \> 470 ms) (QTcF calculated based on the Fridericia formula). * A history of risk factors for torsades de pointes, such as congestive heart failure, hypokalemia, family history of long QT syndrome, and other risk factors. 15. Grade ≥ 2 peripheral neurotoxicity or neuropathy, and other toxicities caused by prior anti-tumor therapy that have not resolved to Grade ≤ 1 (per CTCAE Version 5.0). Exceptions include alopecia, skin hyperpigmentation, other events deemed tolerable by the investigator, or specific-grade toxicities specified in the inclusion/exclusion criteria of this study. 16. Patients with active or chronic corneal disease, other active ophthalmic diseases requiring continuous treatment, or any clinically significant corneal disease that prevents adequate monitoring for drug-induced keratopathy. 17. Active infections requiring systemic anti-infective therapy. 18. Poor patient compliance, or unwillingness or inability to follow the procedures specified in the study protocol.",NA,ALL,NA,"[{'measure': 'Incidence of dose limiting toxicities (DLTs)', 'description': 'The incidence of dose-limiting toxicity (DLT) at different doses of BC2027 in patients with advanced solid malignancies', 'timeFrame': 'Dose limiting toxicities (DLT) will be assessed At the end of Cycle 1 (each cycle is 28 or 21 days).'}, {'measure': 'The safety and tolerability', 'description': 'To assess the safety and tolerability of BC2027 in patients with advanced solid malignancies', 'timeFrame': 'Through study completion, an average of 2 years.'}, {'measure': 'Preliminary antitumor activity', 'description': 'To assess the preliminary antitumor activity of BC2027 in patients with advanced solid malignancies', 'timeFrame': 'Through study completion, an average of 2 years.'}]",NA 71,NCT00661778,"{'fullName': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}",A Study of Avastin (Bevacizumab) in Combination With Docetaxel and Cisplatin in Patients With Metastatic or Locally Advanced Non-small Cell Lung Cancer,COMPLETED,"This study assessed the efficacy and safety of Avastin in combination with docetaxel and cisplatin as first-line treatment of patients with metastatic or locally advanced non-small cell lung cancer. Patients received Avastin 15 mg/kg intravenously (IV), docetaxel 75 mg/m\^2, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle for a maximum of 6 cycles.",['Non-small Cell Lung Cancer'],INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Bevacizumab', 'description': 'Bevacizumab was supplied as a sterile liquid in glass vials.', 'armGroupLabels': ['Bevacizumab + cisplatin + docetaxel'], 'otherNames': ['Avastin']}, {'type': 'DRUG', 'name': 'Cisplatin', 'description': 'Bevacizumab was supplied as a sterile liquid in glass vials.', 'armGroupLabels': ['Bevacizumab + cisplatin + docetaxel']}, {'type': 'DRUG', 'name': 'Docetaxel', 'description': 'Bevacizumab was supplied as a sterile liquid in glass vials.', 'armGroupLabels': ['Bevacizumab + cisplatin + docetaxel'], 'otherNames': ['Taxotere']}]","Inclusion Criteria: * Adult patients, ≥ 18 years of age. * Stage IIIb or IV non-small cell lung cancer. * Chemotherapy-naive. Exclusion Criteria: * Previous treatment for non-small cell lung cancer. * Previous malignant tumor within last 5 years, except for basal cell skin cancer or preinvasive cervical cancer. * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to start of study. * Recent or current chronic treatment with aspirin (\> 325 mg/day).",NA,ALL,NA,"[{'measure': 'Progression-free Survival', 'description': 'Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.', 'timeFrame': 'Baseline to the end of the study (up to 4 years)'}]","[{'measure': 'Percentage of Participants With an Objective Response', 'description': 'An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be \\< 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.', 'timeFrame': 'Baseline to the end of the study (up to 4 years)'}, {'measure': 'Duration of the Objective Response', 'description': 'Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.', 'timeFrame': 'Baseline to the end of the study (up to 4 years)'}, {'measure': 'Overall Survival', 'description': 'Overall survival is defined as the time from the first dose of study medication until death.', 'timeFrame': 'Baseline to the end of the study (up to 4 years)'}, {'measure': '1-year Survival', 'description': 'The probability of surviving 1 year was estimated using the Kaplan-Meier method.', 'timeFrame': 'Baseline to 1 year'}]" 72,NCT04703985,"{'fullName': 'University Hospital, Bordeaux', 'class': 'OTHER'}",Evaluation of the Success of Prophylactic Enteral Nutrition in Therapeutic Intensification With Autograft of Autologous Hematopoietic Cells in Hematology,COMPLETED,"When the digestive tract is functional, learned societies recommend the use of a nutritional support by enteral feeding. Indeed, it has many advantages (maintenance of gut trophicity, reduction of the risk of infection by reducing the incidence of bacterial translocations,...). It has been used for about fifteen years in hematology departments and offers promising results in the context of allogeneic transplantation with prospective trials in progress (NEPHA study). However, its tolerance has not been studied during autologous transplantation. This study aims to assess the success of enteral nutrition in this setting.","['Lymphoma', 'Myeloma']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'DIETARY_SUPPLEMENT', 'name': 'Enteral Nutrition', 'description': 'Protocol of Enteral Nutrition adapted to the conditioning autograft (BEAM or Melphalan 200)', 'armGroupLabels': ['Patients under the protocol of Enteral Nutrition']}]","Inclusion Criteria: * Patient with lymphoma or myeloma * Patient admitted for therapeutic intensification with autologous hematopoietic cells who are eligible for nutritional support by enteral nutrition * Free, informed and written consent signed by the patient Exclusion Criteria: * Refusal of the enteral nutrition * All patients with absolute or enteral nutrition contraindications: * Digestive fistula * Intestinal obstruction * Intestinal ischemia * Active digestive bleeding * Digestive malabsorption (short hail syndrome, bariatric surgery, gastrectomy) * Trauma to the base of the skull or significant deviation of the nasal septum not allowing the insertion of an naso gastric probe. * Esophagitis or barrett's esophagus * Persistent gastro-duodenal dysfunction (gastroparesis) * Patients admitted for autograft for the treatment of conditions other than lymphoma or myeloma (e. g. solid tumours or leukaemia)",Patients with lymphoma or myeloma,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Success rate of enteral feeding', 'description': 'Enteral Nutrition will be considered as a success if : TEI / ER \\> 70%. On average until recovery from aplasia (or transfer to the intensive care unit or death).\n\nTEI : Total Energy Intake (per-os + enteral nutrition + glucose solutions) ER : Energy Requirement (assessed patient needs)', 'timeFrame': 'From admission to recovery from aplasia (or transfer to the intensive care unit or death)'}]","[{'measure': 'Causes of failure of enteral nutrition', 'description': 'All causes of primary or secondary failure that necessitated the cessation of enteral nutrition', 'timeFrame': 'From admission to recovery from aplasia (an average of 3 weeks)'}, {'measure': 'Evolution of total energy intake', 'description': 'All sources of energy intake (per-os, enteral nutrition, parenteral nutrition, glucose solutions) These will be compared to the estimated needs of patients and expressed as a % of coverage of these needs', 'timeFrame': 'Every day from admission to discharge (an average of 4 weeks)'}, {'measure': 'Evolution of albuminemia', 'description': 'Blood test carried out on admission and once a week', 'timeFrame': 'Once a week from admission to discharge (an average of 4 weeks)'}, {'measure': 'Weight evolution', 'description': 'Weighing carried out on admission and on discharge. Will be used to calculate the percentage of weight loss and assess nutritional status', 'timeFrame': 'From admission to discharge (an average of 4 weeks)'}, {'measure': 'Evolution of muscular strength', 'description': 'Measurements performed at admission and at discharge of the patient. Muscular strength is measured using a dynamometer (in kg)', 'timeFrame': 'From admission to discharge (an average of 4 weeks)'}, {'measure': 'Number of bacteremia and type of germs', 'timeFrame': 'From admission to discharge (an average of 4 weeks)'}, {'measure': 'Number of transfers to the intensive care unit', 'timeFrame': 'From admission to discharge (an average of 4 weeks)'}, {'measure': 'Duration of hospitalization', 'description': 'Number of days of hospitalization', 'timeFrame': 'From admission to discharge (an average of 4 weeks)'}, {'measure': 'Prokinetic and associated antiemetic treatments', 'timeFrame': 'From admission to discharge (an average of 4 weeks)'}, {'measure': 'Type conditioning', 'description': 'BEAM or Melphalan 200', 'timeFrame': 'On admission, between 1 and 7 days before autologous stem cell transplantation'}]" 73,NCT06786585,"{'fullName': 'Eastern Cooperative Oncology Group', 'class': 'NETWORK'}",Extended Clinical Follow up and Biospecimen Collection for Patients Enrolled in TAILORx and RxPONDER: A Companion Protocol,NOT_YET_RECRUITING,"The purpose of this study is to retrieve tissue samples from individuals with breast cancer who previously enrolled on the PACCT-1 (TAILORx) or S1007 (RxPONDER) trials and experiences a recurrence of their cancer (Cohort 1, 2, and 3), and/or the tumor initially removed at surgery in patients previously enrolled in step 1 of S1007 (RxPONDER) and found to have a high Recurrence Score of 26-100 (Cohort 3) but not followed on the study after that point. The tissue will be used for future research designed to understand why breast cancer recurs despite hormonal therapy or chemotherapy plus hormonal therapy.",['Breast Cancer'],OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}",NA,"Inclusion Criteria: * Patient must have met the criteria for 1 of the 3 possible cohorts described below: 1. Cohort 1: Previously enrolled on TAILORx (PACCT-1) with recurrence score (RS) 0-100 AND had a biopsy-confirmed locoregional, distant, or both locoregional and distant recurrence prior to registration on this protocol. 2. Cohort 2: Previously enrolled on Step 2 of RxPONDER (S1007) with a recurrence score (RS) of 0-25 AND had a biopsy-confirmed locoregional, distant, or both locoregional and distant recurrence prior to registration on this protocol. 3. Cohort 3: Previously enrolled on Step 1 of RxPONDER and found to have a high Oncotype DX RS 26-100. * Patient must have been a TAILORx (RS 0-100) or RxPONDER (RS 0-100) study participant who has the ability to understand and the willingness to sign a written informed consent document for participation in this non-intervention study (cohorts 1, 2, or 3). Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible. * Patient must have tumor tissue available from each cohort as outlined below: * Patients from Cohorts 1 and 2 must have relapse tumor tissue specimen available at the time of registration for submission to ECOG-ACRIN Central Biorepository and Pathology Facility within 30 days of registration. * Patients from Cohort 3 must have primary tumor tissue specimen available at time of EA1241 registration for submission to ECOG-ACRIN Central Biorepository and Pathology Facility within 30 days of registration Exclusion Criteria:",Patients previously enrolled on TAILORx with a recurrence score (RS) 0-100\_and RxPONDER with a recurrence score(RS) 0-25 and patients previously enrolled on RxPONDER with a recurrence score (RS) 26-100.,FEMALE,NON_PROBABILITY_SAMPLE,"[{'measure': 'Patterns of clonal evolution', 'description': ""Conditional logistic regression for matched pairs, with the recurrence sample representing the case and the baseline sample the non-case in each pair, will be used to test for differences between recurrence and baseline, to estimate odds ratios, and to jointly model effects. The test for association of a single binary factor in this approach is equivalent to McNemar's test."", 'timeFrame': '2 years'}, {'measure': 'Prevalence of the integrative cluster (IntClust) and intrinsic (PAM50) subtypes', 'description': ""Conditional logistic regression for matched pairs, with the recurrence sample representing the case and the baseline sample the non-case in each pair, will be used to test for differences between recurrence and baseline, to estimate odds ratios, and to jointly model effects. The test for association of a single binary factor in this approach is equivalent to McNemar's test."", 'timeFrame': '2 years'}, {'measure': 'Molecular signatures of primary tumor specimens', 'description': ""Conditional logistic regression for matched pairs, with the recurrence sample representing the case and the baseline sample the non-case in each pair, will be used to test for differences between recurrence and baseline, to estimate odds ratios, and to jointly model effects. The test for association of a single binary factor in this approach is equivalent to McNemar's test."", 'timeFrame': '2 years'}]","[{'measure': 'Immune composition', 'description': 'Evaluated using weighted Cox models', 'timeFrame': '2 years'}, {'measure': 'TME and cell-cell interactions', 'description': 'Evaluated using weighted Cox models', 'timeFrame': '2 years'}, {'measure': 'Prevalence of IntClust and PAM50', 'description': 'Evaluated using weighted Cox models', 'timeFrame': '2 years'}, {'measure': 'Molecular signatures', 'description': 'Evaluated using weighted Cox models', 'timeFrame': '2 years'}]" 74,NCT04334785,"{'fullName': 'Fudan University', 'class': 'OTHER'}",Evaluation for the Effectiveness and Safety of Cryo-ablation in the Treatment of Early Invasive Breast Cancer,UNKNOWN,"Recently, researchers in America reported a clinical research (Alliance Z1072) which proved that cryo-ablation could be considered as a non-surgical treatment of early-stage breast cancer. The long term effectiveness and safety of cryo-ablation in early invasive breast cancer is still unknown. Therefore, this prospective study are designed to evaluate the effectiveness and safety of cryo-ablation in early invasive breast cancer.",['Breast Cancer'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DEVICE', 'name': 'cryo-ablation', 'description': 'Under the guide of ultrasound, cryo-ablation for the lump of early invasive breast cancer will be conducted.', 'armGroupLabels': ['cryo-ablation group']}]","Inclusion Criteria: stage 1: 1. female 2. ≥18 years old 3. invasive ductal carcinoma proved by core needle biopsy. Other type of breast cancer should be well considered and decided by investigators. Pathological report should be complete (with the result of ER, PR , HER2, KI67 etc., and FISH report of ERBB2 gene if necessary). 4. lump can be detected by ultrasound. 5. image results (including ultrasound, mammography and MR image) prove the lump is single-center, the maximum diameter of the lump \<2cm. 6. with enough breast tissue, and enough space from lump to skin. 7. patients is not pregnant and has no plan for pregnancy in 2 years. 8. ECOG level: 0-2 9. serum creatinine≤1.1 mg/dl 10. for patients with double side (left and right side) breast cancer, both side of the tumor should meet the inclusion criteria. 11. patients are accessible for the follow up and mentally healthy. stage 2: 1. female 2. ≥18 years old 3. invasive ductal carcinoma proved by core needle biopsy. Other type of breast cancer should be well considered and decided by investigators. Pathological report should be complete (with the result of ER, PR , HER2, KI67 etc., and FISH report of ERBB2 gene if necessary). 4. lump can be detected by ultrasound. 5. image results (including ultrasound, mammography and MR image) prove the lump is single-center, the maximum diameter of the lump \<1.5cm. 6. with enough breast tissue, and enough space from lump to skin. 7. clinically N0 before cryo-ablation. 8. patients is not pregnant and has no plan for pregnancy in 2 years. 9. ECOG level: 0-2 10. serum creatinine≤1.1 mg/dl 11. for patients with double side (left and right side) breast cancer, both side of the tumor should meet the inclusion criteria. 12. patients are accessible for the follow up and mentally healthy. Exclusion Criteria: stage 1: 1. \< 18 years old 2. male 3. the same side breast of the lump have been treated by surgery or other physical treatment within 3months. 4. benign tumor or tumor in situ or tumor in situ with micro-invasion proved by core needle biopsy. Pathological report is not complete (with the result of ER, PR , HER2, KI67 etc., and FISH report of ERBB2 gene if necessary). 5. image results (including ultrasound, mammography and MR image) prove the lump is multi-center, the maximum diameter of the lump ≥2cm. 6. image results (including ultrasound, mammography) prove calcium region ≥ 5mm 7. lump can not be clearly detected by ultrasound. For example, the boundary of tumor is not clear, or the maximum diameter detected by MRI is more than 1.5 times larger than the maximum diameter detected by ultrasound. 8. before the endpoint, patients is treated by other local treatment. 9. ECOG Level \>2 10. serum creatinine\>1.1 mg/dl 11. patients are not accessible for the follow up and mentally unhealthy. 12. patients are pregnant or lactating, or have plan for pregnancy in 2 years. 13. other situations which make patients not suitable for the trail or cryo-ablation. stage 2: 1. \< 18 years old 2. male 3. the same side breast of the lump have been treated by surgery or other physical treatment within 3months. 4. benign tumor or tumor in situ or tumor in situ with micro-invasion proved by core needle biopsy. Pathological report is not complete (with the result of ER, PR , HER2, KI67 etc., and FISH report of ERBB2 gene if necessary). 5. absolute contraindication for breast conserving surgery. 6. image results (including ultrasound, mammography and MR image) prove the lump is multi-center, the maximum diameter of the lump ≥1.5cm. 7. image results (including ultrasound, mammography) prove calcium region ≥ 5mm 8. lump can not be clearly detected by ultrasound. For example, the boundary of tumor is not clear, or the maximum diameter detected by MRI is more than 1.5 times larger than the maximum diameter detected by ultrasound. 9. NOT clinically N0 before cryo-ablation. 10. patients are treated after neoadjuvant chemotherapy or neoadjuvant endocrine therapy. 11. patients with advanced breast cancer or other type of cancers. 12. with BRCA1/2 mutation 13. before the endpoint, patients is treated by other local treatment. 14. ECOG Level \>2 15. serum creatinine\>1.1 mg/dl 16. can not finish the radiotherapy afterwards or with contraindication of radiotherapy 17. patients are not accessible for the follow up and mentally unhealthy. 18. patients are pregnant or lactating, or have plan for pregnancy in 2 years. 19. other situations which make patients not suitable for the trail or cryo-ablation.",NA,FEMALE,NA,"[{'measure': 'Stage 1: Effectiveness of cryo-ablation', 'description': 'In the first stage, patients will receive traditional surgery 1month after the cryo-ablation. After the traditional surgery (mastectomy or breast conserving surgery), the pathological report will show whether there is tumor tissue left in the breast tissue. If there is no tumor left in breast, cryo-ablation is effective in eliminating the tumor. Otherwise, cryo-ablation is ineffective.', 'timeFrame': '1 month'}, {'measure': 'Stage 2: LRFS(local-regional free survival)', 'description': 'In the second stage, 5-year local-regional free survival will be evaluated for patients with the treatment of cryo-ablation and traditional surgery is spared.', 'timeFrame': '5 years'}, {'measure': 'Stage 2: Effectiveness of cryo-ablation (3 months after cryo-ablation)', 'description': 'In the second stage, patients will receive muti-point core needle biopsy (which collect multi-point tissue from the region which was once the tumor region, as reported by MRI or ultrasound) 3months after the cryo-ablation. After the multi-point core needle biopsy, the pathological report will show whether there there is tumor tissue left in the breast tissue. If there is no tumor left in breast, cryo-ablation is effective in eliminating the tumor. Otherwise, cryo-ablation is ineffective.', 'timeFrame': '3 month'}]","[{'measure': 'Stage 1: instant success rate', 'description': 'Instant success rate will be evaluated instantly by the surgeon after the cryo-ablation, by his/her own judgement and ultrasound image.', 'timeFrame': '3 minutes'}, {'measure': 'Stage 1: negative predictive value of ultrasound', 'description': 'In the first stage, ultrasound will be conducted twice on day 14 and day 28 after the cryo-ablation (16 or 2 days before the traditional surgery). Negative predictive value of ultrasound will be calculated according to the pathological report after the traditional surgery in day 30. Negative predictive value = number of the patients who is pathologically negative AND ultrasound-negative/ number of patients who is ultrasound-negative', 'timeFrame': '14 days and 28 days'}, {'measure': 'Stage 1: adverse events', 'description': 'Short-term safety of cryo-ablation after the treatment', 'timeFrame': '1 month'}, {'measure': 'Stage 2: instant success rate', 'description': 'Instant success rate will be evaluated instantly by the surgeon after the cryo-ablation, by his/her own judgement and ultrasound image.', 'timeFrame': '3 minutes'}, {'measure': 'Stage 2: shrinking rate', 'description': 'Comparing with the baseline tumor size, shrinking rate of the lump will be calculated in 3 months, 6 months, 12 months, 18 months, 2 years, 3 years, 4 years, 5 years after cryo-ablation. The size of the lump will be evaluated by MR image.', 'timeFrame': '5 years'}, {'measure': 'Stage 2: adverse events', 'description': 'Short-term and long-term safety of cryo-ablation after the treatment', 'timeFrame': '5 years'}, {'measure': 'Stage 2: breast self evaluation', 'description': 'breast self evaluation for patients with cryo-ablation and for whom traditional surgery is spared, as assessed by BREAST Q© index. The BREAST-Q has a modular, procedure-specific structure with scales that evaluate both satisfaction and quality of life. Psychometric evaluation reveals high reliability, validity and responsiveness to surgical intervention across all scales. Breast Q is composed of aesthetical and emotional modules, and each score ranges from 1 to 4 points (higher values represent a better self evaluation). By comparing the sum of the score in different modules before and after the surgery, Breast Q can help to facilitate a self evaluation for breast cancer patients.', 'timeFrame': '5 years'}]" 75,NCT04656678,"{'fullName': 'Northwell Health', 'class': 'OTHER'}",Focal US-guided Cryo-ablation Using DynaCAD / UroNAV Preplanning / Guidance of Intermediate Risk Prostate Cancer,UNKNOWN,The purpose of this research study is to determine the safety and feasibility of using the UroNav software and DynaCAD software for planning and treating prostate cancer as an add on to the already approved workflow of using ultrasound only during the cryoablation of the prostate. The software application may aid doctors in locating a prior biopsy proven cancer location from the UroNav biopsy that patients previously had and then use that information to guide the treatment.,"['Prostate Cancer', 'Prostate Disease']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DEVICE', 'name': 'Cryo-ablation Using DynaCAD / UroNAV preplanning / guidance', 'description': 'Focal ultrasound guided cryoablation using uroNav system Version 4.0 and Dyna CAD software version 5.0.', 'armGroupLabels': ['DynaCAD / UroNAV']}]","Inclusion Criteria: 1. Patients must have documented histological or cytological evidence of tumor(s) of the prostate. 2. Patients must be ≥ 45 years of age. 3. Patients must be able to read, understand and sign an informed consent. 4. Organ confined clinical T1C or clinical T2a prostate cancer that is visualized on MR imaging. 5. Prostate cancer is diagnosed by MR image guided biopsies. 6. Gleason Score ≤ 7; and 2 or less positive lesions on prior MR US fusion guided prostate biopsy. 7. A non MRI visible cancer detected via systematic standard biopsy will not be considered an exclusion condition provided the non-MRI visible cancer is singularly located in the contralateral hemisphere of the prostate; is Gleason 6 cancer; and comprises no more than 6mm linear extent of cancer in a single core on standard biopsy. 8. If any standard biopsy cores are positive on the same hemisphere of the prostate gland, they must be confirmed as likely to form a contiguous lesion with the target lesion detected on MRI and therefore be from the same location in the prostate as MR lesion was biopsied and proven to be cancerous. (e.g., Left/Right, Base, Mid Gland, Apex). 9. Prior mpMRI results dated within 120 days prior to ablation. 10. No metastatic disease as per NCCN guidelines (www.nccn.org) - Bone scan indicated to r/o metastatic disease if clinical T1 and PSA \> 20 or T2 and PSA \> 10 11. PSA \< 15 ng/ml or PSA density \< 0.15 ng/ml2 in patients with a PSA \> 15 ng/ml. Exclusion Criteria: 1. ASA status \> 3 2. Very Low Risk Prostate Cancer based on Epstein's Criteria having a tumor \<0.2 cc (AUA Guidelines 2017 pg. 9) GG1, PSA \< 10 ng/ml, no more than two positive cores and no core \> 50% involvement. 3. Contraindications to MRI 3.1 Claustrophobia 3.2 Implanted ferromagnetic materials or foreign objects 3.3 Known intolerance to the MRI or US contrast agents. 3.4 Severely abnormal coagulation (INR\>1.5) 4. Patients with unstable cardiac status including: 4.1 Unstable angina pectoris on medication 4.2 Patients with documented myocardial infarction within 40 days prior to enrolment 4.3 Congestive heart failure NYHA class IV 4.4 Patients with unstable arrhythmia status, already on anti-arrhythmic drugs 5. Severe hypertension (diastolic BP \> 100 on medication) 6. Severe cerebrovascular disease (multiple CVA or CVA within 6 months) 7. History of orchiectomy, PCa-specific chemotherapy, brachytherapy, cryotherapy, Photodynamic therapy or radical prostatectomy for treatment of prostate cancer; any prior radiation therapy to the pelvis for prostate cancer or any other malignancy. 8. Patient under medications that can affect PSA for the last 3 months prior to UroNAV Ablation system aided cryo-ablation treatment (Androgen Deprivation Treatment) 9. Patients with lesions of Gleason 7 or greater outside the planned treatment area. 10. Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (approximately 3 hrs.) 11. Any rectal pathology, anomaly or previous treatment, which could change acoustic properties of rectal wall or prevent safe US probe insertion (e.g., fistula, stenosis, fibrosis, inflammatory bowel disease, etc). 12. Any spinal pathology which can prevent safe administration of epidural/spinal anesthesia 13. Evidence for lymph node involvement of cancer 14. Bladder cancer 15. Urethral stricture/bladder neck contracture 16. Patients with incontinence demonstrated by use of more than 1 pad/day. . 17. Active UTI 18. Prostatitis NIH categories I, II and III. 19. Compromised renal function 20. Interest in future fertility 21. Current participation in another clinical investigation of a medical device or a drug or has participated in such a study within 30 days prior to study enrollment.",NA,MALE,NA,"[{'measure': 'Assessment of safety of the DynaCAD /UroNAV ablation planning and guidance system aided cryo-ablation in the treatment of low-intermediate risk, localized (organ confined) prostate cancer tumors.', 'description': 'Incidence and severity of device/treatment related complications from treatment day visit through 24 month follow up.', 'timeFrame': '24 months'}]","[{'measure': 'Assessment of tumor control achieved by treatment.', 'description': 'Primary effectiveness analyses will be based on the 12-month biopsy results. Post-treatment PSA, non-perfused volume (NPV) by multi-parametric MRI, and EPIC - 26 (The Expanded Prostate Cancer Index Composite) questionnaire results through Month 24 visit will be summarized as secondary measures of effectiveness.', 'timeFrame': '24 months'}]" 76,NCT02520778,"{'fullName': 'National Cancer Institute (NCI)', 'class': 'NIH'}",Osimertinib and Navitoclax in Treating Patients With EGFR-Positive Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer,COMPLETED,This phase Ib trial studies the side effects and best dose of osimertinib and navitoclax when given together and to see how well they work in treating patients with previously treated epidermal growth factor receptor (EGFR)-positive non-small cell lung cancer that has spread to other places in the body (metastatic) or has not responded to previous treatment with initial EGFR kinase inhibitor. Osimertinib and navitoclax may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.,"['Advanced Lung Non-Squamous Non-Small Cell Carcinoma', 'Metastatic Lung Non-Squamous Non-Small Cell Carcinoma', 'Stage III Lung Non-Small Cell Cancer AJCC v7', 'Stage IIIA Lung Non-Small Cell Cancer AJCC v7', 'Stage IIIB Lung Non-Small Cell Cancer AJCC v7', 'Stage IV Lung Non-Small Cell Cancer AJCC v7']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Navitoclax', 'description': 'Given PO', 'armGroupLabels': ['Treatment (navitoclax, osimertinib)'], 'otherNames': ['A-855071.0', 'ABT-263', 'BcI-2 Family Protein Inhibitor ABT-263']}, {'type': 'DRUG', 'name': 'Osimertinib', 'description': 'Given PO', 'armGroupLabels': ['Treatment (navitoclax, osimertinib)'], 'otherNames': ['AZD 9291', 'AZD-9291', 'AZD9291', 'Mereletinib']}]","Inclusion Criteria: * Histologically confirmed non-squamous NSCLC, with incurable advanced or metastatic disease * Prior genotyping positive for an EGFR activating mutation (L858R, exon 19 deletion, G719X, L861Q) * Progression after prior treatment with an EGFR TKI; in addition to this one prior line of therapy, any additional prior lines of therapy are permitted; prior treatment with a third-generation EGFR TKI is allowed for the dose escalation phase, but is not permitted for the expansion cohort * Adequate archival tissue from a biopsy performed after progression of disease on previous EGFR TKI; or willing to undergo a new tumor biopsy prior to registration (for the dose escalation portion only this requirement can be waived if T790M status has already been determined using a local assay) * For the dose expansion portion only, patient must: 1) have a tumor which is EGFR-T790M positive and 2) be treatment naive to T790M-directed EGFR TKI (e.g. AZD9291, rociletinib, etc); T790M testing may be done locally or centrally on study, but if done locally, tissue must be available for central confirmation * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) * Any number of prior therapies are allowed * Age \>= 18 years. NSCLC is exceedingly rare in patients \< 18 years of age. Because no dosing or adverse event data are currently available on the use of AZD9291 in combination with navitoclax in patients \< 18 years of age, children are excluded from this study * Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (Karnofsky \>= 70%) * Patients must have the ability to swallow oral dosage forms * Life expectancy of greater than 3 months * Leukocytes \>= 3,000/mcL * Absolute neutrophil count \>= 1,500/mcL * Hemoglobin \>= 8.0 g/dL * Platelets \>= 100,000/mcL * Activated partial thromboplastin time (aPTT), prothrombin time (PT) =\< 1.2 x upper limit of normal (ULN) * Total bilirubin =\< 1.5 x ULN (patients with Gilbert's syndrome may have serum bilirubin \> 1.5 x ULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x institutional ULN * Creatinine =\< 2.0 mg/dL OR * Creatinine clearance \>= 50 mL/min * The effects of AZD9291 and navitoclax on the developing human fetus are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception using one of the methods listed below prior to study entry, for the duration of study participation, and for 3 months for women and 6 months for men following the date of the last dose of AZD9291 and/or navitoclax: * Total abstinence from sexual intercourse (minimum one complete menstrual cycle prior to study drug administration) * Vasectomized male subject or vasectomized partner of female subjects * Hormonal contraceptives (oral, parenteral, transdermal or vaginal ring) for at least 3 months prior to study drug administration; if the subject is currently using a hormonal contraceptive, she should also use a barrier method during this study and for 3 months after study completion * Intrauterine device (IUD) * Double-barrier method: male condom plus diaphragm or vaginal cap with spermicide (contraceptive sponge, jellies or creams) * Additionally, male subjects (including those who are vasectomized) whose partners are pregnant or might be pregnant must agree to use condoms for the duration of the study and 6 months following completion of therapy * Women of childbearing potential must have a negative urine pregnancy test within 7 days prior to initiation of treatment; women will be considered not of childbearing potential if they are surgically sterile (bilateral oophorectomy or hysterectomy) and/or post-menopausal (amenorrheic for at least 12 months) * Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately * Patients with a prior history of brain metastases are eligible provided: * The brain metastases have been treated * The patient is asymptomatic from the brain metastases * Corticosteroids prescribed for the management of brain metastases have been discontinued at least 7 days prior to registration * The brain metastases are stable on pre-registration imaging * Patients must have completed last chemotherapy \>= 3 weeks or radiotherapy \>= 2 weeks prior to receiving study drugs * Patients must have recovered from adverse events attributable to previous treatment to =\< grade 1, except for alopecia and sensory neuropathy =\< grade 2 * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Major surgery within 21 days of starting protocol treatment * Patients must discontinue previous EGFR-TKI at least 7 days prior to study enrollment * Patients who are receiving any other investigational agents * Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease * Patients currently receiving (or unable to stop use at least 1 week prior to receiving the 1st dose of AZD9291) medications or herbal supplements known to be potent inhibitors of cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) and potent inhibitors or inducers of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) are ineligible; patients are eligible if they stop use of these compounds at least 1 week prior to receiving any treatment on this protocol * Patients receiving anticoagulation or anti-platelet therapy are excluded due to the risk of thrombocytopenia with navitoclax; excluded agents include heparin or low molecular weight heparin, warfarin, clopidogrel, ibuprofen and other nonsteroidal anti-inflammatory drug (NSAIDS), tirofiban, and other anticoagulants, drugs, or herbal supplements that affect platelet function; administration of heparin to keep subject's infusion lines patent is allowed; low-dose anticoagulation medications that are used to maintain the patency of a central intravenous catheter are allowed; aspirin will not be allowed within 7 days prior to the first dose of navitoclax or during navitoclax administration; however, subjects who have previously received aspirin therapy for thrombosis prevention, may resume a low dose (i.e., maximum 100 mg QD) of aspirin if platelet counts are stable (\>= 50,000/mm\^3) through 6 weeks of navitoclax administration; all decisions regarding treatment with aspirin therapy will be determined by the investigator in conjunction with the medical monitor * Patients with an underlying condition predisposing them to bleeding or currently exhibiting signs of clinically significant bleeding * Patients with a recent history of non-chemotherapy-induced thrombocytopenic-associated bleeding within 1 year prior to the first dose of study drug * Patients with a significant history of cardiovascular disease (e.g., myocardial infarction \[MI\], thrombotic or thromboembolic event in the last 6 months) * Any of the following cardiac criteria: * Mean resting corrected QT interval (QTc using Frederica's formula \[QTcF\]) \> 470 msec * Any clinically important abnormalities in rhythm, conduction or morphology of resting electrocardiogram (ECG) (e.g., complete left bundle branch block, third degree heart block, second degree heart block) * Congenital long QT syndrome or family history of long QT syndrome * Patients with active malignancies other than NSCLC or patients with prior curatively treated malignancy at high risk of relapse during the study period with the exception of localized squamous or basal cell skin cancers * Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, gastrointestinal disease limiting absorption of AZD9291 such as a malabsorption syndrome or inflammatory bowel disease or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study because AZD9291 and navitoclax have the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AZD9291 and navitoclax, breastfeeding should be discontinued if the mother is treated with AZD9291 and navitoclax * History of hypersensitivity to AZD9291 (or drugs with a similar chemical structure or class to AZD9291) or any excipients of these agents * Patients with human immunodeficiency virus (HIV) on antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AZD9291",NA,ALL,NA,"[{'measure': 'Incidence of toxicity (dose escalation)', 'description': 'Incidence of toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03. Frequency and severity of adverse events will be tabulated using counts and proportions detailing frequently occurring, serious and severe events of interest. Adverse events will be summarized using all adverse events experienced, although a sub-analysis may be conducted including only those adverse events in which the treating physician deems possibly, probably or definitely attributable to one or both study treatments.', 'timeFrame': 'Up to 2 years'}, {'measure': 'Feasibility of the combination therapy in T790M+ lung cancer (dose expansion)', 'description': 'Will be measured as at least 50% of patients achieving the expected dose duration and intensity. The proportion of patients completing 3 courses of therapy with \\> 75% of total dose of each drug will be quantified. The combination dosing will be considered potentially feasible if at least 50% of patients achieve the expected dose duration and intensity (95% confidence interval 30%-70%).', 'timeFrame': 'Up to 12 weeks (3 cycles of treatment)'}]","[{'measure': 'Pharmacokinetics parameters (maximum observed plasma drug concentration, area-under-the concentration-time-curve, trough drug concentration at steady state, and half-life) of osimertinib in combination with navitoclax', 'description': 'Pharmacokinetic calculations will incorporate consideration of the dosing change in navitoclax between the two measurement days.', 'timeFrame': 'Pre-dose, 1, 2, 4, 6, and 8 hours after navitoclax administration (day 3 of cycle 1 and day 1 of cycle 2)'}, {'measure': 'Objective response rate', 'description': 'Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST). Calculated in the 20 patient expansion cohort and compared to the expected response rate of 61% in T790M+ lung cancer.', 'timeFrame': 'Baseline up to 30 days after completion of study drug'}, {'measure': 'Change in plasma concentration of EGFR T790M and other EGFR mutations', 'description': 'Change in plasma concentration of EGFR T790M and other EGFR mutations will be studied in an exploratory fashion and compared to tumor response on imaging.', 'timeFrame': 'Baseline to up to 2 years'}, {'measure': 'Biomarkers of apoptosis such as BCL2-like 1 (BCL-XL) and BCL2-like 11 (apoptosis facilitator) (BIM) levels in tumor tissue', 'description': 'Biomarkers of apoptosis such as BCL-XL and BIM levels will be measured in tumor tissue and correlated with response in an exploratory fashion, under the hypothesis that navitoclax will have greater activity in cancers with high BCL-XL levels and inadequate apoptotic response.', 'timeFrame': 'Baseline'}]" 77,NCT00720785,"{'fullName': 'National Institutes of Health Clinical Center (CC)', 'class': 'NIH'}",Natural Killer Cells and Bortezomib to Treat Cancer,COMPLETED,"Natural killer (NK) cells are white blood cells that have a limited ability to kill cancer cells. This ability might be enhanced if they are given 24 hours after an injection of the drug bortezomib. This study will determine the following: * What dose of NK cells can be given safely to subjects with metastatic solid tumors or leukemia. * The effectiveness and side effects of NK cell therapy * How the body handles NK cells. People between 18 and 70 years of age who have a solid tumor or leukemia, and for whom standard treatments are not effective, may be eligible for this study. Participants undergo the following procedures: Apheresis to collect NK cells. For this procedure, a catheter (plastic tube) is placed in a vein in the subject s arm. Blood flows from the vein into a cell separator machine, which separates the white cells from the other blood components. The white cells are extracted and the rest of the blood is returned to the body through a second tube placed in a vein in the other arm. Chemotherapy with the drug pentostatin to suppress the immune system and prevent it from attacking the NK cells that will be infused. Chemotherapy with bortezomib to increase NK cell function. Infusion of the NK cells. In this dose-escalating study, successive groups of patients entering the study receive increasingly higher numbers of cells to determine the highest safe dose level. Up to ten dose levels may be studied. Interleukin-2 drug therapy to maintain NK cell activity. Evaluations during therapy including: * Clinical assessment, history and review of medications * Blood draws for routine and research tests. * Pharmacokinetics study after the NK infusion to see how the body handles the cells. For this test, the number of NK cells in the blood are measured over time. This requires drawing about 1 teaspoon of blood at 15 minutes, 30 minutes, 1, 2, 4, 8, 12, and 24 hours after the infusion (day 1); then every 24 hours on days 2 through 7, then once on days 10, 14, and 21. * Bone marrow biopsy (subjects with leukemia only). * Chest x-ray. * CT scan, bone scan and PET scan, if indicated, for disease evaluation. Subjects who respond well after one treatment cycle may be eligible to continue NK cell therapy.","['Chronic Myeloid Leukemia (CML)', 'Pancreatic Ca', 'Colon/Rectal Ca', 'Multiple Myeloma', 'Carcinoma, Non-Small -Cell Lung']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Bortezomib', 'description': 'Parenteral formulation. It is supplied as a 3.5 mg single use vial containing a sterile lyophilized powder that requires reconstitution.', 'armGroupLabels': ['2']}, {'type': 'BIOLOGICAL', 'name': 'NK cells', 'description': 'NK Cell Infusion', 'armGroupLabels': ['1']}]","* INCLUSION CRITERIA: 1. Diagnosed with histologically confirmed metastatic solid tumor - cancer of the lung (small cell or non small cell), prostate (adenocarcinoma), colorectum, kidney (renal cell carcinoma), pancreas (adenocarcinoma),or malignant melanoma, metastatic Ewing's sarcoma, or metastatic epithelial neoplasms and adenocarcinoma of unknown primary, and disease confirmed to be metastatic and unresectable for which standard curative or beneficial treatments are no longer effective OR Diagnosed with a hematological malignancy (multiple myeloma, \[MM\] chronic myelogenous leukemia \[CML\] or chronic lymphocytic leukemia \[CLL\] or small lymphocytic lymphoma \[SLL\]) and disease resistant or refractory to standard therapy and CLL/SLL patients are required to have failed prior treatment with at least one nucleoside analogue. Myeloma patients are required to have disease which has progressed following treatment with bortezomib. 2. At least 4 weeks since any prior systemic therapy (excluding corticosteroid therapy) to treat the underlying malignancy (standard or investigational). NOTE: subjects on FDA-approved tyrosine kinase inhibitors or other targeted therapies for RCC such as mTOR inhibitors that have evidence of disease progression on therapy may continue these medicines until the time of study enrollment (as accelerated disease progression following discontinuation of these drugs has been described). 3. At least 2 weeks since prior palliative radiotherapy. 4. Ages greater than or equal to 18 years and less than or equal to 70 years. 5. Evidence of progressive disease over a 3-month interval. 6. RBC transfusion independent (solid tumor patients only). EXCLUSION CRITERIA: 1. Disease not evaluable radiographically (applies to solid tumor patients only). 2. Disease involving greater than 25% of the liver radiographically (estimated based on review of liver lesions seen on CT scan). 3. History of an allogeneic hematopoietic stem cell transplant. 4. Brain metastases (with the exception of patients with a single brain metastasis less than 1cm treated with either sterotactic or gamma knife radiotherapy) due to poor prognosis and potential for neurological dysfunction that would confound evaluation of neurological and other adverse events). 5. Peripheral neuropathy of grade greater than 1, which would require reduction of bortezomib dose. 6. Acute diffuse infiltrative pulmonary disease. 7. Acute pericardial disease. 8. Life expectancy less than 3 months. 9. ECOG performance status 2, 3 or 4. 10. Uncontrolled concurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, life threatening cardiac arrhythmia. Patients with symptoms of coronary artery disease, cardiac arrhythmias or an abnormal thallium stress test must be evaluated and cleared by cardiology prior to enrollment. 11. Ongoing or active infection 12. Contraindication for administration of pentostatin, bortezomib, and/or interleukin-2. 13. Allergy or hypersensitivity to bortezomib, boron or mannitol by history. 14. Concurrent use of corticosteroids. 15. For all tumor types: Marrow function characterized by -Absolute neutrophil count less than 500/mcL (must be present off growth factors) Organ function characterized by * Total bilirubin greater than 3 times upper limit of normal * AST (SGOT)/ALT (SGPT) greater than 4 times upper limit of normal * Creatinine clearance less than 50 cc/min based on a 24 hour urine collection * Left ventricular ejection fraction less than 40% by echocardiogram (ECHO) * Hypercalcemia greater than 2.5 mmol/L For all Hematologic malignancies: Marrow function characterized by * Neutrophil count less than or equal to 500/mcl * Platelets less than or equal to 20,000/mcl 16. HIV-positive patients 17. Hepatitis C positive patients (Hep C PCR positive) 18. Active Hepatitis B infection (Hep B surface antigen positive) 19. Pregnant or nursing 20. Psychiatric illness/social situations that would limit compliance with study requirements and ability to comprehend the investigational nature of the study and provide informed consent.",NA,ALL,NA,"[{'measure': 'safety of escalating NK cell doses of adoptively infused ex vivo expanded autologous NK cells in subjects with treatment refractory metastatic tumors or hematological malignancies that are sensitized to NK cell toxicity with bortezomib.', 'description': 'Safety', 'timeFrame': 'After each 3 week cycle'}]",NA 78,NCT04397185,"{'fullName': 'CairnSurgical, Inc.', 'class': 'INDUSTRY'}",Breast Cancer Locator Guided vs. Wire Localized Partial Mastectomy for Breast Cancer,COMPLETED,"This prospective, multicenter, 1:1 randomized, controlled trial is designed to evaluate the safety and effectiveness of the Breast Cancer Locator (BCL) in subjects with non-palpable invasive breast cancer or ductal carcinoma in situ (DCIS). Subjects will be randomized to breast conserving surgery (BCS) utilizing either the BCL or wire localization (WL) to guide surgery.",['Breast Cancer Female'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Pathologist will be blinded to the study assignment (BCL vs. WL)', 'whoMasked': ['OUTCOMES_ASSESSOR']}}","[{'type': 'DEVICE', 'name': 'Breast Cancer Locator (BCL) guided partial mastectomy', 'description': 'The BCL is a patient-specific, plastic, bra-like form which is placed on the breast to localize the tumor during surgery.', 'armGroupLabels': ['Breast Cancer Locator (BCL)']}, {'type': 'DEVICE', 'name': 'Wire Localized (WL) partial mastectomy', 'description': 'Standard of care procedure', 'armGroupLabels': ['Wire Localization (WL)']}]","Inclusion Criteria: * Female gender * Age \> 18 years * Histologic diagnosis of invasive breast cancer or DCIS * The surgeon determines that pre-operative tumor localization is required because the tumor cannot be definitively detected by palpation * The tumor is unifocal or multifocal with satellite lesions \< or = 2 cm from primary tumor * The tumor enhances on prone breast MRI imaging * The tumor is ≥ 1 cm in diameter on prone breast MRI * Subject and surgeon agree to perform BCS * Subject voluntarily provides informed consent Exclusion Criteria: * Absolute contraindication to MRI, including presence of implanted electrical device (e.g., pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes * Severe claustrophobia that precludes prone or supine MRI * Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy * Compromised renal function including chronic, severe kidney disease (GFR \< 30 ml/min/1.73m2), or acute kidney injury * Pregnancy - In women of childbearing potential, a urine pregnancy test will be performed * Subjects who have received or plan to receive neoadjuvant chemotherapy * Sternal notch to nipple distance of \> 32 cm as measured in a sitting or standing position * Measurement of widest circumference around breasts and arms \> 135 cm for sites using 60cm bore scanners, and measurement of widest circumference around breasts and arms \>145 cm for sites using 70 cm bore scanners * Subjects with known allergy to materials present in the device * Use of localization with devices other than a localization wire, including intraoperative ultrasound guidance, radiofrequency emitting implants, magnetic seeds, radioactive seeds, and tissue inspection devices (MarginProbe) * Subject would require \> 2 localization wires, if randomized to standard of care * Subjects with multicentric tumors (additional tumors \> 2 cm from primary) * Subject would require chest wall muscle nerve block as part of the operation",NA,FEMALE,NA,"[{'measure': 'Positive margin rate', 'description': 'To provide evidence that the positive margin rate following BCS using the BCL is not inferior to the standard of care (WL) for surgical guidance', 'timeFrame': 'At completion of study recruitment, approximately 18 months after first subject enrolled'}]","[{'measure': 'Specimen volumes', 'description': 'To compare specimen volumes for women randomized to BCL vs. WL-guided BCS', 'timeFrame': 'At completion of study recruitment, approximately 18 months after first subject enrolled'}, {'measure': 'Re-excision rate', 'description': 'To compare re-excision rate for women randomized to BCL vs. WL-guided BCS', 'timeFrame': 'At completion of study recruitment, approximately 18 months after first subject enrolled'}, {'measure': 'Cancer localization rate', 'description': 'To compare cancer localization rate for women randomized to BCL vs. WL-guided BCS', 'timeFrame': 'At completion of study recruitment, approximately 18 months after first subject enrolled'}, {'measure': 'Operative times', 'description': 'To compare operative times for women randomized to BCL vs. WL-guided BCS', 'timeFrame': 'At completion of study recruitment, approximately 18 months after first subject enrolled'}, {'measure': 'Adverse event rate', 'description': 'To compare adverse event rate for women randomized to BCL vs. WL-guided BCS', 'timeFrame': 'At completion of study recruitment, approximately 18 months after first subject enrolled'}, {'measure': 'Rate of additional shave biopsies', 'description': 'To compare rate of additional shave biopsies for women randomized to BCL vs. WL-guided BCS', 'timeFrame': 'At completion of study recruitment, approximately 18 months after first subject enrolled'}, {'measure': 'Costs of care', 'description': 'To compare costs of care for women randomized to BCL vs. WL-guided BCS', 'timeFrame': 'At completion of study recruitment, approximately 18 months after first subject enrolled'}]" 79,NCT06834685,"{'fullName': ""Institut du Cancer de Montpellier - Val d'Aurelle"", 'class': 'OTHER'}",Evaluating Laser Photobiomodulation for the Treatment of Neuropathic Pain in Chemotherapy-induced Peripheral Neuropathy in Cancer Patients,RECRUITING,"Chemotherapy-induced peripheral neuropathy (CIPN) (including taxanes, platinum, al pervenche from Madagascar alkaloids...), is a frequent secondary effect of treatments: 68% at 1-month post-chemotherapy, 60% at 3 months and 30% after 6 months. Symptoms associated with CIPN are usually symmetric and bilateral (typical distribution in ""gloves and socks"") inducing sensory alterations, paresthesias, dysesthesias, numbness and pain. Neuropathic Pain (NP) is an important characteristic of CIPN, affects 25-80% of patients with CIPN, and reduces quality of life (e.g., concomitant psychological distress, risks of falls, risks of neurocognitive impairments, and sleep disorders). In severe cases, it is even necessary to delay and/or reduce the dose of chemotherapy. The benefit of drug interventions on NP remains limited. To date, there are no proven preventive strategies and few evidence-based treatment options for CIPN. Also, the use of complementary or non-pharmacological interventions are common, including photobiomodulation (PBM). PBM is the therapeutic use of non-ionizing laser light for its anti-inflammatory and regenerative effects. Its use is currently recommended only for the prevention of oral mucositis related to cancer treatments. Recent preliminary clinical evidence suggests that PBM may be beneficial to established CIPN, with safety and improvement beyond the intervention. However, to date, clinical trials are rare, have methodological weaknesses, and/or focus on global CIPN. The overall objectives of the study are therefore to assess the effectiveness, feasibility and safety of the PBM for treating NP in the CIPN.","['Cancer Survivors', 'Peripheral Neuropathic Pain']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}","[{'type': 'DEVICE', 'name': 'Photobiomodulation sessions', 'description': 'The treatment will be administered by an ATP38 device delivering a power of 4 Joules/cm2 at wavelengths of 620 and 820 nm', 'armGroupLabels': ['Experimental arm']}]","Inclusion Criteria: * Male or female aged 18 years minimum; * Patient treated at the Montpellier Cancer Institute for a cancer (whatever the location) requiring a chemotherapy; * Patient with significant NP defined as a score of 4 at the clinician-rated DN4 ; * Patient with a NP for at least 3 months after the end of an adjuvant or neo-adjuvant chemotherapy; * Women of childbearing potential must have a pregnancy urinary test within a maximum of 7 days before starting the study treatment. A negative result must be documented before study treatment is started. Women without reproductive potential are postmenopausal women or women who have undergone permanent sterilisation (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy); * Effective contraception for women of childbearing age * Patient having signed informed consent prior to any study procedure; * Patient affiliated to a French social protection system; * Patient sufficiently fluent in French to complete questionnaires, as the investigator clinical discretion. Exclusion Criteria: * Patient unable to come twice a week to the Montpellier Cancer Institute; * Patient unable to sit for a 30-minutes period; * Patient with an open wound or ulcer on the treatment area; * Patient whose diagnosis of peripheral neuropathy is due to another cause (n.b., diabetes without neuropathy will not be a specific exclusion); * Patient with uncontrolled psychiatric illness or neurocognitive impairment that may interfere with assessments, as the investigator clinical discretion; * Patient whose estimated life expectancy is less than 3 months, as estimated by a clinical investigator; * Patient using another concurrent non-pharmacological intervention or complementary therapy for neuropathy during the study; * Patient who has been treated with CAPSAISINE during the previous 3 months; * Patient with pacemaker; * Epileptic patient; * Patient with photosensitive medications, or any medical condition causing sensitivity to light (n.b., Lupus); * Pregnant and/or breastfeeding woman; * Patient with primary tumor and/or metastases in areas to be treated by BPM (i.e., hands and/or feet); * Patient with pre-existing eye disease (such as maculopathy, glaucoma, cataract and retinal lesions), or a history of family eye diseases; * Patient who has been already been treated with photobiomodulation on the area of interest. * Participation in another concomitant clinical study with neuropathic pain or chemo-induced peripheral neuropathy as the primary endpoint. * Presence of a tattoo on the area to be treated.",NA,ALL,NA,"[{'measure': 'Evaluation of the efficacy of photobiomodulation on neuropathic pain in a experimental group and evaluate the placebo effect in a controlled group', 'description': 'the proportion of responders to a photobiomodulation intervention on their neuropathic pain at 12 weeks', 'timeFrame': 'from the baseline to 12 weeks after the treatment'}]","[{'measure': 'Description of the evolution of neuropathic pain', 'description': 'description by the scores of the clinician-rated neuropathic pain questionnaire (from 0 to 10, 0 no neuropathic pain, 10 : worst neuropatic pain)', 'timeFrame': 'from the baseline to 6 months after the treatment'}, {'measure': 'Description of the evolution of neuropathic pain', 'description': 'description by the scores of the self-questionnaire Neuropathic Pain Symptom Inventory (from 0 to 100, 0 no neuropathic pain, 100 : worst neuropatic pain)', 'timeFrame': 'from the baseline to 6 months after the treatment'}, {'measure': 'Exploration of the evolution of global pain measures', 'description': 'The global pain will be assessed using the scores of the self-questionnaire Brief Pain Inventory (from 0 to 110, 0 no neuropathic pain, 110 : worst neuropatic pain)', 'timeFrame': 'from the baseline to 6 months after the treatment'}, {'measure': 'Exploration of the evolution of global pain measures', 'description': 'The global pain will be assessed using the scores of the Numeric Scale of pain (from 0 to 10, 0 no pain, 10 worst pain)', 'timeFrame': 'from the baseline to 6 months after the treatment'}, {'measure': 'Description of the evolution of the Chemotherapy-induced peripheral neuropathy', 'description': 'The chemotherapy-induced peripheral neuropathy will be described using the scores of the self-questionnaire FACT/GOG-Ntx-13, and the grade of chemotherapy-induced peripheral neuropathy assessed by the clinician via the Common Terminology Criteria for Adverse Events (ranging from 0 to 5, a high score indicates a strong neuropathy).', 'timeFrame': 'from the baseline to 6 months after the treatment'}, {'measure': 'Exploration of the evolution of quality of life', 'description': 'The quality of life will be explored using the self-questionnaire Functional Assessment of Chronic illness Therapy-Global scores \\[the global score and its 4 sub-scales scores (physical, social/family, emotional, functional\\] and the number of falls reported by the patient during the last month (from 0 to 108, 0 bad quality of life, 108 good quality of life)', 'timeFrame': 'from the baseline to 6 months after the treatment'}, {'measure': 'Exploration of the evolution of sleep disorders', 'description': 'Sleep disorders will be explored using the self-assessment Sleep Severity Index (ISI).', 'timeFrame': 'from the baseline to 6 months after the treatment'}, {'measure': 'Description of the evolution of neurocognitive executive functioning', 'description': 'Neurocognitive functioning will be assessed using the clinician-rated scores of the test modified-Delis-Kaplan Executive Function System (m-DKEFS)', 'timeFrame': 'from the baseline to 6 months after the treatment'}, {'measure': 'Description of the evolution of neurocognitive executive functioning', 'description': 'Neurocognitive functioning will be assessed using the scores of the Trail Making Test (TMT A and B)', 'timeFrame': 'from the baseline to 6 months after the treatment'}, {'measure': 'Assessment of the photobiomodulation adherence', 'description': 'The adherence to the intervention will be assessed by the number of PBM sessions performed by patients', 'timeFrame': 'from the baseline to 4 weeks after the beginning of the treatment'}, {'measure': 'Evaluation of the safety of the photobiomodulation', 'description': 'The safety of PBM will be assessed by the number and the severity of target adverse events recorded during the study period, using the CTCAE scale (v5.0)', 'timeFrame': 'from the baseline to 6 months after the treatment'}, {'measure': 'Assessment of emotional distress', 'description': 'Emotional distress will be measured by the score of the Hospital Anxiety and Depression Scale (HADS) Questionnaire at baseline and at the end of photobiomodulation treatment', 'timeFrame': 'from the baseline to 4 weeks after the treatment'}]" 80,NCT04740385,"{'fullName': 'National Cancer Institute, Egypt', 'class': 'OTHER'}",Role of Lung Ultrasound in Confirmation of Correct Double Lumen Endotracheal Tube Placement in Thoracic Surgeries,COMPLETED,to assess the efficacy of lung ultrasound versus conventional auscultation method and fiberoptic bronchoscopy in confirmation of double lumen tube position,['Diagnostic Accuracy'],OBSERVATIONAL,"{'observationalModel': 'OTHER', 'timePerspective': 'CROSS_SECTIONAL'}","[{'type': 'DIAGNOSTIC_TEST', 'name': 'Lung auscultation', 'description': 'auscultation of air entry through chest wal', 'armGroupLabels': ['Lung cancer patients']}, {'type': 'DEVICE', 'name': 'Fiberoptic bronchoscopy', 'description': 'Checking correct double lumen position through direct vision using fiberoptic bronchoscopy', 'armGroupLabels': ['Lung cancer patients']}, {'type': 'DEVICE', 'name': 'Lung Ultrasound', 'description': 'real time visualization of air entry to the lungs using trans-thoracic lung ultrasound', 'armGroupLabels': ['Lung cancer patients']}]","Inclusion Criteria: * patients scheduled for surgeries under general anesthesia requiring double lumen endotracheal intubation * ASA I-II Exclusion Criteria: * patient refusal * patients not meeting the inclusion criteria",lung cancer patients undergoing thoracic surgeries requiring double lumen intubation,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'sensitivity and specificity of lung ultrasound in confirmation of correct double lumen position', 'description': 'real time visulaization of air entry to the lung', 'timeFrame': '5 minutes'}]","[{'measure': 'procedural time', 'description': 'time taken to confirm tube position', 'timeFrame': '5 minutes'}]" 81,NCT02017743,"{'fullName': 'Trio Grup Clinical Research', 'class': 'INDUSTRY'}",Effectiveness And Safety of LMWH Treatment in Cancer Patients Diagnosed With Non-High Risk Venous Thromboembolism,UNKNOWN,"This study is a multicenter post authorization observational study. Cancer patients diagnosed with non high risk VTE and are followed up in an outpatient setting will be treated with LMWH and the data will be recorded. Since this is an observational study there are no specific treatment protocols, i.e., patients will be treated according to the best investigator's criteria. Treatment protocol will be based on the routine treatment practice of the involved investigator. Patients to enroll will be cancer patients diagnosed for VTE and who are able to receive outpatient LMWH treatment. There will be no specific hypothesis to be tested.",['Venous Thromboembolism'],OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}",NA,"Inclusion Criteria: * 18 years or upper age * A signed informed consent document * Cancer patient diagnosed for VTE * Life expectancy \> 6 months * Eligible for criteria of outpatient administration of LMWH Exclusion Criteria: * Patients with active bleeding or at-risk for bleeding * Major surgery in the last 7 days * Cardiopulmonary unstability * Severe systemic venous occlusion * Patients at high risk for pulmonary embolism * Thrombocytopenia (\<50000/microliter) * Inpatients under medical or surgery supervision * Patients with low ability to communicate and for whom it is not possible to provide care at home * INR≥1.5 due to liver functions impairment * Diagnosed for cerebral vascular aneurism * Active gastric and/or duodenum ulcer * Diagnosed for bacterial endocarditis * Severe renal function impairment (Creatinine clearance \< 30 ml/min) * Grade 3 hypertension (DBP \>= 110 mmHg and/or SBP \>= 180 mmHg) * \<35 kg or ≥110 kg weight * Known allergy to heparin and/or its derivatives * History of cerebrovascular event in the last 1 month * Active haemorrhage within the last 3 months",Patients to enroll will be cancer patients diagnosed for VTE and who are able to receive outpatient LMWH treatment.,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Evaluation of effectiveness of LMWH used in the treatment of thrombosis in cancer patients with VTE regarding new thrombosis.', 'timeFrame': '[Time to new thrombosis in 15 days]'}, {'measure': 'Evaluation of effectiveness of LMWH used in the treatment of thrombosis in cancer patients with VTE regarding resolution.', 'timeFrame': '[Time to resolution in 15 days]'}, {'measure': 'Evaluation of effectiveness of LMWH used in the treatment of thrombosis in cancer patients with VTE regarding bleeding', 'timeFrame': '[Time to bleeding in 15 days]'}]",NA 82,NCT00072215,"{'fullName': 'Alliance for Clinical Trials in Oncology', 'class': 'OTHER'}",Cisplatin and Ifosfamide Combined With Either Paclitaxel or Vinblastine in Treating Men With Progressive or Recurrent Metastatic Germ Cell Tumors,TERMINATED,"RATIONALE: Drugs used in chemotherapy, such as ifosfamide, cisplatin, paclitaxel, and vinblastine, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether ifosfamide and cisplatin are more effective when combined with paclitaxel or vinblastine in treating germ cell tumors. PURPOSE: This randomized phase III trial is studying paclitaxel, ifosfamide, and cisplatin to see how well they work compared to vinblastine, ifosfamide, and cisplatin in treating men with progressive or recurrent metastatic germ cell tumors.","['Extragonadal Germ Cell Tumor', 'Testicular Germ Cell Tumor']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'cisplatin', 'description': 'given IV', 'armGroupLabels': ['Regimen A: TIP', 'Regimen B: VeIP']}, {'type': 'DRUG', 'name': 'ifosfamide', 'description': 'given IV', 'armGroupLabels': ['Regimen A: TIP', 'Regimen B: VeIP']}, {'type': 'DRUG', 'name': 'paclitaxel', 'description': 'given IV', 'armGroupLabels': ['Regimen A: TIP']}, {'type': 'DRUG', 'name': 'vinblastine', 'description': 'given IV', 'armGroupLabels': ['Regimen B: VeIP']}]","DISEASE CHARACTERISTICS: * Histologically confirmed germ cell tumor (GCT), including 1 of the following primary tumor sites: * Seminoma * Testis * Retroperitoneum * Mediastinum * Other extragonadal site * Nonseminoma * Testis * Retroperitoneum * Other extragonadal site * No tumor of the mediastinum * Must have evidence of metastatic disease, including either of the following: * Unidimensionally measurable lesions * At least 20 mm by conventional techniques (e.g., physical exam for clinically palpable lymph nodes and superficial skin lesions or chest x-ray for clearly defined lung lesions surrounded by aerated lung) OR at least 10 mm by spiral CT scan or MRI * Nonmeasurable lesions, including the following: * Small lesions * Bone lesions * Pleural or pericardial effusions * Ascites * Irradiated lesions, unless progression is documented after radiotherapy * Progressive or recurrent disease meeting at least 1 of the following criteria: * Measurable progressive disease * Biopsy-proven residual disease * Persistently elevated or rising ß-human chorionic gonadotropin (HCG) or alpha-fetoprotein (AFP) titers with no other clear cause for elevation * Previously treated with 1 and only 1 regimen comprising etoposide and cisplatin with or without bleomycin AND exhibits clinical resistance by at least 1 of the following conditions after therapy\*: * Progressive GCT after a partial response to first-line therapy * Relapse after complete response (CR) to first-line therapy, including partial response (PR) surgically converted to CR * Second testicular primary with evidence of metastases after first-line therapy * Relapse after adjuvant chemotherapy NOTE: \*Patients failing to achieve PR or CR with first-line therapy as evidenced by rising markers or new disease within 4 weeks of first-line therapy are not eligible PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Not specified Life expectancy * Not specified Hematopoietic * Granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9 g/dL (transfusion allowed) Hepatic * Bilirubin ≤ 1.5 times upper limit of normal\* (ULN) * AST and ALT ≤ 2.5 times ULN\* NOTE: \*Unless hepatic metastases are present Renal * Creatinine ≤ 1.5 times ULN OR * Creatinine clearance ≥ 50 mL/min Other * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * No prior dose-intensive therapy with stem cell replacement Chemotherapy * See Disease Characteristics * At least 3 weeks since prior chemotherapy * No prior paclitaxel * No prior docetaxel * No prior ifosfamide * No other concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * At least 3 weeks since prior radiotherapy * Concurrent or sequential radiotherapy to brain metastases allowed * No other concurrent palliative radiotherapy Surgery * See Disease Characteristics * Concurrent surgery for brain metastases allowed Other * Recovered from prior therapy",NA,MALE,NA,"[{'measure': 'Overall survival', 'timeFrame': '2 months'}]",NA 83,NCT01955915,"{'fullName': 'OHSU Knight Cancer Institute', 'class': 'OTHER'}",Blood Vessel Patterns in Small Choroidal Tumors,UNKNOWN,The purpose of this study is to see if mapping blood vessel patterns with optical coherence tomography (OCT) will help identify life-threatening choroidal tumors in their early stages and improve overall patient survival through early detection.,['Small Posterior Choroidal Tumors'],OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}",NA,"Inclusion Criteria: * Adults older than age 18 with small (\< 3mm) choroidal tumors located within the posterior pole region which can be imaged using OCT technology. Subjects with benign-appearing and malignant-appearing lesions meeting these criteria will be enrolled. Exclusion Criteria: * Inability to give informed consent. * Inability to maintain stable fixation for OCT imaging. * Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant. * A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control). * Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible. * Women who are pregnant or lactating at the time of enrollment due to unknown safety of fluorescein angiography. Women that become pregnant during the course of the study may remain enrolled; however, flurorescein and ICG angiography will not be performed until they are no longer pregnant or nursing an infant. * Patients receiving treatment for uveal melanomas will be excluded from the longitudinal natural history portion of this study, but may enroll for a single study visit prior to treatment of their melanoma. They will then be eligible to enroll in IRB 9501, which will follow radiation-treated patients longitudinally.",This study will measure blood vessel pattern/flow changes in 15 patients with small posterior choroidal tumors.,ALL,PROBABILITY_SAMPLE,"[{'measure': 'Blood vessel patterns in small choroidal tumors', 'description': 'To determine if identifying early changes in blood vessel patterns will aid in early diagnosis and treatment of potentially aggressive choroidal tumors. This will be assessed using functional OCT angiography technology.', 'timeFrame': '24 months'}]",NA 84,NCT06327932,"{'fullName': 'Affiliated Cancer Hospital & Institute of Guangzhou Medical University', 'class': 'OTHER'}",HIVEC in Patients With Non-Muscle-Invasive Bladder Cancer,NOT_YET_RECRUITING,The purpose of this study is to determine the efficacy and safety of Hyperthermic Intravesical Chemotherapy (HIVEC) with Gemcitabine (GEM) after Transurethral Resection of Bladder Tumors (TURBT) in the treatment of medium or high-risk group Non-Muscle-Invasive Bladder Cancer (NMIBC).,['Non-Muscle-Invasive Bladder Cancer'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'PROCEDURE', 'name': 'TURBT', 'description': 'Transurethral Resection of Bladder Tumors', 'armGroupLabels': ['HIVEC', 'Matched control']}, {'type': 'PROCEDURE', 'name': 'HIVEC', 'description': 'Hyperthermic Intravesical Chemotherapy with Gemcitabine (3g/150ml NS) at 45 °C for 60 minutes. Induction perfusion was required to start within 4 weeks, once a week (±5 days) for 6 to 8 times. After the last induction infusion, maintenance infusion was performed, once every month (±2 weeks) for 1 year from the first induction infusion.', 'armGroupLabels': ['HIVEC']}, {'type': 'PROCEDURE', 'name': 'Intravesical Chemotherapy', 'description': 'Intravesical Chemotherapy with Gemcitabine (3g/150ml NS). Induction perfusion was required to start within 4 weeks, once a week (±5 days) for 6 to 8 times. After the last induction infusion, maintenance infusion was performed, once every month (±2 weeks) for 1 year from the first induction infusion.', 'armGroupLabels': ['Matched control']}, {'type': 'DRUG', 'name': 'Gemcitabine', 'description': 'Gemcitabine (3g/150ml NS).', 'armGroupLabels': ['HIVEC', 'Matched control']}]","Inclusion Criteria: 1. Patients who did not receive induction perfusion within 4 weeks after complete resection of bladder tumor with TURBT (Patients who were judged by the investigator to be in need of secondary electrotomy, for the last time). 2. Recurrence risk and prognosis of Non-Muscle-Invasive Bladder Cancer were divided into medium-risk group or high-risk group (patients who underwent multiple electrosurgical biopsies, and the pathological results were based on higher grade tumors). 3. KPS score ≥80, expected survival \> 30 months. 4. Pathological suggested non-myoinvasive urothelial carcinoma of the bladder. 5. Age between 18 and 70 years, all genders. 6. Volunteer to participate in this clinical trial and written informed consent. Exclusion Criteria: 1. Patients with bladder cancer in situ. 2. Combined with proven upper urinary tract or urethral tumors. 3. The patients were complicated with bladder perforation, gross hematuria or urinary tract infection of grade 3-4. 4. Patients with urethral discontinuity, urethral stricture, or inability to use a three lumen catheter normally affect perfusion therapy. 5. Patients who had undergone partial cystectomy or abnormal bladder structure were judged by the investigator to be unsuitable for perfusion therapy. 6. Patients with severe coagulation dysfunction. 7. A history of allergy to injected drugs (gemcitabine). 8. History of pelvic radiation, systemic chemotherapy, or immunotherapy. 9. Complicated with cardiovascular, cerebrovascular, hematopoietic, immune system and other serious diseases. 10. Patients with mental illness, substance abuse, alcoholism, and inability to cooperate. 11. Breastfeeding, pregnant, or planning to have a baby in the near future. 12. Recurrent patients with a prior history of BCG or bladder thermoperfusion therapy. 13. Participated in other clinical trials 1 month before the trial. 14. Vesicoureteral regurgitation. 15. The investigator considered it inappropriate to participate in this clinical trial.",NA,ALL,NA,"[{'measure': 'Recurrence rate', 'description': 'The patients were observed for 2 years since they received HIVEC or intravesical chemotherapy，and cystoscopy was repeated every 3 months. If a new tumor-like organism is seen under the microscope, and pathology indicates urothelial carcinoma of the bladder after TURBT or cystoscopic biopsy, the tumor is considered to have recurred. 2-year recurrence rate = number of recurrence cases within 2 years / total number of enrolled cases \\* 100%.', 'timeFrame': '2-year'}]","[{'measure': '1-year recurrence rate', 'description': '1-year recurrence rate = number of recurrence cases within 1 years / total number of enrolled cases \\* 100%.', 'timeFrame': '1-year'}, {'measure': 'Recurrence-free survival (RFS) rate', 'description': 'Recurrence free survival is calculated from the date of randomization to the date of record recurrence or death from any cause, whichever occurred first.', 'timeFrame': '2-year'}, {'measure': 'Time to treatment failure', 'description': ""Time to treatment failure is calculated from the date of randomization to the date of treatment discontinuation/termination, including any reason for discontinuation/termination, such as disease progression, death, withdrawal due to adverse events, subject's refusal to continue the study, or use of a new treatment."", 'timeFrame': '2-year'}, {'measure': 'Success rate of therapeutic operation', 'description': 'Success rate of therapeutic operation', 'timeFrame': '2-year'}, {'measure': 'Quality of international prostate symptom score', 'description': 'IPSS is International Prostate Symptom Score (IPSS), 0\\~35, the higher the score, the worse the symptom severity is.', 'timeFrame': 'Evaluation was performed during the screening period and at 3, 12 and 24 months after initiation of treatment.'}, {'measure': 'Quality of bother of score', 'description': 'BS is Bother of Score (BS), 0\\~6, the higher the score, the worse the performance is.BS is the Bother of Score (BS), 0\\~6, the higher the score, the worse the performance is.', 'timeFrame': 'Evaluation was performed during the screening period and at 3, 12 and 24 months after initiation of treatment'}]" 85,NCT00064298,"{'fullName': 'Wake Forest University Health Sciences', 'class': 'OTHER'}","Fruit and Vegetable Extracts in Treating Patients With Stage I-IV, Stage IVA/IVB Head and Neck Cancer",COMPLETED,"RATIONALE: Chemoprevention therapy is the use of certain substances to try to prevent the development or recurrence of cancer. Fruit and vegetable extracts may be effective in preventing the recurrence or further development of head and neck cancer. PURPOSE: This randomized phase II trial is studying how well fruit and vegetable extracts work in preventing the recurrence of stage I, stage II, stage III, stage IVA, or stage IVB head and neck cancer.",['Head and Neck Cancer'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}","[{'type': 'DIETARY_SUPPLEMENT', 'name': 'fruit and vegetable extracts', 'description': 'Given orally', 'armGroupLabels': ['Arm I - JuicePlus']}, {'type': 'DIETARY_SUPPLEMENT', 'name': 'placebo', 'description': 'Given orally', 'armGroupLabels': ['Arm II - Control']}]","DISEASE CHARACTERISTICS: * Curatively treated stage I-IV (including stage IVA and IVB) squamous cell carcinoma of the upper aerodigestive tract of 1 of the following primary sites: * Oral cavity * Oropharynx * Hypopharynx * Larynx * Disease-free for at least 6 months and no more than 3 years after completion of surgery, radiotherapy, and/or chemotherapy * No synchronous tumors PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% OR * Zubrod 0-1 Life expectancy * At least 6 months Hematopoietic * Hemoglobin ≥ 10 g/dL * WBC ≥ 3,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 mg/dL * SGOT ≤ 40 U/L * SGPT ≤ 56 U/L Renal * Creatinine ≤ 1.5 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 5 years except curatively treated head and neck squamous cell carcinoma, nonmelanoma skin cancer, or carcinoma in situ of the cervix * No other serious medical or psychiatric illness that would preclude giving informed consent * No nausea ≥ grade 2 PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics * More than 6 months and less than 3 years since prior chemotherapy * No concurrent chemotherapy * No other concurrent chemopreventive agents Endocrine therapy * More than 6 months and less than 3 years since prior hormonal therapy Radiotherapy * See Disease Characteristics * More than 6 months and less than 3 years since prior radiotherapy * No concurrent radiotherapy Surgery * See Disease Characteristics * More than 6 months and less than 3 years since prior surgery * No concurrent surgery Other * More than 6 months and less than 3 years since prior investigational agents * More than 2 months since prior high-dose vitamins (i.e., 10 times the recommended daily allowance \[8,000-10,000 IU of vitamin A, 600 mg of vitamin C, or 80-100 IU of vitamin E\])",NA,ALL,NA,"[{'measure': 'Expression of p27 Cell Cycle Regulatory Protein at Baseline and Week 12', 'description': 'Expression of p27 cell cycle regulatory protein at baseline and week 12. p27 is measured continuously. Lower values are worse.', 'timeFrame': 'baseline and 12 weeks'}]","[{'measure': 'Cell Proliferation (Ki-67) at Baseline and Week 12', 'description': 'Cell proliferation (Ki-67) at baseline and week 12. Ki67 is a cell proliferation associated nuclear protein. It is measured continuously. Higher values are worse.', 'timeFrame': 'baseline and 12 weeks'}]" 86,NCT01113398,"{'fullName': 'Duke University', 'class': 'OTHER'}",AMG 102 and Avastin for Recurrent Malignant Glioma,COMPLETED,"The primary purpose of the study is to assess the response rate of AMG 102 and Avastin treatment in subjects with advanced malignant glioma. Secondary objectives are to estimate overall survival and 6-month progression-free survival rates in this population and to assess the safety of this combination in this population. Patients must have recurrent histologically confirmed diagnosis of World Health Organization (WHO) grade IV malignant glioma (glioblastoma multiforme or gliosarcoma) with no more than 3 prior progressions. Subjects will receive Avastin and AMG 102 every two weeks. Avastin will be administered prior to AMG 102. Up to 36 adult subjects will take part in this study at Duke. In initial Phase I and II clinical trials, four potential Avastin-associated safety issues were identified: hypertension, proteinuria, thromboembolic events, and hemorrhage. The most common side effect for AMG 102 have been nausea and fatigue.","['Glioblastoma Multiforme', 'Gliosarcoma']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'AMG 102', 'description': 'AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.', 'armGroupLabels': ['AMG 102 with Avastin'], 'otherNames': ['rilotumumab']}, {'type': 'DRUG', 'name': 'Avastin', 'description': 'Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102.', 'armGroupLabels': ['AMG 102 with Avastin'], 'otherNames': ['Bevacizumab']}]","Inclusion Criteria: * Patients must have recurrent histologically confirmed diagnosis of WHO grade IV malignant glioma (glioblastoma multiforme or gliosarcoma) with no more than 3 prior progressions. * Age ≥ 18 years. * Karnofsky ≥ 60%. * An interval of at least 4 weeks between either prior tumor biopsy or prior major surgical procedure and study enrollment. * Bi-dimensionally measurable disease as assessed by magnetic resonance imaging. * Hemoglobin ≥9.0 g/dl, ANC ≥1500 cells/µl, Platelets ≥125,000 cells/µl (without transfusion within 14 days before enrollment). * Serum creatinine \< 1.5 mg/dl, bilirubin \< 1.5 times upper limit of normal, and serum SGOT (AST) and SGPT (ALT) \< 2.5 times upper limit of normal. * For patients on corticosteroids, they must be on a stable dose for 1 week prior to entry, and the dose should not be escalated over entry dose level, if clinically possible. * Signed informed consent approved by the Institutional Review Board. * No evidence of active CNS hemorrhage on the baseline MRI or CT scan. * If sexually active, patients will take contraceptive measures for the duration of treatment as stated in the informed consent. Exclusion Criteria: * Pregnancy or breast-feeding. * Baseline ECG with QTc \> 0.45 second * Co-medication that may interfere with study results; e.g. immuno-suppressive agents other than corticosteroids. * Thrombosis or vascular ischemic events within the last twelve months, such as deep venous thrombosis, pulmonary embolism, transient ischemic attack, cerebral infarction, or myocardial infarction. * Active infection requiring IV antibiotics 7 days before enrollment. * History of central nervous system bleeding as defined by stroke or intraocular bleed (including embolic stroke) within 6 months before enrollment. * Evidence of acute intracranial hemorrhage; except for subjects with stable grade 1 hemorrhage. * Less than 12 weeks from radiation therapy, unless progressive disease outside of the radiation field or 2 consecutive scans or histopathologic confirmation. * Treated previously with any c-Met or HGF targeted therapy. * Treated previously with VEGF or VEGFR therapies, including antibodies and tyrosine kinase inhibitors. * Treated with thalidomide or tamoxifen within 1 week before enrollment unless the patient has recovered from the toxic effects of such therapy. * Treated with immunotherapeutic agents, vaccines, or MAb therapy within 4 weeks before enrollment unless the patient has recovered from the toxic effects of such therapy. * Treated with alkylating agents within 4 weeks before enrollment or if the patient has been treated with daily or metronomic chemotherapy unless the patient has recovered from the toxic effects of such therapy. * Treated with chemotherapy (non-alkylating agents) within 2 weeks before enrollment unless the patient has recovered from the toxic effects of such therapy. * Less than 4 weeks after surgical resection of the brain tumor or less than 2 weeks after stereotactic biopsy before enrollment unless the patient has recovered from acute side effects of such procedures except for neurological effects. * Plans to receive surgery, radiation therapy or other elective surgeries during the course of the study. * Concurrent severe and/or uncontrolled medical disease (e.g. uncontrolled diabetes, congestive cardiac failure, myocardial infarction within 6 months before enrollment) that could compromise participation in the study. * Concurrent or prior (within 7 days of enrollment) anticoagulation therapy, except: Use of low dose coumadin-type anticoagulants (≤ 2 mg PO QD) low molecular weight heparins (LMWH), e.g. Enoxaparin sodium (Lovenox) and unfractionated heparin for prophylaxis against central venous catheter thrombosis is allowed. * Grade 2 or greater peripheral edema or effusion (pleural, pericardial, or ascites). * Inability to comply with study and/or follow-up procedure. * Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study. Avastin-Specific Exclusion Criteria Subjects meeting any of the following criteria are ineligible for study entry: * Inadequately controlled hypertension (defined as systolic blood pressure \>150 mmHg and/or diastolic blood pressure \> 100 mmHg) * Prior history of hypertensive crisis or hypertensive encephalopathy * New York Heart Association (NYHA) Grade II or greater congestive heart failure * History of myocardial infarction or unstable angina within 6 months prior to Day 1, the day protocol therapy starts. * History of stroke or transient ischemic attack within 6 months prior to Day 1 * Significant vascular disease (e.g. aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) (within 6 months prior to Day 1). * History of hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 28 days prior to Day 1 * Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation) * Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 * Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1 * Serious, non-healing wound, active ulcer or untreated bone fracture * Proteinuria as defined by ≥ +1 on urinalysis dipstick * Known hypersensitivity to any component of Avastin * Pregnant (positive pregnancy test) or lactation.",NA,ALL,NA,"[{'measure': 'Radiographic Response', 'description': 'The percentage of participants with a complete or partial response as determined by modified Response Assessment in Neuro-Oncology (RANO) criteria will be determined. Complete Response (CR) is defined as complete disappearance on MR/CT of all enhancing tumor and mass effect, off all corticosteroids (or receiving only adrenal replacement doses) and accompanied by a stable or improving neurologic examination. Partial Response (PR) is defined as greater than or equal to 50% reduction in tumor size on MR/CT by bi-dimensional measurement, on a stable or decreasing dose of corticosteroids and accompanied by a stable or improving neurologic examination. Tumor assessments are done at baseline and the end of every 6-week cycle thereafter.', 'timeFrame': '2 years'}]","[{'measure': 'Median Overall Survival (OS)', 'description': 'Overall survival is defined as the time in months from the start of protocol treatment until the date of death, or the date of last follow-up if alive. Kaplan-Meier methods will be used to estimate overall survival.', 'timeFrame': '2 years'}, {'measure': 'Six-month Progression-free Survival (PFS6)', 'description': 'The percentage of participants alive and progression-free at 6 months after the start of study treatment will be determined. PFS6 will be calculated from the date study treatment started until the date of progression or death, or the date of last follow-up if participants are alive without progression. Kaplan-Meier methods will be used to estimate survival.', 'timeFrame': '6 months'}, {'measure': 'Percentage of Participants Who Experience Treatment-related Grade 2 or Greater CNS Hemorrhage or Grade 4 or Greater Non-hematologic Toxicities', 'description': 'The percentage of participants who experience unacceptable toxicity, defined as any treatment-related grade 2 or greater CNS hemorrhage or grade 4 or greater non-hematologic toxicity, will be calculated.', 'timeFrame': '2 years'}]" 87,NCT02404363,"{'fullName': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}",Safety and Efficacy of Clopidogrel in Locally Advanced and Metastatic Pancreatic Adenocarcinoma Treated With Chemotherapy,TERMINATED,"Clopidogrel has been shown to slow down tumor progression in orthoptic pancreatic murine tumor. In a pilot study, the rate of microparticles was correlated with response rate of pancreatic adenocarcinoma. The aim of the study is; * to compare the phenotypes of coagulation, the tumor progression and metastasis formation with and without clopidogrel treatment in association with chemotherapy in advanced pancreatic cancer patients * to correlate the decrease of microparticles levels after one month of chemotherapy with tumor response (ancillary study)","['Locally Advanced Pancreatic Cancer', 'Adenocarcinoma, Pancreas', 'Metastatic Pancreatic Cancer']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}","[{'type': 'DRUG', 'name': 'Clopidogrel', 'description': 'Clopidogrel tablets 75 mg for six months:\n\nIn case of treatment with aspirin \\< or = 75 mg/d or prophylactic LMWH --\\> clopidogrel 75 mg/d If aspirin = 0 + LMWH = 0 --\\> clopidogrel 150 mg/d x 7days then 75mg/d', 'armGroupLabels': ['Clopidogrel']}, {'type': 'DRUG', 'name': 'Placebo', 'description': 'Placebo tablets 75 mg for six months:\n\nIn case of treatment with aspirin \\< or = 75 mg/d or prophylactic LMWH --\\> placebo 75 mg/d If aspirin = 0 + LMWH = 0 --\\> placebo 150 mg/d x 7days then 75mg/d', 'armGroupLabels': ['Comparator']}]","Inclusion Criteria: * 18 years of age or older * Histologically or cytologically confirmed adenocarcinoma of the pancreas * Locally advanced or metastatic pancreatic cancer * Measurable primary pancreatic cancer or metastasis * No previous chemotherapy either in an adjuvant or metastatic setting * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Adequate bone marrow: granulocyte count ≥ 1.5 G/L; and platelet count ≥ 100 G/L * Adequate liver function: bilirubin ≤ 2 times the upper limit of the normal range, transaminases (AST and ALT) ≤ 3 times the upper limit of the normal range * Adequate renal function: calculated clearance rate \> 60 m.mn-1 (Estimated glomerular filtration rate using Modification of Diet in Renal Disease (MDRD) formula or Cockcroft-Gault formula) * Women of childbearing potential must use an effective birth control method Exclusion Criteria: * Endocrine or acinar pancreatic carcinoma * Pancreatic metastasis of other primary tumors * Previous radiotherapy for measurable lesions * Previous chemotherapy * History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis * Other prior malignancy. Adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or any other cancer from which the patient has been disease free for \> 5 years are allowed. * Known HIV disease requiring antiretroviral treatment * Hemorrhagic diathesis * Aspirin with a daily dose \> 75 mg * Curative dose of LMWH * Recent venous thromboembolism (\< 1 year) * Patients under VKA * Lesion of the digestive tract that could be hemorrhagic with clopidogrel treatment * Active infection * Chronic diarrhea * Cardiac disease with a left ventricular ejection fraction below 45% * Hypersensitivity to clopidogrel or its excipients * Patients with severe hepatic impairment * Patients who are pregnant or breast feeding, or who are not using effective birth control methods * Participation in another clinical research protocol, participation in a trial of routine care is authorized at the same time as PANCREADOGREL * Patient under tutorship or curatorship * Patients unwilling or unable to comply with the protocol * Not affiliated to health system (""bénéficiaire ou ayant droit"")",NA,ALL,NA,"[{'measure': 'Response to treatment based on RECIST 1.1 criterion', 'description': 'Progression free survival', 'timeFrame': 'up to 6 months'}]","[{'measure': 'Venous thromboembolic events', 'description': 'Diagnosis of pulmonary embolism (PE), deep venous thrombosis (DVT) and visceral vein event.', 'timeFrame': 'up to 12 months'}, {'measure': 'Response to treatment based on RECIST 1.1 criterion', 'description': 'Overall response rate', 'timeFrame': 'up to 12 months'}, {'measure': 'Overall survival', 'description': 'Overall survival is defined as time from randomization to death from any cause', 'timeFrame': 'up to 12 months'}, {'measure': 'Bleedings', 'description': 'All suspected bleedings will be classified as major, minor, clinically relevant non-major or no bleeding', 'timeFrame': 'up to 12 months'}]" 88,NCT05818163,"{'fullName': 'National Taiwan University Hospital', 'class': 'OTHER'}",Association of Perioperative Electroencephalography Spectral Analysis With Postoperative Complications,UNKNOWN,"Using data from electroencephalogram (EEG) obtained through intraoperative depth of anesthesia monitoring devices, combined with clinical symptoms such as postoperative pain and delirium, investigate their correlation and verify whether intraoperative EEG spectral analysis can predict the occurrence of postoperative pain, nausea and vomiting, restlessness, or delirium in patients undergoing surgery.","['Anesthesia', 'Pain', 'EEG']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'DEVICE', 'name': 'electroencephalography spectral analysis', 'description': 'Before inducing general anesthesia in the patient entering the operating room, an anesthesia depth monitoring patch is attached to the forehead, and EEG data during anesthesia is collected using the currently used anesthesia depth monitoring device.\n\nThe EEG data is transformed into a frequency and energy distribution and density spectral array (DSA) graph using Fourier transform (FFT) for spectral analysis.', 'armGroupLabels': ['with postoperative complications', 'without postoperative complications'], 'otherNames': ['density spectral array', 'patient state index (PSI)']}]","Inclusion Criteria: 1. Aged 20 years or older. 2. Patients who received general anesthesia within the our hospital system. Exclusion Criteria: 1. Individuals with suspected infections, such as a fever higher than 38.3℃ 2. Individuals with renal dysfunction, such as those with creatinine levels higher than 1.5 or those who require long-term dialysis 3. Individuals with cardiac dysfunction, such as those with NYHA class III or higher heart failure or coronary heart disease Individuals with neurological diseases, such as those with brain tumors, dementia, stroke, or epilepsy 4. Vulnerable populations, such as minors (under 20 years of age), pregnant women and fetuses, prisoners, adults who cannot give informed consent, individuals with disabilities, individuals with mental illness, residents of nursing homes or long-term care facilities, or those who may be subject to coercion or unable to make decisions freely.",Patients aged 20 years or older who received general anesthesia within the National Taiwan University Hospital system.,ALL,PROBABILITY_SAMPLE,"[{'measure': 'pain in the postanesthesia care unit', 'description': 'Visual Analog Scale (VAS) \\> 3 in the postanesthesia care unit', 'timeFrame': 'up to 2 hours, postanesthesia'}, {'measure': 'agitation in the postanesthesia care unit', 'description': 'Richmond Agitation-Sedation Scale (RASS)\\>2 in the postanesthesia care unit', 'timeFrame': 'up to 2 hours, postanesthesia'}]","[{'measure': 'delirium', 'description': 'delirium after anesthesia, CAM-ICU', 'timeFrame': 'up to 2 days, postanesthesia'}, {'measure': 'nausea and vomiting', 'description': 'nausea and vomiting', 'timeFrame': 'up to 1 day, postanesthesia'}]" 89,NCT07634263,"{'fullName': 'Odense University Hospital', 'class': 'OTHER'}",Why Patients Decline or Are Being Deemed Ineligible to Receive Home-based Treatment: a Mixed Methods Study,NOT_YET_RECRUITING,"Treatment for blood cancers has improved significantly, and more patients are now living longer. However, these treatments are often intensive and long-lasting, and many patients experience serious side effects and symptoms. As more patients require ongoing treatment and long-term care, the demand for haematology services is increasing. Home-based treatment is expected to play an increasingly important role in the future. It can support more patient-centred care, help patients maintain their everyday lives, improve quality of life, and reduce pressure on hospitals. Despite these benefits, some patients are either not eligible for home-based treatment or choose to decline it. The reasons for this are not yet well understood. This study combines quantitative data-such as medical information, sociodemographic characteristics, and questionnaire responses about quality of life and health literacy-with qualitative interviews involving patients, relatives, and healthcare professionals. The aim is to identify barriers and differences between patients, and to better understand why some patients opt out of or are unable to participate in home-based treatment. The findings will help support the development of more inclusive and patient-centred care models, ensure more equal access to home-based treatment, and improve support for socially vulnerable patients. The results will be shared with patients and families through patient organisations, with hospitals through the Treat@Home programme, and at national and international conferences.","['Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma', 'Multiple Myeloma Progression', 'Multiple Myeloma Refractory']",OBSERVATIONAL,"{'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}",NA,"Inclusion Criteria: * \>=18 years old * diagnosed Multiple Myeloma or acute leukemia, and recieving treatment with either Daratumumab or Cytarabine. Exclusion Criteria: \- Dementia, psychotic disorders, or other cognitive impairments limiting participation.","All patients from the Department of Hematology at Odense University Hospital and Zealand University Hospital who are enrolled in the two Treat@Home studies will be invited to participate, including those who accept, decline, or are deemed ineligible for home-based treatment. We aim to include 50 participants, with 25 recruited from each site.",ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Perceptions - patient', 'description': 'Semi-structured interviews with patients at inclusion', 'timeFrame': 'Day 1'}, {'measure': 'Perception - caregivers', 'description': 'Semi-structured interviews with caregiver (together with patient) at inclusion', 'timeFrame': 'Day 1'}, {'measure': 'Perception - Healthcare staff', 'description': 'Focus group interview with Healthcare staff at end of study (after inclusion of all patients) in regards to barriers and possibilities in home administration', 'timeFrame': 'At study completion (end of inclusion of all patients)'}]","[{'measure': 'Biological sex', 'description': 'male, female', 'timeFrame': 'Day 1'}, {'measure': 'Patient reported outcomes', 'description': 'Health literacy was assessed using the Health Literacy Questionnaire (HLQ), which contains multiple domains scored on separate scales, with higher scores indicating better health literacy.', 'timeFrame': 'Day 1'}, {'measure': 'Patient Reported Outcome', 'description': 'Quality of life was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30; scores range from 0-100, with higher functional and global health scores indicating better quality of life and higher symptom scores indicating greater symptom burden).', 'timeFrame': 'Day 1'}, {'measure': 'Caregiver burden', 'description': 'Caregiver burden was assessed using the Caregiver Roles and Responsibilities Scale (CRRS), with higher scores indicating greater caregiver burden.', 'timeFrame': 'Day 1'}, {'measure': 'Age', 'description': 'Number', 'timeFrame': 'Day 1'}, {'measure': 'Residents', 'description': 'Capital, Zealand, Southern, Middle, North', 'timeFrame': 'Day 1'}, {'measure': 'Distance to hospital from home address', 'description': 'kilometer (number)', 'timeFrame': 'day 1'}, {'measure': 'Urbanicity', 'description': '1\\. Cities (densely populated area), 2. Towns, 3. suburbs (intermediate density area), and 4. rural (thinly populated area)', 'timeFrame': 'Day 1'}, {'measure': 'Performance status', 'description': '0, 1, 2, 3, 4', 'timeFrame': 'Day 1'}, {'measure': 'Hematologic diagnosis', 'description': 'multiple myeloma or acute myeloid leukemia', 'timeFrame': 'Day 1'}, {'measure': 'Diagnose subtype', 'description': 'IgA, IgG, IgM, Light chain, non-secretory, plasma cell, de novo, secondary, or relapsed/refractory', 'timeFrame': 'Day 1'}, {'measure': 'Blasts in bone marrow', 'description': 'Number', 'timeFrame': 'Day 1'}, {'measure': 'Planned treatment regime', 'description': 'Mono-therapy or combination', 'timeFrame': 'Day 1'}, {'measure': 'Previous lines of treatment', 'description': 'number', 'timeFrame': 'Day 1'}, {'measure': 'Time of diagnosis', 'description': 'Date', 'timeFrame': 'day 1'}, {'measure': 'Weight', 'description': 'kilogram (number)', 'timeFrame': 'Day 1'}, {'measure': 'Etnicity', 'description': 'White, Inuit, other (text)', 'timeFrame': 'Day 1'}, {'measure': 'Civil status', 'description': 'Married/cohabiting, widowed, divorced, single, other (text)', 'timeFrame': 'Day 1'}, {'measure': 'Number of children', 'description': 'Number', 'timeFrame': 'Day 1'}, {'measure': 'Living situation', 'description': 'Living with other, living alone, other', 'timeFrame': 'Day 1'}, {'measure': 'Educational level', 'description': 'Folkeskole, Gymnasie, Kort videregående uddannelse (\\<3 years), Middel videregående uddannelse (3-4 years), Lang videregående uddannelse (\\>4 years), Erhvervsuddannelse, or other (text)', 'timeFrame': 'Day 1'}, {'measure': 'Employment status', 'description': 'full-time, part-time, unemployed, retired, sick leave', 'timeFrame': 'Day 1'}, {'measure': 'Previous self-administered home-based treatment (e.g., injections or a medication pump)', 'description': 'yes, no', 'timeFrame': 'Day 1'}, {'measure': 'Smoking habits', 'description': 'Never, Former, Current', 'timeFrame': 'Day 1'}, {'measure': 'Alcohol use behaviour', 'description': 'Never, Former, Current', 'timeFrame': 'Day 1'}, {'measure': 'Regularly follow up for other illnesses than MM/AML at the hospital or with your general practitioner (at least once a month)', 'description': 'yes, no', 'timeFrame': 'Day 1'}, {'measure': 'Receive help from home care and/or visiting nurses on a daily basis', 'description': 'yes, no', 'timeFrame': 'Day 1'}, {'measure': 'Nearest relative most involved in disease', 'description': 'spouse, child, family member, friend, neighbor, other', 'timeFrame': 'Day 1'}]" 90,NCT07386587,"{'fullName': ""University of Child Health Sciences and Children's Hospital, Lahore"", 'class': 'OTHER'}",Methotrexate Alone vs Methotrexate + Etanercept for Minimal/Low Disease Activity in Juvenile Idiopathic Arthritis,ENROLLING_BY_INVITATION,"This open labelled randomized controlled trial will be carried out at the University of Child Health and the Children's Hospital, Lahore consisting of 6 months . In total 60 patients (30 in each group) fulfilling the inclusion criteria will be selected and enrolled in this study. Patients will be divided into two groups; Group A (Injection Etanercept+ Tab methotrexate) and Group B (Injection Etanercept+ Tab methotrexate). Data will be collected at baseline, 1,3 and 6 months. Data will be collected and recorded",['Juvenile Idiopathic Arthritis'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is an open label study, No masking both the participants and the investigators, including care providers and outcome assessors, are aware of the treatment assignments.'}}","[{'type': 'DRUG', 'name': 'Injection, Etanercept, 25 Mg (Code May Be Used for Medicare When Drug Administered Under the Direct Supervision of A Physician, Not for Use When Drug is Self Administered)', 'description': 'Injection Etanercept is biological TNF Inhibitor.', 'armGroupLabels': ['Group A', 'Group B']}]","Inclusion Criteria: Polyarticular JIA patients aged 2-16years Male or female patients Newly diagnosed patients Exclusion Criteria: Other type of JIA including systemic-onset JIA, psoriatic arthritis, enthesitis-related arthritis, and oligoarticular arthritis Chronic or acute infection or severe infection episodes that required hospitalization or intravenous administration of antibiotics 30 days prior to study initiation A previous history of malignancy Active tuberculosis or any opportunistic infection, including herpes zoster Hepatitis B Positive patients A history of any chronic disease (except for JIA) that could influence the effectiveness or safety of the investigational medicinal product in investigator's opinion \-",NA,ALL,NA,"[{'measure': 'Achievement of Minimal/Low Disease Activity Level in Polyarticular JIA', 'description': 'Proportion of patients achieving minimal/Low disease activity based on JDAS-10 between 0.8 t0 3.9 in Polyarticular Juvenile Idiopathic Arthritis.', 'timeFrame': '24 weeks'}]",NA 91,NCT05598593,"{'fullName': 'First Affiliated Hospital of Zhejiang University', 'class': 'OTHER'}",Modified TBF Regimen as Conditioning Regimen Prior to Allo-HSCT for T-ALL/LBL,UNKNOWN,"T cell acute lymphoblastic leukemia (T-ALL)/Lymphoblastic lymphoma (LBL) is a hematological malignancy caused by malignant transformation and clonal expansion of T-lineage precursor cells. The long-term cure rate of pediatric patients with T-ALL/LBL reaches 90%, but long-term survival of adult patients is less than 60%. Moreover, patients with high-risk factors such as PTEN/NRAS gene mutation, early T cell precursor (ETP) phenotype or positive minimal residual disease (MRD) have high rates of chemoresistance and dismal outcome. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) can significantly improve the prognosis of high-risk T-ALL/LBL. Total body irradiation (TBI)-based conditioning chemotherapy regimen is the preferred regimen for allo-HSCT in children and young adults with ALL because of lower relapse rates and satisfactory survival. Different from children, the non-relapse-related mortality (NRM) after TBI-based preconditioning in adults (especially those \>35 years old) was reported as high as 38%. In addition, serious sequelae after TBI seriously affect the quality of life and non-radiation conditioning chemotherapy regimens are urgently needed for T-ALL/LBL. The reported recurrence rates after BUCY (busulfan + cyclophosphamide) conditioning regimen for T-ALL as 41.2%. -56.7% and long-term survival was only 30-50%. Thiotepa is an ethyleneimine alkylating agent with anti-tumor effects and immunosuppressive effects, thus is widely used in conditioning regimen before HSCT. Retrospective paired analysis from EBMT indicated conditioning regimen thiotepa achieved similar relapse rates, long-term survival and faster granulocyte and platelet engraftment than TBI regimen. A recent retrospective study of childhood ALL from Turkey also reported that the TBF(thiotepa + fludarabine + busulfan) regimen had a recurrence rate of only 11.9% , a non-relapse mortality rate of 14.0% and a long-term survival of 79.1%. Data from a large retrospective paired study suggested TBF regimen can significantly reduce the relapse rate of acute myeloid leukemia after the first remission (HR=0.4, CI 0.2-0.7, P = .02) without increasing treatment related deaths compared with the traditional BUCY regimen. Based on these data, we modified the TBF regimen with additional cytarabine for allo-HSCT in T-ALL/LBL with expection to reduced disease relapse and improved long-term survival.","['Cytarabine+Thiotepa + Fludarabine + Busulfan', 'T Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'cytarabine+thiotepa+ fludarabine + busulfan', 'description': 'cytarabine+thiotepa+ fludarabine + busulfan intravenous injection', 'armGroupLabels': ['Modified TBF Conditioning Regimen']}]","Inclusion Criteria: 1. Age younger than 65 years 2. Patients diagnosed with T cell acute lymphoblastic leukemia/lymphoma , T-ALL/LBL according to WHO diagnostic criteria. 3. Patients who have donors and plane to accept allogeneic hematopoietic stem cell transplantation treatment. 4. ECOG body status score 0-2. 5. Good organ function level: ANC (neutrophil absolute value \>=1.0x10\^9/ L; PLT \>=30x10\^9/L; HB \>=80g/L; Tibil \<=1.5 ULN; ALT / AST \<=2.5 ULN; bun / Cr \<=1.5 ULN; LVEF \>=50%). 6. Patients who voluntarily participate in the clinical trial, understand the research procedure and can sign the informed consent in writing. Exclusion Criteria: 1. Patients who with severe cardiac insufficiency, cardiac ejection fraction EF is less than 60%; or severe arrhythmia, the investigator can not tolerate conditioning chemotherapy; 2. In patients with severe pulmonary insufficiency (obstructive and / or restrictive ventilation disorders), the researchers evaluated the patients who could not tolerate conditioning chemotherapy; 3. Patients with severe liver function impairment and liver function indexes (alt, TBIL) more than 3 ULN were evaluated as intolerant of conditioning chemotherapy; 4. In patients with severe renal insufficiency, the renal function index (CR) is more than 2 times of the upper limit of the normal value (ULN), or the 24-hour creatinine clearance rate (CR) is less than 50ml / min, the researchers evaluated that they could not tolerate conditioning chemotherapy; 5. In patients with severe active infection, the researchers evaluated that they could not tolerate conditioning chemotherapy; 6. Patients who had allergic reactions or serious adverse reactions in the previous use of pretreatment related drugs could not be included in the study. 7. Other reasons why the researchers could not be selected.",NA,ALL,NA,"[{'measure': 'Disease free survival', 'description': '2-year DFS', 'timeFrame': '2 year'}]","[{'measure': 'incidence of toxic reaction', 'description': '2-year incidence of toxic reaction', 'timeFrame': '2 year'}, {'measure': 'overall survival', 'description': '2-year OS', 'timeFrame': '2 year'}, {'measure': 'umulative incidence of relapse', 'description': '2-year incidence of relapse', 'timeFrame': '2 year'}, {'measure': 'ncidence of acute and or chronic graft verus host disease', 'description': '2-year incidence of cGVHD', 'timeFrame': '2 year'}]" 92,NCT01727921,"{'fullName': 'Samsung Medical Center', 'class': 'OTHER'}",Comparative Study of 22 and 25 Gauge ProCore EUS-guided Biopsy in Pancreatic Mass,COMPLETED,"Background: EUS-guided fine needle aspiration (FNA) is a major diagnostic tool in the patient with pancreatic mass with high specificity, specificity and accuracy. However FNA with small needle has sometimes failed in acquisition of tissue due to small caliber. To overcome this limitation, newly designed ProCore needle was developed and flexible 22 and 25 gauge ProCore needles were frequently used. However there was no comparative study of the efficacy and accuracy between 22 and 25 gauge ProCore needle yet. Aim: To compare the efficacy and accuracy of EUS-guided FNA between 22 and 25 gauge ProCore needle. (The investigators hypothesized that the accuracy of 25 gauge Procore needle is not inferior to 22 gauge ProCore needle.)",['Pancreatic Neoplasms'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}","[{'type': 'DEVICE', 'name': '22 gauge ProCore needle biopsy', 'description': '22 gauge, EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle', 'armGroupLabels': ['22 gauge ProCore needle biopsy']}, {'type': 'DEVICE', 'name': '25 gauge ProCore needle biopsy', 'description': '25 gauge, EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle', 'armGroupLabels': ['25 gauge ProCore needle biopsy']}]","Inclusion Criteria: * Patients who agree to participate in research * 18 years of age and older patients * Patients who have pancreatic or peripancreatic mass in imaging studies Exclusion Criteria: * Contraindication to endoscopy * Patients younger than 18 years old * Bleeding tendency * Cardiopulmonary dysfunction",NA,ALL,NA,"[{'measure': 'Diagnostic accuracy', 'description': 'Diagnostic accuracy include histologic diAgnosis and cytologic diagnosis', 'timeFrame': 'October. 2014'}]","[{'measure': 'Technical success', 'description': 'Technical success means the gain of tissue or cells through EUS-guided FNA.', 'timeFrame': 'October. 2014'}]" 93,NCT02029521,"{'fullName': 'Brigham Young University', 'class': 'OTHER'}",Supplementation of Oral Reduced Glutathione in Pediatric Cystic Fibrosis Patients,COMPLETED,"Many individuals with cystic fibrosis experience growth failure. The reasons are not clear, but inflammation of the gut in these patients seems to be one important reason. Glutathione is important to normal function of the intestine and lungs. Glutathione functions to decrease inflammation and to thin mucus. However, in cystic fibrosis, glutathione gets trapped inside of cells, so it cannot travel to the surface of the cells and perform its proper function. Moreover, glutathione has been shown to improve nutritional status in patients with AIDS and cancer. Investigators hypothesize that supplementation of oral glutathione to pediatric individuals with cystic fibrosis could improve growth failure.",['Cystic Fibrosis'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}","[{'type': 'DIETARY_SUPPLEMENT', 'name': 'Oral reduced l-glutathione', 'description': 'The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.', 'armGroupLabels': ['Oral reduced l-glutathione']}, {'type': 'DIETARY_SUPPLEMENT', 'name': 'Placebo', 'description': 'calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.', 'armGroupLabels': ['Placebo Calcium Citrate']}]","Inclusion Criteria: -Diagnosis of Cystic Fibrosis by either of the following criteria: \>60 sweat chloride test or paired deleterious DNA cystic fibrosis transmembrane conductance regulator (CFTR) mutations (Ambry genetics, Genetech or ARUP); -Pancreatic insufficient as defined by doctor's prescription of pancreatic enzymes. Exclusion Criteria: * Hospitalized for bowel obstruction or surgery in the six months prior to enrollment; * had had a pulmonary exacerbation or oral steroid use or IV antibiotics within one month of enrollment, * who had been taking either GSH or N-acetyl cysteine (NAC) within the 12 month period immediately prior to the trial, * chronically infected with Burkholderia cepacia.",NA,ALL,NA,"[{'measure': 'Weight Percentile at 3 Months', 'description': 'Weight Percentile at 3 months adjusted for sex and age', 'timeFrame': '3 months'}, {'measure': 'Height Percentile', 'description': 'Height Percentile adjusted for sex and age', 'timeFrame': '3 months'}, {'measure': 'BMI Percentile', 'description': 'Body Mass Index percentile adjusted for sex and age. Standard BMI are not available for participants under 2 years of age', 'timeFrame': '3 months'}, {'measure': 'BMI Percentile', 'description': 'Body Mass Index percentile adjusted for sex and age. Not available for participants under 2 years of age.', 'timeFrame': '6 months'}, {'measure': 'Weight Percentile', 'description': 'Weight percentile, adjusted for sex and age', 'timeFrame': '6 months'}, {'measure': 'Height Percentile', 'description': 'The subjects were measured over the course of the study to determine if treatment improved height percentile.', 'timeFrame': '6 Months'}, {'measure': 'Fecal Calprotectin', 'description': 'Fecal Calprotectin, a measure of gut inflammation, was measured to see if the treatment decreased this outcome.', 'timeFrame': '6 months'}]","[{'measure': 'Forced Vital Capacity', 'description': 'Forced vital capacity percent predicted', 'timeFrame': '3 months'}, {'measure': 'FEV1', 'description': 'Forced expiratory volume at one second, percent predicted', 'timeFrame': '3 months'}, {'measure': 'Bacteriology', 'description': 'Expectorated sputum or throat swab', 'timeFrame': '3 months'}, {'measure': 'Forced Vital Capacity', 'description': 'Percent predicted of forced vital capacity.', 'timeFrame': '6 months'}, {'measure': 'FEV1', 'description': 'Forced expiratory volume at one second, percent predicted.', 'timeFrame': '6 months'}, {'measure': 'C-Reactive Protein (CRP)', 'description': 'CRP was measured to determine if this test fell during the course of treatment.', 'timeFrame': '6 months'}, {'measure': 'White Blood Cell Count', 'description': 'White blood cell count was measure at the beginning and end of the study to determine if treatment affected this test.', 'timeFrame': '6 months'}, {'measure': 'Vitamin E', 'description': 'Serum Vitamin E levels were measured to determine if treatment affected this test.', 'timeFrame': '6 months'}, {'measure': 'Alanine Aminotransferase (ALT)', 'description': 'ALT was measured to determine if liver function was affected by treatment over the course of the study.', 'timeFrame': '6 Months'}, {'measure': 'Bacteriology', 'description': 'Expectorated sputum or throat swab', 'timeFrame': '6 Months'}, {'measure': 'Frequency of Abdominal Pain', 'description': 'Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent', 'timeFrame': '6 months'}, {'measure': 'Severity of Abdominal Pain', 'description': 'Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe', 'timeFrame': '6 months'}, {'measure': 'Frequency of Belching', 'description': 'Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent', 'timeFrame': '6 months'}, {'measure': 'Severity of Belching', 'description': 'Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe', 'timeFrame': '6 months'}, {'measure': 'Frequency of Flatulence', 'description': 'Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent', 'timeFrame': '6 months'}, {'measure': 'Severity of Flatulence', 'description': 'Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe', 'timeFrame': '6 months'}, {'measure': 'Frequency of Lack of Appetite', 'description': 'Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent', 'timeFrame': '6 months'}, {'measure': 'Severity of Lack of Appetite', 'description': 'Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe', 'timeFrame': '6 months'}, {'measure': 'Frequency of Bloating', 'description': 'Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent', 'timeFrame': '6 months'}, {'measure': 'Severity of Bloating', 'description': 'Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe', 'timeFrame': '6 months'}, {'measure': 'Frequency of Nausea', 'description': 'Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent', 'timeFrame': '6 months'}, {'measure': 'Severity of Nausea', 'description': 'Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe', 'timeFrame': '6 months'}, {'measure': 'Frequency of Vomiting', 'description': 'Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent', 'timeFrame': '6 months'}, {'measure': 'Severity of Vomiting', 'description': 'Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe', 'timeFrame': '6 months'}, {'measure': 'Frequency of Heart Burn', 'description': 'Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent', 'timeFrame': '6 months'}, {'measure': 'Severity of Heart Burn', 'description': 'Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe', 'timeFrame': '6 months'}, {'measure': 'Frequency of Diarrhea', 'description': 'Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent', 'timeFrame': '6 months'}, {'measure': 'Severity of Diarrhea', 'description': 'Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe', 'timeFrame': '6 months'}, {'measure': 'Frequency of More Than 2 Bowel Movements Per Day', 'description': 'Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent', 'timeFrame': '6 months'}, {'measure': 'Severity of More Than 2 Bowel Movements Per Day', 'description': 'Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe', 'timeFrame': '6 months'}, {'measure': 'Frequency of Less Than 2 Bowel Movements Per Week', 'description': 'Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most frequent', 'timeFrame': '6 months'}, {'measure': 'Severity of Less Than 2 Bowel Movements Per Week', 'description': 'Part of the Qualitative Symptom Assessment; scaled from 1-4 with 4 being the most severe', 'timeFrame': '6 months'}]" 94,NCT02827916,"{'fullName': 'Fondation Hôpital Saint-Joseph', 'class': 'OTHER'}",Exploration of Neuropathic Pain Induced by Oxaliplatin Electrophysiological Approach,COMPLETED,"Oxaliplatin is an anticancer agent commonly used in the treatment of colorectal cancer. However, the development of neuropathic pain under treatment limits its use. These are manifested by acute hyperesthesia / distal cold allodynia and chronic course of hypoesthesia. It is widely reported that these pains are consecutive to hyperexcitability of some ioniques2 channels (mainly sodium and potassium channels). However, the pathophysiological mechanisms of neurotoxicity are multifactorial and still imperfectly described. Since May 2014, the hospital group Paris Saint Joseph led the pilot study LIPIDOXA whose challenge is to quantify / measure NAION and explained by a biochemical approach, specifically Lipidomics. The CANALOXA study is the logical continuation of LIPIDOXA study insofar design methodology relies heavily on techniques developed for LIPIDOXA study and that the expected results will be complementary to those of LIPIDOXA.","['Peripheric Neuropathy', 'Chemo-induced Neuropathy']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DEVICE', 'name': 'Assessment of neuropathic pain with theThermotest device', 'description': 'Measure of painful neuropathy with thermotest', 'armGroupLabels': ['All patients']}, {'type': 'DEVICE', 'name': 'Assessment of neuropathic pain with SUDOSCAN device', 'description': 'Measure of painful neuropathy with sudoscan Devices', 'armGroupLabels': ['All patients']}, {'type': 'DEVICE', 'name': 'Assessment of neuropathic pain with the Neuropathic Pain Symptom Inventory.', 'description': 'Measure of painful neuropathy with Neuropathic Pain Symptom Inventory.', 'armGroupLabels': ['All patients']}]","Inclusion Criteria: * Patient newly treated with oxaliplatin * Patient suffering from any type of cancer treated with oxaliplatin * Man or Woman over 18 Exclusion Criteria: * Patient with brain or leptomeningeal metastases * Patient previously treated with cisplatin * Patient addicted to alcohol * Diabetic patient with peripheral neurological disorders * Patient receiving calcium or magnesium salts intravenously * Patient suffering from peripheral neuropathy * Patient suffering from psychiatric disorders * Patient treated with at least one of the following drug: venlafaxine, carbamazepine, gabapentin, pregabalin, clomipramine, amitriptyline, imipramine, duloxetine.",NA,ALL,NA,"[{'measure': 'Evaluation of neuropathy by electrophysiological methods using SUDOSCAN', 'description': 'The SUDOSCAN is a new technology fast and non-invasive to quantify the degree of neuropathy objectively through evaluation of chloride conductance of the skin on the palm of the hand and soles of the feet2). This can evaluate the neuropathy for quantitative measurement of neuropathic pain', 'timeFrame': 'Day 1'}]","[{'measure': 'Evaluation of neuropathy by devices for quantitative measurement of neuropathic pain', 'description': 'The pain symptoms are evaluated through various semi- objective neuropathy quantification tools (Quantitative Sensory Testing devices)6 :\n\n\\- Le Thermotest (Somedic®) : medical device that measures the thermal sensitivity thresholds to cold and hot: cold sensitivity threshold, threshold of sensitivity to hot, cold pain threshold, pain threshold warm. These stimuli are transmitted by the fiber Adelta and C. Since dysesthesia to thermal stimuli (allodynia in acute and hypoesthesia in chroniqe) are typical of oxaliplatin, Thermotest is fundamental.', 'timeFrame': 'Day 1'}, {'measure': 'NPSI ange of Characterization of pain neuropathy', 'description': 'Questionnaire NPSI (Neuropathic Pain Symptom Inventory) widely used in the field and validated.', 'timeFrame': 'Day 1'}]" 95,NCT05145816,"{'fullName': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}",Phase 1/2a Study of Belantamab Mafodotin in Relapsed or Refractory AL Amyloidosis,RECRUITING,"The goal of this study is to test the safety of drug, Belantamab Mafodotin, and see what effects (good and bad) it has on people who take it and have amyloidosis, and to determine the most effective dose of the drug. The study will have 2 phases (parts). The first phase of the study will test different doses of Belantamab Mafodotin. The second phase will test Belantamab Mafodotin at the dose level found to be safe and effective in phase 1","['AL Amyloidosis', 'Amyloidosis']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'This is an open-label, dose-escalation trial consisting of two parts: a Part 1 dose escalation phase and a Part 2 cohort expansion phase for safety and clinical activity testing.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Belantamab mafodotin 2.5 mg/kg (8 weeks)', 'description': '2.5 mg/kg IV Belantamab mafodotin IV every 8 weeks for Part 1', 'armGroupLabels': ['Cohort (DL +1) for Part 1']}, {'type': 'DRUG', 'name': 'Belantamab mafodotin 1.9 mg/kg (8 weeks)', 'description': '1.9 mg/kg IV Belantamab mafodotin IV every 8weeks for Part 1', 'armGroupLabels': ['Cohort (DL 0) for Part 1']}, {'type': 'DRUG', 'name': 'Belantamab mafodotin 1.4 mg/kg (12 weeks)', 'description': '1.4 mg/kg Belantamab mafodotin IV every 12 weeks for Part 1', 'armGroupLabels': ['Cohort (DL -2) for Part 1']}, {'type': 'DRUG', 'name': 'Belantamab mafodotin 1.9 mg/kg (12 weeks)', 'description': '1.9 mg/kg Belantamab mafodotin IV every 12 weeks for Part 1', 'armGroupLabels': ['Cohort (DL -1) for Part 1']}, {'type': 'DRUG', 'name': 'Belantamab mafodotin every 8 weeks or 12 weeks as determined by Part 1 recommended dosages', 'description': 'Belantamab mafodotin Dose 1.0 mg/kg, 1.4 mg/kg, 1.9mg/kg or 2.5mg/kg every 8 weeks or 12 weeks as determined by Part 1 recommended dosages.', 'armGroupLabels': ['Cohort Dose Expansion for Part 2']}, {'type': 'DRUG', 'name': 'Belantamab mafodotin 1.0 mg/kg (12 weeks)', 'description': '1.0 mg/kg Belantamab mafodotin IV every 12 weeks for Part 1', 'armGroupLabels': ['Cohort (DL -3) for Part 1']}]","Inclusion Criteria: 1. Participants medically diagnosed with relapsed or refractory Amyloid Light Chain Amyloidosis (AL amyloidosis) with one or more line of treatment as below: 1. Must have received a proteosome inhibitor, alkylator and anti-cluster of differentiation 38 (CD38) antibody (e.g., daratumumab - for patients who were eligible to receive in newly diagnosed AL Amyloidosis) and autologous stem cell transplant (for transplant eligible candidates). OR 2. Failed treatment and/or intolerant/ineligible for above agents NOTE: Patients who fail to achieve Partial Hematological Response or better after 2 cycles of induction therapy for newly diagnosed AL Amyloidosis are also eligible. 2. Participant must be over 18 years of age inclusive, at the time of signing the informed consent. 3. Participant and Disease Characteristics: Patient must have primary systemic AL amyloidosis, histologically confirmed at the initial diagnosis before initiation of 1st-line treatment by positive Congo red stain with green birefringence on polarized light microscopy, Or characteristic appearance by electron microscopy AND confirmatory AL amyloid typing (mass spectrometry-based proteomic analysis or immunofluorescence). 4. Patient must have measurable disease within 28 days prior to registration; serum quantitative immunoglobulins (immunoglobulin G (IgG), immunoglobulin A (IgA), and immunoglobulin M (IgM), serum free kappa and lambda, and serum protein electrophoresis (SPEP) with M-protein quantification must be obtained within 14 days prior to registration. 5. Measurable disease of amyloid light chain amyloidosis as defined by at least One of the following: a. Serum M-protein ≥0.5 g/dL by protein electrophoresis (routine serum protein electrophoresis and immunofixation). b. Serum free light chain ≥50 mg/L with an abnormal kappa: lambda ratio or the difference between the involved and uninvolved free light chains (dFLC) ≥50 mg/L. 6. One or more organs impacted by AL Amyloidosis according to consensus guidelines below per National Comprehensive Cancer Network (NCCN)Guidelines Version 1.2016: a. Cardiac Involvement i. Mean left ventricular wall thickness on echocardiogram greater than or equal to 12 mm in the absence of hypertension or valvular heart disease, OR N-terminal fragment brain natriuretic protein (NT-pro) brain natriuretic peptide (BNP) greater than 332 ng/mL provided that patient does not have impaired renal function (as defined by calculated creatinine clearance less than 25 mL/min) within 14 days prior to registration, OR prior cardiac biopsy (at time of diagnosis) showing amyloid deposition with past documented or presently noted clinical symptoms and signs supportive of a diagnosis of heart failure in the absence of an alternative explanation for heart failure. b. Non-Cardiac Organ Involvement i. Kidney: albuminuria greater than or equal to 500 mg per day on a 24-hour urine specimen within 35 days prior to registration, OR prior kidney biopsy (at the time of diagnosis) showing amyloid deposition. ii. Liver: hepatomegaly (total liver span \> 15 cm) as demonstrated by computed tomography (CT) or magnetic resonance imaging (MRI) within 35 days prior to registration OR alkaline phosphatase (ALP) greater than 1.5 times the institutional upper limit of normal within 14 days prior to registration, OR prior liver biopsy (at the time of diagnosis) showing amyloid deposition. iii. Gastrointestinal tract: direct biopsy verification with symptoms. iv. Lung: biopsy verifications with symptoms and interstitial radiographic pattern. v. Soft tissue: tongue enlargement, clinical, arthropathy, claudication, presumed vascular amyloid, skin involvement, carpal tunnel syndrome, myopathy by biopsy or pseudohypertrophy. 7. Patients must have completed other systemic therapy or investigational drug ≥ 28 days or five half-lives prior to registration, surgery (other than biopsies) ≥ 28 days prior to registration, and any autologous stem cell transplant (ASCT) ≥ 100 days prior to registration. 8. Patients must have a complete medical history and physical exam within 14 days prior to registration. 9. New York Heart Association (NYHA) Class 1 - 3a which has been clinically stable for 56 days before registration 10. Eastern Cooperative Oncology Group (ECOG) performance score 0, 1 or 2 11. Left ventricular ejection fraction (LVEF) by echocardiogram (ECHO) \> 35% within 28 days prior to registration. 12. Adequate organ system functions within 14 days of registration as defined by the laboratory assessments below: a) Hematologic i) Absolute neutrophil count (ANC): ≥1.0 × 10(9)/ L \* ii) Hemoglobin: ≥8.0 g/dL \* iii) Platelets: ≥50 × 10(9)/L \* b) Hepatic i) Total bilirubin: ≤1.5 × upper limit of normal (ULN); (Isolated bilirubin ≥1.5 × ULN is acceptable if bilirubin is fractionated, and direct bilirubin is \<35%) ii) Alanine aminotransferase (ALT): ≤2.5 × ULN c) Renal i) Estimated glomerular rate (eGFRª): ≥30 mL/min/1.73 m2 Note: Laboratory results obtained during Screening should be used to determine eligibility criteria. In situations where laboratory results are outside the permitted range, the investigator may re-test the participant and the subsequent within range screening result may be used to confirm eligibility. \* Without growth factor or cell transfusion support for the past 14 days prior to testing, excluding erythropoietin. ª As calculated by Modified Diet in Renal Disease (MDRD) formula (Appendix 4 in Protocol) 13. Females of childbearing potential: These participants must have a negative baseline pregnancy test using serum or urine within 14 days prior to starting therapy and a confirmatory negative serum pregnancy test with a sensitivity of at least 50 mIU/mL within 72 hours prior to registration; females of childbearing potential must also agree: (1) to have a pregnancy test prior to the start of each treatment cycle and (2) to either commit to continued abstinence from heterosexual intercourse or to use effective contraception while receiving study drug and for at least 4 months after receiving the last dose of study drug; females are considered to be of childbearing potential if they have had menses at any time in the preceding 24 consecutive months; in addition to routine contraceptive methods, effective contraception also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation; however, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, she is responsible for beginning contraceptive measures. 1. Is a woman of child bearing potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of \<1% per year), preferably with low user dependency (as described in Appendix 9), during the intervention period and for at least 4 months after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. 2. A WOCBP must have a negative serum pregnancy test (as required by local regulations) within 72 hours before the first dose of study intervention. 3. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with a nearly undetected pregnancy. 4. Non-childbearing potential is defined as follows (by other than medical reasons): i. ≥45 years of age and has not had menses for \>1 year. ii. Patients who have been amenorrhoeic for \<2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation. iii. Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure. 14\. Male participants are eligible to participate if they agree to the following during the intervention period and for 6 months after the last dose of study treatment to allow for clearance of any altered sperm: 1. Refrain from donating sperm Plus, either: 2. be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent Or 3. agree to use a barrier method of birth control (e.g., male condom), even if they have undergone a successful vasectomy, and female partner to use an additional highly effective contraceptive method with a failure rate of \<1% per year as when having sexual intercourse with a woman of childbearing potential (including pregnant females). 15\. Patients with Human Immunodeficiency Virus (HIV) infection are eligible if: a. patients without a history of Acquired Immune Deficiency Syndrome (AIDS)-defining opportunistic infections b. patients with a history of AIDS-defining opportunistic infection may be eligible if they have not had an opportunistic infection within past 12 months. c. Patients on active anti-retroviral therapy are eligible as long as anti-retroviral therapy is established for at least four weeks and have HIV viral load less than 400 copies/ml prior to enrollment. 16\. Patients with chronic Hepatitis B Virus (HBV) infection or chronic Hepatitis C Virus (HCV) infection or virologically suppressed on HCV treatment are eligible if: 1. Hepatitis B surface antigen (HBsAg)-negative, anti-Hemoglobin C (HBc)-positive patients are at lower risk of HBV reactivation compared with HBsAg-positive patients, risk of HBV reactivation should be considered in all patients and if patients can be on anti-HBV prophylaxis prior to initiation of anti-cancer therapy. 2. Patients with chronic HBV infection with active disease who meet the criteria for anti HBV therapy should be on a suppressive antiviral therapy prior to initiation of cancer therapy. 3. Patients actively on treatment for HCV should have HCV below the limit of quantification before initiation of anti-cancer therapy. 4. Patients who are HCV antibody (Ab) positive but HCV Ribonucleic Acid (RNA) negative due to prior treatment or natural resolution of infection are eligible. Exclusion Criteria: 1. Patients previously treated for active symptomatic multiple myeloma. 2. Any corneal disease except for mild epithelial punctate keratopathy. 3. Patients with known immediate or delayed hypersensitivity reaction or idiosyncratic reactions to belantamab mafodotin or drugs chemically related to belantamab mafodotin, or any of the components of the study treatment. 4. Patients eligible for autologous stem cell transplantation (ASCT). 5. Evidence of significant cardiovascular condition as specified below: 1. N-terminal-prohormone of brain natriuretic peptide (NT-proBNP) ≥ 8500ng/L within 14 days of registration. 2. New York Heart Association (NYHA) classification IIIB (3b) through IV (4) heart failure 3. Heart failure that in the opinion of the investigator is on the basis of ischemic heart disease (e.g., prior myocardial infarction with documented history of cardiac enzyme elevation and electrocardiogram (ECG) changes) or uncorrected valvular disease and not primarily due to AL amyloid cardiomyopathy 4. Unstable heart failure defined as emergency hospitalization for worsening, or decompensated heart failure, or syncopal episode within 1 month of screening 5. Subjects with a history of sustained ventricular tachycardia or aborted ventricular fibrillation or with a history of atrioventricular nodal or sinoatrial (SA) nodal dysfunction for which a pacemaker/implantable cardioverter-defibrillator (ICD) is indicated but not placed (Subjects who do have a pacemaker/ICD are allowed on study) 6. Interval from the Q wave on the ECG to point T using Fredericia's formula (QTcF) \> 500 msec. Subjects who have a pacemaker may be included regardless of calculated QTc interval 7. Symptomatic, clinically significant autonomic neuropathy which the Investigator feels will preclude administration of study treatment 8. Acute coronary syndrome, or any form of coronary revascularization procedure including coronary artery bypass grafting (CABG), within 6 months of screening 9. Prior solid organ transplant, or anticipated to undergo solid organ transplantation, or requiring left ventricular assist device (LVAD) implantation, during the course of the study 10. Stroke within 6 months of screening, or transient ischemic attack (TIA) within 3 months of screening 11. Evidence of current clinically significant uncontrolled arrhythmias, including clinically significant ECG abnormalities such as 2nd degree (Mobitz Type II) or 3rd degree atrioventricular (AV) block 12. History of myocardial infarction, acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting or bypass grafting within three (3) months of Screening 13. Uncontrolled hypertension 6. Prior history of malignancy with the exception of the following: adequately treated basal cell or squamous cell skin cancer, curatively treated non-melanoma skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least two years. 7. Presence of any comorbid or uncontrolled medical condition (e.g. uncontrolled hypertension) - defined as defined as an average SBP ≥ 160mm Hg or diastolic ≥ 100mm Hg despite optimal treatment) at screening, which in the opinion of the investigator would increase the potential risk to the subject. 8. Unwillingness or inability to follow the procedures outlined in the protocol. 9. Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks or five half-lives, whichever is shorter, before Cycle 1 Day 1. 10. Participant must not use contact lenses while participating in this study. 11. Participant must not have had major surgery ≤ 4 weeks prior to initiating study treatment. 12. Participant must not have any evidence of active mucosal or internal bleeding. 13. Participant must not have any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormalities) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures. 14. Participants must not be pregnant or lactating. 15. Participant must not be simultaneously enrolled in any interventional clinical trial. 16. Participant must not have an active infection requiring treatment. 17. Participant must not have current unstable liver or biliary disease defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice, or cirrhosis. Note: Stable non-cirrhotic chronic liver disease (including Gilbert's syndrome or asymptomatic gallstones) or hepatobiliary involvement of malignancy is acceptable if otherwise meets entry criteria.",NA,ALL,NA,"[{'measure': 'Safety/Tolerability as measured by number of subjects with dose limiting toxicity (Part 1)', 'description': 'Safety/Tolerability is measured by the number of participants treated with different dose level of belantamab mafodotin who experience dose limiting toxicity adverse events (AE) \\>= Grade 3, as defined by Common Terminology Criteria for Adverse Events by CTCAE v5.0 for Part 1.', 'timeFrame': 'Up to 24 weeks from Cycle 1 Day 1'}, {'measure': 'Safety/Tolerability at the recommended Phase II dose of Belantamab Mafodotin, as measured by number of subjects with dose limiting toxicity (Part 2)', 'description': 'Safety/Tolerability at the recommended Phase II dose of Belantamab Mafodotin is measured by the number of subjects who experience dose limiting toxicities (\\>= Grade 3, as defined by Common Terminology Criteria for Adverse Events by CTCAE v5.0) and cardiac and ocular AEs.', 'timeFrame': 'Up to 90 days after completing therapy'}]","[{'measure': 'Percentage of subjects with preliminary hematological responses associated with Belantamab mafodotin (Part 1)', 'description': 'Hematologic responses are assessed as the Overall Response Rate (ORR) which is the percentage of subjects with a confirmed partial response (PR) or better i.e. very good partial response (VGPR), complete hematological response (CHR). The criteria for : i) PR is - Baseline dFLC (difference between iFLC and uninvolved FLC) ≥ 50mg/L: A greater than 50% reduction in the dFLC, Baseline dFLC \\< 50 mg/L: ≥ 50% reduction in serum M-protein plus reduction in 24-hr urine M-protein by ≥ 90% or to \\<200 mg/24 hours ; ii) Very good partial response is - Baseline dFLC ≥ 50mg/L:Reduction in the dFLC\\<40mg/L, Baseline dFLC \\< 50 mg/L: ≥ 90% reduction in serum M-protein plus urine M-protein \\<100 mg/24 hours ; iii) CHR is - the normalization of free light chain (FLC) levels and ratio, negative serum and urine immunofixation (IFE)', 'timeFrame': 'Up to 2 years after the last dose'}, {'measure': 'Percentage of subjects with preliminary hematological responses associated with Belantamab mafodotin (Part 2)', 'description': 'Hematologic responses are assessed as the Overall Response Rate (ORR) which is the percentage of subjects with a confirmed partial response (PR) or better i.e. very good partial response (VGPR), complete hematological response (CHR). The criteria for : i) PR is - Baseline dFLC (difference between iFLC and uninvolved FLC) ≥ 50mg/L: A greater than 50% reduction in the dFLC, Baseline dFLC \\< 50 mg/L: ≥ 50% reduction in serum M-protein plus reduction in 24-hr urine M-protein by ≥ 90% or to \\<200 mg/24 hours ; ii) Very good partial response is - Baseline dFLC ≥ 50mg/L:Reduction in the dFLC\\<40mg/L, Baseline dFLC \\< 50 mg/L: ≥ 90% reduction in serum M-protein plus urine M-protein \\<100 mg/24 hours ; iii) CHR is - the normalization of free light chain (FLC) levels and ratio, negative serum and urine immunofixation (IFE)', 'timeFrame': 'Up to 2 years after the last dose'}, {'measure': 'Percentage of subjects with cardiac response associated with Belantamab mafodotin (Part 2)', 'description': 'Cardiac Response is assessed as Overall Cardiac Response Rate (OcRR) which is the percentage of participants with a confirmed plasma NT-proBNP reduction from baseline of ≥ 30% .', 'timeFrame': 'Up to 2 years after the last dose'}, {'measure': 'Percentage of subjects with non-cardiac organ response associated with Belantamab mafodotin (Part 2)', 'description': 'Non-Cardiac Organ Response (i.e. kidney and/or liver) assessed as: Organ response rate (OrRR) as defined as:\n\n1. Kidney: reduction in proteinuria by ≥ 30% from baseline; or, a reduction in proteinuria \\< 0.5g/24 hours without renal progression\n2. Liver: 50% decrease in abnormal alkaline phosphatase (ALP) from baseline', 'timeFrame': 'Up to 2 years after the last dose'}, {'measure': 'Percentage of participants with Complete Hematological Response (CHR) (Part 2)', 'description': 'Complete Hematological Response (CHR), defined as normalization of the free light chain levels and ratio, negative serum and urine immunofixation', 'timeFrame': 'Up to 2 years after the last dose'}, {'measure': 'Duration of Response (DoR) (Part 2)', 'description': 'Duration of Response (DoR), defined as the time from first documented evidence of PR or better until progressive disease (PD) or death due to PD among participants who achieve confirmed PR or better. Progressive disease is defined using this criteria.', 'timeFrame': 'From time of documented evidence of PR or better until PD or death due to PD in participants with confirmed PR or better, assessed up to 2 years after the last dose'}, {'measure': 'Time to Response (TTR) (Part 2)', 'description': 'Time to Response (TTR), defined as the time between the start of therapy and the first documented evidence of response (PR or better) among participants who achieve confirmed PR or better.', 'timeFrame': 'From time of start of therapy to the first documented evidence of response (PR or better), assessed up to 2 years after the last dose'}, {'measure': 'Time to Best Response (TTBR) (Part 2)', 'description': 'Time to Best Response (TTBR), defined as the time between the earliest date of achieving best response among participants with a confirmed PR or better.', 'timeFrame': 'From time of earliest date of best response with confirmed PR or better, assessed up to 2 years after the last dose'}, {'measure': 'Time to Progression (TTP) (Part 2)', 'description': 'Time to Progression (TTP), defined as the time from the start of therapy until the earliest date of documented hematological progression, or death due to hematologic progression, where hematologic progression is defined as one of the following: From complete hematological response (CHR), abnormal free light chain ratio (light chain ratio must double) or from CHR/VGPR/PR, 50% increase in serum M-protein to \\>0.5 g/dL or 50% increase in urine M-protein to \\>200 mg/day (a visible peak must be present) ; Involved Free light chain (iFLC) increase of 50% to \\>100 mg/L', 'timeFrame': 'From time of start of therapy to the earliest date of documented hematological progression or death due to hematological progression, up to 2 years after the last dose'}, {'measure': 'Duration of Cardiac Response (DocR) (Part 2)', 'description': 'Duration of Cardiac Response (DocR), defined as the time from first documented evidence of a 30% reduction, or better, in plasma NT-proBNP until cardiac progression as defined as a \\> 30% \\& \\> 300 ng/L increase in plasma NT-proBNP; Or, \\> 75% increase in high-sensitivity (hs) cardiac troponin-T (cTnT).', 'timeFrame': 'From time of first documented evidence of a 30% reduction, or better, in plasma NT-proBNP until cardiac progression, up to 2 years after the last dose'}, {'measure': 'Time to Cardiac Response (TTcR) (Part 2)', 'description': 'Time to Cardiac Response (TTcR), defined as the time between the date of starting treatment and the first documented evidence of plasma NT-proBNP cardiac response.', 'timeFrame': 'From date of starting treatment and the first documented evidence of plasma NT-proBNP cardiac response, up to 2 years after the last dose'}, {'measure': 'Time to Cardiac Progression (TTcP) (Part 2)', 'description': 'Time to Cardiac Progression (TTcP), defined as the time from the date of starting treatment until the earliest date of documented cardiac disease progression as defined above, or death due to progressive cardiac disease.', 'timeFrame': 'From date of starting treatment until the earliest date of documented cardiac disease progression or death due to progressive cardiac disease, up to 2 years after the last dose'}]" 96,NCT06300216,"{'fullName': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}",A Real-world Study of Octreotide Microspheres in Chinese Patients With Neuroendocrine Tumors,NOT_YET_RECRUITING,"The aim of this multicenter, open-label, observational study is to evaluate the safety and efficacy of octreotide microspheres in the treatment of advanced neuroendocrine tumors in real clinical practice, especially to evaluate the treatment of octreotide microspheres in various subgroups of neuroendocrine tumor patients.",['Neuroendocrine Tumors'],OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'DRUG', 'name': 'Octreotide microspheres', 'description': '20mg/30mg Q4W', 'armGroupLabels': ['Octreotide microspheres standard dose monotherapy']}]","Inclusion Criteria: 1. Sign an informed consent form and voluntarily participate in this study; 2. Patients with unresectable or metastatic neuroendocrine tumors confirmed by histopathology. Patients with recurrence and progression after surgery or local treatment can also be included in the study; 3. Age ≥ 18 years old; 4. Treatment with octreotide microspheres. Exclusion Criteria: 1. Confirmed pregnant or lactating women; 2. Participating in any research with intervention measures outside of routine clinical practice; 3. Other situations unsuitable for inclusion in the study determined by the researcher.",Patients with advanced neuroendocrine tumors treated with octreotide microspheres will be eligible to participate in the study.,ALL,PROBABILITY_SAMPLE,"[{'measure': 'Treatment Emergent Adverse Events', 'description': 'Treatment emergent adverse events were recorded according to Common Terminology Criteria for Adverse Events (version 5.0) of the National Cancer Institute that participants received at least one dose of protocol treatment.', 'timeFrame': 'up to 46 months'}]",NA 97,NCT04996316,"{'fullName': 'OHSU Knight Cancer Institute', 'class': 'OTHER'}",MammoScreen Breast Cancer Risk Assessment and Decision Aid for Breast Cancer Screening and Referrals,ENROLLING_BY_INVITATION,This study collects information to implement MammoScreen for Breast Cancer Screening and Referrals. MammoScreen is a risk assessment questionnaire that identifies individuals at average and increased risk for breast cancer and guides their screening decisions.,['Breast Carcinoma'],OBSERVATIONAL,"{'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'OTHER', 'name': 'Electronic Health Record Review', 'description': 'Health record reviewed', 'armGroupLabels': ['Clinical staff (interview, training, survey)', 'Patients (interview, MammoScreen)']}, {'type': 'OTHER', 'name': 'Interview', 'description': 'Participate in interview', 'armGroupLabels': ['Clinical staff (interview, training, survey)', 'Patients (interview, MammoScreen)']}, {'type': 'OTHER', 'name': 'Media Intervention', 'description': 'Use MammoScreen', 'armGroupLabels': ['Patients (interview, MammoScreen)']}, {'type': 'OTHER', 'name': 'Survey Administration', 'description': 'Complete survey', 'armGroupLabels': ['Clinical staff (interview, training, survey)']}, {'type': 'OTHER', 'name': 'Training and Education', 'description': 'Undergo training', 'armGroupLabels': ['Clinical staff (interview, training, survey)']}]","Inclusion Criteria: * Women between the ages of 40 and 74 * Enrolled in MyChart * Able to read English Exclusion Criteria: * Personal history of breast or ovarian cancer * Currently Pregnant * Currently in Hospice",Women between the ages of 40 and 74,FEMALE,NON_PROBABILITY_SAMPLE,"[{'measure': 'Uptake of MammoScreen', 'description': 'Defined as the proportion of women who enroll and use MammoScreen. Proportions of invitations for newly eligible women and uptake of MammoScreen during the maintenance period, overall and by clinical team, will be characterized along with 95% exact confidence intervals.', 'timeFrame': 'Up to 5 years'}, {'measure': 'Number of women with above-average risk for breast cancer identified by MammoScreen integrated with the electronic health record', 'timeFrame': 'Up to 5 years'}]","[{'measure': 'Rates of mammography screening referral', 'timeFrame': 'Up to 5 years'}, {'measure': 'Screening completed', 'description': 'The proportions of patients who open, and complete MammoScreen and 95% confidence intervals will be calculated. Demographic and clinical characteristics of patients who complete MammoScreen versus those who do not will be compared using a two-sample t-test or chi-square test as appropriate. Variation in completing MammoScreen by patient (e.g., age) and provider characteristics (e.g., panel size) will be explored.', 'timeFrame': 'Up to 5 years'}, {'measure': 'Mammography results', 'description': 'Will be stratified by risk category. Will be analyzed similarly using proportions and 95% confidence intervals, and a regression model if allowed by data.', 'timeFrame': 'Up to 5 years'}, {'measure': 'Number of above average risk MammoScreen users who received a genetic counseling referral', 'description': 'Will be analyzed similarly using proportions and 95% confidence intervals, and a regression model if allowed by data.', 'timeFrame': 'Up to 5 years'}, {'measure': 'Number of above average risk MammoScreen users who completed a genetic counseling visit', 'timeFrame': 'Up to 5 years'}, {'measure': 'Number of above average risk MammoScreen users who had a genetic test done', 'timeFrame': 'Up to 5 years'}]" 98,NCT02685306,"{'fullName': 'Peregrine Pharmaceuticals', 'class': 'INDUSTRY'}",A Study of Neoadjuvant Paclitaxel in Combination With Bavituximab in Early- Stage Triple- Negative Breast Cancer,WITHDRAWN,"The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug taxane, will improve the results of the treatment for early- stage Triple Negative Breast Cancer followed by Standard- of- Care surgery","['Breast Cancer', 'Triple Negative Breast Neoplasms', 'Triple-Negative Breast Neoplasm', 'Triple-Negative Breast Cancer', 'Triple Negative Breast Cancer', 'ER-Negative PR-Negative HER2-Negative Breast Neoplasms', 'ER-Negative PR-Negative HER2-Negative Breast Cancer']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'Bavituximab', 'description': '12 weekly doses of bavituximab given on Days 1, 8,15,22,29, 36, 43, 50, 57, 64, 71, 78', 'armGroupLabels': ['Bavituximab plus Taxane']}, {'type': 'DRUG', 'name': 'Taxane', 'description': '12 weekly doses of taxane on Days 1, 8,15,22,29, 36, 43, 50, 57, 64, 71, 78', 'armGroupLabels': ['Bavituximab plus Taxane', 'Taxane'], 'otherNames': ['Paclitaxel']}]","Inclusion Criteria: 1. Written informed consent has been obtained prior to screening. 2. Target Population 1. Female or male at least 18 years of age. 2. Invasive breast cancer confirmed by pathology evaluation of core biopsy. 3. Early-stage TNBC according to the American Joint Committee on Cancer (AJCC) Staging Manual Clinical Stage I (T1c, \> 1.5 cm), Stage II or Stage III invasive breast cancer. 4. Tumors must be ER/PgR status negative (IHC \< 1%) and lack of HER2/neu overexpression or amplification as measured by local hospital pathology laboratory (IHC +/- fluorescence in situ hybridization (FISH) and IHC \< 3+, and FISH \< 2.2) as described in the NCCN Guidelines. 5. Patient must consent to a minimum of 1 tumor-containing formalin fixed paraffin embedded core (or archival tissue) or baseline research biopsy. 3. Eastern Cooperative Oncology Group Performance Status 0 or 1. 4. Adequate hematologic function (absolute neutrophil count ≥ 1,500 cells/µL; hemoglobin \> 9 g/dL, platelets \> 100,000/µL.). 5. Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min using Cockcroft-Gault equation). 6. Adequate hepatic function: total bilirubin ≤ upper limit of normal (ULN), serum albumin ≥≥ 3.0 g/dL, alanine aminotransferase and aspartate aminotransferase ≤ 1.5 x ULN. 7. Prothrombin time and/or international normalized ratio (INR) ≤ 1.5 x ULN and activated partial thromboplastin time ≤ 1.5 x ULN, if patient is not on anticoagulant therapy. 8. Female patients must have a negative serum human chorionic gonadotropin test within 1 week of Day 1 (pregnancy test not required for patients with bilateral oophorectomy and/or hysterectomy or for those patients who are \> 1 year postmenopausal 9. Women of childbearing potential must avoid becoming pregnant and men must avoid fathering a child during and for 3 months after the end of study treatment. Exclusion Criteria: 1. Surgically unresectable, inflammatory, or metastatic breast cancer. 2. Any prior treatment for current breast cancer including chemotherapy, hormonal therapy, radiation, or other experimental therapy. 3. Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand disease or hemophilia). 4. Clinically significant bleeding, such as gross hematuria, gastrointestinal bleeding before screening (if clinically significant bleeding has occurred within 6 months of screening, but the cause has been identified and adequately treated \[e.g., cystitis, ulcer\], then this exclusion criterion does not apply. Minor biopsy-related bleeding lasting \< 24 hours and resolved at least 1 week before Day 1 is allowed. 5. Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or arterial thrombosis) occurring within 6 months before screening. 6. Uncontrolled intercurrent disease (e.g., diabetes, hypertension, thyroid disease, active infections). 7. Autoimmune disease requiring treatment with chronic systemic immunosuppressive therapy. Prior allotransplantation. 8. History of hypersensitivity to any of the excipients of paclitaxel (e.g., Cremaphor). 9. Has an active infection requiring systemic therapy. 10. Major surgery within 4 weeks prior to Day 1 11. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 12. Investigational therapy within 28 days prior to Day 1. 13. Is pregnant or breastfeeding, or expecting to conceive within the projected duration of the trial. 14. Has a known history of human immunodeficiency virus (HIV) (HIV1/2 antibodies) or active hepatitis B (e.g., HBsAg reactive) or hepatitis C (e.g., hepatitis C virus RNA \[qualitative\] is detected.",NA,ALL,NA,"[{'measure': 'Pathological Complete Response (pCR) rate of neoadjuvant paclitaxel in combination with bavituximab in patients with early- stage triple- negative breast cancer (TNBC)', 'timeFrame': 'Approximately 24 months'}]","[{'measure': 'Safety Measures - Adverse Events and Laboratory Evaluations', 'timeFrame': 'approximately 24 months'}]" 99,NCT06319404,"{'fullName': 'Shanxi Province Cancer Hospital', 'class': 'OTHER'}",Immune Function of Colorectal Cancer Lymph Nodes,UNKNOWN,"Lymph nodes are very important immune organs in the human body and play an important role in the physiological and pathological activities of the body, especially in anti-tumor immunity. The role of regional draining lymph nodes in the development of colorectal cancer is still unknown. In this study, the role of lymph nodes in the development of colorectal cancer was investigated through multicenter and multi-omics data.","['Colorectal Cancer', 'Lymph Node']",OBSERVATIONAL,"{'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'OTHER', 'armGroupLabels': ['negative lymph node', 'postive lymph node']}]","Inclusion Criteria: * Stage I-III colorectal cancer patients undergoing radical surgery * Complete imaging, pathology and genetics multi-omics data available * 18-75 years old Exclusion Criteria: * Patients with preoperative neoadjuvant therapy * Patients with incomplete clinical information * Patients with other malignant tumors * Patients with acute infections or untreated chronic infections","Stage I-III colorectal cancer patients undergoing radical surgery with complete clinical imaging, pathology, and genetic data.",ALL,PROBABILITY_SAMPLE,"[{'measure': 'To investigate the difference of immune pathway activation in tumor-draining lymph node based on genomics', 'description': 'BULK-RNA sequencing was performed on tumor draining lymph nodes to detect the activation of immune pathways in lymph nodes and explore the differences between them', 'timeFrame': '2024.04-2026.04'}, {'measure': 'To investigate the relationship between the type and number of immune cells in tumor draining lymph nodes and the activation of immune pathways is based on pathomics', 'description': 'Multiple immunohistochemistry was used to identify the type and number of immune cells and to explore the relationship between the activation state of immune pathways', 'timeFrame': '2024.04-2026.04'}, {'measure': 'The immune function of tumor draining lymph nodes of colorectal cancer patients was previously identified based on radiomics', 'description': 'Preoperative imaging data (CT, MRI) of patients were collected, and information in the images was extracted based on artificial intelligence algorithms. Predictive models were constructed to identify patients with good or bad immune function before surgery and guide subsequent treatment', 'timeFrame': '2024.04-2026.04'}]",NA 100,NCT05353504,"{'fullName': 'Max Planck Institute for Human Cognitive and Brain Sciences', 'class': 'OTHER'}",Impact of Microbiome-changing Interventions on Food Decision-making,RECRUITING,"The investigators aim to test the hypothesis that a microbiome-changing dietary intervention improves food decision-making and to determine the underlying microbiotal and metabolic mechanisms. To this end, 90 overweight/obese adults will be enrolled in a randomized controlled trial to test the effects of a pre-biotic dietary intervention (supplementary intake of soluble fibre) or a behavioural lifestyle intervention (weekly educational program) vs. control condititon (supplementary intake of isocaloric starch) over a period of 26 weeks. Before and after the intervention/control period, participants will undergo task-based functional and structural MRI and cognitive testing. The gut microbiota will be assessed using 16S rDNA next-generation sequencing (V3/V4 region) in stool samples. Diet, anthropometry and lifestyle will be monitored with questionnaires and metabolomics will be assayed in peripheral blood and stool (e.g. SCFA). Using a modulation of gut-brain communication through a prebiotic diet and lifestyle intervention, respectively, the investigators will be able to discover microbiota communities that play a key role for eating behaviour. Related mechanistic insights could help to develop novel preventive and therapeutic options to combat unhealthy weight gain in our obesogenic society.",['Overweight and Obesity'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'People will be randomly assigned to the three arms and blinded towards receipt of dietary fibre supplement or placebo supplement. However, behavioural lifestyle intervention arm cannot be blinded to participants.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}","[{'type': 'DIETARY_SUPPLEMENT', 'name': 'Inulin', 'description': '28g/day delivered in 2 sachets throughout the day with main meals', 'armGroupLabels': ['prebiotic dietary supplement']}, {'type': 'BEHAVIORAL', 'name': 'Lifestyle intervention', 'description': ""weekly educational sessions to improve individual's eating behaviour"", 'armGroupLabels': ['behavioural lifestyle intervention']}, {'type': 'DIETARY_SUPPLEMENT', 'name': 'Placebo', 'description': 'equicaloric maltodextrin delivered in 2 sachets throughout the day with main meals', 'armGroupLabels': ['placebo dietary supplement']}]","Inclusion Criteria: * BMI \>= 25 kg/m2 or WHR \>= 0.9/0.85 (m/d, f) * no MRI contra-indication * written informed consent Exclusion Criteria: * athletes * occurrence of a clinically relevant psychiatric disease in the last 12 months, e.g. depression, substance abuse, eating disorders, schizophrenia * any chronic inflammatory or malignant disease * type 1 diabetes * previous bariatric/gastric surgery * pregnancy or breastfeeding woman",NA,ALL,NA,"[{'measure': 'blood-oxygenation-level-dependent (BOLD) activity during food wanting', 'description': 'BOLD-acitvity will be measured using event-related echo-planar T2\\*-weighted magnetic resonance imaging (MRI) during food wanting task according to previously described procedures (details of preprocessing at: https://osf.io/ynkxw). Onsets of food and art stimuli presentation will be modelled as separate regressors convolving delta functions with a canonical hemodynamic response function. Wanting rating scores (on an 8-point likert scale) per stimulus will be added as covariates. In a parallel model, kcal of food stimuli will be added multiplied with wanting scores to model high caloric food wanting interaction. At the group level, we will assess the contrasts food \\> art and wanting modulation.', 'timeFrame': '6 months'}]","[{'measure': 'microbial alpha and beta diversity', 'description': 'Changes in alpha and beta diversity assessed using 16S rRNA sequencing of stool samples', 'timeFrame': '6 months'}, {'measure': 'fMRI BOLD activity memory performance', 'description': 'BOLD-acitvity will be measured using event-related echo-planar T2\\*-weighted magnetic resonance imaging (MRI) during food wanting and food memory recognition tasks according to previously described procedures (details of preprocessing at: https://osf.io/ynkxw). Onsets of food and art stimuli presentation in encoding and recognition will be modelled as separate regressors convolving delta functions with a canonical hemodynamic response function. Correctly remembered and correctly rejected, as well as misses and false alarms will be modeled separately. In parallel models, similar and new items als well as wanting rating scores (on an 8-point likert scale) per stimulus and kcal of food stimuli multiplied with wanting scores will be added as covariates. At the group level, we will assess the contrasts correct \\> false and wanting modulation.', 'timeFrame': '6 months'}, {'measure': 'satiety', 'description': 'self-reported hunger feeling on a 8-point score from minimum 0 (not at all) to maximum 8 (very much).', 'timeFrame': '6 months'}, {'measure': 'ghrelin', 'description': 'ghrelin pg/ml in blood', 'timeFrame': '6 months'}, {'measure': 'leptin', 'description': 'leptin ng/ml in blood', 'timeFrame': '6 months'}, {'measure': 'GLP-1', 'description': 'Glucagon-like peptide-1 (GLP-1) pg/ml in blood', 'timeFrame': '6 months'}, {'measure': 'PYY', 'description': 'peptide YY pg/ml in blood', 'timeFrame': '6 months'}, {'measure': 'insulin', 'description': 'insulin in blood uU/ml', 'timeFrame': '6 months'}, {'measure': 'HbA1c', 'description': 'hemoglycated globulin A1c in blood %', 'timeFrame': '6 months'}, {'measure': 'inflammatory markers', 'description': 'high sensitive C-reactive protein mg/l (and optionally tumor necrosis factor alpha and interleukin 6 in blood, pg/ml)', 'timeFrame': '6 months'}, {'measure': 'microbial metabolic markers in blood', 'description': 'short-chain fatty acids (SCFA), bile acids', 'timeFrame': '6 months'}, {'measure': 'body mass index', 'description': 'weight kg/height in m squared', 'timeFrame': '6 months'}, {'measure': 'waist hip ratio', 'description': 'waist (cm) to hip (cm) circumeference ratio', 'timeFrame': '6 months'}, {'measure': 'body fat', 'description': 'body fat % according to bioelectrical impedance analysis', 'timeFrame': '6 months'}, {'measure': 'food craving', 'description': 'assessed with the food craving questionnaire (Meule et al., 2012, German version).', 'timeFrame': '6 months'}, {'measure': 'executive attention performance', 'description': 'measured using the attention network task (ANT)', 'timeFrame': '6 months'}]" 101,NCT04483804,"{'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}",Application of Radiomics in Breast Cancer,RECRUITING,"Little is known about the correlation between ultrasound characteristics (conventional, elastography and contrast enhanced ultrasound (CEUS) )and pathological prognostic factors in breast cancer. The aim of this study was to explore the correlation between ultrasound characteristics and pathological prognostic factors using radiomics.","['Breast Cancer', 'Ultrasound', 'Elastography', 'Pathology', 'Radiomics']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'COMBINATION_PRODUCT', 'name': 'Endocrine therapy', 'description': 'Endocrine therapy', 'armGroupLabels': ['disease free survival', 'non-disease free survival']}]","Inclusion Criteria: Clinical diagnosis of breast cancer Exclusion Criteria: Missing pathology Missing follow-up results Missing data",patients with breast cancer,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'metastasis', 'description': 'lymph node metastasis and/or distant metastasis', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'death', 'description': 'death', 'timeFrame': 'through study completion, an average of 1 year'}]",NA 102,NCT06896552,"{'fullName': 'Rabin Medical Center', 'class': 'OTHER'}","Single-Center Trial on Ketogenic Diet and Immunotherapy in Advanced Cancer This Study Evaluates the Safety and Effects of a Ketogenic Diet (KD) Combined With Immunotherapy in Adults With Advanced Melanoma, cSCC, or RCC.",NOT_YET_RECRUITING,"This clinical trial aims to evaluate whether a ketogenic diet (KD), when combined with immunotherapy, can improve immune function and treatment outcomes in patients with advanced melanoma, cutaneous squamous cell carcinoma (cSCC), or renal cell carcinoma (RCC). Why Is This Study Important? Immunotherapy is a promising cancer treatment, but not all patients respond well. Research suggests that diet, particularly a high-fat, low-carbohydrate ketogenic diet, may help boost the immune system and make treatments more effective. What Will This Study Examine? Researchers want to understand: Is the ketogenic diet well-tolerated for cancer patients? Does the diet improve immune responses and treatment effectiveness? How Will the Study Work? Participants will be placed into one of two groups: Ketogenic Diet (KD) Group: A structured high-fat, low-carb diet (intermittent schedule: 2 weeks on, 1 week off). Standard Diet (SD) Group: A typical diet with no major changes. Throughout the study, a dietitian will closely support and guide you. Both groups will continue their standard immunotherapy treatment. What Will Participants Do? Write their food intake three times a week to help assess dietary adherence Follow their assigned diet for 10 weeks Have weekly check-ins with a dietitian (in-person at the hospital or via phone) Have weekly blood glucose and ketone level checks using a home device. Provide monthly blood samples to measure immune response during routine immunotherapy infusions Provide stool samples for gut microbiome analysis at the start and end of the study Measure Monthly Weight, body composition, and resting calorie burn Complete quality-of-life questionnaires What Are the Potential Benefits? Improved response to immunotherapy Better understanding of how diet influences cancer treatment Potential for a new supportive strategy for cancer care This study may help uncover ways to enhance cancer treatment through personalized nutrition.","['Cancer', 'Immunotherapy', 'Ketogenic Diet']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Single-center, open-label, prospective, non-randomized, controlled, sequential two-arm clinical trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DIETARY_SUPPLEMENT', 'name': 'Ketogenic diet', 'description': ""Ketogenic Diet as an Adjunct to Immunotherapy: Unlike many trials focused on chemotherapy or targeted therapies, this study specifically investigates the synergistic effects of the ketogenic diet with immune checkpoint inhibitors (ICIs), a promising approach for enhancing immunotherapy efficacy. The diet's high-fat, low-carbohydrate regimen is designed to shift metabolism towards ketone bodies and fatty acid utilization, potentially modulating immune responses and tumor immunogenicity in a way that standard diets do not."", 'armGroupLabels': ['Ketogenic Diet (KD) Group: A high-fat, low-carb diet (intermittent schedule: 2 weeks on,1 week off))']}]","Inclusion Criteria: * • Males and females, age \>= 18 years * Patients with a histologically confirmed melanoma or cSCC or RCC receiving first line treatment with combination nivolumab and ipilimumab /relatlimab or single agent ipilimumab, nivolumab, pembrolizumab, Cemiplimab. * Able to read, understand, and provide written informed consent * Willing and able to complete all study-specific procedures and visits * Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤2. * Blood tests: * Creatinine (Cr) \< 1.5 mg/dL. * Magnesium normal range ( 1.5 -2,6 mg/dL) * Liver function tests (LFTs) 2.5x upper limit of normal (ULN). * Neutrophils ≥ 1,000/mm3, platelets ≥ 50,000/mm3, Hb\>8 g/dL * Women of childbearing potential must have a negative β-HCG pregnancy test documented within 1 week of registration. Exclusion Criteria: * • Individuals \< 18 years of age * Unable or unwilling to provide consent * Other active malignancy (other than adequately treated and cured basal or squamous cell skin cancer, curatively treated in situ disease, or any other cancer from which the patient has been disease free \>=2 years) * Currently consuming a low-carbohydrate (\< 130 g/day) or KD or done so in the last 6-months * Patients currently participating in an interventional or therapeutic clinical trial involving the use of active anti-cancer therapy. * Active autoimmune diseases requiring active Immune suppressive medications * Systemic steroid therapy, excluding for replacement due to adrenal insufficiency * Major surgery within last 3 months * BMI \<18 or \>35 * Medical contraindications to the intervention diet as determined by the treating physician. * Self-reported major dietary restrictions related to the intervention such as irritable bowel syndrome (IBS). * Patients with a history or active eating disorder * Uncontrolled Diabetes mellitus or patients receiving insulin * Known diagnosis of HIV * Known active hepatitis B or hepatitis C * Known inborn errors of lipid metabolism * Sever or uncontrolled Hyperlipidemia (total cholesterol over 400 mg / dL, low-density lipoprotein (LDL) above 300 mg / dL, triglycerides over 500 mg / dl.). * Pregnant or lactating. * Patients who have undergone a transplant",NA,ALL,NA,"[{'measure': 'Number of Participants Adhering to the Ketogenic Diet and Experiencing Treatment-Related Adverse Events as Assessed by CTCAE v5.0', 'description': 'This measure will assess the feasibility and tolerability of the ketogenic diet (KD) in cancer patients undergoing immunotherapy by evaluating:\n\nDiet Adherence: The number of participants who maintain KD for at least 80% of the study duration, based on dietary intake logs and ketone level measurements.\n\nTolerability: The number of participants experiencing treatment-related adverse events (AEs), as assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. The severity and frequency of AEs will be documented and categorized.', 'timeFrame': 'From enrollment to the end of treatment at 10 weeks'}, {'measure': 'Change in Peripheral Blood Mononuclear Cell (PBMC) Composition at Baseline, During, and Post-Intervention', 'description': 'This measure will evaluate changes in immune cell composition in response to the ketogenic diet (KD) and immunotherapy.\n\nPBMC Composition: Assessed using cytometry by time-of-flight (CyTOF) to characterize shifts in immune cell subsets (e.g., T cells, natural killer cells, monocytes).\n\nData Analysis: Changes from the baseline will be reported as absolute values and fold-changes over time.', 'timeFrame': 'Monthly (week 0, 4, 10 ±1 week).'}, {'measure': 'Serum Cytokine Levels at Baseline, During, and Post-Intervention', 'description': 'This measure will evaluate changes in cytokine levels in response to the ketogenic diet (KD) and immunotherapy.\n\nSerum Cytokine Levels: Quantified using multiplex immunoassays to measure the concentrations of key cytokines, such as IL-2, IFN-γ, TNF-α, and IL-10.\n\nData Analysis: Changes from baseline will be reported as absolute values and fold-changes over time.', 'timeFrame': 'Monthly (week 0, 4, 10 ±1 week).'}]","[{'measure': 'Overall response rate according to RECIST v1.', 'timeFrame': 'End of treatment at 10 weeks'}, {'measure': 'Adherence to Dietary Interventions - Ketone Level Measurements', 'description': 'Ketone Level Measurements: Ketone levels will be measured to assess whether participants are in a state of ketosis (\\>0.3 Mm), indicating adherence to the ketogenic diet.\n\nData Analysis: Ketone levels will be analyzed to determine adherence to the ketogenic diet.', 'timeFrame': 'Weekly from Baseline (Week 0) to Week 10'}, {'measure': 'Change in Body Weight (kg) Over the Study Period', 'description': 'Body weight (in kilograms) will be measured using a calibrated digital scale at specified time points. Changes from baseline will be reported as absolute weight differences and percentage change', 'timeFrame': 'Baseline (Week 0), Week 4, Week 10, and Week 14 (±1 week).'}, {'measure': 'Change in Quality of Life Score Assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)', 'description': ""Quality of life will be assessed using the EORTC QLQ-C30 questionnaire, a validated tool for measuring cancer patients' health-related quality of life.\n\nThe EORTC QLQ-C30 consists of 30 items, evaluating functional scales (physical, role, emotional, cognitive, and social functions), symptom scales (fatigue, pain, nausea/vomiting, etc.), and global health status.\n\nScores range from 0 to 100. Higher scores on functional and global health scales indicate better quality of life.\n\nHigher scores on symptom scales indicate greater symptom burden (worse outcome).\n\nChanges from baseline to Week 10 will be reported as mean score differences."", 'timeFrame': 'At enrollment (Baseline, Week 0) and at the end of treatment (Week 10).'}, {'measure': 'Fecal microbiome', 'description': 'Such as, but not limited to, 16S analysis', 'timeFrame': 'At enrollment (baseline) and at the end of treatment at 10 weeks'}, {'measure': 'Sarcopenia', 'description': 'Assessed using CT scans of the axial L3 sections and customized software', 'timeFrame': 'At enrollment (baseline) and at the end of treatment at 10 weeks'}, {'measure': 'Body composition-- Fat Mass and Lean Mass', 'description': 'This measure will assess changes in body composition using bioelectrical impedance analysis (BIA).\n\nFat Mass(kg) and Lean Mass (kg): Body composition will be assessed using Bioelectrical Impedance Analysis (BIA) to measure fat mass(kg) and lean mass(kg).\n\nData Analysis: Changes in fat mass and lean mass will be reported as absolute values and fold-changes over time.', 'timeFrame': 'Monthly (week 0, 4, 10 ±1 week).'}, {'measure': 'Resting Energy Expenditure (REE)', 'description': 'Measured by indirect calorimeter - Q-NRG', 'timeFrame': 'Monthly (week 0, 4, 10 ±1 week).'}, {'measure': 'The Rate of immune-related adverse events', 'timeFrame': 'From enrollment to the end of treatment at 10 weeks'}]" 103,NCT03515252,"{'fullName': 'Ivy Life Sciences, Co., Ltd', 'class': 'INDUSTRY'}",Study of Autologous Immune Killer Cells in Patients With Late Stage Hepatocellular Carcinoma or Lung Cancer,COMPLETED,This is a phase I clinical study. Blood is drawn from the patient and brought to our laboratory for isolation of immune cells. These immune cells are then proliferated over a two week period and used to produce our patented product IKC (Immune Killer Cells). The IKC will then infused back into the patient to treat the cancer. Each patient will receive a total of six infusions.,"['NSCLC Stage IIIB', 'NSCLC Stage IV', 'Hepatocellular Carcinoma by BCLC Stage', 'Lung Cancer', 'Liver Cancer']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'Immune Killer Cells (IKC)', 'armGroupLabels': ['Late stage lung cancer and liver cancer']}]","Inclusion Criteria: 1. subjects had voluntarily given written informed consent 2. subjects had CT scan on lung or liver tumors within the past 4 weeks of the screening visit 3. subjects who were histologically or pathologically confirmed with locally advanced or metastatic lung cancer or HCC 4. subjects who did not have valid therapy, ever failed with other therapy, or refused or were not appropriate for other therapies for lung cancer or HCC 5. subjects' ECOG performance status ≤ 2 6. subjects with life expectancy ≥ 3 months Exclusion Criteria: 1. subjects with medical history of gout 2. subjects who had participated other clinical trials within 4 weeks before the screening visit 3. subjects with positive result of HIV or HTLV test within 4 weeks before the screening visit 4. subjects with clinically significant diseases other than cancer 5. subjects with myocardial infraction, stroke, or congestive heart failure within 3 months before the screening visit 6. female subjects who were pregnant or lactating or women of child-bearing potential but unable to take adequate contraception 7. subjects with history of alcohol, drug or other substance abuse 8. subjects with disease of bacteremia",NA,ALL,NA,"[{'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety]', 'description': 'Adverse Events (AE) and Serious Adverse Events (SAE) will be recorded and evaluated for their relationship to the treatment', 'timeFrame': '5 months'}]","[{'measure': 'Response Evaluation Criteria in Solid Tumors (RECIST)', 'description': 'Record net changes of tumor sizes', 'timeFrame': '4 months'}, {'measure': 'Quality of Life (QOL)', 'description': ""The assessment will be performed using The World Heath Organization Quality of Life Questionnaire (WHOQOL)\n\nThis questionnaire produces a quality of life profile. It is possible to derive four domain scores. The four domain scores denote an individual's perception of quality of life in each particular domain (1. Physical health 2. Psychological 3. Social relationships 4. Environmental) Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life).\n\nThe mean score of items within each domain is used to calculate the domain score (min: 0 max: 100)\n\nDomain scores are then calculated (divide domain score by 4) to produce a final QOL Score (i.e. higher scores denote higher quality of life min: 0 max:100)."", 'timeFrame': '5 months'}]" 104,NCT04974047,"{'fullName': 'BeOne Medicines', 'class': 'INDUSTRY'}",Study of Tislelizumab in Participants With Resectable Esophageal Squamous Cell Carcinoma,COMPLETED,The purpose of this study is to evaluate the pathological complete response (pCR) in participants receiving tislelizumab plus chemotherapy/chemoradiotherapy as neoadjuvant treatment.,['Resectable Esophageal Squamous Cell Carcinoma'],INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Tislelizumab', 'description': 'Administered intravenously on Day 1 of each 21-Day Cycle.', 'armGroupLabels': ['Cohort A (Responder)', 'Cohort B (Non-responder)'], 'otherNames': ['BGB-A317']}, {'type': 'DRUG', 'name': 'Paclitaxel', 'description': '135 mg/m\\^2 administered intravenously on Day 1 of each 21-Day Cycle.', 'armGroupLabels': ['Cohort A (Responder)', 'Cohort B (Non-responder)']}, {'type': 'DRUG', 'name': 'Cisplatin', 'description': '80 mg/m\\^2 administered intravenously on Day 1 of each 21-Day Cycle.', 'armGroupLabels': ['Cohort A (Responder)', 'Cohort B (Non-responder)']}, {'type': 'DRUG', 'name': '5-fluorouracil', 'description': '1000 mg/m\\^2 administered intravenously over Day 1 through 4 of each 21-Day Cycle.', 'armGroupLabels': ['Cohort B (Non-responder)']}, {'type': 'RADIATION', 'name': 'Radiotherapy', 'description': '40 grays/20 fractions', 'armGroupLabels': ['Cohort B (Non-responder)']}, {'type': 'PROCEDURE', 'name': 'Surgical resection', 'description': 'Performed as indicated in the treatment arm.', 'armGroupLabels': ['Cohort A (Responder)', 'Cohort B (Non-responder)']}]","Key Inclusion Criteria: * Eastern Cooperative Oncology Group Performance Status of 0 or 1. * Histologically confirmed esophageal squamous cell carcinoma (ESCC). * Stage cT1-2N+M0 and cT3NanyM0 (per The American Joint Committee on Cancer 8th Edition). * Evaluation by the investigator to confirm eligibility for an R0 resection with curative intent. * Adequate hematologic and organ function, defined by protocol-specified laboratory test results obtained within 14 days before first dose. Key Exclusion Criteria: * Ineligible for treatment with any of the chemotherapy doublets of protocol-specified chemotherapy. * Any prior therapy for current ESCC, including investigational agents, chemotherapy, radiotherapy, targeted therapy agents, or prior therapy with an anti-programmed cell death protein-1, anti-programmed cell death protein ligand-1, anti-programmed cell death protein ligand-2, or any other antibody or drug specifically targeting T-Cell co-stimulation or checkpoint pathways. * History of fistula due to primary tumor invasion. * Participants with high risk of fistula or sign of perforation evaluated by investigator. * Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before first dose. \* Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent) and topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption, and short course (≤ 7 days) of corticosteroid prescribed prophylactically or for the treatment of a non-autoimmune condition are permitted. * Active autoimmune diseases or history of autoimmune diseases that may relapse. \* Controlled Type I diabetes, hypothyroidism only requiring hormone replacement, controlled celiac disease, skin diseases (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. * History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases. * With infections requiring systemic antibacterial, antifungal, or antiviral therapy, including tuberculosis infection. * Severe infections within 4 weeks before first dose, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia. * Receive therapeutic oral or intravenous antibiotics within 2 weeks before first dose. Note: Other protocol defined Inclusion/Exclusion criteria may apply.",NA,ALL,NA,"[{'measure': 'Pathological Complete Response (pCR) Rate', 'description': 'The pCR rate was defined as the percentage of participants with absence of residual tumor in the resected primary tumor and all resected lymph nodes after completion of neoadjuvant treatment. pCR rates were assessed by a pathologist at each site.', 'timeFrame': 'pCR was determined from samples taken during surgery; surgery occurred 4-6 weeks after the last dose of chemotherapy, approximately Day 71-86'}]","[{'measure': 'R0 Resection Rate', 'description': 'Defined as the percentage of participants with R0 resection. R0 resection refers to a surgical procedure where the entire tumor is completely removed with no evidence of residual cancer tissue at the surgical margins.', 'timeFrame': 'Resection was planned to occur 4-6 weeks after the last dose of chemotherapy, approximately Day 71-86'}, {'measure': '1-year/3-year Disease-free Survival (DFS) Rate', 'description': 'The DFS rate is defined as the percentage of participants free from disease events at 1 year and 3 years after the first date of no disease (R0 resection as surgery outcome). Disease events include local or distant recurrence or death due to any cause. The DFS rate was analyzed only for participants who underwent R0 resection. Disease-free rates were estimated using the Kaplan-Meier method with 95% confidence intervals estimated using the Greenwood formula.', 'timeFrame': '1 year and 3 years after surgery'}, {'measure': '1-year/3-year Event-free Survival (EFS) Rate', 'description': 'The EFS rate is defined as the percentage of participants free from EFS events at 1 year and 3 years after the first dose. The EFS events include progression of disease that precludes definitive surgery, local or distant recurrence, or death due to any cause. Event-free rates were estimated using the Kaplan-Meier method with 95% confidence intervals estimated using the Greenwood formula.', 'timeFrame': '1 year and 3 years after first dose date'}, {'measure': 'Objective Response Rate (ORR)', 'description': 'The ORR is defined as the percentage of participants who have a complete response or partial response before surgery as assessed by the investigator per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) in all participants with measurable disease at baseline. Tumor response was assessed by computed tomography (CT) or magnetic resonance imaging (MRI) of the neck, chest, and abdomen.\n\nComplete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \\< 10 mm.\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.', 'timeFrame': 'ORR was assessed prior to surgery, Day 71 to 86'}, {'measure': 'Number Of Participants Experiencing Treatment-Emergent Adverse Events', 'description': 'Immune-mediated AEs were reported until 90 days after the last dose of tislelizumab', 'timeFrame': 'From the first dose of study drug up to 30 days after last dose of any component of treatment or surgery or the initiation of subsequent anticancer therapy, whichever occurred first. Up to approximately 9 months.'}]" 105,NCT02955758,"{'fullName': 'Stanford University', 'class': 'OTHER'}",Pembrolizumab in Patients With Metastatic Non-squamous Non-small Cell Lung Cancer,COMPLETED,"This phase II trial studies how well pembrolizumab works in treating patients with non-squamous non-small cell lung cancer which has spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.",['Metastatic Non-Squamous Non-Small Cell Lung Carcinoma'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'Pembrolizumab', 'description': 'Given IV, 200mg fixed dose, every 3 weeks', 'armGroupLabels': ['Treatment (pembrolizumab)'], 'otherNames': ['Keytruda', 'Lambrolizumab', 'MK-3475', 'SCH 900475']}]","Inclusion Criteria: 1. Has a pathologically proven recurrent or metastatic non squamous non small cell lung cancer 2. (a) Previously received at least one line of prior systemic therapy for metastatic disease. i. If the patient has a sensitizing EGFR mutation or ALK rearrangement, the patient must have received at least one prior targeted therapy for metastatic disease (ie, EGFR TKI therapy or ALK TKI therapy, respectively). ii. There is no limit on prior therapies allowed. Patients must have completed previous treatment (including other investigational therapy) in greater than or equal to the following times prior to initiation of trial treatment: 1. Anti cancer monoclonal antibody (mAb) therapy must be completed ≥ 3 weeks prior to trial treatment 2. Chemotherapy administered in a daily or weekly schedule must be completed ≥ 1 week prior to trial treatment 3. Chemotherapy administered in an every 2 week schedule must be completed ≥ 2 weeks prior to trial treatment 4. Chemotherapy administered in an every 3 week schedule must be completed ≥ 3 weeks prior to trial treatment 5. Targeted small molecule therapy must be completed ≥ 1 week prior to trial treatment OR (b) Have not received prior systemic therapy for their cancer in recurrent or metastatic setting, AND have a tumor with Tumor Proportion Score (TPS) ≥ 50% as measured by 22C3 PD L1 IHC test, AND no evidence of a sensitizing EGFR mutation or ALK rearrangement. 3. Prior radiation therapy allowed as long as completed in the following times prior to initiation of trial treatment: 1. Definitive curative intent radiation ≥ 3 weeks prior to trial treatment 2. Palliative body radiation ≥ 1 week prior to trial treatment 3. Stereotactic brain radiation ≥ 1 week prior to trial treatment 4. Whole brain radiation ≥ 2 weeks prior to trial treatment 4. Patients with previously treated (with radiation or surgery) brain metastases that are stable are allowed. Patients with stable or progressing metastases must have metastases ≤ 1.5 cm, be asymptomatic, and either not be on steroids or be on 10 mg prednisone equivalent or less. 5. Has measurable disease based on RECIST v1.1 criteria 6. Is medically able and willing to undergo needle biopsy of a tumor lesion. PD L1 expression is not required to enroll in the trial. 7. Has life expectancy ≥ 3 months 8. Ability to understand and the willingness to sign a written informed consent document. 9. ≥ 18 years of age on day of signing informed consent 10. ECOG performance status of 0 or 1 (Appendix A) 11. Adequate organ function: 1. Absolute neutrophil count (ANC) ≥ 1,000/mcL 2. Platelets ≥ 75,000/mcL 3. Hemoglobin ≥ 8 g/dL 4. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance ≥ 50 mL/min for patient with creatinine levels \> 1.5 x institutional ULN 5. Serum total bilirubin ≤ 1.5 x ULN OR Direct bilirubin ≤ ULN for patients with total bilirubin levels \> 1.5 ULN 6. AST (SGOT) and ALT (SGPT) ≤ 3 x ULN OR ≤ 5 x ULN for patients with liver metastases 12. Female patients of childbearing potential must have a negative urine or serum pregnancy test prior to the first dose of trial treatment. They must also agree to two barrier methods or a barrier method plus a hormonal method, or agree to abstain from heterosexual activity, for the course of the study through 120 days after the last dose of trial treatment. Females who have been surgically sterilized or are free from menses for \> 1 year (postmenopausal) may enroll. 13. Male patients with a female partner of childbearing potential should agree to use a barrier method of contraception, or agree to abstain from heterosexual activity for the course of the study through 120 days after the last dose of trial treatment. Exclusion Criteria: 1. Is currently receiving another investigational therapy 2. Has received prior anti PD 1 or anti PD L1 therapy 3. Has clinically significant toxicities from previous anti cancer therapy that have not resolved, or have not stabilized at a new baseline 4. Has undergone a surgical procedure involving general anesthesia within 2 weeks of starting trial treatment, or has inadequate healing or recovery from complications of surgery prior to starting trial treatment. This does not apply to low risk procedures such as thoracentesis; paracentesis; chest tube/PleurX catheter placement; line placement; needle biopsy of tumor; and bronchoscopy. 5. Is receiving high dose systemic steroid therapy within 3 days of trial treatment. Topical and intraarticular steroid injections are allowed, as are physiologic doses of systemic steroids (≤ 10 mg of prednisone equivalent daily). 6. Has carcinomatous meningitis as determined by positive CSF cytology 7. Has known active additional malignancy that is undergoing active treatment. 8. Has active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, supra physiologic doses of systemic corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin; or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Asthma; type I diabetes mellitus; hypothyroidism; and vitiligo are allowed. 9. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator. This includes known active tuberculosis; Grade 3 active infection; history of allogeneic bone marrow transplant or solid organ transplant; known history of Human Immunodeficiency Virus (HIV); known active Hepatitis B (eg, Hep B DNA positive in prior 3 months) or known active Hepatitis C (eg, HCV RNA \[qualitative\] is detected in prior 3 months). 10. Known active interstitial lung disease, or current (non infectious) pneumonitis or history of (non infectious) pneumonitis that required oral steroids. 11. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting",NA,ALL,NA,"[{'measure': 'Correlation of Tumor-informed CAPP-Seq ctDNA Analysis With Radiologic Tumor Assessments', 'description': 'Circulating tumor DNA (ctDNA) levels will be measured using Cancer personalized profiling by deep sequencing (CAPP Seq) with radiographic tumor assessments using RECIST v1.1 criteria in patients with metastatic NSCLC treated with pembrolizumab. ctDNA will be measured as percentage of total circulating free DNA. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.', 'timeFrame': 'Up to 2 years'}]","[{'measure': 'Overall Response Rate (ORR)', 'description': 'Overall Response Rate (ORR) defined as proportion of complete responses + partial responses will be measured using RECIST v1.1 criteria', 'timeFrame': 'Up to 2 years'}, {'measure': 'PFS Measured Using RECIST v1.1 Criteria', 'description': 'Progression-free survival (PFS) will be measured from the time of first treatment with pembrolizumab to the time of radiographic progression, unequivocal clinical progression, or death from any cause, whichever comes earlier', 'timeFrame': 'From the time of first treatment with pembrolizumab to the time of progression or death from any cause, whichever comes earlier, assessed up to 2 years'}, {'measure': 'Overall Survival (OS)', 'description': 'Overall Survival of all treated participants', 'timeFrame': 'From the time of first treatment with pembrolizumab to the time of death, assessed up to 3 years'}, {'measure': 'Incidence of Adverse Events Graded According to Common Terminology Criteria for Adverse Events Version 4.03', 'timeFrame': 'Up to 2 years'}]" 106,NCT01923948,"{'fullName': 'Eastern Hepatobiliary Surgery Hospital', 'class': 'OTHER'}",Preoperative Pain Control in Liver Surgery Patients,COMPLETED,"Pregabalin 150mg or placebo are administered 1 hour preoperatively in patients undergoing partial hepatectomy. Postoperatively, patients receive morphine as rescue analgesic. Morphine consumption in the first 48 hours is documented. Postoperative pain is measured by the visual analogue scale (VAS) score.","['Pain, Postoperative', 'Hepatocellular Carcinoma']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}","[{'type': 'DRUG', 'name': 'Pregabalin', 'description': 'One 150 mg oral dose of Pregabalin given before surgery', 'armGroupLabels': ['Pregabalin'], 'otherNames': ['Lyrica']}, {'type': 'DRUG', 'name': 'Placebo (for Pregabalin)', 'description': 'One oral dose of placebo given before surgery', 'armGroupLabels': ['Sugar Pill'], 'otherNames': ['Sugar pill manufactured to mimic Pregabalin 150 mg tablet']}]","Inclusion Criteria: * patients undergoing partial hepatectomy Exclusion Criteria: * contraindication against pregabalin * creatinine \> 2.0 mg/dl * GGT \>165, AST \>105, ALT \>135 * peptic Ulcus * haemorrhagic diathesis * angina pectoris, myocardial infarction * stroke * bronchial asthma * opioid abuse",NA,ALL,NA,"[{'measure': 'Postoperative Opioid Consumption', 'timeFrame': '48 hours'}]","[{'measure': 'Postoperative Pain Scores on the Visual Analog Scale', 'timeFrame': '24 hours'}]" 107,NCT01819285,"{'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}",Early Compared With Delayed Hormone Therapy in Treating Patients With Nonmetastatic Prostate Cancer,COMPLETED,"Objectives I. Compare, in a randomized Phase III multi-institutional setting, symptom-free survival time of patients with asymptomatic carcinoma of the prostate (T0-4, N0-2, M0) not suited for local curative treatment who are randomly assigned to immediate vs. delayed endocrine intervention (orchiectomy or luteinizing hormone releasing hormone (LHRH) agonist therapy). II. Compare the overall survival of these two groups of patients. III. Compare the time to first evidence of distant progression (N4 or M1) of these two treatment groups. IV. Evaluate the prognostic significance of pretreatment laboratory data and monitor these parameters following endocrine therapy. V. Study the prognosis of various sub-groups of patients stratified according to performance status, local tumor extent, nodal status, and choice of endocrine treatment.","['Neoplasm, Prostate']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'PROCEDURE', 'name': 'Immediate Orchiectomy or depot LHRH', 'armGroupLabels': ['Immediate Endocrine Therapy']}, {'type': 'PROCEDURE', 'name': 'Delayed Orchiectomy or depot LHRH', 'armGroupLabels': ['Delayed Endocrine Therapy']}]","Inclusion Criteria: * Histologically or cytologically proven, newly diagnosed asymptomatic (with the exception of voiding disturbances) carcinoma of the prostate T0-4 N0-2 M0 which is not suitable for local treatment with curative intent (radical prostatectomy, radiation therapy). * All T stages are acceptable (UICC 1982). The stage is determined by rectal palpation. * Patients with regional lymph node metastases smaller than 5 cm (N0-2), determined either by CT or ultrasonography, preferable with cytologic confirmation. * Life expectancy of at least six months. * WHO performance status score 0-1. * Informed consent. Patients must be prepared to undergo an orchiectomy or continuous treatment with a depot LHRH analogue. * Continuous follow-up until death if possible. Exclusion Criteria: * Other malignancies diagnosed during the last 10 years, apart from treated basal cell carcinoma of the skin. * Prostate cancer known for longer than one month before entering the study. * Pain caused by the prostate cancer or its metastases. * Any previous treatment for prostate cancer (radical prostatectomy, radiation therapy, endocrine treatment, etc.) Note: TUR-P for voiding disturbances is allowed at any time and is not an exclusion criterion. * Patients with ureteric obstruction caused by local infiltration of prostatic cancer and other evidence of locally advanced disease which could cause fatal complications if untreated (e.g. rectal stenosis, thrombosis of pelvic veins). * Patients with palpable or juxtaregional lymph node metastasis (paraaortic, supraclavicular, inguinal, N3-4). * Patients with evidence of distant metastases (bone, lung, liver). * Age over 80 years. Performance status WHO score 2, 3 and 4 (any reason). * Patient who refuses orchiectomy or longterm subcutaneous implants of LHRH analogue in two monthly intervals. Expected difficulties with follow-up for any reason.",NA,MALE,NA,"[{'measure': 'Overall survival', 'timeFrame': '13 years from first patient in'}]","[{'measure': 'Overall symptom free survival time', 'timeFrame': '13 years from first patient in'}, {'measure': 'Time until first evidence of distant progression', 'timeFrame': '13 years from first patient in'}, {'measure': 'Prognostic importance of pretreatment laboratory data', 'description': 'prostate cancer mortality and overall mortality according to pretreatment laboratory data', 'timeFrame': '13 years from first patient in'}, {'measure': 'Prognosis of particular sub-groups', 'description': 'prostate cancer mortality and overall mortality according to particular sub-groups (following stratification factors): performance status (0 vs 1), the local tumor extent (T0-2 vs T3-4), nodal status (N0 vs N1-2), the choice of hormonal therapy.', 'timeFrame': '13 years from first patient in'}]" 108,NCT04205955,"{'fullName': 'SWOG Cancer Research Network', 'class': 'NETWORK'}",Testing Diet Intervention Versus Non-Diet Intervention for Management of Bowel Symptoms in Rectal Cancer Survivors,COMPLETED,"This phase II trial studies how a diet intervention works in improving bowel dysfunction symptoms related in colon or rectal cancer survivors. Changing a diet may be helpful in reducing the severity of bowel symptoms, including diarrhea and constipation, and improve quality of life in colon or rectal cancer survivors and help doctors learn how to help patients better in the future.","['Rectal Carcinoma', 'Rectosigmoid Carcinoma']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}","[{'type': 'OTHER', 'name': 'Best Practice', 'description': 'Receive healthy living education via phone call', 'armGroupLabels': ['Arm II (standard of care, motivational messages)'], 'otherNames': ['standard of care', 'standard therapy']}, {'type': 'DIETARY_SUPPLEMENT', 'name': 'Dietary Intervention', 'description': 'Receive diet modification coaching via phone call', 'armGroupLabels': ['Arm I (diet modification coaching, motivational messages)'], 'otherNames': ['Dietary Modification', 'intervention, dietary', 'Nutrition Intervention', 'Nutrition Interventions', 'Nutritional Interventions']}, {'type': 'OTHER', 'name': 'Message', 'description': 'Receive motivational messages via email and/or text message', 'armGroupLabels': ['Arm I (diet modification coaching, motivational messages)', 'Arm II (standard of care, motivational messages)']}, {'type': 'OTHER', 'name': 'Quality-of-Life Assessment', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (diet modification coaching, motivational messages)', 'Arm II (standard of care, motivational messages)'], 'otherNames': ['Quality of Life Assessment']}, {'type': 'OTHER', 'name': 'Questionnaire Administration', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (diet modification coaching, motivational messages)', 'Arm II (standard of care, motivational messages)']}]","Inclusion Criteria: * PRIOR TO STEP 1 REGISTRATION: * Patients must have prior history of rectosigmoid colon cancer or rectal cancer * Patients must have a post-surgical permanent ostomy or anastomosis * Patient's last date of treatment for rectal cancer (any surgery, chemotherapy, radiation therapy) must be at least 6 months prior to registration and not more than 24 months prior to registration * Anastomosis patients must have low anterior resection syndrome (LARS) score of 21-42 (minor to major symptoms) within 5 calendar days prior to registration * Patient must have completed all baseline questionnaires within 5 days prior to registration * Patients must be able to read, write and speak English. Study materials and telephone calls are only available in English * Patients with a prior malignancy or concurrent malignancy that is currently not being treated, whose natural history or treatment (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Patients who are currently undergoing treatment for another cancer will have a different symptom profile than what this study is targeting and are not eligible * Patients who have been diagnosed with inflammatory bowel disease (IBD), such as ulcerative colitis or Crohn's disease, are not eligible * PRIOR TO STEP 2 REGISTRATION: * Patient must meet all eligibility criteria for step 1 * Patient must have successfully completed (""pass"") the run-in period, as per email notification from the University of Arizona * Patient must be registered to step 2 no more than 40 days after step 1 registration. If day 40 falls on a weekend or holiday, the limit may be extended to the next working day * Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines * As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system",NA,ALL,NA,"[{'measure': 'Bowel Function', 'description': 'Will be measured by the Memorial Sloan-Kettering Cancer Center Bowel Function Instrument (BFI) total score. Score range 18-90. Higher scores indicate better bowel function. Will be conducted according to a modified intention-to-treat principle. Study arm differences in BFI at 18 weeks will be assessed by a linear regression model as a function of randomization assignment, BFI baseline value, and stratification factors.', 'timeFrame': 'At 18 weeks after randomization'}]",NA 109,NCT03186326,"{'fullName': 'Federation Francophone de Cancerologie Digestive', 'class': 'OTHER'}",Standard Chemotherapy vs Immunotherapie in 2nd Line Treatment of MSI Colorectal Mestastatic Cancer,COMPLETED,"Immune chekpoints (ICI) are evaluated in many digestive cancers. Certain types of cancer appear to be rather refractory to ICI such as colorectal cancers (CRC). However, the MSI CRC representing approximately 15% of the CRCs exhibits a high mutational load which generates many potentially immunogenic neoantigens. In addition, strong expression of PD-L1 was found in the MSI CRCs relative to the CRC (MSS) stages. Localized MSI CRCs have a better prognosis than MSS CRCs, probably due to immunogenic neoantigens associated with a CD8 + T-specific immune response. On the oher hand, in metastatic CRC (mCRC) things are different because i) the MSI frequency is only 4 to 7% and ii) the good prognosis conferred by the MSI status is controversial. Preliminary results suggest that patients with MSI mCRC are highly sensitive to ICI even chemoresistant tumors receiving several lines of chemotherapy. Recently, another anti-PD1 alone or in combination with an anti-CTLA4 (antigen associated with cytotoxic T-lymphocyte 4) was tested in the MSI CRCs and a selection of interesting results in heavily pretreated patients with a disease control rate of 56% for monotherapy and 81% for combinated therapy. Anti-PD1s now have marketing authorization for patients with melanoma and metastatic pulmonary carcinoma , Which are known to have a high level of mutations . ICIs appear to be as promising in MSI CRCs as in other tumors and therefore face the same major challenges. Avalumab is an anti-PD-L1 antibody recently tested in several different types of tumors with promising results and is currently being studied in phase III in gastric cancer. There is no data on the effectiveness of this ICI in the MSI mCRCs. In addition, only anti-PD1 was used in the MSI-mCRC and not the anti-PD-L1, and only in chemoresistance (3rd line or more). The main objective of the SAMCO study is to test the efficacy and tolerance of avelumab in the 2nd line of treatment in patients with a MSI mCRC progression after standard 1st line chemotherapy +/- targeted therapy.","['Metastatic Colorectal Cancer', 'MSI']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'FOLFOX regimen', 'description': 'A course of treatment every 14 days\n\nOxaliplatin: 85 mg/m² IV over 2 hours Folinic acid: 400 mg/m² (or 200 mg/m² if Elvorine) IV over 2 hours 5FU bolus: 400 mg/m² IV bolus over 10 minutes in 100 ml 0.9% NaCl 5FU continuous: 2,400 mg/m² in NaCl 0.9% in IV over 46 hours', 'armGroupLabels': ['Arm A Chemotherapy (standard treatment)']}, {'type': 'DRUG', 'name': 'FOLFIRI Protocol', 'description': 'A course of treatment every 14 days\n\nIrinotecan: 180 mg/m² IV over 1H30 Folinic acid: 400 mg/m² (or 200 mg/m² if Elvorine) IV over 2 hours 5FU bolus: 400 mg/m² IV bolus over 10 minutes in 100 ml 0.9% NaCl 5FU continuous: 2,400 mg/m² in NaCl 0.9% in IV over 46 hours', 'armGroupLabels': ['Arm A Chemotherapy (standard treatment)']}, {'type': 'DRUG', 'name': 'Avelumab', 'description': 'A course of treatment every 14 days. Premedication obligatory with antihistamines and paracetamol (example: 25-50 mg diphenhydramine and 500-650 mg paracetamol) IV, approximately 30 to 60 minutes before each dose of avelumab.\n\nThen:\n\nAvelumab: 10 mg/kg IV in 1 hour diluted with 0.9% saline solution; alternatively a 0.45% saline solution can be used if needed', 'armGroupLabels': ['Arm B - Immunotherapy (experimental arm)']}, {'type': 'DRUG', 'name': 'Panitumumab', 'description': 'Administered at 6 mg/Kg', 'armGroupLabels': ['Arm A Chemotherapy (standard treatment)']}, {'type': 'DRUG', 'name': 'Cetuximab', 'description': 'Administered at 500 mg/m²', 'armGroupLabels': ['Arm A Chemotherapy (standard treatment)']}, {'type': 'DRUG', 'name': 'Bevacizumab', 'description': 'Administered at 5 mg/Kg', 'armGroupLabels': ['Arm A Chemotherapy (standard treatment)']}, {'type': 'DRUG', 'name': 'Aflibercept', 'description': 'Administered at 4 mg/Kg', 'armGroupLabels': ['Arm A Chemotherapy (standard treatment)']}]","Inclusion Criteria: * Histologically proven colorectal adenocarcinoma with metastasis(es) non-resectable * MSI-H determined by immunohistochemistry (loss of expression of MLH1, MSH2, MSH6 and/or PMS2) or by molecular biology * At least one measurable target (primary tumor or metastasis) according to RECIST v1.1 * Mutational status RAS and BRAF * Age ≥ 18 * OMS ≤ 2 * Life expectancy \< 3 months * Patient failure (progression or unacceptable toxicity) of chemotherapy containing fluoropyrimidine (capecitabine or 5FU) +/- irinotecan +/- oxaliplatin with or without cetuximab, bevacizumab and panitumumab (patients in progression during or within 3 months after discontinuation of adjuvant chemotherapy are eligible) * PNN \> 1500/mm3, platelets \> 100 000/mm3, Hb \> 9 g/dL * Total bilirubin \< 25 µmol/L, ASAT \< 5x LSN, ALAT \< 5 x LSN, PT \> 60%, , PAL\<2.5 x LSN ( \< 5 x LSN in case of hepatic metastasis) * Creatinine clearance \> 50 ml/min according to MDRD formula (≥ 30 ml/min according to the Cockcroft-Gault formula) * Patient belonging to a social security scheme * Patient information and signature of the informed consent Exclusion Criteria: * Patient immediately eligible for a curative therapy (surgical and/or percutaneous) after discussion in CPR * Patient treated with FOLFIRINOX or FOLFOXIRI in 1st line * Cerebral metastasis * Previous treatment with anti-PD1 or anti-PDL1 * Autoimmune disease that might be aggravated during treatment with an immuno-stimulating agent (patients with type I diabetes, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible) * Immunosuppressive long-term treatment (patients necessitating a corticotherapy are eligible if they are administered in doses \< or = to the equivalent of 10 mg of prednisone daily, administration of steroids by a route resulting in minimal systemic exposure (local, intra-anal, intraocular or inhalation) are eligible). * Transplant patients (including stem cell transplants), HIV positive or other immune deficiency syndromes * Active infection by HBV or HCV * Known severe hypersensitivity to monoclonal antibodies or history of anaphylactic shock, or uncontrolled asthma * Any known specific contraindication or allergy to the treatments used in the study * Persistence of toxicities related to 1st line chemotherapy grade \> 2 (NCI-CTC v4.0) (except alopecia and neuropathy sequelae of oxaliplatin) * Vaccination during the 4 weeks preceding the start of treatment * Known deficit in DPD * QT/QTc interval \> 450 msec for men and \> 470 msec for women * K+ \< LIN, Mg2+ \< LIN, Ca2+ \< LIN * Following alterations in the 6 months prior to inclusion: myocardial infarction, angina, severe/unstable angina, coronary artery bypass surgery, congestive heart failure NYHA class II, III or IV, stroke or transient ischemic attack * Any progressive pathology not stabilised over the past 6 months: hepatic failure, renal failure, respiratory failure * Patient with interstitial pneumonitis or pulmonary fibrosis * History of chronic diarrhea or inflammatory disease of the colon or rectum, or unresolved occlusion or sub-occlusion in symptomatic treatment * History of malignant pathologies during the past 5 years except basocellular skin carcinoma or in situ cervical carcinoma, properly treated * Patient already included in another clinical trial during treatment with an experimental molecule for L2 * Lack of effective contraception in patients (men and/or women) of childbearing age, pregnant or breastfeeding women, women of childbearing age not having had a pregnancy test * Persons deprived of liberty or under supervision * Impossibility of undergoing medical monitoring during the trial for geographic, social or psychological reasons",NA,ALL,NA,"[{'measure': 'Progression-free survival (PFS) according to the investigator', 'description': 'Progression is defined as RECIST v1.1 criteria. Death is also considered as an event', 'timeFrame': 'up to 12 months'}]","[{'measure': 'Overall Survival', 'description': 'Defined as death due to all causes', 'timeFrame': 'up to 60 months'}]" 110,NCT01342978,"{'fullName': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}",Human Papillomavirus (HPV) Oral Transmission Study in Partners Over Time,COMPLETED,This research is being done to understand more about a sexually transmitted virus called Human papillomavirus (HPV) in people with oropharyngeal cancer and their partners.,"['Oropharyngeal Cancer', 'Human Papillomavirus']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}",NA,"Inclusion Criteria: * 18 years or older and incident oropharyngeal cancer Exclusion Criteria: * Presence of medical or psychiatric condition affecting ability to give voluntary, informed consent * Cancer patients with a history of organ transplant, autoimmune disorder treated with steroids or immunosuppressive drug, lymphoma, leukemia or bone marrow transplant are also ineligible (partners with these conditions are eligible)",cohort of cancer patients with matched enrollment of spouses and non-cancer controls,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'HPV DNA detection in oral rinse sample', 'description': 'Detection of 17 types of HPV DNA in exfoliated oral cells of cases and partners collected using an oral rinse and gargle', 'timeFrame': 'baseline'}]",NA 111,NCT06892743,"{'fullName': 'Cairo University', 'class': 'OTHER'}",Analgesic Efficacy of Ultrasound-guided External Oblique Intercostal Plane Block Versus Posterior Transversus Abdominis Plane Block in Patients Undergoing Open Nephrectomy,RECRUITING,"Renal cell carcinoma (RCC) accounts for 2-3% of all cancers and is a common malignancy of the genitourinary tract. Open nephrectomy, performed through midline, subcostal, or flank incisions, remains a standard treatment but often results in significant postoperative pain, leading to respiratory muscle dysfunction, increased pulmonary complications, and prolonged hospital stays. Acute surgical pain arises from inflammatory responses, activation of spinal pain pathways, and muscle spasms. While postoperative pain typically improves during recovery, some patients develop chronic postsurgical pain (CPSP), lasting at least two months postoperatively. Opioids and epidural analgesia are commonly used for pain control, but their side effects and invasiveness necessitate safer, effective alternatives. Ultrasound (US)-guided peripheral nerve and field blocks have become integral to multimodal analgesia. One such technique, the \*\*external oblique intercostal plane block (EOIPB)\*\*, was introduced as a modification of fascial plane blocks, targeting anterior and lateral cutaneous nerves (T6-T10). EOIPB offers advantages over quadratus lumborum block (QLB) and erector spinae plane block (ESPB) by being performed in the supine position and providing superior midline analgesia compared to serratus intercostal plane block (SIPB). Similarly, the transversus abdominis plane (TAP) block, particularly the posterior approach, delivers analgesia from T7 to T12 by anesthetizing anterior and lateral cutaneous nerve branches. While case series suggest EOIPB may be effective for post-nephrectomy pain, comparative studies between EOIPB and posterior TAP block in open nephrectomy: Aim of the Study: To evaluate the postoperative analgesic effects of posterior transversus abdominis plane (TAP) block and external oblique intercostal plane block (EOIPB) in patients undergoing open nephrectomy under general anesthesia.",['Postoperative Pain'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}}","[{'type': 'PROCEDURE', 'name': 'US-guided external oblique intercostal plane block (EOIPB)', 'description': 'US Guided external oblique intercostal plane block (EOIPB) or Posterior TAP Block:', 'armGroupLabels': ['EOIPB-Group', 'Posterior TAP - Group'], 'otherNames': ['US Guided Posterior TAP Block:']}]","Inclusion Criteria: * Patients whom diagnosed as having renal carcinoma and scheduled for open nephrectomy under general anesthesia. * ASA class II- III. * Age ≥ 18 and ≤ 70 years. * Body mass index (BMI) less than 40kg/m2. Exclusion Criteria: 1. Patient refusal. 2. Hepatic and renal insufficiency. 3. Unstable cardiovascular or pulmonary disease. 4. History of psychiatric and cognitive disorders. 5. Patients with known sensitivity or contraindications to the drug used. 6. Patients on regular opioid consumption.",NA,ALL,NA,"[{'measure': 'Postoperative morphine consumption (mg) in the first 24 hrs .', 'timeFrame': 'Time elapsed from the end of the block procedure till the end of the 24 hours postoperatively'}]",NA 112,NCT05487235,"{'fullName': 'Genentech, Inc.', 'class': 'INDUSTRY'}","A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-1971 in Combination With Atezolizumab in Participants With Locally Advanced or Metastatic Solid Tumors",COMPLETED,"The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of GDC-1971 when administered in combination with atezolizumab in participants with locally advanced or metastatic solid tumors. The study will have 2 stages- dose finding stage and expansion stage. In expansion stage participants with non-small cell lung cancer programmed death ligand -1 high (NSCLC PD L-1 high), NSCLC PD L-1 low, head and neck squamous cell carcinoma (HNSCC) PD L-1 positive, BRAF wild type (BRAF WT) melanoma and any locally advanced or metastatic solid tumors will be enrolled.","['Advanced Solid Tumors', 'Metastatic Solid Tumors']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'GDC-1971', 'description': 'Capsule or tablet administered orally.', 'armGroupLabels': ['Dose-finding Stage: GDC-1971', 'Expansion Stage: GDC-1971'], 'otherNames': ['RO7517834, RLY-1971']}, {'type': 'DRUG', 'name': 'Atezolizumab', 'description': 'Administered as IV infusion.', 'armGroupLabels': ['Dose-finding Stage: GDC-1971', 'Expansion Stage: GDC-1971'], 'otherNames': ['RO5541267']}, {'type': 'DRUG', 'name': 'Omeprazole', 'description': 'Administered orally as tablet or capsule in the acid-reducing agent assessment.', 'armGroupLabels': ['Expansion Stage: GDC-1971']}]","Inclusion Criteria: * Has Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1 * Has Life expectancy \>= 12 weeks * Adequate organ function * Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). Inclusion Criteria for Dose-Finding Stage: * Histologically confirmed locally advanced or metastatic solid tumor that has progressed after at least one available standard therapy or for which approved standard therapy has proven to be ineffective or intolerable Inclusion Criteria for Expansion Stage: NSCLC Cohort * Histologically confirmed locally advanced or metastatic NSCLC * Absence of epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) * PD- L1 positive * No prior systemic therapy for locally advanced or metastatic NSCLC Inclusion Criteria for Expansion Stage: HNSCC Cohort * Histologically confirmed recurrent, or metastatic HNSCC * PD-L1 positive * No prior systemic therapy for recurrent or metastatic HNSCC Inclusion Criteria for Expansion Stage: BRAF WT melanoma Cohort * Histologically confirmed locally advanced or metastatic or unresectable locally advanced cutaneous BRAF WT melanoma or melanomas of unknown primary that are non-mucosal and non -uveal that has progressed on or after treatment that included anti PD1 or anti PD-L1 therapy Inclusion Criteria for Expansion Stage: Other Advanced or Metastatic Solid Tumors Cohort * Histologically confirmed locally advanced or metastatic solid tumor that has progressed after at least one available standard therapy or for which approved standard therapy has proven to be ineffective or intolerable, standard therapy is considered inappropriate, or an investigational agent is a recognized standard of care Exclusion Criteria: * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. * Has leptomeningeal disease or carcinomatous meningitis * Has uncontrolled hypertension * Has left ventricular ejection fraction \< institutional lower limit of normal or \< 50% * Has clinically significant history of liver disease including viral or other hepatitis, current alcohol abuse, or cirrhosis * Has an active or history of autoimmune disease or immune deficiency including myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or multiple sclerosis. Participants with a history of autoimmune- related hypothyroidism on thyroid replacement hormone or with controlled Type I diabetes mellitus on a stable dose of an insulin regimen are eligible for this study",NA,ALL,NA,"[{'measure': 'Percentage of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'Percentage of Participants With Clinically Significant Change From Baseline in Vital Signs', 'timeFrame': 'Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years)'}, {'measure': 'Percentage of Participants With Clinically Significant Change from Baseline in Clinical Laboratory Test Results', 'timeFrame': 'Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years)'}, {'measure': 'Percentage of Participants With Clinically Significant Change From Baseline in RR and QT Intervals as Measured by Electrocardiogram (ECG)', 'timeFrame': 'Baseline up to 30 days after final dose of study treatment (up approximately to 2.5 years)'}, {'measure': 'Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs)', 'timeFrame': 'From Day 1 to Day 21 of Cycle 1 of the dose finding stage'}, {'measure': 'Plasma Concentration of GDC-1971', 'timeFrame': 'Up to approximately 2.5 years'}]","[{'measure': 'Area Under the Concentration-Time Curve From Time 0 to 96 hours (AUC0-96 hr) Following GDC-1971 Capsule or Tablet Administration', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'AUC From Time 0 to Infinity (AUCinf) Following GDC-1971 Capsule or Tablet Administration', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'Cmax of GDC-1971 Following Capsule or Tablet Administration', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'AUC 0-96 hr Following GDC-1971 Tablet Administration Under Fasted and Fed Conditions', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'AUC inf Following GDC-1971 Tablet Administration Under Fasted and Fed Conditions', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'Cmax of GDC-1971 Following Tablet Administration Under Fasted and Fed Conditions', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'AUC 0-24 hr at Steady State Following GDC-1971 Tablet Administration and in Combination With Omeprazole', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'Cmax at Steady State Following GDC-1971 Tablet Administration and in Combination With Omeprazole', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Up to approximately 2.5 years'}, {'measure': 'PFS Rate', 'timeFrame': 'Month 6'}, {'measure': 'Overall Survival (OS) Rate', 'timeFrame': 'Months 6 and 12'}]" 113,NCT06805630,"{'fullName': 'Duke University', 'class': 'OTHER'}",Urine Methylation Markers in UTUC,RECRUITING,"This is a research study to measure DNA markers in the urine of patients with upper tract urothelial cancer (UTUC) before surgery and during follow-up visits. Identifying these DNA markers could improve diagnosis before surgery, help assess risk, and predict early recurrence of the cancer. Urine samples will be de-identified and sent to Pangea Laboratory LLC for analysis. The results of this test will be compared to the traditional tests in upper tract urothelial cancer, such as cells in the urine and tissue biopsy.",['Upper Tract Urothelial Cancer'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DIAGNOSTIC_TEST', 'name': 'Bladder CARE™', 'description': 'Urine methylation biomarker test', 'armGroupLabels': ['Patients with primary UTUC (upper tract urothelial carcinoma)']}]","Inclusion Criteria: * \>=18 years * Primary UTUC Exclusion Criteria: * Patients who do not understand and/or are unwilling to sign a written informed consent",NA,ALL,NA,"[{'measure': 'Methylation level of urothelial-specific biomarker TRNA-Cys', 'timeFrame': 'Baseline, 3 months, 6 months'}, {'measure': 'Methylation level of urothelial-specific biomarker SIM2', 'timeFrame': 'Baseline, 3 months, 6 months'}, {'measure': 'Methylation level of urothelial-specific biomarker NKX1-1', 'timeFrame': 'Baseline, 3 months, 6 months'}]",NA 114,NCT06090630,"{'fullName': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}",MR Correlated Spectroscopic Imaging for Diagnosing Breast Cancer,COMPLETED,"This trial studies how well an imaging technique called magnetic resonance (MR) spectroscopic imaging works in identifying breast cancer in women with benign or suspicious areas in the breast. Magnetic resonance imaging (MRI) is a diagnostic tool used to investigate the location of tumors in different organs. Since radiological pictures do not have sufficient information for tumor grades, invasive procedure such as biopsy is performed on patients with breast cancers for diagnosis. Breast tissue contains water, fat, and chemicals known as metabolites. MR spectroscopic imaging may help to characterize the various breast metabolite steady state levels and identify the differences between necrosis and tumor recurrence, which is difficult using radiological procedures such as MRI.","['Benign Breast Neoplasm', 'Breast Carcinoma', 'Malignant Breast Neoplasm']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'PROCEDURE', 'name': 'Diffusion Weighted Imaging', 'description': 'Undergo DWI-MRI', 'armGroupLabels': ['Diagnostic (DWI, magnetic resonance spectroscopic imaging)'], 'otherNames': ['Diffusion Weighted MRI', 'Diffusion-Weighted Magnetic Resonance Imaging', 'Diffusion-Weighted MR Imaging', 'Diffusion-Weighted MRI', 'DW-MRI', 'DWI', 'DWI MRI', 'DWI-MRI', 'MR Diffusion-Weighted Imaging']}, {'type': 'PROCEDURE', 'name': 'Magnetic Resonance Spectroscopic Imaging', 'description': 'Undergo MR spectroscopic imaging', 'armGroupLabels': ['Diagnostic (DWI, magnetic resonance spectroscopic imaging)'], 'otherNames': ['1H- Nuclear Magnetic Resonance Spectroscopic Imaging', '1H-nuclear magnetic resonance spectroscopic imaging', 'Magnetic Resonance Spectroscopy', 'MRS', 'MRS Imaging', 'MRSI', 'MS', 'Proton Magnetic Resonance Spectroscopic Imaging']}]","Inclusion Criteria: * Malignant tumor subjects must have malignant needle biopsy results with concordant imaging and pathological findings. * Benign tumor subjects must have benign needle biopsy results. Benign subjects will only include those with concordant benign imaging and pathological findings. * Control subjects: healthy and have no previous history of any type of cancers. * The women should be able to read and understand English. Hence, non-English speaking subjects will be excluded. However, if there will be a necessity of translating the written informed consent form in the subject's mother tongue (such as Hispanic, Chinese, Persian, Indian, etc.), the translated consent form will be submitted for expedited approval to the office of University of California, Los Angeles (UCLA) Institutional Review Board (IRB). Exclusion Criteria: * Pregnant women will be excluded. * Breast feeding women. * MR incompatible items: cardiac pacemaker, aneurysm clip, heart valve prosthesis, nitroglycerin transdermal patch, implanted cardiac defibrillator, implanted electrode, including pacing wires, cochlear implant, other, implanted drug infusion device, implanted insulin pump, intravascular coil, filter or stent: (e.g., Gianturco coil, Gunther inferior vena cava \[IVC\] filter, etc.), intraventricular shunt, neurostimulator/biostimulator, Swan-Ganz catheter, any type of electronic, mechanical or magnetic implant, any type of implant held in place by a magnet, artificial limb or joint, contraceptive device (e.g., intrauterine device \[IUD\], diaphragm), dentures, ear implant, eye/orbital implant, foreign body (e.g., shrapnel, bullet, etc.), halo vest or metallic cervical fixation device, orthopedic item (for example: pins, rods, screws, clips, plates, wires, etc.), surgical clip or staple, vascular access port, wire mesh, hearing aid (must remove prior to the exam), tattooed eyeliner (a small percentage of patients with tattooed eyeliner have experienced transient skin irritation in association with MRI). The patients using transdermal patches will be asked to remove the patch and will be excluded if the patch cannot be removed.",NA,FEMALE,NA,"[{'measure': 'Apparent diffusion coefficient (ADC) maps', 'description': 'ADC maps will be calculated from diffusion weighted (DW) images by using linear regression of logarithmic intensities by using software for combinations of two, three, four, and five DW images with different b values. ADC maps will also be calculated for the remaining combinations of up to 10 evenly distributed b values. In total, 501 value combinations will be automatically processed and analyzed.', 'timeFrame': 'At the time of imaging'}]",NA 115,NCT04722692,"{'fullName': 'Uppsala University', 'class': 'OTHER'}",Delayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ,RECRUITING,"The trial aims to investigate the use of superparamagnetic iron oxide (SPIO) nanoparticles as a tracer for delayed sentinel lymph node dissection (d-SLND) in patients where upfront axillary surgery (SLND) is oncologically deemed unnecessary and should be avoided. This includes but is not limited to patients with a preoperative diagnosis of ductal cancer in situ of the breast (DCIS), an unclear BIRADS 4-5 planned for diagnostic excision or women planned for risk reducing mastectomy. SPIO is injected in the primary operation, and should final specimen pathology demonstrate invasive breast cancer, only then is an operation in the axilla (d-SLND) performed.","['DCIS', 'Breast Cancer', 'Breast Neoplasms', 'Sentinel Lymph Node']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All patients will have been injected with SPIO during the breast procedure. Those who have invasive breast cancer on final pathology will receive radioisotope and undergo SLND. Patients will be randomly allocated to one of two arms: Experimental arm (SLND will be SPIO-guided and the isotope activity will be controlled as background) and control arm (SLND will be isotope-guided and SPIO activity will be controlled as background).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DIAGNOSTIC_TEST', 'name': 'Delayed SLND', 'description': 'SLND performed after surgery for DCIS or other pre-invasive lesions, where final pathology showed invasive breast cancer. Patients have received SPIO in the breast at the first operation, prior to dissection and resection and the SLN has already been marked with SPIO. These SLNs are to be removed.\n\nSLND is divided into the following steps:\n\n1. Transcutaneous signal\n2. Incision in the axilla (skin, subcutaneous fat and fascia) and ""In situ"" signal\n3. SLN identification ""in situ""\n4. SLN excision and signal ""ex vivo""\n5. Background axillary counts. For step ""d"" the radioactive counts are registered for each SLN that has been excised. When the procedure is completed successfully with SPIO, then background axillary isotope counts are registered and, if present, SLND continues as described above with the isotope as primary tracer.', 'armGroupLabels': ['Delayed SLND (SPIO-first arm)']}, {'type': 'DIAGNOSTIC_TEST', 'name': 'Late SLND', 'description': 'SLND performed after surgery for DCIS or other pre-invasive lesions, where final pathology showed invasive breast cancer. Patients will be injected with radioisotope in the operated breast before SLND according to standard of care. Any SLNs detected with this intervention are to be removed.\n\nSLND is divided into the following steps:\n\n1. Transcutaneous signal\n2. Incision in the axilla (skin, subcutaneous fat and fascia) and ""In situ"" signal\n3. SLN identification ""in situ""\n4. SLN excision and signal ""ex vivo""\n5. Background axillary counts. For step ""d"" the magnetic counts are registered for each SLN that has been excised. When the procedure is completed successfully with the isotope, then background axillary iSPIO counts are registered and, if present, SLND continues as described above with the SPIO as primary tracer.', 'armGroupLabels': ['Late SLND (RI-first arm)']}]","Inclusion Criteria: A. Preoperative diagnosis of DCIS, of any grade and any size if planned for mastectomy. B. Planned Risk-reducing mastectomy, if it would be considered for upfront SLND due to institutional practice or in case of an individualised recommendation. C. Any case with a preoperative diagnosis of pre-invasive or unclear lesion, that upfront SLND would be otherwise considered, such as, but not limited to: * Patients with a preoperative diagnosis of DCIS grade 3 any size or, DCIS grade 2 larger than or equal to 20 mm on mammography and planned for breast conserving surgery or * Patients with a preoperative diagnosis of DCIS on core biopsy with a palpable mass on clinical examination or mass effect on radiology or * Patients with a preoperative diagnosis of DCIS with suspicion of micro-invasion on core biopsy or * Patients with a mammographic/ultrasound/MRI finding, suspicious for breast cancer (BIRADS 4 or 5) planned for diagnostic excision with breast conserving surgery, with no definitive diagnosis of invasive cancer or * Patients with a preoperative diagnosis of DCIS, any grade, any size and planned for a complex oncoplastic procedure or * Patients with a preoperative diagnosis of DCIS, any grade, any size and planned for a procedure that may compromise detection rate for a future SLND, such as, but not confined to: lesions in the upper outer quadrant or the axillary tail, removal of the nipple areola complex and so on or * The above mentioned categories with a preoperative diagnosis of pleomorphic Lobular Cancer in Situ (pLCIS), classic Lobular Neoplasia (LN) or Atypical Ductal Hyperplasia (ADH). Exclusion Criteria: * Intolerance/hypersensitivity to iron, dextran compounds or SPIO * An iron overload disease * Patient deprived of liberty or under guardianship * Pregnant or lactating patients",NA,FEMALE,NA,"[{'measure': 'd-SLND detection rate', 'description': 'Number of subjects in whom SPIO detected at least one node divided by the number of subjects who underwent the SLND procedure. Analyses will be performed cumulatively and +/-BD and per type of surgery (BCT or mastectomy).', 'timeFrame': 'One-time (At operation)'}, {'measure': 'l-SLND detection rate', 'description': 'Number of subjects in whom radioisotope detected at least one node divided by the number of subjects who underwent the SLND procedure. Analyses will be performed cumulatively and +/-BD and per type of surgery (BCT or mastectomy).', 'timeFrame': 'One-time (At operation)'}, {'measure': 'Nodal concordance', 'description': 'Number of nodes identified by both test (SPIO) and control (isotope) out of all nodes identified. Analyses will be performed cumulatively and +/-BD and per type of surgery (BCT or mastectomy).', 'timeFrame': 'One-time (At operation)'}]","[{'measure': 'SLND avoidance rate', 'description': 'Number of subjects with pure DCIS or microinvasive/invasive cancer on specimen pathology who did not undergo SLND out of total number recruited in the trial and injected. Analyses will be performed cumulatively and +/-BD and per type of surgery (BCT or mastectomy).', 'timeFrame': 'One-time (At operation)'}, {'measure': 'Per patient concordance', 'description': 'Number of subjects in whom at least one node was identified by both test and control out of subjects in whom at least one node was identified by control. Analyses will be performed cumulatively and +/-BD and per type of surgery (BCT or mastectomy).', 'timeFrame': 'One-time (At operation)'}, {'measure': 'Malignancy rate', 'description': 'Number of subjects in whom at least one malignant lymph node was identified by any method divided by the number of subjects who underwent the SLND procedure. Comparisons and analyses will be performed cumulatively and by type of tracer (SPIO+/-BD vs isotope +/-BD) and per type of surgery (BCT or mastectomy).', 'timeFrame': 'One-time (At operation)'}, {'measure': 'Nodal Malignancy rate', 'description': 'Number of malignant lymph nodes identified by any method divided by the number of nodes who retrieved during SLND procedure. Comparisons and analyses will be performed cumulatively and by type of tracer (SPIO+/-BD vs isotope +/-BD) and per type of surgery (BCT or mastectomy).', 'timeFrame': 'One-time (At operation)'}]" 116,NCT05039892,"{'fullName': '3D Medicines', 'class': 'INDUSTRY'}",Efficacy and Safety of 3D185 Monotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Cholangiocarcinoma,NOT_YET_RECRUITING,The purpose of this study is evaluate the efficacy of 3D185 in subjects with advanced/metastatic cholangiocarcinoma with FGFR2 Gene Alterations who have failed at least 1 previous treatment.,"['Cholangiocarcinoma,Adult']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': '3D185', 'description': 'All eligible subjects will receive the RP2D regimen to be established based on the results of the ongoing phase I study from Cycle 1 Day 1 (C1D1) until disease progression, intolerable toxicity, withdrawal of consent, whichever occurs first.', 'armGroupLabels': ['All eligible subjects']}]","Inclusion Criteria: 1. Histologically or cytologically confirmed cholangiocarcinoma. 2. Documented disease progression following at least one previous systemic cancer therapy 3. Tumor assessment for FGF/FGFR gene alteration status. 4. Have measurable disease according to RECIST v1.1 5. ECOG Performance Status ≤ 2 6. Life expectancy ≥ 12 weeks. Exclusion Criteria: 1. Previously received selective FGFR inhibitor therapy. 2. History of and/or current evidence of ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, myocardia, or lung, excepting calcified lymph nodes and asymptomatic arterial or cartilage/tendon calcifications. 3. Have any of the following eye diseases/conditions: 1) history of retinal pigment epithelial detachment (RPED); 2) history of laser treatment or intraocular injection for macular degeneration; 3) history of dry or wet age-related macular degeneration; 4) history of retinal vein occlusion (RVO); 5) history of retinal degenerative diseases; 6) history of chorioretinal lesions.. 4. Received CYP3A4 and/or CYP2C8 strong inhibitors or CYP3A4 strong inducers within 14 days prior to the first dose and subject who need to continue using these drugs.",NA,ALL,NA,"[{'measure': 'ORR', 'description': 'defined as the proportion of subjects who achieved a confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by investigators.', 'timeFrame': '24 months'}]","[{'measure': 'Duration of response (DoR)', 'description': 'DoR is defined as the time from the date of first CR or PR based on RECIST v1.1 to the date of first documented progressive disease based on RECIST v1.1 or death, whichever occurs first.', 'timeFrame': '24 months'}, {'measure': 'Disease control rate (DCR)', 'description': 'defined as the proportion of subjects who achieve a confirmed complete response (CR) or partial response (PR) or stable disease (SD) based on RECIST v1.1 as assessed by investigators.', 'timeFrame': '24 months'}, {'measure': 'Progression-free survival (PFS)', 'description': 'PFS is defined as the time from the date of first study dose to disease progression based on RECIST v1.1 or death, whichever occurs first.', 'timeFrame': '24 months'}, {'measure': 'Overall survival (OS)', 'description': 'OS is defined as the date of first study dose to the date of death from any cause.', 'timeFrame': '24 months'}, {'measure': '3D185 Plasma concentration', 'description': 'The pharmacokinetic and pharmacodynamics assessments will be analyzed descriptively and presented in appropriate tables or figures.', 'timeFrame': '24 months'}, {'measure': 'Serum phosphate levels', 'description': 'The pharmacokinetic and pharmacodynamics assessments will be analyzed descriptively and presented in appropriate tables or figures.', 'timeFrame': '24 months'}]" 117,NCT02357836,"{'fullName': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}",Neoadjuvant Itraconazole in Non-small Cell Lung Cancer,COMPLETED,The purpose of this study is to determine the pharmacodynamics effects of itraconazole in early-stage non-small cell lung cancer.,['Non-small Cell Lung Cancer'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Itraconazole', 'description': 'Once on study, itraconazole will be taken twice daily for a total of 10-14 days. After being on itraconazole for 7-10 days, ""Post-treatment"" assessments will include a skin biopsy, blood draw for the PK (pharmacokinetics) analyses and the cytokine panel, and also MRI evaluations (anticipated to last 45-50 minutes). Toxicity assessments and laboratory checks will also be conducted during that time. Following these assessments, itraconazole will be continued until the day of surgery. At the time of surgical resection, a tissue sample (with adjacent normal tissue as per standard resection technique) will be obtained to complete the analysis. Following resection, subjects will be followed per standard post-operative procedure.', 'armGroupLabels': ['Itraconazole']}]","Inclusion Criteria: 1. Histologically or cytologically proven NSCLC planned for surgical resection. All NSCLC histologic subtypes are eligible. Alternatively, patients in whom a diagnosis of NSCLC is highly suspected based on history and imaging studies and who are, therefore, scheduled for diagnostic biopsy and/or surgical resection will also be eligible for screening, enrollment, and study treatment if they meet all additional eligibility criteria. In the event that biopsies do not confirm NSCLC, such patients will be removed from study but monitored for any adverse events resulting from study participation. 2. No prior therapy but planned for surgical resection 3. Age ≥ 18 years. 4. ECOG (Eastern Cooperative Oncology Group) 0-2 performance status 5. Adequate organ function as defined below: * total bilirubin within normal institutional limits * AST (Aspartate Aminotransferase) (SGOT)/ALT (Alanine Aminotransferase) (SPGT) ≤ 2.5 X institutional upper limit of normal * creatinine ≤ 2 X institutional upper limit of normal 6. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 6.1 A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy; or * Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 7. Ability to understand and willingness to sign a written informed consent. Exclusion Criteria: 1. Subjects may not be receiving any investigational agents that would confound interpretation of study pharmacodynamic endpoints. 2. History of allergic reactions attributed to itraconazole or to compounds of similar chemical or biologic composition to itraconazole. 3. Uncontrolled, concurrent medical illness. 4. Active hepatitis or symptomatic liver disease. 5. History of or current evidence of uncontrolled cardiac ventricular dysfunction (congestive heart failure) or NYHA (New York Heart Association) Class III or IV heart failure. 6. Current use of medications significantly affecting metabolism of itraconazole (certain anti-convulsants, corticosteroids). See 3.5 Drug Interactions in protocol. 7. Current evidence of hyperthyroidism (which would increase metabolism of itraconazole). 8. Pregnant or lactating female or any female trying to get pregnant. 9. Claustrophobia that would interfere with MRI studies anticipated to last 45-50 minutes. 10. Metal implants deemed at risk for migration during MRI studies. 11. CrCl (Creatinine clearance) \< 45 mL/min (increased risk of nephrogenic systemic fibrosis \[NSF\] from MRI Gadolinium contrast). 12. Known allergy to MRI contrast.",NA,ALL,NA,"[{'measure': 'Changes in Tumor Tissue Microvessel Density [MVD] From Baseline', 'description': ""Images of DAPI (4',6-Diamidino-2-Phenylindole) , CD31 (cluster of differentiation 31 ), and CD34 (cluster of differentiation 34) were taken from the same field of view and then merged."", 'timeFrame': 'Baseline and Post Treatment (after 7-10 days of itraconazole bid)'}]","[{'measure': 'Change in HIF1α From Baseline', 'description': 'A commercially available kit will be used to measure HIF1α levels.', 'timeFrame': 'Baseline and Post Treatment (after 7-10 days of itraconazole bid)'}, {'measure': 'Change in VEGFR2 From Baseline', 'description': 'A commercially available kit will be used to measure VEGFR2 levels.', 'timeFrame': 'Baseline and Post Treatment (after 7-10 days of itraconazole bid)'}, {'measure': 'Change in Phospho-VEGFR2 From Baseline', 'description': 'A commercially available kit will be used to measure Phospho-VEGFR2 levels.', 'timeFrame': 'Baseline and Post Treatment (after 7-10 days of itraconazole bid)'}, {'measure': 'Mean Percent Change in Other Plasma Cytokine From Baseline to Post-Treatment', 'description': 'The following plasma cytokines were measured using a commercially available kit.', 'timeFrame': 'Baseline and Post Treatment (after 7-10 days of itraconazole bid)'}, {'measure': 'Mean Percent Change in Angiogenic Cytokines From Baseline', 'description': 'A commercially available kit will be used to measure Angiogenic Cytokines levels.', 'timeFrame': 'Baseline and Post Treatment (after 7-10 days of itraconazole bid)'}, {'measure': 'Changes in Perfusion (Ktrans)', 'description': 'DCE (dynamic contrast enhanced ) MRI is an established technology to assess microvessel density (MVD) and tumor capillary permeability.', 'timeFrame': 'Baseline and Post Treatment (after 7-10 days of itraconazole bid)'}, {'measure': 'Number of Participants With Tumor SMO (Smoothened) Gene Mutations, GLI2 and CCND1 Copy Number, PI3K-mTOR Pathway Activation', 'description': 'phosphatidylinositol-3-kinase (PI3K)/Akt and the mammalian target of rapamycin (PI3K-mTOR pathway )', 'timeFrame': 'Baseline and Post Treatment (after 7-10 days of itraconazole bid)'}, {'measure': 'Change in Tumor Tissue GLI1, SHH and PTCH1 Levels From Baseline', 'description': 'This can be measured by analyzing frozen-treated tumor tissue for GLI1 (glioma-associated oncogene ) and PTCH1(patched-1) mRNA (Messenger Ribonucleic Acid) by qPCR.', 'timeFrame': 'Baseline and Post Treatment (after 7-10 days of itraconazole bid)'}, {'measure': 'Change in Skin Biopsy GLI1 Levels From Baseline', 'description': 'We analyzed serial skin biopsies for GLI1 mRNA by qPCR (quantitative polymerase chain reaction).', 'timeFrame': 'Baseline and Post Treatment (after 7-10 days of itraconazole bid)'}, {'measure': 'Change in Skin Biopsy SHH Levels From Baseline', 'description': 'We analyzed serial skin biopsies for SHH (Sonic Hedgehog )levels mRNA by qPCR.', 'timeFrame': 'Baseline and Post Treatment (after 7-10 days of itraconazole bid)'}, {'measure': 'Change in Skin Biopsy PTCH1 Levels From Baseline', 'description': 'We analyzed serial skin biopsies for PTCH1 mRNA by qPCR.', 'timeFrame': 'Baseline and Post Treatment (after 7-10 days of itraconazole bid)'}, {'measure': 'Number of Participants With Tumor Cell Proliferation/Apoptosis', 'description': 'Tumor proliferation and apoptosis will be assessed by tumor Ki67 and cleaved caspase 3 levels', 'timeFrame': 'Baseline and Post Treatment (after 7-10 days of itraconazole bid)'}, {'measure': 'Itraconazole Levels in Post-treatment Serum', 'description': 'Itraconazole levels assessed by post-treatment serum', 'timeFrame': 'Post Treatment (after 7-10 days of itraconazole bid)'}, {'measure': 'Itraconazole Levels in Tumor Tissue', 'description': 'Itraconazole levels assessed by tumor tissue', 'timeFrame': 'Baseline and Post Treatment (after 7-10 days of itraconazole bid)'}, {'measure': 'Itraconazole Levels in Skin Biopsy', 'description': 'Itraconazole levels assessed by skin biopsy', 'timeFrame': 'Baseline and Post Treatment (after 7-10 days of itraconazole bid)'}]" 118,NCT03737734,"{'fullName': 'Alpha Tau Medical LTD.', 'class': 'INDUSTRY'}","Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia (DaRT)",ACTIVE_NOT_RECRUITING,"A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia","['Skin Cancer', 'Mucosal Neoplasm of Oral Cavity', 'Soft Tissue Neoplasm']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DEVICE', 'name': 'Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)', 'description': 'An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.', 'armGroupLabels': ['DaRT Seeds'], 'otherNames': ['DaRT']}]","Inclusion Criteria: * Subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma. * Subjects with a tumor size ≤ 7 centimeters in the longest diameter. * Patients who have either failed first-line treatment, or are medically unfit for standard of care (surgery, external-beam radiation therapy or chemotherapy), or refuse standard of care. * Subjects' ECOG Performance Status Scale is \< 2. * Subjects' life expectancy is more than 6 months. * Platelet count ≥100,000/mm3. * International normalized ratio of prothrombin time ≤1.8. * Creatinine ≤1.9 mg/dL. * Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test. * Subjects are willing to sign an informed consent form. Exclusion Criteria: * Subject has a tumor of Keratoacanthoma histology. * Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.) * Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids * Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT. * High probability of protocol non-compliance (in opinion of investigator) * Women who are pregnant or breastfeeding.",NA,ALL,NA,"[{'measure': 'Tumor response to DaRT', 'description': 'Assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)', 'timeFrame': '9-11 weeks post DaRT insertion'}, {'measure': 'Adverse Events', 'description': 'The incidence, frequency, severity and causality of acute adverse events related to the DaRT treatment according to Common Terminology and Criteria for adverse events (CTCAE) version 5.0.', 'timeFrame': 'Up to 24 Months'}]","[{'measure': 'Reduction in tumor volume', 'description': 'based on imaging', 'timeFrame': '9-11 weeks post DaRT insertion'}, {'measure': 'DaRT seeds placement', 'description': 'Assessment by localization of the DaRT seeds in the tumor using CT imaging on the day of DaRT insertion', 'timeFrame': 'Day of insertion procedure'}, {'measure': 'Change in quality of life', 'description': 'Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skindex-16 questionnaire score', 'timeFrame': 'Day 15, Day 30, Day 70, Day 180 post DaRT insertion'}, {'measure': 'Change in quality of life', 'description': 'Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skin Cancer Index (SCI) questionnaire score', 'timeFrame': 'Day 30, Day 70, Day 180 post DaRT insertion'}, {'measure': 'Adverse Events', 'description': 'All Adverse Events (AE) related and unrelated to the study treatment', 'timeFrame': 'Up to 24 Months'}, {'measure': 'Progression Free Survival', 'description': 'Time elapsed from response to disease progression', 'timeFrame': '24 months post DaRT insertion'}]" 119,NCT01433809,"{'fullName': 'Mayo Clinic', 'class': 'OTHER'}",Biomarkers to Distinguish Benign From Malignant Thyroid Neoplasm,COMPLETED,"This protocol will evaluate microRNA biomarkers in blood and fine-needle aspirate biopsies (FNAB) of thyroid nodules. MicroRNA profiles will be determined and evaluated for their utility in pre-operative diagnosis, in particular to distinguish benign from malignant throid neoplasms. Post-surgical fresh-frozen thyroid cancer tissue will be assessed for somatic mutations, mRNA, and microRNA expression patterns. FFPE tissue will be used to obtain H\&E and unstained slides to specific biomarker results using immunohistochemistry.","['Cancer of the Thyroid', 'Neoplasms, Thyroid', 'Thyroid Adenoma', 'Thyroid Cancer', 'Thyroid Carcinoma']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}",NA,"Inclusion Criteria: * Patient with palpable thyroid nodule suspicious for thyroid neoplasm * Patient selected to undergo fine needle biopsy for cytologic diagnosis * Male (18 years of age or older) * Female (18 years of age or older)","All individuals undergoing fine needle biopsy for diagnosis of thyroid cancer, who provide written consent to enter the study.",ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Distinguish follicular adenoma from follicular carcinoma', 'description': 'Biomarkers will be identified to distinguish benign follicular adenoma from follicular carcinoma of the thyroid.', 'timeFrame': '3 years'}]",NA 120,NCT06999798,"{'fullName': 'Mayo Clinic', 'class': 'OTHER'}","An Optimized Ultrasound Twinkling Marker for the Imaging of Lymph Nodes in Patients With Clinically Node-Positive Breast Cancer, The UTMOST2 Trial",RECRUITING,"This phase I trial studies the performance, including ultrasound visibility, of an optimized ultrasound twinkling marker in imaging lymph nodes in patients with clinically node-positive breast cancer. In patients with biopsy-proven breast cancer, biopsy markers are used to identify the sites of cancer involvement in both the breasts and lymph nodes. These biopsy markers are critical for guiding surgical management many months after the marker is placed. For breast radiologists and breast surgeons, there is a need for simple, consistent visibility of biopsy markers by ultrasound, particularly several months after marker placement. Ultrasound is the imaging method of choice, particularly for lymph nodes in the armpit (axilla). Ultrasound is non-ionizing and is more comfortable for patients compared to mammography. However, ultrasound visibility of these markers is challenging and inconsistent, with ultrasound failing to detect the marker approximately 25% of the time. The Mayo-designed investigational biopsy marker takes advantage of an ultrasound phenomenon called twinkling artifact. The Mayo-designed optimized ultrasound twinkling marker may work better than standard biopsy clip marker in imaging lymph nodes in patients with clinically node-positive breast cancer.","['Anatomic Stage II Breast Cancer AJCC v8', 'Anatomic Stage III Breast Cancer AJCC v8', 'Anatomic Stage IV Breast Cancer AJCC v8', 'Locally Advanced Breast Carcinoma']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DEVICE_FEASIBILITY', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'PROCEDURE', 'name': 'Diagnostic Mammography', 'description': 'Undergo mammography', 'armGroupLabels': ['Diagnostic (optimized twinkling marker placement, ultrasound)'], 'otherNames': ['diagnostic mammogram']}, {'type': 'PROCEDURE', 'name': 'Resection', 'description': 'Undergo surgical resection of the lymph node as part of standard care.', 'armGroupLabels': ['Diagnostic (optimized twinkling marker placement, ultrasound)'], 'otherNames': ['Surgical Resection']}, {'type': 'PROCEDURE', 'name': 'Ultrasound Imaging', 'description': 'Undergo ultrasound imaging. Ultrasound images will be evaluated for presence and visibility/conspicuity of the twinkling marker.', 'armGroupLabels': ['Diagnostic (optimized twinkling marker placement, ultrasound)'], 'otherNames': ['2-Dimensional Grayscale Ultrasound Imaging', '2-Dimensional Ultrasound Imaging', '2D-US', 'Ultrasonography', 'Ultrasound', 'Ultrasound Test', 'Ultrasound, Medical', 'US']}, {'type': 'DEVICE', 'name': 'Twinkling Marker Placement', 'description': 'Undergo ultrasound-guided placement of the optimized twinkling marker into the positive lymph node after confirmation of metastatic axillary lymph node involvement.', 'armGroupLabels': ['Diagnostic (optimized twinkling marker placement, ultrasound)'], 'otherNames': ['Twinkle Marker', 'Mayo Twinkle Marker', 'Biopsy Twinkle Marker', 'Biopsy Twinkling Marker', 'Mayo-designed Twinkling Marker']}]","Inclusion Criteria: * Patient 18 years or older with breast cancer and biopsy-proven malignant involvement of an axillary lymph node * Surgical management will be determined by the surgeon, who will decide if preoperative Iodine (I)-125 seed localization of the positive node is necessary or if they will retrieve the positive node with intraoperative ultrasound guidance. During surgery, the targeted node, its associated biopsy markers, I-125 seed if placed, and optimized twinkling marker will be resected. The position of the marker in the lymph node or proximity to the node will be noted from the surgical and pathology documentation * Surgery will be performed by one of the surgeons in the Division of Breast and Melanoma Surgical Oncology (Doctor \[Dr.\] Judy Boughey, Dr. Amy Degnim, Dr. Tina Hieken, Dr. Jeffrey Johnson, Dr. Mary Mrdutt, Dr. Shon Black) * Patients must be able to understand the study procedures and comply with them for the entire length of the study * No contraception is necessary or required Exclusion Criteria: * Patients who are pregnant * Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements * Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention",NA,FEMALE,NA,"[{'measure': 'Conspicuity of the optimized Mayo-developed twinkling marker', 'description': 'Assessed by the visibility/conspicuity of the twinkling marker under ultrasound occurring as part of standard of care \\[neoadjuvant systemic therapy (NST)\\].', 'timeFrame': 'Baseline up to final pre-operative imaging before surgery; generally 6-9 months'}, {'measure': 'Migration of the optimized Mayo-developed twinkling marker', 'description': 'Will be determined from surgical and pathology documentation after node resection', 'timeFrame': 'At time of surgery (baseline)'}]","[{'measure': 'Incidence of adverse events (safety of twinkling marker)', 'description': 'Adverse events (AEs) are defined as any untoward or unfavorable medical occurrence in a clinical research study participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants\' involvement in the research, whether or not considered related to participation in the research. AEs will be assessed as Mild (events require minimal or no treatment and do not interfere with the participant\'s daily activities); Moderate (events result in a low level of inconvenience or concern with the therapeutic measures. Moderate events may cause some interference with functioning); or Severe (Events interrupt a participant\'s usual daily activity and may require systemic drug therapy or other treatment. Severe events are usually potentially life-threatening or incapacitating).Of note, the term ""severe"" does not necessarily equate to ""serious"".', 'timeFrame': 'Baseline up to final visit before surgery; generally 6-9 months'}]" 121,NCT03220893,"{'fullName': 'Mayo Clinic', 'class': 'OTHER'}",Molecular Breast Imaging and Digital Breast Tomosynthesis in Screening Patients With Dense Breast Tissue,COMPLETED,"This study compares molecular breast imaging (MBI) and digital breast tomosynthesis (DBT) in screening patients with dense breast tissue. Breast imaging may help doctors find breast cancer sooner, when it may be easier to treat. Molecular breast imaging (MBI) uses an injection of a small amount of radioactive material that is taken up in tissues of the body that are actively changing, such as breast cancer. A specialized camera, called a gamma camera, takes pictures of the gamma rays emitted by this material. MBI may detect cancers that are not visible on mammograms. This study may help researchers determine how MBI testing compares to DBT screening.",['Breast Carcinoma'],INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'PROCEDURE', 'name': 'Digital Breast Tomosynthesis (DBT)', 'description': 'DBT is standard of care breast screening', 'armGroupLabels': ['DBT + MBI', 'DBT alone'], 'otherNames': ['DBT', 'Digital Breast Tomosynthesis', 'Digital Tomosynthesis Mammography', 'Digital Tomosynthesis of the Breast']}, {'type': 'RADIATION', 'name': 'Scintimammography', 'description': 'Undergo MBI', 'armGroupLabels': ['DBT + MBI'], 'otherNames': ['Breast-Specific Gamma Imaging', 'MBI', 'Miraluma Scan', 'Miraluma Test', 'Molecular Breast Imaging', 'Nuclear Medicine Breast Imaging', 'sestamibi breast imaging', 'Sestamibi Scintimammography']}]","Inclusion Criteria: * Patient is a consenting female age 40-75 years * Patient is scheduled for routine screening DBT * Patient is asymptomatic for breast disease * Patient had heterogeneously dense or extremely dense breasts on most recent prior mammography examination (Breast Imaging Reporting and Data System \[BI-RADS\] c or d) within 24 months of enrollment * Patient is able to participate fully in all aspects of the study (completing study visits and study data collection) * Patient understands and signs the study informed consent * Patient anticipates being able to return one year after study enrollment to complete the second round of screening Exclusion Criteria: * Patient is currently pregnant or plans to become pregnant during the course of the study * Patient is currently lactating * Patient has had a prior MBI * Patient has had a prior whole breast ultrasound (WBUS) for screening, with either a hand-held ultrasound probe or automated system, within 12 months prior to study enrollment * Patient has had a prior breast MRI * Patient has had a prior contrast-enhanced mammogram (contrast enhanced spectral mammography \[CESM\] or contrast-enhanced digital mammography \[CEDM\]) * Patient is concurrently participating in any other breast imaging research studies that involve undergoing additional breast imaging tests beyond routine screening with mammography, including but not limited to contrast-enhanced mammography, WBUS, MBI, or contrast-enhanced breast MRI * Patient has had a breast biopsy within 3 months prior to study enrollment * Patient has had breast surgery within 12 months prior to study enrollment * Patient is currently undergoing treatment for breast cancer or planning surgery for a high-risk breast lesion (atypical ductal hyperplasia \[ADH\], atypical lobular hyperplasia \[ALH\], lobular carcinoma in situ \[LCIS\], papilloma, radial scar) * Patient is currently taking a chemoprevention agent for breast cancer risk reduction or osteoporosis prevention (tamoxifen, raloxifene, anastrazole, letrozole, exemestane) * Patient has a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder study adherence",NA,FEMALE,NA,"[{'measure': 'Rate of Detection of Invasive Cancers', 'description': 'Compare the rate of detection of invasive cancers between DBT alone versus (vs.) the combination of digital breast tomosynthesis (DBT) with supplemental molecular breast imaging (MBI) at initial (year 1) screening. For each modality, the detection rate of invasive cancers will be estimated as the proportion of participants in the analysis set who had an invasive cancer detected by the modality and verified by pathology.', 'timeFrame': 'At year 1 screening'}]",NA 122,NCT02506816,"{'fullName': 'MedSIR', 'class': 'OTHER'}",Preoperative Olaparib Endometrial Carcinoma Study (POLEN),COMPLETED,"The primary objective of this study is to identify, in human tumour samples, biomarker changes associated to short exposure to AZD2281 as potential predictors of activity in Endometrial Carcinoma (EC). This is an exploratory study with a biological primary endpoint. Clinical efficacy or safety are not a primary objective of the study.",['Endometrial Carcinoma'],OBSERVATIONAL,"{'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'DRUG', 'name': 'Olaparib', 'description': 'Drug exposure has a limited duration 28 (+/- 5) days and at lower dose (600mg/day) than therapeutical accepted (800mg/day).', 'armGroupLabels': ['Olaparib'], 'otherNames': ['Lynparza']}]","Inclusion Criteria: * Patients must have histologically-confirmed type I primary endometrial carcinoma (EC). Diagnosis biopsy must contain 3-12 mg of tumour cellularity/stroma (Tumour: 5-20 mm) and this will be checked in the central laboratory for this trial. If tumour cellularity/stroma is inadequate, one re-biopsy with adequate tumour cellularity/stroma will be mandatory before study entry. * WHO performance status ≤ 2. * Adequate bone marrow function as shown by: ANC ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L, Hb \>10g/dL. * Adequate liver function as shown by: serum bilirubin ≤ 1.5 x ULN INR \< 1.3 (or \< 3 on anticoagulants) ALT and AST ≤ 2.5x ULN * Adequate renal function: serum creatinine ≤ 1.5 x mg/dL. * Fasting serum cholesterol ≤300 mg/dL or ≤7.75 mmol/L and fasting triglycerides ≤ 2.5 x ULN. * Signed informed consent, including consent to tissue collection and blood samples as specified by the protocol. Exclusion Criteria: * Subjects who have received prior anticancer therapies for the current endometrial cancer (including chemotherapy, radiotherapy, antibody based therapy, hormonotherapy or surgery). * Patients, who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study. * Prior treatment with any investigational drug within the preceding 4 weeks. * Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent, except corticosteroids with a daily dosage equivalent to prednisone ≤ 20 mg. However, patients receiving corticosteroids must have been on a stable dosage regimen for a minimum of 4 weeks prior the study entry. Topical or inhaled corticosteroids are allowed. * Patients who have received immunization with attenuated live vaccines within one week of study entry (note: during study period these kind of vaccines are also not allowed). * Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: Symptomatic congestive heart failure of New York heart Association Class III or IV Unstable angina pectoris, myocardial infarction within 6 months of start of study drug, Serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease Severely impaired lung function Uncontrolled diabetes as defined by fasting serum glucose \>1.5 x ULN Active (acute or chronic) or uncontrolled severe infections Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis A known history of HIV seropositivity. * Patients with an active, bleeding diathesis. * Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Hormonal contraceptives are acceptable as a sole method of contraception. (Women of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to administration of AZD2281). * History of noncompliance to medical regimens. * Patients unwilling to or unable to comply with the protocol.",Patinets diagnosed with endometrial carcinoma prior surgery,FEMALE,NON_PROBABILITY_SAMPLE,"[{'measure': 'Expression of Cell Cycle-related Proteins', 'description': 'We assessed the change from baseline in the histological score (H-score) of the cell cycle-related proteins on endometrial tumor tissues after 28 (+/- 5) days of olaparib-based therapy. In detail, expression of the cyclin D1, Ki67, and caspase-3 active proteins evaluated by an H-score according to the following formula:\n\nH-score= 1x(%light staining) + 2x(%moderate staining) + 3x(%strong staining).\n\nThe final score ranges from 0 to 300, where 0 indicates absence of staining (corresponding to the lowest tumor proliferation rate and better outcome) and 300 the maximum staining (corresponding to the highest tumor proliferation score and worse outcome).', 'timeFrame': 'Baseline and Day 28 (+/- 5)'}]","[{'measure': 'Protein Expression of Biomarkers Related to PARP-inhibition', 'description': 'We assessed the change from baseline in the H-score of several biomarkers targeted by olaparib-based therapy on endometrial tumor tissues after 28 (+/- 5) days of treatment. In detail, expression of protein involved in the DNA repair (PARP1, ɣH2AX), angiogenesis (VEG, HIF-1α, PTEN), apoptosis (p65, p50, p53), glucose metabolism (GLUT1), proliferation (PH3), and regulation of gene transcription (ARID1A) were evaluated by an H-score according to the following formula:\n\nH-score= 1x(%light staining) + 2x(%moderate staining) + 3x(%strong staining).\n\nThe final score ranges from 0 to 300, where 0 indicates absence of staining and 300 the maximum staining.', 'timeFrame': 'Baseline and Day 28 (+/- 5)'}, {'measure': 'Plasma Levels of Olaparib', 'description': 'Plasma concentration of olaparib administered at dosis of 300mg twice in a day (600mg/day). Values of plasma level of olaparib on days 7,14,21 and 28 were collected at time when maximum of drug concentration is reached. Data are reported as µg/mL.', 'timeFrame': 'Days 7,14,21 and 28'}, {'measure': 'Number of Participants With Olaparib-Associated Toxicities', 'description': 'To assess the tolerability for all treated patients (N=36) according to NCI-CTCAE v.4.03.', 'timeFrame': 'Up to 28 days (+/- 5)'}]" 123,NCT06610604,"{'fullName': 'China-Japan Friendship Hospital', 'class': 'OTHER'}",Health-Related Quality of Life and Emotions in Patients with Thyroid Nodules,RECRUITING,The purpose of this observational research is to evaluate and compare the health-related quality of life and emotional well-being of patients with thyroid nodules before and after treatment. This is a data collection study by allowing investigators to access information generated before and after treatment.,['Thyroid Nodule'],OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'PROCEDURE', 'name': 'thermal ablation', 'description': 'thermal ablation including microwave ablation, radiofrequency ablation of thyroid nodules', 'armGroupLabels': ['thermal ablation']}, {'type': 'PROCEDURE', 'name': 'thyroidectomy', 'description': 'surgical resection of thyroid nodules', 'armGroupLabels': ['thyroidectomy']}]","Inclusion Criteria: * Clinical diagnosis of benign thyroid nodules or papillary thyroid carcinoma ; * underwent microwave ablation or thyroidectomy; * ability to understand and cooperate with the survey Exclusion Criteria: * serious primary diseases in the liver, kidney, hematopoietic, or endocrine systems； * a history of mental illness, personality disorders, cognitive impairments, or organic brain disease",patients with thyroid nodules before and after treatments,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'The Thyroid Cancer-Specific Quality of Life Questionnaire to assess the thyroid-specific quality of life', 'description': 'The Thyroid Cancer-Specific Quality of Life Questionnaire (THYCA-QoL), as a methodologically developed questionnaire, was used to assess thyroid-specific symptoms in thyroid cancer survivors. The questionnaire consists of seven symptom scales (neuromuscular, voice, concentration, sympathetic, throat/mouth, psychological and sensory problems) and six single items (problems with scar, felt chilly, tingling hands/feet, gained weight, headache, less interest in sex), with a time frame of the previous week (except for less interest in sex item, which is four weeks), and each item is scored on a four-point response scale ranging from 1, ""not at all"", to 4, ""very much"". Scores were linearly transformed to a 0-100 scale. A higher score on this scale means more symptoms and complaints.', 'timeFrame': 'before treatment and 1month, 6months, and 12 months after treatment'}, {'measure': 'the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire to assess the general quality of life', 'description': 'The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) was adopted as a valid measurement of quality of life for cancer patients. It consists of 5 functional scales , 3 symptom scales, 6 single-item common symptom, and global health status (GHS) subscales. The time frame of the questions is the previous week, and each item is scored on a four-point response scale ranging from 1 to 4, except the global status scale, which is scored on a seven-point modified linear analog scale ranging from 1, ""very poor"" to 7, ""excellent"". After linear transformation, all scales and single item measures range in score from 0-100. A higher score on the functional scales and global status scale means a better level of functioning and HRQoL, whereas a a higher score on the symptom scales and single item corresponds to more discomfort and complaints.', 'timeFrame': 'before treatment and 1month, 6months, and 12 months after treatment'}, {'measure': 'Hospital Anxiety and Depression Scale to assess the emotional status', 'description': 'The Hospital Anxiety and Depression Scale consists of 14 items measuring symptom severity on a scale of 0-3 with subscales for anxiety (HADS\\_A) and depression (HADS\\_D), and a range of possible scores for each subscale of 0-21. Cut-off scores of 8+ for both subscales demonstrate the optimal balance between sensitivity and specificity for identifying cases of anxiety disorders and depression, with sensitivity and specificity of approximately .8 for both subscales.', 'timeFrame': 'before treatment and 1month, 6months, and 12 months after treatment'}, {'measure': 'The functional assessment of chronic illness therapy-spiritual well-being questionnaire to assess spiritual well-being', 'description': 'The functional assessment of chronic illness therapy-spiritual well-being scale consists of 12 items formatted in a five-point Likert scale ranging from 0 = not at all to 4 = very much, with the exception of two negatively stated items (4 and 8) coded in a reverse manner. The responses to the self-reported items refer to a 7-day recall period. The scores are added to generate a total score ranging from 0 to 48. With the highest scores representing better spiritual wellbeing.', 'timeFrame': 'before treatment and 1month, 6months, and 12 months after treatment'}]","[{'measure': 'serum thyroid hormone', 'description': 'changes in serum thyroid hormone', 'timeFrame': 'before treatment and 1month, 6months, and 12 months after treatment'}, {'measure': 'Percent Volume Changes of Nodules', 'description': 'Percent Volume Changes of Nodules: ((Volume (baseline)- Volume (\\*m\\*))/Volume (baseline))\\*100', 'timeFrame': 'before treatment and 1month, 6months, and 12 months after treatment'}]" 124,NCT03491033,"{'fullName': 'Yonsei University', 'class': 'OTHER'}",Genomic Profiling of the Residual Disease of Advanced-stage Ovarian Cancer After Neoadjuvant Chemotherapy,COMPLETED,"Tumor response to NAC predicts survival and can be considered a surrogate prognostic marker. Three tiered chemotherapy response score (CRS) of omental tissue sections showed a significant association with survival. In patients with CRS 1 or 2, NAC selects a subpopulation of chemotherapy resistant tumor cells. This study will examine comprehensive molecular analyses on the residual disease of 104 clinically defined high-grade serous carcinoma after NAC, including next-generation sequencing on 14 matched pretreatment biopsies. This information together with immune marker expression and BRCA expression, will provide a unique opportunity to guide biomarker-driven adjuvant studies targeting these chemotherapy-resistant tumor cells.",['Advanced-stage Ovarian Cancer'],OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}","[{'type': 'DRUG', 'name': 'chemotherapy', 'description': 'All of the patients in this study underwent NAC regimens consisting of taxane and platinum combination chemotherapy. After NAC, all of the patients underwent interval debulking surgery. Subsequently, additional cycles of chemotherapy were administered after IDS to complete a total of 6 cycles at the discretion of the treating physician.', 'armGroupLabels': ['advanced-stage ovarian cancer group']}]","Inclusion Criteria: * patients with pathologically confirmed epithelial ovarian cancer who received at least 1 cycle of neoadjuvant chemotherapy * The patient inclusion criteria included 1) high grade serous carcinoma 2) stage III/IV disease 3) availability of clinical data and tumor tissue 4) viable residual tumors after neoadjuvant chemotherapy. Exclusion Criteria: * patients with complete pathologic response (CRS 3) as IHC staining was insufficient or unavailable",tirtiary medical center,FEMALE,NON_PROBABILITY_SAMPLE,"[{'measure': 'genomic profiling', 'description': 'demonstrates the spectrum of genomic alterations/ profiling present in residual disease after neoadjuvant chemotherapy.', 'timeFrame': '3 months'}]","[{'measure': 'immunohistochemistry', 'description': 'To evaluate the prognostic significance of BRCA-1 IHC in residual disease after neoadjuvant chemotherapy in ovarian cancer', 'timeFrame': '3 months'}]" 125,NCT05064852,"{'fullName': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}",A Real-world Study of the Safety and Efficacy of Surufatinib in the Treatment of Biliary Tract Carcinoma,UNKNOWN,"This is a prospective, single-arm, open-label,multi-center, observational real-world clinical study to observe and evaluate the efficacy and safety of Surufatinib in the treatment of patients with biliary tract cancer (BTC).",['Biliary Tract Carcinoma'],OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'DRUG', 'name': 'Surufatinib', 'description': 'The study is a real-world study. According to the actual medical history of patients, the usage of Surufatinib was collected.', 'armGroupLabels': ['Surufatinib']}]","Inclusion Criteria: 1. Age ≥18, male or female; 2. Patients with histologically or cytologically confirmed unresectable or metastatic BTC, including intrahepatic cholangiocarcinoma (IHCC), extrahepatic cholangiocarcinoma (EHCC), and gallbladder cancer (GBC); Surgical resection with positive margins are allowed; 3. ECOG score 0-2; 4. Expected survival of ≥12 weeks; 5. Confirmed measurable (or evaluable) lesions that meet the requirements of RECIST 1.1; 6. It is not less than 7 days since the end of the last systematic treatment, and the palliative treatment of the limited area is allowed Treatment has been over 4 weeks; 7. The function of major organs and bone marrow was basically normal; 8. Fully understand this study, voluntarily participate in it, and sign the informed consent. 9. Fertile male or female patients shall volunteer to use effective contraceptive methods, such as double barrier contraception, condoms, oral or injected contraceptives, and intrauterine devices, during the study period and within 90 days after the last dosing of the investigational drug. All-female patients will be considered fertile unless they have had natural menopause, or artificial menopause, or sterilization (such as hysterectomy, bilateral adnexectomy, or ovarian radiation) Exclusion Criteria: 1. Fine basal skin that has been diagnosed with other malignant tumors within the past 5 years and has been effectively treated (Except for cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer and breast cancer after effective resection outside); 2. Receiving other investigational drugs or approved or under development antitumor therapies; 3. Patients with contraindications to Surufatinib (e.g., active bleeding, ulcers, intestinal perforation, bowel)Obstruction, medically uncontrolled hypertension, grade III-IV cardiac dysfunction, major surgery within 30 days, severe liver and kidney insufficiency, etc.); 4. The patient has any current disease or condition that affects the absorption of the drug, or the patient cannot take it orally Surufatinib; 5. Demonstrated allergy to any component of the test drug and/or its excipients; 6. Pregnant (positive pregnancy test before dosing) or breast-feeding women; 7. Patients with large pleural effusion or ascites requiring drainage; 8. Taken a drug containing hyperforin perforatum within 3 weeks prior to the first study, or before taken other CYP3A4 strong inducer or inhibitor within 2 weeks; 9. The investigator determined that liver metastases accounted for 50% or more of the total volume of the liver; 10. Clinically intervened biliary obstruction was not in remission or required anti-infective therapy as determined by the investigator 14 days prior to the first study drug treatment; 11. Previous liver transplantation; 12. Clinically significant electrolyte abnormalities as determined by the investigator; 13. Any other diseases with clinically significant metabolic abnormalities, abnormal physical observations, or abnormal laboratory findings, which are judged by the investigator as evidence that the patient has a disease or condition that is unsuitable for the study drug (e.g., epileptic seizures requiring treatment), or that would interfere with the interpretation of the study results, or that may put the patient at high risk.",Patients with Biliary Tract Carcinoma,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Progression-free survival (PFS)', 'description': 'PFS was defined as the length of time from the administration of the first-dose until disease progression or death from any cause before disease progression.', 'timeFrame': '6 months after the last patient enrolled'}]","[{'measure': 'Safty', 'description': 'The rate of AE and SAE in patients with BTC receiving surufatinib,AEs/SAEs were evaluated using NCI-CTCAE v5.0', 'timeFrame': 'up to 4 weeks after the last dose'}, {'measure': 'Disease Control Rate(DCR)', 'description': 'DCR was defined as the percentage of patients with complete response (CR), partial response (PR) and stable disease (SD) according to Response Evaluation Criteria in Solid Tumours (RECIST).', 'timeFrame': '6 months after the last patient enrolled'}, {'measure': 'Overall survival (OS)', 'description': 'OS was defined as the length of time from the administration of the first-dose until death from any cause.\n\nor lost of follow-up', 'timeFrame': '6 months after the last patient enrolled'}, {'measure': 'Objective Response Rate (ORR)', 'description': 'ORR was defined as the percentage of patients with complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumours (RECIST).', 'timeFrame': '6 months after the last patient enrolled'}]" 126,NCT02997449,"{'fullName': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}",Complete Endosonographic Intrathoracic Nodal Staging of Lung Cancer Patients in Whom SABR is Considered,UNKNOWN,"Rationale: Accurate staging of lung cancer is important because it directs treatment and determines prognosis. The development of Stereotactic Ablative Radiotherapy (SABR), has revolutionized radiation therapy for early stage lung cancer and results demonstrate similar outcomes in comparison to surgical resection of the lung tumor. The staging work-up program for patients with a potentially resectable Non-Small-Cell Lung Cancer (NSCLC) includes at least a computed tomography (CT) scan of the chest and integrated Positron Emission Tomography - Computed Tomography (PET/CT) scans, and when indicated, invasive mediastinal staging. However, patients who are treated with SABR do not routinely undergo the same nodal staging work-up as do surgical candidates. As both surgery and SABR appear to achieve comparable rates of local and regional tumor control, it appears only logical to perform a similar staging work-up in all patients with early stage lung cancer who will be treated with either of the two curative local modalities. In the past, a lack of invasive nodal sampling before SABR was considered acceptable as invasive surgical staging (mediastinoscopy) was widely considered the preferred procedure. However, with minimally invasive and safe endosonography procedures now available, improved pre-treatment staging has become possible for patient groups who are eligible for SABR, including those with significant comorbidities. Hypothesis: Complete endosonographic (combined endobronchial and esophageal) staging of hilar and mediastinal lymph nodes in patients with (suspected) non-small cell lung cancer (NSCLC) will result in change of loco-regional nodal status in 20% of patients, in comparison to staging by PET-CT alone. Study population: Patients with either established or suspected early-stage NSCLC who are medically inoperable, or who refuse surgery but are potential candidates for SABR with curative intent (provided no intrathoracic metastases are present). Patients will undergo a single scope complete mediastinal and hilar staging procedure (combined EndoBronchial UltraSound (EBUS) and Transesophageal Endoscopic Ultrasound with EBUS scope (EUS-B)).","['Non Small Cell Lung Cancer (NSCLC)', 'Intrathoracic Nodal Staging']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}",NA,"Inclusion Criteria: * Proven, or highly suspected, non-small cell lung cancer (NSCLC) * Absence of distant metastases based on PET-CT * Stereotactic ablative radiotherapy (SABR) with curative intent is contemplated * One of the following features based on PET-CT: * Centrally located clinical T1-T2 N0 tumor * Peripheral located clinical T2 N0 tumor * Suspicion of N1- N2 disease based on either size (short axis \> 10mm CT) or FDG uptake * Non-FDG avid primary lung tumor and lymph nodes Exclusion Criteria: * Medically operable patients with a resectable lung tumor (unless SABR is the explicit preference of the patients or treating physicians preference). * Bulky nodal disease based on PET-CT * Contra-indications for endosonography and / or bronchoscopy * Pregnancy * Age under 18 * No informed consent","Patients with either established or suspected early-stage NSCLC who are medically inoperable, or who refuse surgery but are potential candidates for stereotactic ablative radiotherapy (SABR) with curative intent (provided no intrathoracic metastases are present)",ALL,PROBABILITY_SAMPLE,"[{'measure': 'Proportion of patients with change in nodal status based on imaging compared to nodal status based on endosonography.', 'description': 'Prior to endoscopy the nodal status (single outcome measure either N0,N1,N2,N3) will be defined based on (PET) CT imaging. After complete endosonographic staging (EBUS+EUS-B) of the hilus and mediastinum again the nodal status will be defined (single outcome measure either N0,N1,N2,N3) based on endosonography findings.\n\nThe sensitivities, negative predictive values (NPV) and positive predictive values (PPV) for endosonography and PET-CT imaging will be calculated.', 'timeFrame': '0-6 months'}]","[{'measure': 'Radiotherapy plan based on imaging (prior to endosonography) compared to the radiotherapy plan based on endosonography outcomes.', 'description': 'The radiotherapist will make a radiation plan (Gross Tumor Volume (GTV) primary tumor, internal target volume (ITV) primary tumor and planning target volume (PTV) primary tumor) based on (PET) CT imaging prior to endosonography. After endosonography the radiotherapist will make another radiotherapy plan based on endosonography staging results. The proportions of changed radiotherapy plans per patient basis will be calculated.', 'timeFrame': '1 month'}, {'measure': 'Incremental pathological confirmation of the diagnosis of lung cancer in patients with only a clinical diagnosis, following endosonographic staging.', 'timeFrame': '1 month'}, {'measure': 'Complication rate of a complete endosonographic procedure in this patients group', 'timeFrame': '1 month'}]" 127,NCT02394548,"{'fullName': 'Massachusetts General Hospital', 'class': 'OTHER'}",Phase I Trial Of IMRT Using A Contralateral Esophagus Sparing Technique (CEST) In Locally Advanced Lung Cancer,COMPLETED,This research study is examining the benefit of a novel radiation planning approach on the likelihood of developing severe esophagitis (irritation and inflammation of the esophagus) during the course of radiation therapy with concurrent chemotherapy which is associated with very painful and difficult swallowing.,"['Non-small Cell Lung Carcinoma', 'Small Cell Lung Carcinoma']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'RADIATION', 'name': 'Contralateral Esophageal Sparing Technique (CEST)', 'description': 'Determine whether CEST decreases rate of severe acute esophagitis', 'armGroupLabels': ['Contralateral Esophagus Sparing Technique (CEST)']}]","Inclusion Criteria: Participants must meet the following criteria on screening examination to be eligible to participate in the study. * Histologically or cytologically proven diagnosis of NSCLC or SCLC * NSCLC, patients with clinical stage IIB-IV patients (AJCC, 7th ed.) are eligible, and for SCLC, limited-stage patients are eligible, if documented to be a candidate for definitive radiation and concurrent chemotherapy in the radiation oncologist or medical oncologist clinic note. * Stage IV NSCLC patients are eligible only if they have a solitary brain metastasis * Patients with non-malignant pleural effusion are eligible. --- If a pleural effusion is present, the following criteria must be met to exclude malignant involvement: * When pleural fluid is visible on both the CT scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative. * Exudative pleural effusions are excluded, regardless of cytology; * Effusions that are minimal (ie, not visible on chest x-ray) that are too small to safely tap are eligible. * Gross tumor (primary tumor or involved lymph node) must be within 1 cm of esophagus on the most recent chest CT scan. * ECOG performance status 0-1 within 30 days prior to registration; * Age ≥18 * Women of childbearing potential must indicate that there is not a possibility of being pregnant at the time of enrollment or have a negative serum pregnancy test prior to the initiation of radiation therapy. * Women of childbearing potential and male participants must practice adequate contraception. * Patient must provide study-specific informed consent prior to study entry. Exclusion Criteria: Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study. * Greater than minimal, exudative, or cytologically positive pleural effusions * Tumor suspected or known to invade the esophagus * Prior chemotherapy if this precludes administration of concurrent chemotherapy for protocol treatment. Note that induction chemotherapy is allowed as long as concurrent chemotherapy is possible. * Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields * Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive. Protocol-specific requirements may also exclude immuno-compromised patients. * Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic. * Any history of allergic reaction to chemotherapies used",NA,ALL,NA,"[{'measure': 'Number of Participants With Grade 3 or Higher Acute Esophagitis (CTCAE)', 'description': 'Esophagitis will be measured using the Common Toxicity Criteria for Adverse Effects (CTCAE) v4 scoring scale', 'timeFrame': 'up to 3 months'}]","[{'measure': 'Number of Participants With Grade 3 or Higher Acute Esophagitis (RTOG)', 'description': 'Esophagitis will be measured using the historical Radiation Therapy Oncology Group (RTOG) scoring scale', 'timeFrame': 'Baseline , up to 3 Months'}, {'measure': 'Number of Participants With Adverse Events', 'description': 'Adverse events will be measured using CTCAE v4 scoring scale', 'timeFrame': 'Baseline, up to 2 Years'}, {'measure': 'Rate of Local and Regional Failure', 'description': 'Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) guideline. No isolated locoregional tumor failures at a median follow-up of up to 2 years.', 'timeFrame': 'Median follow-up of up to 2 years'}, {'measure': 'Overall Survival Rate', 'description': 'Follow-up time will be calculated from the date of registration to the date of death or the last follow-up date on which the patient was reported alive. Overall survival rates will be estimated using the Kaplan-Meier method.', 'timeFrame': '2 Years'}]" 128,NCT01830426,"{'fullName': 'Epic Sciences', 'class': 'INDUSTRY'}",Circulating Tumor Cells in Non-Small Cell Lung Carcinoma,COMPLETED,"The purpose of this study is to establish the circulating tumor cell (CTC) assay as a surrogate for tissue diagnosis of suspected primary lung cancer. This is done through evaluating clinical and molecular markers to stratify the outcome/survival in patients with thoracic malignancies treated at Yale University/Yale-New Haven Hospital, University of California San Diego/Moores Cancer Center, Billings Clinic Cancer Center.",['Primary Lung Cancer'],OBSERVATIONAL,"{'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}",NA,"Inclusion Criteria: * Suspected lung cancer * Planned to undergo tissue biopsy. Tissue biopsy does not need to be limited to an intrathoracic structures. Biopsies of the supraclavicular lymph nodes are allowed * Age \>18 Exclusion Criteria: * Patients with history of a separate (not a primary lung cancer) malignancy within past two years. * Recent history (past two weeks) of trauma (INCLUDING diagnostic surgery, biopsy, etc) * Prior lung cancer treatment chemotherapy, radiation, surgery, etc. in past two years. * Inability to provide informed consent. * Hgb less than 8.","A primary lung cancer bearing population will be studied. Eligible patients will include those presenting to the specified clinical centers with a tissue confirmed primary lung cancer or radiographic abnormality deemed highly suspicious for primary lung cancer by collaborating clinical team, in whom definitive tissue diagnosis is planned. All stages of primary lung cancer will considered.",ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'CTC Enumeration', 'description': 'After informed consent of the patients, a single tube of blood will be drawn and processed according to the standard protocol. These blood draws will occur upon patient screening or rather the baseline of their treatment, a 6-12 week follow-up, as well as a 12 month follow-up.Furthermore, a biopsy will be taken between baseline and 6-12 week follow-up which will be used upon results of CTC enumeration to illustrate concordance. Epic Sciences staff is fully blinded to the clinical data of the patients until final analysis. Patients will be considered CTC positive at a count of greater than 2 CTCs per ml of blood.', 'timeFrame': '3 months from baseline, an average of 2 weeks post patient tissue biopsy'}]","[{'measure': 'Lung Cancer Subtyping', 'description': 'Based on the blood draws from the primary outcome, Epic will utilize the identified CTCs as biopsy material for lung cancer subtyping that distinguishes between adenocarcinoma (ACA), squamous cell carcinoma (SCC) from other types of primary lung cancer. Lung cancer histology will be evaluated for each patient sample: Two slides will be run with the ACA-CTC assay (TTF1 or Napsin A) and two slides will be run with the SCC-CTC (p63) assay. For the purpose of assay development and validation, we have all already procured a validated set of patient samples with known histology.', 'timeFrame': '3 months from baseline, an average of 2 weeks post patient tissue biopsy'}, {'measure': 'Nodal Staging', 'description': 'For patients ultimately diagnosed with lung cancer and deemed to be surgical candidates, surgical intervention will be performed. In accordance to a standard practice mediastinal lymph node dissection will accompany the surgery. Nodal staging for each patient in the trial with diagnosed lung cancer will be evaluated clinically and pathologically. Clinical staging will be determined by the treating clinician prior to information being available from surgery and recorded in the case report form. The diagnostic accuracy of the clinical stage will be determined by comparison with the pathological stage which will be abstracted from the pathology report for surgically staged patients. We will determine the sensitivity and specificity of the CTC count as a test that identifies patients who will ultimately be ""upstaged"" from N0 to N1 or from N1 to N2-3 at the time of surgical staging when comparing the clinical and pathological stage.', 'timeFrame': '3 months from baseline, an average of 2 weeks post patient tissue biopsy'}, {'measure': 'Establish the Prognostic Value by measuring CTC count over time.', 'description': 'This measure will work to establish the prognostic value of the initial test by drawing the correlation with outcome data. For the 260 patients recruited to this clinical trial, stage specific Kaplan-Meier overall and disease free survival curves for the population will be generated after 2 years of follow-up. For each stage, the results of the CTCs will then be used to separate the population for each stage into a low CTC and high CTC group to determine if the disease free survival curves for each stage separate on the basis of the assay and are statistically significant using a retrospective analysis of the prospectively collected data, this will determine if knowledge of the CTC assay provides useful information about disease free survival beyond that which is obtained by clinical staging alone.', 'timeFrame': 'Baseline, 3 months, 24 months and 66 months'}]" 129,NCT07718243,"{'fullName': 'Institute of Cancer Research, United Kingdom', 'class': 'OTHER'}","Investigating the Combination of Bexmarilimab and Nivolumab in Solid Tumours, Melanoma and NSCLC",NOT_YET_RECRUITING,"The trial will test if the combination of bexmarilimab and nivolumab can help patients whose cancers have stopped responding to immunotherapy treatment. It will focus on two cancers: non-small cell lung cancer and melanoma. Early research suggests bexmarilimab may change some immune cells inside the tumour so they create a stronger ""attack"" signal, which could help other immune cells recognise and kill cancer cells more effectively. This may make it easier for PD-1 immunotherapy drugs to work again by helping the immune system stay active against the tumour. This is a Phase I/II clinical trial. In Phase I, researchers will give increasing doses of bexmarilimab together with a standard (fixed) dose of nivolumab to patients with solid tumours, to find the safest and most suitable dose to use going forward (the recommended Phase 2 dose). In Phase II, the study will treat two groups of patients-one with non-small cell lung cancer and one with melanoma-using that selected dose.","['Melanoma (Skin Cancer)', 'Non Small Cell Lung Cancer', 'Solid Tumor in Advanced Stage']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Bexmarilimab 1mg/kg and nivolumab 1mg/kg', 'description': 'Dose Level 1', 'armGroupLabels': ['Phase I: Dose Escalation']}, {'type': 'DRUG', 'name': 'Bexmarilimab 3mg/kg and nivolumab 1mg/kg', 'description': 'Dose Level 2', 'armGroupLabels': ['Phase I: Dose Escalation']}, {'type': 'DRUG', 'name': 'Recommended Phase II Dose', 'description': 'Recommended Phase II Dose of bexmarilimab in combination with nivolumab established from Dose Escalation', 'armGroupLabels': ['Phase II: Dose Expansion']}]","Inclusion Criteria: 1. Part A: Histologically proven solid tumour, refractory to conventional treatment, or for which no conventional therapy exists or is declined by the patient Part B1: Histologically proven NSCLC. * Patient has received at least one but not more than three lines of systemic anticancer therapy for metastatic disease. * Patient has received at least two cycles of immune checkpoint inhibitor and has demonstrated disease progression within 12 weeks of last dose. * Patient has had a benefit to prior immune checkpoint inhibitor defined as greater than 6 months of treatment or partial response. * Patients with actionable EGFR, ALK, or other known genomic alterations must have received at least 1 relevant targeted therapy treatment if available. Part B2: Histologically proven cutaneous melanoma. * Patient has received at least one but not more than three lines of systemic anticancer therapy for metastatic disease. * Patient has received at least two cycles of immune checkpoint inhibitor and has demonstrated disease progression within 12 weeks of last dose. * Patients with BRAF mutations must have received relevant targeted therapy. * Patient has had a benefit to prior immune checkpoint inhibitor defined as greater than 6 months of treatment or partial response 2. Life expectancy of at least 12 weeks 3. World Health Organisation (WHO) performance status of 0-1 (Appendix 2) 4. Measurable disease as assessed by iRECIST 5. Biologically female patients are eligible to participate in the trial if they are not pregnant, not breast feeding and meet one of the following criteria: 1. a biological woman of childbearing potential (WOCB) who has a negative serum or urine pregnancy test before enrolment and agrees to use a highly effective form of contraception (refer to Appendix 3) from signing the consent form, throughout the trial and for six months afterwards. A biological woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. 2. A biological woman of non-childbearing potential; a postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in biological women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. 6. Biologically male patients are eligible to participate in the trial if they meet one of the following criteria: 1. is fertile and agrees to use and ensure their partners (if WOCBP) use a highly effective form of contraception (refer to Appendix 3) from signing the consent form, throughout the trial and for six months afterwards. Biological men with pregnant or lactating partners must be advised to use barrier method contraception (refer to Appendix 3) to prevent exposure of the foetus or neonate; a biological man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy 2. is infertile 7. Negative serology for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) 8. Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week (Day -7 to Day 1) prior to the patient's first dose of IMP Laboratory Test Value required Haemoglobin (Hb) ≥ 9.0 g/dL Absolute neutrophil count ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L Serum bilirubin ≤ 1.5 x ULN; with the following exception: Patients with known Gilbert disease who have serum bilirubin level ≤ 3 × ULN may be enrolled ALT ≤ 2.5 x ULN unless raised due to tumour in which case up to 5 x ULN is permissible AST ≤ 2.5 x ULN unless raised due to tumour in which case up to 5 x ULN is permissible Renal function Calculated creatinine clearance (using the Wright, Cockcroft \& Gault formula) Glomerular filtration rate ≥ 30 mL/min (uncorrected value) 9. 18 years or over 10. Written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up Exclusion Criteria: 1. Radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy or chemotherapy during the previous four weeks (six weeks for nitrosoureas, Mitomycin-C) and 4 weeks for investigational medicinal products) before treatment. 2. Ongoing toxic manifestations of previous treatments. Exceptions to this are alopecia/vitiligo, treated endocrinopathies (i.e. on physiological doses of endocrine replacement) or certain Grade 1 toxicities, which in the opinion of the Investigator and the CI should not exclude the patient. 3. Known untreated or active central nervous system (CNS) metastases (progressing or requiring corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible, provided they meet all of the following criteria: * Evaluable or measurable disease outside the CNS is present. * Radiographic stability upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the baseline disease assessment * Not requiring corticosteroids. 4. Major thoracic or abdominal surgery from which the patient has not yet recovered. 5. At high medical risk because of non-malignant systemic disease including active uncontrolled infection. 6. Known to be serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus. 7. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment 8. Has an active autoimmune disease that has required systemic treatment in past 3 months (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs) or is at risk of recurrence. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Patients with a history of inflammatory bowel diseases such as Crohn's disease or ulcerative colitis will be excluded from the study. Patients with Sjogren's syndrome will not be excluded from the study. 9. Are receiving chronic systemic steroids (\> 10 mg/day prednisone equivalent). Use of topical, inhalational, intranasal, and intraocular steroids will be permitted. 10. Patients that experienced a Grade 3 or higher immune-related AEs from prior treatment with immunotherapy will be excluded from the study. 11. Has received a live vaccine within 30 days of planned start of study therapy. Note: The inactivated virus vaccines used for seasonal influenza vaccines for injection are allowed; however intranasal influenza vaccines (e.g. FluMist®) are live attenuated vaccines and are not allowed. 12. Any of the following cardiac criteria: * Mean resting corrected QT interval (QTc) \> 470 msec obtained from 3 consecutive electrocardiograms (ECGs) within 5 minutes of each other. * Known congenital QT syndrome or history of torsades de pointes. Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG, e.g. complete left bundle branch block, third degree heart block. Controlled atrial fibrillation is allowed. * Experience of any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association \[NYHA Grade 2 or above\], severe valvular disease, uncontrolled hypertension despite optimal therapy. 13. Prior bone marrow transplant, allogenic tissue/solid organ transplant or have had extensive radiotherapy to greater than 25% of bone marrow within eight weeks. 14. Current malignancies of other types, with the exception of adequately treated cone biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. An exception to this criteria are cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for three years or more and are deemed at negligible risk for recurrence, are eligible for the trial. 15. Is a patient or plans to participate in another interventional clinical trial, whilst taking part in this study. Participation in an observational trial would be acceptable. 16. Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial. 17. Symptoms of COVID-19 and/or documented COVID-19 infection 18. Hypersensitivity to the active substance or to any of the IMP excipients 19. Active or known pre-existing or history of non-infectious/interstitial lung disease/pneumonitis",NA,ALL,NA,"[{'measure': 'To establish a recommended Phase II dose (RP2D) of bexmarilimab in combination with nivolumab', 'timeFrame': 'At the end of Cycle 2 (Cycle 1 is 28 days and Cycle 2 is 21 days)"".'}, {'measure': 'Determining causality of each adverse event to bexmarilimab and nivolumab and grading severity according to the NCI CTCAE Version 5.0', 'timeFrame': 'From the start of treatment until the end of the trial (due to documented disease progression or withdrawal of consent or toxicity), with follow-up continuing for 28 days after the last dose of the IMP.'}, {'measure': 'Evaluation of disease response by RECIST criteria version 1.1, immune-modified RECIST (iRECIST) and thus overall response rate', 'timeFrame': 'From date of enrolment until the date of first documented progression, assessed up to 48 months'}]","[{'measure': 'Evaluation of disease response by RECIST criteria version 1.1, iRECIST and thus response rate, clinical benefit rate, radiological PFS and overall survival.', 'timeFrame': 'From date of enrolment until the date of first documented progression, assessed up to 48 months'}, {'measure': 'Determination of changes in markers of target inhibition and immune microenvironment in tumour and blood.', 'timeFrame': '48 months'}]" 130,NCT06806930,"{'fullName': 'George Washington University', 'class': 'OTHER'}",Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT),RECRUITING,"The goal of this clinical trial is to determine how the duration of hormone blocking (endocrine) therapy given prior to surgery (called ""neoadjuvant"" treatment) affects breast cancer. The main questions the trial aims is answer are: 1. How breast cancer responds to endocrine therapy given prior to surgery? 2. To predict tumor pre-operative endocrine prognostic index (PEPI) score for subjects enrolled in cohort B or C Participants with early-stage breast cancer (Stage I-III) who are eligible for Neoadjuvant Endocrine Therapy (NET) will be enrolled in the study. Participants will: * receive endocrine therapy as part of regular care for breast cancer * consent to samples of blood and tissue evaluation to determine how endocrine therapy effects the tumor * participate in this research anywhere from 2 weeks to 1 year, depending on duration of endocrine therapy and when surgery will be performed","['Breast Cancer Stage I', 'Breast Cancer Stage II', 'Breast Cancer Stage III', 'Carcinoma, Breast']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}","[{'type': 'DRUG', 'name': 'Neoadjuvant endocrine therapy', 'description': 'Cohort A: Short duration NET. Patients in this cohort can be treated with NET up to 8weeks (\\<= 8 weeks)', 'armGroupLabels': ['Cohort A: Short Duration NET']}, {'type': 'DRUG', 'name': 'Neoadjuvant endocrine therapy', 'description': 'Cohort B: Intermediate duration NET. Patients in this cohort can be treated with NET \\> 8weeks but \\<=24 weeks', 'armGroupLabels': ['Cohort B: Intermediate Duration NET']}, {'type': 'DRUG', 'name': 'Neoadjuvant endocrine therapy', 'description': 'Cohort C: Extended duration NET. Patients in this cohort can be treated with NET \\>24 weeks but \\<= 52 weeks', 'armGroupLabels': ['Cohort C: Extended Duration NET']}]","Inclusion Criteria: * Be capable of understanding the investigational nature of the study and all pertinent aspects of the study * Be capable of signing and providing written consent in accordance with institutional and federal guidelines * Histologically or cytologically confirmed diagnosis of invasive carcinoma of the breast * Clinical stage 1 to 3 breast cancer * Candidate for surgical resection * Estrogen receptor \> 10% positive stained cells based on most recent tumor biopsy and documented by a local laboratory or medical record. * HER2 negative or HER2 low breast cancer based on the most recent tumor biopsy and documented by a local laboratory or medical record. HER2 negative tumor is defined per American Society of Clinical Oncology and the College of American Pathologists guidelines, 2018. Patients with HER2 low tumors are eligible as long as patients are not candidates for any HER2 directed therapy. * Ability to take oral medication * Be willing and able to comply with scheduled visits, treatment plan, and follow up with research staff * Age ≥ 21 years Exclusion Criteria: * Inability to comply taking NET * Inability to comply to study procedures",NA,ALL,NA,"[{'measure': 'Response to neoadjuvant endocrine therapy (NET)', 'description': 'Response to neoadjuvant endocrine therapy is defined as clear margins (defined as greater than 1mm) measured in the surgical pathology report. The proportion of women in each cohort with response will be estimated with exact 95% binomial confidence intervals. This is a categorical outcome (Success/Failure). Success is defined as clear margins \\>1mm; Failure is defined as margins ≤1mm.', 'timeFrame': 'From enrollment to the end of treatment at <=52 weeks'}]","[{'measure': 'Physicians will predict Preoperative Endocrine Prognostic Index (PEPI) score after NET for subjects enrolled in cohort B or C', 'description': 'Preoperative Endocrine Prognostic Index (PEPI) score is determined from surgical pathology report. The score ranges from 0 to 12. The score is a composite of tumor size, nodal status, Ki67 level, and ER status. Higher scores indicate a worse outcome (increased risk of relapse), while a score of 0 (PEPI-0) represents a superior prognosis.', 'timeFrame': 'From enrollment to the end of treatment at <=52 weeks'}, {'measure': 'Physicians will predict Ki67 after NET: Ki67 Labeling Index (percentage of Ki67-positive tumor cells).', 'description': 'Physicians will make a prediction of what the Ki67 will be in the surgical pathology specimen. It will correlate with the surgical pathology report data recorded by pathologist. Ki67 measures the proportion of actively dividing cancer cells. Higher scores indicate a worse outcome (higher cell proliferation and potentially more aggressive disease). Scores range from 0% to 100%.', 'timeFrame': 'From enrollment to the end of treatment at <=52 weeks'}]" 131,NCT00553800,"{'fullName': 'Fox Chase Cancer Center', 'class': 'OTHER'}",Study of Bevacizumab and Erlotinib in Patients With Advanced Non-small Cell Lung Cancer,COMPLETED,This study will evaluate the combination of bevacizumab and erlotinib in elderly patients with advanced non-small cell lung cancer.,"['Carcinoma, Non-Small-Cell Lung']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'bevacizumab', 'armGroupLabels': ['Bevacizumab & Erlotinib'], 'otherNames': ['Other names: Avastin']}, {'type': 'DRUG', 'name': 'Erlotinib', 'armGroupLabels': ['Bevacizumab & Erlotinib'], 'otherNames': ['Other name: Tarceva']}]","Inclusion Criteria: * Cytologically or histologic confirmed non-small cell lung cancer, stage IIIB or IV or recurrent after primary surgery or radiotherapy. * ECOG PS 0-1 * 70 years of age or older * Must have measurable disease * ANC \> 1500, platelets \> 100,000 * Total bilirubin \/= 1.0 * Prior treatment with an investigational or marketed inhibitor of the EGFR pathway or anti-angiogenesis agent (includes thalidomide) * Prior treatment for advanced stage disease, with the exception of surgery or radiation (no systemic) * History of gross hemoptysis within 1 month of enrollment unless treated with surgery or radiation * Evidence of bleeding diathesis or coagulopathy or other serious/acute internal bleeding within 6 months of enrollment. * Current, ongoing treatment with full dose warfarin or equivalent * Current(within 10 days)use of aspirin (\> 325mg/day) or other NSAID with antiplatelet activity * History of hemorrhagic or thrombotic stoke, TIA, or other CNS bleeding w/in last 6 months. Clinically significant PVD * Known CNS disease except for treated brain mets. * Squamous cell histology * Blood pressure \> 150/100 that cannot be ameliorated with standard anti-hypertensives * History of hypertensive crisis or hypertensive encephalopathy * NYHA grade II or \> CHF * History of MI within 6 months of enrollment * Major surgery, open biopsy, significant trauma within 28 days of enrollment * Pregnancy, lactation * Abdominal or other fistula, abcess, perforation",NA,ALL,NA,"[{'measure': 'Progression Free Survival (PFS)', 'description': 'Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions', 'timeFrame': '3 years'}]",NA 132,NCT03130192,"{'fullName': 'Chung Shan Medical University', 'class': 'OTHER'}","A Study of the Correlation Between CRF, Survival and Physiological Factors in NSCLC Patients Under Chemotherapy",UNKNOWN,"Worldwide, non-small cell lung cancer (NSCLC) is one of the most common causes of cancer mortality. Also, the first leading cause of death is lung cancer in Taiwan 2012. Most patients are diagnosed at advanced stages and their median survival with supportive care is only 3-6 months. The common regimens used on advanced NSCLC treatment consists of platinum-based doublet chemotherapy, the survival benefit of which is able to extend the survival to approximately 10 months. However, disease and treatment-related toxicities in cancer patients may result in fatigue and interfered quality of life (QoL). According to the others reports, eight QoL areas including physical functioning, fatigue, pain, and appetite loss have been showed a statistically significant association with survival rate of NSCLC patients. Cancer-related fatigue (CRF), an indicator of QoL, has been reported as the most frequent and distressing toxicity of lung cancer chemotherapy. Proposed criteria for CRF have been adopted for inclusion in the International Statistical Classification of Disease and Related Health Problems, Tenth Revision, Clinical Modification (ICD-10-CM). Therefore, more in-depth researches on CRF are needed in Taiwan. In addition, electrolyte disturbance like hyponatremia has been reported to be counted as one of the many contributing factors for fatigue in palliative care patients and associated with poorer overall survival rate (OS) in lung cancer. Thus, the correlation between CRF and electrolyte possibly would be a strong link for physician to improve the QoL and survival rate of NSCLC patients. The objective of this observational study is to evaluate the correlation between CRF, survival and physiological factors in NSCLC patients under chemotherapy. The study will compare the effect of QoL and CRF on survival with or without CRF treatment and investigate the correlation between the variation of CRF and physiological factors which have been examined and recorded on medical record under clinical practice. These results will supply physicians with more understanding about CRF, and help them to enhance the quality on lung cancer care to being perfected in the future.",['Non-small Cell Lung Cancer'],OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}",NA,"Inclusion Criteria: * Patients who signed the informed consent form. * Aged 20 years and older. * Patients who have been given a diagnosis of stage II-IV NSCLC cancer. * Patients who are under/ or scheduled for chemotherapy treatment. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. * Patients who are able to complete QoL questionnaires. Exclusion Criteria: * Patients have enrolled or have not yet completed other investigational drug trials within 30 days before screening.",Non-small cell lung cancer (NSCLC) patients with chemotherapy,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Cancer-related fatigue evaluation by brief fatigue inventory-Taiwanese form (BFI-T)', 'timeFrame': 'Change from baseline cancer-related fatigue at 6 chemotherapy cycles (24 weeks)'}]","[{'measure': 'Quality of life assessments by functional assessment of cancer therapy-general 7 (FACT-G7)', 'timeFrame': 'Change from baseline quality of life at 6 chemotherapy cycles (24 weeks)'}]" 133,NCT00095836,"{'fullName': 'Massachusetts General Hospital', 'class': 'OTHER'}",Gefitinib in Treating Patients With Locally Advanced or Metastatic Thyroid Cancer That Did Not Respond to Iodine Therapy,COMPLETED,"RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have locally advanced or metastatic thyroid cancer that did not respond to iodine therapy.",['Head and Neck Cancer'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Gefitinib', 'description': 'Taken orally once a day for duration of benefit. Treatment is continuous until there is evidence of disease progression or unacceptable toxicity.', 'armGroupLabels': ['Gefitinib 250mg'], 'otherNames': ['ZD1839', 'IRESSA']}]","Inclusion Criteria: 1. Histologically or cytologically confirmed thyroid cancer, metastatic or locally advanced, not amenable or refractory to local therapy and/or radioactive iodine, depending on the cell type. 2. Thyroid cancer that is unresponsive or refractory to radioactive iodine. All medullary and anaplastic thyroid carcinomas will be considered unresponsive on the basis of histopathologic diagnosis alone. Well-differentiated thyroid cancers (papillary and follicular) will be considered refractory if either there is no evidence of uptake on radioactive iodine scanning or tumor growth persists in spite of treatment with radioactive iodine. 3. Measurable disease. 4. Patient is at least 18 years of age. 5. Eastern Cooperative Oncology Group performance status of 0-2. 6. If female and of reproductive potential, a negative β-HCG (human chorionic gonadotropin) and use of effective birth control for the course of the study. 7. Patient is capable of providing signed, informed consent. Exclusion Criteria: 1. Concurrent chemotherapy, concurrent systemic anticancer treatment, or concurrent radiation therapy. Patients will not be excluded from the study on the basis of prior radiation therapy. 2. Treatment with a non-approved or investigational drug within 30 days before Day 1 of trial treatment. 3. Currently pregnant or nursing. 4. Absolute neutrophil count \<1.5 × 109/L, platelet count \< 75 × 109/L, bilirubin \> 1.5 × normal, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 × normal. 5. Serum creatinine greater than Common Toxicity Criteria (CTC) grade 2. 6. Concomitant use of phenytoin, carbamazepine, barbiturates, rifampin, St John's Wort. 7. Concomitant use of systemic retinoids, cyclosporine, verapamil, diltiazem, nicardipine, nifedipine, nitrendipine, erythromycin, theophylline, ketoconazole, itraconazole, and antihistamines such as terfenadine and astemizole. 8. Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy. 9. Incomplete healing from previous oncologic or other major surgery. 10. Known severe hypersensitivity to ZD1839 or any of the excipients of this product. 11. As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease). 12. Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the trial. 13. Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)",NA,ALL,NA,"[{'measure': 'Objective Tumor Response Rate at 3, 6, and 12 Months', 'description': 'Response rate as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Tumor assessment is performed within 4 weeks of initiation of treatment and then every 8 weeks. If a patient has stable disease for four tumor assessments (6 months), then tumor assessment may occur every 4 months. If the patient continues to experience stable disease after 2 years, tumor assessments may occur every 6 months. If the patient continues to experience stable disease after 5 years, tumor assessments may occur once a year.\n\nComplete Response (CR): Disappearance of all target lesions\n\nPartial Response (PR): At least a 30% decrease in the sum of diameters of target lesions\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions\n\nStable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD', 'timeFrame': '3 Months, 6 Months, 1 Year'}]","[{'measure': 'Toxicity', 'description': 'Drug related toxicity as assessed by NCI CTCAE that occurred in more than 10% of patients', 'timeFrame': 'Through study completion, on average 12 months'}, {'measure': 'Median Progression-free Survival', 'description': 'The median progression-free survival as assessed by RECIST criteria (Response Evaluation Criteria In Solid Tumors) measured from the time of enrollment until disease progression or death.\n\nProgressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of new lesions.', 'timeFrame': 'From the time of enrollment until disease progression or death, whichever came first'}, {'measure': 'Overall Survival', 'description': 'The median overall survival time, measured from the time of enrollment until death.', 'timeFrame': '5 years'}]" 134,NCT06769971,"{'fullName': 'Sichuan University', 'class': 'OTHER'}",Phase II Study of Ivonescimab and Cadonilimab in Combination with Chemotherapy in Patients with ES-SCLC,RECRUITING,"This is a phase II study. All patients are treatment naive extensive stage small cell lung cancer(ES-SCLC), Eastern Cooperative Oncology Group (ECOG) performance status 0-1. The purpose of this study is to evaluate the efficacy and safety of Ivonescimab and Cadonilimab in combination with chemotherapy in patients with ES-SCLC.",['Small Cell Lung Cancer'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Ivonescimab', 'description': '20mg/kg，IV infusion，Day1，Q3W', 'armGroupLabels': ['ES-SCLC :Ivonescimab and Cadonilimab plus Chemotherapy']}, {'type': 'DRUG', 'name': 'Cadonilimab', 'description': '10mg/kg，IV infusion，Day8，Q6W', 'armGroupLabels': ['ES-SCLC :Ivonescimab and Cadonilimab plus Chemotherapy']}, {'type': 'DRUG', 'name': 'Etoposide', 'description': '100mg/kg，IV infusion，Day1-3，Q3W', 'armGroupLabels': ['ES-SCLC :Ivonescimab and Cadonilimab plus Chemotherapy']}, {'type': 'DRUG', 'name': 'Carboplatin', 'description': 'AUC 5，IV infusion，Day1，Q3W', 'armGroupLabels': ['ES-SCLC :Ivonescimab and Cadonilimab plus Chemotherapy']}]","Inclusion Criteria: 1.Ability to understand and voluntarily sign a written informed consent form (ICF), which must be signed before the specified study procedures required for the study are performed； 2.18 to 75 years old (at the time of inform consent obtained)； 3.Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1； 4.Have a life expectancy of at least 3 months； 5.Have histologically- or cytologically-confirmed diagnosis of Extensive Stage SCLC； 6.Had not received previous systemic therapy; Or ES-SCLC patients who had received definitive chemoradiotherapy for limited-stage small-cell lung cancer but had disease progression \> 6 months earlier; 7.Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator； 8.Be able to provide formalin fixed, paraffin-embedded (FFPE) tumor tissue obtained from either a core or excisional tumor biopsy； 9.Have adequate organ function； 10.All female and male subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 120 days after the last dose of study treatment； Exclusion Criteria: 1. Active malignancies within the past 5 years, with the exception of tumors in this study and cured local tumors； 2. Received palliative local treatment, non-specific immunomodulatory treatment within 2 weeks prior to the first dose; and Chinese herbal medicine or traditional Chinese medicinal products with anti-tumor indications within 1 weeks prior to the first dose； 3. Subjects who received any prior treatments targeting the mechanism of tumor immunity； 4. Subjects who received any prior anti-angiogenic therapy； 5. Tumor surrounds important blood vessels or has obvious necrosis, cavitation, or invades surrounding important organs and blood vessels； 6. Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment； 7. Symptomatic metastases of the central nervous system； 8. Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage； 9. History of perforation of the gastrointestinal tract and/or fistula, history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection, complicated by chronic diarrhea) within 6 months before the first study drug administration； 10. Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected); 11. History of myocardial infarction, unstable angina, cardiac or other vascular stenting, angioplasty, or surgery within 12 months prior to day 1 of study treatment; 12. Severe infection within 4 weeks prior to the first dose, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; active infection that has received systemic anti-infective therapy within 2 weeks prior to the first dose (excluding antiviral therapy for hepatitis B or C)； 13. Concurrent enrollment in another clinical study, unless it is a noninterventional clinical study or the follow-up period of the interventional study is more than 4 weeks from the last dose of the prior clinical study or more than 5 half-lives of the prior study drug, whichever is shorter.",NA,ALL,NA,"[{'measure': 'ORR', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Safety', 'description': 'Grade 3-4 AEs', 'timeFrame': 'Up to approximately 2 years'}]","[{'measure': 'DCR', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'DOR', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'TTR', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'PFS', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'OS', 'timeFrame': 'Up to approximately 2 years'}]" 135,NCT07257471,"{'fullName': 'Beijing Haidian Hospital', 'class': 'OTHER'}",Application Research of Methylation Markers in Early-stage Lung Cancer Patients Treated With Co-ablation System Therapy,RECRUITING,"Lung cancer has the highest global incidence and mortality among malignancies. While surgery is the primary curative treatment for early-stage patients, approximately 25-35% are ineligible due to comorbidities. For these patients, Co-ablation system therapy is a key minimally invasive option. However, even after imaging indicates complete tumor removal (""tumor-free status""), minimal residual disease (MRD) may persist, leading to recurrence. Current mainstream MRD detection relies on identifying mutations in circulating tumor DNA (ctDNA). This approach faces challenges like high mutational heterogeneity and the frequent need for tumor tissue sequencing (Tumor-informed). In contrast, DNA methylation markers offer advantages: they do not require prior knowledge of tumor mutations, appear early in tumorigenesis, are tissue-specific, and allow sensitive detection via multiple consistent CpG sites. Recent studies confirm that ctDNA methylation-based MRD detection can predict recurrence in lung and colorectal cancers earlier than imaging and effectively stratify patient risk. This study aims to investigate the role of SHOX2 and PTGER4 genes in plasma, for monitoring MRD and evaluating therapeutic efficacy in lung cancer patients after Co-ablation system therapy. The study will enroll non-small cell lung cancer (NSCLC) patients undergoing Co-ablation system therapy. Peripheral blood will be collected at multiple timepoints (pre-treatment up to 24 months post-treatment) for ctDNA methylation analysis. The correlation between methylation levels and radiological findings will be assessed. The predictive power for recurrence will be evaluated using ROC curves. Patients will be stratified into high-risk and low-risk groups based on methylation status. Kaplan-Meier survival analysis and Cox regression models will compare recurrence-free survival between groups and evaluate the independent predictive value of SHOX2/PTGER4 methylation for recurrence risk, providing a scientific basis for personalized treatment decisions and recurrence prediction.",['Lung Cancer (NSCLC)'],OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}",NA,"Inclusion Criteria: * Diagnosed with non-small cell lung cancer by histopathology/clinical diagnosis; assessed by MDT as not suitable or refusing open or thoracoscopic resection surgery. * Age 18-85 years old, gender unrestricted. * The maximum diameter of the tumor is ≤ 5 cm (peripheral type) or ≤ 3 cm (central type), and the distance from major blood vessels/trachea is ≥ 1 cm. * Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1, with an expected survival period of ≥ 6 months. * The subjects should have clear case information, including age, gender, and clinical diagnosis, etc. Exclusion Criteria: * Those with a history of other malignant tumors or autoimmune diseases。 * Pregnant or lactating women; or patients with lung cancer who were negative for methylation before treatment. * Patients with clinical or pathological diagnosis of lung metastatic cancer. * Ppatients with multiple nodules and the current treatment cannot completely address all positive nodules. * Patients whose clinical information or follow-up during the study may not be completed; and other factors that the researcher deems unsuitable for participation in this study.","Patients with non-small cell lung cancer (NSCLC) diagnosed by histopathology/clinical diagnosis and scheduled for Co-ablation system therapy were selected, with ages ranging from 18 to 85 years old. All enrolled patients had peripheral blood drawn within one week before treatment, and at 3 days, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months after treatment for the detection of SHOX2/PTGER4 methylation in plasma circulating tumor DNA (ctDNA).",ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'The median lead time of SHOX2/PTGER4 methylation compared with traditional methods (tumor markers, imaging) for prediction.', 'description': 'Measure time point of outcome: Preoperatively, 3 days, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively, and at the time of recurrence.\n\nMeasure method: SHOX2/PTGER4 Methylation Detection Kit (PCR Fluorescence Method).', 'timeFrame': 'Through study completion, an average of 2 years.'}, {'measure': 'Disease-free survival: Differences in DFS based on methylation status after treatment.', 'description': 'Measure time point of outcome: Preoperatively, 3 days, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively, and at the time of recurrence.\n\nMeasure method: Kaplan-Meier method.', 'timeFrame': 'Through study completion, an average of 2 years.'}, {'measure': 'Dynamic concentration changes: The relative change rate of methylation levels before and after treatment and during recurrence.', 'description': 'Measure time point of outcome: Preoperatively, 3 days, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively, and at the time of recurrence.\n\nMeasure method: SHOX2/PTGER4 Methylation Detection Kit (PCR Fluorescence Method).', 'timeFrame': 'Through study completion, an average of 2 years.'}]","[{'measure': 'The rate of methylation ""turning negative"" after treatment', 'description': 'Measure time point of outcome: Preoperatively, 3 days, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively, and at the time of recurrence.\n\nMeasure method: SHOX2/PTGER4 Methylation Detection Kit (PCR Fluorescence Method).', 'timeFrame': 'Through study completion, an average of 2 years.'}, {'measure': 'The relationship between methylation status and overall survival.', 'description': 'Measure time point of outcome: Preoperatively, 3 days, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively, and at the time of recurrence.\n\nMeasure method: Multivariate Cox regression, Log-rank test', 'timeFrame': 'Through study completion, an average of 2 years.'}, {'measure': 'Forecast performance', 'description': 'Measure time point of outcome: Preoperatively, 3 days, 1 month, 3 months, 6 months, 12 months, 18 months and 24 months postoperatively, and at the time of recurrence.\n\nMeasure method: Receiver Operating Characteristic Curve.', 'timeFrame': 'Through study completion, an average of 2 years.'}]" 136,NCT00684099,"{'fullName': 'Hellenic Oncology Research Group', 'class': 'OTHER'}",Docetaxel/Pemetrexed as 1st Line Treatment in Patients With Non Small Cell Lung Cancer (NSCLC),COMPLETED,This trial will determine the maximum tolerated dose the recommended phase II dose and the efficacy of this combination in locally advanced or metastatic NSCLC patients,['Non Small Cell Lung Cancer'],INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Docetaxel', 'description': 'Docetaxel at starting dose of 65 mg/m2 IV on day 1 every 3 weeks for a total of 6 cycles', 'armGroupLabels': ['1'], 'otherNames': ['Taxotere']}, {'type': 'DRUG', 'name': 'Pemetrexed', 'description': 'Pemetrexed at starting dose of 400 mg/m2 IV on day 1 every 3 weeks for a total of 6 cycles', 'armGroupLabels': ['1'], 'otherNames': ['Alimta']}]","Inclusion Criteria: * Histologically confirmed inoperable (stage IIIB-IV) NSCLC. A block of Formaline Fixed Parafine Embedded tissue representative for the primary diagnosis should be available for genomic analysis (phase II part) * Written informed consent * Prior chemotherapy with platinum compounds in association with or without taxanes (phase I part) * Previously untreated with docetaxel and pemetrexed (phase II part) * Bidimensionally, non-irradiated measurable disease (according to RECIST criteria) (phase II) * Age ≥18 years * World Health Organization (WHO) performance status (PS) 0-2 * Life expectancy of at least 12 weeks * Serum bilirubin less than 1.5 times the upper normal limit (UNL) * AST and ALT less than 2.5 times the UNL in the absence of demonstrable liver metastases, or less than 5 times the UNL in the presence of liver metastases. * Serum creatinine less than 1.5 times the UNL * Neutrophil count more than 1.5x 109 /L * Platelet count more than 100x 109 /L Exclusion Criteria: * Other co-existing malignancies or malignancies diagnosed within the last 5 years (with the exception of basal cell carcinoma or cervical cancer in situ) * Any evidence of severe uncontrolled concomitant disease (in the opinion of the investigator) * Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy * Patients with unstable central nervous system metastases * Malnutrition (loss of ≥ 20% of the original body weight) * Performance status: 4 * Psychiatric illness or social situation that would preclude study compliance * Pregnant or lactating women",NA,ALL,NA,"[{'measure': 'Evaluation of Dose Limited Toxicity and Maximum Tolerated Dose for the docetaxel/pemetrexed doublet', 'timeFrame': '2 years'}]","[{'measure': 'Response rate for the docetaxel/pemetrexed doublet', 'timeFrame': '2 years'}]" 137,NCT01799499,"{'fullName': 'UroGen Pharma Ltd.', 'class': 'INDUSTRY'}",A Prospective Open Label Comparative Dose Ranging Study Evaluating the Effect of Pre-TURBT Intravesical Instillation of Mitomycin C (MMC) Mixed With TC-3 Gel in Patients With Non Muscle Invasive Bladder Cancer (NMIBC),WITHDRAWN,"This study is a prospective randomized open labeled dose ranging comparative study. Twenty four (24) patients with NMIBC who meet the inclusion/exclusion criteria will be recruited for the study following the initial diagnostic cystoscopy. The investigators believe that this study is of importance on several aspects: 1. It evaluates a new mode of bladder instillation that may bypass the drawbacks of the current instillation mode. 2. If proved effective, this mode of treatment might save the need for TURBT performance and serve as a new mode of tumor ablation. 3. Even if proved partially effective, this mode of treatment will diminish tumors size and/or number, thus enable a more limited TURBT procedure. 4. This mode of treatment will enable immediate medical attendance to the patient's tumor recurrence without the waiting period (resulting from queues in the medical centers) for TURBT. This might improve the patient's prognostic outcome. 5. If this experimental treatment will prove to have a better ablative effect in comparison to the standard of care known in the art, this could be translated to a better prophylactic effect of tumor recurrence. 6. Finding the minimal, yet optimal, effective dose for tumor ablation and tumor recurrence prevention will enable us to reduce adverse effects of higher drug dosage.",['Non Muscle Invasive Bladder Cancer'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DEVICE', 'name': 'TC-3 hydrogel', 'armGroupLabels': ['Group A: 20 mg MMC mixed with 60cc TC-3']}, {'type': 'DEVICE', 'name': 'TC-3 hydrogel', 'armGroupLabels': ['• Group B: 40 mg MMC mixed with 60cc TC-3']}, {'type': 'DEVICE', 'name': 'TC-3 hydrogel', 'armGroupLabels': ['• Group C: 80 mg MMC mixed with 60cc TC-3 hydrogel (n=8)']}]","Inclusion Criteria: 1. Patient is 21 years of age or older. 2. Patient has signed Informed Consent Form and is willing and able to abide by the protocol. 3. Single or multiple tumors (n≤7) 4. Naïve or Recurrent tumor 5. No prior history of HG and/or T1 and/or Tis 6. At least one Tumor ≥ 1mm as evaluated visually by the investigator 7. Largest tumor diameter ≤ 30mm as evaluated visually by the investigator 8. Cystoscopic appearance of papillary Low grade tumor 9. The patient had upper urinary tract evaluation in the previous year excluding urothelial carcinoma, hydronephrosis or Renal Cell Carcinoma or other renal cancers. 10. Good performance status (Karnofsky performance status 70% or greater). 11. No active urinary tract infection as confirmed by urine culture. 12. If the patient is a female of childbearing potential she is using an acceptable/effective method of contraception and has a negative pregnancy test at screening. Exclusion Criteria: 1. Carcinoma In Situ (CIS). 2. Over 7 lesions 3. Lesion is larger than 30mm in diameter. 4. ""High Grade"" urine cytology. 5. Cystoscopic Appearance suspicious for HG and/or solid and/or Tis 6. histologic results of cold cup biopsy are indicative of HG tumor. 7. Tumor located in prostatic urethra. 8. Previous systemic chemotherapy or pelvic radiotherapy. 9. Pregnant or breastfeeding patient. 10. Previous treatment with BCG within the last 24 months. 11. The patient did not have at least 3 months cystoscopically confirmed tumor-free interval between the last tumor recurrence and screening. 12. Treatment with intravesical chemotherapy within the 3 last months. 13. The patient has/had any bladder tumor with histology other than TCC 14. Contraindication to MMC. 15. The patient has a history of urinary retention or a PVR≥250cc by bladder scan or ultrasound (PVR test may be repeated up to 3 times). 16. The patient has a bleeding disorder or a screening platelet count \<50X109/L. 17. The patient has screening hemoglobin \<10mg/dL. 18. The patient has a history of Acquired Immunodeficiency Syndrome or HIV positive. 19. The patient has a condition or a concurrent severe and/or uncontrolled medical or psychiatric disease (e.g. uncontrolled diabetes, compensated congestive heart failure (NYHA III and over), myocardial infarction within 6 months of study, unstable or uncontrolled hypertension or an active uncontrolled infection), which according to the PIs decision could compromise participation, compliance with scheduled visits and/or completion. 20. The patient participated in an investigational protocol within the past 90 days. 21. The patient has life expectancy of \<3 years. 22. The patient had another malignancy or received therapy for any malignancy in the last five years except for: * Non-melanoma skin tumors * stage 0 (in situ) cervical carcinoma * prostatic carcinoma 23. The patient has documented vesica-ureteral reflux or an indwelling ureteral stent 24. The patient has the tumor in the bladder diverticulum",NA,ALL,NA,"[{'measure': 'Ablative effect of pre-TURBT intravesical instillations with 20,40,80 mg of MMC mixed with 60cc TC-3 Hydrogel on bladder lesion(s) of NMIBC patients', 'description': 'Cystoscopic and pathological effect (evaluated during TUR-BT visit) of pre-TURBT intravesical instillations with 20,40,80 mg of MMC mixed with 60cc TC-3 Hydrogel on bladder lesion(s) of NMIBC patients.', 'timeFrame': '2 Years'}, {'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability rate.', 'description': 'Demonstration of Pre-TURBT TC-3 gel-MMC instillation safety and adverse event rate.Adverse events will be defined as any adverse change in health or side effect that occurs in the clinical trial participant while the patient is receiving the treatment or until the completion of the post-treatment follow-up cystoscopy.', 'timeFrame': '2 years'}]",NA 138,NCT00003193,"{'fullName': 'Massachusetts General Hospital', 'class': 'OTHER'}",Paclitaxel and Radiation Therapy Plus Chemoprotection With Amifostine in Treating Patients With Stage III or Stage IV Head and Neck Cancer,COMPLETED,"RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase I/II trial to study the effectiveness of paclitaxel and radiation therapy plus chemoprotection with amifostine in treating patients with stage III or stage IV head and neck cancer.","['Head and Neck Cancer', 'Oral Complications']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'amifostine trihydrate', 'armGroupLabels': ['Paclitaxel, amifostine, RT']}, {'type': 'DRUG', 'name': 'paclitaxel', 'armGroupLabels': ['Paclitaxel, amifostine, RT']}, {'type': 'PROCEDURE', 'name': 'conventional surgery', 'armGroupLabels': ['Paclitaxel, amifostine, RT']}, {'type': 'RADIATION', 'name': 'radiation therapy', 'armGroupLabels': ['Paclitaxel, amifostine, RT']}]","DISEASE CHARACTERISTICS: * Histologically confirmed stage III or IV squamous cell head and neck cancer * T3-4, N0-3, M0 PATIENT CHARACTERISTICS: Age: * 18 and over Performance Status: * ECOG 0-2 Life Expectancy: * Not specified Hematopoietic: * WBC at least 2,000/mm\^3 * Platelet count at least 50,000/mm\^3 Hepatic: * Bilirubin no greater than 3.0 mg/dL * SGOT no greater than 3 times upper limit of normal Renal: * Creatinine no greater than 3.0 mg/dL Other: * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * No concurrent beta-adrenergic blocking agents",NA,ALL,NA,"[{'measure': 'Safety', 'description': 'Safety is evaluated in this dose-escalation study', 'timeFrame': '6 months'}]","[{'measure': 'Response rate', 'description': 'Response in terms of CR, PR, stable disease, or progression was determined', 'timeFrame': '6 months'}]" 139,NCT04733521,"{'fullName': 'RaND Biosciences', 'class': 'INDUSTRY'}",A Phase 1/2 Study of SC-43 in Combination With Cisplatin,UNKNOWN,"SC-43 is STAT3 inhibitor. Based on the phase I data of SC-43 monotherapy, this is a Phase 1/2, Open-label, Study to Investigate the Safety, Tolerability, and Efficacy of SC-43 Administered in Combination with Cisplatin in Subjects with Advanced or Refractory Non-small Cell Lung Cancer or Biliary Tract Carcinoma","['Advanced Non-small-cell Lung Cancer', 'Advanced Biliary Tract Cancer']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'SC-43', 'description': 'SC-43 oral, every day of 21-day cycle', 'armGroupLabels': ['BTC', 'NSCLC']}, {'type': 'DRUG', 'name': 'Cisplatin', 'description': 'cisplatin 75mg/m2 on day 1 of 21-day cycle', 'armGroupLabels': ['BTC', 'NSCLC']}]","Inclusion Criteria: * Life expectancy ≥ 12 weeks. * Histologically or cytologically confirmed NSCLC or BTC. * At least 1 measurable target lesion ≥ 10 mm as measured by MRI or CT according to RECIST v1.1-criteria. Target lesions within the field of prior efficacy irradiation or in the area of local treatment (intervention or ablation therapy) are considered measurable in case of confirmation of progression. * Optional availability of archival or fresh tumor specimen that is suitable for analysis. Acceptable samples must have been acquired from a surgical operation, using core needle biopsy, or excisional biopsy. Samples that were acquired using fine needle aspiration are not acceptable. Archival samples from the primary or recurrent cancer will have been taken within 5 years prior to screening. formalin fixed, paraffin-embedded tumor * Presence of all the following clinical laboratory findings at screening: * Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, or hemoglobin ≥ 9 g/dL. * Total bilirubin ≤ 1.5 × upper limit of normal (ULN) unless liver metastasis or BTC in which case ≤ 2.5 × ULN is permitted at the investigator's discretion. * For BTC subjects, alkaline phosphatase and gamma-glutamyl transferase ≤ 5 × ULN. * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN unless disease (NSCLC with liver metastases or BTC) related, in which case ≤ 5 × ULN is permitted at the investigator's discretion. * Creatinine ≤ 1.5 × ULN, or calculated or measured creatinine clearance (CrCl) ≥ 60 mL/min as calculated by the Cockcroft-Gault method, or 24-hour measured urine CrCl ≥ 50 mL/min. * Eastern Cooperative Oncology Group performance status \< 2. * For subjects with chronic hepatitis B or C * If a female subject or a female spouse/partner of male subject is of childbearing potential, she must agree to use highly effective contraceptives from signing informed consent to 28 days or 5 half-lives of SC-43, whichever is the longest, after the last dose of study drug administration * Male subjects should be willing to use a condom (with spermicidal foam/gel/film/cream/suppository) to prevent pregnancy and exposure of a female partner and should refrain from donating sperm or fathering a child from signing informed consent to 90 days after the last dose of study drug administration. * Able to comprehend and willing to sign an informed consent form (ICF) Exclusion Criteria: * Clinically active or untreated central nervous system (CNS) metastases. Subjects with a history of treated CNS metastases that are asymptomatic are eligible. * Malignancies other than NSCLC or BTC within 5 years prior to study enrollment, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent, or breast ductal carcinoma in situ treated surgically with curative intent). * Any ≥ grade 2 (according to NCI-CTCAE v 5.0) AE at baseline (other than those previously allowed in the inclusion criteria). * History of organ or tissue transplantation. * History of autoimmune disease. * Any serious acute, chronic infections that require systemic antimicrobial, antifungal, or antiviral therapy at screening, excluding viral hepatitis. * History of human immunodeficiency virus infection. * Significant cardiovascular disease, including: * Heart disease classified as New York Heart Association class III or IV. * Ongoing uncontrolled hypertension. * History of congenital long QT syndrome. * Ongoing prolonged QT interval corrected for heart rate using Fridericia's method (QTcF) defined as ≥ 470 msec. * History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation). * Subjects with atrial fibrillation, that is well controlled with treatment, can be enrolled. * Ascertained hypersensitivity to any ingredient of SC-43 or drugs with similar chemical structures, including sorafenib. If there is suspicion that the subject may have an allergy, the subject should be excluded. * Uncontrolled nausea or vomiting or any symptom that would prevent the ability to comply with daily oral SC-43 treatment * Significant gastrointestinal disorder(s) within 12 weeks prior to screening that would, in the opinion of the investigator, prevent absorption of an orally available agent * Active bleeding during the last 4 weeks prior to screening or in the investigator's judgment, the existence of high bleeding tendency lesions such as active gastrointestinal ulcers or prominent esophageal or gastric varices. * Requirement for ongoing immunosuppressive agents (including azathioprine, mycophenolate, cyclophosphamide, chlorambucil, methotrexate, cyclosporine), or systemic steroid with equivalent dosage higher than prednisolone 30 mg/day for more than 14 days. * Received an investigational agent within 4 weeks prior to screening. * Had previous anticancer therapy (surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, biological therapy, or hormonal therapy) within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to the first dose of SC-43",NA,ALL,NA,"[{'measure': 'Recommended phase 2 dose(RP2D) of SC-43', 'description': 'to determine a RP2D of SC-43 for each population of non-small cell lung cancer and biliary tract carcinoma subjects', 'timeFrame': '18 weeks'}, {'measure': 'preliminary antitumor activity of SC-43', 'description': 'the preliminary antitumor activity of SC-43 in combination with other anticancer agents as measured by overall response rate (ORR) according to standard criteria (Response Evaluation Criteria in Solid Tumors version 1.1 \\[RECIST v1.1\\])', 'timeFrame': '18 weeks'}]","[{'measure': 'incidence of treatment-related adverse events as assessed by NCI-CTCAE v5.0', 'description': 'incidence of treatment-related adverse events in combination with cisplatin in subjects with non-small cell lung cancer and biliary tract carcinoma. All adverse events will be assessed for severity based on NCI-CTCAE version 5.0', 'timeFrame': '18 weeks'}, {'measure': 'Maximum plasma concentration (Cmax)', 'description': 'PK blood samples will be collected at predefined time intervals, and the maximum plasma concentration will be determined.', 'timeFrame': 'day 1 of cycle 1, day 1 of cycle 2 (each 21-day cycle)'}, {'measure': 'Area under the plasma concentration versus time curve (AUC)', 'description': 'PK blood samples will be collected at predefined time intervals, and the AUC from time 0 to the last time point will be calculated.', 'timeFrame': 'day 1 of cycle 1, day 1 of cycle 2 (each 21-day cycle)'}, {'measure': 'Objective response rate (ORR) according to RECIST criteria version 1.1', 'description': 'Objective response rate (ORR) is defined as the proportion of subjects with complete response (CR) or partial response (PR) as best overall response evaluated according to RECIST criteria version 1.1 on MRI or CT results', 'timeFrame': '18 weeks'}, {'measure': 'Disease control rate (DCR) according to RECIST criteria version 1.1', 'description': 'Disease control rate (DCR) is defined as the proportion of subjects with complete response (CR), partial response (PR), or stable disease (SD) as best overall response evaluated according to RECIST criteria version 1.1 on MRI or CT results.', 'timeFrame': '18 weeks'}, {'measure': 'Duration of response(DOR) according to RECIST criteria version 1.1', 'description': 'Duration of response(DOR) is defined as the time between the date of first response and the date of disease progression.', 'timeFrame': '18 weeks'}, {'measure': 'Progression free survival(PFS) according to RECIST criteria version 1.1', 'description': 'progression free survival(PFS) is defined as the time between the date of first dose of SC-43 and the date of progression or death, whichever occurs first', 'timeFrame': '18 weeks'}, {'measure': 'overall survival(OS) according to RECIST criteria version 1.1', 'description': 'overall survival(OS) time is defined as the length of time from the first dose of SC-43 to the date of death, regardless of the cause of death', 'timeFrame': '18 weeks'}]" 140,NCT01111604,"{'fullName': 'Eli Lilly and Company', 'class': 'INDUSTRY'}",A Study of Ramucirumab or Icrucumab in Colorectal Cancer,COMPLETED,"The purpose of this study is to determine if participants with metastatic colorectal cancer live longer without their cancer progressing when treated with standard chemotherapy, standard chemotherapy plus ramucirumab, or standard chemotherapy plus icrucumab.","['Colon Cancer', 'Rectal Cancer']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'Ramucirumab', 'description': '8 mg/kg IV Q2W', 'armGroupLabels': ['mFOLFOX-6 + Ramucirumab'], 'otherNames': ['IMC-1121B', 'LY3009806']}, {'type': 'BIOLOGICAL', 'name': 'Icrucumab', 'description': '15 mg/kg IV Q2W', 'armGroupLabels': ['mFOLFOX-6 + Icrucumab'], 'otherNames': ['IMC-18F1', 'LY3012212']}, {'type': 'DRUG', 'name': 'mFOLFOX-6', 'description': 'Oxaliplatin: 85 milligram per square meter (mg/m²) IV every 2 weeks (Q2W)\n\nFA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).\n\n5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W', 'armGroupLabels': ['mFOLFOX-6', 'mFOLFOX-6 + Icrucumab', 'mFOLFOX-6 + Ramucirumab']}]","Inclusion Criteria: * Disease progression on an irinotecan-based first-line chemotherapy regimen (ie FOLFIRI or CAPIRI \[capecitabine + irinotecan\], with or without bevacizumab) * Age ≥ 18 years * Life expectancy of ≥ 6 months * Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1 at study entry * Agrees to adequate contraception during the study period and for 12 weeks after the last dose of study medication * Provided signed informed consent Exclusion Criteria: * Has received prior oxaliplatin-based chemotherapy for locally advanced unresectable or metastatic Colorectal Cancer (CRC) (Prior oxaliplatin-based adjuvant chemotherapy is allowed if the last dose of oxaliplatin was administered \> 12 months prior to randomization) * Has documented and/or symptomatic brain or leptomeningeal metastases * Has an ongoing or active infection, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders * On chronic non-topical corticosteroid treatment. A participant discontinuing such treatment \> 3 months prior to randomization is eligible * Has uncontrolled or poorly controlled hypertension on a standard regimen of antihypertensive therapy * Has a concurrent active malignancy. A participant with previous history of malignancy is eligible, provided that he/she has been disease free for \> 3 years * If female, is pregnant (confirmed by serum beta human chorionic gonadotropin \[βHCG\] test) or lactating * Has received a prior autologous or allogeneic organ or tissue transplantation * Has undergone major surgery within 28 days prior to randomization * Has had a serious nonhealing wound, ulcer, or bone fracture within 28 days prior to randomization * Has an elective or planned major surgery to be performed during the course of the trial * Has a history of inflammatory bowel disease requiring pharmacological and/or surgical intervention in the 12 months prior to randomization",NA,ALL,NA,"[{'measure': 'Progression-Free Survival (PFS)', 'description': 'PFS is defined as the time from baseline until the date of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or death from any cause, whichever was first. Participants who die without a reported prior progression will be considered to have progressed on the day of their death. Participants who did not progress, are lost to follow-up, or have missed two or more scheduled tumor assessments will be censored at the day of their last radiographic tumor assessment, if there are no post-baseline tumor measurements for a randomized and treated participant, the participant will be censored at the date of randomization. If death or progressive disease (PD) occurs after 2 or more missing radiographic visits, censoring will occur at the date of the last radiographic visit prior to the last visit.', 'timeFrame': 'Baseline until Disease Progression or Death from Any Cause (Up to 95 Weeks)'}]","[{'measure': 'Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])', 'description': 'The ORR is the percentage of participants with Complete Response (CR, the disappearance of target lesions and any pathological lymph nodes \\[target or non-target\\] taking as reference the baseline sum of diameters in response to treatment) or Partial Response (PR, at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters in response to treatment) according to RECIST v1.1 from the start of the treatment until disease progression.', 'timeFrame': 'Baseline until Disease Progression (Up to 95 Weeks)'}, {'measure': 'Overall Survival (OS)', 'description': 'Overall survival is defined as the time from baseline to the date of death from any cause. If the participant is alive at the end of the follow-up period or is lost to follow-up, OS will be censored on the last date the participant is known to be alive.', 'timeFrame': 'Baseline Until Death from Any Cause (Up to 163 Weeks)'}, {'measure': 'Duration of Response (DoR)', 'description': 'DoR was measured from the time measurement criteria are first met for Complete Response or Partial Response or until the first date that the criteria for disease progression or death from any cause. whichever is first recorded. As defined according to RECIST v1.1, CR is the disappearance of all non-nodal target lesions, and PR is the short axes of any target lymph nodes reduced to \\< 10 mm and at least a 30% decrease in the sum of the diameters of target lesions including the short axes of any target lymph nodes.)', 'timeFrame': 'Criteria First Met for CR or PR until Disease Progression or Death from Any Cause (Up to 95 Weeks)'}, {'measure': 'Pharmacokinetics (PK): Maximum Concentration (Cmax) at Cycle 5', 'description': 'Maximum concentration (1 hour post end of infusion, Cmax) is the concentration measured in serum.', 'timeFrame': 'Cycle 5, 1 Hour Post End of Infusion'}, {'measure': 'Pharmacokinetics (PK): Trough Serum Concentrations (Ctrough) at Cycle 5', 'description': 'Trough (prior to infusion, Ctrough) concentrations measured in serum.', 'timeFrame': 'Cycle 5, Prior to Infusion'}, {'measure': 'Maximum Concentration (Cmax) at Day 8', 'description': 'Maximum concentration (Cmax) is the maximum peak concentration measured in blood plasma after drug infusion.', 'timeFrame': 'Day 8 (cycles 1 and 5)'}, {'measure': 'Maximum Concentration (Cmax) at Day 15', 'description': 'Cmax is the maximum peak concentration measured in blood plasma after drug infusion.', 'timeFrame': 'Day 15 (Cycles 1 and 5)'}, {'measure': 'Minimum Concentration (Cmin) at Day 1', 'description': 'Cmin is the minimum peak concentration measured in blood plasma after drug infusion.', 'timeFrame': 'Day 1 (cycles 1, 5, 9, and 13)'}, {'measure': 'Minimum Concentration (Cmin) at Day 4', 'description': 'Cmin is the minimum peak concentration measured in blood plasma after drug infusion.', 'timeFrame': 'Day 4 (cycles 1 and 5)'}, {'measure': 'Minimum Concentration (Cmin) at Day 8', 'description': 'Minimum concentration (Cmin) is the minimum peak concentration measured in blood plasma after drug infusion.', 'timeFrame': 'Day 8 (cycles 1 and 5)'}, {'measure': 'Minimum Concentration (Cmin) at Day 15', 'description': 'Minimum concentration (Cmin) is the minimum peak concentration measured in blood plasma after drug infusion.', 'timeFrame': 'Day 15 (cycles 1 and 5)'}, {'measure': 'Number of Participants With Serum Ramucirumab Antibody Assessment', 'description': 'A sample will be considered positive for anti-Ramucirumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-Ramucirumab antibody level seen in healthy untreated individuals.', 'timeFrame': '31 Weeks'}, {'measure': 'Serum Anti-Icrucumab Antibody Assessment', 'description': 'A sample will be considered positive for anti-icrucumab antibodies if it exhibits a post-baseline antibody level exceeding the normal anti-icrucumab antibody level seen in healthy untreated individuals.', 'timeFrame': '31 Weeks'}, {'measure': 'Number of Participants With Adverse Events', 'description': 'A summary of serious AEs (SAEs) and all other non-serious AEs regardless of causality, is located in the Reported Adverse Events module.', 'timeFrame': 'Baseline up to 165 weeks'}]" 141,NCT00707252,"{'fullName': 'Louisiana State University Health Sciences Center Shreveport', 'class': 'OTHER'}",Study of Polyphenon E in Addition to Erlotinib in Advanced Non Small Cell Lung Cancer,TERMINATED,"The purpose of this study is to study if the addition of the green tea extract, Polyphenon E, to Erlotinib is safe and if it has potential to improve outcomes in second line therapy for Advanced Stage IIIb/IV Non-small cell lung cancer.",['Non-Small Cell Lung Cancer'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Polyphenon E', 'description': 'Patients will be assigned to 3 sequential cohorts of three different dose levels of Polyphenon E (providing 200, 400 and 800mg of Polyphenon E given once daily) in a step-wise manner.', 'armGroupLabels': ['Phase I/II'], 'otherNames': ['""Polyphenon extract, Green Tea""']}, {'type': 'DRUG', 'name': 'Tarceva', 'description': 'All patients will also receive Erlotinib 150mg po/day from Day 1.', 'armGroupLabels': ['Phase I/II'], 'otherNames': ['(Erlotinib)']}]","Inclusion Criteria: 1. Biopsy proven NSCLC 2. Stage IIIB or IV measurable disease burden after routine staging work up. 3. Documented disease progression after first or second line chemotherapy. This will be assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) 4. Ability to give informed consent and willingness to adhere to study protocol 5. Ability to take oral medication 6. Age ≥ 18 years. 7. Eastern Cooperative Oncology Group (ECOG) Performance Status between 0-2 8. Adequate hematological, hepatic and renal function defined as below: granulocyte count \> 1500/mm3, platelet count \> 100.000/mm3, serum creatinine \< 1.5; bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase (ALP) at or below institutional upper limit of normal (IULN). All lab values should be obtained within 14 days of registration. 9. Patients have to have recovered from any toxic effects of prior chemotherapy or radiation therapy to a Grade 1 or less (except from alopecia). Enrollment should occur no less than 28 days after completion of prior therapy. 10. Ability to comply with the use of contraceptive measures starting 1 week before and ending 2 weeks after the last dose of study drug. Exclusion Criteria: 1. Liver or kidney problems that would interfere with metabolism of study drug. This includes any preexisting elevation of AST, ALT, ALP or bilirubin. 2. Any condition that would hamper informed consent or ability to comply with the study protocol 3. Participation in another research study in the last three months 4. Known malignancy at any site other than NSCLC 5. Recent consumption of green tea (5 or more cups per day within one week of study enrollment) 6. Significant history of cardiac disease, e.g. uncontrolled hypertension, unstable angina, congestive-heart failure, myocardial infarction within the last six months or ventricular arrhythmias requiring medication. 7. Presence of metastatic brain lesions 8. Documented history of bleeding diathesis 9. Need to be on therapeutic anticoagulation 10. Pregnant and lactating women 11. Patients with a known seizure disorder who are taking Phenytoin, Carbamazepine or Phenobarbital 12. Patients taking medications known to interfere with erlotinib metabolism as listed below. * Atazanavir * Clarithromycin * Indinavir * Itraconazole * Ketoconazole * Nefazodone * Nelfinavir * Ritonavir * Saquinavir * Telithromycin * Troleandomycin * Voriconazole * Rifampicin * Rifabutin * Rifapentine * Phenytoin * Carbamazepine * Phenobarbital * St John's Wort.",NA,ALL,NA,"[{'measure': 'Phase 1: Number of Participants with Adverse Events.', 'description': 'Toxicity evaluation of all adverse events monitored by physical exam, weight, vital signs, Complete Blood Count (CBC), Complete Metabolic Panel (CMP), coagulation panel and Computed Tomography (CT) scans of the chest, abdomen and pelvis, CT/Magnetic Resonance Imaging (MRI) of the head.', 'timeFrame': 'At Screening and every week for first 4 weeks and then week 6, 8 and then every 4 weeks in Phase I study. Liver function tests will be monitored at least every 4 weeks as applicable. The patients will be followed up to 2 years on average.'}, {'measure': 'Phase 1: Maximum Tolerated Dose', 'description': 'Dose-Limiting Toxicity (DLT) is defined as two or more events with grade 3 toxicity or a single event with grade 4-5 toxicity possibly or probably related to the study medications at a specific dose of Polyphenon E.', 'timeFrame': 'Day 1 of Phase I until progression, death or intolerable side effects would occur. The patients will be followed up to 2 years on average.'}, {'measure': 'Phase 2: Response Rate', 'description': 'Response Rate defined as Complete (CR) + Partial Response (PR) using RECIST criteria.\n\nComplete response (CR):\n\nComplete disappearance of all measurable and non-measurable disease, no new lesions, no disease related symptoms, and normalization of markers and other abnormal lab values. All disease must be assessed using the same technique as baseline.\n\nPartial Response (PR):\n\nApplies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non measurable disease. No new lesions. All target measurable lesions must be assessed using the same techniques as baseline.', 'timeFrame': 'Start of Phase 2 to until progression, death or intolerable side effects occur. The patients will be followed up to 2 years on average.'}]","[{'measure': 'Phase I: Response rate', 'description': 'Response Rate defined as Complete (CR) + Partial Response (PR) using RECIST criteria.\n\nComplete response (CR):\n\nComplete disappearance of all measurable and non-measurable disease, no new lesions, no disease related symptoms, and normalization of markers and other abnormal lab values. All disease must be assessed using the same technique as baseline.\n\nPartial Response (PR):\n\nApplies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non measurable disease. No new lesions. All target measurable lesions must be assessed using the same techniques as baseline.', 'timeFrame': 'From registration until progression or intolerable side effects occur. The patients will be followed up to 2 years on average.'}, {'measure': 'Phase 1: Progression Free Survival', 'description': 'Progression- Free Survival:\n\nFrom date of registration to date of first observation of progressive disease, death due to any cause or symptomatic deterioration.', 'timeFrame': 'From registration until progression or intolerable side effects occur. The patients will be followed up to 2 years on average.'}, {'measure': 'Phase 2: Progression Free Survival', 'description': 'From date of registration to date of first observation of progressive disease, death due to any cause or symptomatic deterioration.', 'timeFrame': 'From registration until progression or intolerable side effects occur. The patients will be followed up to 2 years on average.'}, {'measure': 'Phase 2: Overall Survival', 'description': 'Time from registration to death of any cause measured in months.', 'timeFrame': 'From registration until progression or intolerable side effects occur. The patients will be followed up to 2 years on average.'}, {'measure': 'Phase 2: Correlation between level of EGFR expression on the original tumor tissue and the presence of EGFR mutations in exons 18, 19 and 21 in serum DNA and original tumor tissue with the treatment response and outcome.', 'description': 'To analyze signaling pathway activity western blot analysis will be performed using antibodies that recognize serum interleukin-8 (IL-8), VEGF and HGF levels. The level of circulating C-met RNA will be measured using Real Time Polymerase Chain Reaction (RT-PCR).', 'timeFrame': 'Pre-study until progression or intolerable side effects occur. The patients will be followed up to 2 years on average.'}, {'measure': 'Phase 2: Correlation of KRAS mutations (in exons 2 and 3) in the original tumor tissue with treatment response and outcome.', 'description': 'Clinical assay for detecting mutations in KRAS (direct sequencing).', 'timeFrame': 'Pre-study until progression or intolerable side effects occur. The patients will be followed up to 2 years on average.'}]" 142,NCT00542048,"{'fullName': 'MediGene', 'class': 'INDUSTRY'}",A Trial Evaluating the Pharmacokinetics and Mode of Action of EndoTAG®-1 in Tumor Patients With Hepatic Metastases,COMPLETED,"The primary objective of study CT 4003 is to assess the behavior of EndoTAG®-1 in the body (making a so-called pharmacokinetic profile). Therefore, the course of the drug in the body is examined, i.e. the amount and speed of the drug uptake as well as the distribution and the elimination of the drug is being investigated. Further objectives of the study are to assess the effect of EndoTAG®-1 on liver metastases concerning size and blood supply measured by imaging techniques (contrast-enhanced ultrasound and magnetic resonance imaging as well as duplex sonography) and to assess the effect on blood markers which are indicators for the destruction and neoplasm of blood vessels (so-called markers of angiogenesis).","['Liver Cancer', 'Neoplasm Metastasis']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'EndoTAG®-1', 'description': 'EndoTAG®-1 22 mg/m² twice weekly', 'armGroupLabels': ['1']}]","Inclusion Criteria: * Unresectable hepatic metastases of a carcinomatous origin with exception of HCC, biliary or bile duct carcinoma * At least one measurable hepatic metastases \> 20 mm in diameter (measured in MRI) * Last application of palliative chemotherapy (drug dependent on the primary tumor) at least 7 days ago * Gender: male and female (at least 6 individuals of each gender) * Age \>= 18 years * Negative pregnancy test (females of childbearing potential) * Willingness to perform double-barrier-contraception during the study and for 6 month post study medication * ECOG performance status 0,1 or 2 * Assumed life expectancy of \> 3 month * Signed informed consent Exclusion Criteria: * History of significant liver pathology (other than metastases, e.g. cirrhosis of the liver, PSC, PBC) or liver transplantation * Laboratory tests (hematology, chemistry) outside specific limits: * ANC \<= 1.0 x 10\^9/L * Platelets \<= 100 x 10\^9/L * Hb \<= 9.0 g/dL (\<= 5.6 mmol/L) * Total Bilirubin \> 2.0 mg/dL * Serum Creatinine \> 1.5 mg/dL * Renal insufficiency with a GFR \< 60 mL/min * Currently ongoing taxane-containing palliative chemotherapy regimen or history of taxane administration within 4 weeks prior to study entry * Pregnancy or nursing status * Positive HIV, HBV or HCV testing * The patient has a contraindication for MRI or CEUS according to accepted clinical guidelines * Known hypersensitivity to any component of the EndoTAG®-1 formulation, gadolinium-based MR-contrast media or sulphur hexafluoride * Claustrophobia or history of active or significant neurological disorder and/or psychiatric disorder that would prohibit the understanding and giving of informed consent, or would interfere in the clinical and radiological evaluation of the patient during the trial * Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study entry",NA,ALL,NA,"[{'measure': 'Pharmacokinetic profile', 'timeFrame': 'Last patient out'}]","[{'measure': 'Tumor response, Tumor perfusion, Soluble markers of angiogenesis, Pharmacodynamics, Safety', 'timeFrame': 'Last patient out'}]" 143,NCT05355155,"{'fullName': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}",Bevacizumab Biosimilar Plus FOLFOX4 in the Treatment of Recurrent HCC After Liver Transplantation,UNKNOWN,"This study is a single arm, single center, prospective and open exploratory study. About 15 patients with recurrent hepatocellular carcinoma (HCC) after liver transplantation are expected to be enrolled.Patients will be treated with bevacizumab and FOLFOX4.Treatment was continued until disease progression, development of intolerable toxicities, death, withdrawal of consent, initiation of new antitumor therapy, whichever occurred first.","['Post-orthotopic Liver Transplantation', 'Hepatocellular Carcinoma Recurrent']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Bevacizumab Biosimilar IBI305', 'description': 'Patients received bevacizumab and FOLFOX4 every two weeks', 'armGroupLabels': ['Bevacizumab combine with FOLFOX4'], 'otherNames': ['FOLFOX4']}]","Inclusion criteria: * adult patients with hepatocellular carcinoma who have received liver transplantation have postoperative radiographic or pathological evidence of recurrence; * have not received the first line of standard treatment or have received the first line of standard treatment failure; * at least one measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; * Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 2; * Child-Pugh class A or B (Child-Pugh score ≤7 ); * adequate organ function; * a predicted life expectancy of at least 3 months. Exclusion Criteria: * allergy to the study drugs or their expedients or severe allergy to other monoclonal antibodies; * receipt of attenuated inactivated vaccines within 4 weeks of the start of the study or scheduled for such vaccination during the study; * evident concern of GI bleeding (local active ulcer, Guaic test at least ++) or a history of GI bleeding within the preceding 6 months; * uncontrolled pleural or peritoneal effusion; * pulmonary tuberculosis, sarcoidosis, HIV infection, or active HBV or HCV infection; * uncontrolled cardiac arrhythmia (including QTC interval ≥500 ms); * hepatic encephalopathy; * Known hepatocholangiocarcinoma, mixed hepatocellular and cholangiocellular carcinoma, fibrolamellar carcinoma, or a history of or concurrent cancer except cervical carcinoma in situ and cured basal cell carcinoma; * pregnant or lactating women or women contemplating pregnancy; * severe concomitant illness that jeopardizes patient safety or interferes with the completion of the study as deemed by the investigators; * esophageal or gastric variceal bleeding with portal hypertension within the past 6 months.",NA,ALL,NA,"[{'measure': 'Objective Response Rate (ORR) ,Based on RECIST 1.1', 'description': 'ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by investigator analysis. Responses (PR or CR) were confirmed no less than 4 weeks after the initial response. CR defined as disappearance of all target lesions and non-target lesions (a short diameter is \\<10 millimeter \\[mm\\] if it exists in a lymph node). PR defined as at least 30% decrease in the sum of the long diameter (LD) (hereafter referred to as sum of LD) of all target lesions, as compared with Baseline summed LD.', 'timeFrame': 'From the first dose of study drug to the first date of documentation of disease progression or death whichever occurred first (up to approximately 2 years )'}]","[{'measure': 'Progression-free Survival (PFS), Based on RECIST 1.1 and mRECIST', 'description': 'PFS was defined as the time from the first study dose date to the date of first documentation of disease progression or death (whichever occurred first) based on RECIST 1.1 and mRECIST assessed by investigator review. PD was defined as at least a 20% increase in the sum of LD of target and non-target lesions as compared with the smallest sum of LD and the increase of LD was at least 5 mm (including new lesions).', 'timeFrame': 'From the first study dose date to the date of first documentation of disease progression or death (whichever occurred first) (up to approximately 2 years )'}, {'measure': 'Disease Control Rate (DCR) ,Based on RECIST 1.1 and mRECIST', 'description': 'the proportion of patients who achieved CR, PR, or SD as their best overall response', 'timeFrame': 'Proportion of patients whose tumor volume control (reduced or enlarged) reaches a predetermined value and can maintain a minimum time limit(up to approximately 2 years)'}, {'measure': 'Duration of Response (DOR) ,Based on RECIST 1.1 and mRECIST', 'description': 'From date of first documented confirmed CR or PR until date of first documentation of PD or death whichever occurred first (up to approximately 2 years)', 'timeFrame': 'DOR was defined as the time from the first documentation of CR or PR to the date of first documentation of PD or death (whichever occurred first) in participants with confirmed CR or PR based on RECIST 1.1 and mRECIST assessed by investigator analysis.'}, {'measure': 'Overall Survival (OS)', 'description': 'From the date of first dose of study drug until date of death from any cause (up to approximately 2 years )', 'timeFrame': 'From the date of first dose of study drug until date of death from any cause (up to approximately 2 years )'}, {'measure': 'Time-to Response (TTR) Based on RECIST1.1 and mRECIST', 'description': 'TTR was defined as the time from the date of first study dose to the date of first documentation of CR or PR, in participants with confirmed CR or PR. It was evaluated according to RECIST1.1 and mRECIST assessed by investigate.', 'timeFrame': 'From date of first dose of study drug until CR or PR (up to approximately 2 years'}, {'measure': 'Objective Response Rate (ORR) ,Based on mRECIST', 'description': 'ORR was defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) based on mRECIST) assessed by investigator analysis.', 'timeFrame': 'From the first dose of study drug to the first date of documentation of disease progression or death whichever occurred first (up to approximately 2 years )'}, {'measure': 'Safety as measured by number and grade of adverse events', 'description': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From first dose until 30 days after the last dose (up to approximately 2 years )'}]" 144,NCT00066885,"{'fullName': 'Novacea', 'class': 'INDUSTRY'}",Study of DN101 and Taxotere in Patients With Advanced Non-Small Cell Lung Cancer,COMPLETED,"This Phase 1/2 clinical trial is a multi-center, open-label study with three main objectives. The first (Phase 1A) is to determine the maximum-tolerated dose of DN-101 when administered in combination with Taxotere (docetaxel) every three weeks (closed). The second is to determine the maximum-tolerated dose of DN-101 when administered weekly in combination with Taxotere(docetaxel)devery three weeks (open). The third is to evaluate the safety and objective tumor response rate of the combination in NSCLC. DN-101 doses will be escalated at three dosing levels. Patients will receive oral DN-101 on day one, followed by intravenous docetaxel on day two of a 21-day cycle. Treatment cycles will be repeated at the same dose level each 21 days until disease progression or unacceptable toxicity.","['Carcinoma, Non-Small-Cell Lung']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'calcitriol + docetaxel'}]","Inclusion Criteria: * Histopathologically or cytologically proven non-small cell carcinoma of the lung (NSCLC), either Stage IIIB or Stage IV, that has progressed on or after first or second-line chemotherapy * Measurable disease by RECIST criteria * Eastern Cooperative Oncology Group (ECOG) Performance Status \< 1 * Life expectancy \> 3 months * Age \> 18 years * Agrees to use adequate contraception throughout the treatment period and for at least 6 months following treatment * Able to give informed patient consent",NA,ALL,NA,NA,NA 145,NCT00602667,"{'fullName': ""St. Jude Children's Research Hospital"", 'class': 'OTHER'}","Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma",ACTIVE_NOT_RECRUITING,"RATIONALE: In this study a combination of anti-cancer drugs (chemotherapy) is used to treat brain tumors in young children. Using chemotherapy gives the brain more time to develop before radiation is given. The chemotherapy in this study includes the drug methotrexate. This drug was an important part of the two clinical trials which resulted in the best survival results for children less than 3 years of age with medulloblastoma. Most patients treated on this trial will also receive radiation which is carefully targeted to the area of the tumor. This type of radiation (focal conformal or proton beam radiotherapy) may result in fewer problems with thinking and learning than radiation to the whole brain and spinal cord. PURPOSE: This clinical trial is studying how well giving combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed central nervous system tumors.",['Brain and Central Nervous System Tumors'],INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Induction Chemotherapy', 'description': 'All patients will receive 4 identical cycles of induction chemotherapy including highdose (5 g/m2 or 2.5g/m2 for patients less than or equal to 31 days of age at enrollment) intravenous methotrexate and standard dose vincristine, cisplatin, and cyclophosphamide.', 'armGroupLabels': ['High-Risk Patients', 'Intermediate-Risk Therapy', 'Low-Risk Patients'], 'otherNames': ['MTX (methotrexate)', 'Oncovin(R) (vincristine)', 'Platinol-AQ(R) (cisplatin)', 'Cytoxan(R) (cyclophosphamide)']}, {'type': 'DRUG', 'name': 'Low-Risk Therapy', 'description': 'Induction will be followed by further conventional chemotherapy with carboplatin, cyclophosphamide, and etoposide. After consolidation, patients will receive 6 cycles of oral maintenance chemotherapy with cyclophosphamide, topotecan, and depending on the diagnosis, either erlotinib or etoposide (VP-16).', 'armGroupLabels': ['Low-Risk Patients'], 'otherNames': ['Cytoxan(R) (cyclophosphamide)', 'Paraplatin(R) (carboplatin)', 'Vepesid(R), VP-16 (etoposide)', 'Hycamptin(R) (topotecan)', 'Tarceva(TM) (erlotinib)']}, {'type': 'DRUG', 'name': 'High-Risk Therapy', 'description': 'High risk patients will also receive vinblastine with each course of induction chemotherapy. Induction will be followed by either chemotherapy with targeted intravenous topotecan and cyclophosphamide or optional craniospinal irradiation (CSI). CSI will be offered only to patients who reach 3 years of age by the end of induction only. After consolidation, all patients will receive 6 cycles of oral maintenance chemotherapy with cyclophosphamide, topotecan, and depending on the diagnosis, either erlotinib or etoposide (VP-16).', 'armGroupLabels': ['High-Risk Patients'], 'otherNames': ['Velban(R) (vinblastine)', 'Cytoxan(R) (cyclophosphamide)', 'Hycamptin(R) (topotecan)', 'Tarceva(TM) (erlotinib)', 'Vepesid(R), VP-16 (etoposide)']}, {'type': 'DRUG', 'name': 'Intermediate-Risk Therapy', 'description': 'Induction will be followed by consolidation focal radiotherapy (RT) to the tumor bed. Patients less than 12 months old upon completion of induction will receive low risk chemotherapy to delay RT until the age of 12 months. After consolidation, patients will receive 6 cycles of oral maintenance chemotherapy with cyclophosphamide, topotecan, and depending on the diagnosis, either erlotinib or etoposide (VP-16).\n\nNote: The option to receive focal proton beam irradiation was suspended 10/29/2015. Focal photon beam irradiation continues as part of the treatment plan.', 'armGroupLabels': ['Intermediate-Risk Therapy'], 'otherNames': ['Cytoxan(R) (cyclophosphamide)', 'Hycamptin(R) (topotecan)', 'Tarceva(TM) (erlotinib)', 'Vepesid(R), VP-16 (etoposide)']}]","Histologically confirmed newly diagnosed CNS tumors of any of the following : * Medulloblastoma (all histologic subtypes, including medullomyoblastoma and melanotic medulloblastoma) * Supratentorial primitive neuroectodermal tumor (PNET) (including CNS neuroblastoma or ganglioneuroblastoma, medulloepithelioma, and ependymoblastoma) * Pineoblastoma * Atypical teratoid rhabdoid tumor (ATRT) * Choroid plexus carcinoma * High grade glioma (including anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic ganglioglioma, pleomorphic xanthoastrocytoma with anaplastic features, high-grade astroblastoma , anaplastic pilocytic astrocytoma, malignant glioneuronal tumor, glioblastoma multiforme), or gliosarcoma, * Ependymoma (including all ependymoma histological variants) * Age \< 3 years at time of diagnosis for all histological diagnosis. Medulloblastoma patients ≥ 3 and \< 5years old at diagnosis who have non-metastatic disease with no more than 1cm2 of residual tumor are also eligible. * Meets criteria for 1 of the following risk groups: * Low-risk group: * Histologically confirmed nodular desmoplastic medulloblastoma, including medulloblastoma with extensive nodularity * Focal areas of anaplasia or other atypical features suggesting more aggressive phenotype in a tumor otherwise considered nodular desmoplastic should be treated on the intermediate-risk group, with final risk stratification at the discretion of principal investigator and study pathologist * No evidence of CNS metastasis 7 to 28 days after surgery by MRI and cytologic examination of lumbar cerebrospinal fluid (CSF) * Ventricular CSF from a shunt or Ommaya reservoir may be used to rule out M1 disease when lumbar puncture is medically contraindicated * Intermediate-risk group assignment when there is no other evidence of metastasis and CSF sampling is not possible * Gross total resection, defined as residual tumor or imaging abnormality (not definitive for residual tumor) with a size of \< 1 cm2 confirmed on postoperative CT scan or MRI * Brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size \< 1 cm2) and otherwise meets criteria for the low-risk group, the patient will be classified as low-risk * Desmoplastic medulloblastoma patients who are ≥3 -\<5 years of age will NOT be eligible for the low risk arm of the protocol. * Intermediate-risk group: * Histologically confirmed nodular desmoplastic medulloblastoma with less than gross total resection and no evidence of metastasis * Any eligible histologic diagnosis other than desmoplastic medulloblastoma with no evidence of CNS metastasis * Medulloblastoma patients who are ≥3 and \< 5 yrs of age irrespective of histology and with no evidence of CNS metastasis * High-risk group: * Any eligible histologic diagnosis with evidence of CNS metastasis * Patients with extraneural metastasis are eligible for treatment on the high-risk group PATIENT CHARACTERISTICS: * Lansky performance status ≥ 30 (except for posterior fossa syndrome) * WBC \> 2,000/mm3 * Platelets \> 50,000/mm3 (without support) * Hemoglobin \> 8 g/dL (with or without support) * ANC \> 500/mm3 * Serum creatinine \< 3 times upper limit of normal (ULN) * ALT \< 5 times ULN * Total bilirubin \< 3 times ULN PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No more than 31 days since prior definitive surgery * No prior radiotherapy or chemotherapy other than corticosteroid therapy",NA,ALL,NA,"[{'measure': 'Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients', 'description': 'Progression was defined as 25% increase in the size of any measurable lesion; the appearance of a new lesion; or the conversion of negative cerebrospinal fluid (CSF) cytology to positive. Defined as the time interval from date on treatment until the date of first progression, medulloblastoma-related death or date of last contact for patients who have not experienced an event. All eligible medulloblastoma patients who received any methotrexate are included in this analysis.', 'timeFrame': 'From date on treatment until date of first progression or relapse or disease related death or date of last contact, estimated at 1 year after treatment'}, {'measure': 'Percent Probability of Progression-free Survival (PFS) for Medulloblastoma Patients by DNA Methylation Subgroup', 'description': 'Defined as the time interval from date on treatment until the date of first progression, medulloblastoma-related death or date of last contact for patients who have not experienced an event. Eligible medulloblastoma patients who received any methotrexate and had molecularly confirmed medulloblastoma are included in this analysis. Five patients were excluded as 3 had no archival tissue available and 2 were found to not be medulloblastoma by methylation profile.', 'timeFrame': 'From date on treatment to date of first progression or relapse or disease related death or date of last contact, estimated at 1 year after treatment'}, {'measure': 'Percent Probability of Event-free Survival (EFS) for Medulloblastoma Patients', 'description': 'Defined as the time interval from date on treatment until the date of first progression, second malignancy or death due to any cause; or date of last contact for patients who have not experienced an event. All eligible medulloblastoma patients who received any methotrexate are included in this analysis.', 'timeFrame': 'From date on treatment to date of first progression, relapse, second malignancy or death from any cause or to date of last contact, estimated at 1 year after'}]","[{'measure': 'Number of Participants With Chromosomal Abnormalities', 'description': 'Amplifications and deletions (gains and losses) for chromosomes of interest are shown in the table of measured values.', 'timeFrame': 'Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment'}, {'measure': 'Numbers of Patients With Gene Alterations', 'description': 'Gene alterations, which include single nucleotide variants (SNPs), amplifications, deletions, translocations, indels, and germline alterations are shown for specific genes of interest in the results table.', 'timeFrame': 'Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment'}, {'measure': 'Numbers of Patients With Molecular Abnormalities by Tumor Type', 'description': 'Alterations included single nucleotide variants (SNPs), amplifications, deletions, translocations, indels, and germline alterations. Cytogenetic information shows gains and losses as specified in the table of measured values.', 'timeFrame': 'Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment'}, {'measure': 'Number of Successful Collections for Frozen and Fixed Tumor Samples', 'description': 'Successful collections will be defined as the number of patients who have frozen/fixed tumor samples available.', 'timeFrame': 'Based on samples obtained at the time of initial surgery or repeat surgery prior to treatment'}, {'measure': 'Event-free Survival (EFS) Compared to Historical Controls', 'description': 'EFS was measured from the date of initial treatment to the earliest date of disease progression, second malignancy or death for patients who fail; and to the date of last contact for patients who remain at risk for failure. 1-year EFS estimates are reported by risk group. EFS was compared to St. Jude historical cohorts by risk group using hazard ratios with 95% confidence intervals.', 'timeFrame': 'From date on treatment until date of first event (progression, second malignancy or death) or until date of last contact, assessed up to 10 years'}, {'measure': 'Overall Survival (OS) Compared to Historical Controls', 'description': 'OS was measured from the date of initial treatment to date of death or to date of last contact for survivors. 1-year OS estimates were reported by risk group. OS was compared to St. Jude historical cohorts by risk group using hazard ratios with 95% confidence intervals.', 'timeFrame': '1 year after treatment initiation of last patient'}, {'measure': 'Percentage of Patients With Objective Responses Rate to Induction Chemotherapy', 'description': 'For patients treated in the intermediate and high risk strata with residual or metastatic disease we will estimate the stratum-specific objective response rate (complete response (CR) or partial response \\[ PR\\]). All patients who receive at least 1 -dose of methotrexate are evaluable for response. Objective responses must be sustained for at least eight weeks.', 'timeFrame': 'From on-study date to 2 months after completion of induction chemotherapy (up to 4 months after on-study date)'}, {'measure': 'Feasibility and Toxicity of Administering Vinblastine With Induction Chemotherapy for Patients With Metastatic Disease as Measured by the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity', 'description': 'For the subset of patients with metastatic disease (high-risk group patients), during induction, the proportion percentage of courses during which subsequent chemotherapy administration was delayed for more than 7 days due to toxicity will be calculated. Patients were to receive 4 courses of induction and then consolidation chemotherapy.', 'timeFrame': 'From on-study date up to 4 months after on-study date'}, {'measure': 'Feasibility and Toxicity of Administering Consolidation Therapy Including Cyclophosphamide and Pharmacokinetically Targeted Topotecan to Patients With Metastatic Disease Based on the Percentage of Courses Delayed for More Than 7 Days Due to Toxicity', 'description': 'For the subset of patients with metastatic disease (high-risk group patients), during consolidation, we will calculate the number and proportion of courses during which subsequent chemotherapy administration was delayed for more than 7 days due to toxicity. Patients were to received 2 courses of consolidation chemotherapy and then maintenance therapy.', 'timeFrame': 'At completion of consolidation therapy (up to 6 months after on-study date)'}, {'measure': 'Percent of Patients With Sustained Objective Responses Rate After Consolidation', 'description': 'For patients enrolled on the high-risk arm with measurable residual disease after induction treated with consolidation therapy, we will estimate the objective response (complete response (CR)/partial response (PR)) rate after consolidation therapy with a 95% confidence interval. Objective responses must be sustained for at least eight weeks. All patients who receive at least 1 dose of cyclophosphamide or topotecan during consolidation are evaluable for response.', 'timeFrame': '8 weeks after completion of consolidation therapy (up to 8 months after on-study date)'}, {'measure': 'Feasibility and Toxicity of Administering Oral Maintenance Therapy in Children <3 Years of Age as Measured by the Percentage of Total Scheduled Maintenance Doses Received', 'description': 'These data are based on patient diaries. For children \\<3 years of age, we will calculate the percentage of total scheduled doses each patient received per course for each of the oral maintenance courses and report the overall average number percentage of doses received per course across patients. If patients received all planned doses, their percentage would be 100%. If the average percentage was less than 75%, then feasibility would be in question.', 'timeFrame': 'From start of oral maintenance therapy (approximately 6 months after on-study date) to completion of oral maintenance therapy (up to 1 year after on-study date)'}, {'measure': 'Percent of PET Scans With Loss of Signal Intensity', 'description': 'Measures will be analyzed for intermediate risk participants who receive proton beam therapy (PBT) and who consent. This objective aims to assess the feasibility of using post-proton beam therapy (PBT) positron emission tomography (PET) as an in-vivo dosimetric and distal edge verification system in this patient population. To quantify the decay in signal, 134 scans from 53 patients were analyzed by recording the mean activation value (MAV), the average recorded PET signal from activation, within the target volume. With each patient being given the same dose, the percent standard deviation in the MAV can serve as a quantitative representation of signal loss due to radioactive decay.', 'timeFrame': 'Up to 3 times during RT consolidation'}, {'measure': 'Concentration of Cerebrospinal Fluid Neurotransmitters', 'description': 'Concentrations of various neurotransmitters in cerebrospinal fluid were measured at 5 timepoints. The median concentration of each neurotransmitter at each time point was calculated and provided with a full range.', 'timeFrame': 'Baseline, at the completion of therapy, and every 12 months up to 36 months after off therapy date'}, {'measure': 'Number and Type of Genetic Polymorphisms', 'description': 'Types of genetic polymorphisms of neurotransmitters were examined. We studied 3 genetic polymorphisms; these were types of genetic polymorphisms involved in dopamine metabolism. They were as follows: rs6323, rs4680, and rs6280.', 'timeFrame': 'At study enrollment (Day 0)'}, {'measure': 'Pharmacogenetic Variation on Central Nervous System Transmitters', 'description': 'Frequencies of genetic polymorphisms were reported.', 'timeFrame': 'At study enrollment (Day 0)'}, {'measure': 'Number of Participants With Endocrinopathy', 'description': 'Endocrine screening and growth hormone (GH) testing were done in consenting intermediate risk patients at the end of induction therapy, the end of all therapy, and at 6, 12, 24, 36, 48, and 60 months off therapy. Endocrinopathy was defined as the presence of central hypothyroidism (free T4 concentration below normal with low or normal TSH concentration), growth hormone deficiency (peak growth hormone concentration below 5 ng/mL on dynamic testing), or ACTH deficiency (cortisol concentration below 14 ug/dL after low dose cosyntropin stimulation). Numbers of participants with endocrinopathy at each time point are reported. Please note the small numbers of participants with available data.', 'timeFrame': 'End of induction therapy (approximately 16 weeks from start of treatment), end of therapy (approximately 48 weeks from start of treatment), and 6, 12, 24, 36, 48, and 60 months off therapy'}, {'measure': 'Growth Hormone Secretion', 'description': 'Growth hormone secretion was measured in consenting intermediate risk patients at the end of induction therapy, the end of all therapy, and at 6, 12, 24, 36, 48, and 60 months off therapy. Mean growth hormone secretion values are reported by assessment time point. Please note the small numbers of participants with available data.', 'timeFrame': 'End of induction therapy (approximately 16 weeks from start of treatment), end of therapy (approximately 48 weeks from start of treatment), and 6, 12, 24, 36, 48, and 60 months off therapy'}, {'measure': 'Methotrexate Clearance in Induction Cycle 1', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis.', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of Methotrexate (MTX)'}, {'measure': 'Methotrexate Clearance in Induction Cycle 2', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis.', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX'}, {'measure': 'Methotrexate Clearance in Induction Cycle 3', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis.', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX'}, {'measure': 'Methotrexate Clearance in Induction Cycle 4', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate clearance are obtained using post hoc analysis.', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX'}, {'measure': 'Methotrexate Volume of Central Compartment in Induction Cycle 1', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis.', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX'}, {'measure': 'Methotrexate Volume of Central Compartment in Induction Cycle 2', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis.', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX'}, {'measure': 'Methotrexate Volume of Central Compartment in Induction Cycle 3', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis.', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX'}, {'measure': 'Methotrexate AUC0-66h in Induction Cycle 1', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis.', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX'}, {'measure': 'Methotrexate AUC0-66h in Induction Cycle 2', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis.', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX'}, {'measure': 'Methotrexate Volume of Central Compartment in Induction Cycle 4', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate volume of central compartment are obtained using post hoc analysis.', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX'}, {'measure': 'Methotrexate AUC0-66h in Induction Cycle 3', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis.', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX'}, {'measure': 'Methotrexate AUC0-66h in Induction Cycle 4', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate AUC0-66h (area under concentration curve from time 0 to 66 hours post-dose) are obtained using post hoc analysis.', 'timeFrame': 'Pre-infusion and 6, 23, 42, 66 hours from start of MTX'}, {'measure': 'Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 1', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 1. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis.', 'timeFrame': '42 hours from start of MTX'}, {'measure': 'Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 2', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 2. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis.', 'timeFrame': '42 hours from start of MTX'}, {'measure': 'Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 3', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 3. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis.', 'timeFrame': '42 hours from start of MTX'}, {'measure': 'Methotrexate Concentration at 42 Hours Post-dose in Induction Cycle 4', 'description': 'Methotrexate plasma concentration-time data are collected after the start of methotrexate infusion in induction cycle 4. Population parameters and inter-subject variability are estimated. Individual estimates of methotrexate concentration at 42 hours post-dose are obtained using post hoc analysis.', 'timeFrame': '42 hours from start of MTX'}, {'measure': 'Cyclophosphamide Clearance in Induction Chemotherapy', 'description': 'Cyclophosphamide plasma concentration-time data are collected on day 9 in one cycle of induction chemotherapy. Individual estimates of cyclophosphamide clearance are obtained using post hoc analysis.', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion'}, {'measure': 'Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 1', 'description': 'Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of cyclophosphamide clearance are obtained using post hoc analysis.', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion'}, {'measure': 'Cyclophosphamide Clearance in Consolidation Chemotherapy Cycle 2', 'description': 'Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of cyclophosphamide clearance are obtained using post hoc analysis.', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion'}, {'measure': 'Cyclophosphamide Apparent Oral Clearance in Maintenance Chemotherapy Cycle A1', 'description': 'Cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of cyclophosphamide apparent oral clearance are obtained using post hoc analysis.', 'timeFrame': 'Pre-dose, 0.5, 1.75, 3 and 6 hours post-dose'}, {'measure': 'Cyclophosphamide AUC0-24h in Induction Chemotherapy', 'description': 'Cyclophosphamide plasma concentration-time data are collected on day 9 in one cycle of induction chemotherapy. Individual estimates of cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion'}, {'measure': 'Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1', 'description': 'Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion'}, {'measure': '4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 1', 'description': '4-OH cyclophosphamide plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion'}, {'measure': 'Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2', 'description': 'Cyclophosphamide plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion'}, {'measure': 'Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1', 'description': 'Cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of cyclophosphamide AUC0-24h are obtained using post hoc analysis.', 'timeFrame': 'Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose'}, {'measure': '4-OH Cyclophosphamide AUC0-24h in Induction Chemotherapy', 'description': '4-OH cyclophosphamide plasma concentration-time data are collected on day 9 in one cycle of induction chemotherapy. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion'}, {'measure': '4-OH Cyclophosphamide AUC0-24h in Consolidation Chemotherapy Cycle 2', 'description': '4-OH cyclophosphamide plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion'}, {'measure': '4-OH Cyclophosphamide AUC0-24h in Maintenance Chemotherapy Cycle A1', 'description': '4-OH cyclophosphamide plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of 4-OH cyclophosphamide AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.', 'timeFrame': 'Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose'}, {'measure': 'CEPM AUC0-24h in Induction Chemotherapy', 'description': 'Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected on day 9 in one induction cycle. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion'}, {'measure': 'CEPM AUC0-24h in Consolidation Chemotherapy Cycle 1', 'description': 'Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected in consolidation cycle 1. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion'}, {'measure': 'CEPM AUC0-24h in Consolidation Chemotherapy Cycle 2', 'description': 'Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected in consolidation cycle 2. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.', 'timeFrame': 'Pre-infusion, end of infusion, 3, 6, and 24 hours from end of cyclophosphamide infusion'}, {'measure': 'CEPM AUC0-24h in Maintenance Chemotherapy Cycle A1', 'description': 'Carboxyethylphosphoramide mustard (CEPM) plasma concentration-time data are collected on day 1 of maintenance cycle A1. Individual estimates of CEPM AUC0-24h (area under concentration curve from time 0 to 24 hours post-dose) are obtained using post hoc analysis.', 'timeFrame': 'Pre-dose, 0.5, 1.75, 3, 6, and 24 hours post-dose'}, {'measure': 'Participants With Empirical Dosage Achieving Target System Exposure of Intravenous Topotecan', 'description': 'Number of participants who successfully achieve target systemic exposure of intravenous topotecan after an empiric dosage during consolidation phase of therapy are reported.', 'timeFrame': 'Pre-infusion, 5 min., 1, and 3 hours from end of infusion'}, {'measure': 'Participants With PK-guided Dosage Adjustment Achieving Target System Exposure of Intravenous Topotecan', 'description': 'Number of participants who successfully achieve target systemic exposure of intravenous topotecan after a pharmacokinetic-guided dosage adjustment during consolidation phase of therapy are reported.', 'timeFrame': 'Pre-infusion, 5 min., 1, and 3 hours from end of infusion'}, {'measure': 'Topotecan Clearance in Consolidation Chemotherapy', 'description': 'Topotecan plasma concentration-time data are collected on day 1 of consolidation cycle 1 after a single IV dose. Individual estimates of topotecan clearance are obtained using post hoc analysis.', 'timeFrame': 'Pre-infusion, 5 min., 1, and 3 hours from end of infusion'}, {'measure': 'Topotecan Apparent Oral Clearance in Maintenance Chemotherapy', 'description': 'Topotecan plasma concentration-time data are collected on day 1 of maintenance cycle A1 after a single oral dose. Individual estimates of topotecan apparent oral clearance are obtained using post hoc analysis.', 'timeFrame': 'Pre-dose, 0.25, 1.5 and 6 hours post-dose'}, {'measure': 'Topotecan AUC0-24h in Consolidation Chemotherapy', 'description': 'Topotecan plasma concentration-time data are collected on day 1 of consolidation cycle 1 after a single IV dose. Individual estimates of topotecan AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.', 'timeFrame': 'Pre-infusion, 5 min., 1, 3, and 24 hours from end of infusion'}, {'measure': 'Topotecan AUC0-24h in Maintenance Chemotherapy', 'description': 'Topotecan plasma concentration-time data are collected on day 1 of maintenance cycle A1 after a single oral dose. Individual estimates of topotecan AUC0-24h (area under concentration curve from time 0 to 24 hours post- dose) are obtained using post hoc analysis.', 'timeFrame': 'Pre-dose, 0.25, 1.5, 6, and 24 hours post-dose'}, {'measure': 'Erlotinib Apparent Oral Clearance', 'description': 'Erlotinib plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of erlotinib apparent oral clearance are obtained using post hoc analysis.', 'timeFrame': 'Pre-dose, 1, 2, 4, 8, and 24 hours post-dose'}, {'measure': 'Erlotinib Apparent Volume of Central Compartment', 'description': 'Erlotinib plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of erlotinib apparent volume of central compartment are obtained using post hoc analysis.', 'timeFrame': 'Pre-dose, 1, 2, 4, 8, and 24 hours post-dose'}, {'measure': 'Erlotinib AUC0-24h', 'description': 'Erlotinib plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of erlotinib AUC0-24h (area under concentration curve from 0 to 24 hours post-dose) are obtained using post hoc analysis.', 'timeFrame': 'Pre-dose, 1, 2, 4, 8, and 24 hours post-dose'}, {'measure': 'OSI-420 AUC0-24h', 'description': 'Erlotinib metabolite OSI-420 plasma concentration-time data are collected on day 1 of maintenance cycle B2. Individual estimates of OSI-420 AUC0-24h (area under concentration curve from 0 to 24 hours post-dose) are obtained using post hoc analysis.', 'timeFrame': 'Pre-dose, 1, 2, 4, 8, and 24 hours post-dose'}, {'measure': 'Rate of Local Disease Progression', 'description': 'Local failure was defined as the interval from end of RT to date of local failure (or combined local + distant failure). Competing events were distant failure or second malignancy. Patients without an event were censored at date of last contact. The 1-year cumulative incidence was estimated and reported with a 95% confidence interval.', 'timeFrame': '1 year after completion of radiation therapy for last patient'}, {'measure': 'Rate of Distant Disease Progression', 'description': 'Distant failure was defined as the interval from end of RT to date of distant failure (or combined local + distant failure). Competing events were local failure or second malignancy. Patients without an event were censored at date of last contact. The 1-year cumulative incidence was estimated and reported with a 95% confidence interval.', 'timeFrame': '1 year after completion of radiation therapy for last patient'}, {'measure': 'Neurocognitive Performance Related to Global Cognitive Functioning as Measured by Cognitive Composite Scores and Estimated IQ Scores', 'description': 'Global cognitive functioning was measured based on Cognitive Composite Scores from the Bayley III instrument for subjects \\<3 years of age and on estimated IQ scores from the Stanford Binet V instrument for subjects ≥3 years of age. Higher scores indicate better performance. The normative mean is 100 with a standard deviation of 15.', 'timeFrame': 'Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy'}, {'measure': 'Neurocognitive Performance Related to Attention as Measured by Attention Problems T-scores', 'description': 'Scores measuring attention were obtained from the Attention Problems T-score on the BASC-2 instrument which is a parent report. Higher scores indicate more attention problems. The normative mean is 50 with a standard deviation of 10.', 'timeFrame': 'Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy'}, {'measure': 'Neurocognitive Performance Related to Processing Speed as Measured by Visual Matching Standard Scores', 'description': 'Scores measuring processing speed were obtained based on the visual matching standard score from the Woodcock Johnson III instrument. Higher scores indicate better performance. The normative mean is 100 with a standard deviation of 15.', 'timeFrame': 'Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy'}, {'measure': 'Neurocognitive Performance Related to Executive Functioning as Measured by Global Executive Composite T-scores', 'description': 'Scores measuring executive functioning were obtained from Global Executive Composite (GEC) T-scores, which were obtained from the Behavior Rating Inventory of Executive Function (BRIEF) instrument which is a parent report. Higher scores indicate more problems. The normative mean is 50 with a standard deviation of 10.', 'timeFrame': 'Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy'}, {'measure': 'Neurocognitive Performance Related to Working Memory as Measured by Working Memory T-scores', 'description': 'Scores measuring working memory were obtained from Working Memory T-scores, which were obtained from the Behavior Rating Inventory of Executive Function (BRIEF) instrument which is a parent report. Higher scores indicate more problems. The normative mean is 50 with a standard deviation of 10.', 'timeFrame': 'Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy'}, {'measure': 'Neurocognitive Performance Related to Verbal Fluency as Measured by Retrieval Fluency Standard Scores', 'description': 'Scores measuring verbal fluency were obtained from Retrieval Fluency standard scores on the Woodcock Johnson III instrument. Higher scores indicate better performance. The normative mean is 100 with a standard deviation of 15.', 'timeFrame': 'Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy'}, {'measure': 'Neurocognitive Performance Related to Visual-spatial Reasoning as Measured by Visual Motor Integration (VMI) T-scores', 'description': 'Scores measuring visual-spatial reasoning were obtained from VMI T-scores on the Beery VMI instrument. Higher scores indicate better performance. The normative mean is 50 with standard deviation of 10.', 'timeFrame': 'Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy'}, {'measure': 'Neurocognitive Performance Related to Visual-spatial Reasoning as Measured by Visual Perception T-scores', 'description': 'Scores measuring visual-spatial reasoning were obtained from Visual Perception T-scores on the Beery Visual Motor Integration (VMI) instrument. Higher scores indicate better performance. The normative mean is 50 with a standard deviation of 10.', 'timeFrame': 'Baseline, prior to maintenance therapy, completion of therapy, and 12 months, 24 months, 36 months, 48 months, and 60 months off therapy'}, {'measure': 'Change in Neurostructure, Especially White Matter Volume and Integrity', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in right frontal-lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)'}, {'measure': 'Change in Neurostructure, Especially White Matter Volume and Integrity', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in left frontal lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)'}, {'measure': 'Change in Neurostructure, Especially White Matter Volume and Integrity', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in right parietal lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)'}, {'measure': 'Change in Neurostructure, Especially White Matter Volume and Integrity', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in left parietal lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)'}, {'measure': 'Change in Neurostructure, Especially White Matter Volume and Integrity', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in right occipital lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)'}, {'measure': 'Change in Neurostructure, Especially White Matter Volume and Integrity', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in left occipital lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)'}, {'measure': 'Change in Neurostructure, Especially White Matter Volume and Integrity', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in right temporal lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)'}, {'measure': 'Change in Neurostructure, Especially White Matter Volume and Integrity', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in left temporal lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)'}, {'measure': 'Change in Quantitative Magnetic Resonance (MR) Measures in the Frontal Lobe', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in frontal lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)'}, {'measure': 'Change in Quantitative MR Measures in the Right Frontal-parietal Regions', 'description': 'Quantitative MRI measures Fractional Anisotropy (FA) change per month in right frontal-parietal region over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy.\n\nFractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1', 'timeFrame': 'From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)'}]" 146,NCT02363400,"{'fullName': 'National Health Research Institutes, Taiwan', 'class': 'OTHER'}",A Phase III Trial in NPC With Post-radiation Detectable Plasma EBV DNA,TERMINATED,"Nasopharyngeal carcinoma (NPC) is a geographically endemic, Epstein-Barr virus (EBV)-associated carcinoma of epidermoid origin. It occurs most commonly in Southern China and Southeast Asia. The NPC cells are poorly differentiated or undifferentiated with a high incidence of lymphatic and hematological dissemination. Because of the inherent anatomic constraints and a high degree of radiosensitivity, radiotherapy (RT) has been the primary treatment for NPC patients. NPC is also a chemosensitive tumor. Various modes of combined chemoradiotherapy have been used to treat NPC patients with advanced-stage diseases during recent 20 years. However, treatment outcome for locoregionally advanced NPC is still unsatisfactory.",['Nasopharyngeal Carcinoma'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'MEP', 'description': 'Adjuvant Chemotherapy', 'armGroupLabels': ['Adjuvant Chemotherapy'], 'otherNames': ['epirubicin', 'cisplatin', 'oral Tegafur-uracil', 'mitomycin-C']}]","Inclusion Criteria: 1.Histological proven NPC. 2.2010 AJCC stage II-IVB. 3.Age ≧ 20 years old. 4.Performance status of ECOG ≦ 2. 5.Finished RT ≧ 66 Gy (± induction and/or concurrent chemotherapy). 6.pEBV DNA \> 0 copy/ml at 1±1 week post-RT. 7.Re-staging work-ups at 10±2 weeks post-RT showing no active lesions. 8.Adequate liver, renal, and bone marrow function 4 weeks before randomization. 9.Signed informed consent. Exclusion Criteria: 1. Pathologically-proven the presence of locoregional disease and/or distant metastasis. 2. Unequivocally-shown active NPC (locoregional/distant) by imaging studies. 3. Inadequate RT. 4. Received any post-RT adjuvant chemotherapy. 5. pEBV DNA = 0 copy/ml at 1±1 week post-RT. 6. Previous delivery of cisplatin dose \> 600 mg/m2. 7. Previous delivery of epirubicin \> 360 mg/m2. 8. History of a malignancy except those treated with curative intent for skin cancer (other than melanoma), in situ cervical cancer, ductal carcinoma in situ (DCIS) of breast. 9. Severe cardiopulmonary diseases (unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the last 12 months; chronic obstructive pulmonary disease exacerbation other respiratory illness requiring hospitalization) or clinically significant psychiatric disorders. 10. Female patients who are pregnant or lactating.",NA,ALL,NA,"[{'measure': 'Time to progression', 'timeFrame': '5 years'}]","[{'measure': 'Progression-free survival and relapse rate', 'timeFrame': '5 years'}, {'measure': 'Overall survival', 'timeFrame': '5 years'}, {'measure': 'Toxicity profile and tolerance, according to CTCAE 4.1', 'timeFrame': '5 years'}, {'measure': 'Predicting value of plasma EBV DNA', 'timeFrame': '5 years'}]" 147,NCT00002707,"{'fullName': 'NSABP Foundation Inc', 'class': 'NETWORK'}",Chemotherapy in Treating Women With Breast Cancer That Can Be Surgically Removed,COMPLETED,"RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if chemotherapy given before surgery is more effective with or without docetaxel given before or after surgery for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of chemotherapy using doxorubicin and cyclophosphamide with or without docetaxel in treating women who have stage II or stage III breast cancer.",['Breast Cancer'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Cyclophosphamide', 'description': '600 mg/m2 IV every 21 days for 4 cycles', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}, {'type': 'DRUG', 'name': 'Docetaxel', 'description': '100 mg/m2 IV every 21 days for 4 cycles', 'armGroupLabels': ['Group 2', 'Group 3']}, {'type': 'DRUG', 'name': 'Doxorubicin', 'description': '60 mg/m2 IV every 21 days fo 4 cycles', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}, {'type': 'DRUG', 'name': 'Tamoxifen', 'description': '20 mg p.o. once daily for 5 years starting on day 1 of ther first AC cycle', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}]","DISEASE CHARACTERISTICS: Histologically or cytologically proven invasive adenocarcinoma of the breast Fine-needle aspiration is acceptable Core or Tru-cut biopsies are preferable No more than 63 days between initial diagnosis and randomization Tumor palpable on clinical exam and confined to the breast and ipsilateral axilla If clinically negative axillary nodes (N0): primary tumor greater than 1 cm (T1c-T3) If clinically positive axillary nodes (N1): any size primary tumor (T1-3) No N2 disease, i.e., ipsilateral nodes clinically fixed to one another or to other structures No skeletal pain unless: Bone scan and/or roentgenologic exam negative for metastatic disease Suspicious findings confirmed as benign by x-ray, MRI, or biopsy No ulceration, erythema, skin infiltration (complete fixation), or peau d'orange, or skin edema of any magnitude Tethering or dimpling of skin or nipple inversion allowed No bilateral malignancy Suspicious contralateral mass proven benign on biopsy allowed None of the following unless proven benign on biopsy: Suspicious palpable nodes in contralateral axilla Palpable supraclavicular or infraclavicular nodes Hormone receptor status: Any status PATIENT CHARACTERISTICS: Age: Any age Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: At least 10 years (exclusive of cancer diagnosis) Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal AST/ALT normal Alkaline phosphatase normal Renal: Creatinine normal Cardiovascular: No active cardiac disease that would preclude doxorubicin, e.g.: Documented myocardial infarction History of congestive heart failure Angina pectoris requiring medication Valvular disease with documented cardiac function compromise Arrhythmia associated with heart failure or cardiac dysfunction Poorly controlled hypertension, i.e., diastolic blood pressure greater than 100 mm Hg Cardiomegaly on chest x-ray or ventricular hypertrophy on EKG unless left ventricular ejection fraction at least 45% by MUGA Other: No other malignancy within the past 10 years except: Segmentally resected lobular carcinoma in situ of the ipsilateral or contralateral breast Effectively treated nonmelanomatous skin cancer Surgically treated carcinoma in situ of the cervix No systemic disease that would preclude therapy No psychiatric or addictive disorder that would preclude informed consent Geographically accessible for follow-up Not pregnant PRIOR CONCURRENT THERAPY: No prior therapy for breast cancer No prior anthracyclines for any malignancy No concurrent sex hormones (e.g., birth control pills or ovarian replacement therapy)",NA,FEMALE,NA,"[{'measure': 'Determine if 4 cycle of pre-op or post-op Taxotere given after 4 cycles of pre-op AC will more effectively prolong survival (S) than does 4 cycles of pre-op AC alone.', 'timeFrame': 'Time from randomization to death from any cause.'}]","[{'measure': 'Prolonging disease-free survival (DFS).', 'timeFrame': 'Time from randomization to first related event of inoperable disease; residual disease following surgery; local, regional or distant recurrence; second primary cancer; death from any cause other than cancer.'}, {'measure': 'Clinical loco-regional tumor response to preoperative chemotherapy.', 'timeFrame': '3-4 weeks after the last cycle of pre-op chemotherapy.'}, {'measure': 'Pathologic loco-regional tumor response to pre-op chemotherapy.', 'timeFrame': 'At time of surgery.'}, {'measure': 'Breast conservation assessment.', 'timeFrame': 'Assessed following surgery.'}, {'measure': 'Evaluate if post-op Taxotere is of benefit in patients who received pre-op AC and, if so, whether it is of benefit in certain subgroups of patients.', 'timeFrame': 'DFS and S will be assessed in patient subgroups.'}]" 148,NCT07022509,"{'fullName': 'Batterjee Medical College', 'class': 'OTHER'}",Matrix Rotation Flap Versus Single Incision Lateral Sulcus Mammoplasty,COMPLETED,"The study seeks to compare the single-incision lateral mammoplasty technique with the matrix rotation flap in patients with breast carcinoma. The primary outcome assessed is postoperative complications, while secondary outcomes include cosmetic appearance and patient satisfaction.",['Breast Cancer Early Stage Breast Cancer (Stage 1-3)'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Statisticians', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}","[{'type': 'OTHER', 'name': 'proceduder surgery', 'description': 'The single-incision lateral sulcus mammoplasty is a breast-conserving surgical technique that involves making a single incision along the lateral aspect of the inframammary fold or within the natural skin crease of the lateral sulcus. This approach provides direct access to the lateral quadrants of the breast, which are commonly affected in breast carcinoma, allowing for effective tumor excision while preserving the breast contour.\n\nIn SILSM, the incision is carefully planned to align with natural anatomical lines, ensuring optimal cosmetic results and minimal visible scarring. Through this lateral access point, the surgeon performs both tumor resection and glandular reshaping. The technique often involves mobilization and rearrangement of the remaining breast tissue to fill the defect left by the tumor excision, thereby maintaining breast symmetry and volume.\n\nThis techn', 'armGroupLabels': ['Group SLIM']}, {'type': 'OTHER', 'name': 'Technique surgery', 'description': 'The matrix rotation flap is a versatile oncoplastic surgical technique employed in the reconstruction of partial breast defects following tumor excision. This method involves the creation of a rotational skin and glandular flap, mobilized from adjacent breast tissue, typically using an inferolateral or inferomedial pedicle. The flap is designed in a curvilinear or semicircular fashion, allowing it to rotate into the defect site while maintaining adequate vascular supply.\n\nThe MRF technique is particularly useful for defects in the lower quadrants of the breast, where direct tissue advancement may be limited. The surgeon carefully outlines a skin paddle adjacent to the resection cavity and undermines the surrounding breast parenchyma. The flap is then rotated and inset into the tumor bed to fill the defect, with the skin paddle contributing to both volume replacement and skin resurfacing if required.\n\nThis approach provides robust coverage of the surgical cavity, helps restore breast co', 'armGroupLabels': ['Group MRF']}]","Inclusion Criteria: * Upper Quadrant Breast Carcinomas. Exclusion Criteria: * Patients with T4 tumors, inflammatory breast cancer and distant metastasis, multi-centric breast cancer in more than one quadrant and diffuse microcalcifications were excluded from the study.",NA,FEMALE,NA,"[{'measure': 'Postoperative complications', 'description': 'The total number (percentage) of participants in each group who got post-operative complications such as wound infection, hematoma, and seroma.', 'timeFrame': '4 weeks'}]","[{'measure': 'Asthetic outcomes', 'description': ""Vancouver's scar scale with ranges from 0 (normal skin) to 13 (worst scar possible)"", 'timeFrame': '6 months'}, {'measure': ""Patients' satisfaction"", 'description': 'Five-point Likert scale with one being excellent, two good, three fair, four poor, and five bad. The higher the score, the worse is the result.', 'timeFrame': '6 months'}]" 149,NCT03976999,"{'fullName': ""Institut du Cancer de Montpellier - Val d'Aurelle"", 'class': 'OTHER'}","Development of a Cinical and Biological Database in Ovarian, Fallopian Tube and Peritoneal Cancers",RECRUITING,"A Clinical and Biological Database will provide to the scientific community a collection of blood and tissues with clinical datas to improve knowledge about cancer and help to develope new cancer treatments. This database is specific to epithetial ovarian cancer, Fallopian tube cancer and Primitive peritoneal cancer.","['Carcinoma, Ovarian Epithelial', 'Fallopian Tube Neoplasms', 'Peritoneal Neoplasms']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'OTHER', 'name': 'Biological collection', 'description': '* Blood samples collected at different times : Before treatment (T1) , after chemotherapy (T2), after interval surgery (T3) and after cancer reccurence (T4)\n* Tissue samples (tumor tissue and healthy tissue) collected during the surgery', 'armGroupLabels': ['Biological collection']}]","Inclusion Criteria: * 18 or older * Patient at the diagnosis of an epithelial ovarian cancer, or a fallopian tube caner or a primitive peritoneal cancer * Patient eligible for, at least, one surgery and a chemotherapy * Patient having given his informed, written and express consent Exclusion Criteria: * Patient not affiliated to a social protection scheme * Pregnant and / or nursing women * Subject under tutelage, curatorship or safeguard of justice * Patient whose regular follow-up is impossible for psychological, familial, social or geographical reasons",NA,ALL,NA,"[{'measure': 'Proportion of patients who gave their consent to participate in the study', 'description': 'The proportion of patients who consent to participate in the study among the screened patients', 'timeFrame': 'Until the study completion : 3 years'}]",NA 150,NCT04743999,"{'fullName': 'Henry Ford Health System', 'class': 'OTHER'}",Evaluation of Outcomes in Women Undergoing Multimodality Treatment for Advanced Stage Endometrial Carcinoma,TERMINATED,"Patients with FIGO stage III endometrial carcinoma often require multimodality adjuvant therapy to improve survival and recurrence rates; however, the optimal adjuvant therapy sequence is yet to be established. Several studies have tried to answer this question including RTOG 9708, PORTEC-3, and GOG 258. Collectively, these studies show that concurrent chemotherapy and radiation (chemoRT) with cisplatin followed by additional chemotherapy (CT) and CT alone are acceptable regimens. However, both strategies show that distant recurrence remains a problem when CT is delayed after RT, and local control is compromised without RT. We wish to prospectively assess outcomes of women with advanced endometrial carcinoma who receive concurrent chemoRT with a carboplatin/paclitaxel-based regimen. A total of 60 patients with FIGO stage III uterine carcinoma will be prospectively enrolled after undergoing surgical staging (currently accruing). CT will start approximately 4 weeks after surgery. Patients will receive 6 cycles of carboplatin (AUC 6) and paclitaxel (175 mg/m2). RT will be given during CT cycles 1-3. External beam RT will be given via intensity-modulated RT in once-daily fractions of 1.8-2.0 Gy for a total dose of 44-45 Gy to the pelvis (vaginal cuff, pelvic LN, and para-aortic lymph nodes). If there is grossly visible nodal disease seen at the time of treatment planning, a boost to 54 Gy will be given to those areas. If the patient has cervical stromal invasion, we will recommend that she receive a brachytherapy boost. Data will be collected on OS and PFS endpoints. Data will also be collected on provider- and patient-reported treatment toxicity. Patients will receive a series of questionnaires at baseline, 3, 6, 12, and 24 months after surgery. These are prospectively-validated questionnaires and include FACT-G, FACT-En, FACT/GOG-NTX, and FACT-C. For statistical analyses, continuous and categorical variables will be analyzed. Kaplan-Meier survival estimates will be calculated for local control and survival end points. For each patient, disease characteristics and adjuvant treatment will be placed in a simple logistic regression model for predicting survival endpoints. A multivariate analysis will be performed for exploratory purposes. Hazard ratios and 95% confidence intervals will be reported. Tests will be considered significant at p \< 0.05.",['Endometrial Cancer'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'OTHER', 'name': 'Quality of life questionnaire', 'description': ""We will evaluate patients' quality of life with a series of questionnaires at baseline, 3, 6, 12, and 24 months after surgical staging. These are prospectively validated questionnaires and include FACT-G (physical and functional well-being sections), FACT-En (additional concerns section), FACT/GOG-NTX-4 (additional concerns section), and FACT-C (items C3 and C5).These sections will be combined into one single form for ease of completion for the patients (a total of 36 items)."", 'armGroupLabels': ['Quality of life evaluation']}]","Inclusion Criteria: * FIGO stage III uterine carcinoma * candidates for combined modality treatment (surgery, chemotherapy with carbo/Taxol, and radiation therapy) Exclusion Criteria: * Patients who are not FIGO stage III * patients with carcinosarcoma histology * patients who are ineligible for combined modality treatment",NA,FEMALE,NA,"[{'measure': 'Assessment of Physical and Functional Well-being as Assessed by the FACT-G Questionnaire', 'description': 'The Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire is a prospectively validated form that assesses physical side effects of treatment (eg pain, nausea, fatigue) as well as treatment\'s functional impact (eg ability to work, enjoy hobbies). Scale: 0-4. 0: Not at all, 4: Very much\n\nValues reported as ""0.00 (0.00)"" are accurate in all outcome measures.', 'timeFrame': 'Baseline, 3-month, 6-month, 12-month, 24-month'}, {'measure': 'Assessment of Severity of Various Treatment-related Side Effects as Assessed by the FACT-En Questionnaire', 'description': 'The Functional Assessment of Cancer Therapy - Endometrial (FACT-EN) questionnaire is a prospectively-validated questionnaire that asks patients to rated the severity of various possible treatment side effects (eg GI pain, pelvic pain, shortness of breath) Scale: 0-4. 0: Not at all, 4: Very much', 'timeFrame': 'Baseline, 3-month, 6-month, 12-month, 24-month'}, {'measure': 'Assessment of Severity of Neurotoxicity Side Effects as Assessed by the FACT/GOG-NTX-4 Scale', 'description': 'The Functional Assessment of Cancer Therapy/Gynecologic Oncology Group - Neurotoxicity 4 Item Version (FACT/GOG-NTX-4) scale is a prospectively-validated questionnaire that assesses the severity of side effects related to neurotoxicity (paresthesia, pain in hands/feet) Scale: 0-4. 0: Not at all, 4: Very much', 'timeFrame': 'Baseline, 3-month, 6-month, 12-month, 24-month'}, {'measure': 'Assessment of Severity of GI Side Effects as Assessed by the FACT-C Questionnaire', 'description': 'The Functional Assessment of Cancer Therapy - Colorectal (FACT-C) scale is a prospectively-validated questionnaire that asses GI-related side effects (diarrhea, fecal incontinence) Scale: 0-4. 0: Not at all, 4: Very much', 'timeFrame': 'Baseline, 3-month, 6-month, 12-month, 24-month'}]",NA 151,NCT00823732,"{'fullName': 'City of Hope Medical Center', 'class': 'OTHER'}",Effects of Palliative Care on Quality of Life and Symptom Control in Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery,COMPLETED,"RATIONALE: Palliative care may be more effective than standard care in improving quality of life and symptoms in patients with lung cancer. PURPOSE: This clinical trial is studying the effects of palliative care on quality of life and symptom control in patients with stage IIIB or stage IV non-small cell lung cancer that cannot be removed by surgery.",['Lung Cancer'],INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'OTHER', 'name': 'educational intervention', 'description': 'Undergo individualized interdisciplinary palliative care intervention', 'armGroupLabels': ['Phase 2 Intervention']}, {'type': 'OTHER', 'name': 'medical chart review', 'description': 'Ancillary studies', 'armGroupLabels': ['Phase 2 Intervention']}, {'type': 'OTHER', 'name': 'questionnaire administration', 'description': 'Ancillary studies', 'armGroupLabels': ['Phase 2 Intervention']}, {'type': 'PROCEDURE', 'name': 'end-of-life treatment/management', 'description': 'Undergo end-of-life treatment/management', 'armGroupLabels': ['Phase 2 Intervention']}, {'type': 'PROCEDURE', 'name': 'psychosocial assessment and care', 'description': 'Undergo psychosocial assessment and care', 'armGroupLabels': ['Phase 2 Intervention']}, {'type': 'PROCEDURE', 'name': 'quality-of-life assessment', 'description': 'Ancillary studies', 'armGroupLabels': ['Phase 2 Intervention']}, {'type': 'PROCEDURE', 'name': 'management of therapy complications', 'description': 'Undergo management of therapy complications', 'armGroupLabels': ['Phase 2 Intervention'], 'otherNames': ['complications of therapy, management of']}, {'type': 'PROCEDURE', 'name': 'assessment of therapy complications', 'description': 'Undergo assessment of therapy complications', 'armGroupLabels': ['Phase 2 Intervention']}]","Criteria: * Diagnosis of stage IIIb-IV unresectable NSCLC * Undergoing treatment with chemotherapy, radiation, or combined modalities * Living within a 50 mile radius of the City of Hope * No previous cancer within the past 5 years",NA,ALL,NA,"[{'measure': 'Overall quality of life and psychological distress', 'timeFrame': '6 months after study enrollment'}, {'measure': 'Symptom control', 'timeFrame': '6 months after study enrollment'}, {'measure': 'Geriatric assessment outcomes as measured by OARS Instrumental Activities of Daily Living, MOS Activities of Daily Living, MOS Social Activities Limitation Scale, Hospital Anxiety and Depression Scale scores, and Karnofsky performance scale', 'timeFrame': '6 months after study enrollment'}, {'measure': 'Resource use as measured by chart audits', 'timeFrame': '6 months after study enrollment'}, {'measure': 'Identification of subgroups of patients who benefit most from the palliative care intervention in relation to sociodemographic characteristics, treatment factors, and geriatric assessment predictors at week 24', 'timeFrame': 'Week 24 after study enrollment'}]",NA 152,NCT00482014,"{'fullName': 'Eli Lilly and Company', 'class': 'INDUSTRY'}","A Study of Pemetrexed Plus Carboplatin, or Pemetrexed Plus Cisplatin With Radiation Therapy Followed by Pemetrexed in Patients With Inoperable Non-Small-Cell Lung Cancer",COMPLETED,The primary purpose of this study is to determine the 2-year survival rate of both of the chemotherapy regimens in patients with inoperable non-small-cell lung cancer.,['Non-Small-Cell Lung Cancer'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'pemetrexed', 'description': 'Phase 1 - 500 milligram/meter squared (mg/m²), administered intravenously, every 21 days for 3 cycles\n\nPhase 2 - 500 mg/m², administered intravenously, every 21 days for 3 cycles\n\nConsolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation therapy for each phase', 'armGroupLabels': ['A: Pemetrexed + Carboplatin', 'B: Pemetrexed + Cisplatin'], 'otherNames': ['LY231514', 'Alimta']}, {'type': 'DRUG', 'name': 'cisplatin', 'description': 'Phase 1 - 30 mg/m² and 75 mg/m², administered intravenously, Days 1, 8, 22, 29 and 43\n\nPhase 2 - 75 mg/m², administered intravenously, every 21 days for 3 cycles', 'armGroupLabels': ['B: Pemetrexed + Cisplatin']}, {'type': 'DRUG', 'name': 'carboplatin', 'description': 'Phase 1 - dosed at area under the curve (AUC) 2 milligram/milliliter\\*minute (mg/mL\\*min), administered intravenously, Days 1, 8, 22, 29 and 43\n\nPhase 2 - dosed at AUC 5 mg/mL\\*min, administered intravenously, every 21 days for 3 cycles', 'armGroupLabels': ['A: Pemetrexed + Carboplatin']}, {'type': 'RADIATION', 'name': 'radiation therapy', 'description': 'Phase 1 - 2 Gray, daily, 5 days a week for Days 1-51\n\nPhase 2 - 2 Gray, daily, 5 days a week for Days 1-45', 'armGroupLabels': ['A: Pemetrexed + Carboplatin', 'B: Pemetrexed + Cisplatin']}]","Inclusion Criteria: * Inoperable non small cell lung cancer * No weight loss greater than 10% in 3 months prior to enrolling in trial * Adequate kidney function * Adequate liver function * Adequate lung function Exclusion Criteria: * Previous surgery to remove lung tumor * Previous chemotherapy or radiation therapy or lung cancer * Inability to take vitamin supplementation * Heart attack within past 6 months * Active infection",NA,ALL,NA,"[{'measure': 'Phase 1 - Maximum Tolerated Dose (MTD) of Carboplatin', 'description': 'MTD was defined as a dose at which the occurrence of at least 2 dose-limiting toxicities (DLTs) was observed. DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course, including a 2-week recovery period following completion of RT: Grade 4 neutropenia (\\<0.5 x 10\\^9 cells per liter) lasting \\>7 days, febrile neutropenia; ≥Grade 3 neutropenia with fever \\>38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations) and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis).', 'timeFrame': 'Phase 1 enrollment to the end of study treatment up to Week 11'}, {'measure': 'Phase 1 - Maximum Tolerated Dose (MTD) of Cisplatin', 'description': 'MTD was defined as a dose at which the occurrence of at least 2 dose-limiting toxicities (DLTs) was observed. DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course, including a 2-week recovery period following completion of RT: Grade 4 neutropenia (\\<0.5 x 10\\^9 cells per liter) lasting \\>7 days, febrile neutropenia; ≥Grade 3 neutropenia with fever \\>38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations) and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis).', 'timeFrame': 'Phase 1 enrollment to the end of study treatment up to Week 11'}, {'measure': 'Phase 2 - Survival Probability at 2 Years', 'timeFrame': 'Phase 2 randomization up to 2 years'}]","[{'measure': 'Phase 1 - Pharmacology Toxicity: Number of Participants With Dose Limiting Toxicities (DLTs)', 'description': 'Phase 1 pharmacology toxicity was defined as the number of participants experiencing dose limiting toxicities (DLTs). DLT was defined as any of the following events occurring during the entire radiation therapy (RT) course: Grade 4 neutropenia (\\<0.5 x 10\\^9 cells per liter) \\>7 days, febrile neutropenia, ≥Grade 3 neutropenia with fever \\>38.5 degrees Celsius (°C), Grade 4 thrombocytopenia, Grade 3 thrombocytopenia with ≥Grade 2 bleeding, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, and transaminase elevations), and ≥Grade 3 pulmonary or esophageal toxicity (radiation-related pneumonitis or esophagitis). Grade 5 events are the events leading to the death.', 'timeFrame': 'Phase 1 enrollment up to Week 11'}, {'measure': 'Phase 1 - Percentage of Participants With Complete Response or Partial Response (Response Rate)', 'description': 'Response rate is the percentage of participants with complete response (CR) or partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.', 'timeFrame': 'Phase 1 enrollment to the end of the study treatment up to Week 11'}, {'measure': 'Phase 2 - Pharmacology Toxicity: Number of Participants With Adverse Events', 'description': 'Phase 2 pharmacology toxicity was defined as the number of participants who experienced serious adverse events or all other nonserious adverse events during the study. A summary of serious adverse events and other nonserious adverse events is located in the Reported Adverse Events section.', 'timeFrame': 'Phase 2 randomization to the end of the study treatment up to 30.0 months'}, {'measure': 'Phase 2 - Time to Progression', 'description': 'Time to disease progression was measured from randomization of Study Phase 2 to the first observation of disease progression according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Disease progression is ≥20% increase in sum of longest diameter of target lesions and/or a new lesion.', 'timeFrame': 'Phase 2 randomization to measured disease progression up to 24 months'}, {'measure': 'Phase 2 - Median Survival', 'timeFrame': 'Phase 2 randomization to death as the result of any cause up to 30.0 month'}, {'measure': 'Phase 2 - Percentage of Participants With Complete Response or Partial Response (Response Rate)', 'description': 'Response rate is the percentage of participants with complete response (CR) or partial response (PR), as assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines. CR is disappearance of all target and non-target lesions; PR is ≥30% decrease in sum of longest diameter of target lesions. Response rate is calculated as a total number of participants with CR or PR divided by the total number of participants treated multiplied by 100.', 'timeFrame': 'Phase 2 randomization to the end of the treatment up to 30.0 months'}]" 153,NCT07488533,"{'fullName': 'Sun Yat-sen University', 'class': 'OTHER'}",Comparing the Combination of Sullumab and Fruquintinib in Postoperative Adjuvant Therapy for High Recurrence Risk Non Transparent Renal Cell Carcinoma,ACTIVE_NOT_RECRUITING,"This study is testing a new treatment approach for people who have had surgery to remove a type of kidney cancer called non-clear cell renal cell carcinoma (non-ccRCC). This kind of kidney cancer is different from the most common type and tends to come back after surgery, especially in high-risk patients. After surgery, many patients are at risk of their cancer returning. Right now, there is no standard treatment to prevent this from happening. This study aims to find out if combining two medications-Serplulimab (a PD-1 inhibitor) and Fruquintinib (a targeted drug that blocks blood vessel growth in tumors)-can help reduce the chance of cancer coming back. The study will include up to 40 adults aged 18 to 75 who have had surgery to remove the tumor and are at high risk of recurrence. All participants will receive both drugs as part of an adjuvant therapy, meaning it is given after surgery to lower the risk of cancer returning. Serplulimab will be given by IV every three weeks. Fruquintinib will be taken orally daily, with a schedule of 3 weeks on and 1 week off. Treatment will last up to 12 months. Participants will be closely monitored throughout the study with regular check-ups, blood tests, imaging scans (like CT or MRI), and safety assessments. The main goal is to see how long patients stay free of cancer (called ""disease-free survival""). Other goals include checking how well the treatment works, how safe it is, and whether certain biomarkers (like PD-L1 levels or genetic changes in tumor DNA) can predict who benefits most. All medical care related to the study-including visits, scans, lab tests, and the study drugs-will be provided at no cost to participants. Participants may also have access to advanced molecular testing through a partner laboratory. This is a single-center, open-label study, meaning everyone involved knows which treatment is being used. There is no placebo group; all participants receive active treatment. The study team believes this combination could offer a promising way to improve outcomes for people with high-risk non-ccRCC after surgery. If successful, it may lead to a new standard of care for this patient group. Participation is voluntary. Patients can leave the study at any time without affecting future medical care. Risks include side effects from the drugs, such as fatigue, high blood pressure, diarrhea, or immune-related reactions. The research team will monitor these carefully and provide appropriate care. This study is being conducted by researchers at a single hospital in China and supported by domestic pharmaceutical companies. It follows all national and international guidelines for ethical research involving human participants. It is hoped that this study will help better understand how to prevent kidney cancer from returning and improve survival for patients.",['Non-Clear Cell Renal Cell Carcinoma'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Serplulimab in combination with Fruquintinib', 'description': 'This intervention consists of a combination of Serplulimab, a humanized anti-PD-1 monoclonal antibody, and Fruquintinib, a selective oral inhibitor of vascular endothelial growth factor receptors (VEGFRs). Serplulimab is administered intravenously at 3 mg/kg every 3 weeks. Fruquintinib is taken orally at 5 mg daily on a 3-week-on/1-week-off schedule. The regimen is given for up to 12 months following radical nephrectomy as adjuvant therapy in patients with high-risk non-clear cell renal cell carcinoma. The dual mechanism aims to enhance anti-tumor immunity by blocking immune checkpoint inhibition while simultaneously inhibiting tumor angiogenesis.', 'armGroupLabels': ['Serplulimab + Fruquintinib Adjuvant Therapy'], 'otherNames': ['Serplulimab + Fruquintinib']}]","Inclusion Criteria: * Age between 18 and 75 years, inclusive. * Histologically confirmed diagnosis of non-clear cell renal cell carcinoma (non-ccRCC), including papillary, chromophobe, collecting duct, or other non-clear cell subtypes. * Completed radical nephrectomy (open or laparoscopic) with no evidence of residual tumor by imaging or pathology. * High-risk features defined as one or more of the following: pT3 or higher, regional lymph node involvement (N1), sarcomatoid differentiation, tumor necrosis, Fuhrman/ISUP nuclear grade ≥3, or positive surgical margin. * ECOG performance status of 0 or 1. * Adequate organ function: neutrophils ≥1.5 × 10⁹/L, platelets ≥100 × 10⁹/L, hemoglobin ≥9 g/dL; total bilirubin ≤1.5 × ULN; ALT/AST ≤2.5 × ULN; creatinine clearance ≥50 mL/min; INR ≤1.5. * No prior adjuvant or neoadjuvant systemic anti-tumor therapy. * Willing and able to provide written informed consent and comply with study procedures. Exclusion Criteria: * Pathological diagnosis of clear cell renal cell carcinoma or mixed histology with ≥20% clear cell component. * Evidence of distant metastasis (M1) at baseline. * History of active autoimmune disease (e.g., lupus, rheumatoid arthritis, inflammatory bowel disease) or current use of immunosuppressive agents. * Uncontrolled hypertension (systolic \>150 mmHg or diastolic \>100 mmHg), significant cardiovascular disease, or uncontrolled heart failure.",NA,ALL,NA,"[{'measure': 'Overall Survival (OS)', 'description': 'OS will be estimated using the Kaplan-Meier method and compared with historical controls.', 'timeFrame': 'From the date of radical nephrectomy until death from any cause, assessed up to 60 months.'}]","[{'measure': 'DFS', 'description': 'Disease-Free Survival', 'timeFrame': 'From randomization until disease recurrence or death, assessed up to 60 months.'}]" 154,NCT04868149,"{'fullName': 'The University of Hong Kong', 'class': 'OTHER'}",Clinical Outcome and Future Liver Remnant Regenerative Response in Laparoscopic Versus Open ALPPS,RECRUITING,"Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) is a new surgical procedure that induces rapid liver regeneration in patients with small liver remnant planning for major liver resection. It is a two-staged operation with stage I including portal vein ligation and splitting the right liver away from the left liver. After stage I, the left liver will undergo rapid liver regeneration and the stage II operation can be performed at 7-10 days after stage I operation when the liver remnant reaches an adequate size. In stage II operation, the right liver that contains the tumor is then removed. This surgical procedure was incepted in Germany in 2013 and was later started in Queen Mary Hospital in Hong Kong for the first time in December 2015. The initial indication was mainly for colorectal liver metastasis but due to the relatively high incidence of hepatocellular carcinoma in Hong Kong, HBP surgery team of Queen Mary Hospital has transferred this procedure to be applied for hepatitis-related hepatocellular carcinoma and so far, the centre has cumulated one of the largest single-center experience in the literature. Nonetheless, the usual approach for ALPPS involved open surgery and induced substantial surgical stress to the patient, especially after stage I operation. With the advent of minimally invasive liver surgery in recent years, the team has successfully applied laparoscopic surgery to ALPPS in 2019. Despite the advancement in laparoscopic surgical skills that rendered laparoscopic ALPPS feasible, there is scarcity of data in the literature to evaluate its outcome in comparison with open ALPPS with regard to perioperative recovery and liver regeneration. Hence, the aim of this project is to evaluate the short-term clinical outcomes of laparoscopic ALPPS and the impact of laparoscopy on liver remnant regeneration after ALPPS in a prospective randomised clinical trial setting.",['Liver Cancer'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'Patient are randomly assigned into either open or laparoscopic approach. The ratio of open and laparoscopic is 1:1.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'PROCEDURE', 'name': 'Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS)', 'description': 'Associating liver partition and portal vein ligation for staged hepatectomy (ALPPS) is a surgical procedure that induces rapid liver regeneration in patients with small liver remnant planning for major liver resection. It is a two-staged operation with stage I including portal vein ligation and splitting the right liver away from the left liver. After stage I, the left liver will undergo rapid liver regeneration and the stage II operation can be performed at 7-10 days after stage I operation when the liver remnant reaches an adequate size. In stage II operation, the right liver that contains the tumor is then removed.', 'armGroupLabels': ['Laparoscopic ALPPS', 'Open ALPPS'], 'otherNames': ['ALPPS']}]","Inclusion Criteria: 1. Patients with a diagnosis of malignant liver tumor contemplating for extended right hepatectomy or right trisectionectomy 2. Patient consent 3. Age \>/= 18 4. FLR/ESLV \ 100x10\^9/L 7. Child A cirrhosis (due to hepatitis B/C virus, or alcohol, or autoimmune disease) 8. American Society of Anaesthesiology score \< 3 9. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Technical factors eligible for laparoscopic ALPPS * single long-segment portal Exclusion Criteria: 1. Absence of consent 2. Decompensated liver disease as indicated by the presence of ascites, varices and hepatic encephalopathy 3. ECOG performance status \>/= 3 4. Main portal vein thrombosis 5. FLR/ESLV \> 30% Technical factors not eligible for laparoscopic ALPPS * Short-segment right portal vein or early bifurcation of right anterior/posterior portal vein, or other portal vein anomalies * Large tumor size with diameter \> 5 cm * Intolerance to CO2 pneumoperitoneum",NA,ALL,NA,"[{'measure': 'Amount of future liver remnant volume increment by percentage after stage I ALPPS', 'description': 'Amount of future liver remnant volume increment by percentage after stage I ALPPS', 'timeFrame': 'During hospital stay after stage I ALPPS, an average of 1-2 weeks'}]","[{'measure': 'Preoperative blood loss during stage 1 ALPPS', 'description': 'Preoperative blood loss during stage 1 ALPPS', 'timeFrame': 'During hospital stay after stage I ALPPS, an average of 1-2 weeks'}, {'measure': 'Length of hospital stay after stage 1 ALPPS', 'description': 'Length of hospital stay after stage 1 ALPPS', 'timeFrame': 'During hospital stay after stage I ALPPS, an average of 1-2 weeks'}, {'measure': 'Overall morbidity in number and mortality rates in percentage after stage 1 ALPPS', 'description': 'Overall morbidity and mortality rates after stage 1 ALPPS', 'timeFrame': 'During hospital stay after stage I ALPPS, an average of 1-2 weeks'}, {'measure': 'Inflammatory markers associated with inflammation and regeneration after stage 1 ALPPS', 'description': 'Inflammatory markers e.g. IL-6 (pg/ml), IL-8 (pg/ml) and TNF-alpha (pg/ml) associated with inflammation and regeneration after stage 1 ALPPS', 'timeFrame': 'During hospital stay after stage I ALPPS, an average of 1-2 weeks'}]" 155,NCT05557838,"{'fullName': 'AstraZeneca', 'class': 'INDUSTRY'}",Durvalumab Plus Tremelimumab as First-line Treatment in Chinese Patients With uHCC,ACTIVE_NOT_RECRUITING,"This is a prospective, open label, multi-center, interventional study to assess the safety and efficacy of Druvalumab plus Tremelimumab as first-line treatment in Chinese patients with unresectable hepatocellular carcinoma.",['Hepatocellular Carcinoma'],INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Durvalumab', 'description': 'Durvalumab IV (intravenous infusion)', 'armGroupLabels': ['cohort 1', 'cohort 2'], 'otherNames': ['MEDI4736']}, {'type': 'DRUG', 'name': 'Tremelimumab', 'description': 'Tremelimumab IV (intravenous infusion) CTLA-4 inhibitor', 'armGroupLabels': ['cohort 1', 'cohort 2'], 'otherNames': ['There is no other names for tremelimumab.']}]","Inclusion Criteria For inclusion in the study, patients should fulfill the following criteria: 1. Provide written informed consent to participate in the study before the start of the study 2. Age ≥18 years at the time of study entry. 3. Body weight \>30 kg. 4. Confirmed HCC based on histopathological findings from tumor tissue or radiologically findings. 5. Must not have received prior systemic therapy for HCC. 6. At least 1 measurable lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have a short axis ≥15 mm) with computerized tomography (CT) or magnetic resonance imaging (MRI), and that is suitable for accurate repeated measurements as per RECIST 1.1 guidelines. A lesion which progressed after previous ablation or TACE could be measurable if it meets these criteria. 7. Must not be eligible for locoregional therapy for unresectable HCC. For patients who progressed after locoregional therapy for HCC, locoregional therapy must have been completed ≥28 days prior to the baseline scan for the current study. 8. Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C. 9. Child-Pugh Score classification on liver disease and WHO/ECOG PS at enrolment must comply with one of the following criteria, not cumulatively: 1. Child-Pugh Score class A with WHO/ECOG PS 0-1 at enrolment will be enrolled in cohort1; 2. Child-Pugh class B with WHO/ECOG 0-1 will be enrolled in cohort 2; 3. Child-Pugh class A with WHO/ECOG 2 will be enrolled in cohort 2; Exclusion Criteria 1\) Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). 2）Previous study drug(s) assignment in the present study. 3）Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study. 4）Have received an investigational product within 28 days prior to the first dose of study drug(s). 5\) Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria: * Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis. * Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab or tremelimumab may be included (eg, hearing loss). 6\) Any concurrent chemotherapy, or biologic or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable. 7\) Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients. 8\) Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 28 days of the first dose of study drug(s). 9\) Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study drug(s). Note: Local surgery of isolated lesions for palliative intent is acceptable. 10\) History of allogeneic organ transplantation (eg, liver transplant). 11）History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy (eg, no lactulose, rifaximin, etc. if used for purposes of hepatic encephalopathy). 12\) Clinically meaningful ascites, defined as ascites requiring increasingly frequent non-pharmacologic intervention (eg, paracentesis) and/or escalation in pharmacologic intervention to maintain symptomatic control, within 2 months prior to the first scheduled dose. Subjects on stable doses of diuretics for ascites for ≥2 months are eligible. Also, uncontrolled pleural effusion, pericardial effusion requiring recurrent drainage procedures (once monthly or more frequently) . 13）Patients with main portal vein tumor thrombosis (Vp4). 14）Active or prior documented GI bleeding (eg, esophageal varices or ulcer bleeding) within 6 months.",NA,ALL,NA,"[{'measure': '≥Grade 3 Adverse Events and Adverse Events of Special Interest of Cohort 1', 'description': 'Safety endpoint', 'timeFrame': 'From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 44months'}]","[{'measure': '≥Grade 3 Adverse Events and Adverse Events of Special Interest of Cohort 2', 'description': 'Safety endpoint', 'timeFrame': 'From the time of signature of informed consent, throughout the treatment period, and up to the follow-up period, assessed up to 44 months'}, {'measure': 'Overall Survival (OS)', 'description': 'efficacy endpoint', 'timeFrame': ""From the first dose of treatment to the date of death, regardless of the actual cause of the subject's death, assessed up to 44 months""}, {'measure': 'Progression Free Survival (PFS) per RECIST v1.1/mRECIST', 'description': 'efficacy endpoint', 'timeFrame': 'From first dose of treatment until progression per RECIST 1.1/ mRECIST as assessed by the Investigator or death due to any cause prior to progression, assessed up to 15 months'}, {'measure': 'Objective Response Rate (ORR) per RECIST 1.1/ mRECIST', 'description': 'efficacy endpoint', 'timeFrame': 'Until progression, assessed up to 15 months'}, {'measure': 'Disease Control Rate (DCR) per RECIST 1.1/ mRECIST', 'description': 'efficacy endpoint', 'timeFrame': 'Until progression, assessed up to 15 months'}, {'measure': 'Duration of response (DoR) per RECIST 1.1/mRECIST', 'description': 'efficacy endpoint', 'timeFrame': 'From the first dose, until progression, assessed up to 15 months'}]" 156,NCT01213758,"{'fullName': 'University of Aarhus', 'class': 'OTHER'}",Changes in Liver Function After Stereotactic Body Radiation Therapy Measured by PET/CT,COMPLETED,"Patients treated with stereotactic radiotherapy for liver tumors undergo PET/CT using the galactose analogue 18-F-deoxy-galactose (FDGal) before and after radiotherapy. This technique provides volumetric mapping of liver function and it allows quantisation of liver function. The method may be used for selection of patients for stereotactic radiotherapy of liver tumors, for determination of radiation induced liver dysfunction and may be included into the treatment planning process of stereotactic radiotherapy.","['Hepatocellular Carcinoma', 'Cholangiocarcinoma', 'Metastases', 'Stereotactic Body Radiotherapy']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'OTHER', 'name': 'Measuring liver function by PET/CT', 'description': 'Measuring liver function by use of FDGal and PET/CT before, 1 month and 3 months after stereotactic radiotherapy for liver tumors', 'armGroupLabels': ['Liver tumors']}]","Inclusion Criteria: * liver tumor * referred for stereotactic radiation therapy * age \> 18 years Exclusion Criteria: * Impaired kidney function * Pregnancy",Patients with liver tumors reffered for stereotactic body radiation therapy,ALL,PROBABILITY_SAMPLE,"[{'measure': 'Uptake of FDGal', 'description': 'Volumetric uptake of FDGal can be measured is measured by PET/CT', 'timeFrame': 'Before, 1 month and 3 months after stereotactic radiotherapy'}]",NA 157,NCT07687758,"{'fullName': 'Siriraj Hospital', 'class': 'OTHER'}",Non-Invasive Risk Stratification for Hepatocellular Carcinoma in HCV-Related Compensated Advanced Chronic Liver Disease Following Sustained Virological Response: Validation of the aMAP Score,COMPLETED,"This retrospective cohort study evaluated the performance of non-invasive risk scores for predicting de novo hepatocellular carcinoma in adults with hepatitis C virus-related compensated advanced chronic liver disease who achieved sustained virological response after sofosbuvir-based direct-acting antiviral therapy. Patients treated at Siriraj Hospital between 2013 and 2023 were included if they had compensated advanced chronic liver disease and documented SVR12. The study compared FIB-4, APRI, ALBI, and aMAP scores calculated at SVR12 for prediction of hepatocellular carcinoma during long-term follow-up. The primary aim was to identify a very-low-risk subgroup in whom hepatocellular carcinoma surveillance might potentially be de-escalated.","['Hepatitis C Virus Infection', 'Compensated Advanced Chronic Liver Disease', 'Hepatocellular Carcinoma (HCC)']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}","[{'type': 'OTHER', 'name': 'Non-invasive Risk Score Assessment', 'description': 'FIB-4, APRI, ALBI, and aMAP scores were calculated using laboratory values at SVR12 to evaluate their performance for predicting de novo hepatocellular carcinoma during follow-up.', 'armGroupLabels': ['HCV-related cACLD After SVR']}]","Inclusion Criteria: * Age 18 years or older * Chronic hepatitis C virus infection treated with direct-acting antiviral therapy * Documented sustained virological response at 12 weeks after treatment completion * Evidence of compensated advanced chronic liver disease before direct-acting antiviral therapy, defined by at least one of the following: histologic F3 or F4 fibrosis, vibration-controlled transient elastography \>10 kPa, radiologic features compatible with advanced fibrosis or cirrhosis, or clinical or endoscopic evidence of portal hypertension * Minimum follow-up of 12 months after sustained virological response Exclusion Criteria: * Incomplete or missing medical records precluding outcome assessment * Known or suspected hepatocellular carcinoma before initiating direct-acting antiviral therapy * Failure to achieve sustained virological response at 12 weeks",Adult patients with chronic hepatitis C virus infection and compensated advanced chronic liver disease who initiated sofosbuvir-based direct-acting antiviral therapy at Siriraj Hospital between 2013 and 2023 and achieved sustained virological response at 12 weeks after treatment completion.,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Development of de novo hepatocellular carcinoma', 'description': 'Occurrence of newly diagnosed hepatocellular carcinoma after achievement of sustained virological response (SVR12). Patients with known or suspected hepatocellular carcinoma before direct-acting antiviral therapy were excluded.', 'timeFrame': 'From SVR12 until diagnosis of hepatocellular carcinoma, last follow-up, or up to 8 years after SVR12.'}]","[{'measure': 'Predictive accuracy of the FIB-4 score for de novo hepatocellular carcinoma', 'description': 'Time-dependent area under the receiver operating characteristic curve (AUC) of the FIB-4 score for predicting de novo hepatocellular carcinoma.', 'timeFrame': 'At 1, 3, 5, and 8 years after SVR12'}, {'measure': 'Predictive accuracy of the APRI score for de novo hepatocellular carcinoma', 'description': 'Time-dependent area under the receiver operating characteristic curve (AUC) of the APRI score for predicting de novo hepatocellular carcinoma.', 'timeFrame': 'At 1, 3, 5, and 8 years after SVR12'}, {'measure': 'Predictive accuracy of the ALBI score for de novo hepatocellular carcinoma', 'description': 'Time-dependent area under the receiver operating characteristic curve (AUC) of the ALBI score for predicting de novo hepatocellular carcinoma.', 'timeFrame': 'At 1, 3, 5, and 8 years after SVR12'}, {'measure': 'Predictive accuracy of the aMAP score for de novo hepatocellular carcinoma', 'description': 'Time-dependent area under the receiver operating characteristic curve (AUC) of the aMAP score for predicting de novo hepatocellular carcinoma.', 'timeFrame': 'At 1, 3, 5, and 8 years after SVR12'}]" 158,NCT06739655,"{'fullName': 'Cancer Research Antwerp', 'class': 'OTHER'}",Preoperative Radiation Therapy and Immediate Breast Reconstruction,RECRUITING,"The goal of this phase III randomized controlled trial (PRADAIIBE) is to assess if preoperative radiation therapy (Preop-RT) combined with immediate breast reconstruction (IBR) can safely improve both aesthetic and quality of life outcomes in breast cancer patients, compared to the standard of care (SoC) therapy consisting of post-mastectomy radiation therapy (PMRT) and delayed/immediate breast reconstruction, in a population of breast cancer patients with an indication of mastectomy and PMRT. The following hypotheses and outcomes will be assessed at the primary endpoint of 1 year of follow-up: * Efficacy: Does Preop-RT+IBR lead to a higher BREAST-Q satisfaction with breasts score (primary endpoint), EQ-5D-5L VAS score , EQ-5D-5L Index score, AIS-Total Aesthetic Score, or a shorter treatment duration compared to SoC? * Safety: Does Preop-RT+IBR lead to an increase in adverse events (general or surgical), a lower rate of pathologic Complete Response (pCR), or worse survival outcomes compared to SoC? \[Note: this study was not powered as a non-inferiority trial, all outcomes will be pooled internationally with parallel studies\] Eligible and consenting participants will undergo screening and baseline assessments. They will then be randomised between experimental (Preop-RT+IBR) and control (SoC) groups, in a 1:1 stratified variable block size design. Follow-up will take place at 3 months, 1, 2, 5, and 10 years after the last study treatment. At baseline and during each follow-up visit each participant will complete the Breast Q 'satisfaction with breasts' and EQ-5D-5L scales, photographs will be taken. During follow-up pCR will be assessed if applicable, adverse events will be registered, and oncological follow-up will be recorded.","['Breast Neoplasms', 'Breast Carcinoma', 'Breast Adenocarcinoma', 'Cancer', 'Neoplasm']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter phase 3 (non-pharmacological) randomized controlled trial, with a parallel design and a 1:1 assignment ratio.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is an open-label study due to the impracticalities and ethical considerations regarding blinding of both radiation therapy and (sham-)surgeries.\n\nThe assessment of the photographs by an external expert panel will be blinded.'}}","[{'type': 'RADIATION', 'name': 'Preoperative radiotherapy', 'description': 'In this study patients assigned to the experimental treatment arm will receive preoperative radiation therapy instead of postoperative radiation therapy (PMRT).\n\nThis preoperative radiation therapy will be administered according to the standard of care (SoC) principles for PMRT and Whole Breast Radiation Therapy (WBRT) as defined by international guidelines.', 'armGroupLabels': ['Experimental treatment arm (PreOperative RT)'], 'otherNames': ['Preop-RT', 'Neoadjuvant radiation therapy', 'NART']}, {'type': 'RADIATION', 'name': 'Postoperative radiotherapy', 'description': 'Standard of care (SoC) postoperative radiotherapy, as defined by international guidelines.', 'armGroupLabels': ['Standard treatment arm (SoC; PostOperative RT)'], 'otherNames': ['Postop-RT', 'Postmastectomy Radiation Therapy', 'PMRT', 'Adjuvant Radiation Therapy', 'ART']}, {'type': 'PROCEDURE', 'name': 'Immediate breast reconstruction', 'description': 'In the experimental arm of the PRADAIIBE, the participants will undergo immediate breast reconstruction surgery. This is defined as breast reconstruction taking place at the same time as oncological surgery. Using one of the following primary techniques: 1) Autologous tissue reconstruction ; 2) Breast implant based reconstruction; 3) Combined autologous tissue and breast implant reconstruction. These techniques can take place in a single phase, or in a two-phased (tissue expander) approach.\n\nAdjuvant techniques (e.g.: lipofilling, mesh, ADM etc.) could be added.', 'armGroupLabels': ['Experimental treatment arm (PreOperative RT)'], 'otherNames': ['IBR']}, {'type': 'PROCEDURE', 'name': 'Immediate or delayed breast reconstruction', 'description': 'In the standard arm of the PRADAIIBE, the participants will undergo immediate or delayed breast reconstruction surgery. This is defined as breast reconstruction taking place at the same time as oncological surgery (immediate), or at a later time (delayed). Using one of the following primary techniques: 1) Autologous tissue reconstruction ; 2) Breast implant based reconstruction; 3) Combined autologous tissue and breast implant reconstruction. These techniques can take place in a single phase, or in a two-phased (tissue expander) approach. Adjuvant techniques (e.g.: lipofilling, mesh, ADM etc.) could be added.', 'armGroupLabels': ['Standard treatment arm (SoC; PostOperative RT)']}]","Screening assessments, including review of all study eligibility criteria must be completed before enrolment and randomisation. Inclusion criteria: In order to be eligible to participate in this study, a participant must meet all of the following criteria: 1\. Women ≥18 years with histopathologically confirmed breast cancer who: 1.a. require SSM/NSM for any reason (e.g. extensive disease) 1.b. require postoperative radiation therapy of at least the chest wall 1. c. have a wish for a breast reconstruction 2. An Eastern Cooperative Oncology Group (ECOG) performance status grade ≤ 2 3. Participant is able and willing to provide written informed consent, which includes compliance with and ability to undergo all study procedures, and attend the scheduled follow-up visit(s) per protocol. Exclusion criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study: 1. A previous history of breast cancer or irradiation of the chest wall for any other indication, on the other side (ipsilateral). A bilateral SSM/NSM + reconstruction (e.g. in case of a contralateral prophylactic SSM/NSM), or previous contralateral breast cancer disease/treatment, do not fall under this criterium and are thus allowed. 2. Collagen synthesis disease 3. Ongoing pregnancy 4. Actively breastfeeding 5. Smoking at time of inclusion (a history of smoking is allowed but needs to be registered in the eCRF). No interval between smoking cessation and study inclusion is defined, but the reconstructive surgeon needs to be willing to operate the patient using autologous tissue transfer. This generally translates to a smoking cessation of \>3months preoperatively. 6. BMI \> 35 kg/m2 7. cT4d tumour, metastatic disease or any reason making SSM/NSM not indicated",NA,FEMALE,NA,"[{'measure': ""Patient's satisfaction with breasts."", 'description': 'Operationalisation (measurement variable):\n\nThe satisfaction with breasts outcome variable is operationalised through the ""satisfaction with breasts"" scale from the BREAST-Q (v2) \'Reconstruction\', \'Breast Conserving Treatment\', or \'Mastectomy\' modules (as applicable). The answers from the questionnaire are then transformed into a \'BREAST-Q Score\', using the provided conversion scales.(3) The BREAST-Q score can range from 0 to100.\n\nAnalysis metric:\n\nThe transformed value of the BREAST-Q score will be used for analysis.\n\nMethod of aggregation:\n\nMean, SD, median, IQR, and range will be reported. For comparisons and estimands, please refer to the SAP.', 'timeFrame': 'Measured at 3 months, 1year, 2 years, 5 years and 10 years after last locoregional treatment. Primary endpoint: 1 year after LST.'}]","[{'measure': 'Quality of Life (EQ-5D-5L VAS score)', 'description': ""Operationalisation (measurement variable):\n\n'Quality of Life' will be assessed using the EQ-5D-5L questionnaire. Deriving the VAS-score from the VAS-scale Range EQ-5D-5L VAS-score: 0-100\n\nAnalysis metric:\n\nThe VAS-score will be used as recorded.\n\nMethod of aggregation:\n\nMean, SD, median, IQR, and range will be reported. For comparisons and estimands, please refer"", 'timeFrame': 'A baseline assessment is performed during the screening visit, followed by repeated measurements during the IMFU (if applicable), 3M, 1Y, 2Y, 5Y, and 10Y follow-up visits.'}, {'measure': 'Quality of Life (Index score)', 'description': ""Operationalisation (measurement variable):\n\n'Quality of Life' will be assessed using the EQ-5D-5L questionnaire. The index score is calculated from the Likert-scale answers, using a formula validated in the Belgian population.\n\nRange EQ-5D-5L Index-score: -0.533-0.962.\n\nAnalysis metric:\n\nThe Index-score will be transformed to a scale between 0 and 1, proportional to its original distribution using the following formula:\n\nF(IS) = (IS+0.533)/1.495 The rationale for this transformation, is to adhere to the scale proposed by the EQ-5D-5L documentation, and improve interpretability.\n\nMethod of aggregation:\n\nMean, SD, median, IQR, and range will be reported. For comparisons and estimands, please refer"", 'timeFrame': 'A baseline assessment is performed during the screening visit, followed by repeated measurements during the IMFU (if applicable), 3M, 1Y, 2Y, 5Y, and 10Y follow-up visits.'}, {'measure': 'Breast cosmesis, objective assessment (AIS - TAS)', 'description': ""Operationalisation (measurement variable):\n\nBreast cosmesis will be assessed through a blinded panel of experts, using the 'Aesthetic Items Scale' to score a set of photographs taken during study visits. This set will consist of 4 2D digital photographs. The AIS has 5 items, each are scored from 1 to 5. These items are then summed to derive the 'Total Aesthetic Score' (TAS). The TAS can range from 5 to 25.\n\nAnalysis metric:\n\nThe derived value of the Total Aesthetic Score (TAS) from each assessor will be averaged to derive the TAS of each set of photos.\n\nMethod of aggregation:\n\nMean, SD, median, IQR, and range will be reported. For comparisons and estimands, please refer to the SAP."", 'timeFrame': 'Photographs are taken during the screening visit, followed by repeated photographs during the IMFU (if applicable), 3M, 1Y, 2Y, 5Y, and 10Y follow-up visits. Expert panel assessment will take place at a later moment.'}, {'measure': 'Frequency and severity of adverse events (General AEs)', 'description': ""During the study all adverse events (AEs) codes and grades will be recorded in the eCRF, based on the 'National Cancer Institute Common Terminology Criteria for Adverse Events' (NCI-CTCAE) v5.0 reporting system.\n\nAnalysis metric:\n\nTabulation of AE frequency, type and severity. As well as the highest grade AE for each participant.\n\nMethod of aggregation:\n\nAEs will be aggregated based on their grades. Two composite measures will be reported, consisting of 1) any AE vs. no AE, and 2) grade \\> 3 AEs vs. no or grade \\<3 AEs. Tables presenting both frequency and proportions of each grade and the composite measures will be presented. Proportions will be reported as AEs compared to 'highest grade per patient', and to 'total set of AEs'. For comparisons and estimands, please refer to the SAP."", 'timeFrame': 'AEs will be assessed and recorded continuously, with explicit querying during all follow-up visits.'}, {'measure': 'Frequency and severity of adverse events (Surgical AEs)', 'description': ""During the study all adverse events (AEs) codes and grades will be recorded in the eCRF, based on the 'National Cancer Institute Common Terminology Criteria for Adverse Events' (NCI-CTCAE) v5.0 reporting system. ). The relationship to surgical study interventions will be registered in the eCRF.\n\nAnalysis metric:\n\nTabulation of surgical AE frequency, type and severity. As well as the highest grade surgical AE for each participant.\n\nMethod of aggregation:\n\nSurgical AEs will be aggregated based on their grades. Two composite measures will be reported, consisting of 1) any AE vs. no AE, and 2) grade \\> 3 AEs vs. no or grade \\<3 AEs, relating to surgical AEs. Tables presenting both frequency and proportions of each grade and composite measures will be presented. Proportions will be reported as surgical AEs compared to 'highest grade per patient', and to 'total set of surgical AEs'. For comparisons and estimands, please refer to the SAP."", 'timeFrame': 'AEs will be assessed and recorded continuously, with explicit querying during all follow-up visits.'}, {'measure': 'Treatment duration', 'description': ""Operationalisation (measurement variable):\n\nThe dates of diagnostic, study, and treatment milestones will be recorded in the eCRF. Time intervals expressed in days, will be assessed for:\n\n* Randomisation to last study treatment (LST)\n* Randomisation to oncological breast surgery\n* Oncological breast surgery to last study treatment (LST)\n\nAnalysis metric:\n\nThe 'randomisation to last study treatment (LST)' time interval, expressed in days.\n\nMethod of aggregation:\n\nKM-estimates and derived estimates for central tendency and spread will be provided. For comparisons and estimands, please refer to the SAP"", 'timeFrame': 'These outcome variables will be continuously recorded as the participant progresses through the study and the data is entered in the eCRF.'}, {'measure': 'Pathological complete response rate (pCR)', 'description': ""Operationalisation (measurement variable):\n\nPatients receiving preoperative therapy undergo pathological response assessment of the removed breast tissues (SoC assessment). The reported response Pinder-classification or 'No preoperative therapy' will be recorded in the eCRF.\n\nAnalysis metric:\n\nThe response category as described in the pathology report will be recorded for all participants, but this outcome will only be assessed in participants receiving preoperative-systemic therapy (with, or without Preop-RT).\n\nThis is due to the fact that no response is expected at 2-6 weeks after radiation therapy monotherapy, which would result in an unfair comparison.\n\nBoth this subset of the ITT set, and the complete safety set will be used in the safety assessment, as described in the SAP.\n\nMethod of aggregation:\n\nThe frequency and proportion of the response categories will be presented in a table. For comparisons and estimands, please refer to the SAP."", 'timeFrame': 'This outcome variable will be assessed after the pathology report of the removed breast tissues is available. This is checked intermittently during the treatment phase, or at least during the 3 months follow-up visit.'}]" 159,NCT00862355,"{'fullName': 'Sun Pharma Advanced Research Company Limited', 'class': 'INDUSTRY'}",Bioequivalence Study of SPARC147609 in Patients With Ovarian Cancer,COMPLETED,Bioequivalence study of SPARC147609,['Ovarian Carcinoma'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'SPARC147609', 'description': 'IV infusion', 'armGroupLabels': ['1']}, {'type': 'DRUG', 'name': 'Reference147609', 'description': 'IV infusion', 'armGroupLabels': ['2']}]","Inclusion Criteria: * Subjects meeting all of the following criteria will be considered for enrollment in the study: * Availability of subject for the entire study period and willingness to adhere to protocol requirements. * Patients with documented diagnosis of Ovarian Cancer and eligible for receiving a dose 50mg/m2 of Doxorubicin liposome(preferably on no other concomitant medication, however, if considered necessary, to be documented and given). * Patients at least 18-years of age or older. iv. Subjects who have no evidence of underlying disease (except ovarian cancer) during screening medical history and whose physical examination is performed within 21 days prior to commencement of the study. * Patients with Performance ≤ 2 on the ECOG performance scale. vi. Subjects whose screening laboratory values are within normal limits or considered by the clinical Investigator/Co-Investigator to be of no clinical significance. * Informed consent form given in written form. Exclusion Criteria: * History or presence of significant: * Allergy or Significant history of hypersensitivity or idiosyncratic reactions to Doxorubicin Hydrochloride and/or any related compounds etc. * Cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. * Alcohol dependence, alcohol abuse or drug abuse or addiction with any recreational drug within past one year. * Clinically significant illness (except ovarian cancer)within 4 weeks before the start of the study v. Positive result to HIV, HCV, RPR and HBsAg. * Use of enzyme-modifying drugs (like Phenytoin, Carbamazepine, Barbiturates, Gresiofulvine etc.) in the previous 30 days before day 1 of this study and during the study. * Donation of 350 mL or more of blood in the previous 90 days before day 1 of this study. * Participation in another clinical trial within the preceding 90 days of study start * Subjects who have: * Systolic blood pressure less than 90 mm of Hg or more than 140 mm of Hg * Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg * Pulse rate below 60/min. or above 100/min",NA,FEMALE,NA,"[{'measure': '90% confidence interval of the relative mean Cmax, AUC0-t, AUC0-∞, of the test and reference product', 'timeFrame': '2 cycles'}]","[{'measure': 'Treatment emergent adverse events', 'timeFrame': '2 cycles'}]" 160,NCT04852926,"{'fullName': 'University Hospital, Lille', 'class': 'OTHER'}",Study of the Sexual Health of Patients Treated for Breast Cancer and Followed up in the Observatory of Fertility at Jeanne de Flandre Hospital.,COMPLETED,"Study of sexual health by repeated anonymous self-administered questionnaires in patients treated for non-metastatic breast cancer and referred to Jeanne de Flandre hospital for possible preservation of their fertility. Sexual health is affected by treatments and improves after the treatments. Sexual health is influenced by multiple factors : oncology treatments received, self-esteem, body image, anxiety, depression, professional activity","['Breast Cancer', 'Breast Neoplasms', 'Breast Carcinoma', 'Breast Tumor']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'OTHER', 'name': 'Self-administered questionnaires', 'description': '6 self-administered questionnaires (EORTC-QLQ-C30, RSE, BIS, HAD, FSFI, DAS-4) completed by the patients at every usual follow-up consultation.\n\n1 (FSFI) or 2 (MSHQ, PEP) self-administered questionnaires completed by the partner (respectively female or male) between every usual follow-up consultation.\n\nFollow-up usual consultations :\n\n* T0 (at inclusion) : before disease + since diagnosis\n* C4 (chemotherapy course n°4)\n* C6 (chemotherapy course n°6)\n* M3 (3 months after chemotherapy)\n* M6 (6 months after chemotherapy)\n* A1 (1 year after chemotherapy)\n* A2 (2 years after chemotherapy)', 'armGroupLabels': ['A prospective cohort of patients']}]","Inclusion Criteria: * Female from 18 years * In a relationship with a man or a woman * Developing invasive carcinoma of breast cancer * Planned medical therapy project by chemotherapy * Followed up in the Observatory of fertility * Patient who gave written consent to participate in the study * Insured Social Patient * Patient willing to follow all study procedures and duration Exclusion Criteria: \-","* Refusal of oncologic treatments * Other cancer than breast cancer * Metastatic breast cancer * Unable to receive informed information, unable to participate in the entire study, lack of social security coverage, refusal to sign consent * Person under protection * Minor * Persons deprived of liberty * Persons unable to consent",FEMALE,NON_PROBABILITY_SAMPLE,"[{'measure': 'variation of score FSFI (female sexual function index)', 'description': 'The FSFI score assesses female sexual functioning over the past four weeks. It is a self-evaluation by questionnaire. It consists of 19 questions with 5 or 6 possible answers per question, scored respectively from 1 to 5 and from 0 To evaluate, in women with non-metallic breast cancer followed in the Fertility Observatory at the Jeanne de Flandre Hospital, 1-year sexual health progression from chemotherapy initiation to sexual health assessment prior to cancer diagnosis announcement.', 'timeFrame': 'At 1 year after the start of chemotherapy'}]","[{'measure': 'evolution of quality of life and psychometric factors at 1 year from the start of chemotherapy compared to the evaluation of these factors before the cancer diagnosis is announced.', 'timeFrame': 'At inclusion, at 1 year and 2 years after chemotherapy'}, {'measure': 'association between psychometric factors assessed prior to cancer diagnosis and sexual health progression at 1 year of chemotherapy initiation', 'timeFrame': 'At inclusion, at 1 year and 2 years after chemotherapy'}, {'measure': 'correlation between quality of life and psychometric factors and the assessment of sexual health of patients measured at all times.', 'timeFrame': 'At inclusion, at 1 year and 2 years after chemotherapy'}, {'measure': ""describe partners' sexual health by MSHQ (man)/FSFI (woman) during follow-up"", 'description': 'MSHQ (Male Sexual Health Questionnaire) consists of 25 questions. It is a self-evaluation by the partner. A total score out of 125 is calculated. A high score corresponds to a good quality of male sexual life.', 'timeFrame': 'At inclusion, at chemotherapy course n°4, at chemotherapy course n°6, at 3 months and at 6 months after chemotherapy, at 1 year and 2 years after chemotherapy,'}, {'measure': ""describe partners' sexual health by PEP (man)/FSFI (woman) during follow-up"", 'description': 'The PEP (Premature ejaculation profile) score explores premature ejaculation by self-questionnaire. It consists of 4 questions scored from 1 to 5. A high score corresponds to good male sexual health. A low score indicates premature ejaculation with repercussions on male sexual health.', 'timeFrame': 'At inclusion, at chemotherapy course n°4, at chemotherapy course n°6, at 3 months and at 6 months after chemotherapy, at 1 year and 2 years after chemotherapy,'}, {'measure': 'testimony of patients expressing their experience of follow-up in the Fertility Observatory', 'timeFrame': 'At inclusion, at chemotherapy course n°4, at chemotherapy course n°6, at 3 months and at 6 months after chemotherapy, at 1 year and 2 years after chemotherapy,'}]" 161,NCT00963326,"{'fullName': 'National Cancer Institute (NCI)', 'class': 'NIH'}","Study of Blood and Tissue Samples From Patients With Larynx Cancer, Pharynx Cancer, or Oral Cavity Cancer",UNKNOWN,"RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is looking at blood and tissue samples from patients with larynx cancer, pharynx cancer, or oral cavity cancer.",['Head and Neck Cancer'],OBSERVATIONAL,NA,"[{'type': 'OTHER', 'name': 'laboratory biomarker analysis'}]","DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the larynx, pharynx, or oral cavity * No risk factors of alcohol consumption, smoking, or occupational hazards such as asbestos, hydrocarbons, paints, nickel, stone dust, or wood dust. * Must be a life-time non-smoker, not a former smoker * Measurable disease by RECIST criteria PATIENT CHARACTERISTICS: * WHO performance status 0-1 * No other serious concomitant medical conditions precluding general anesthesia * No psychological, familial, social, or geographical reasons that would preclude follow up PRIOR CONCURRENT THERAPY: * Not specified",NA,ALL,NA,[{'measure': 'Tumor response rate by RECIST criteria'}],NA 162,NCT00175578,"{'fullName': 'University of British Columbia', 'class': 'OTHER'}",Detection of Early Lung Cancer by Serum Protein Expression Profiling,UNKNOWN,Promising new technology exists to examine small proteins that are shed by cancers into the blood stream. The purpose of this study is to see if there are differences in the proteins and protein levels in blood from individuals with early stage lung cancer compared to healthy adults.,['Non-small Cell Lung Cancer'],OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}",NA,"Inclusion Criteria: * Presence of early stage non-small cell lung cancer * Elective surgical resection of lung lesion at Vancouver General Hospital (VGH) * No preoperative chemoradiation therapy * No previous cancer * Ability to provide informed consent",Patients with non-small cell lung cancer and healthy heavy smoking adults.,ALL,PROBABILITY_SAMPLE,NA,NA 163,NCT06737367,"{'fullName': 'Jinling Hospital, China', 'class': 'OTHER'}",Integrating Machine Learning for Prognostic Prediction in Stage I NSCLC by CT Images and Pathological Factors,COMPLETED,"The investigators retrospectively collected the participants with stage I non-small cell lung cancer (NSCLC) patients resected between January 2010 to December 2020 for training and internal validation. The Clinical data, preoperative clinical information, laboratory results and CT images were collected. The investigators also collected the disease-free survival time. On the Deepwise multi-modal research platform, the images were semi-automatically segmented and expanded outward by 3mm to obtain the peritumor tissue. PyRadiomics was used to extract the radiomic features. LASSOcox and rsf were used to select the features. we developed a machine learning-based integrative prognostic model that utilizes radiomic and pathological variables as input using LOOCV framework. And it was further tested on the internal and external cohorts. Discrimination was assessed by using the C-index and area under the receiver operating characteristic curve (AUC), IBS, DCA.",['Lung Cancer - Non Small Cell'],OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}","[{'type': 'OTHER', 'name': 'CT radiomic analysis', 'description': 'Radiomic features of tumor and peritumor tissue', 'armGroupLabels': ['external test set', 'training set']}]","Inclusion Criteria: patients with stage I NSCLC (ninth AJCC edition) who underwent curative R0 resections between January 2010 and December 2020 - Exclusion Criteria: 1. absence of enhanced CT 2. history of lung cancer or synchronous lung cancers 3. follow-up records ≤3 Months 4. carcinoma in situ (CIS) or minimally invasive NSCLC 5. death within 30 days of surgery 6. no pathological slides or reports","Jinling Hospital, China",ALL,PROBABILITY_SAMPLE,"[{'measure': 'DFS（Disease-free survival）', 'description': 'DFS was defined as the duration from the date of primary surgery to the first occurrence of recurrence or death from any cause.', 'timeFrame': 'Record from the date of surgery to the date of recurrence or death from any cause, whichever comes first, and assess up to a maximum of 5 years.'}]",NA 164,NCT00744900,"{'fullName': 'University Hospital, Brest', 'class': 'OTHER'}",Pemetrexed Plus Cisplatin for Brain Metastasis of Advanced Non - Small Cell Lung Cancer (NSCLC),COMPLETED,"NSCLC patients often have cerebral metastasis : 10% at diagnosis and 40% during disease management. Neurosurgery is not indicated in the majority of cases because of presence of several lesions in the brain, failure of primary tumor control or presence of extra-cerebral metastasis. Cerebral metastasis lead to death in 30 to 50% of these cases. Management of these patients in this situation is based on supportive care and whole-brain radiotherapy. The place of chemotherapy for patients with good performance status was discussed for a long time and it is now admitted. However, the place of new drugs such as pemetrexed, which is currently used as a second line treatment for NSCLC, needs to be further studied. It is known that pemetrexed when added to cisplatin for treatment of NSCLC provides a similar effectiveness when compared to other drugs associations commonly used in this indication. In addition, Cisplatin with Pemetrexed probably present a better safety profile. The present study is based upon the hypothesis stipulating that the association cisplatin-pemetrexed will be at least as efficient as the others association currently used for treatment of NSCLC and will present a better safety profile. The primary objective of this study is overall response rate on brain metastasis according to RECIST criteria. Secondary judgment criterias are : Overall response rate, PFS after first-line CDDP plus pemetrexed, safety profile, quality of life, neurological symptoms, overall survival. The trial will enroll up to 45 patients in this single-arm two-stage sequential phase II study with the possibility of stopping the study early because of lack of efficacy.",['Lung Cancer'],INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Pemetrexed, cisplatin', 'description': 'Alimta 500mg/m² IV 10 min infusion and Cisplatin 75mg/m² IV 60 min on day 1. Cycle will be repeated each 21 days.Folic acid orally 400µg should begin 5-7days prior to the first dose of pemetrexed and continuing daily until 3 weeks after the last dose of pemetrexed. Vitamin B12 will be administered as a 1000 mg intramuscular injection, approximately one week before Day 1 of cycle 1 and should repeat approximately every 9 weeks Dexamethasone, 4 mg or equivalent, should be taken orally twice per day on the day before, the day of, and the day after each dose of pemetrexed.WBRT will be administered with high energy photons systematically after cycle 6 or in case of stable disease (SD) after cycle 4 or progressive disease (PD) at any time. The dose will be 3Gy by fraction, 1 fraction per day, for 10 days.', 'armGroupLabels': ['A']}]","Inclusion Criteria: * Patients with cytologically or histologically confirmed NSCLC. * Patient with brain metastasis not amenable to surgery or radiosurgery with curative intent * At least one brain measurable lesion using RECIST criteria * ECOG Performance Status ≤2 * No prior chemotherapy for this cancer * Prior surgery is allowed provided there is a relapse or progression after the procedure. * Adequate organ function including the following: Adequate bone marrow reserve: absolute neutrophil count (ANC) superior or equal to 1.5 X109/L, platelets superior or equal to 100 X 109/L, and hemoglobin superior or equal to 9 g/dL; Hepatic: bilirubin \<1.5 times the upper limit of normal (ULN), alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) \<3xULN (or \<5xULN with liver metastases); Renal: Calculated creatinine clearance (CrCl) superior or equal to 45mL/min based on the standard Cockroft and Gault formula * Signed informed consent document from the patient * Patient must be at least 18 years of age. * Estimated life expectancy of at least 12 weeks. * Effective contraception (men and women) for and during the 6 months following the end of treatment Exclusion Criteria: * Symptomatic brain metastasis * Have received prior radiotherapy for brain metastasis * Unable or unwilling to take folic acid, vitamin B12 supplementation or dexamethasone (or equivalent corticosteroid); or any other inability to comply with protocol or study related procedures. * A prior malignancy other than NSCLC, except carcinoma in situ of the cervix or non-melanoma skin cancer, adequately treated low grade \[Gleason score \<6\] localized prostate cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence * Serious concomitant systemic disorders (for example, active infection or abnormal electrocardiogram (ECG) indicative of cardiac disease) that, in the opinion of the investigator, would compromise the safety of the patient and his/her ability to complete study. * Inability to discontinue administration of aspirin at a dose \>1.3g/day or other non-steroidal anti-inflammatory agents for 2 days before, the day of, and 2 days after the dose of pemetrexed (5 days prior for long-acting agents such as piroxicam). * Presence of fluid accumulations in third spaces, e.g., ascite or pleural effusion, which can be detected clinically (during physical examination), and which cannot be adequately controlled by drainage or other procedures prior to inclusion in the study. * Peripheral neuropathy \> CTC Grade 2 * Patient compliance or geographic distance precluding adequate follow up.",NA,ALL,NA,"[{'measure': 'Objective of this study is overall response rate on brain metastasis according to RECIST criteria.', 'timeFrame': 'After cycles 2, 4 and 6 and every 6 weeks after study drug completion in absence of disease progression.'}]","[{'measure': 'Overall response rate, PFS after first-line CDDP plus pemetrexed, safety profile, quality of life, neurological symptoms and overall survival.', 'timeFrame': 'After cycles 2, 4 and 6 and every 6 weeks after study drug completion.'}]" 165,NCT04851834,"{'fullName': 'Xennials Therapeutics Australia Pty Ltd', 'class': 'INDUSTRY'}",NTX-301 Monotherapy in Advanced Solid Tumours and in Combination With Platinum-based Chemotherapy in Advanced Ovarian & Bladder Cancer and in Combination With Temozolomide in High-grade Glioma,TERMINATED,"This is a Phase 1/2, open-label, dose-exploration, combination/expansion study, which will start by evaluating the safety and tolerability of NTX-301, an oral DNMT1 inhibitor, as a monotherapy in patients with advanced solid tumours, who have failed treatment with available therapies known to be active for treatment of their corresponding disease. It will then explore the safety and tolerability of NTX-301 in combination with platinum-based therapy in patients with ovarian and bladder cancer. Optionally, the safety and tolerability of NTX-301 in combination with Temozolomide (TMZ) in patients with Isocitrate Dehydrogenase 1 (IDH1) mutated high-grade glioma will also be assessed.","['Advanced Solid Tumor', 'Platinum-Resistant Ovarian Cancer', 'Platinum-Resistant Urothelial Carcinoma', 'High-grade Glioma']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Dose escalation to determine MTD/RP2D, then dose expansion', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'NTX-301', 'description': 'Oral hypomethylating agent', 'armGroupLabels': ['NTX-301 Monotherapy Dose Escalation', 'NTX-301 Temozolomide doublet therapy Dose Escalation', 'NTX-301 Temozolomide doublet therapy Dose Expansion', 'NTX-301 platinum-based doublet therapy Dose Escalation', 'NTX-301 platinum-based doublet therapy Dose Expansion']}, {'type': 'DRUG', 'name': 'Platinum-based Chemotherapy', 'description': 'Standard of care for ovarian and bladder cancer', 'armGroupLabels': ['NTX-301 platinum-based doublet therapy Dose Escalation', 'NTX-301 platinum-based doublet therapy Dose Expansion'], 'otherNames': ['Cisplatin', 'Carboplatin']}, {'type': 'DRUG', 'name': 'Temozolomide', 'description': 'Standard of care for high-grade glioma', 'armGroupLabels': ['NTX-301 Temozolomide doublet therapy Dose Escalation', 'NTX-301 Temozolomide doublet therapy Dose Expansion']}]","Inclusion Criteria: 1. Ability to understand and be willing to sign an informed consent form. 2. Male or female, ≥ 18 years old at the time of screening. 3. Diagnosis of histologically or cytologically confirmed: 1. Locally advanced or metastatic cancer (all solid tumours). Subjects must be considered refractory or intolerant to SOC therapies or have refused standard therapy. If the last treatment a subject received was an inhibitor of DNA synthesis or a hypomethylating agent, at least 5 half-lives must have passed prior to commencing treatment. (Phase 1a, Dose Escalation Monotherapy), OR 2. Locally advanced or metastatic cancer (ovarian or bladder cancer and other solid tumours where in the opinion of the investigator, retreatment with cisplatin or carboplatin may be beneficial to the subject). Subjects must be considered refractory or intolerant to SOC therapies or have refused standard therapy, in such a case, reason for the refusal to be captured in Case Report Form (CRF). If subject is having a drug holiday to recover from cisplatin toxicity, entry to the trial is allowed if the PI feels the subject will receive further benefit from cisplatin, the toxicity has recovered to ≤ CTCAE Grade 1 and all other eligibility criteria are met. Last treatment prior to trial entry with a platinum is not required. If the last treatment a subject received was an inhibitor of DNA synthesis or a hypomethylating agent, at least 5 half-lives must have passed prior to commencing study treatment). (Phase 1b, Dose \& Disease Expansion Combination Arms, Arms 1 \& 2), OR 3. High-grade glioma, such as glioblastoma multiforme (GBM) that are: Newly diagnosed and are undergoing, or are planned to undergo, 42 Days of SOC chemoradiation therapy as per part 1 of the eviQ protocol 3364 v.1. Subjects successfully enrolled will receive a subsequent combination of NTX-301, Days 1-5 and 8-12 as well Temozolomide on Days 15-19 of their first 28-Day cycle of part 2 of the eviQ protocol 3364 v.1. This combination arm replaces the Temozolomide monotherapy SOC maintenance therapy as described in Part 2 of the eviQ protocol 3364 v.1. In order to prevent any potential delays after radiotherapy, subjects can be enrolled at any time during Chemoradiation (eviQ Part 1). In order to commence the TMZ combination arms the subject is required to complete the full 42 Days of eviQ part 1, and also receive their first dose of the TMZ combination arm within the screening window. This timing can be adjusted based on medical need on a subject-by-subject basis as per the discretion of the principal investigator together with the approval of the medical monitor (Phase 1b, 2a, Dose \& Disease Expansion Combination GBM (optional) Arm, Arms 3 \& 4) Note: subjects must also have at least one measurable disease lesion per RECIST 1.1 \&/or RANO criteria. For Phase 1a only, non-measurable disease may also be included based on PI and MM discretion on a case-by-case basis. 4. Eastern Cooperative Oncology Group performance status of 0 to 1 5. Able to take oral medications and willing to record daily adherence to the study drug. 6. Cardiac 1. QT interval corrected using the Fridericia method (QTcF) ≤ 450 msec for males and ≤ 470 msec for females at screening and on Day 1, prior to dose administration (the mean of triplicate measurements will be used to determine eligibility) 2. LVEF \>45% based on ECHO Scan within 60 Days of screening. 7. Evidence of adequate hepatic function at screening, as defined by the following: 1. AST and ALT ≤2.5 × upper limit of normal (ULN) (≤5 × ULN if liver metastases are present); and 2. Total bilirubin ≤1.5 × ULN (\< 2.0 x ULN for subjects with liver metastases or documented Gilbert's syndrome). 8. Adequate haematology laboratory assessment at screening, as defined by: 1. Absolute neutrophil count ≥1.00 x109/L; 2. Haemoglobin ≥90 g/L; and 3. Platelet count ≥100 x109/L. 9. Evidence of adequate renal function, as defined by a calculated creatinine clearance ≥45 mL/min using the Cockcroft-Gault equation, renal nuclear medical scan, or a 24-hour urine collection with plasma and urine creatinine concentrations respectively. There can be exceptions on a case-by-case basis as per the discretion of the principal investigator and approval by the Medical Monitor and Sponsor. 10. Adequate coagulation laboratory assessments (i.e., within normal reference range values) at screening, in the opinion of the Investigator. 11. Female subjects must: 1. Be of non-child-bearing potential i.e. surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before the Screening visit) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle-stimulating hormone level consistent with postmenopausal status, per local laboratory guidelines), or 2. If of child-bearing potential, must agree not to attempt to become pregnant, must not donate ova, and, if engaging in sexual intercourse with a male partner, must agree to use an acceptable method(s) of contraception from signing the consent form until at least 45 Days after the last dose of study drug. 12. Male subjects must agree not to donate sperm and if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception from signing the consent form until at least 90 Days after the last dose of study drug 13. Estimated life expectancy of at least 3 months, in the opinion of the Investigator. Willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures. 14. Willing and able to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures. Exclusion Criteria: 1. Investigational agents, including hypomethylating agents, in the past 5 half-lives 2. Patients with symptomatic brain metastases. 3. Evidence of abnormal cardiac function as defined by any of the following: 1. Myocardial infarction within 6 months of Cycle 1, Day 1 2. Symptomatic congestive heart failure (New York Heart Association \> class II) 3. Unstable angina 4. Unstable cardiac arrhythmia. Stable cardiac arrhythmia that is Medically managed is allowable. Borderline subjects are allowable on a case-by-case basis as per the discretion of the Principal Investigator and approval by the Medical Monitor and Sponsor. 4. Unable to swallow oral medications. 5. Gastrointestinal (GI) Gastrointestinal conditions that, in the opinion of the Investigator, could affect the absorption of NTX-301 6. History of bowel obstruction, abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of the first administration of NTX-301 (Cycle 1, Day 1) (unless otherwise approved by the Investigator). 7. Unless approved by treating physician, use of any herbal or prescription medications, or consumption of foods known to be strong inhibitors of cytochrome P450 3A (CYP3A) enzymes within 7 Days prior to the first administration of NTX-301 (Cycle 1, Day 1). These include (but are not limited to): 1. Certain Medications defined within the study protocol 2. Foods: Grapefruit or Seville orange (or grapefruit- or Seville orange-containing products, including juices). 8. Use of any herbal or prescription medications known to be strong inducers of CYP3A enzymes within 7 Days prior to the first administration of NTX-301 (Cycle 1, Day 1) 9. Clinically significant active infection within 2 weeks of the first dose of NTX-301 (Cycle 1, Day 1). 10. Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the Screening visit. 11. History of other malignancy within the past 2 years, with the following exceptions: 1. Malignancy treated with curative intent and with no known active disease present for ≥ 2 years before enrolment and felt to be at low risk for recurrence by the treating physician. 2. Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease. 3. Adequately treated cervical carcinoma in situ without evidence of disease. 4. Adequately treated breast ductal carcinoma in situ without evidence of disease. 5. Prostatic intraepithelial neoplasia without evidence of prostate cancer. 6. Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ. 12. Major surgery within 28 Days of Cycle 1, Day1, with the following exceptions: 1. Major surgical procedures ≤28 Days of beginning study drug, or 2. Minor surgical procedures ≤7 Days. 3. No waiting required following port-a-cath placement or for venous access. 4. Planned elective surgery unrelated to the subject's oncologic diagnosis, such as hernia repair, may be allowed, at the discretion of the Investigator, as long as it was performed at least 2 weeks prior to starting NTX-301, and the subject has recovered fully from this procedure. 13. Received cancer-directed therapy within the following timeframes: 1. Anti-tumour therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy or investigational agent) within 28 Days or (unless 5 times the half-life is shorter than 28 Days); Note: concurrent use of hormone deprivation therapy for hormone-refractory prostate cancer, bisphosphonate or denosumab for skeletal related events per institution guideline is permitted. 2. Wide field radiation administered ≤28 Days or limited field radiation for palliation ≤7 Days prior to starting study drug or has not recovered from side effects of radiation therapy. 3. Receiving treatment with any other concurrent investigational device(s) or conventional agent(s) within 28 Days (unless 5 times the half-life is shorter than 28 Days) of Cycle 1, Day 1. 14. Adverse Events due to investigational or conventional agents \>4 weeks earlier that have not recovered to a severity of Grade 0 or Grade 1 (per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 or higher), with the exception of alopecia. Note: (applies to Phase 1a, dose levels 3-5 and Phase 1b only): i. Subjects with chronic Grade 2 toxicities may be eligible per discretion of the Investigator and Sponsor (e.g., Grade 2 chemotherapy induced neuropathy). ii. Grade 2 or 3 toxicities from prior anti-tumour therapy that are considered irreversible - defined as having been present and stable for \> 6 months (such as ifosfamide-related proteinuria) may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the Investigator and Sponsor 15. For women of childbearing potential, a positive pregnancy test at screening, or on Day 1, prior to dose administration. 16. Pregnant or breast-feeding (or planning to breastfeed while on study through 15 Days after the last dose of study drug. 17. Hypersensitivity or other clinically significant reaction to the study drug or its inactive ingredients. 18. Known substance abuse or medical, psychological, or social conditions that, in the opinion of the Investigator, may interfere with the subject's participation in the clinical study or evaluation of the clinical study results. 19. Any other condition or prior therapy that in the opinion of the Investigator would make the subject unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements 20. COVID-19 vaccinations: Administration of an approved COVID-19 vaccine less than14 Days prior to dosing.",NA,ALL,NA,"[{'measure': 'Safety & Tolerability: Incidence, type, and severity of Adverse Events (AE)', 'timeFrame': '15 Months'}, {'measure': 'Safety & Tolerability: Dose-limiting Toxicities (DLT)', 'timeFrame': '15 Months'}]","[{'measure': 'Incidence of DLTs according to the MTD/RP2D evaluation process', 'timeFrame': '12 Months'}, {'measure': 'Pharmacokinetics (PK): Maximum observed concentration (Cmax)', 'timeFrame': '12 Months'}, {'measure': 'Pharmacokinetics (PK): Time to Cmax (Tmax)', 'timeFrame': '12 Months'}, {'measure': 'Pharmacokinetics (PK): Trough concentrations', 'timeFrame': '12 Months'}, {'measure': 'Pharmacokinetics (PK): Area under the concentration-time curve (AUC0-t)', 'timeFrame': '12 Months'}, {'measure': 'Pharmacokinetics (PK): Apparent terminal elimination half-life (t1/2)', 'timeFrame': '12 Months'}]" 166,NCT03178409,"{'fullName': 'University of Milan', 'class': 'OTHER'}",Combined HCC-MFCCC,COMPLETED,Combined hepatocellular and mass-forming cholangiocarcinoma (cHCC-MFCCC) is a rare tumor. The aim of this study was the analysis of the outcome comparing such tumor with classic hepatocellular carcinoma (HCC) and mass-forming cholangiocarcinoma (MFCCC).,"['Liver Carcinoma', 'Hepatocellular Carcinoma', 'Cholangiocarcinoma', 'Surgery']",OBSERVATIONAL,"{'observationalModel': 'CASE_CONTROL', 'timePerspective': 'RETROSPECTIVE'}","[{'type': 'PROCEDURE', 'name': 'Hepatectomy', 'description': 'Removal of a part of the liver', 'armGroupLabels': ['HCC', 'MFCCC', 'cHCC-MFCCC'], 'otherNames': ['Liver resection', 'Liver surgery']}]","Inclusion Criteria: * positive histology for cHCC-MFCCC, HCC, and MFCCC * complete clinical, surgical, pathological and follow-up data. Exclusion Criteria: * patients preoperatively treated with chemotherapy, radiofrequency ablation or trans-arterial therapies were excluded. * patients operated for recurrent disease and/or with non-radical surgery * patients with missing data were also excluded","Patients affected by cHCC-MFCCC, or HCC or MFCCC.",ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Survival analysis', 'description': 'Analysis of overall and disease-free survival of patients resected for cHCC-MFCCC versus those resected for HCC versus those resected for MFCCC', 'timeFrame': 'From 3 months after surgery up to 60 months after surgery'}]",NA 167,NCT04711109,"{'fullName': 'Alliance for Clinical Trials in Oncology', 'class': 'OTHER'}",Studying the Effect of Denosumab on Preventing Breast Cancer in Women With a BRCA1 Germline Mutation,ACTIVE_NOT_RECRUITING,"This phase III trial compares denosumab to placebo for the prevention of breast cancer in women with a BRCA1 germline mutation. A germline mutation is an inherited gene change which, in the BRCA1 gene, is associated with an increased risk of breast and other cancers. Denosumab is a monoclonal antibody that is used to treat bone loss in order to reduce the risk of bone fractures in healthy people, and to reduce new bone growths in cancer patients whose cancer has spread to their bones. Research has shown that denosumab may also reduce the risk of developing breast cancer in women carrying a BRCA1 germline mutation.","['BRCA1 Mutation', 'Breast Cancer', 'Breast Diseases', 'Breast Neoplasms', 'Breast Carcinoma', 'Neoplasms']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}","[{'type': 'DRUG', 'name': 'Denosumab', 'description': 'Given SC', 'armGroupLabels': ['Arm A (denosumab)']}, {'type': 'DRUG', 'name': 'Placebo', 'description': 'Given SC', 'armGroupLabels': ['Arm B (placebo)']}, {'type': 'OTHER', 'name': 'Quality-of-Life Assessment', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm A (denosumab)', 'Arm B (placebo)']}]","Inclusion Criteria: * Women with a confirmed deleterious or likely deleterious BRCA 1 germline mutation (variant class 4 or 5) * Age \>= 25 years and =\< 55 years at randomization * No evidence of breast cancer by MRI or mammography (MG) and clinical breast examination within the last 6 months prior to randomization * No clinical evidence of ovarian cancer at randomization * Negative pregnancy test at randomization for women of childbearing potential * No preventive breast surgery planned at time of randomization * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Written informed consent before any study-specific procedure is performed Exclusion Criteria: * Prior bilateral mastectomy * History of ovarian cancer (including fallopian and peritoneal cancer) * History of breast cancer * History of invasive cancer except for basal cell or squamous cell skin cancer or carcinoma in situ of the cervix, stage 1 papillary or follicular thyroid cancer, atypical hyperplasia or LCIS (lobular carcinoma in situ) * Pregnant or lactating women (within the last 2 months prior to randomization) * Unwillingness to use highly effective contraception method during and within at least 5 months after cessation of denosumab/placebo therapy in women of childbearing potential. (Note: Women of childbearing potential should be monitored for pregnancy prior to each denosumab/placebo injection) * Clinically relevant hypocalcemia (history and current condition), or serum calcium \< 2.0 mmol/L (\< 8.0 mg/dL) \* Hypocalcemia defined by calcium below the normal range (a single value below the normal range does not necessarily constitute hypocalcemia, but should be 'corrected' before dosing the subject). Monitoring of calcium level in regular intervals (usually prior to investigational product \[IP\] administration) is highly recommended * Tamoxifen, raloxifene or aromatase inhibitor use during the last 3 months prior to randomization or for a duration of more than 3 years in total (current and prior hormone replacement therapy \[HRT\] is permitted) * Prior use of denosumab * Subject has a known prior history or current evidence of osteonecrosis or osteomyelitis of the jaw, or an active dental/jaw condition which requires oral surgery including tooth extraction within 3 months of enrollment * Concurrent treatment with a bisphosphonate or an anti-angiogenic agent * Any major medical or psychiatric condition that may prevent the subject from completing the study * Known active infection with hepatitis B virus or hepatitis C virus * Known infection with human immunodeficiency virus (HIV) * Use of any other investigational product (current or prior aspirin or non-steroidal anti-inflammatory drugs \[NSAIDs\] are permitted)",NA,FEMALE,NA,"[{'measure': 'Time to the occurrence of any breast cancer (invasive or ductal carcinoma in situ [DCIS])', 'description': 'Time to breast cancer (invasive or DCIS) will be compared between the two treatment arms using a stratified Cox proportional hazards regression model.', 'timeFrame': 'From randomization to the occurrence of breast cancer (invasive or DCIS), assessed up to 5 years'}]","[{'measure': 'Time to invasive breast cancer', 'description': 'Will be compared between the two treatment arms using a stratified Cox proportional hazards regression model.', 'timeFrame': 'Up to 5 years post treatment'}, {'measure': 'Time to invasive triple negative breast cancer', 'description': 'Will be compared between the two treatment arms using a stratified Cox proportional hazards regression model.', 'timeFrame': 'Up to 5 years post treatment'}, {'measure': 'Time to ovarian, fallopian and peritoneal cancer (in women who have not undergone prophylactic bilateral salpingo-oophorectomy)', 'description': 'Will be compared between the two treatment arms using a stratified Cox proportional hazards regression model. Time to ovarian cancer will be analyzed in the overall group and in different strata (oral contraceptive use, hormone replacement therapy use, and menopausal status).', 'timeFrame': 'Up to 5 years post treatment'}, {'measure': 'Time to other (nonbreast or ovarian cancer) malignancies, including those known to be associated with BRCA1 mutations', 'description': 'Will be compared between the two treatment arms using a stratified Cox proportional hazards regression model.', 'timeFrame': 'Up to 5 years post treatment'}, {'measure': 'Time to clinical fractures in pre- and postmenopausal women', 'description': 'Will be compared between the two treatment arms using a stratified Cox proportional hazards regression model.', 'timeFrame': 'Up to 5 years post treatment'}, {'measure': 'Frequency of breast biopsies', 'description': 'May be recommended as part of care based on a finding on mammogram, MRI, ultrasound or physical exam performed as part of monitoring for breast cancer. Will be compared between the two treatment arms via chi-square analysis.', 'timeFrame': 'Up to 5 years post treatment'}, {'measure': 'Frequency of benign breast lesions', 'description': 'May be recommended as part of care based on a finding on mammogram, MRI, ultrasound or physical exam performed as part of monitoring for breast cancer. Will be compared between the two treatment arms via chi-square analysis.', 'timeFrame': 'Up to 5 years post treatment'}, {'measure': 'Assess incidence, nature and severity of adverse events (AEs) using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0', 'description': 'Overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment will be reported per treatment arm.', 'timeFrame': 'Up to 5 years post treatment'}]" 168,NCT00837993,"{'fullName': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}",Ancillary Study GOG 158: Survival Analysis Based on Reclassification to a Two-Tier Grading System,COMPLETED,"Primary Objective: * To reclassify the histologic grade of the serous ovarian cancer specimens of patients enrolled on Gynecologic Oncology Group (GOG) protocol 158 using a two-tier system. Secondary Objective: * To determine the overall and progression-free survival of patients with serous carcinoma of the ovary treated on GOG protocol 158 when reclassified according to tumor grade (low vs. high). Tertiary Objective: * To correlate histologic grade with other prognostic factors.",['Ovarian Cancer'],OBSERVATIONAL,"{'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}",NA,"Inclusion Criteria: * All patients enrolled on GOG protocol 158 with a diagnosis of serous carcinoma of the ovary. Exclusion Criteria: * None",All patients enrolled on GOG protocol 158 with a diagnosis of serous carcinoma of the ovary.,FEMALE,NON_PROBABILITY_SAMPLE,"[{'measure': 'Reclassification of histologic grade of the serous ovarian cancer specimens of patients enrolled on Gynecologic Oncology Group (GOG) protocol 158 using a two-tier system.', 'timeFrame': '2 Years'}]","[{'measure': 'Overall and Progression-free survival of patients with serous carcinoma of the ovary treated on GOG protocol 158 when reclassified according to tumor grade (low vs. high)', 'timeFrame': '2 Years'}]" 169,NCT03185416,"{'fullName': 'University of Miami', 'class': 'OTHER'}",Early Palliative Care Integration in Interventional Cancer Care,WITHDRAWN,"A mixed methods randomized control trial assessing the impact of early palliative care incorporation in liver cancer and metastatic colorectal cancer on caregiver well-being, patient physical and psychosocial outcomes, and health services utilization.","['Palliative Care', 'Cancer Liver', 'Cancer Colon']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The present study is a randomized single-center therapeutic clinical trial including the following two prospective groups: Control group and the intervention group.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'OTHER', 'name': 'Palliative Care Training', 'description': 'The intervention group- will include 30 patients receiving treatment by the Interventional Radiology team along with their primary caregiver. Patients and caregivers will receive a brief palliative care training intervention during their first follow-up visit. Patients and their caregivers will receive questionnaires to assess their health status (physical and psychosocial) and health services utilization outcomes at 1, 2, and 3 months post-procedure during their follow-up visits.', 'armGroupLabels': ['Intervention Group'], 'otherNames': ['Counseling']}]","Inclusion Criteria: \- Patients over 18 years of age with a confirmed diagnosis of liver cancer or metastatic colorectal cancer requiring treatment from the IR team. Exclusion Criteria: \- None",NA,ALL,NA,"[{'measure': 'Changes in Edmonton Symptom Assessment Score (ESAS-R)', 'description': ""Measure the impact of an early palliative care intervention on patient physical and psychosocial outcomes. The early integration of palliative care at diagnosis or immediately post- procedure, will improve patients' physical and psychosocial symptoms. The score of such assessment should decrease from baseline as the result of the intervention."", 'timeFrame': '1, 2 and 3 months'}]","[{'measure': 'Measure of the Eastern Cooperative Oncology Group (ECOG) performance Status', 'description': 'Measure the decrease of the ECOG status as a result of the proposed intervention.', 'timeFrame': '1, 2 and 3 months'}]" 170,NCT05111314,"{'fullName': 'Mayo Clinic', 'class': 'OTHER'}",Comparison of Hepatic Intraarterial Versus Systemic Intravenous 68Ga-PSMA PET/CT for Detection of Hepatocellular Carcinoma,WITHDRAWN,"This phase 0/1 study evaluates intraarterial administration of gallium Ga 68 gozetotide (68Ga-PSMA) for the detection of prostate-specific membrane antigen (PSMA) positive liver cancer by positron emission tomography (PET)/computed tomography (CT). 68Ga-PSMA is an imaging agent used with PET/CT scans to locate PSMA positive lesions. This study evaluates intraarterial administration of this agent, compared to intravenous administration.",['Hepatocellular Carcinoma'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'RADIATION', 'name': 'Gallium Ga 68 Gozetotide', 'description': 'Given IA', 'armGroupLabels': ['Diagnostic (embolization, 68Ga-PSMA, PET/CT)'], 'otherNames': ['(68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC', '(68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC', '(68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC', '(68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC', '(68Ga)Glu-urea-Lys(Ahx)-HBED-CC', '68Ga-DKFZ-PSMA-11', '68Ga-HBED-CC-PSMA', '68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC', '68Ga-PSMA', '68Ga-PSMA-11', '68Ga-PSMA-HBED-CC', '[68Ga] Prostate-specific Membrane Antigen 11', '[68Ga]GaPSMA-11', 'Ga PSMA', 'Ga-68 labeled DKFZ-PSMA-11', 'Ga-68 labeled PSMA-11', 'GA-68 PSMA-11', 'Gallium Ga 68 PSMA-11', 'Gallium Ga 68-labeled PSMA-11', 'GALLIUM GA-68 GOZETOTIDE', 'Gallium-68 PSMA', 'Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC', 'GaPSMA', 'PSMA-HBED-CC GA-68']}, {'type': 'PROCEDURE', 'name': 'Hepatic Artery Embolization', 'description': 'Undergo hepatic artery embolization', 'armGroupLabels': ['Diagnostic (embolization, 68Ga-PSMA, PET/CT)']}, {'type': 'PROCEDURE', 'name': 'Positron Emission Tomography and Computed Tomography Scan', 'description': 'Undergo PET/CT scan', 'armGroupLabels': ['Diagnostic (embolization, 68Ga-PSMA, PET/CT)'], 'otherNames': ['PET-CT Scan', 'PET/CT SCAN', 'Positron Emission Tomography/Computed Tomography']}]","Inclusion Criteria: * Patients with either an imaging diagnosis of HCC by CT or magnetic resonance imaging (MRI) (Liver Imaging and Reporting Data System 5 \[LI-RADS 5\]) confirmed by a board-certified abdominal radiologist, or with biopsy-proven HCC * Already enrolled in ongoing Transform the Practice or Department of Defense 68Ga-PSMA studies * PSMA avid HCC detected by 68Ga-PSMA PET/CT after intravenous administration of 68Ga-PSMA confirmed by a board certified nuclear radiologist * Undergoing planned hepatic artery embolization (HAE) per standard clinical care * Male or female with age greater than 18 years, with the capacity and willingness to provide a written informed consent Exclusion Criteria: * Subjects requiring emergent surgery for a ruptured/bleeding HCC * Pregnant and/or breast-feeding subjects. A negative pregnancy test within 48 hours of the PET scan * Subjects with higher than the weight/size limitations of PET/CT scanner",NA,ALL,NA,"[{'measure': 'Intraindividual intralesional difference in maximum standardized uptake value (SUVmax)', 'description': 'Intraindividual intralesional difference in maximum standardized uptake value (SUVmax) will be evaluated as fold change and absolute difference for a given lesion between intra-arterially (I.A.) and intravenous (I.V.) prostate-specific membrane antigen (PSMA) positron emission tomography (PET). Qualitative evaluation assesses the intensity of PSMA uptake in hepatic lesions, graded as follows: grade 1: uptake \\< normal liver; grade 2: uptake = normal liver; grade 3: uptake \\> normal liver; grade 4: uptake \\> spleen or kidneys. Semi-quantitative analysis is undertaken by calculating intraindividual difference in SUVmax for each lesion between I.A. and I.V. PSMA PET followed by a two-sided one sample t-test. Maximum and mean standardized uptake value (SUVmax, SUVmean, SUVmin) of the lesion(s), and SUVmax of the background liver are noted.', 'timeFrame': 'Up to 2 years'}]","[{'measure': 'Intraindividual intralesional differences in tumor to background (TBR) of SUVmax', 'description': 'For each lesion, tumor-to-liver background ratio (TBR) of SUVmax will be calculated and the intraindividual intralesional difference in TBR of SUVmax will be compared on a lesion basis between I.A. and I.V. PSMA PET.', 'timeFrame': 'Up to 2 years'}, {'measure': 'Difference in PSMA uptake measured by SUVmax (fold change, absolute difference) in the kidneys, spleen and salivary glands between I.A. and I.V. PSMA PET.', 'description': 'SUVmax will be measured for the kidneys, spleen and salivary glands and the difference in PSMA uptake measured by SUVmax (fold change, absolute difference) in the kidneys, spleen and salivary glands will be compared between I.A. and I.V. PSMA PET', 'timeFrame': 'Up to 2 years'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Up to 2 years'}]" 171,NCT06328049,"{'fullName': ""Taixing People's Hospital"", 'class': 'OTHER'}",A Study of Trilaciclib Combined With Chemotherapy in the Treatment of NSCLC,UNKNOWN,"The aim of this study is to investigate the safety and efficacy of the prophylactic use of Trilaciclib in patients with non-small cell lung cancer (NSCLC) receiving platinum-based chemotherapy, so as to provide more evidence-based medical evidence for the optimal diagnosis and treatment strategy in this population.",['NSCLC'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Trilaciclib Injection', 'description': 'Patients with lung adenocarcinoma were given Trilaciclib combined with pemetrexed and carboplatin, Q3W; For patients with lung squamous cell carcinoma,Trilaciclib combined with paclitaxel/albumin-bound paclitaxel and carboplatin, Q3W. From cycle 2 onwards, patients chose whether to use trasylol with chemotherapy.', 'armGroupLabels': ['Trilaciclib plus chemotherapy'], 'otherNames': ['CDK4/6 inhibitors']}]","Inclusion Criteria: * Age above 18 years old (including 18 years old)，regardless of gender； * ECOG-PS score of 0-1,； * expected survival≥12 weeks； * There was no tumor deterioration in the 2 weeks prior to study drug treatment. * Advanced non-small cell lung cancer without systemic chemotherapy. * At least one tumor lesion with a maximum diameter ≥10 mm (short diameter ≥15 mm if it is a lymph node) that could be measured accurately at baseline according to RECIST1.1 criteria. Baseline tumor imaging was performed within 28 days before the first dose. * Women of childbearing age should use appropriate contraception and should not breastfeed from screening until 3 months after discontinuation of study treatment. * Male subjects should use barrier contraception (i.e., condoms) for 3 months from screening until discontinuation of study treatment. * All subjects voluntarily participated and signed the informed consent form in person. Exclusion Criteria: * Uncontrolled ischemic heart disease or clinically significant congestive heart failure (NYHA class III or IV); * stroke or cardio-cerebrovascular event within 6 months before enrollment; * QTcF interval \> 480msec at screening or \> 500msec for patients with implanted ventricular pacemakers; * Previous hematopoietic stem cell or bone marrow transplantation; * Allergy to the study drug or its components; * Others considered by the investigator to be unsuitable for this study.",NA,ALL,NA,"[{'measure': 'Incidence of febrile neutropenia (FN)', 'description': 'Incidence of febrile neutropenia in the first treatment cycle', 'timeFrame': 'during Trilaciclib plus chemotherapy assessed up to 21 days'}]","[{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'description': 'Occurrence and severity of AEs by NCI CTCAE v5.0', 'timeFrame': 'Up to 2 years'}, {'measure': 'Antibiotic Use rate', 'description': 'Antibiotic Use rate in the first treatment cycle', 'timeFrame': 'during Trilaciclib plus chemotherapy assessed up to 21 days'}, {'measure': 'Number of medication delays', 'description': 'Number of delays in the second treatment cycle due to myelosuppression', 'timeFrame': 'At the end of Cycle 1 (each cycle is 28 days)'}, {'measure': 'Number of chemotherapy dose reductions', 'description': 'Number of chemotherapy dose reductions in the second treatment cycle due to myelosuppression', 'timeFrame': 'At the end of Cycle 1 (each cycle is 28 days)'}]" 172,NCT01219348,"{'fullName': 'Herlev Hospital', 'class': 'OTHER'}",IDO Peptid Vaccination for Stage III-IV Non Small-cell Lung Cancer Patients.,COMPLETED,"Title: IDO peptid vaccination in combination with immune stimulating agent Aldara and the adjuvant Montanide, for treatment of patients with locally advanced or metastatic non small-cell lung cancer. A first-in-man phase I trial. Hypothesis: In this trial the investigators assess a new immunotherapeutic strategy targeting the immune inhibiting enzyme, IDO to investigate the potential of vaccination against IDO as a possible anticancer target.","['NSCLC', 'Lung Cancer']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'IDO peptide vaccination', 'description': 'Vaccination every second week', 'armGroupLabels': ['Indeolamine 2,3 deoxygenase']}]","Inclusion Criteria: 1\. Histological or cytological verified non small cell lung cancer 2. Metastatic or locally advanced incurable stage III-IV NSCLC 3. Patients need to be off chemotherapy treatment 4. Evaluable disease according to RECIST V. 1,1 criteria 5. Patients must be HLA-A2 positive 6. Patients \> 18 years old 7. Performance status 0-1 8. Life expectancy of \> 3 months 9. Acceptable bone marrow function, defined as a. White blood cell count \> 2,5 \* 109 /l b. Neutrophil count\> 1,5 \* 109 /l c. Platelet count \> 75 \* 109/l 10. Creatinin measured \< 2,5 \* upper limit value 11. Acceptable liver function, defined as 1. ASAT \< 100 U/L 2. Bilirubin \< 30 U/L 12. Women with child-bearing potential must have controlled s-hcg before inclusion 13. Patients must provide written informed concent before inclusion 13. Termination of chemotherapy treatment \> 28 days before inclusion 14\. Termination of radiotherapy treatment \> 28 days before inclusion 15\. Inclusion at least \> 4 weeks after complicated gastric surgery \- Exclusion Criteria: 1. Other malignancies except from non-melanoma skin cancer in the previous 5 years until study inclusion 2. Brain metastasis are allowed after radical excision, and if the patient at least 1 month afterwards is not in clinical or radiographic progression 3. Patients with active gastric ulcer disease; patients taking antacid treatment can be included. 4. Severe medical condition, severe asthma, severe COLD, severe arteriosclerosis or diabetic disease 5. Acute or chronic infection (ie. HIV, hepatitis, tuberculosis) 6. Severe allergic reaction or previous anaphylactic shock 7. Autoimmune diseases (ie. autoimmune neutropenia/thrombopenia, hæmolytic anaemia, systemic lupus erythematosis, Sjøgrens disease, sclerodermia, Goodpastures syndrome, Addisons disease, active Graves disease) 8. Pregnant or lactating women 9. Psychiatric disease, which can influence compliance 10. Known hypersensitivity towards the adjuvance Montanide, the Aldara creme, or adhesive tape. 11. Treatment with immunosuppressive therapy (ie. dexamethasone, methotrexate) 12. Treatment with other experimental therapy 13. Treatment with other anti-cancer therapy, except from treatment of osteoporosis 14. No systemic chemotherapy, immunotherapy or radiation therapy (except locally) are allowed until 28 days before inclusion. \-",NA,ALL,NA,"[{'measure': 'evidence of toxicity', 'description': 'CTCAE = Common Terminology Criteria for Adverse Events v. 3.0 will be used for registration of toxicity', 'timeFrame': '12 months'}]","[{'measure': 'evaluation of immunological and clinical responses', 'description': 'immunological assays will be used to identify immunological responses. CT scans will be used for evaluation of clinical responses.', 'timeFrame': '18 months'}]" 173,NCT05007548,"{'fullName': 'National Atomic Research Institute, Taiwan', 'class': 'OTHER'}",to Assess the Accuracy and Reliability of the Ga68-Dolacga Positron Emission Tomography Compared to Computer Tomography Volumetry and Indocyanine Green Retention Test for Measurement of Liver Reserve,COMPLETED,This is a phase 2 open-labeled study to compare the Ga68-Dolacga positron emission tomography with computer tomography volumetry and indocyanine green retention test for measurement of liver reserve among scheduled surgery operation patients.,['Hepatic Carcinoma'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Ga68-Dolacga Injection', 'description': 'Ga68-Dolacga Injection, 2.0±1.0 mCi, single dose, iv bolus', 'armGroupLabels': ['Ga68-Dolacga Injection'], 'otherNames': ['Ga68-INER038']}]","Inclusion Criteria: 1. Scheduled operation subjects with diagnosed hepatic carcinoma. The eligibility criteria for operation refer to protocol Appendix II: Diagnosis and Treatment Guidelines for Hepatocellular Carcinoma in Chang Gung Memorial Hospital; 2. Subjects without ascites or with controllable ascites; 3. Serum total bilirubin level \< 2.0 mg/dL; 4. Written informed consent must be obtained before any assessment is performed. 5. Male or female subjects aged 20 or above, inclusive, at date of consent. Exclusion Criteria: 1. Presence of distant metastases; 2. A body weight loss of \>10% during the 6 months before operation; 3. Presence of seriously impaired function of vital organs due to respiratory, renal, or heart disease; 4. Cholangiocarcinoma; 5. General PET exclusion criteria; 6. Pregnant women, lactating or breast-feeding women; 7. Patient who can't be followed up for any reason.",NA,ALL,NA,"[{'measure': 'Measurement of liver reserve obtained from Ga68-Dolacga PET performed in patients scheduled surgical operation (Percentage of injection dose, %ID)', 'description': 'The liver reserve obtained from Ga68-Dolacga PET is expressed in ""percentage of injection dose (%ID).""', 'timeFrame': 'visit 2 (Day 1)'}, {'measure': 'Measurement of liver reserve obtained from CTV performed in patients scheduled surgical operation (Remnant volume rate (%))', 'description': 'The liver reserve obtained from computer tomography volumetry (CTV) is expressed in ""remnant volume rate (%).""', 'timeFrame': 'within 7 days prior to Day 1'}, {'measure': 'Measurement of future liver remnant volume rate (FLRV%)', 'description': 'The future liver remnant volume rate (FLRV%) is calculated by dividing the future remnant liver volume by the total functional liver volume from CTV and expressed as %.', 'timeFrame': 'within 7 days prior to Day 1'}, {'measure': 'Measurement of future liver remnant function rate (FLRF%)', 'description': 'The future liver remnant function rate (FLRV%) is calculated by dividing the uptake in the future remnant liver volume by the uptake in the total liver volume from Ga68-Dolacga PET and expressed as %.', 'timeFrame': 'visit 2 (Day 1)'}, {'measure': 'Correlation of the percentage of injection dose (%ID) in liver determined by Ga68-Dolacga PET with conventional liver function tests', 'description': 'The conventional liver function tests parameters include alanine aminotransferase (U/L), aspartate aminotransferase (U/L), total bilirubin (mg/dL), direct bilirubin (mg/dL), gamma-glutamyl transpeptidase (U/L), total protein (g/dL), albumin/globulin ratio, albumin (g/dL), prothrombin time/International Normalized Ratio (PT/INR), platelet count (×10\\^3/μL), ICGR15 (%), Child-Pugh classification (Class A to Class C), MELD score.', 'timeFrame': 'from pre-dose to Day 1'}, {'measure': 'Correlation of the remnant volume rate determined by CTV with conventional liver function tests', 'description': 'The conventional liver function tests parameters include alanine aminotransferase (U/L), aspartate aminotransferase (U/L), total bilirubin (mg/dL), direct bilirubin (mg/dL), gamma-glutamyl transpeptidase (U/L), total protein (g/dL), albumin/globulin ratio, albumin (g/dL), prothrombin time/International Normalized Ratio (PT/INR), platelet count (×10\\^3/μL), ICGR15 (%), Child-Pugh classification (Class A to Class C), MELD score.', 'timeFrame': 'from pre-dose to Day 1'}, {'measure': 'Correlation of the ICGR15 with the conventional liver function tests', 'description': 'The conventional liver function tests parameters include alanine aminotransferase (U/L), aspartate aminotransferase (U/L), total bilirubin (mg/dL), direct bilirubin (mg/dL), gamma-glutamyl transpeptidase (U/L), total protein (g/dL), albumin/globulin ratio, albumin (g/dL), prothrombin time/International Normalized Ratio (PT/INR), platelet count (×10\\^3/μL), Child-Pugh classification (Class A to Class C), MELD score.', 'timeFrame': 'from pre-dose to Day 1'}]","[{'measure': 'Correlation of the percentage of injection dose (%ID) in liver determined by Ga68-Dolacga PET with the fibrosis indices', 'description': 'The fibrosis indices include liver stiffness measurement (kPa) determined by Fibroscan and the Fibrosis-4 (FIB-4) index.', 'timeFrame': 'from pre-dose to Day 1'}, {'measure': 'Correlation of the ICGR15 with the fibrosis indices', 'description': 'The fibrosis indices include liver stiffness measurement (kPa) determined by Fibroscan and the Fibrosis-4 (FIB-4) index.', 'timeFrame': 'from pre-dose to Day 1'}, {'measure': 'Number of subjects with clinically significant changes in systolic blood pressure and diastolic blood pressure', 'timeFrame': 'from pre-dose to 14±2 days post dose'}, {'measure': 'Number of subjects with body temperature abnormalities', 'timeFrame': 'from pre-dose to 14±2 days post dose'}, {'measure': 'Number of subjects with clinically significant changes in Heart Rate', 'timeFrame': 'from pre-dose to 14±2 days post dose'}, {'measure': 'Number of subjects reporting clinically significant changes in serum biochemical tests', 'timeFrame': 'from pre-dose to 14±2 days post dose'}, {'measure': 'Number of subjects reporting clinically significant changes in hematological tests', 'timeFrame': 'from pre-dose to 14±2 days post dose'}, {'measure': 'Number of subjects reporting clinically significant changes in urinalysis', 'timeFrame': 'from pre-dose to 14±2 days post dose'}, {'measure': 'Number of subjects with clinically significant changes in electrocardiogram(ECG)', 'description': 'The ECG parameters include: PR interval (milliseconds), QTc interval (milliseconds), QRS duration (milliseconds)', 'timeFrame': 'from pre-dose to 14±2 days post dose'}, {'measure': 'Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'description': 'All laboratory abnormalities which are compared with screening values and out of the reference range will be considered as AE and will be assessed its relationship to the study drug. Any ECG changes including ECG waveform will be assessed as AE(s) and will be followed to assess whether they resolved and when they resolved.', 'timeFrame': '14 days'}, {'measure': 'Incidence of posthepatectomy liver failure (PHLF)', 'timeFrame': 'on or after postoperative day 5 (POD 5)'}, {'measure': 'Severity grading of PHLF as defined by the International Study Group of Liver Surgery (ISGLS)', 'description': 'Subjects diagnosed with PHLF are classified as grade A, grade B or grade C based on its severity.', 'timeFrame': 'on or after postoperative day 5 (POD 5)'}, {'measure': 'Comparison of CTV and Ga68-Dolacga PET parameters in patients with PHLF', 'description': 'Following parameters will be compared:\n\n* liver reserve obtained from CTV vs liver reserve obtained from Ga68-Dolacga PET\n* FLRV% vs FLRF%', 'timeFrame': 'on or after postoperative day 5 (POD 5)'}]" 174,NCT07382726,"{'fullName': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}",Phase 1 Study Of Izalontamab Brengitecan + Adagrasib In NSCLC - The IZA-A Trial,NOT_YET_RECRUITING,"This research is being done to test a combination of two drugs, Izalontamab Brengitecan (iza-bren) and Adagrasib, in patients with advanced KRAS G12C-mutant NSCLC that hasn't responded to other treatments. The purpose is to see if this combination works better than existing treatments for people whose cancer keeps growing despite KRAS G12C inhibitors.",['Non-small Cell Lung Cancer'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Adagrasib', 'description': 'Given by mouth', 'armGroupLabels': ['Combo Treatment with Izalontamab Brengitecan (IV) + Adagrasib (PO) Q3W'], 'otherNames': ['Krazati']}, {'type': 'DRUG', 'name': 'Iza-bren', 'description': 'Given by IV', 'armGroupLabels': ['Combo Treatment with Izalontamab Brengitecan (IV) + Adagrasib (PO) Q3W']}]","Inclusion Criteria: * Patients must have histologically or cytologically confirmed diagnosis of NSCLC or NSCLC predominant histology. * Patients must have a diagnosis of metastatic or locally advanced NSCLC not amenable to curative therapy * Tumor must harbor a KRAS G12C mutation. Testing available through multigene NGS panels performed in the Molecular Diagnostics Laboratory in UT MD Anderson Cancer Center and can be performed using either tissue or blood assays. Use of standard of care (SOC) results are allowed to meet this requirement. * Patients must have progressed on a prior KRAS G12C inhibitor as monotherapy or as combination therapy. * Patients must have received at least one prior line of therapy and up to 3 prior lines of therapy. * Patients must have measurable disease per RECIST v1.1. * Age ≥18 years - no dosing or adverse event data are currently available on the use of izabren and adagrasib in patients \<18 years of age; children are excluded from this study. * ECOG performance status 0 - 1. * Most recent prior systemic therapy (e.g., chemotherapy, immunotherapy or, investigational agent) discontinued at least 2 weeks before first dose date. * Most recent radiation treatment discontinued at least 1 week prior to first dose date (includes brain radiation). * Patients must have adequate organ and marrow function as defined below: Hemoglobin ≥9.0g/dL Absolute neutrophil count ≥1,500/mcL Platelets ≥100,000/mcL Total bilirubin ≤ institutional upper limit of normal (ULN) (if associated with liver metastases or Gilbert's disease, ≤ 3 x ULN) AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN (if associated with liver metastases, ≤ 5 x ULN) Creatinine ≤ 1.5 mg/dL or CrCl ≥ 45 mL/min (calculated using a validated prediction equation - e.g., Cockcroft-Gault, MDRD, or 24-hour urine CrCl) * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable. * Patients with a history of hepatitis C virus (HCV) infection must have documentation of undetectable HCV viral load. * Patients with treated brain metastases are eligible if patients are neurologically stable for at least 1 week prior to the first dose of study treatment without the use of corticosteroids or are on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent). * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. * Because adagrasib and iza-bren are known to be teratogenic, women of child-bearing potential (WCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 4 (men) and 7 (WCBP) months after completion of study treatment administration. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients less than 55 years of age unless the patient presents with an applicable exclusionary factor which may be one of the following: * Postmenopausal (no menses in greater than or equal to 12 consecutive months). * History of hysterectomy or bilateral salpingo-oophorectomy. * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy). * History of bilateral tubal ligation or another surgical sterilization procedure. * Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. * Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and for 4 months after completion of study treatment administration. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) except for alopecia and parameters superseded by other eligibility criteria \[e.g., laboratory parameters\]). * Patients who are receiving any other investigational agents. * Patients with active untreated brain metastases or carcinomatous meningitis. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to adagrasib and iza-bren. * Patients with prior history of pneumonitis or interstitial lung disease. Patients with prior history of radiation pneumonitis which was asymptomatic or resolved with steroid treatment, and without evidence of clinically active radiation pneumonitis are eligible. * Human immunodeficiency virus (HIV)-infected patients. Those on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. * Patients with psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant and actively breastfeeding woman due to concerns for teratogenicity and infant toxicity. * Major surgery within 4 weeks prior to first dose of study treatment. * History of intestinal disease or major gastric surgery likely to alter absorption of study treatment or inability to swallow oral medications. * Prolonged QTc interval (\>470 milliseconds for women and \>450 milliseconds for men), or immediate family or medical history of congenital Long QT Syndrome. * History of stroke or transient ischemic attack within 6 months prior to first dose of study treatment. * History of unstable angina, myocardial infarction, and symptomatic atrial fibrillation within 6 months prior to first dose of study treatment. * Any serious illness, uncontrolled inter-current illness, psychiatric illness, active or uncontrolled infection, or other medical history, including laboratory results, which, in the Investigator's opinion, would be likely to interfere with the patient's participation in the study, or with the interpretation of the results.",NA,ALL,NA,"[{'measure': 'Safety and Adverse Events (AEs)', 'description': 'Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0', 'timeFrame': 'Through study completion; an average of 1 year'}]",NA 175,NCT06105021,"{'fullName': 'Affini-T Therapeutics, Inc.', 'class': 'INDUSTRY'}",Phase I Study of Autologous CD8+ and CD4+ Engineered T Cell Receptor T Cells in Subjects With Advanced or Metastatic Solid Tumor,ACTIVE_NOT_RECRUITING,"This study is open to adult patients with solid tumors who have a KRAS G12V mutation. This mutation is often found in non-small cell lung cancer (NSCLC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC) and other cancers. The study is for patients whose cancer has spread through the body and for whom previous treatments were not successful or treatment does not exist. Patients must also be positive for HLA-A\*11:01. The purpose of this study is to find the best dose of AFNT-211 that is safe and can shrink tumors in patients. AFNT-211 is an investigational therapy and this is the first time that AFNT-211 is being administered to patients. AFNT-211 is an autologous T cell product which means that it is made from a patient's own T cells. These cells are engineered and grown to recognize the KRAS G12V protein on the cell surface of cancer cells. AFNT-211 is infused into patients after a short course of lymphodepleting chemotherapy. Patients will frequently visit the study site. The doctors there will regularly check the size of the cancer and the patient's health. They will also take note of any unwanted effects. Patients may continue in this study for as long as they benefit from the treatment.","['Pancreatic Ductal Adenocarcinoma', 'Non-Small Cell Lung Cancer', 'Colorectal Cancer', 'Solid Tumor', 'KRAS G12V']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'This is a Phase I, FIH, multicenter, open-label study of AFNT-211 consisting of a dose escalation part and a dose expansion part. During dose escalation the optimal biological dose (OBD) will be determined as well as the recommended phase 2 dose (RP2D). Additional subjects will enroll in expansion cohorts treated at OBD/RP2D found in escalation.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'AFNT-211', 'description': 'Engineered TCR T-Cell', 'armGroupLabels': ['Dose Escalation', 'Dose Expansion: Adv Solid Tumors', 'Dose Expansion: CRC', 'Dose Expansion: NSCLC', 'Dose Expansion: PDAC']}]","Key Inclusion Criteria: 1. Confirmed KRAS G12V mutational status and HLA-A\*11:01 allele 2. Histologically confirmed advanced or metastatic, unresectable solid tumor 3. Progressed on or intolerant of at least one prior line of standard systemic therapy for the current malignancy. 4. Measurable disease per RECIST v1.1. 5. ECOG performance status 0-1 6. Adequate organ and bone marrow function Key Exclusion Criteria: 1. Any systemic cytotoxic chemotherapy, investigational agents, or any anti-tumor drug from a previous treatment regimen or clinical study (including small molecules and I/O compounds) within 5 half-lives or 14 days of Screening, whichever is shorter. 2. Any prior gene therapy utilizing an integrating vector 3. Previous allogeneic stem cell transplantation or prior organ transplantation 4. History of treated primary immunodeficiency, autoimmune, or inflammatory disease including inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, myasthenia gravis, or Grave's disease 5. Primary brain tumor 6. Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression. 7. Uncontrolled active bacterial, viral, fungal, or mycobacterial infection 8. Pregnant or lactating subjects 9. Surgery or catheter-based interventions 10. Previously identified allergy, hypersensitivity, or known contraindication to cyclophosphamide, fludarabine, or any other agent associated with lymphodepleting chemotherapy (LDC) or AFNT-211 product 11. Uncontrolled significant intercurrent or recent illness 12. Diagnosis of another malignancy within 2 years prior to screening. 13. Seropositive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) 14. Seropositive for hepatitis C antibody. 15. Known human immunodeficiency virus (HIV) infection",NA,ALL,NA,"[{'measure': 'Determine the Optimal Biological Dose (OBD)', 'description': 'Quantify the desirability of a dose in terms of toxicity-efficacy tradeoff during the dose escalation portion of the study', 'timeFrame': '60 months'}, {'measure': 'Determine the Recommended Phase 2 Dose', 'description': 'This will be selected based on Bayesian optimal interval Phase I/II (BOIN12) design recommendation and the totality of benefit-risk evidence during dose escalation', 'timeFrame': '60 months'}, {'measure': 'Incidence of Treatment Emergent Adverse Events', 'description': 'The incidence of TEAEs will be used to determine safety and tolerability of AFNT-211', 'timeFrame': '60 months'}, {'measure': 'Incidence of Serious Adverse Events', 'description': 'The incidence of SAEs will be used to determine safety and tolerability of AFNT-211', 'timeFrame': '60 months'}, {'measure': 'Incidence of Dose Limiting Toxicities', 'description': 'The incidence of DLTs during Dose Escalation will be used to determine safety and tolerability of AFNT-211', 'timeFrame': '18 months'}]","[{'measure': 'Overall Response Rate (ORR)', 'description': 'Percentage of subjects who achieved partial response (PR) or complete response (CR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1', 'timeFrame': '60 months'}, {'measure': 'Duration of Response (DOR)', 'description': 'Time from first documentation of response of PR or better to first documentation of disease progression or death from any cause, whichever occurs first.', 'timeFrame': '60 months'}, {'measure': 'Progression-free Survival (PFS)', 'description': 'From enrollment to first documentation of disease progression or death of any cause, whichever occurs first.', 'timeFrame': '60 months'}, {'measure': 'Time to Response (TTR)', 'description': 'Time from first AFNT-211 infusion to first documentation of PR or better.', 'timeFrame': '60 months'}, {'measure': 'Clinical Benefit Rate (CBR)', 'description': 'Percentage of subjects who have achieved PR or CR, or had stable disease (SD) for 6 months or more.', 'timeFrame': '60 months'}, {'measure': 'Overall Survival (OS)', 'description': 'From time of enrollment to death from any cause', 'timeFrame': '60 months'}]" 176,NCT04628806,"{'fullName': 'Charite University, Berlin, Germany', 'class': 'OTHER'}",Heat Shock Protein (HSP) 70 to Quantify and Characterize Circulating Tumor Cells,UNKNOWN,"This study investigates the ability of heat shock protein HSP70 to isolate and quantify circulating tumor cells (CTCs) in patients with advanced or metastatic tumors. CTCs will be isolated from peripheral blood before antineoplastic treatment and again after three months. Isolation using HSP70 will be compared with standard CTC isolation by EpCAM. Additionally, imaging parameters of the primary tumor (if available) and metastases will be analysed and correlations between molecular alterations and imaging parameters will be assesed.","['Melanoma Stage IV', 'Sarcoma', 'Squamous Cell Carcinoma', 'Pancreatic Cancer Stage IV', 'Prostate Cancer', 'Breast Cancer Stage IV']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'DIAGNOSTIC_TEST', 'name': 'CTC isolation by HSP70', 'description': 'patients will receive additional blood examinations with quantification of circulating tumor cells by HSP70 antibodies and EpCAM.', 'armGroupLabels': ['HSP70CTC']}]","Inclusion Criteria: * Metastatic malignant melanoma (stage IV) * Metastatic or unresectable pancreatic adenocarcinoma (stage III or IV) * Metastatic breast cancer * Metastatic sarcoma * Metastatic squamous cell carcinoma of the cervix uteri, head and neck region, vulva, anus or penis * hormone-refractory prostate cancer Exclusion Criteria: * psychiatric disorders that impede adequate informed consent",oncological patients treated at a tertiary center,ALL,PROBABILITY_SAMPLE,"[{'measure': 'Radiographic response to initial treatment', 'description': 'radiographic response to treatment will be scored according to RECIST criteria and associated with the number of CTC', 'timeFrame': '3 months after study enrollment'}]","[{'measure': 'Correlation between number of CTC isolated with HSP70 compared to EpCAM', 'description': 'the number of CTCs obtained by the novel HSP70 method will be compared to the current gold standard that uses EpCAM. This will be performed for the whole cohort and separate for each tumor site', 'timeFrame': '3 months (at both CTC assessment timepoints)'}, {'measure': 'Correlation between differential expressed radiommic parameters between primary tumor and metastases and genetic alterations of the primary tumor and CTCs', 'description': 'computed tomography parameters of primary tumors and metastases will be analysed and parameters extraced that are differentially expressed between both. The same will be performed for genomic mutations and gene expression of the primary tumor and CTC. Correlation analyses will be performed to analyze if radiographic parameters resemble genetic alterations', 'timeFrame': '3 months (at both CTC assessment timepoints)'}, {'measure': 'Progression free survival', 'description': 'Progression free survival will be evaluated with the number of CTC as variable. This will be performed for the whole cohort and separate for each tumor site', 'timeFrame': '2 years'}, {'measure': 'Overall survival', 'description': 'Overall survival will be evaluated with the number of CTC as variable. This will be performed for the whole cohort and separate for each tumor site', 'timeFrame': '2 years'}]" 177,NCT04703426,"{'fullName': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}",Sargramostim (GM-CSF) + PD-1,WITHDRAWN,"This research study is testing the combination of two drugs, sargramostim and pembrolizumab. The study is designed to see if the combination of these study drugs would improve the control of unresectable or metastatic melanoma cancer when compared to use of these drugs alone. The names of the study drugs involved in this study are: * Pembrolizumab * Sargramostim (GM-CSF)","['Unresectable Melanoma', 'Metastatic Melanoma', 'Stage III Melanoma', 'Stage IV Melanoma']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Sargramostim (GM-CSF)', 'description': 'Drug that binds to the protein PD-1 to help immune cells kill cancer cells better, it is given as an intravenous injection through a vein.', 'armGroupLabels': ['Sargramostim (GM-CSF) + Pembrolizumab (anti-PD-1)'], 'otherNames': ['Leukine']}, {'type': 'DRUG', 'name': 'Pembrolizumab (anti-PD-1)', 'description': 'Drug that stimulates blood cells that may help support the immune system during cancer treatment, given as intravenous infusion', 'armGroupLabels': ['Sargramostim (GM-CSF) + Pembrolizumab (anti-PD-1)'], 'otherNames': ['Keytruda']}]","Inclusion Criteria: * Histologic or cytologic diagnosis of metastatic or unresectable stage III or IV cutaneous melanoma * Prior treatment with immunotherapy * Age ≥ 18 years. * ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A) * Participants must have normal organ and marrow function as defined below: * leukocytes ≥3,000/mcL * absolute neutrophil count ≥1,500/mcL * platelets ≥100,000/mcL * total bilirubin within normal institutional limits * AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal * creatinine within normal institutional limits OR creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal. * Measurable disease (by CT, PET/CT or MRI) * The effects of GMCSF and PD-1 inhibition on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 7 months after completion of study drug administration. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Participants who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. * Participants who are receiving any other investigational agents. * Participants with known brain metastases must have documented stability over a four week interval and not be requiring active treatment for these. Prior radiation, surgery and stereotactic radiosurgery are allowed but must be completed four weeks prior to initiating therapy. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Pembrolizumab or sargramostim. * Need for systemic steroids at the time of enrollment. Physiologic replacement at a dose of less than 10mg daily prednisone equivalent is allowed. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Participants who are considered Women of Child-Bearing Potential (WOCBP) must have a negative serum pregnancy test in order to be eligible. Pregnant women are excluded from this study because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Pembrolizumab, breastfeeding should be discontinued if the mother is treated with Pembrolizumab. These potential risks may also apply to other agents used in this study. * Known active HIV, Hepatitis B or Hepatitis C patients. HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for an immunologic effect with the therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated. * Autoimmune disease that requires treatment at the time of enrollment.",NA,ALL,NA,"[{'measure': 'Overall Response Rate (ORR)', 'description': 'The primary study endpoint is response rate per RECIST criteria.', 'timeFrame': '12 weeks'}]","[{'measure': 'Number of Participants With Treatment-Related Adverse Events', 'description': 'Number and proportion of adverse events, graded as defined by CTCAE version 5.0', 'timeFrame': '12 weeks'}, {'measure': 'Overall Survival Rate', 'description': 'Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) will be used.', 'timeFrame': '12 weeks'}, {'measure': 'Progression Free Survival Rate', 'description': 'Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) will be used.', 'timeFrame': '12 weeks'}, {'measure': 'Overall Response Rate (ORR)-irRC', 'description': 'To evaluate the overall response rate in advanced melanoma to combination anti- PD-1 therapy and sargramostim by irRC criteria.', 'timeFrame': '12 weeks'}, {'measure': 'CD4+ ICOS T cell changes', 'description': 'Evaluate changes in CD4+ ICOS T cells from biopsies (pre-treatment, on-treatment, post-treatment) and correlate using Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)', 'timeFrame': '12 weeks'}]" 178,NCT03285230,"{'fullName': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}",The French E3N Prospective Cohort Study,ACTIVE_NOT_RECRUITING,"The French E3N cohort was initiated in 1990 to investigate the risk factors associated with cancer and other major non-communicable diseases in women. The participants were insured through a national health system that primarily covered teachers, and were enrolled from 1990 after returning baseline self-administered questionnaires and providing informed consent. The cohort comprised nearly 100 000 women with baseline ages ranging from 40 to 65 years. Follow-up questionnaires were sent approximately every 2-3 years after the baseline and addressed general and lifestyle characteristics together with medical events (cancer, cardiovascular diseases, diabetes, depression, fractures and asthma, among others). The follow-up questionnaire response rate remained stable at approximately 80%. A biological material bank was generated and included blood samples collected from 25 000 women and saliva samples from an additional 47 000 women. Ageing among the E3N cohort provided the opportunity to investigate factors related to agerelated diseases and conditions as well as disease survival.","['Breast Cancer', 'Colo-rectal Cancer', 'Parkinson Disease', 'Asthma', 'Diabetes', 'Inflammatory Bowel Diseases', 'Melanoma', 'Endometriosis', 'Thyroid Cancer', 'Hypertension', 'Endometrial Cancer', 'Crohn Disease', 'Depression', 'Cardiovascular Diseases']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}",NA,"Inclusion Criteria: * only women * born between 1925 and 1950 * insured by the Mutuelle Générale de l'Education Nationale (MGEN) Exclusion Criteria: \- men","The cohort comprised nearly 100 000 women with baseline ages ranging from 40 to 65 years, all insured through a French national health system (MGEN).",FEMALE,PROBABILITY_SAMPLE,"[{'measure': 'Anthropometric measurements', 'description': 'Height, weight, hip circumference and waist circumference', 'timeFrame': 'From 1990 until now'}, {'measure': 'Educational level', 'timeFrame': '1990'}, {'measure': 'Professional activity', 'description': 'Insee categories', 'timeFrame': '1992 and 2005'}, {'measure': 'Age at cessation of activity', 'timeFrame': 'From 2005 until now'}, {'measure': 'Menstrual factors', 'description': 'Age at menarche, length of menstrual cycle', 'timeFrame': 'From 1990 to 2002'}, {'measure': 'Reproductive history', 'description': 'Number of pregnancies, age at each pregnancy, durations and outcomes of pregnancies, breastfeeding, infertility', 'timeFrame': 'From 1990 to 1992'}, {'measure': 'Menopause', 'description': 'Age, type', 'timeFrame': '1990, 1995, 1997, 2000, 2002, 2005'}, {'measure': 'Hormonal Treatments', 'description': 'Menopausal Hormonal Treatments (MHT), oral contraceptives', 'timeFrame': 'From 1992 to 2008'}, {'measure': 'Tobacco consumption', 'description': 'Type, quantity, time of smoking', 'timeFrame': 'From 1990 until now'}, {'measure': 'Alcohol consumption', 'description': 'Type of alcohol, quantity', 'timeFrame': '1993, 1997, 2005'}, {'measure': 'Physical activity', 'description': 'Moderate and intense activity, sedentarity', 'timeFrame': '1990,1997,2002, 2005, 2014'}, {'measure': 'Diet questionnaire', 'description': 'Precise annual diet questionnaire', 'timeFrame': '1993 and 2002'}, {'measure': 'Family history of diseases', 'description': 'Cancer, diabetes and cardiovascular diseases', 'timeFrame': '1990 to 2005'}, {'measure': 'Medication use', 'description': 'linked with the drug reimbursement files from the health insurance', 'timeFrame': 'From 1990 until now'}, {'measure': 'Medical and surgical history', 'timeFrame': 'From 1990 until now'}, {'measure': 'Mental Health', 'description': 'Centre for Epidemiologic Studies Depression Scale (CESD) and Depression', 'timeFrame': 'From 1990 until now'}, {'measure': 'Health outcomes', 'timeFrame': 'From 1990 until now'}]",NA 179,NCT04789421,"{'fullName': 'Azienda Ospedaliero-Universitaria di Modena', 'class': 'OTHER'}","Advanced Non-invasive Diagnostics for Early Cutaneous Tumor Diagnosis, Clinical-therapeutic and Economic Management",COMPLETED,"The incidence of cutaneous melanoma (MM) is increasing worldwide. The best therapeutical solution for MM is early diagnosis and efforts over the last 50 years have been directed towards early and precise diagnoses. Dermoscopy has improved diagnostic accuracy compared to the naked eye, but is limited by an associated higher number of unnecessary excisions. Reflectance confocal microscopy (RCM) is a novel technique enabling in vivo examination of the skin at cellular-level resolution, with excellent diagnostic accuracy. This study hypothesis is that the systematic application of RCM in the triage and management of patients suspicious for skin cancer, may improve diagnostic accuracy and reduce the number of unnecessary biopsy. Reducing the burden of unnecessary surgery excisions should benefit the health system, both in saving surgical and pathology procedural associated costs and reducing the overwhelming waiting lists for excisions and consequent risk for delayed diagnoses.",['Cutaneous Melanoma'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A two-arm prospective, multi-center study of the triage of patients with equivocal skin lesions suspicious for melanoma, compared with the standard of care (i.e. clinical and dermoscopic examination). A 1:1 randomization into the interventional or control arms occurred at the time of enrolment. Arm 1 (interventional) included lesions that were evaluated with RCM with management decisions taken according with overall information (2 possible outcomes: excision or digital monitoring. Arm 2 (control) included lesions that were not evaluated with RCM, with management decisions taken according to clinical and dermoscopy evaluations only (2 possible outcomes: excision or follow-up).', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Randomisation of patients to Arm 1 (with RCM evaluation) or Arm 2 (without RCM evaluations) was performed following clinical and dermoscopy evaluation, and was only revealed to the clinician at presentation of RCM evaluation request.', 'whoMasked': ['CARE_PROVIDER']}}","[{'type': 'DEVICE', 'name': 'Clinical, dermoscopy and Reflective confocal microscopy evaluations', 'description': 'Adjunctive reflective confocal microscopy to dermoscopy and clinical dermatological evaluation.', 'armGroupLabels': ['Arm 1 (interventional)']}, {'type': 'DEVICE', 'name': 'Clinical, dermoscopy evaluations', 'description': 'Dermoscopy and clinical dermatological evaluation only', 'armGroupLabels': ['Arm 2 (control)']}]","Inclusion Criteria: \- Patient's with at least 1 unequivocal lesion following standard of care (clinical and dermoscopy evaluations), \>= 18 years old Exclusion Criteria: * (i) the presence of an unequivocal aspect of melanoma or of any other malignant skin cancer, * (ii) lesion located on a skin area where reflectance confocal microscopy cannot be performed (for example: skin folds, mucosa, etc.), * (iii) lesion larger than 2 cm in its largest diameter * (iv) lesion where RCM examination is hampered for over the 30% of its surface (for example, for presence of crusting, oozing, erosion, ulceration, etc.).",NA,ALL,NA,"[{'measure': 'Number needed to excise (NNE)', 'description': 'Measure the number of lesions needed to excise for a cutaneous melanoma diagnosis', 'timeFrame': '03/2016 - 02/2020'}, {'measure': 'Early diagnosis', 'description': 'Measure the breslow index of excised lesions', 'timeFrame': '03/2016 - 02/2020'}, {'measure': 'RCM diagnostic sensibility and sensitivity', 'description': 'Diagnostic sensibility of RCM in identifying cutaneous melanoma among equivocal lesions suspicious for melanoma (without clear demoscopy criteria for melanoma)', 'timeFrame': '03/2016 - 02/2020'}]","[{'measure': 'Head and neck pigmented lesions', 'description': 'Diagnostic accuracy of pigmented head and neck lesions where differential diagnosis is difficult to achieve and improper treatments (cryotherapy, laser, radiofrequency).', 'timeFrame': '03/2016 - 02/2020'}, {'measure': 'Diagnostic accuracy of non melanoma skin cancer', 'description': 'Pre-and intra-operative imaging for surgical margins', 'timeFrame': '03/2016 - 02/2020'}]" 180,NCT06880198,"{'fullName': 'Fondazione Melanoma Onlus', 'class': 'OTHER'}",Study to Evaluate Impact® as Support to Anti PD1 or Anti PD1 Based Regimen Treatment in Patients With Inoperable Locally Advanced or Metastatic Melanoma,RECRUITING,"This is a monocentric, prospective study evaluating the effectiveness in reducing immune-related adverse events, and translational study conducted on 20 patients with inoperable locally advanced or metastatic melanoma. The patients will be treated with Oral Impact® administered at the dose of two bricks/day for 21 days + one brick/day for 14 days, starting exactly one week before Anti PD-1 treatment (nivolumab) or anti PD1 based regimen therapy (Nivolumab plus Ipilimumab or Nivolumab plus Relatlimab) as per clinical practice. The comparison will be done with historical literature data on patients matched by age, sex, disease stage, and therapy dosage, not treated with Impact.","['Melanoma Metastatic', 'Locally Advanced Melanoma']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DIETARY_SUPPLEMENT', 'name': 'Oral Impact®', 'description': 'One Arm: 2 Impact brick/d for 21 days + 1 brick/d for 14 days, starting exactly one week before Anti PD-1 treatment in patients with inoperable locally advanced or metastatic melanoma Treatment duration: 35 days', 'armGroupLabels': ['Oral Impact®: single arm']}]","Inclusion Criteria: 1. Age ≥ 18 years; 2. Histologically confirmed stage III (unresectable) or stage IV Cutaneous Melanoma; 3. PD-L1 evaluation and as per standard clinical practice, patients with PD-L1 \< 1% will be treated with anti PD1 based regimen and patients with PD-L1\>1% will be treated with anti-PD1 in monotherapy; 4. Anti-PD1 (Nivolumab) or anti PD1 based regimen (Nivolumab plus Ipilimumab or Nivolumab plus Relatlimab) planned as per standard clinical practice and decision by the treating oncologist; ; 5. Measurable disease by computed tomography (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria; 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1; 7. Screening laboratory values must meet the following criteria before starting the treatment: 1. WBCs ≥2000/μL 2. Neutrophils ≥1500/μL 3. Platelets ≥100 x 10³/μL 4. Hemoglobin ≥9.0 g/dL 5. Serum creatinine of ≤1.5 times the upper normal limits or creatinine clearance \>40 mL/minute 6. AST ≤ 3 times the upper normal limits 7. ALT ≤ 3 times the upper normal limits 8. Total bilirubin ≤1.5 times the upper normal limits (except patients with Gilbert Syndrome who must have total bilirubin \<3.0 mg/dL) 8. Prior palliative radiotherapy must have been completed at least 2 weeks prior to study drug administration; 9. Patients of reproductive potential, must use adequate contraception methods; 10. Signed written consent form; Exclusion Criteria: 1. Active brain metastases; 2. Patients with previous malignancies unless a complete remission was achieved at least 2 years prior to study entry; 3. Patients with prior systemic anticancer therapy for unresectable or metastatic melanoma; 4. Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the patient to receive protocol therapy; 5. Presence of active, known, or suspected autoimmune disease; 6. Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of treatment; 7. Participation in any interventional drug or medical device study within 30 days prior to treatment start; 8. Patients with active hepatitis B (defined as having a positive hepatitis B surface antigen \[HBsAg\] test at screening) or active C hepatitis or active HIV; 9. History of severe hypersensitivity reactions to other monoclonal antibodies; 10. Pregnant and breast-feeding women; 11. Patients of reproductive who refuse to use effective methods of contraception.",NA,ALL,NA,"[{'measure': 'the role of immunonutrition with Oral Impact® in reducing G3 - G4 irAEs frequency and severity grade of anti-PD1 therapy (Nivolumab) or anti-PD1 based regimen in patients with inoperable locally advanced or metastatic melanoma.', 'timeFrame': 'up to 12 months from EoT'}]","[{'measure': 'Prognostic bio-markers evaluation', 'description': 'Evaluation of peripheral blood biomarkers, metagenomic sequencing of gut microbiota, gene profile analysis, and, if archived tissues are available, tumor tissue biomarkers.', 'timeFrame': 'from day -7 up to EoT'}]" 181,NCT03552549,"{'fullName': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}","SCH 54031 PEG12000 Interferon Alfa-2b (PEG Intron, MK-4031) vs. INTRON®A (SCH 30500, MK-2958) as Adjuvant Therapy for Melanoma (C98-135, MK-4031-002)",TERMINATED,"This is a Phase II/III randomized, controlled, multicenter, open-label study designed to assess the safety, efficacy, and impact on quality of life of PEG Intron (MK-4031) and INTRON® A (MK-2958) and the pharmacokinetics of PEG Intron when given as adjuvant (after surgery) therapy in participants with resected (surgically removed) Stage III node-positive cutaneous melanoma.",['Melanoma'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'PEG-Intron', 'description': 'Polyethylene glycol (PEG)12000 Interferon alfa 2-b subcutaneous injection.', 'armGroupLabels': ['PEG-Intron'], 'otherNames': ['peginterferon alfa-2b, SCH 54031, MK-4031']}, {'type': 'BIOLOGICAL', 'name': 'INTRON A', 'description': 'Interferon alfa-2b, recombinant for intravenous injection.', 'armGroupLabels': ['INTRON A'], 'otherNames': ['interferon alfa-2b, SCH 30500, MK-2958']}]","Inclusion Criteria: * Participants must have histologically documented primary cutaneous melanoma meeting one of the following staging criteria: * Primary melanoma of any stage in the presence of N1 regional lymph node metastases detected at elective lymph node dissection or sentinel node biopsy, with clinically inapparent regional lymph node metastasis (any pTN1M0). * Clinically apparent N1 or N2a regional lymph node involvement synchronous with primary melanoma of T1-4 (any pTN1-2aM0). * Regional lymph node recurrence at any interval after appropriate surgery for primary melanoma of any depth (any primary tumor \[pT\], r N1-2a M0). * Participants must have had all known disease completely resected with adequate surgical margins within 56 days prior to randomization into the study * Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Participants must have adequate hepatic, renal and bone marrow function as defined by the following parameters obtained within 14 days prior to initiation of study treatment: * Hematology: white blood cells (WBC) ≥3,000 cells/µL and hemoglobin ≥9 g/dL. * Renal and hepatic function: serum creatinine \<2.0 mg/dL; aspartate aminotransferase (AST or SGOT) and alanine aminotransferase (ALT or SGPT) \<2 times upper limit of laboratory normal (ULN); and serum bilirubin \<2 times ULN * Participants must sign and date a voluntary informed consent form before study entry, be willing to participate in this study and agree to complete all follow-up assessments. Exclusion Criteria: * Participants who have received any prior chemotherapy, immunotherapy hormonal or radiation therapy for melanoma. * Participants who have evidence of distant or non-regional lymph node metastases, in-transit metastases, or positive lymph nodes with an unknown primary. * Participants whose disease cannot be completely surgically resected because of gross extracapsular extension. * Participants who have previously received interferon for any reason. * Participants who have severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment, congestive heart failure (New York Heart Association \[NYHA\] Class III or IV) or symptomatic ischemic heart disease. * Participants who have a history of neuropsychiatric disorder requiring hospitalization. * Participants with thyroid dysfunction not responsive to therapy. * Participants with uncontrolled diabetes mellitus. * Participants with a history of prior malignancy within the past 5 years other than surgically cured non-melanoma skin cancer or cervical carcinoma in situ. * Participants who have a history of seropositivity for human immunodeficiency virus (HIV). * Participants who are pregnant, lactating, or of reproductive potential and not practicing an effective means of contraception. * Participants with active and/or uncontrolled infection, including active hepatitis. * Participants with a medical condition requiring chronic systemic corticosteroids. * Participants who are known to be actively abusing alcohol or drugs. * Participants who have received any experimental therapy within 30 days prior to randomization in this study. * Participants who have not recovered from the effects of recent surgery.",NA,ALL,NA,"[{'measure': 'Progression-free Survival (PFS)', 'description': 'Progression-free survival time was defined as the time from the date of randomization to the date of disease progression or the date of death regardless of the cause. PFS was to be assessed by clinical observation, with recurrence documented by appropriate radiographic and histologic methods, and confirmed by Independent Central Review.', 'timeFrame': 'From time of randomization to time of progression or death (up to approximately 26 months)'}]","[{'measure': 'Overall Survival', 'description': 'Overall survival (OS) is the time from randomization to death due to any cause. Participants were to be followed for survival every 3 months. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. After the early termination of the study, participants were followed for safety only. Although the OS analysis is not in the clinical study report due to early termination of the study, an OS ad hoc analysis was requested by the FDA and is therefore presented in this outcome measure. Below table presents the median duration of survival for participants.', 'timeFrame': 'From time of randomization to time of death (up to approximately 26 months)'}]" 182,NCT00338130,"{'fullName': 'AstraZeneca', 'class': 'INDUSTRY'}",Randomised Study to Compare the Efficacy of AZD6244 vs TMZ,COMPLETED,The primary purpose of this study is to compare the efficacy of AZD6244 (ARRY-142886) with temozolomide in patients with advanced melanoma,['Melanoma'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'AZD6244', 'description': 'Oral liquid or Capsule', 'armGroupLabels': ['2'], 'otherNames': ['ARRY-142886']}, {'type': 'DRUG', 'name': 'Temozolomide', 'description': 'oral', 'armGroupLabels': ['1']}]","Inclusion Criteria: * Diagnosed with late stage malignant melanoma * Aged 18 or over * Female patients must be post-menopausal or with negative urine pregnancy test if pre-menopausal Exclusion Criteria: * Any previous radiotherapy or chemotherapy (palliative radiotherapy is acceptable) * Participation in any other trial with an investigational product within the previous 30 days",NA,ALL,NA,"[{'measure': 'To compare the efficacy of AZD6244 vs temozolomide in patients with unresectable AJCC stage 3 or 4 malignant melanoma by assessing progression free survival (PFS)', 'timeFrame': 'From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)'}, {'measure': 'Time to death', 'timeFrame': 'From date of randomisation until 6 months after first dose or to date of death (whichever is the earliest)'}, {'measure': 'Objective Response Rate', 'timeFrame': 'RECIST data collected as per institutional standard practise'}, {'measure': 'Duration of response', 'timeFrame': 'RECIST data collected as per institutional standard practise'}]","[{'measure': 'Assessment of the safety and tolerability of AZD6244', 'timeFrame': 'Assessed at all visits'}, {'measure': 'Investigation of the pharmacokinetics of AZD6244', 'timeFrame': 'Day 1 & 8 (for patients on AZD6244)'}, {'measure': 'Assessment of the efficacy of AZD6244 versus temozolomide in patients who are BRAF and BRAF and /or NRAS mutation positive', 'timeFrame': 'From date of randomisation until 6 months after first dose or study withdrawal (whichever is the earliest)'}]" 183,NCT03293784,"{'fullName': 'Institut Claudius Regaud', 'class': 'OTHER'}",TNF-Inhibitor as Immune Checkpoint Inhibitor for Advanced MELanoma,COMPLETED,"This is a Phase 1b, open-label study of immune checkpoints inhibitors Nivolumab+Ipilimumab administered in combination with the anti-TNF-α either Infliximab or Certolizumab, in patients with advanced melanoma.",['Melanoma'],INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'COMBINATION_PRODUCT', 'name': 'Nivolumab+Ipilimumab in combination with Anti TNF-α Certolizumab', 'description': 'Induction phase: Nivolumab (1mg/kg) and Ipilimumab (3 mg/kg) injected at Week 0, 3, 6, and 9 with Certolizumab injected at the dose of 400mg at weeks 0, 3, and 6, and at the dose of 200mg at week 9.\n\nMaintenance phase: Nivolumab (3 mg/kg) alone injected from week 12 and then every 2 weeks with Certolizumab (200 mg) injected from week 12 and then every 2 weeks.', 'armGroupLabels': ['COHORT 1']}, {'type': 'COMBINATION_PRODUCT', 'name': 'Nivolumab+Ipilimumab in combination with Anti TNF-α Infliximab', 'description': 'Induction phase: Nivolumab (1mg/kg) and Ipilimumab 3 mg/kg injected at Week 0, 3, 6, and 9 with Infliximab (5mg/kg) injected at weeks 0, 3 and 6.\n\nMaintenance phase: Nivolumab (3 mg/kg) alone injected from week 12 and then every 2 weeks with Infliximab (5mg/kg) injected from week 14 and then every 8 weeks.', 'armGroupLabels': ['COHORT 2']}]","Inclusion Criteria: 1. Patient with histologically-proven metastatic and/or unresectable melanoma (stage IIIc-IV, M1a-c as per AJCC 2009), including mucosal melanoma, without evidence of active intra-cranial disease. 2. Subjects are included regardless of BRAFV600 mutation status. BRAFV600 mutation status must be documented. 3. Measurable disease per RECIST 1.1 4. Age ≥18 years and ≤70 years at the time of study entry. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. 6. Life expectancy of at least 3 months. 7. Patient able to participate and willing to give informed consent prior to performance of any study-related procedures and to comply with the study protocol. 8. Screening laboratory values must meet the following criteria and should be obtained prior to commencement of treatment: White blood count (WBC) ≥ 2000/μL Neutrophils ≥ 1500/μL Platelets ≥ 100 x103/μL Hemoglobin \> 9.0 g/dL Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (if using the Cockcroft-Gault formula below): Female CrCl = (140 - age in years) x weight in kg x 0.85 / 72 x serum creatinine in mg/dL Male CrCl = (140 - age in years) x weight in kg x 1.00 / 72 x serum creatinine in mg/dL AST/ALT ≤ 3 x ULN (except subjects with hepatic metastasis, who can have AST/ALT ≤ 5 x ULN) Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL) 9. Adequate cardiac and respiratory functions defined as New York Heart Association (NYHA) class 1 and SaO2 \> 90%. 10. Patient must be naïve to systemic treatment for locally advanced and/or metastatic disease (i.e., no prior systemic anticancer therapy for advanced disease; stage IIIc and IV). Prior adjuvant therapies (including Interferon α and Ipilimumab) is permitted if it was completed at least 12 weeks before start of treatment and all related AEs have either returned to baseline or stabilized. 11. Prior radiotherapy or radiosurgery must have been completed at least 4 weeks prior to the first dose of the study treatment. 12. Women of childbearing potential (WOCBP) must use two appropriate methods of contraception to avoid pregnancy for 23 weeks (30 days plus the time required for Nivolumab/Ipilimumab to undergo five half-lives) after the last dose of investigational drug. 13. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25IU/L or equivalent units of HCG) within 24 hours prior to the start of study treatment. 14. Men who are sexually active with WOCBP must use two contraceptive methods including at least one method with a failure rate of less than 1% per year for a period of 31 weeks after the last dose of investigational product. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception. 15. Absence of any psychological, familial, sociological or geographical condition that potentially hampers compliance with the study protocol and follow-up after treatment discontinuation schedule. 16. Patient affiliated to a Social Health Insurance in France. 17. Patient must provide written informed consent prior to any study specific procedures. Exclusion Criteria: 1. Patient pregnant, or breast-feeding. 2. Uveal melanoma. 3. Active and/or symptomatic intra cranial metastasis (including melanomatous meningitis). Patients with intra cranial metastasis may be eligible if all known lesions have been treated with stereotactic radiotherapy or surgery or both AND there has been no magnetic resonance imaging (MRI) evidence of disease progression in the CNS for ≥ 4 weeks after treatment and within 28 days prior the first dose of study drug administration. 4. Previous treatment with B-RAF or MEK inhibitors within 12 weeks prior start of treatment. 5. Hypersensitivity to the drugs of the study. 6. Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. 7. Clinically significant cardiac dysfunction including congenital, familial, and genetic cardiac disorders, current instable angina, current symptomatic congestive heart failure of NYHA class 2 and higher, current uncontrolled hypertension ≥ grade 3; Left Ventricular Ejection Fraction (LVEF) below institutional lower limit of normal (LLN) or below 50%, whichever is lower. 8. Patient with active malignancy other than melanoma or a history of previous within the past 3 years; except for patients with resected Basal cell carcinoma or resected Spindle cell carcinoma, resected carcinoma in situ of the cervix and resected carcinoma in situ of the breast. 9. History of untreated tuberculosis and/or positive quantiferon test without previous prophylaxis tuberculosis treatment, or untreated active infection with mycobacterium tuberculosis. For patients with asymptomatic (including radiologic symptoms) infection with mycobacterium tuberculosis, inclusion may be possible after 4 weeks of adequate antibiotics treatment. 10. Active, known or suspected autoimmune disease including but not restricted to multiple sclerosis, optical nevritis and demyelinating neuropathy. Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger. 11. Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus (HCV ribonucleic acid or HCV antibody) indicating acute or chronic infection. 12. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). 13. Vaccination with any live attenuated conventional vaccine within the 3 months preceding the start of study treatment. 14. Any current severe or uncontrolled disease, including, but not limited to ongoing or active infection. 15. Patient included in another study with an experimental molecule and/or procedure. 16. Unwillingness or inability to provide written informed consent. 17. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the compliance of treatment and the study protocol. 18. Patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.",NA,ALL,NA,"[{'measure': 'Dose Limiting Toxicities (DLT) incidence, in part 1 of the study.', 'description': 'For each patient, DLT incidence will be evaluated during the Part 1 of the study: 12 weeks after the initial dose of study drug.', 'timeFrame': '12 weeks per patient (part 1)'}]","[{'measure': 'Safety and tolerability according to the classification of the National Cancer Institute Common Toxicity Criteria for Adverse Effects (NCI-CTCAE) Version 4.03.', 'description': 'The assessment of safety and tolerability will be based on the incidence of Adverse Events (AEs), Serious Adverse Events, AEs leading to discontinuation, and death. In addition, clinical laboratory test abnormalities will be examined. Tolerability will be evaluated by collecting dose interruptions and dose delays.', 'timeFrame': '15 months per patient'}, {'measure': 'Progression Free Survival', 'description': 'Progression Free Survival (PFS) is defined as the time from inclusion until progression or deaths; patients alive at last follow-up news are censored at this date.', 'timeFrame': '24 months per patient'}, {'measure': 'Objective Response Rate', 'description': 'Objective Response Rate (ORR) is defined as the number of patients with Best Overall Response divided by the number of included patients in each cohort.', 'timeFrame': '24 months per patient'}]" 184,NCT02866149,"{'fullName': 'Institut Curie', 'class': 'OTHER'}",Analysis of Circulating Tumor Markers in the Blood (ALCINA),COMPLETED,Exploratory study on blood-borne biological markers and their correlation with clinical and pathological characteristics.,['Cancer'],INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'Blood sampling', 'description': 'Up to 5 blood samplings can be performed at different time points', 'armGroupLabels': ['Cohort 1 - ""Anti checkpoint""', 'Cohort 10 - ""Palbociclib II""', 'Cohort 11 - Sarcomas', 'Cohort 12 - Faslorad', 'Cohort 13 - MUm', 'Cohort 14 - CNBC Snipe', 'Cohort 15 - Breast CLI', 'Cohort 16 - Mum immunothérapie', 'Cohort 2 - ""Oncoscan®""', 'Cohort 3 - ""CirCe-PLA""', 'Cohort 4 - ""CDX PDX""', 'Cohort 5 - ""Post-TP53""', 'Cohort 6 - ""Palbociclib""', 'Cohort 7 - ""CTC_PD-L1_Breast""', 'Cohort 8 - ""CTC_PD-L1_Broncho-Pulmonary""', 'Cohort 9 - ""NSCLC""']}, {'type': 'PROCEDURE', 'name': 'Tumor sampling', 'description': 'One tumor sampling can be performed, if applicable', 'armGroupLabels': ['Cohort 14 - CNBC Snipe', 'Cohort 15 - Breast CLI', 'Cohort 3 - ""CirCe-PLA""', 'Cohort 4 - ""CDX PDX""', 'Cohort 9 - ""NSCLC""']}, {'type': 'OTHER', 'name': 'Stool sampling', 'description': 'Up to 5 blood samplings can be performed at different time points', 'armGroupLabels': ['Cohort 9 - ""NSCLC""']}]","Inclusion Criteria: 1. Patient with any tumoral disease (proven or suspected), of any type and stage 2. More than18 years old 3. Signed informed consent form Additional inclusion criteria if a tumor sample is needed: 4. Tumor considered as accessible by biopsy 5. Normal blood coagulation tests on the last blood analysis Non-inclusion Criteria: 1. Patient in detention or protected by the law 2. Patient who cannot comply with the study follow up for geographical, social or psychological reasons Additional non-inclusion criteria if a tumor sample is needed: 3. Anticoagulant or antiaggregant that cannot be interrupted for the biopsy 4. central-nervous system metastases only (unless a diagnostic or curative surgery is planned before the inclusion in the study)",NA,ALL,NA,"[{'measure': 'Feasibility of the analysis of different blood-borne tumor biomarkers', 'description': 'Success rate of the tested detection techniques. The success rate of a given detection technique is calculated by the ratio "" detection success "" / "" number of screened patients "".', 'timeFrame': '18 months'}]","[{'measure': 'Correlation with biological and clinical data', 'description': 'Number of biological analysis results correlated to clinical data. Establishment of a proof of concept', 'timeFrame': '18 months'}]" 185,NCT04293289,"{'fullName': 'Cancer Intelligence Care Systems, Inc.', 'class': 'INDUSTRY'}",Boron Neutron Capture Therapy Using CICS-1 and SPM-011 for Malignant Melanoma and Angiosarcoma,COMPLETED,"Among skin malignancies, patients with malignant melanoma or angiosarcoma are treated with BNCT using CICS-1 and SPM-011 (borofalan (10B)). Through this trial, safety and appropriate treatment dose will be determined.","['Malignant Melanoma', 'Angiosarcoma']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'OTHER', 'name': 'CICS-1 (investigational device),SPM-011(investigational drug)', 'description': 'Intravenous administration of SPM-011 and neutron irradiation with CICS-1.', 'armGroupLabels': ['Treatment']}]","Inclusion Criteria: 1. Patients with primary malignant melanoma or angiosarcoma diagnosed histopathologically 2. Patients with superficial skin lesions whose maximum diameter of the target lesion is 15 cm or less 3. Patients with lesions that are lying 6 cm or less from the skin surface to the deepest part of the tumor 4. Patients with lesions in the head, neck, chest, or extremities 5. Patients who do not have apparent abnormal hematological and biochemical values in the latest screening test within 28 days of registration Exclusion Criteria: 1. Patients with obvious disseminated lesions 2. Patients who have undergone previous treatment of radiation therapy exceeding 75 Gy for the target lesion. 3. Patients with active lesions / active multiple cancers in addition to the target lesion 4. Patients with infections that require systemic treatment. 5. Patients with active implantable medical devices 6. Patients with a history of BNCT treatment",NA,ALL,NA,"[{'measure': 'The frequency of DLT(Dose Limiting Toxicity) occurence (Safety)', 'description': 'Evaluate the safety at each dose level by the frequency of DLT occurrence', 'timeFrame': '90 days'}]","[{'measure': 'The incidence of adverse events and failures', 'description': 'Evaluate the incidence of adverse events and failures during the study period', 'timeFrame': '180 days'}, {'measure': 'Tumor shrinkage ratio, tumor best shrinkage ratio', 'timeFrame': '30, 60, 90, 180 days'}, {'measure': 'Response rate', 'timeFrame': '30, 60, 90, 180 days'}, {'measure': 'Progression-free survival', 'timeFrame': '30, 60, 90, 180 days'}, {'measure': 'Survival length', 'timeFrame': '30, 60, 90, 180 days'}, {'measure': 'Best response rate for target lesion', 'timeFrame': '30, 60, 90, 180 days'}, {'measure': 'Progression-free period', 'timeFrame': '30, 60, 90, 180 days'}, {'measure': 'Period until chronic adverse event', 'timeFrame': '30, 60, 90, 180 days'}]" 186,NCT03073304,"{'fullName': 'Vastra Gotaland Region', 'class': 'OTHER_GOV'}",A Randomized Controlled Study Comparing Priming Solution Containing Crystalloid or Packed Red Blood Cells in Patients Treated With Isolated Limb Perfusion.,COMPLETED,The primary aim of this study is to investigate the possibility to replace an erythrocyte based prime solution with a crystalloid based prime solution while maintaining metabolic function. Secondary also to study if potentially reduced immunological influence is obtained during hyper thermic isolated limb perfusion with a crystalloid based prime solution.,"['Melanoma', 'Sarcoma']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Crystalloid based prime solution', 'description': 'Crystalloid based prime solution', 'armGroupLabels': ['Intervention']}, {'type': 'DRUG', 'name': 'Erythrocyte based prime solution', 'description': 'Erythrocyte based prime solution', 'armGroupLabels': ['Control']}]","Inclusion Criteria: 1. The patient scheduled for treatment with isolated hyperthermic perfusion 2. Age over 18 years. 3. Signed informed consent",NA,ALL,NA,"[{'measure': 'Lactate level during and after perfusion.', 'description': 'Lactate level during and after perfusion.', 'timeFrame': '1 hour'}]","[{'measure': 'Arterial oxygen and regional venous oxygen saturation during and after completion of perfusion.', 'description': 'Arterial oxygen and regional venous oxygen saturation during and after completion of perfusion.', 'timeFrame': '1 hour'}, {'measure': 'Hematocrit during and after completion of perfusion.', 'description': 'Hematocrit during and after completion of perfusion.', 'timeFrame': '1 hour'}, {'measure': 'Oxygen extraction during, and after perfusion.', 'description': 'Oxygen extraction during, and after perfusion.', 'timeFrame': '1 hour'}, {'measure': 'Complications', 'description': 'Serious Adverse Events (SAEs) level III-V within 30 days.', 'timeFrame': '30 days'}, {'measure': 'Immunological effects', 'description': 'Changes in proportion of immune cells measured as CD3 + (T cells), CD3 + 4 + (helper T cells), CD3 + 8 + (cytotoxic T cells), CD3 + DR + (activated T cells), CD3 + 4 + 45RA + (naive helper T cells), CD3 + 8 + 45RA + (naïve cytotoxic T cells), CD3 + 4 + 45RO + (helper T cells), CD3 + 8 + 45RO + (cytotoxic memory T cells), CD3-56 + 16 + (NK cells), CD3 + 56 + 16 + (activated T cells), CD5 + (T-cells and some B-cells), CD19 + (B cells), CD5 + 19 + (subset of mature B cells mainly form polyspecific antibodies of the IgM class) will be measured before ILP, after 7 and 30 days post ILP', 'timeFrame': '30 days'}]" 187,NCT00311558,"{'fullName': 'The Cleveland Clinic', 'class': 'OTHER'}","Sodium Stibogluconate and Interferon in Treating Patients With Advanced Solid Tumors, Lymphoma, or Myeloma",TERMINATED,"RATIONALE: Sodium stibogluconate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Interferon may interfere with the growth of cancer cells. Giving sodium stibogluconate together with interferon may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of sodium stibogluconate when given together with interferon in treating patients with advanced solid tumors, lymphoma, or myeloma.",['Cancer'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'recombinant interferon alfa-2b', 'description': 'SSG x 5 week', 'armGroupLabels': ['SSG & INF'], 'otherNames': ['Sodium Stibocluconate']}, {'type': 'DRUG', 'name': 'sodium stibogluconate', 'description': 'SSG \\& IFN', 'armGroupLabels': ['SSG & INF']}, {'type': 'DRUG', 'name': 'SSG & interferon', 'description': '1 arm study with SSG \\& interferon', 'armGroupLabels': ['SSG & INF'], 'otherNames': ['Sodium Stiboglucante']}]","DISEASE CHARACTERISTICS: * Histologically confirmed malignancy, including, but not limited to, any of the following: * Renal cell carcinoma * Melanoma * Kaposi's sarcoma * Breast, prostate, colorectal, or lung adenocarcinoma * Bone and soft tissue sarcomas * Lymphoma * Myeloma * Tumors of neuroendocrine and endothelial cell origin * Stage IV disease * Refractory disease, resistant to established treatments, or no effective treatment available * Measurable or evaluable disease * CNS metastases allowed if no prior definitive therapy within the past 3 months and no glucocorticoids required PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Granulocyte count \> 1,500/mm\^3 * Platelet count \> 100,000/mm\^3 * Creatinine \< 1.0 times upper limit of normal (ULN) * Creatinine clearance ≥ 60 mL/min * Bilirubin \< 1.5 times ULN * AST/ALT \< 1.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study treatment * No history of any of the following: * Atrial fibrillation, atrial flutter, or other serious arrhythmia (excluding asymptomatic atrial and ventricular premature complexes) * Congestive heart failure currently requiring treatment * Angina pectoris * Other severe cardiovascular disease (i.e., New York Heart Association class III or IV heart disease) * No baseline ECG abnormalities suggestive of cardiac conduction delay, i.e., 1° or greater atrio-ventricular block and/or complete or incomplete (QRS \> 120 ms) bundle branch block, or repolarization abnormalities (i.e., QTc ≥ 0.48 sec) * No systemic infections requiring antibiotics within the past 14 days * No known hepatitis B surface antigen positivity * Psychologically prepared to participate in study treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 4 weeks since prior interferon (IFN) therapy and/or ≤ 400 million units of IFN * At least 3 weeks since prior major surgery * At least 3 weeks since prior radiation therapy or chemotherapy * No prior solid organ allografts or allogeneic bone marrow transplantation * No concurrent daily glucocorticoids except for physiological replacement * No other concurrent medications known to prolong QT interval",NA,ALL,NA,"[{'measure': 'Tolerance, safety, and maximum tolerated dose at 1 week after each course', 'timeFrame': '3 years'}]",NA 188,NCT03107663,"{'fullName': 'ImaginAb, Inc.', 'class': 'INDUSTRY'}",⁸⁹Zr-Df-IAB22M2C PET/CT in Patients With Selected Solid Malignancies or Hodgkin's Lymphoma,COMPLETED,To determine the safety and feasibility of 89Zr-Df-IAB22M2C as an immunoPET tracer; determine the best time window and protein dose for imaging; determine the pharmacokinetic (PK) and biodistribution of the probe; and to determine imaging parameters for optimal lymphoid and tumor visualization.,"['Positron-Emission Tomography', 'Immunomodulation', 'Metastatic Solid Malignancies', 'Hodgkin Lymphoma']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': '⁸⁹Zr-Df-IAB22M2C Infusion', 'description': 'A single dose of 3.0 (±20%) mCi of ⁸⁹Zr-Df-IAB22M2C (with 0.2 mg, 0.5 mg, 1.0mg, 1.5 mg, 5.0 mg, or 10.0 mg of protein) will be administered intravenously over 5-10 minutes.', 'armGroupLabels': ['⁸⁹Zr-Df-IAB22M2C Infusion']}]","Inclusion Criteria: 1. Patients with selected solid malignancies (NSCLC, SCLC, SqCCHN, melanoma, merkel cell tumor, renal, bladder, hepatocellular, triple negative breast, or gastroesophageal cancer) or Hodgkin's lymphoma 2. At least 1 measurable lesion documented on CT/MRI (RECIST criteria 1.1) 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Appendix B: ECOG Scoring) 4. Age ≥ 18 years 5. Ability to understand the purposes and risks of the trial and has signed a IRB-approved informed consent form 6. Willingness and ability to comply with all protocol required procedures 7. For men and women of child-bearing potential, use of effective contraceptive methods during the study Exclusion Criteria: Patients meeting any of the following criteria will not be eligible for study entry: 1. Known infection with human immunodeficiency virus (HIV) 2. Serious nonmalignant disease or conditions that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives 3. Patients who have had splenectomy. 4. Patients who have any splenic disorders that in the opinion of the investigator and/or ImaginAb could compromise protocol objectives. 5. Patients who are currently receiving any other investigational agent 6. Pregnant women or nursing mothers 7. Hepatic laboratory values: 1. Bilirubin \> 1.5 x ULN (institutional upper limits of normal) 2. Albumin \< 2 g/dL 3. Other local safety laboratory test results (clinical chemistry and hematology) are determined to be exclusionary by the Investigator. 8. Known sensitivity to glutamic acid or glutamate.",NA,ALL,NA,"[{'measure': 'Safety and tolerability of ⁸⁹Zr-Df-IAB22M2C assessed by local and systemic signs and symptoms of infusion reactions,incidence of adverse events,changes in laboratory test results,dose limiting toxicities,vital signs and 12-lead electrocardiogram findings', 'timeFrame': 'From infusion of ⁸⁹Zr-Df-IAB22M2C up to 12 weeks'}]","[{'measure': 'Evaluate imaging time window with ⁸⁹Zr-Df-IAB22M2C', 'timeFrame': 'From infusion of ⁸⁹Zr-Df-IAB22M2C through up to Day 6'}, {'measure': 'Evaluate protein dose for imaging with ⁸⁹Zr-Df-IAB22M2C', 'timeFrame': 'From infusion of ⁸⁹Zr-Df-IAB22M2C through up to Day 6'}, {'measure': 'Evaluate the radioactive pharmacokinetics of ⁸⁹Zr-Df-IAB22M2C by determining the time-activity curves for serum (% injected dose/liter), AUC, clearance, volume of distribution, Tmax and Cmax.', 'description': 'The data from the actual concentration and the parameters will be summarized descriptively and also presented as subject specific listings.', 'timeFrame': 'From infusion of ⁸⁹Zr-Df-IAB22M2C through up to Day 6'}, {'measure': 'Evaluate the dosimetry of a single dose of ⁸⁹Zr-Df-IAB22M2C', 'description': 'Dosimetry will be determined from the ⁸⁹Zr-Df-IAB22M2C PET/CT scans obtained during the course of this study at 1-2 hours, 6-8 hours (optional), 24 (± 4 hours), 48 (± 4 hours) hours and 92-144 hours post infusion in patients at the optimal dosing cohort. Regions of interest will be drawn at each PET/CT time point to capture target and major organ uptakes. Once all five PET/CT scans are analyzed, the biologic clearance will be evaluated from the ""dynamic"" sequence of the scans and the final estimated radiation dose calculated using the clearance seen in the images. The data for dosimetry also comes from Imaging Endpoints. Patterns of radiotracer uptake and estimates of semi-quantitative measurements, using typical SUV (Standardized uptake value) estimates (SUV max; SUV peak; SUV mean) will be presented. The data will be summarized descriptively and will also be presented as subject specific listings.', 'timeFrame': 'From infusion of ⁸⁹Zr-Df-IAB22M2C through up to Day 6'}]" 189,NCT03464604,"{'fullName': 'Nova Scotia Health Authority', 'class': 'OTHER'}",Melanoma Accuracy Study; Phase 2,TERMINATED,"The purpose of this study is to evaluate the process, accuracy and patient outcomes of pre-screening dermatology referrals in a clinical setting by a qualified nurse. The long-range goal of the proposed program is to improve referral wait times for patients to see a dermatologist for lesions suspicious for melanoma in comparison to normal standards of care in NS. If effective, this screening program would decrease wait times for those patients with lesions suspicious for melanoma providing earlier diagnosis and expedited treatment, and potentially reducing mortality rates.",['Melanoma'],OBSERVATIONAL,"{'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'DIAGNOSTIC_TEST', 'name': 'active', 'description': 'Pre-screening for melanoma by qualified nurse', 'armGroupLabels': ['Group 2 Active group']}]","Inclusion Criteria: * New referral from a general practitioner to a dermatologist * Males and females, over the age of 18 are eligible to participate * Written informed consent from the patient * Lesion or mole is new, changing color, growing rapidly or has a change in sensation * Willing to have the lesion excised if necessary per standard of care * Ability to complete the imaging procedure and willing to complete a basic history * Pigmented lesion considered low, moderate or high risk for melanoma by a general practitioner Exclusion Criteria * Lesions which are not amenable * Participant unable to read, understand or sign consent * Participant under active care by a dermatologist * Lesion \<2 mm or \>15mm in diameter * Lesion located on areas of scars, crusts, psoriasis, eczema or similar skin conditions * Lesion on hair covered areas (e.g. scalp, beard, mustache) where hair cannot be removed * Lesions located on genitalia not accessible to equipment * Lesions located in an area that has previously biopsied or subjected to any kind of surgical or ablative procedure * Lesion with foreign matter, e.g. tattoo or splinter * Lesion and/or reference located on acute sunburn * Skin surface not measurable, e.g. lesion on a stalk * Skin surface not accessible, e.g. inside ears, ears, under nails * Skin not intact (measurement area), e.g. bleeding or with clinically noticeable ulceration * Lesions located within 1cm of the eye * Lesions light in pigment or thick and nodular * Participants not willing to have the lesion excised",Patients are 18+ (male or female) referred to the Department of Dermatology at the NSHA for a suspicious pigmented lesion(s).,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Pre-screening lesions low to moderate risk for melanoma by a nurse, will facilitate a more timely diagnosis of melanoma.', 'description': 'Pre-screening referrals to the Department of Dermatology by a qualified nurse for patients with lesions, low to moderate risk for melanoma, would facilitate a more timely diagnosis of melanoma, and appropriate triaging of benign lesions.', 'timeFrame': '3 years'}]",NA 190,NCT03780608,"{'fullName': 'Samsung Medical Center', 'class': 'OTHER'}",This Study is a Phase II Study of AZD6738 in Combination With Durvalumab in Patients With Solid Tumor (Cohort A (N=30): GC Who Have Failed Secondary Chemotherapy Treatments Regimen; Cohort B (B=30): Melanoma Patients Who Have Failed to IO),UNKNOWN,"This study is a phase II study of AZD6738 in combination with durvalumab in patients with solid tumor (cohort A (N=30): GC who have failed secondary chemotherapy treatments regimen; cohort B (B=30): melanoma patients who have failed to IO). Patients will receive AZD6738 plus durvalumab combination regimen. AZD6738 will be administered at 240 mg twice daily on days 1 to 7 in Cycle 0 (lead-in period) and therafter at 240 mg BD on days 22 to 28 in a 28-day cycle. Durvalumab will be administered at 1500 mg every 4 weeks from cycle 1 day 1. Tumour evaluation using modified RECIST 1.1 will be conducted at screening (within 28 days prior to first dose) and every 8 weeks relative to the date of first dose, up to week 40, then every 12 weeks until objective disease progression (within a window of +/- 7 days of the scheduled date). Patients will continue to receive treatment with AZD6738 and durvalumab provided that the treatment is tolerable and there is evidence of clinical benefit (as judged by the investigator) and secure supply of medication. Upon confirmation of objective disease progression, or treatment disconiutation criteria are met, both durvalumab and AZD6738 must be discontinued. Patients may continue with AZD6738/durvalumab beyond objective disease progression (determined by modified RECIST 1.1) at the discretion of the investigator if they are clinically benefiting from the treatment and they do not meet any other discontinuation criteria. If either durvalumab and/or AZD6738 are deemed intolerable (as judged by the investigator) so that discontinuation of either agent is deemed in the patient's best interest despite dose interruptions, dose modification and initiation of supportive treatments, both durvalumab and AZD6738 must be discontinued and the patient withdrawn from the study. Patients are not permitted to continue either AZD6738 or durvalumab as monotherapy. There is no maximum duration of treatment with AZD6738 and durvalumab. The imaging modalities used for modified RECIST 1.1 assessment will be CT or MRI scans of chest,abdomen and pelvis. modified RECIST 1.1 scans will be analysed by the investigator on site. Patients will also be requested to provide tumour samples from the primary or metastatic tumours pre-study and on progression. Sample provision is mandatory, subject to aspecific consent, and will aid understanding of resistance mechanisms. However, if biopsy site is not feasible, the protocol will allow waiving the rebiopsy procedure.","['Gastric Adenocarcinoma', 'Malignant Melanoma']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'AZD6738', 'description': 'AZD6738 will be administered at 240 mg twice daily on days 1 to 7 in Cycle 0 (lead-in period) and therafter at 240 mg BD on days 22 to 28 in a 28-day cycle.', 'armGroupLabels': ['GC', 'Melanoma']}, {'type': 'DRUG', 'name': 'Durvalumab', 'description': '. Durvalumab will be administered at 1500 mg every 4 weeks from cycle 1 day 1.', 'armGroupLabels': ['GC', 'Melanoma']}]","Inclusion Criteria: 1. Provision of fully informed consent prior to any study specific procedures. 2. Patients must be ≥ 18 years of age 3. Patient with ATM deficient or ATM proficient through IHC. ATM expression status will be assessed prospectively. Minimum numbers of each patient group (ATM proficient and deficient) will be required for analysis, therefore central prospective screening will be deployed to ensure this is achieved. 4. Body weight \>30kg 5. Cohort A: Confirmed histological or cytological diagnosis of gastric adenocarcinoma (including GEJ) that is at an advanced stage and that has progressed following who have failed secondary chemotherapy treatments (confirmed by imaging) 6. Cohort B: Confirmed melanoma (metastatic) who has progressed to prior anti-PD(L)1 therapy (immediate prior regimen) 7. Have the presence of measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (modified RECIST) version 1.1 which is suitable for accurate repeated measurements. 8. Provision of tumor sample (from either a resection or biopsy) for ATM IHC and other exploratory biomarker 9. Patients are willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations. 10. ECOG performance status 0-1 with no deterioration between screening and the first dose of study treatment 11. Patients must have a life expectancy ≥ 3 months from proposed first dose date. 12. Patients must have had a washout period of 3 weeks for any prior therapy prior to the start ot study drug. The following intervals between the end of the prior treatment and first dose of study drug must be observed: ≥ 4 weeks for radiotherapy (patients who receive palliative radiation for nontarget lesions need not have a 4 week washout period and can be enrolled immediately); patients may receive a stable dose of bisphosphonates or denusomab as long as these were started at least 4 weeks prior to treatment; ≥ 4 weeks for major surgery; ≥ 7 days for minor surgical procedures; ≥ 14 days (or 5 half lives whoever is longest) for any investigational product. 13. Patients must have acceptable bone marrow, liver and renal function measured within 28 days prior to administration of study treatment as defined below: * Haemoglobin ≥9.0 g/dL (transfusion not permitted within 14 days of study medication) * Absolute neutrophil count (ANC) ≥ 1.5 x 109/L * INR ≥1.5 or evidence of impaired hepatic synthesis function * Platelet count ≥100 x 109/L (transfusion not permitted within 14 days of study medication * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) * AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal unless liver metastases are present in which case it must be ≤ 5x ULN * Serum creatinine ≤1.5 x institutional ULN * Glomerular filtration rate \< 45 mL/min as assessed by standard methodology at the investigating centre * Haematuria: +++ on microscopy or dipstick 14. Female patients of childbearing potential must have a negative pregnancy test (urine or serum), must not be breastfeeding and using adequate contraceptive measures. Female patients must use a highly effective contraceptive measure from screening until 90 days after the last dose of drug. All methods of contraception (except for total abstinence) should be used in combination with the use of a condom by a male sexual partner for intercourse (see Restrictions below). Female patients must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening: 1. Post-menopausal women defined as aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatment. 2. Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy, but not tubal ligation. 3. Amenorrhoeic for 12 months and serum follicle-stimulating hormone (FSH), lutenizing hormone (LH) and plasma oestradiol levels in the postmenopausal range for the institution 15. For the duration of the study and for 1 week after the last study drug administration, sexually active male patients must be willing to use barrier contraception i.e. condoms with all sexual partners. Where the sexual partner is a 'women of child-bearing potential' who is not using effective contraception, men must use a condom (with spermicide) during the study and for 6 months after the last dose of a study drug. 16. Mandatory biopsy during the screening window prior to dosing and at progression (fresh frozen will be mandatory if clinically feasible) Exclusion Criteria: 1. Diagnosis of ataxia telangiectasia. 2. Any previous treatment with ATR inhibitors, DNA -damage repair inhibitors 3. Any gastrointestinal condition that would preclude adequate abosrportion of AZD6738 including but not limited to inability to swallow oral medication, refractory nausea and vomiting, chronic gastrointestinal diseases or previous significant bowel resection, intestinal obstruction or CTCAE grade 3 or grade 4 upper GI bleeding within 4 weeks before the enrollment. 4. Active or prior documented autoimmune or inflammatory disorders (including IBD\[e.g. Chohn's disease, ulcerative colitis or diverticulitis\], SLE, sarcoidosis syndrome, tuberculosis, Wegener syndrome, myasthenia gravis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, history of primary immunodeficiency or HIV infection, known hepatitis B or hepatitis C infection, history of organ transplant that requires use of immunosuppressives, glomerulonephritis, nephritic syndrome, Fanconi Syndrome or renal tubular acidosis within the past 2 years prior to the start of treatment. The following are exceptions to this criterion: * Subjects with vitiligo or alopecia, hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment; patients with coeliac disease controlled by diet alone and patients without active disease in the last 5 years may be included after consultation with Chief Investigator. 5. Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression. Note: Subjects previously treated for CNS metastases that are asymptomatic, radiographically and neurologically stable for at least 4 weeks and do not require corticosteroids (of any dose) for symptomatic management for at least 4 weeks prior to the first dose of treatment are not excluded. 6. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤3 years. 7. Current or prior use of immunosuppressive medication within 4 weeks prior to the first dose of durvalumab, with the exceptions of intranasal, topical, and inhaled corticosteroids; systemic corticosteroids at physiologic doses not to exceed a dose \> 10 mg prednisone / day or equivalent) 8. Patient was in receipt of any live attenuated vaccination within 30 days prior to study entry or within 30 days of receving study therapy. 9. Receiving or having received, concomitant medications, herbal supplements, and/or foods that significantly modulate P450 3A4 (CYP3A4) or Pgp activity (washout periods of 5 half-lives). Note these include common azole antifungals, macrolide antibioics and other medications. 10. Patient with any of the following cardiac criteria: * Mean QT interval corrected for heart rate (QTc) ≥ 470 ms calculated from 3 electrograms (ECGs) using Friderecia's correction * Any clinciallly important abnormalities in fhythm, conduction or morphology of resting ECG e.g. complete left bundle branch block , third degree heart block, second degree heart block. * Any factors that increae the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or concomitant medication known to prolong the QT interval * Uncontrolled hypotension: systolic BP \< 90 mmHg and/or diastolic BP 60 mmHg or clinically relvant orthostatic hypotension, including a fall in blood pressure of \> 20 mmHg * Atrial fibrillation with a ventricular rate \>100 bpm on ECG at rest * Symptomatic heart failure (NYHA grade II-IV) * Known reduced LVEF \< 55% * Prior or current cardiomyopathy * Severe valvular heart disease * Uncontrolled angina (Canadian Cardiovascular Society grade II-IV despite medical therapy) * Stroke or transient ischaemic attack in the last 6 months prior to screening * Acute coronary syndrome within 6 months prior to starting treatment 11. Ophthalmological conditions as follows:Intra-ocular pressure \>21 mmHg, or uncontrolled glaucoma (irrespective of intra-ocular pressure), Current or past history of central serous retinopathy or retinal vein occlusion 12. Any evidence of severe or uncontrolled systemic disease, including active infection (requiring antibiotics, antifungals or antivirals), diabetes type I and II, uncontrolled seizures, bleeding diatheses, severe COPD, severe Parkinson's disease. 13. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable. 14. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy. 15. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.",NA,ALL,NA,"[{'measure': 'ORR', 'description': 'Objective reponse rate (ORR) by modified RECIST 1.1', 'timeFrame': '2 years'}]",NA 191,NCT05645484,"{'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}",The Prognostic Value of 18F-PFPN PET Imaging in Patients With Malignant Melanoma,UNKNOWN,"This is a monocentric prospective study. This study aims to investigate the prognostic value of the novel melanin-targeted imaging modality 18F-PFPN PET in patients with melanoma and seek independent prognostic factors for progression-free survival (PFS) and overall survival (OS). The patients with clinically highly suspected or confirmed melanoma who underwent 18F-PFPN and 18F-FDG PET scans will be enrolled consecutively. Patients' PET images, clinical characteristics, and follow-up information will be collected for prognostic analyses. This study plans to set the sample size as 100 cases.",['Melanoma'],OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'DRUG', 'name': '18F-PFPN', 'description': '18F-PFPN (dose: 3.0-5.4 MBq/kg) will be injected intravenously prior to imaging.', 'armGroupLabels': ['18F-PFPN PET imaging'], 'otherNames': ['18F-PEG3-FPN']}, {'type': 'DRUG', 'name': '18F-FDG', 'description': '18F-FDG (dose: 3.7-5.4 MBq/kg) will be injected intravenously prior to imaging.', 'armGroupLabels': ['18F-FDG PET imaging'], 'otherNames': ['18F-fluorodeoxyglucose']}]","Inclusion Criteria: * Patients with histopathologically confirmed melanoma; * Patients with complete clinical and follow-up data (including TNM stage, subtypes, and treatment strategies). Exclusion Criteria: * Uncertain histopathology; * A history of other malignancies.",Patients with clinically highly suspected or confirmed melanoma underwent 18F-PFPN and 18F-FDG PET scans in the PET center.,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Progression-free Survival (PFS)', 'description': 'PFS time is calculated from the date of PET imaging to the first recurrence/progression or death or the endpoint of follow-up. The disease recurrence/progression is confirmed after a thorough review of following-up imaging or pathologic findings.', 'timeFrame': '1-2 years'}, {'measure': 'Overall Survival (OS)', 'description': 'OS time is defined as the time from PET imaging to death or the endpoint of follow-up.', 'timeFrame': '1-2 years'}]",NA 192,NCT04550247,"{'fullName': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}",A Prospective Non-Interventional Study in Participants Receiving Nivolumab in Adjuvant Setting for Resected Melanoma in Real-World Conditions in France,ACTIVE_NOT_RECRUITING,"This is an observational prospective study to estimate in real world conditions the effectiveness, the safety profile and the pattern of use of adjuvant nivolumab in adults participants with stage III/IV resected melanoma, and subsequent treatments administered in case of relapse.",['Melanoma'],OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}",NA,"For more information regarding Bristol-Myers Squibb Clinical Trial participation,please visit www.BMSStudyConnect.com. Inclusion Criteria: * Participants with a primary diagnosis of melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection and have no evidence of disease * Decision to treat with adjuvant nivolumab therapy has already been taken * Participants who provide oral informed consent to participate in the study Exclusion Criteria: * Any participant with a current diagnosis of persisting advanced melanoma * Participants with a current primary diagnosis of a cancer other than advanced melanoma, ie, a cancer other than melanoma that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator) * Any participants currently enrolled in an interventional clinical trial for his/her melanoma treatment (note: patients who have completed their participation in an interventional trial or who are no longer receiving the study drug and are only followed up for OS/RFS can be enrolled. In case of a blinded study, the treatment arm needs to be known). * Pregnant women * Person under guardianship Other protocol defined inclusion/exclusion criteria apply",The study will collect data primarily from hospital based dermatology and oncology care facilities,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Relapse-Free Survival (RFS)', 'timeFrame': 'up to 60 months'}]","[{'measure': 'Distant Metastatasis-Free Survival (DMFS)', 'timeFrame': 'Up to 60 months'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'Up to 60 months'}, {'measure': 'Relapse-Free Survival 2 (RFS2)', 'timeFrame': 'Up to 60 months'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'Up to 60 months'}, {'measure': 'Assessment of health related quality of life', 'timeFrame': 'Up to 60 Months'}, {'measure': 'Assessment of sociodemographic characteristics', 'timeFrame': 'Up to 60 months'}, {'measure': 'Assessment of clinical characteristics', 'timeFrame': 'Up to 60 months'}, {'measure': 'Frequency of nivolumab therapy: number of infusions', 'timeFrame': 'Up to 60 months'}, {'measure': 'Frequency of nivolumab therapy: number of dosing', 'timeFrame': 'Up to 60 months'}, {'measure': 'Frequency of Nivolumab: pattern of use', 'timeFrame': 'Up to 60 months'}, {'measure': 'Characteristics of nivolumab adjuvant safety profile: incidence', 'timeFrame': 'Up to 60 months'}, {'measure': 'Characteristics of nivolumab adjuvant safety profile: grade', 'timeFrame': 'Up to 60 months'}, {'measure': 'Characteristics of nivolumab adjuvant safety profile: type', 'timeFrame': 'Up to 60 months'}, {'measure': 'Characteristics of nivolumab adjuvant safety profile: time to onset of select AEs', 'timeFrame': 'Up to 60 months'}, {'measure': 'Characteristics of nivolumab adjuvant safety profile: time to onset of other immune- related AEs', 'timeFrame': 'Up to 60 months'}, {'measure': 'Characteristics of nivolumab adjuvant safety profile: time to resolution of select AEs', 'timeFrame': 'Up to 60 months'}, {'measure': 'Characteristics of nivolumab adjuvant safety profile: time to resolution of other immune-related AEs', 'timeFrame': 'Up to 60 months'}, {'measure': 'Describe the use of subsequent therapies after relapse following adjuvant nivolumab', 'timeFrame': 'Up to 60 months'}, {'measure': 'Estimate of the effectiveness of systemic therapies administered after relapse following adjuvant nivolumab, in terms of time and duration of response', 'timeFrame': 'Up to 60 months'}, {'measure': 'Estimate of the effectiveness of systemic therapies administered after relapse following adjuvant nivolumab, in terms of overall response rate', 'timeFrame': 'Up to 60 months'}, {'measure': 'Safety profile of systemic therapies administered after relapse in terms of severe adverse events incidence, type, management and outcome', 'timeFrame': 'Up to 60 months'}, {'measure': 'Estimate the effectiveness of subsequents treatments administered after relapse in terms of PFS', 'timeFrame': 'Up to 60 months'}, {'measure': 'Estimate the effectiveness of subsequents treatments administered after relapse in terms of RFS2', 'timeFrame': 'Up to 60 months'}, {'measure': 'Estimate the effectiveness of subsequents treatments administered after relapse in terms of OS', 'timeFrame': 'Up to 60 months'}, {'measure': 'Characteristics of nivolumab adjuvant safety profile: management', 'timeFrame': 'Up to 60 months'}, {'measure': 'Characteristics of nivolumab adjuvant safety profile: outcome', 'timeFrame': 'Up to 60 months'}, {'measure': 'Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Incidence', 'timeFrame': 'Up to 60 months'}, {'measure': 'Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Type', 'timeFrame': 'Up to 60 months'}, {'measure': 'Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Management', 'timeFrame': 'Up to 60 months'}, {'measure': 'Safety profile of systemic therapies administered after relapse in terms of severe adverse events: Outcome', 'timeFrame': 'Up to 60 months'}]" 193,NCT01843738,"{'fullName': 'University of Utah', 'class': 'OTHER'}",Radiation Use During Vemurafenib Treatment,WITHDRAWN,"Patients are being asked to take part because they have melanoma that has spread to other organs in their body (metastatic). As part of this study, patients will receive radiation therapy and an approved drug (Vemurafenib).","['BRAFV600 Mutation', 'Stage IV Melanoma']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'RADIATION', 'name': 'Radiation therapy', 'description': 'Per standard of care', 'armGroupLabels': ['All participants']}, {'type': 'DRUG', 'name': 'Vemurafenib', 'description': ""The starting dose of vemurafenib will be the patient's baseline tolerating dose, between 720 - and 960 mg PO bid."", 'armGroupLabels': ['All participants']}]","Inclusion Criteria: * Age \> 18 years old * Diagnosis of BRAFV600 mutated Stage IV or unresectable Stage III melanoma * Actively receiving treatment with vemurafenib as single agent and tolerating at least 720 mg bid for one cycle (28 days). * In the opinion of the investigator, patients who are progressing in an area where radiation may provide benefit from either: * Symptom control * Oligo-progression, defined as progression in up to 3 areas where focal treatment would provide benefit. * Patients with brain metastases will be allowed provided they meet all of the following criteria: * Small, \< 1cm metastases which are untreated are allowed so long as in the opinion of the investigator they do not require immediate treatment by radiation or surgery * Asymptomatic, treated brain metastases which are stable for 4 weeks prior to study entry are allowed * If patients are requiring steroids for their brain metastases, they must be on a stable dose for two weeks prior to study entry, and maintain that steroid dosing during the radiation treatments * Adequate bone marrow function as defined by: ANC \> 1.0 k/uL, Platelets \> 75 k/uL, Hemoglobin \> 8 g/dL * Adequate hepatic function: Total bilirubin \< 1.5 times the institutional upper limit of normal, ALT/AST \< 2.5 times the institutional upper limit of normal * Adequate renal function as defined by serum creatinin \< 1.5 times the upper limit of normal. * Negative serum pregnancy test at screening for women of child bearing potential within 10 days of starting vemurafenib treatment . Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for \> 1 year * Fertile men and women must agree to use an acceptable method of birth control during treatment and for at least 2 months after discontinuation of vemurafenib. * Able and willing to provide informed consent to an approved consent form that conforms to federal and institutional guidelines. Exclusion Criteria: * Screening QTc interval \> 450 msec on EKG * Known HIV positivity or AIDS-related illness, or active HBV, or active HCV. * Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, serious cardiac arrhythmia requiring medication, uncontrolled hypertension, cerebrovascular accident or transient ischemic attack, or symptomatic pulmonary embolism. * Malabsorption disorder that would preclude adequate vemurafenib absorption. * Other medical condition present that in the opinion of the investigator will hinder the subjects ability to complete the study.",NA,ALL,NA,"[{'measure': 'Number of patients with adverse events as a measure of safety and tolerability', 'description': 'To evaluate the safety of radiation combined with vemurafenib treatment in patients with BRAFV600 mutated Stage IV or unresectable Stage III melanoma', 'timeFrame': '36 months'}]","[{'measure': 'Response rate', 'description': 'To evaluate response rates as assessed by RECIST criteria 1.1, at baseline, and at 8 week intervals throughout the study', 'timeFrame': '36 months'}]" 194,NCT01223248,"{'fullName': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}",Randomized Study Comparing Two Dosing Schedules for Hypofractionated Image-Guided Radiation Therapy,ACTIVE_NOT_RECRUITING,"The purpose of this study is to find out which way of giving high-dose radiation works best for treatment of cancer that has spread to bone, the spine, soft tissue, or lymph nodes. This study will look at the effects, good and/or bad, of giving 27 Gy in three fractions (3 days) or 24 Gy in one fraction (1 day) using image-guided intensity-modulated radiotherapy (IG-IMRT). IG-IMRT is radiation that is given directly to the cancer site and reduces the exposure to normal tissue. Currently there are no studies that compare the effects of giving radiation in either hypofractionated doses (higher total doses of radiation spread out over several treatment days) or a single-fraction dose (entire radiation dose given in one treatment session). The patient may be asked to participate in an additional part of this study where we will get a a (DW/DCE) MRI before treatment start and within one hour after radiation treatment. If the patient is asked to take part in this portion of the study, all they will need to do is get up to 3 MRIs with standard contrast injection. The purpose of this is to see if as a result of the treatment there are changes in the blood flow going to the cancer which could suggest that the treatment may be successful. In addition some patients can present new lesions and may be asked if they would like to have these new lesions treated on the protocol. If they are given this option, this will not extend their follow up period. The follow up of the new lesions will match with the prior follow up dates.","['Melanoma', 'Ovarian Cancer', 'Sarcoma', 'Bone', 'CNS-Spinal CD/MEMBR, NOS', 'Lymph Nodes', 'Soft Tissue']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'RADIATION', 'name': 'IGIMRT using a single dose of 24 Gy', 'description': 'Pts in both the hypofractionated \\& single dose arms will receive the same following standard procedures. The only difference between the arms is the dose delivered at each treatment. 20 MSKCC pts (10 per treatment arm) will be accrued to undergo baseline DW-MRI \\& DCE-MRI pretreatment for both arms \\& 1 hour after their initial treatment for single fraction pts, \\& within one hour of their initial \\& final radiation treatment for the hypofractionated pts. Pts will be considered for this scan based on compliance to scan schedule \\& MRI availability for performing the scan within one hour of the planned IGRT. 24 MSKCC pts (12 per treatment arm) will be accrued for the blood collection (optional) up to 4 hours prior, 50-90 minutes after, \\& approximately 24 hours \\[MCPG2.3\\]after treatment for single fraction pts. For pts partaking in both sub-studies, the post-treatment blood collection may be done in a 50-120 minute window to account for scheduling conflicts with the research MRI.', 'armGroupLabels': ['stereotactic IGIMRT using a single dose of 24 Gy']}, {'type': 'RADIATION', 'name': 'IGIMRT 27 Gy in 3 fractions', 'description': 'Pts in both the hypofractionated \\& single dose arms will receive the same following standard procedures. The only difference between the arms is the dose delivered at each treatment. 20 MSKCC pts (10 per treatment arm) will be accrued to undergo baseline DW-MRI \\& DCE-MRI pretreatment for both arms \\& within 1 hour after their initial treatment for single fraction pts, \\& within one hour of their initial \\& final radiation treatment for the hypofractionated pts. Pts will be considered for this scan based on compliance to scan schedule \\& MRI availability for performing the scan within one hour of the planned IGRT. 24 MSKCC pts (12 per treatment arm) will be accrued for the blood collection (optional) up to 4 hours prior, 50-90 minutes after, \\& approximately 24 hours \\[MCPG2.3\\]after treatment for single fraction pts. For pts partaking in both sub-studies, the post-treatment blood collection may be done in a 50-120 minute window to account for scheduling conflicts with the research MRI.', 'armGroupLabels': ['stereotactic IGIMRT 27 Gy in 3 fractions']}]","Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of cancer (including epithelial carcinoma, sarcoma, and melanoma) The diagnosis can be done at MSKCC or at participating institutions. * Sites of metastatic disease to be treated on protocol are limited to bone, spine, soft tissue, and lymph nodes only. * Patients with American Joint Committee on Cancer (6th edition, 2002) Stage IV cancer with distant metastases * Age 18 years or older * Life expectancy \>3 months * Maximum tumor dimension of ≤6 cm in lymph nodes, soft tissue, osseous metastases, or spinal metastases seen on imaging (computed tomography \[CT\], magnetic resonance imaging \[MRI\], or PET/CT) and considered amenable for RT. * If the lesion(s) to be treated are soft-tissue or lymph Nodes unidimensionally measurable disease is required. Bone \& spine lesions are eligible even if considered non-measurable. * Measurable disease is defined as: * ≥ 10mm for soft-tissue lesions * ≥ 15mm on the short axis of lymph nodes * KPS ≥ 80 * Patients must have normal bone marrow function as defined below:(within 2 months of registration) Hemoglobin ≥9.0 g/dl Absolute neutrophil count (ANC) ≥1,500/μl Platelets ≥100,000/μl Exclusion Criteria: * Prior radiotherapy delivered to the target region * Disease to be treated on protocol is less than 2 mm from the spinal cord and therefore will not meet dose constraints\* * Pregnancy or Breast-Feeding (Participants of child-bearing potential are eligible but must consent to using effective contraception during therapy and for at least 3 months after completing therapy). * Chemotherapy given on the day of the planned radiotherapy treatment * Lesions which comprise \>70% of the width of weight bearing bones, such as the femur. * Existing cortical bone destruction, where orthopedic stabilization would be required. * Areas to be treated on protocol do not include metastases to liver, brain or lung. * Note: Patients with eligible and ineligible lesions will be accrued to this protocol. Only target eligible lesions will be treated per protocol. Other eligible and ineligible lesions will be treated at the discretion of the treating physician.""",NA,ALL,NA,"[{'measure': 'To compare the loco-regional control rates of two established hypo-fractionated radiation treatment regimens', 'description': 'a single dose of 24 Gy versus 27 Gy in three fractions for patients with metastatic disease', 'timeFrame': '2 years'}]","[{'measure': 'To compare toxicity outcomes', 'timeFrame': '2 years'}, {'measure': 'To compare patterns of failure between these two cohorts.', 'timeFrame': '2 years'}, {'measure': 'To look at changes in SUV uptake as a measure of tumor response.', 'description': 'For patients who are followed with PET/CTs', 'timeFrame': '2 years'}, {'measure': 'changes in tumor perfusion', 'description': 'resulting from high-dose IGRT for patients treated with this approach to focal metastases using dynamic contrast-enhanced (DCE)-MRI.', 'timeFrame': '2 years'}]" 195,NCT02054104,"{'fullName': 'National Institutes of Health Clinical Center (CC)', 'class': 'NIH'}","Adjuvant Tumor Lysate Vaccine and Iscomatrix With or Without Metronomic Oral Cyclophosphamide and Celecoxib in Patients With Malignancies Involving Lungs, Esophagus, Pleura, or Mediastinum",TERMINATED,"Background: During recent years, cancer-testis (CT) antigens (CTA), particularly those encoded by genes on the X chromosome (CT-X genes), have emerged as attractive targets for cancer immunotherapy. Whereas malignancies of diverse histologies express a variety of CTAs, immune responses to these proteins appear uncommon in cancer patients, possibly due to low-level, heterogeneous antigen expression, as well as immunosuppressive regulatory T cells present within tumor sites and systemic circulation of these individuals. Conceivably, vaccination of cancer patients with tumor cells expressing high levels of CTAs in combination with regimens that deplete or inhibit T regulatory cells will induce broad immunity to these antigens. In order to examine this issue, patients with primary lung and esophageal cancers, pleural mesotheliomas, thoracic sarcomas, thymic neoplasms and mediastinal germ cell tumors, as well as sarcomas, melanomas, germ cell tumors, or epithelial malignancies metastatic to lungs, pleura or mediastinum with no evidence of disease (NED) or minimal residual disease (MRD) following standard multidisciplinary therapy will be vaccinated with H1299 tumor cell lysates with Iscomatrix adjuvant. Vaccines will be administered with or without metronomic oral cyclophosphamide (50 mg by mouth (PO) twice a day (BID) x 7day (d) every (q) 14d), and celecoxib (400 mg PO BID). Serologic responses to a variety of recombinant CTAs as well as immunologic responses to autologous tumor or epigenetically modified autologous Epstein-Barr virus (EBV) transformed lymphocytes will be assessed before and after a six month vaccination period. Primary Objectives: 1\. To assess the frequency of immunologic responses to CTAs in patients with thoracic malignancies following vaccinations with H1299 cell lysate/Iscomatrix(TM) vaccines alone in comparison to patients with thoracic malignancies following vaccinations with H1299 cell lysate/Iscomatrix vaccines in combination with metronomic cyclophosphamide and celecoxib. Secondary Objectives: 1. To examine if oral metronomic cyclophosphamide and celecoxib therapy diminishes the number and percentage of T regulatory cells and diminishes activity of these cells in patients with thoracic malignancies are at risk of recurrence. 2. To examine if H1299 cell lysate/Iscomatrix(TM) vaccination enhances immunologic response to autologous tumor or epigenetically modified autologous EBV-transformed lymphocytes (B cells). Eligibility: * Patients with histologically or cytologically proven small cell or non-small cell lung cancer (SCLC;NSCLC), esophageal cancer (EsC), malignant pleural mesothelioma (MPM), thymic or mediastinal germ cell tumors, thoracic sarcomas, or melanomas, sarcomas, or epithelial malignancies metastatic to lungs, pleura or mediastinum who have no clinical evidence of active disease (NED), or minimal residual disease (MRD) not readily accessible by non-invasive biopsy or resection/radiation following standard therapy completed within the past 26 weeks. * Patients must be 18 years or older with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2. * Patients must have adequate bone marrow, kidney, liver, lung and cardiac function. * Patients may not be on systemic immunosuppressive medications at time vaccinations commence. Design: * Following recovery from surgery, chemotherapy, or chemo/radiotherapy (XRT), patients with NED or MRD will be vaccinated via IM injection with H1299 cell lysates and Iscomatrix(TM) adjuvant monthly for 6 months. * Vaccines will be administered with or without with metronomic oral cyclophosphamide and celecoxib. * Systemic toxicities and immunologic response to therapy will be recorded. Pre and post vaccination serologic and cell mediated responses to a standard panel of CT antigens as well as autologous tumor cells (if available) and EBV-transformed lymphocytes will be assessed before and after vaccination. * Numbers/percentages and function of T regulatory cells in peripheral blood will be assessed before, during, and after vaccinations. * Patients will be followed in the clinic with routine staging scans until disease recurrence. * The trial will randomize 28 evaluable patients per arm to either receive vaccine alone or vaccine plus chemotherapy in order to have 80% power to determine if the frequency of immune responses on the combination arm exceeds that of the vaccine alone arm, if the expected frequencies of immune responses on the two arms were 20% and 50%, using a one-sided 0.10 alpha level Fisher's exact test. * Approximately 60 patients will be accrued to this trial.","['Thoracic Sarcomas', 'Thorasic Cancers', 'Cancers of Non-thoracic Origin With Metastases to the Lungs or Pleura', 'Sarcoma', 'Melanoma']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'H1299 cell lysates', 'description': 'H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED).', 'armGroupLabels': ['1/Vaccine Plus Chemotherapy', '2/Vaccine Alone']}, {'type': 'DRUG', 'name': 'Cyclophosphamide', 'description': '50 mg by mouth (PO) twice a day (BID) for 7 days prior to the first dose of vaccine and then on days 8 through 14, and 22 through 28 of each treatment cycle.', 'armGroupLabels': ['1/Vaccine Plus Chemotherapy'], 'otherNames': ['Cytoxan']}, {'type': 'DRUG', 'name': 'Celecoxib', 'description': '400 mg by mouth (PO) twice a day (BID) for 7 days prior to the first dose of vaccine and then on days 1 through 28 of each treatment cycle.', 'armGroupLabels': ['1/Vaccine Plus Chemotherapy'], 'otherNames': ['Celebrex']}, {'type': 'BIOLOGICAL', 'name': 'Iscomatrix adjuvant', 'description': 'H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and no clinical evidence of active disease (NED).', 'armGroupLabels': ['1/Vaccine Plus Chemotherapy', '2/Vaccine Alone']}]","-INCLUSION CRITERIA: 1. Patients with histologically or cytologically proven lung or esophageal cancers, thymic or mediastinal germ cell tumors, malignant pleural mesotheliomas, or primary thoracic sarcomas, as well as patients with sarcomas, melanomas, germ cell tumors, or epithelial malignancies metastatic to the lungs, mediastinum, or pleura that have no clinical evidence of active disease (NED) or minimal residual disease (MRD) not readily accessible by non-invasive biopsy or resection/radiation following standard therapy. 2. Diagnosis must be confirmed by the National Cancer Institute (NCI) Laboratory of Pathology. 3. Patients must be enrolled within 56 weeks following completion of therapy. 4. Patients must have completed standard therapy for their malignancy and recovered from all toxicities to less than or equal to Grade 2 within 3 weeks prior to enrollment. 5. Patients with intracranial metastases, which have been treated by surgery or radiation therapy, may be eligible for study provided there is no evidence of active disease and no requirement for anticonvulsant therapy or steroids following treatment. 6. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 7. Patients must be 18 years of age or older due to the unknown effects of immunologic responses to this vaccine during childhood and adolescent development. 8. Patients must have evidence of adequate bone marrow reserve, hepatic and renal function as evidenced by the following laboratory parameters: * Absolute neutrophil count greater than 1500/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 8g/dl (patients may receive transfusions to meet this parameter) * Prothrombin (PT) within 2 seconds of the upper limit of normal (ULN) * Total bilirubin \<1.5 x upper limits of normal * Serum creatinine less than or equal to 1.6 mg/ml or the creatinine clearance must be greater than 70 ml/min/1.73m\^2. 9. Seronegative for human immunodeficiency virus (HIV) antibody. Note: The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who are HIV seropositive may have decreased immune competence and thus may be less responsive to the experimental treatment. 10. Seronegative for active hepatitis B, and seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patient must be tested for the presence of antigen by reverse transcription polymerase chain reaction (RT-PCR) and be hepatitis C virus (HCV) ribonucleic acid (RNA) negative. 11. The effects of the study treatment on the developing human fetus are unknown; thus, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) within 28 days prior to study entry, for the duration of study participation and up to 120 days after the last dose of the drug. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 12. Patients must be willing to sign an informed consent. 13. Ability and willingness to co-enroll on the screening and tissue collection protocol 06C0014, 'Prospective Evaluation of Genetic and Epigenetic Alterations in Patients with Thoracic Malignancies'. EXCLUSION CRITERIA: 1. Patients who are initially rendered no clinical evidence of active disease (NED) or have minimal residual disease (MRD) following standard therapy but exhibit disease progression prior to initiation of vaccination will be excluded from the study. 2. Patients requiring chronic systemic treatment with steroids will be excluded. 3. Patients receiving warfarin anticoagulation, who cannot be transitioned to other agents such as enoxaparin or dabigatran, and for whom anticoagulants cannot be held for up to 24 hours will be excluded. 4. Patients with uncontrolled hypertension (\>160/95), unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated congested heart failure (CHF) (\>New York Heart Association (NYHA) Class II), or myocardial infarction within 6 months of study will be excluded. 5. Patients with other cardiac diseases may be excluded at the discretion of the PI following consultation with Cardiology consultants. 6. Patients with any of the following pulmonary function abnormalities will be excluded: forced expiratory volume (FEV), \< 30% predicted; carbon monoxide (DLCO) \< 30% predicted (post-bronchodilator); oxygen saturation less than 92% on room air. 7. Female patients who are pregnant or breastfeeding. Because there is unknown, potentially harmful effects of immune response to CT-X antigens and stem cell proteins that may be expressed in placenta, fetus, and neonates. 8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations 3 months prior to enrollment that would limit compliance with study requirements.",NA,ALL,NA,"[{'measure': 'Number of Participants With an Immunologic Responses', 'description': 'Immunologic responses are defined as an appearance of new serologic reactivity, or increase in existing antibody response to cancer-testis on the X chromosome (CT-X) antigen. Antigens such as New York esophageal squamous cell carcinoma-1 (NY-ESO1) and melanoma antigen gene (MAGE) family members assessed by enzyme-linked immunosorbent assay (ELISA) one month after the 6th vaccine.', 'timeFrame': 'one month after the 6th vaccine'}]","[{'measure': 'Fold Change From Baseline of Intensity of Programmed Cell Death Protein 1(PD-1) Expression on Tregs', 'description': 'The Mann=Whitney U test was used to compare the fold change of intensity of PD-1 expression on Tregs between the two groups. A decrease in the fold change is consistent with a better outcome. The difference, or the relative difference, in the values at the two time points were obtained and tested to determine if the difference is equal to zero. If a paired t-test is able to be used, with at least 20 evaluable participants, there is 81% power to detect a change equal to ¾ of a standard deviation of the change at the two-sided 0.025 significance level. This was done in order to allow for a conservative adjustment due to determining the significance of the change in the percent of Tregs on two arms.', 'timeFrame': 'one month after first 6 vaccinations'}, {'measure': 'Fold Change From Baseline of Percent Tregs', 'description': 'The Mann-Whitney U test was used to compare the fold change of percent Tregs between the two groups. A decrease in the fold change is consistent with a better outcome. The difference, or the relative difference, in the values at the two time points were obtained and tested to determine if the difference is equal to zero. If a paired t-test is able to be used, with at least 20 evaluable participants, there is 81% power to detect a change equal to ¾ of a standard deviation of the change at the two-sided 0.025 significance level. This was done in order to allow for a conservative adjustment due to determining the significance of the change in the percent of Tregs on two arms.', 'timeFrame': 'one month after first 6 vaccinations'}]" 196,NCT02320058,"{'fullName': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}","An Investigational Immuno-therapy Study to Evaluate Safety and Effectiveness in Patients With Melanoma That Has Spread to the Brain, Treated With Nivolumab in Combination With Ipilimumab, Followed by Nivolumab by Itself",COMPLETED,This is a study of Nivolumab combined with Ipilimumab followed by Nivolumab by itself for the treatment of patients with Melanoma that has spread to the brain. Patients with histologically confirmed Malignant Melanoma and asymptomatic brain metastases are eligible for the study.,['Melanoma'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Ipilimumab', 'armGroupLabels': ['Nivolumab and Ipilimumab'], 'otherNames': ['Yervoy']}, {'type': 'DRUG', 'name': 'Nivolumab', 'armGroupLabels': ['Nivolumab and Ipilimumab'], 'otherNames': ['Opdivo', 'BMS-936558']}]","For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: 1\. Target Population 1. Histologically confirmed malignant melanoma with measurable metastases in the brain. Both asymptomatic and symptomatic patients. 2. Cohort A (asymptomatic patients): At least 1 measurable brain metastasis ≥ 0.5 cm in and ≤ 3 cm in longest diameter that has not been previously irradiated. No clinical requirement for local intervention (surgery, radiosurgery, corticosteroid therapy) or other systemic therapy Cohort B (symptomatic patients): Subjects with neurologic signs and symptoms related to metastatic brain lesions are eligibile. Subjects must have at least 1 measurable brain metastasis ≥ 0.5 cm in and ≤ 3 cm in longest diameter that has not been previously irradiated. No immediate requirement (within 3 weeks prior to first treatment) for local intervention (surgery, radiosurgery, corticosteroid therapy). Steroid use is permitted as defined in the protocol. 3. Prior stereotactic radiotherapy (SRT) and prior excision of up to 3 melanoma brain metastases is permitted if there has been complete recovery, with no neurologic sequelae, and measurable lesions remain. Growth or change in a lesion previously irradiated will not be considered measurable. Regrowth in cavity of previously excised lesion will not be considered measurable. lesions or prior excision must have occurred ≥ 3 weeks before the start of dosing for this study 4. Must have tumor tissue available for biomarker analysis. Biopsy should be excisional, incisional, punch, or core needle 5. Cohort A (asymptomatic): Subjects must be free of neurologic signs and symptoms related to metastatic brain lesions and must not have required or received systemic corticosteroid therapy within 10 days prior to first treatment. Cohort B (symptomatic): Subjects with neurologic signs and symptoms related to metastatic brain lesions are eligible per Amendment 02. Subjects with neurologic signs and symptoms may be treated with a total daily dose of no more than 4 mg of dexamethasone that is stable or tapering for 10 days prior to first treatment. Subjects with neurologic signs and symptoms who are not being treated with steroids are eligible for Cohort B and should have no experience of seizure within 10 days prior to first treatment. 6. Allowable prior therapy: 1. Approved adjuvant therapies, which may include molecularly-targeted agents, IFN α, and ipilimumab. Patients who received ipilimumab as adjuvant therapy must have a 6 month washout before receiving any dosing on this study 2. For advanced disease, interleukin-2 at any dose and/or IFN-α (any formulation, no washout required); MEK and BRAF inhibitors: washout for at least 4 weeks prior to the start of dosing in this study 3. Steroids for physiological replacement are allowed. 7. Cohort A (asymptomatic): ECOG performance status ≤1 Cohort B (symptomatic): ECOG performance status ≤2 Exclusion Criteria: 2\. Target Disease Exceptions 1. History of known leptomeningeal involvement (lumbar puncture not required) 2. Previous stereotactic or highly conformal radiotherapy within 3 weeks before the start of dosing for this study. Note the stereotactic radiotherapy field must not have included the brain index lesion(s) 3. Brain lesions \>3 lesions which were previously treated with SRT 4. Brain lesion size \> 3cm 3. Medical History and Concurrent Diseases a) History of whole brain irradiation b) Subjects with an active, known or suspected autoimmune disease c) Subjects with major medical, neurologic or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolled d) Any concurrent malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix. For any prior invasive malignancy, at least 5 years must have elapsed since curative therapy and patients must have no residual sequelae of prior therapy e) Cohort A (asymptomatic): The use of corticosteroids is not allowed within 10 days prior to first treatment (based upon 5 times the expected half life of dexamethasone) except patients who are taking steroids for physiological replacement. If alternative corticosteroid therapy has been used, consultation with the sponsor Medical Monitor is required to determine the washout period prior to initiating study treatment Cohort B (symptomatic): Subjects with neurologic sign and symptoms related to brain metastases who are being treated with a total daily dose of higher than 4 mg dexamethasone or equivalent within 10 prior to the start of treatment with study drug are excluded. 4\. Physical and Laboratory Test Findings 1. Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection 2. Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) even if fully immunocompetent on ART-due to the unknown effects of HIV on the immune response to combined nivolumab plus ipilimumab or the unique toxicity spectrum of these drugs in patients with HIV 5\. Allergies and Adverse Drug Reaction a) History of allergy to study drug components b) History of severe hypersensitivity reaction to any monoclonal antibody 6\. Other Exclusion Criteria 1. Prisoners or subjects who are involuntarily incarcerated 2. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness Eligibility criteria for this study have been carefully considered to ensure the safety of the study subjects and that the results of the study can be used. It is imperative that subjects fully meet all eligibility criteria Other protocol defined inclusion/exclusion criteria could apply",NA,ALL,NA,"[{'measure': 'Intracranial Clinical Benefit Rate (CBR)', 'description': 'Intracranial Clinical Benefit Rate (CBR) is defined as the percentage of all treated participants whose best overall response is either a complete response (CR) or partial response (PR) or whose best overall response was Stable Disease (SD) with duration of \\>6 months, as determined by modified RECIST 1.1 criteria for index intracranial lesions based on investigator review.', 'timeFrame': 'Up to 66 months'}]","[{'measure': 'Intracranial Objective Response Rate (ORR)', 'description': 'Investigator-Assessed Intracranial Objective Response Rate (ORR) per modified RECIST 1.1 criteria is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants.', 'timeFrame': 'Up to 66 months'}, {'measure': 'Intracranial Progression Free Survival (PFS)', 'description': 'Intracranial progression-free survival (PFS) per modified RECIST 1.1 criteria is defined as the time between the date of first dose of study drug and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Participant who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die will be censored on the date of first dose of study drug. Participants who started anti-cancer therapy without a prior reported progression will be censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.', 'timeFrame': 'Up to 66 months'}, {'measure': 'Extracranial Clinical Benefit Rate (CBR)', 'description': 'Extracranial Clinical Benefit Rate (CBR) is defined as the percentage of all treated participants whose best overall response is either a complete response (CR) or partial response (PR) or whose best overall response was Stable Disease (SD) with duration of \\>6 months, as determined by RECIST 1.1 criteria for index extracranial lesions based on investigator review.', 'timeFrame': 'Up to 66 months'}, {'measure': 'Extracranial Objective Response Rate (ORR)', 'description': 'Extracranial Objective Response Rate (ORR) per RECIST 1.1 criteria is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants.', 'timeFrame': 'Up to 66 months'}, {'measure': 'Extracranial Progression Free Survival (PFS)', 'description': 'Extracranial progression-free survival (PFS) per RECIST 1.1 criteria is defined as the time between the date of first dose of study drug and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Participant who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die will be censored on the date of first dose of study drug. Participants who started anti-cancer therapy without a prior reported progression will be censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.', 'timeFrame': 'Up to 66 months'}, {'measure': 'Global Clinical Benefit Rate (CBR)', 'description': 'Investigator-assessed global (intracranial + extracranial) clinical benefit rate (CBR) per a combination of modified RECIST 1.1 criteria for intracranial lesions and RECIST 1.1 for extracranial disease is defined as the percentage of all treated participants whose best overall response is either a complete response (CR) or partial response (PR) or whose best overall response was Stable Disease (SD) with duration of \\>6 months', 'timeFrame': 'Up to 66 months'}, {'measure': 'Global Objective Response Rate (ORR)', 'description': 'Investigator-assessed global objective response rate (ORR) per a combination of modified RECIST 1.1 criteria for intracranial lesions and RECIST 1.1 for extracranial disease is defined as the number of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR) divided by the number of treated participants.', 'timeFrame': 'Up to 66 months'}, {'measure': 'Global Progression Free Survival (PFS)', 'description': 'Investigator-assessed global progression free survival (PFS) per a combination of modified RECIST 1.1 criteria for intracranial lesions and RECIST 1.1 for extracranial disease is defined as the time between the date of first dose of study drug and the first date of documented progression, as determined by the investigator, or death due to any cause, whichever occurs first. Participant who die without a reported progression will be considered to have progressed on the date of their death. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. Participants who did not have any on study tumor assessments and did not die will be censored on the date of first dose of study drug. Participants who started anti-cancer therapy without a prior reported progression will be censored on the date of their last evaluable tumor assessment prior to the initiation of subsequent anti-cancer therapy.', 'timeFrame': 'Up to 66 months'}, {'measure': 'Overall Survival (OS)', 'description': 'Overall Survival (OS) is defined as the time from the date of the start of treatment until the date of death. For participants who have not died, OS will be censored at the recorded last date of participant contact, and participants with a missing recorded last date of contact will be censored at the last date the participant was known to be alive.', 'timeFrame': 'Up to 66 months'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'description': 'Number of participants with any grade of adverse events (AEs) and any grade of serious adverse events (SAEs) graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE v4.0)', 'timeFrame': 'From first dose to 30 days post last dose (Up to 66 months)'}, {'measure': 'Number of Participants Deaths', 'description': 'Number of participants who died due to any cause.', 'timeFrame': 'Up to 66 months'}, {'measure': 'Number of Participants With Laboratory Abnormalities in Specific Liver Tests', 'description': 'Number of participants with laboratory abnormalities in specific liver tests based on US conventional units to determine the safety and tolerability of Nivolumab and Daratumumab. The number of participants with the following laboratory abnormalities from on-treatment evaluations will be summarized:\n\n* ALT or AST \\> 3 x ULN, \\> 5 x ULN, \\> 10 x ULN and \\> 20 x ULN\n* Total bilirubin \\> 2 x ULN\n* Concurrent (within 1 day) ALT or AST \\> 3 x ULN and total bilirubin \\> 2 x ULN\n* Concurrent (within 30 days) ALT or AST \\> 3 x ULN and total bilirubin \\> 2 x ULN', 'timeFrame': 'From first dose to 30 days post last dose (Up to 66 months)'}, {'measure': 'Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests', 'description': 'Number of participants with laboratory abnormalities in specific thyroid tests based on US conventional units to determine the safety and tolerability of Nivolumab and Daratumumab. The number of subjects with the following laboratory abnormalities from on-treatment evaluations will be summarized:\n\n* TSH value \\> ULN and\n* with baseline TSH value \\<= ULN\n* with at least one FT3/FT4 test value \\< LLN within 2-week window after the abnormal TSH test\n* with all FT3/FT4 test values \\>= LLN within 2-week window after the abnormal TSH test\n* with FT3/FT4 missing within 2-week window after the abnormal TSH test.\n* TSH \\< LLN and\n* with baseline TSH value \\>= LLN\n* with at least one FT3/FT4 test value \\> ULN within 2-week window after the abnormal TSH test\n* with all FT3/FT4 test values \\<= ULN within 2-week window after the abnormal TSH test\n* with FT3/FT4 missing within 2-week window after the abnormal TSH test', 'timeFrame': 'From first dose to 30 days post last dose (Up to 66 months)'}]" 197,NCT02107755,"{'fullName': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}",Stereotactic Radiation Therapy and Ipilimumab in Treating Patients With Metastatic Melanoma,COMPLETED,"This phase II trial studies the effectiveness of the combination of stereotactic radiation therapy and ipilimumab in patients with metastatic melanoma that has spread to four or fewer sites in the body (oligometastatic). Stereotactic radiation therapy is a type of external beam radiation therapy that uses special equipment to position the patient and precisely give a either a single large dose of radiation therapy to a tumor or several large doses of radiation therapy to a tumor using precision and accuracy that is guided by onboard daily imaging prior to radiation therapy. Monoclonal antibodies, such as ipilimumab, can block tumor growth in different ways. Some monoclonal antibodies find tumor cells and help kill them or carry tumor-killing substances to them. Giving stereotactic radiosurgery together with ipilimumab may kill more tumor cells by causing addition melanoma antigens to be presented to the immune system.","['Liver Metastases', 'Lung Metastases', 'Recurrent Melanoma', 'Stage IV Melanoma', 'Tumors Metastatic to Brain']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'ipilimumab', 'description': 'Given IV', 'armGroupLabels': ['Treatment (ipilimumab, stereotactic radiosurgery)'], 'otherNames': ['anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody', 'MDX-010', 'MDX-CTLA-4', 'monoclonal antibody CTLA-4']}, {'type': 'RADIATION', 'name': 'stereotactic radiosurgery', 'description': 'Undergo stereotactic radiosurgery', 'armGroupLabels': ['Treatment (ipilimumab, stereotactic radiosurgery)']}, {'type': 'OTHER', 'name': 'laboratory biomarker analysis', 'description': 'Blood and tissue samples will be collected for research purposes.', 'armGroupLabels': ['Treatment (ipilimumab, stereotactic radiosurgery)']}]","Inclusion Criteria: * Willing and able to give written informed consent * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Histologic diagnosis of melanoma with metastatic disease to a visceral organ (lung, liver, brain, adrenal, nodal station outside the regional lymph drainage of the primary, vertebral bodies) * 1-3 sites of metastatic disease able to be targeted by SABR * White blood cells (WBC) \>= 2000/uL * Absolute neutrophil count (ANC) \>= 1000/uL * Platelets \>= 75 x 10\^3/uL * Hemoglobin \>= 9 g/dL (\>= 80 g/L; may be transfused) * Creatinine =\< 2.0 x upper limit of normal (ULN) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x ULN for patients without liver metastasis, =\< 5 times for liver metastases * Bilirubin =\< 2.0 x ULN, (except patients with Gilbert's syndrome, who must have a total bilirubin less than 3.0 mg/dL) * No active or chronic infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C * Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 26 weeks after the last dose of investigational product, in such a manner that the risk of pregnancy is minimized * WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not post-menopausal; post-menopause is defined as: * Amenorrhea \>= 12 consecutive months without another cause, or * For women with irregular menstrual periods and taking hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level \>= 35 mIU/mL * Women who are using oral contraceptives, other hormonal contraceptives (vaginal products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (eg, vasectomy) should be considered to be of childbearing potential * WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours before the start of ipilimumab * Men of fathering potential must be using an adequate method of contraception to avoid conception throughout the study (and for up to 26 weeks after the last dose of investigational product) in such a manner that the risk of pregnancy is minimized Exclusion Criteria: * Any other malignancy from which the patient has been disease-free for less than 3 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix * Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], systemic lupus erythematosus, autoimmune vasculitis \[eg, Wegener's Granulomatosis\]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and Myasthenia Gravis) * Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of ipilimumab hazardous or obscure the interpretation of adverse events (AEs), such as a condition associated with frequent diarrhea * Any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month before or after any dose of ipilimumab) * A history of prior treatment with ipilimumab or prior cluster of differentiation (CD)137 agonist or cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitor or agonist * A history of prior treatment with anti-programmed death (PD)-1 or anti-PD-L1 antibodies * Concomitant therapy with any of the following: interleukin (IL)-2, interferon, other non-study immunotherapy regimens, cytotoxic chemotherapy, other investigation therapies * Concomitant therapy with immune-suppressants or chronic use of systemic corticosteroids * Must be off prior systemic therapies for 2 weeks prior to enrollment; patients that have been previously treated with systemic therapy adjuvantly or for metastatic disease remain eligible as long as they continue to meet all other eligibility criteria (oligometastatic, no visceral metastasis \> 5 cm, eligible for SABR) * Prior radiation therapy that at the treating physician's discretion makes SABR unsafe * No evidence of pleural effusion or ascites * Congestive heart failure \> class II New York Heart Association (NYHA) or unstable angina * Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * Major surgery, open biopsy or significant traumatic injury within 2 weeks of first dose of study drug * A visceral metastasis greater than 5 cm * A visceral metastasis that due to its location cannot be safely treated with SABR * Women of childbearing potential (WOCBP), defined above who: * Are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for their entire study period and for at least 8 weeks after cessation of study drug, or * Have a positive pregnancy test at baseline, or * Are pregnant or breastfeeding * Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious) illness * Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study drug, or excipients or to dimethyl sulfoxide (DMSO) * Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 8 weeks after ipilimumab is stopped * Sexually active WOCBP must use an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized; before study enrollment, WOCBP must be advised of the importance of avoiding pregnancy during study participation and the potential risk factors for an unintentional pregnancy; all WOCBP MUST have a negative pregnancy test before first receiving ipilimumab; if the pregnancy test is positive, the patient must not receive ipilimumab and must not be enrolled in the study",NA,ALL,NA,"[{'measure': 'Rate of Progression-free Survival by mWHO Criteria', 'description': 'Calculated along with corresponding 95% binomial confidence intervals. Kaplan-Meier curves will be used.', 'timeFrame': 'Time of study enrollment until the first documented date of disease progression, assessed up to 6 months'}]","[{'measure': 'Rate of Progression-free Survival by irRC Criteria', 'description': 'Calculated along with corresponding 95% binomial confidence intervals. Kaplan-Meier curves will be used.', 'timeFrame': 'Time of study enrollment until the first documented date of disease progression, assessed up to 6 months'}, {'measure': 'Number of Participants With Grade 3 and Grade 4 Toxicities According to Common Toxicity Criteria for Adverse Events (CTCAE) Version 4', 'description': 'Frequency and severity of adverse events and tolerability of the regimen in each of the patient groups will be collected and summarized by descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns.', 'timeFrame': 'Up to 90 days after the last ipilimumab infusion'}, {'measure': 'Frequency of Objective Response Rate, Defined as Complete Response + Partial Response, Measured by Computed Tomography (CT) Using mWHO Criteria', 'description': 'The response rate evaluated based on mWHO \\& irRC criteria', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Frequency of Objective Response Rate, Defined Using irRC', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Rate of Local Failure', 'timeFrame': 'Time of study enrollment until the first documented date of failure within the irradiated field, assessed up to 10 years'}, {'measure': 'Rate of Overall Survival', 'description': 'Kaplan-Meier curves will be used.', 'timeFrame': 'Time of study enrollment until the time of death, assessed up to 6 years'}]" 198,NCT00085189,"{'fullName': 'University of Southern California', 'class': 'OTHER'}",Vaccine Therapy in Treating Patients With Stage IIC-IV Melanoma,COMPLETED,This pilot phase II trial studies how well giving vaccine therapy works in treating patients with stage IIC-IV melanoma. Vaccines made from melanoma peptides or antigens may help the body build an effective immune response to kill tumor cells,"['Ciliary Body and Choroid Melanoma, Medium/Large Size', 'Ciliary Body and Choroid Melanoma, Small Size', 'Extraocular Extension Melanoma', 'Iris Melanoma', 'Metastatic Intraocular Melanoma', 'Mucosal Melanoma', 'Recurrent Intraocular Melanoma', 'Recurrent Melanoma', 'Stage IIC Melanoma', 'Stage IIIA Intraocular Melanoma', 'Stage IIIA Melanoma', 'Stage IIIB Intraocular Melanoma', 'Stage IIIB Melanoma', 'Stage IIIC Intraocular Melanoma', 'Stage IIIC Melanoma', 'Stage IV Intraocular Melanoma', 'Stage IV Melanoma']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'gp100 antigen', 'description': 'Given SC', 'armGroupLabels': ['Cohort I (melanoma peptide vaccine, Montanide ISA-51)', 'Cohort II (melanoma peptide vaccine, Montanide ISA 51 VG)'], 'otherNames': ['gp100']}, {'type': 'BIOLOGICAL', 'name': 'tyrosinase peptide', 'description': 'Given SC', 'armGroupLabels': ['Cohort I (melanoma peptide vaccine, Montanide ISA-51)', 'Cohort II (melanoma peptide vaccine, Montanide ISA 51 VG)'], 'otherNames': ['TYRP']}, {'type': 'BIOLOGICAL', 'name': 'recombinant MAGE-3.1 antigen', 'description': 'Given SC', 'armGroupLabels': ['Cohort I (melanoma peptide vaccine, Montanide ISA-51)', 'Cohort II (melanoma peptide vaccine, Montanide ISA 51 VG)'], 'otherNames': ['MAGE-3', 'MAGE-3.1', 'MAGEA3']}, {'type': 'BIOLOGICAL', 'name': 'multi-epitope melanoma peptide vaccine', 'description': 'Given SC', 'armGroupLabels': ['Cohort I (melanoma peptide vaccine, Montanide ISA-51)', 'Cohort II (melanoma peptide vaccine, Montanide ISA 51 VG)'], 'otherNames': ['MULTI-EP MP VAC']}, {'type': 'BIOLOGICAL', 'name': ""incomplete Freund's adjuvant"", 'description': 'Given SC', 'armGroupLabels': ['Cohort I (melanoma peptide vaccine, Montanide ISA-51)'], 'otherNames': ['IFA', 'ISA-51', 'Montanide ISA 51']}, {'type': 'DRUG', 'name': 'Montanide ISA 51 VG', 'description': 'Given SC', 'armGroupLabels': ['Cohort II (melanoma peptide vaccine, Montanide ISA 51 VG)']}, {'type': 'DRUG', 'name': 'agatolimod sodium', 'description': 'Given SC', 'armGroupLabels': ['Cohort I (melanoma peptide vaccine, Montanide ISA-51)', 'Cohort II (melanoma peptide vaccine, Montanide ISA 51 VG)'], 'otherNames': ['CpG 7909', 'PF-3512676']}, {'type': 'OTHER', 'name': 'laboratory biomarker analysis', 'description': 'Correlative studies', 'armGroupLabels': ['Cohort I (melanoma peptide vaccine, Montanide ISA-51)', 'Cohort II (melanoma peptide vaccine, Montanide ISA 51 VG)']}]","Inclusion Criteria: * Stages IIC, III and IV cutaneous, or mucosal melanoma or stages III/IV ocular melanoma that have been completely resected; those rendered disease-free by radiation or systemic chemotherapy and/or immune therapy will also be eligible; patients must be entered within 12 months of disease-free status * Patients must be positive for at least one of human leukocyte antigen (HLA) A1, A3/A11 typed by a standard deoxyribonucleic acid (DNA)-polymerase chain reaction (PCR) assay, and HLA-B44 status must be known; patients who are B44 positive but do not express A1, A3 or A11 are not eligible for this trial * Tumor tissue must be available for analysis of gp100 and tyrosinase expression by immunohistochemistry; positive staining for at least one antigen will be an eligibility criteria for this trial * Serum creatinine of 2.0 mg/dl or less * Total bilirubin of 2.0 mg/dl or less * Serum glutamic oxaloacetic transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) of 2.5 X institutional norm or less * Total white blood cell (WBC) of 3,000 or more * At least 1500 granulocytes * Hemoglobin of 9.0 gm/dl * Platelet count of 100,000 per cu mm * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Patients will be eligible for this trial if they have failed alpha-interferon, if it is felt to be contraindicated due to a pre-existing medical or psychiatric condition or if they have refused treatment with it * Ability to read, understand and willingness to sign an institutional review board (IRB)-approved informed consent Exclusion Criteria: * Who are undergoing or have undergone in the past month any other therapy for their cancer, including radiation therapy and adjuvant therapy; six weeks must have elapsed for nitrosoureas * Have major systemic infections like pneumonia or sepsis, coagulation or bleeding disorders, or other major medical illnesses of the gastrointestinal, cardiovascular or respiratory systems * Who require steroid therapy or have been treated with steroids within 4 weeks of starting the trial * Who are pregnant or lactating, since the risk of autoimmune reactivity to tyrosinase or gp100 is felt to present a risk to the fetus or a breast feeding infant * Who are known to be positive for hepatitis B surface antigen (BsAg), Hepatitis C antibody or human immunodeficiency virus (HIV) antibody; since cells removed for ex vivo handling and tissue culture cannot be virus positive, and the effects of 7909 might be detrimental to HIV positive patients, patients positive for the above viruses will not be treated on this trial * Who have had a known allergic reaction to Montanide ISA 51 or ISA 51 VG * Who have a prior history of uveitis, autoimmune inflammatory eye disease or other autoimmune diseases other than vitiligo or controlled thyroiditis * Who have had another malignancy within the last three years with the exception of squamous or basal carcinoma of the skin or carcinoma in situ of the cervix that have been treated with curative intent * Who have previously received any of the peptides in the vaccine",NA,ALL,NA,"[{'measure': 'Immunologic response defined as either an enzyme-linked immunosorbent spot (ELISPOT) response or a tetramer response for at least one peptide', 'timeFrame': '26 weeks'}]","[{'measure': 'Toxicities of the vaccine preparation graded using Common Toxicity Criteria (CTC)', 'description': 'Will be summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity (by CTC criteria and nadir or maximum values for the laboratory measures), time of onset (i.e. weeks from initial peptide vaccination), duration, and reversibility or outcome.', 'timeFrame': 'Up to 3 years'}, {'measure': 'Time to relapse', 'description': 'Will be summarized with Kaplan-Meier plots to describe the outcome of patients treated on this protocol - for each cohort separately. To evaluate the association between immune response and time to recurrence and overall survival, the landmark method (at 26 weeks, the time of the 2nd leukapheresis for immune assessment) will be used and Kaplan-Meier curves will be calculated and the logrank test statistic will be calculated to compare the outcome of patients with or without an immunologic response.', 'timeFrame': 'Up to 3 years'}, {'measure': 'Overall survival', 'description': 'Will be summarized with Kaplan-Meier plots to describe the outcome of patients treated on this protocol - for each cohort separately. To evaluate the association between immune response and time to recurrence and overall survival, the landmark method (at 26 weeks, the time of the 2nd leukapheresis for immune assessment) will be used and Kaplan-Meier curves will be calculated and the logrank test statistic will be calculated to compare the outcome of patients with or without an immunologic response.', 'timeFrame': 'Up to 3 years'}]" 199,NCT07691255,"{'fullName': 'European Institute of Oncology', 'class': 'OTHER'}",MELanoma Brain Metastasis Treated With CYberknife,NOT_YET_RECRUITING,"Melanoma is a type of cancer that can spread to the brain, making the disease harder to treat and worsening both survival and quality of life. In recent years, treatments have improved significantly thanks to advances in surgery, radiotherapy, immunotherapy, and targeted therapy. These new treatments have greatly increased survival rates for patients with metastatic melanoma. This study focuses on stereotactic radiosurgery, a highly precise form of radiotherapy used to treat brain metastases. Researchers want to better understand how this treatment works when combined with immunotherapy or targeted therapy, and whether the timing and sequence of treatments can improve outcomes. Between 2026 and 2028, patients treated at the IEO for melanoma brain metastases will be observed and their clinical data collected. The goal is to improve future treatment strategies and help doctors choose the best therapeutic approach for each patient.",['Melanoma (Skin Cancer)'],OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}",NA,"Inclusion Criteria: * Age \> 18 * Written informed consent for treatment and research purposes * Melanoma Brain Metastases (MBM) diagnosed with brain MRI/CT * MBM treatable with stereotactic radiotherapy * Systemic therapy (immunotherapy, target therapy, or both) is allowed, as concurrent or non-concurrent treatment with stereotactic radiotherapy Exclusion Criteria: * Leptomeningeal neoplastic infiltration * Previous whole-brain radiotherapy or surgical removal of brain metastases * Patients with histological diagnosis of non-cutaneous melanoma (e.g. uveal melanoma)","Patients receiving stereotactic radiotherapy for melanoma brain metastases as first local approach. Target therapy and immunotherapy in combination or not will be permitted. Given the descriptive nature of the study, no formal sample size calculation was performed. The planned sample size was predefined according to historical data from the RT Division and reflects the expected number of eligible patients treated at our institution over the planned three-year study period. Based on these data, we anticipate enrolling approximately 50 patients.",ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Intracranial in-field progression-free survival (IIFPFS)', 'description': 'The primary objective of the study is to estimate the 1-year intracranial in-field progression-free survival (IIFPFS). Based on results from a retrospective analysis conducted on patients treated at our institution, we expect a 1-year IIFPFS of approximately 57%. With a sample size of 50 patients, the 95% confidence interval (CI) for the 1-year IIFPFS is expected to have an approximate width of 27% (i.e. 43.5-70.5%).', 'timeFrame': 'From the end of radiotherapy through study completion, every three months.'}]","[{'measure': 'Overall survival (OS)', 'description': 'Defined as the time from the end of radiotherapy to death', 'timeFrame': 'From the end of radiotherapy through study completion, every three months.'}, {'measure': 'Progression-free survival (PFS)', 'description': 'Defined as the time from the end of radiotherapy to disease progression (either global intracranial or extracranial) or death, whichever occurred first.', 'timeFrame': 'From the end of radiotherapy through study completion, every three months.'}, {'measure': 'Intracranial out-field progression free survival (IOFPFS)', 'description': 'defined as the time from the end of radiotherapy to intracranial out-field progression', 'timeFrame': 'From the end of radiotherapy through study completion, every three months.'}, {'measure': 'Overall intracranial progression free survival (OIPFS)', 'description': 'defined as the time from the end of radiotherapy to the global intracranial progression', 'timeFrame': 'From the end of radiotherapy through study completion, every three months.'}, {'measure': 'Extracranial progression free survival (EPFS)', 'description': 'defined as the time from the end of radiotherapy to the extracranial progression', 'timeFrame': 'From the end of radiotherapy through study completion, every three months.'}, {'measure': 'Local control (LC)', 'description': 'Defined as the absence of local progression (complete response, partial response, or stable disease) at the last radiological assessment. The LC rate was calculated among evaluable lesions and reported as a proportion with its 95% confidence interval (CI).', 'timeFrame': 'From the end of radiotherapy through study completion, every three months.'}, {'measure': 'Adverse events', 'description': 'Stereotactic radiotherapy related adverse events according CTCAE V5.0 and data about radionecrosis will be systematically collected allong the follow up (every trhee months)', 'timeFrame': 'From the end of radiotherapy through study completion, every three months.'}, {'measure': 'Quality of Life data (QoL) - EORTC QLQ BN20', 'description': 'For EORTC QLQ BN20, 20 items will be completed (score 1-4)', 'timeFrame': 'From the baseline (start of radiotehrapy), to the end of study (12 months), every three months.'}, {'measure': 'Quality of Life data (QoL) - EORTC QLQ C30 questionnaires.', 'description': 'For EORTC QLQ C30, 30 items will be completed (score 1-4).', 'timeFrame': 'From the baseline (start of radiotehrapy), to the end of study (12 months), every three months.'}]" 200,NCT06280040,"{'fullName': 'Medical University of Vienna', 'class': 'OTHER'}",Longitudinal Follow-Up of Patients Treated With Hypofractionated Stereotactic Photon Radiotherapy Due to Uveal Melanoma,UNKNOWN,"The purpose of this study is to evaluate the incidence and severity of retinopathy and opticopathy one year after treatment with hypofractionated stereotactic photon radiotherapy due to uveal melanoma. Patients will be imaged before radiation, as well as 3, 6, 9 and 12 months after radiation using sonography funds photography, optical coherence tomography angiography, oximeter and microperimetry.",['Uveal Melanoma'],OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'DIAGNOSTIC_TEST', 'name': 'Clinical examination and multimodal ocular imaging', 'description': 'Imaging consists of sonography, fundus photography, oximeter, optical coherence tomography angiography, and Microperimetry.', 'armGroupLabels': ['Uveal Melanoma']}]","Inclusion Criteria: * Patients with newly diagnosed uveal melanoma, who will be treated with hypofractionated stereotactic photon radiotherapy as part of clinical routine. Exclusion Criteria: * unwillingness to participate in the study * severe media opacity","Patients with newly diagnosed uveal melanoma, who will be treated with hypofractionated stereotactic photon radiotherapy as part of clinical routine, will be included in the study.",ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Incidence and Severity of Retinopathy', 'description': 'Incidence and severity of retinopathy will be evaluated as non-perfusion areas on optical coherence tomography angiography', 'timeFrame': '1 year'}]","[{'measure': 'Incidence and Severity of Opticopathy', 'description': 'Incidence and severity of retinopathy will be evaluated on clinical examination and fundus photography', 'timeFrame': '1 year'}, {'measure': 'Functional Outcome', 'description': 'Functional outcome will be evaluated as mean retinal sensitivity.', 'timeFrame': '1 year'}, {'measure': 'Incidence and Severity of Retinopathy and Opticopathy in oximeter', 'description': 'Incidence and severity of retinopathy and opticopathy will be evaluated using oxygen saturation', 'timeFrame': '1 year'}]" 201,NCT00091689,"{'fullName': 'Pfizer', 'class': 'INDUSTRY'}",Safety and Efficacy of an Immune Response Modifier to Treat Inoperable Advanced Melanoma Skin Lesions,COMPLETED,"Study 1501-852A is a Phase 1 Study with the objective of determining safety and the highest tolerated dose of an immune response modifier cream directly applied to advanced, inoperable, melanoma skin lesions. The study will also measure blood levels of the drug and examine the potential anti-tumor activity of the cream.",['Melanoma'],INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': '852A'}]","Inclusion Criteria: * Have melanoma cutaneous metastasis or lentigo maligna melanoma unresectable and for which standard curative or palliative measures do not exist or are no longer effective. * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 * Have a life expectancy of 4 months * Have normal organ and bone marrow function Exclusion Criteria: * Need for non-steroidal anti-inflammatory drugs (NSAIDs) during the study * Have a body mass index (BMI)\> 30 kg/m2 * Have a history of, or clinical evidence of, myocardial ischemia, congestive heart failure, or myocardial arrhythmias requiring treatment within the past 6 months * Have uncontrolled intercurrent or chronic illness, but not limited to, ongoing or active infection such as hepatitis B or C, immune dysfunction such as autoimmune disease, endocrine dysfunction such as hypo- or hyperthyroidism, psychiatric illness such as depression or suicidal tendency or social situations that would limit compliance with study requirements * Have a history of disease requiring ongoing steroid treatment * Have a history of seizure disorder (other than febrile seizures in childhood) * Have a history of clinically significant coagulation or bleeding disorders or abnormalities * Are HIV positive. HIV positive subjects are excluded from the study because of possible interactions with the immunomodulatory effects of 852A and because of potential pharmacokinetic interactions associated with combination retroviral therapy.",NA,ALL,NA,NA,NA 202,NCT00518050,"{'fullName': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}","Health Behaviors, Surveillance, Psychosocial Factors, and Family Concerns",COMPLETED,The purpose of this study is to examine the health behaviors of melanoma survivors. We want to know about their thoughts and concerns. Melanoma is a type of skin cancer. The number of people being diagnosed with melanoma is growing. Many people who are diagnosed with melanoma are young. Little research has been done to find out how melanoma survivors feel years after they have been treated.,"['Melanoma', 'Survivors', 'Psychological Factors']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}","[{'type': 'BEHAVIORAL', 'name': 'Focus group', 'description': 'Conduct focus groups in melanoma survivors to enhance the understanding of the behavioral aspects of:\n\n* Screening, skin self-examination, sun protection, and other cancer preventive practices;\n* Cognitive factors (knowledge, awareness, melanoma worry, and perceived risk) related to screening and sun protection practices; and,\n* Impact of melanoma on quality of life, family relationships, and economic issues arising from treatment', 'armGroupLabels': ['Specific Aim 1- Focus Group']}, {'type': 'BEHAVIORAL', 'name': 'Survey', 'description': 'History of sun exposure Medical factors Affect, cognition, and quality of life Behavioral adoption Demographics Phenotypic factors Economic/healthcare factors', 'armGroupLabels': ['Specific Aim 2- Survey Study']}]","Inclusion Criteria: For the focus group recruitment (Specific Aim 1) - Patients with melanoma (invasive primary cutaneous melanoma, stages 1-III), who have been treated at MSKCC from 1996-2005 For the survey group recruitment (Specific Aim 2): patients with melanoma (invasive primary cutaneous melanoma, stages 1-III), who have been treated at MSKCC from 2001-2011• Ability to sign informed consent which indicates the psychosocial, behavioral, epidemiological nature of this study • Age ≥ or = to 18 years and fluent in the English language Exclusion Criteria: * Patients with intraepithelial (in situ) melanoma * Patients with stage IV melanoma * Patients with nodal or visceral melanoma without a documented primary lesion * Patients with prior malignancies For the focus group recruitment (Specific Aim 1): (patients treated at MSKCC from 1996-2005) who have a diagnosis \>10 years ago from treatment. For the survey group recruitment (Specific Aim 2): patients treated at MSKCC from 2001-2011)who have a diagnosis \>10 years ago from treatment. * Patients with a recent diagnosis of melanoma, \<12 months * Patients who are one year or more post diagnosis and are still receiving treatment for their melanoma",Eligible melanoma survivors will be initially identified and screened using the Melanoma DMT Database. We will select a random sample from the database.,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'This pilot study will provide baseline data to enhance our understanding of the behaviors of melanoma survivors.', 'timeFrame': '2 hours'}]","[{'measure': 'Conduct a pilot survey study of melanoma survivors to describe the behavioral and psychosocial issues in melanoma survivors. Results from the survey will enable us to obtain preliminary data in order to conduct a larger scale study.', 'timeFrame': 'half an hour'}]" 203,NCT03428126,"{'fullName': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}",Study of Durvalumab (MEDI4736) (Anti-PD-L1) and Trametinib (MEKi) in MSS Metastatic Colon Cancer,COMPLETED,"The goal of this clinical research study is to learn if durvalumab and trametinib can help to control microsatellite stable (MSS) colorectal cancer. The safety of these drugs will also be studied. This is an investigational study. Durvalumab is FDA approved and commercially available for the treatment of previously treated advanced bladder cancer. Trametinib is FDA approved in combination with another drug called dabrafenib for the treatment of unresectable or metastatic melanoma with BRAF V600E or BRAF V600K. It is investigational to use durvalumab and trametinib to treat MSS colorectal cancer. Up to 56 participants will be enrolled in this study. All will take part at MD Anderson.","['Malignant Neoplasms of Digestive Organs', 'Colorectal Cancer', 'Colon Cancer']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Durvalumab', 'description': 'Dose Escalation and Dose Expansion Dose: 1500 mg by vein every 4 weeks in a 28 day cycle.', 'armGroupLabels': ['Durvalumab + Trametinib'], 'otherNames': ['MEDI4736']}, {'type': 'DRUG', 'name': 'Trametinib', 'description': 'Dose Escalation Starting Dose: 2mg by mouth daily in a 28 day cycle.\n\nDose Expansion Dose: MTD from Dose Escalation.', 'armGroupLabels': ['Durvalumab + Trametinib'], 'otherNames': ['GSK1120212']}]","Inclusion Criteria: 1. Patients must have histologically or cytologically confirmed metastatic colorectal cancer. 2. Patients must have measurable disease per RECIST v1.1 criteria. 3. Patients must have had at least prior treatment with a fluoropyrimidine and either oxaliplatin or irinotecan. 4. Age \>/=18 years. Because no dosing or adverse event data are currently available on the use of this combination in patients \<18 years of age, children are excluded from this study. 5. Body weight \> 30kg. 6. Life expectancy of greater than 6 months. 7. ECOG performance status 0-1 (Karnofsky \>/=70%). 8. Patients must have normal organ and marrow function as defined below: - Leukocytes \>/=3,000/mcL, Absolute neutrophil count \>/=1,500/mcL, Hemoglobin \>/=9.0g/dL, Platelets \>/=75,000/mcL, Total bilirubin \< 1.5 X institutional normal limits (subjects with known Gilbert syndrome are eligible with total bilirubin \< 3.0 mg/dL), AST(SGOT)/ALT(SGPT) \ 40mL/min by Cockcroft-Gault or 24h urine collection. 9. Known MSS status by either IHC or PCR. Known or evaluable BRAF and KRAS status. 10. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal subjects. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: -- Women \<50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy). 11. Inclusion #10 cont'd -- Women \>/=50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \>1 year ago, had chemotherapy-induced menopause with last menses \>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy). 12. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately and will be removed from the study. 13. Ability to understand and the willingness to sign a written informed consent document. 14. Willingness to have 2 tumor biopsies; the first before and the second while on therapy (optional for all patients and may become mandatory in order to ensure 15 patients at MTD have paired biopsies). Exclusion Criteria: 1. Patients who have had chemotherapy within 2 weeks prior to first dose of study drug. 2. Any unresolved toxicity NCI CTCAE Grade \>/=2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria: -- Subjects with Grade \>/=2 neuropathy will be evaluated on a case-by-case basis after consultation with the Principal investigator.-- Subjects with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Principal investigator. 3. Patients may not be receiving any other investigational agents. 4. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of study medication. Note: Local surgery of isolated lesions for palliative intent is acceptable. 5. Patients with known brain metastases or leptomeningeal carcinomatosis will be excluded from this clinical trial. Patients with suspected brain metastases at screening should have an MRI (preferred) or CT each preferably with IV contrast of the brain prior to study entry. 6. Mean QT interval corrected for heart rate (QTc) \>/= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction. 7. History of pneumonitis or interstitial lung disease (ILD). 8. History of allogenic organ transplantation. 9. Subjects with active, known, or suspected autoimmune disease including patients with a history of inflammatory bowel disease (ulcerative colitis or Crohn's disease); patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic sclerosis \[scleroderma\], systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener's granulomatosis), and central nervous system or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome, myasthenia gravis, multiple sclerosis). Subjects with vitiligo, type I diabetes mellitus, Grave's disease, Hashimoto thyroiditis, psoriasis, and other mild autoimmune disease not requiring systemic treatment are permitted to enroll at the discretion of the investigator. 10. Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. 11. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Subjects, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP. 12. Prior exposure to T cell checkpoint inhibitor therapies. 13. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirements, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent. 14. History of active primary immunodeficiency. 15. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice for patients suspected of having active infection), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Subjects with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. 16. Female subjects who are pregnant or breastfeeding or male or female subjects of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of study medications. 17. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.",NA,ALL,NA,"[{'measure': 'Immune-related Best Overall Response Rate.', 'description': 'Best overall response rate (CR+PR) by immune-related response rate.', 'timeFrame': 'From Baseline to 2 years'}]","[{'measure': 'Progression Free Survival as Determined by irRC', 'description': 'The Kaplan-Meier method GraphPad software, V.8 was used for statistical analyses.', 'timeFrame': 'From Baseline to up to 2 years'}, {'measure': 'Overall Survival', 'description': 'The Kaplan-Meier method GraphPad software, V.8 was used for statistical analyses.', 'timeFrame': 'From Baseline to 2 years'}, {'measure': 'Disease Control Rate', 'description': 'Disease control rate (DCR) describes the percentage of patients with advanced cancer whose therapeutic intervention has led to a complete response, partial response, or stable disease.', 'timeFrame': 'From Baseline to 2 years.'}]" 204,NCT01288963,"{'fullName': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}","IL-2 ""SELECT"" Tissue Collection Protocol in Patients With Advanced Melanoma",COMPLETED,"The purpose of this study is to determine which participants with melanoma have a better response to IL-2 and to identify markers that may predict response to IL-2 by collecting participant information (for example; cancer diagnosis and history, prior treatments for cancer, etc.) blood and tumor samples prior to treatment and tumor measurements after treatment.",['Malignant Melanoma'],OBSERVATIONAL,"{'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'DRUG', 'name': 'IL-2', 'description': 'Observation only', 'armGroupLabels': ['IL-2 subjects'], 'otherNames': ['aldesleukin']}]","Inclusion Criteria: * Malignant melanoma that is metastatic or unresectable * Eligible to receive high-dose IL-2 * Tissue block available with adequate tumor to perform RNA extraction and DASL analysis Exclusion Criteria: * Prior immunotherapy for unresectable or metastatic disease * Untreated brain metastases, leptomeningeal disease, or seizure disorder",Subjects enrolled on DF/HCC Protocol 06-149,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'To determine if DASL subclassification can identify a group of patients with advanced melanoma who are significantly more likely to respond to high dose IL-2 based on therapy than the historical 16% response rate in an unselected patient population', 'timeFrame': '2 years'}]","[{'measure': 'To validate the usefulness of serum fibronectin and VEGF levels as negative predictors of response', 'timeFrame': '2 years'}, {'measure': 'To explore the predictive value of several genetic polymorphisms associated with immune function', 'timeFrame': '2 years'}, {'measure': 'To explore the predictive value of BRAF^V600E mutational status as a predictor of response and benefit to high dose IL-2', 'timeFrame': '2 years'}, {'measure': 'To explore the relationship of serum fibronectin and VEGF levels with the molecular signature of immune responsiveness in patients with advanced melanoma receiving high-dose IL-2 in order to identify specific cohorts with dramatic differences in response', 'timeFrame': '2 years'}, {'measure': 'To identify new proteins or patterns of gene expression that might be associated with high-dose IL-2 responsiveness in order to further narrow the application of IL-2 therapy to those who will benefit the most', 'timeFrame': '2 years'}]" 205,NCT00757614,"{'fullName': 'National Cancer Institute (NCI)', 'class': 'NIH'}","Study of Genes and Environment in Patients With Cancer in East Anglia, Trent, or West Midlands Regions of the United Kingdom",UNKNOWN,"RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This study is looking at genetic susceptibility to cancer and interactions between genes and the environment in patients with cancer in East Anglia, Trent, or West Midlands of the United Kingdom.","['Bladder Cancer', 'Brain and Central Nervous System Tumors', 'Esophageal Cancer', 'Intraocular Melanoma', 'Kidney Cancer', 'Lymphoma', 'Melanoma (Skin)', 'Pancreatic Cancer', 'Transitional Cell Cancer of the Renal Pelvis and Ureter']",OBSERVATIONAL,NA,"[{'type': 'GENETIC', 'name': 'DNA analysis'}, {'type': 'GENETIC', 'name': 'polymorphism analysis'}, {'type': 'OTHER', 'name': 'laboratory biomarker analysis'}, {'type': 'OTHER', 'name': 'questionnaire administration'}]","DISEASE CHARACTERISTICS: * Diagnosed with bladder cancer, kidney cancer, esophageal cancer, pancreatic cancer, brain cancer, malignant melanoma, or lymphoma within the past 5 years * Identified through the Cancer Research Network OR through the cancer registry serving any of the following geographic regions of the United Kingdom: * East Anglia * West Midlands * Trent PATIENT CHARACTERISTICS: * Identified by the patient's general practitioner as fit to contact for this study * No serious mental illness or retardation PRIOR CONCURRENT THERAPY: * Not specified",NA,ALL,NA,"[{'measure': 'Acquisition of epidemiological information and biological material'}, {'measure': 'Identification of novel cancer susceptibility genes'}, {'measure': 'Estimation of the age and sex-specific risks associated with variants in predisposition genes'}, {'measure': 'Evaluation of interactions between polymorphisms in predisposition genes and potential lifestyle risk factors'}]",NA 206,NCT01168050,"{'fullName': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}",Efficacy of Nilotinib in First or Second Line Treatment of Primary Melanomas Stage III Unresectable Melanomas.,UNKNOWN,"NILOMEL is a phase II multicentric uncontrolled open national trial assessing the efficacy of Nilotinib in first or second line treatment of primary melanomas , stage III unresectable melanomas, or Stage IV melanomas with c-KIT mutation or amplification. The primary objective is overall response rate (partial and complete response) according to RECIST 1.1 criteria, assessed using CT-SCAN (stage IV melanoma) or MRI (unresectable melanoma) after 6 months therapy with Nilotinib 800 mg/d. Secondary objectives include: * Disease control rate (complete, partial response and stable disease) * Metabolic response * Tolerance NCI CTCAE Version 3.0 * Biomarkers associated to response and disease control.","['Malignant Skin Melanoma T0', 'Stage III Melanoma', 'Stage IV Melanoma', 'Amplification']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Nilotinib', 'description': 'Nilotinib 400 mg twice per day', 'armGroupLabels': ['Nilotinib']}]","Inclusion Criteria: * Patients with histologically proven melanoma with either c-KIT mutation or C-KIT amplification (without BRAF or NRAS mutation) * Unresectable primary or stage III or stage IV melanoma * Measurable disease (RECIST) * The inclusion of patients with primary tumor or metastasis accessible to sequential biopsies will be favored. If such lesions are present, biopsies are mandatory and not optional * No more than 1 previous specific therapy excluding tyrosine kinase inhibitors. 4 weeks wash out will be needed after cytotoxic therapy , 12 weeks wash out after anti -CTLA4 therapy or any immunological treatment * No radiotherapy within 4 weeks ; previously irradiated lesion will not be considered as measurable unless progression at inclusion * ECOG performance status \< 2 * WBC ≥ 3,000/mm³ * PNN ≥ 1,500/mm³ (G-CSF allowed) * platelets ≥ 100,000/mm³ * Hb ≥ 9.0 g/dL ( transfusions allowed as well as recombinant erythropoetin) * Creatinin clearance \> 40ml/mn * Normal kalemia * Normal magnesemia * Total bilirubin \<1.5N ; ASAT and ALAT \<2.5N * PT/INR and PTT normal * NYHA class \< 3 * Signed Written Informed Consent * Affiliated to the National Health Insurance Exclusion Criteria: * Patients refusal * Age \< 18 years * Fertile women who do not want or cannot use effective contraception during the study and up to 8 weeks after the end of study * Women pregnant or nursing * Women with positive pregnancy test at inclusion or before treatment initiation * Fertile and sexually active men whose partner are fertile women who do not use effective contraception * Clinical and/or radiographic evidence of active cerebral metastases * Severe evolutive infection * Known HIV infection * Concomitant therapy with any other anti-cancer, immunomodulator or immunosuppressing agent or radiotherapy (except palliative care if bone metastases, after acceptance of principal investigator). * Previous use of tyrosine kinase inhibitors * More than one line of prior systemic therapies of melanoma by anti-cancer agent or immunotherapy. * Received experimental treatment within 4 weeks of inclusion * Pace-maker * Cardiac dysfunction, as evaluated by one of: * Ejection fraction \< 45% (less than 28 days from inclusion) * Congenital prolonged QT * QTc \> 450 ms * Ventricular tachyarrhythmia within the past 6 months * Bradycardia at rest \< 50/mn * Major conduction dysfunction * Myocardial infarction within the previous 6 months * Unstable angina * Uncontrolled hypertension * Digestive disease that may inhibited NILITINIB absorption * Concomitant medication that may increase QT * Taking CYP3A4 inhibitors * Eating Sevilla oranges (or Sevilla oranges derivates), grapefruit (or grapefruit juice), grapes (or grapes juice), pomegranate (or pomegranate juice) * Hereditary galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption.",NA,ALL,NA,"[{'measure': 'Objective response', 'description': 'Partial or complete response per Response Evaluation Criteria in Solid Tumors (RECIST).', 'timeFrame': '6 months'}]","[{'measure': 'Disease control', 'description': 'Complete or partial response or stable disease per Response Evaluation Criteria in Solid Tumors (RECIST).', 'timeFrame': '6 months'}, {'measure': 'Objective response', 'description': 'Partial or complete response per Response Evaluation Criteria in Solid Tumors (RECIST).', 'timeFrame': '3 months'}, {'measure': 'Metabolic response', 'description': 'Metabolic response as evaluated by TEP-SCAN', 'timeFrame': '6 months'}, {'measure': 'Tolerance', 'description': 'Tolerance will be evaluated according to National Cancer Institute (NCI) Criteria for Adverse Events, CTCAE v3.0', 'timeFrame': '1 year'}]" 207,NCT04223648,"{'fullName': 'Yale University', 'class': 'OTHER'}",Programmed Cell Death 1 + Selected Cell Therapy With Durvalumab (MEDI4736) and Tremelimumab in Metastatic Melanoma,WITHDRAWN,The primary objective of this pilot study is to assess the feasibility of mobilizing PD-1+ T cells to the peripheral blood after a single treatment with tremelimumab/durvalumab in patients with treatment naïve metastatic melanoma.,['Malignant Melanoma'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'tremelimumab/durvalumab, ipilimumab/nivolumab and nivolumab monotherapy', 'description': 'Subjects will receive 1 cycle of tremelimumab/durvalumab\n\n* Subjects will undergo resection to obtain tumor for generation of autologous tumor infiltrating lymphocytes (TIL) cultures and blood draw to obtain peripheral blood mononuclear cell (PBMC)s\n* TIL and PBMC will undergo immunoselection based on binding to an anti-programmed cell death 1 (PD-1) antibody and then will be expanded ex vivo.\n\nSubjects will receive 3 cycles of ipilimumab/nivolumab\n\n• Subjects will undergo staging with computer tomography (CT) chest/abdomen/pelvis and brain magnetic resonance imaging (MRI) or CT scan.\n\nsubjects with stable disease will continue with nivolumab monotherapy; Subjects with progressive disease will proceed to cell therapy.', 'armGroupLabels': ['Treatment']}]","Inclusion Criteria: Untreated metastatic melanoma * A metastatic lesion at least 1.5 cm in diameter that can be removed surgically * Measurable or evaluable disease not including the resected lesion; at least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 target lesion (TL) at baseline. Tumor assessment by computed tomography (CT) scan or magnetic resonance imaging (MRI) must be performed within 28 days prior to enrollment * Capable of giving signed informed consent * Age \>18 years at time of screening * Eastern Cooperative Oncology Group (ECOG) 0-1 * Body weight \>30 kg * Hemoglobin ≥9.0 g/dL * Absolute neutrophil count (ANC ≥1.0 x 109/L (\> 1000 per mm3) * Absolute lymphocyte count (ALC ≥0.5 x 109/L (\> 500 per mm3) Platelet count ≥100 (or 75) x 109/L (\>75,000 per mm3) * Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN). (This will not apply to patients with confirmed Gilbert's syndrome) * Aspartate aminotransferase (AST) (SGOT)/Alanine aminotransferase (ALT) (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN * Measured creatinine clearance (CL) \>40 mL/min or Calculated creatinine CL\>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance * Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply: * Women \<50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy). * Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \>1 year ago, had chemotherapy-induced menopause with last menses \>1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy). * Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up. * Must have a life expectancy of at least 12 weeks. Exclusion Criteria: Received prior treatment for metastatic melanoma * Received prior cell transfer therapy that included non-myeloablative or ablative chemotherapy * Received anti PD-1 immune therapy within prior 6 months * Any contraindication to neutropenia or thrombocytopenia for up to 2 weeks (no active major infection, no site of active, clinically significant bleeding) * Concurrent major medical illnesses * Any form of immunodeficiency * Severe hypersensitivity to any of the agents used in this study * Contraindications for IL-2 administration * Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) * Participation in another clinical study with an investigational product during the last 4 weeks * Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study * Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria * Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician. * Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab, tremelimumab, ipilimumab or nivolumab may be included only after consultation with the Study Physician. * Any concurrent chemotherapy, investigational product (IP), biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable. * Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable. * History of allogenic organ transplantation. * Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion: * Patients with vitiligo or alopecia * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement * Any chronic skin condition that does not require systemic therapy * Patients without active disease in the last 5 years may be included but only after consultation with the study physician * Patients with celiac disease controlled by diet alone * Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent * History of another primary malignancy except for * Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease * Adequately treated carcinoma in situ without evidence of disease * History of leptomeningeal carcinomatosis * History of active primary immunodeficiency * Active infection including tuberculosis (TB) (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B (HBV) (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. * Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab. The following are exceptions to this criterion: * Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection) * Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent * Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication) * Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP. * Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy or180 days after the last dose of durvalumab + tremelimumab combination therapy. * Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients. * Prior randomisation or treatment in a previous durvalumab and/or tremelimumab clinical study regardless of treatment arm assignment. * Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.",NA,ALL,NA,"[{'measure': 'PD1+ cell pharmacodynamic response in blood to tremelimumab/durvalumab treatment', 'description': 'PD response is achieved if a patient achieves either 1) a 30% increase in PD-1+ T cells in the peripheral blood in subjects who have a minimum of 25 cells/microliter (uL) 9 at baseline, or 2) an absolute increase of at least 75 PD-1+ T cells/uL in subjects who do not have a minimum of 25 PD-1+ T cells/uL at baseline.', 'timeFrame': 'up to 10 days post-enrollment.'}]","[{'measure': 'Safety including adverse events (AEs) and lab values', 'description': 'Grading of AEs and lab values will be according to Common Terminology Criteria for Adverse Events 5.0.', 'timeFrame': 'Up to 2 years post-enrollment.'}, {'measure': 'Overall response (OR)', 'description': 'OR will be assessed per Response Evaluation Criteria in Solid Tumors (RECIST 1.1)', 'timeFrame': 'Up to 5 years post-enrollment.'}]" 208,NCT01469455,"{'fullName': 'DNA Therapeutics', 'class': 'INDUSTRY'}",DNA Repair Inhibitor & Irradiation on Melanoma,COMPLETED,"Phase I trial will be conducted in patients suffering local metastatic melanoma with relapsed cutaneous/subcutaneous tumors including melanoma-in-transit. Based on the preclinical data package, DNA Therapeutics has considered that the risk-benefit ratio of DT01 supports the initiation of a phase I clinical study in this population. The recommended starting dose of DT01 for the first injection to human was based on NOAELs and Maximum Recommended Starting Dose (MRSD) calculations and by considering both local and systemic approaches. It was set at 16 mg (4 mg per injection site, 2 injections per tumor, 2 tumors to be treated). This starting dose will be increased up to 96 mg if no DLT occurred during dose escalation. DT01 will be locally administered by peritumoral subcutaneous and/or intratumoral injections in combination with hypo-fractionated radiotherapy (RT) (10x 3 Gy) and chloroquine (100 mg oral QD) starting one week before DT01 and RT treatments. DT01 will be administered 3 times a week during two weeks; The study will be an open, non-randomised, multicentre, phase I dose escalation (16, 32, 48, 64 and 96 mg) safety study with a 3+3 design. The purpose of this study will be to evaluate the safety, tolerance, pharmacokinetics of DT01 in association with palliative radiotherapy and to evaluate pharmacodynamics and the anti-tumor activity of DT01 according to RECIST criteria on day 26, 40 and 54. The duration of response (Time-To-Local Recurrence, TTLR), will be monitored 3, 6, 9 and 12 months after the beginning of the DT01 treatment.",['Local Metastatic Melanoma'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'DT01', 'description': 'DT01 starting dose will be 16 mg and it is planned to be increased to 32, 48 mg and 64 mg, or higher.\n\nDT01 will be administered 3 times a week (e.g., Mondays, Wednesdays and Fridays) over 2 weeks (6 administrations of DT01 in total) at least 3 hours prior to the radiotherapy sessions.', 'armGroupLabels': ['DT01']}]","Inclusion Criteria: * Patients with histologically confirmed metastatic melanoma with relapsed cutaneous tumors, including melanoma-in-transit, who are not eligible for immediate surgery or refractory to conventional treatment; * Patients with at least two measurable tumors of ≤ 4cm in largest diameter. Treated tumors must not be previously irradiated. The consideration of tumor size and number for the 5th and expansion cohorts can be revised based on the observation for the 4 first cohorts, in particular the initial indication of efficacy, after an agreement between Principal Investigators, the DSMB and the Sponsor. * Normal haematopoietic function as assessed by a complete blood count including differential count. i.Absolute neutrophil count ≥ 1.5 x 109/L; ii.Platelet count ≥ 100 x 109/L; iii.Haemoglobin ≥ 10 g/dL (transfusions are permitted); * No clinically relevant abnormalities in the results of the pre-study laboratory tests: i.Creatinine ≤ 1.5 times UNL (upper normal of the limit) ; ii.Bilirubin ≤ 1.5 times UNL; iii.ASAT (SGOT) ≤ 2.5 times the upper limit of normal if no liver metastasis and ≤ 5 times the upper limit of normal in the presence of liver metastasis ; iv.ALAT (SGPT) ≤ 2.5 times the upper limit of normal if no liver metastasis and ≤ 5 times the upper limit of normal in the presence of liver metastasis; * Age ≥18 years old; * The patient is willing and able to comply with the protocol for the duration of the study, including 1 day of hospitalization for PK sample at Day 1 and scheduled follow-up visits and examinations to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care. Exclusion Criteria: * Presence of any serious concomitant systemic disorders incompatible with the study (e.g. active infection); * Known or suspected Central Nervous System (CNS) metastases including leptomeningeal metastases (unless the patient has been previously treated and the patient meets the three following criteria: is asymptomatic, has no evidence of active CNS metastases for more than 3 months prior to enrollment, and has no requirement for steroids or enzyme-inducing anticonvulsants in the last 14 days); * Patients with a history of porphyria; * Patients with active psoriasis; * Clinically significant hepatic disease (particularly cirrhosis) or renal disease; * Severe gastrointestinal, neurological and blood disorders; * Patients receiving anti-vitamin K therapy within 10 days prior to first dose of study treatment (Low Molecular Weight Heparin (LMWH) therapy is allowed); * Anticancer therapy (chemotherapy, hormone therapy or immunotherapy) within 4 weeks prior to first dose of study treatment and immunotherapy with Ipilimumab, within 3 months prior to first dose of study treatment ; * Patients receiving cyclosporin within 10 days prior to first dose of study treatment; * Patients intended to receive any systemic anticancer therapy within 26 days (±2 days) from the anticipated date of the first administration of DT01 * Pregnant or breast-feeding women, or women of child-bearing potential unless effective methods of contraception are used. Child-bearing potential is defined as: i.Has experienced menarche, and ii.Has not undergone successful surgical sterilisation, and iii.Is not post-menopausal (amenorrhea \> 12 consecutive months or is on Hormone Replacement Therapy (HRT) with a documented plasma or serum FSH \> 35 IU/L. iv.Women using oral, implanted, injectable, mechanical or barrier products for the prevention of pregnancy, or who are practising abstinence, or where the partner is sterile (for example, a vasectomy) should be considered to be of child-bearing potential * Concomitant participation to another study; * Hypersensitivity to 4-aminoquinoline compounds (chloroquine) or to any of its derivatives; * HIV and Hepatitis B or C positive patients; * Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2 * Retinal or visual field changes attributable to previous chloroquine administration or any other etiology; * Any reason why, in the Investigator's opinion, the patient should not participate in the study. * Disease burden judged high, and therefore the patient can not likely benefit from the proposed treatment. * Significant coagulation abnormalities",NA,ALL,NA,"[{'measure': 'Tolerability and safety analysis, according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4 (NCI-CTCAE v4.0) criteria.', 'description': 'Tolerability and safety analysis, according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4 (NCI-CTCAE v4.0) criteria.', 'timeFrame': 'over a period of 54 days'}]","[{'measure': 'Profile of pharmacokinetics(PK)', 'description': '* Cmax The plasma peak concentration\n* tmax The time to reach the peak concentration\n* AUCt The area under the concentration-time curve from time zero to the last sample with the quantifiable concentration\n* AUC∞ The area under the concentration-time curve from time zero to infinity\n* t½ The terminal elimination half-life', 'timeFrame': 'pre-dose,1, 2.5, 4.5, 6.5, 9,24h post dose on Day 1, and pre-dose,4.5h post dose on Day 12'}]" 209,NCT05361174,"{'fullName': 'Iovance Biotherapeutics, Inc.', 'class': 'INDUSTRY'}",A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer,RECRUITING,This is a study to investigate the efficacy and safety of an infusion of IOV-4001 in adult participants with unresectable or metastatic melanoma or advanced non-small-cell lung cancer (NSCLC).,"['Unresectable Melanoma', 'Metastatic Melanoma', 'Stage III Non-small Cell Lung Cancer', 'Stage IV Non-small Cell Lung Cancer']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'IOV-4001', 'description': 'A tumor sample is resected from each participant and cultured ex-vivo to manufacture IOV-4001. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, participant is infused with IOV-4001, and followed by IL-2.', 'armGroupLabels': ['Cohort 1', 'Cohort 2']}]","Inclusion Criteria: 1. Participants must have a confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma or Stage III or IV NSCLC. 2. Participants who have received the following previous therapy: 1. Cohort 1 (Melanoma): Participants who have progressed within 12 weeks of last dose of anti-PD-1/PD-L1 blocking antibody and received BRAF/MEK inhibitor in those with BRAF mutations. 2. Cohort 2 (NSCLC): Participants who should have received no more than 3 prior lines of therapy and: * those without oncogene-driven tumors: Have progressed within 12 weeks after last dose of anti-PD-1/PD-L1 blocking antibody * those with oncogene-driven tumors: Have progressed during/after ≥1 targeted therapy AND either: * platinum doublet chemotherapy * Or within 12 weeks after last dose of anti-PD-1/PD-L1 blocking antibody 3. Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Participants who is assessed as having at least one resectable lesion. 5. Participants who have at least one measurable lesion, following resection of the lesion for IOV-4001 generation. 6. Participants who have adequate organ function. 7. Cardiac function test required. 8. Pulmonary function test may be required. 9. Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months. 10. Participants who are \>70 years of age may be allowed to enroll after the investigator discusses with the medical monitor. Exclusion Criteria: 1. Participants who have melanoma of uveal/ocular origin. 2. Participants who have symptomatic untreated brain metastases. 3. Participants who have had a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years. 4. Participants who require systemic steroid therapy 10 mg/day prednisone or another steroid equivalent dose. 5. Participants who have any form of primary immunodeficiency. 6. Participants who have another primary malignancy within the previous 3 years. 7. Participants who have received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMA-LD.",NA,ALL,NA,"[{'measure': 'Phase I: Safety of IOV-4001', 'description': 'The safety of IOV-4001 will be assessed based on the totality of dose-limiting toxicity (DLT) and adverse event (AE) data collected during this phase', 'timeFrame': 'Up to 1 Year or depending on when the recommended phase 2 dose is determined'}, {'measure': 'Phase 2: Objective Response Rate (ORR)', 'description': 'To evaluate the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by the investigator', 'timeFrame': 'Up to 60 months'}]","[{'measure': 'CR Rate', 'description': 'To evaluate the proportion of participants who have a confirmed CR per RECIST v1.1 as assessed by the investigator', 'timeFrame': 'Up to 60 months'}, {'measure': 'Duration of Response (DOR)', 'description': 'To evaluate the duration from the time that criteria are met for CR or PR per RECIST v1.1 as assessed by the investigator until disease progression or death due to any cause', 'timeFrame': 'Up to 60 months'}, {'measure': 'Disease Control Rate (DCR)', 'description': 'To evaluate the percentage of participants with a best overall confirmed response of CR or PR at any time plus stable disease (SD) per RECIST v1.1 as assessed by the investigator', 'timeFrame': 'Up to 60 months'}, {'measure': 'Progression-free Survival (PFS)', 'description': 'To evaluate the time from the date of IOV-4001 infusion until disease progression per RECIST v1.1 as assessed by the investigator or death due to any cause', 'timeFrame': 'Up to 60 months'}, {'measure': 'Overall Survival (OS)', 'description': 'To evaluate the time from the date of IOV-4001 infusion to death due to any cause.', 'timeFrame': 'Up to 60 months'}, {'measure': 'Safety and Tolerability of IOV-4001', 'description': 'This will be characterized by the severity, seriousness, relationship to study treatment, and characteristics of treatment-emergent adverse events (TEAEs).', 'timeFrame': 'Up to 60 months'}, {'measure': 'Feasibility of IOV-4001', 'description': 'This will be assessed by the proportion of participants who had tumor harvested and were treated without manufacturing delay or failure.', 'timeFrame': 'Up to 60 months'}]" 210,NCT00767533,"{'fullName': 'Stanford University', 'class': 'OTHER'}",Immunobiology of Cancer,TERMINATED,"To learn whether or not an Interferon defect in cell signaling, recently discovered in immune cells from melanoma patients as well as breast cancer patients, is common to all cancers.",['Neoplasms'],OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}",NA,Inclusion Criteria:Participants who have cancer or participants who do not have cancer and/or an autoimmune disorder and are age 18 or over. Exclusion Criteria:Participants who have an autoimmune disorder and/or are under the age of 18 years.,Participants who have cancer or participants who do not have cancer and/or an autoimmune disorder and are age 18 or over.,ALL,NON_PROBABILITY_SAMPLE,NA,NA 211,NCT03769285,"{'fullName': ""Women's College Hospital"", 'class': 'OTHER'}",Skin Cancer Prevention With Nicotinamide in Transplant Recipients - Pilot Trial,UNKNOWN,A common long-term side effect of anti-rejection (immunosuppressant) medications is skin cancer. This pilot clinical trial evaluates the feasibility of conducting a larger pivotal trial to examine the efficacy and safety of nicotinamide for prevention of keratinocyte carcinoma in solid organ transplant recipients. This pilot trial will transition into the pivotal trial if all feasibility targets are met.,"['Non-melanoma Skin Cancer', 'Carcinoma, Squamous Cell', 'Carcinoma, Basal Cell']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}","[{'type': 'DRUG', 'name': 'Nicotinamide', 'description': 'Oral nicotinamide (500 mg) twice daily for at least 52 weeks', 'armGroupLabels': ['Nicotinamide'], 'otherNames': ['niacinamide']}, {'type': 'DRUG', 'name': 'Placebo oral capsule', 'description': 'Matching placebo taken twice daily for at least 52 weeks', 'armGroupLabels': ['Placebo']}]","Inclusion Criteria: 1. Age ≥ 18 years old 2. Kidney, liver, heart, or lung transplant at least two years ago 3. History of at least one prior histologically-confirmed keratinocyte carcinoma or squamous cell carcinoma in situ 4. Currently immunosuppressed with a calcineurin inhibitor-based regimen (cyclosporine or tacrolimus) 5. Able to attend follow-up visits 6. Able to speak and understand English (only for cognitive substudy) Exclusion Criteria: 1. Use of mTOR inhibitor (sirolimus, everolimus) within the past 12 weeks 2. Biopsy-confirmed acute rejection episode within the past 12 weeks 3. Active liver disease (elevated AST or ALT \>3 times normal) 4. Severe renal failure (estimated glomerular filtration rate \<20 mL/min/1.73 m2) 5. Current carbamazepine or primidone use 6. Pregnancy and lactation 7. Gorlin syndrome or other genetic skin cancer syndrome 8. Solid organ or hematologic malignancy, invasive Stage II melanoma, Merkel cell carcinoma, or metastatic skin cancer within the past five years, or invasive Stage I melanoma within the past two years 9. Untreated localized skin cancer (invasive squamous cell carcinoma, basal cell carcinoma, or keratoacanthoma) at baseline (the patient can enrol after skin cancer treatment) 10. Use of nicotinamide or niacin (250 mg or more daily) within the past 12 weeks 11. Use of field therapy for actinic keratoses within the past 12 weeks 12. Initiation of systemic chemoprevention within the past 12 weeks",NA,ALL,NA,"[{'measure': 'Feasibility (pertaining to patient recruitment)', 'description': 'Proportion of patients who consent to data linkage to provincial administrative databases', 'timeFrame': '1 year'}, {'measure': 'Feasibility (pertaining to appropriateness of eligibility criteria)', 'description': 'Reasons for exclusion of screened patients', 'timeFrame': '1 year'}, {'measure': 'Feasibility (pertaining to adherence to intervention)', 'description': 'Proportion of capsules returned, reasons for non-adherence', 'timeFrame': '1 year'}, {'measure': 'Feasibility (pertaining to adherence to follow-up assessments)', 'description': 'Proportion of missed assessments and incomplete questionnaire data variables, proportion of patients who withdraw from the trial, patient perception of trial participation', 'timeFrame': '1 year'}, {'measure': 'Feasibility (pertaining to data linkage)', 'description': 'Proportion of patients who consent to data linkage to provincial administrative databases', 'timeFrame': '1 year'}, {'measure': 'Preliminary pooled keratinocyte carcinoma event rate', 'description': 'Pooled keratinocyte carcinoma event rate to be used for sample size re-estimation in the pivotal trial.', 'timeFrame': '1 year'}, {'measure': 'Drug interactions', 'description': 'Proportion of patients with a clinically relevant increase in cyclosporine or tacrolimus blood concentration at 1 week. An increased level will be classified as clinically relevant if the transplant physician reduces the immunosuppressant dose in response to the increased drug level.', 'timeFrame': '1 week'}, {'measure': 'Drug interactions', 'description': 'Proportion of patients with a clinically relevant increase in cyclosporine or tacrolimus blood concentration at 2 weeks. This measurement will be dropped if all cases of clinically relevant drug interactions manifest at 1 week in the first 20 enrolled participants.', 'timeFrame': '2 weeks'}, {'measure': 'Serious adverse events', 'description': 'Descriptive tabulation (preliminary safety)', 'timeFrame': '1 year'}]","[{'measure': 'Feasibility of recruiting for neurocognitive substudy', 'description': 'Proportion of enrolled participants who consent to participate in the neurocognitive substudy', 'timeFrame': '1 year'}, {'measure': 'Baseline prevalence of cognitive impairment (substudy)', 'description': 'Montreal Cognitive Assessment (MoCA) score \\<26, scored out of 30.', 'timeFrame': '1 year'}, {'measure': 'Pooled standard deviation of MoCA test scores (substudy)', 'description': 'Montreal Cognitive Assessment (MoCA), raw scores are scored out of 30, with a higher score representing better cognitive function', 'timeFrame': '1 year'}, {'measure': 'Pooled standard deviation of Hopkins Verbal Learning Test - Revised scores (substudy)', 'description': 'Hopkins Verbal Learning Test - Revised, a memory test scored out of 60, with a higher score representing better memory', 'timeFrame': '1 year'}, {'measure': 'Pooled standard deviation of Trail Making A and B test scores (substudy)', 'description': 'Trail Making A and B, a visual attention test. This records the time (in seconds) to completion, with a faster time representing better cognitive function', 'timeFrame': '1 year'}, {'measure': 'Pooled standard deviation of Controlled Oral Word Association test scores (substudy)', 'description': 'Controlled Oral Word Association, a verbal fluency test, measures the production of words belonging to the same letter. This records total number of words produced, with a higher number representing better verbal fluency.', 'timeFrame': '1 year'}, {'measure': 'Pooled standard deviation of Animal Naming Task scores (substudy)', 'description': 'Animal Naming Task, a verbal fluency task, measures the total number of animals named in one minute, with a higher number representing better verbal fluency', 'timeFrame': '1 year'}, {'measure': 'Pooled standard deviation of cognitive test scores (substudy)', 'description': 'Wechsler Adult Intelligence Scale - Revised, Digit Span subtest, a number sequencing memory test, measures the number of correctly repeated sequences with maximum score of 48. The higher score represents better cognitive function', 'timeFrame': '1 year'}, {'measure': 'Pooled standard deviation of serum phosphate levels (substudy)', 'timeFrame': '1 year'}]" 212,NCT06416085,"{'fullName': 'University Health Network, Toronto', 'class': 'OTHER'}","Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Patients With Advanced Cancer",ACTIVE_NOT_RECRUITING,"The PEARL Pilot is a phase II open-label trial. Participants will receive a single high-dose (25 mg) of psilocybin in the context of Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy.","['Advanced Cancer', 'Stage IV Solid Tumor Cancer', 'Stage IV Sarcoma of Bone', 'Stage IV Lymphoma', 'Stage IV Melanoma', 'Endocrine Cancer']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Psilocybin', 'description': 'Single high-dose (25mg) capsule of psilocybin taken orally in the context of Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy', 'armGroupLabels': ['Psilocybin']}]","Inclusion Criteria: 1. \>18 years of age. 2. Ability to speak and read English (patient to provide written informed consent and participate in PEARL intervention, as determined by study personnel). 3. Resident of Ontario. 4. No cognitive impairment indicated in medical record or by attending oncologist or palliative care physician. 5. Confirmed diagnosis of stage IV solid tumour cancers, sarcoma, endocrine, melanoma cancers, or stage 4 lymphoma with expected survival of greater than 6 months as determined by their oncologist or palliative care physician. 6. At least mild depressive symptoms, defined as \>8 on the Patient Health Questionnaire-9 (PHQ-9) (Kroenke et la., 2001). 7. Interest in and ability to participate in and complete the PEARL intervention and protocol as outlined. 8. Participants who are sexually active and could become pregnant must be using effective birth control (per their physician), prior to study entry, during study participation, and for the duration of the study. Participants who are sexually active and could inseminate a partner must agree to use effective birth control after psilocybin administration until the end of study. For participants of child-bearing potential, a negative serum pregnancy test result is required at screening. A urine pregnancy test will be administered on the morning of psilocybin administration for applicable participants. Participants cannot be pregnant or nursing through the duration of the study. 9. If using prescribed medications or other substances, participants must agree to refrain from taking them if instructed by study investigators. These include: * not using any non-prescription medication, nutritional supplement, or herbal supplement except when approved by the treatment team (exceptions will be evaluated by the Investigator and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals), * not using nicotine for at least 2 hours before psilocybin administration, and not again until approximately 7 hours after psilocybin administration, * consuming approximately the same amount of caffeine-containing beverages (e.g., coffee, tea) that they consume on a usual morning before arriving at the treatment centre for the psilocybin session day, * not taking any as needed medications on the mornings of psilocybin sessions (with the exception of daily and as needed opioid pain medication), * refraining from using any psychoactive drugs, including alcoholic beverages, within 24 hours of the psilocybin administration. 10. Participants must have someone drive them after the session to where they are staying (home, hotel or another location), because psilocybin may affect their alertness and concentration on the evening of the dosing session. Exclusion Criteria: 1. Primary cancer of the brain, or metastasis to the brain associated with clinically significant symptoms (e.g., affective, cognitive, personality-related, psychotic, or other symptoms, including seizures). 2. Symptoms consistent with delirium, psychosis, or other symptoms judged to be incompatible with establishment of rapport or safe exposure to psilocybin. 3. A history of past intolerability of psilocybin or other psychedelics. 4. Past/present psychiatric diagnoses including bipolar I disorder, psychotic disorders, active substance use disorders or suicidality (as distinguished from desire for hastened death or readiness for death, per the discretion of the study team). 5. If participant is under 30 years of age and has first degree relative with a primary psychotic disorder. 6. Severe hypertension (defined as systolic blood pressure \>150/or diastolic pressure \>95) based on two readings on the same day. If the second reading remains over 150/95, the patient can be brought in for another reading on a different day. Patients can be re-screened for participation once blood pressure is adequately controlled. 7. Moderate or severe hepatic impairment, as defined by Child-Pugh class B or C, or elevations in AST or ALT greater than 3 times the upper limit of normal. 8. Severe renal impairment (defined as eGFR \< 30). 9. Known paraneoplastic syndrome or ""ectopic"" hormone production by the primary tumor if incompatible with psilocybin, determined in consultation with the study palliative care physician. Patients could be enrolled if it is determined that the patient's condition is compatible with psilocybin administration. 10. Cardiovascular conditions including uncontrolled hypertension, angina, a clinically significant ECG abnormality (e.g., atrial fibrillation without rate control), transient ischemic attack in the last six months, stroke, peripheral or pulmonary vascular disease (no active claudication). 11. Uncontrolled epilepsy or history of seizures in past 6 months. 12. Participants with diabetes who are unable to skip a meal (lunch), or whose diabetes requires administration of medication more than twice daily, or who have had symptomatic hypoglycemia within the prior 30 days. 13. GI bleed in last 6 months. 14. Use of other agents that would be inappropriate to take with psilocybin in the judgement of the investigator. These agents may include psychoactive prescription medications (e.g., benzodiazepines, lithium, Selective serotonin reuptake inhibitors), medications having a primary pharmacological effect on serotonin-2a (5-HT2A) receptors (e.g., olanzapine), or medications that are monoamine oxidase (MAO) inhibitors, any potent metabolic inducers (e.g. rifamycin, rifampin, rifabutin, rifapentine, carbamazepine, phenytoin, phenobarbital, nevirapine, efavirenz, taxol, dexamethasone, St John's wort) or inhibitors (e.g. HIV protease inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, troleandomycin). 15. Any other medical condition or laboratory abnormality judged to be incompatible with safe exposure to psilocybin Of note, in suitable patients, these medications may be paused or tapered between study enrolment and prior to the start of the intervention when it is deemed safe to do so. A safe and appropriate tapering regimen will then be developed based on the particular medication, on a case-by-case basis. If taking an MAO inhibitor, the psilocybin session will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose. Patients prescribed opioids will be allowed to take their usual dose regimen for analgesia, including the use of as needed analgesic medications on psilocybin session days.",NA,ALL,NA,"[{'measure': 'Recruitment feasibility as assessed by the number of patients who consent/number of patients who meet eligibility criteria.', 'description': 'Used to assess feasibility of PEARL therapy.', 'timeFrame': '24 months'}, {'measure': 'Retention feasibility as assessed by the number of patients completing primary endpoint measures/number of patients consented.', 'description': 'Used to assess feasibility of PEARL therapy.', 'timeFrame': '24 months'}, {'measure': 'Adherence feasibility as assessed by the number of patients completing all PEARL sessions/number of patients consented.', 'description': 'Used to assess feasibility of PEARL therapy.', 'timeFrame': '24 months'}, {'measure': 'Acceptability of PEARL therapy from the perspective of advanced cancer patients obtained through qualitative interviews.', 'description': 'Participants will be interviewed regarding their experiences with PEARL, including acceptability and perceived positive and negative effects of the intervention, with a semi-structured interview guide.', 'timeFrame': '24 months'}, {'measure': 'Safety of PEARL therapy.', 'description': ""Safety will be assessed throughout the trial. Adverse events (AEs) attributed to psilocybin will be monitored for and recorded after the psilocybin session. This study will use CTCAE v5.0 to assess AEs.\n\nSerious adverse events (SAEs) will be tracked until study completion and will be defined as any adverse drug experience that: results in death; that is life-threatening (i.e. any AE that places the participant, in the view of the investigators, at immediate risk of death from the reaction as it occurs); requires hospital admission; results in persistent or significant disability (i.e. a substantial disruption of a person's ability to conduct normal life functions); or may jeopardize the participant or necessitate medical intervention to prevent one of the aforementioned criteria."", 'timeFrame': '24 months'}]","[{'measure': 'Patient perspectives on the clinical relevance of potential PEARL therapy outcomes: Death anxiety in advanced cancer patients as assessed with the DADDS.', 'description': 'The Death and Dying Distress Scale (DADDS) is a 15-item self-report measure designed for populations facing imminent death and addresses fears about the dying process, and about lost opportunities and self-perceived burden placed on others as a result of impending mortality. Total score range is 0 to 75. Higher scores indicate greater death-related distress.', 'timeFrame': '24 months'}, {'measure': 'Patient perspectives on the clinical relevance of potential PEARL therapy outcomes: Depressive symptoms as assessed with the PHQ-9.', 'description': 'The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report scale measuring depressive symptoms. Total score range is 0 to 27. Higher scores indicate greater severity of depression.', 'timeFrame': '24 months'}, {'measure': 'Patient perspectives on the clinical relevance of potential PEARL therapy outcomes: Anxiety symptoms as assessed with the GAD-7.', 'description': 'The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report scale used to screen for and measure anxiety symptoms. Total score range is 0 to 21. Higher scores indicate higher levels of anxiety.', 'timeFrame': '24 months'}, {'measure': 'Patient perspectives on the clinical relevance of potential PEARL therapy outcomes: Loss of meaning and purpose, disheartenment and helplessness as assessed with the DS.', 'description': 'The Demoralization Symptoms (DS) is a 24-item self-report measure that assesses loss of meaning and purpose, disheartenment, and helplessness. Total score range is 0 to 96. Higher scores indicate higher levels of demoralization.', 'timeFrame': '24 months'}, {'measure': 'Patient perspectives on the clinical relevance of potential PEARL therapy outcomes: Overall measure of spiritual well-being, meaning/peace and faith as assessed with the FACIT-Sp.', 'description': ""The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp) is a 12-item scale designed to measure important aspects of spirituality including sense of meaning in one's life, harmony, peacefulness and a sense of comfort and strength from one's faith. Total score range is 0 to 48. Higher scores indicate higher spiritual well-being."", 'timeFrame': '24 months'}, {'measure': 'Patient perspectives on the clinical relevance of potential PEARL therapy outcomes: Broad quality of life construct in patients facing end of life as assessed with the QUAL-EC.', 'description': 'The Quality of Life at the End of Life-Cancer (QUAL-EC) is a 17-item measure that includes subscales which assess symptom impact, preparation for end of life (i.e., the extent to which the family is prepared and financial plans have been made), relationship with healthcare providers (i.e., the extent to which patients feel informed and are able to participate in decisions about their care) and sense of life completion (i.e., being able to share important things and feel connected to others). For Symptom Control, score range is 3 to 15, with higher scores reflecting greater symptom control; for the Relationship with Healthcare Provider, score range is 5 to 25, with higher scores reflecting a better relationship with healthcare providers; for the Preparation for End-of-Life, score range is 4 to 20, with higher scores reflecting greater preparation for end-of-life; and the for Life Completion, score range is 5 to 25, with higher scores reflecting a greater sense of life completion.', 'timeFrame': '24 months'}, {'measure': 'Patient perspectives on the clinical relevance of potential PEARL therapy outcomes: Desire for death in the medically ill as assessed with the SAHD.', 'description': 'The Schedule of Attitudes Toward Hastened Death (SAHD) is a 20-item self-report measure of desire for death in the medically ill. Total score range is 0 to 20. Higher scores indicate greater desire for death.', 'timeFrame': '24 months'}]" 213,NCT05794035,"{'fullName': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}",Impact of Hypofractionated Radiotherapy Strategy After Surgery of Skin Carcinomas in Older Patients,RECRUITING,"Non-melanoma skin cancer (NMSC) incidence as well as morbidity rates are high in older patients. Surgery is the standard of care. About 5 to 10% of NMSC present high-risk clinico-pathologic features that can increase risk of local recurrence (LR). Adjuvant radiation therapy (ART) is often discussed regarding the risk of local recurrence. Despite the lack of high level evidence, ART is indicated in patients according to unfavorable prognostic factors. ART benefit is generally questioned in regard to the potential degradation of the patient's quality of life (QoL). Currently there is no prospective trial or recommendations that take into account geriatric patients' evaluation and profiles during the management of NMSC. In addition, there is no data that could help to define the subgroup of elderly patients who will benefit from ART in tumors with unfavorable prognostic factors. In terms of ART, multiple fractionation schedules are available, ranging from standard fractionation (45-60Gy in 5-6 weeks) to the extreme hypofractionation (HF) delivering 16-18Gy in one fraction. In routine practice, HF is mainly preferred in elderly patients for more convenience by reducing the number of transports and increase health related quality of life (HRQoL). However, there is no data on the fragility profiles of these patients, nor validating any HF schedule in terms of efficacy, acute toxicity, cosmetic results, and impact on HRQoL. the main ain objective is to evaluate the comparative efficacy of two modalities of Radiotherapy over surgery alone on local tumor control in older patients with Non Melanoma Skin Cancer (NMSC) In current practice, adjuvant radiotherapy is discussed regarding the risk of local recurrence as determined by the existence (or not) of unfavorable prognostic factors. The proposed study will include R0-high risk of CBC and CEC of the skin in elderly patients. There is no risk regarding the design of the trial as the last will respond to two important unknown questions regarding the utility of RT and its fractionation in this population. Moreover, it is an excellent opportunity to collect prospectively geriatric evaluation and HRQoL data that are lacking in the literature for skin cancers. No constraints are seen neither in the design, nor in the potential recruitments.","['Skin Cancer, Non-Melanoma']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'After inclusion of patient aged ≥ 70 years with performance status OMS 0-3 who had completed surgery (R0) for SCC and BCC with at least one unfavorable prognostic factor, the patients will be randomized in 3 arms with stratification by center, time from surgery to wound healing and perineural invasion.\n\n* Arm A: Surgery alone\n* Arm B: Surgery + Moderate HF 45Gy in 15 fractions, 3 fractions per week over 5 weeks to the operative bed.\n* Arm C: Surgery + Extreme HF : 30Gy in 5 fractions of 6Gy, 1 fraction per week, over 5 weeks to the operative bed.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'OTHER', 'name': 'Surgery with additional moderate hypofractionation RT (15 fractions)', 'description': 'After randomization, patients will then be followed-up at 3 months post randomization and at each surveillance visit (M6, M12, M24 and M36).\n\nAdjuvant Radiotherapy:\n\n-Arm B: Surgery followed by moderate hypofractionation RT (15 fractions): 45Gy in 15 fractions, 3 fractions per week over 5 weeks to the operative bed.', 'armGroupLabels': ['Surgery + Moderate hypo fractionation (HF)'], 'otherNames': ['Arm B:']}, {'type': 'OTHER', 'name': 'Surgery alone, without radiation post surgery', 'description': 'Arm A: Surgery alone followed by surveillance', 'armGroupLabels': ['Surgery alone']}, {'type': 'RADIATION', 'name': 'Surgery with extreme hypo fractionation treatment (HF)', 'description': 'After randomization, patients will then be followed-up at 3 months post randomization and at each surveillance visit (M6, M12, M24 and M36).\n\nAdjuvant Radiotherapy:\n\n-Arm C= Surgery followed by extreme hypofractionation RT (5 fractions, 2 fractions/week): 30Gy in 5 fractions of 6Gy over 5 weeks to the operative bed.', 'armGroupLabels': ['Surgery + Extreme hypo fractionation (HF)'], 'otherNames': ['Arm C']}]","Inclusion Criteria: * Patients aged ≥ 70 years * OMS 0-3 * Pathology confirmation of invasive SCC or BCC * At least one of high-risk factors for recurrence (R0 but close margins, location/size, microscopic perineural invasion, recurrent primary disease, immunosuppression, thickness including Breslow and Clark level, poorly-moderately differentiated) * No indication of regional nodal RT * No prior RT to the treated site * Written consent from patient or his/her legal representative, trustworthy person or family member if the person is physically unable to give his or her written consent * Life expectancy ≥ 6 months, as clinically estimated by the investigator in charge of enrolment * No contraindication for surgery and RT after multidisciplinary board meeting evaluation * Affiliated to a social security scheme Exclusion Criteria: * Macroscopic incomplete resection of the primary tumor (≥ R1) * Patient with severe dementia not allowing follow-up * Any psychological, familial, sociological, geographical or logistical reasons that would prevent participation to surveillance during treatment and follow-up * Other active cancers in treatment * Participation in another interventional study (therapeutic trial interfering with the study's endpoints) * Patient on AME (state medical aid) * Persons deprived of their liberty by a judicial or administrative decision",NA,ALL,NA,"[{'measure': 'Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)', 'description': 'Levels and changes from baseline in HRQoL as assessed by the cancer-specific European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and QLQ-ELD14 module developed for older patients with cancer, and treatment burden, as assessed by an adapted version of the Treatment Burden Questionnaire (TBQ; EVALUATION AT', 'timeFrame': 'at 3 years'}, {'measure': 'QLQ-ELD14 Questionnaire', 'description': 'Levels and changes from baseline in HRQoL as assessed by the cancer-specific European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and QLQ-ELD14 module developed for older patients with cancer, and treatment burden, as assessed by an adapted version of the Treatment Burden Questionnaire (TBQ; EVALUATION AT', 'timeFrame': 'at 3 years'}, {'measure': 'rate of Toxicity', 'description': 'Acute and late toxicity, as assessed by CTCAE v4.03 criteria', 'timeFrame': 'during RadiotherapyT'}, {'measure': 'efficacy of treatment modalities on regional recurrence (RR), at 3-year follow-up', 'timeFrame': 'at 3 years'}, {'measure': 'progression-free survival (PFS)', 'timeFrame': 'at 3-year follow-up'}, {'measure': 'overall survival (OS)', 'timeFrame': 'at 3 years'}]",NA 214,NCT02862743,"{'fullName': 'CHU de Reims', 'class': 'OTHER'}",Molecular Characterization of Advanced Stage Melanoma by Blood Sampling,COMPLETED,"Analysis of somatic mutations in tumors is currently indicated for daily practice in all metastatic melanoma. Actually, this research is limited to the mutation of three biomarkers validated by the l'Institut National du CAncer (INCA): BRAF, NRAS and CKIT. Moreover, in some cases it requires invasive biopsies. In this context, molecular characterization of a tumor material flowing (circulating tumor DNA and / or circulating tumor cells) could afford to benefit patients in the best conditions of current targeted therapies and future.",['Metastatic Melanoma'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'OTHER', 'name': 'patients with metastatic melanoma', 'description': 'Blood sample to realize molecular characterization of melanoma', 'armGroupLabels': ['patients with metastatic melanoma']}]","Inclusion Criteria: * patient with melanoma confirmed histologically * patient with metastatic melanoma (stage III unresectable or stage IV) * patient consenting to participate to the study * patient enrolled in the national healthcare insurance program * patient older than 18 years Exclusion Criteria: \- Metastatic tumor whose origin is doubtful (uncertain melanoma)",NA,ALL,NA,"[{'measure': 'Diagnostic sensitivity of a panel of biomarker on the circulating tumor DNA from peripheral blood', 'description': 'Number of patients for which a circulating tumor DNA is detected (positivity of at least one marker of the panel)', 'timeFrame': 'Day 0'}]",NA 215,NCT00003308,"{'fullName': 'Eastern Cooperative Oncology Group', 'class': 'NETWORK'}","Radiation Therapy in Treating Patients With Newly Diagnosed Brain Metastases From Kidney Cancer, Melanoma, or Sarcoma",COMPLETED,"RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase II trial to study the effectiveness of radiation therapy in treating patients with newly diagnosed brain metastases from kidney cancer, melanoma, or sarcoma.","['Kidney Cancer', 'Melanoma (Skin)', 'Metastatic Cancer', 'Ovarian Cancer', 'Sarcoma']",INTERVENTIONAL,{'primaryPurpose': 'TREATMENT'},"[{'type': 'RADIATION', 'name': 'stereotactic radiosurgery'}]","DISEASE CHARACTERISTICS: * Histologically confirmed renal cell carcinoma, melanoma, or sarcoma with 1-3 newly diagnosed intraparenchymal brain metastases based on contrast-enhanced MRI (CT scan acceptable if patients have a medical contraindication to MRI) * No lesion greater than 4.0 cm in diameter and, if multiple lesions are present, no more than one greater than 3.0 cm in diameter * No limitation on the extent of extracranial metastatic disease * No metastases in the brain stem, midbrain, pons, or medulla * No leptomeningeal metastases documented by MRI or CSF evaluation * No metastases within 10 mm of optic nerve or chiasm * No history of multiple liver metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Absolute neutrophil count greater than 1,000/mm\^3 * Platelet count greater than 50,000/mm\^3 * Hemoglobin greater than 8 g/dL Hepatic: * Not specified Renal: * Not specified Other: * No major medical illness * No psychoses * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Prior chemotherapy allowed * Systemic chemotherapy may be continued at the discretion of investigator after completion of radiosurgery Endocrine therapy: * Not specified Radiotherapy: * No prior cranial radiotherapy * Prior or concurrent radiotherapy to noncranial sites allowed Surgery: * No prior surgical resection for brain metastases * Prior stereotactic biopsy for diagnostic purposes allowed",NA,ALL,NA,NA,NA 216,NCT06080984,"{'fullName': 'West China Hospital', 'class': 'OTHER'}",The Application of Novel Oncolytic Virus in Late Stage Solid Tumors,UNKNOWN,The purpose of this study is to evaluate the efficacy and safety of novel oncolytic virus in late stage solid tumors.,['Malignant Tumor'],INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Oncolytic Virus SDJ001', 'description': 'Patients in the study receive intratumoral treatment with SDJ001 at two dose levels: 5x10\\^11 and 1x10\\^12 pfu per person. At the current dose levels, intratumoral injection is administered on the first day of each treatment cycle. Each treatment cycle consists of three weeks, continuing until tumor growth is observed following injection or until the patient experiences intolerable toxic effects.\n\nUltrasound-guided injection may be used when necessary (2.0 mL for tumors with a diameter \\>2.5 cm, 1.0 mL for diameters of 1.5-2.5 cm, 0.5 mL for diameters of 0.5-1.5 cm, and 0.1 mL for diameters \\<0.5 cm, with a maximum of 4 mL).', 'armGroupLabels': ['Treatment Cohort 1']}, {'type': 'DRUG', 'name': 'Oncolytic Virus YD06-1', 'description': 'Patients in the study receive intratumoral treatment with a novel oncolytic virus YD06-1 at a concentration of 10\\^6 pfu/mL to 10\\^8 pfu/ml following a dose escalation plan. Each subject receives only one injection at the corresponding concentration, with the dose determined based on the size of the tumor mass. (Diameter ≤1.5 cm, maximum of 1 mL; diameter 1.5-2.5 cm, maximum of 2 mL; diameter greater than 2.5 cm, maximum of 4 mL). The second dose is administered three weeks after the first dose, followed by subsequent doses at two-week intervals.', 'armGroupLabels': ['Treatment Cohort 2', 'Treatment Cohort 3']}]","Inclusion Criteria: 1. Male or female patients: ≥18 years. 2. a)Patients with confirmed advanced squamous cell carcinoma of the head and neck (including nasopharynx) who meet the following criteria: Patients who have failed standard second-line treatment. Tumors that cannot be cured through local treatment (surgery or definitive radiation therapy). b)Patients with stage III malignant melanoma who are not eligible for surgical resection, or patients with stage IV malignant melanoma, who have failed at least two lines of standard treatment (including chemotherapy, immunotherapy or targeted therapy). c)Patients with locally unresectable or metastatic advanced soft tissue sarcomas, who have failed prior systemic treatments. 3. ECOG performance status score: 0-1. 4. Expected survival ≥3 months. 5. Time since the last chemotherapy/radiotherapy/surgery is more than 28 days. 6. Adequate organ function, as defined by the following criteria within 14 days before enrollment: Hematology: Hemoglobin ≥90g/L (without blood transfusion in the last 14 days); Neutrophil count \>1.5×10\^9/L; Platelet count ≥80×10\^9/L. Biochemistry: Total bilirubin ≤1.5×ULN (upper limit of normal); Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5×ULN; if there is liver metastasis, ALT or AST ≤5×ULN; Estimated glomerular filtration rate ≥60ml/min (Cockcroft-Gault formula). Cardiac Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥50%. 7. Patients with injectable lesions (those suitable for direct injection or injection with the assistance of medical imaging), defined as follows: at least one injectable lesion in the skin, mucous membrane, subcutaneous tissue, or lymph node with a longest diameter ≥10 mm, or multiple injectable lesions with a total longest diameter ≥10 mm 8. No continuing acute toxic effects of any prior radiotherapy, chemotherapy, or surgical intervention, i.e., all such effects must have resolved to Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0) Grade 1. 9. Signed written informed consent Subjects must sign a written informed consent form approved by the competent authority and the research institution and date it. The informed consent form must be signed before any protocol-related procedures (not part of the subject's routine medical care) are conducted. Subjects must be willing and able to comply with the scheduled visits, treatment regimen, laboratory tests, and other requirements of the study. Exclusion Criteria: 1. Participated in another drug clinical trial within the past 4 weeks. 2. Tumor located near major blood vessels or the trachea. 3. Has poorly controlled clinical heart symptoms or diseases, such as NYHA class 2 or higher heart failure, unstable angina, myocardial infarction within the past year, clinically significant ventricular or supraventricular arrhythmias requiring treatment or intervention. 4. For female subjects: pregnant or lactating women. 5. Persistent or active infections, including but not limited to: active pulmonary tuberculosis, positive HIV (Human Immunodeficiency Virus) antibodies, positive HBsAg (Hepatitis B Surface Antigen), positive HBcAb (Hepatitis B Core Antibody), and positive HCV (Hepatitis C Virus) antibody test results. 1. Participants who are positive for HBsAg and/or HBcAb must also provide baseline HBV DNA results and undergo HBV DNA monitoring during the treatment according to the protocol. 2. Participants with HBV DNA results of 10\^4 copies/ml or ≥ 2000 IU/mL and any of the following conditions should be excluded: 1) positive results for HBsAg and/or HBeAg; 2) positive results for HBcAb and negative results for all others. 3. Patients with a positive HCV antibody test result are only ineligible for study participation if their HCV RNA test result is positive.. 6. Has a history of substance abuse that cannot be discontinued or has psychiatric disorders. 7. Has any active autoimmune disease or a history of autoimmune disease, including but not limited to uveitis, enteritis, pituitary inflammation, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or childhood asthma that has completely resolved in adulthood without the need for intervention may be included; subjects with asthma requiring bronchodilators for medical intervention cannot be included. 8. Patients who have used systemic corticosteroids (\>10g/day of prednisone or an equivalent dose) or other immunosuppressive drugs in the 4 weeks prior to the initial administration of the study drug will be excluded. 9. Has a history of substance abuse or known medical, psychological, or social conditions, such as a history of alcoholism or drug abuse. 10. Known allergy, hypersensitivity reaction, or intolerance to oncolytic virus research (including any excipients). A history of severe allergies to any drugs, foods, or vaccines, such as anaphylactic shock, angioedema, respiratory distress, purpura, thrombocytopenic purpura, or localized allergic necrotizing reaction (Arthus reaction), etc. 11. Female subjects with pregnancy plans during the screening period or male subjects with partners who have pregnancy plans. 12. Has accompanying diseases judged by the investigator to be seriously harmful to patient safety or affecting the patient's completion of the study. 13. Patients who have undergone major surgery other than diagnosis or have unhealed wounds, ulcers, or fractures within the 28 days prior to the initial administration of the investigational drug will be excluded. For patients with lesion rupture, screening may be considered, and the eligibility will be jointly assessed by the investigator and the sponsor, depending on the specific circumstances of the rupture. The injection site should be as far away from the rupture site as possible, and during the treatment period, rupture-related adverse events should not be recorded as investigational drug-related adverse events. 14. During the course of the study, the use of drugs against HSV, including but not limited to acyclovir, valacyclovir, penciclovir, famciclovir, ganciclovir, foscarnet, and cidofovir, may be required. 15. Patients with episodes of oral herpes (cold sores) may present with small, bead-like, tense vesicles on or around the lips during the initial outbreak, typically measuring approximately 0.5 to 1.5 centimeters in size. These vesicles may also appear in the nose, ear, or finger areas and are often associated with significant pain. Recurrent oral herpes typically presents as ulcers above the vermilion border of the lip (lip herpes) and occasionally as ulcers above the hard palate mucosa.",NA,ALL,NA,"[{'measure': 'Adverse events', 'description': 'Adverse events defined as the number of participants with adverse events', 'timeFrame': 'up to 12 months'}]","[{'measure': 'Objective response rate', 'description': 'ORR is defined as the percentage of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more)', 'timeFrame': 'up to 12 months'}, {'measure': 'Progress-Free Survival', 'description': 'PFS is defined as the time from the administration of the first dose to first disease', 'timeFrame': 'up to 12 months'}, {'measure': 'Overall Survival', 'description': 'OS is defined as the time from the administration of the first dose to death.', 'timeFrame': 'up to 12 months'}]" 217,NCT04066725,"{'fullName': 'University of Utah', 'class': 'OTHER'}",Aspirin as an Ultraviolet (UV) Protectant in Human Subjects at Risk for Melanoma,COMPLETED,This is a phase II placebo-controlled intervention trial assessing aspirin (ASA) as a UV protectant in patients at risk for melanoma.,['Melanoma (Skin)'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}","[{'type': 'DRUG', 'name': 'Aspirin 81 mg', 'description': 'Participants will be given ASA 81 mg orally once daily for a total of 60 days', 'armGroupLabels': ['ASA 81 mg daily'], 'otherNames': ['ASA']}, {'type': 'DRUG', 'name': 'Aspirin 325mg', 'description': 'Participants will be given ASA 325 mg orally once daily for a total of 60 days', 'armGroupLabels': ['ASA 325 mg daily'], 'otherNames': ['ASA']}, {'type': 'DRUG', 'name': 'Placebo oral tablet', 'description': 'Participants will be given placebo orally once daily for a total of 60 days', 'armGroupLabels': ['Placebo']}]","Inclusion Criteria: * Must have at least 2 nevi (each \>5 mm diameter) not clinically suspicious for melanoma that can be biopsied. * Must be older than age 18. * Must be able to receive informed consent and sign an approved consent form that conforms to federal and institutional guidelines. Exclusion Criteria: * The patient cannot speak / understand English or Spanish. * The patient is pregnant or breastfeeding. * The patient is a prisoner, critically or mentally ill, or otherwise incapacitated or considered vulnerable. * The patient has history of allergic reaction to ASA. * The patient has history of severe asthma. * The patient has been taking ASA or any NSAID in the past 2 weeks. * The patient has been taking a blood thinner in the past 2 weeks. * The patient has history of bleeding disorder. * The patient has history of peptic ulcer disease. * The patient has had recent intense UV exposure in the past month.",NA,ALL,NA,"[{'measure': 'Change in minimal erythemal dose (MED) from baseline to day 60.', 'description': 'Baseline minimal erythemal dose (MED) measurements will will be compared to MED results at day 60. We will use the conventional definition of MED as the lowest UV dose resulting in erythema that completely fills the 8-mm irradiated site (homogeneous erythema).', 'timeFrame': 'Change from baseline to day 60'}, {'measure': 'Change in concentration of prostaglandin E2 (PGE2) in plasma from baseline to day 60.', 'description': 'Baseline PGE2 levels in plasma specimens will be compared to PGE2 levels at day 60.', 'timeFrame': 'Change from baseline to day 60'}, {'measure': 'Change in concentration of prostaglandin E2 (PGE2) in nevus tissue from baseline to day 60.', 'description': 'Baseline PGE2 levels in tissue specimens will be compared to PGE2 levels at day 60.', 'timeFrame': 'Change from baseline to day 60'}]","[{'measure': 'Change in concentration of oncometabolite 2-hydroxyglutarate (2-HG) in plasma from baseline to day 60.', 'description': 'Baseline 2-HG levels in plasma specimens will be compared to 2-HG levels at day 60.', 'timeFrame': 'Change from baseline to day 60'}, {'measure': 'Change in concentration of 8-oxoguanine (8-OG) in plasma from baseline to day 60.', 'description': 'Baseline 8-OG levels in plasma specimens will be compared to 8-OG levels at day 60.', 'timeFrame': 'Change from baseline to day 60'}, {'measure': 'Change in concentration of oncometabolite 2-hydroxyglutarate (2-HG) in nevus tissue from baseline to day 60.', 'description': 'Baseline 2-HG levels in tissue specimens will be compared to 2-HG levels at day 60.', 'timeFrame': 'Change from baseline to day 60'}, {'measure': 'Change in concentration of 8-oxoguanine (8-OG) in nevus tissue from baseline to day 60.', 'description': 'Baseline 8-OG levels in tissue specimens will be compared to 8-OG levels at day 60.', 'timeFrame': 'Change from baseline to day 60'}]" 218,NCT04526730,"{'fullName': 'H. Lee Moffitt Cancer Center and Research Institute', 'class': 'OTHER'}",Neoadjuvant Immunotherapy With Tavo + Electroporation in Combination With Nivo. in Melanoma Patients,COMPLETED,"This is a Phase 2 open-label, single-arm study of neoadjuvant treatment of intratumoral tavo-EP plus nivolumab IV infusion. Eligible participants will be those with pathological diagnosis of operable locally-regionally advanced melanoma.",['Melanoma'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Tavo', 'description': 'Tavo will be injected on Days 1 and 8 every 4 weeks at a dose volume of ¼ of the calculated lesion volume with a minimum dose volume per lesion of 0.1 mL for lesions of volume \\<0.4 cm3', 'armGroupLabels': ['Neoadjuvant Treatment']}, {'type': 'DRUG', 'name': 'Nivolumab', 'description': 'Nivolumab will be administered 480 mg every 4 weeks over 30 minute infusions', 'armGroupLabels': ['Neoadjuvant Treatment']}, {'type': 'DEVICE', 'name': 'OncoSec Medical Electroporation Therapy System', 'description': 'The OMS (OncoSec Medical Electroporation Therapy System), a medical EP device system, consists of 3 components: 1. an Electroporation Generator that generates electric pulses, 2. a sterile Applicator Tip containing needle array, and 3. an Applicator Handle that connects to the Electroporation Generator at the proximal end and connects to the Applicator Tip at the distal end.\n\nUpon user activation of the attached Foot Switch, the OMS Electroporation Generator delivers controlled electrical pulses in a square wave pulse pattern yielding optimal transmembrane potential for electroporation to occur. EP pulses occur between 6 hexagonal opposing needle electrodes. After the first pulse, the polarity between the opposing needle electrode pairs is reversed and the needle pair is pulsed again. After the initial paired pulse, the pulse delivery is rotated clockwise to the next opposing needle pairs until a total of 6 pulses are delivered to complete the EP sequence.', 'armGroupLabels': ['Neoadjuvant Treatment'], 'otherNames': ['Electroporation']}]","Inclusion Criteria: * Participant must be ≥ 18 years of age inclusive, at the time of signing the informed consent * Histologic diagnosis of melanoma * Must be considered surgically operable and may present as any of the following groups: 1. Primary melanoma with clinically apparent regional lymph node metastases, confirmed by pathological diagnosis. 2. Clinically detected recurrence of melanoma at regional lymph node basin(s), confirmed by pathological diagnosis. 3. Clinically or histologically detected primary melanoma involving multiple regional nodal groups, confirmed by pathological diagnosis. 4. Clinically detected single site of nodal metastatic melanoma arising from an unknown primary, confirmed by pathological diagnosis. 5. Participants with in transit or satellite metastases with or without lymph node involvement are allowed if they are considered surgically resectable at Screening by the treating surgical oncologist. 6. Participants with distant cutaneous/subcutaneous, soft tissue or nodal metastases with or without regional lymph node involvement are allowed if they are considered potentially surgically resectable and can be biopsied at Screening by the treating surgical oncologist. Elevated LDH is not an exclusion. * Participants are eligible for this study either at presentation for primary melanoma with concurrent regional nodal and/or in-transit or distant metastasis, or at the time of clinically detected nodal, in transit, or distant recurrence * Participants must be evaluated by standard-of-care full body imaging studies including positron emission tomography - computed tomography (PET-CT ;preferred; including diagnostic CT component if possible) or CT (if PET-CT cannot be done) as well as magnetic resonance imaging (MRI) of the brain (or CT if MRI cannot be done) as part of the initial clinical work-up at Screening (no more than 4 weeks prior to Cycle 1, Day 1). * Have measurable disease based on RECIST v1.1, with at least one anatomically distinct lesion. Lesion or lesions must meet all the following baseline criteria: 1. Accessible for electroporation 2. Must be measured in at least one dimension (longest diameter in the plane of measurement is to be recorded) 3. Greater than 3 mm * Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Male Participants: Male subjects of childbearing potential must be surgically sterile, or must agree to use adequate method of contraception during the study and at least 5 months following the last day of study drug administration. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject * Female participants: Women of childbearing potential must have negative serum or urine pregnancy test within 72 hours prior to receiving the first study drug administration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. For women of childbearing potential, must be willing to use an adequate method of contraception from 30 days prior to the first study drug administration and 5 months following last day study drug administration (either tavo or nivolumab); acceptable methods include hormonal contraception (oral contraceptives - as long as on stable dose, patch, implant, and injection), intrauterine devices, or double barrier methods (e.g. vaginal diaphragm/vaginal sponge plus condom, or condom plus spermicidal jelly), sexual abstinence or a vasectomized partner. Women may be surgically sterile or at least 1-year post-last menstrual period. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. * Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol Exclusion Criteria: * Participant has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. Also, includes patients who are considered disease-free for at least 3 years from the last definitive treatment for a second malignancy. * Participants who have Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies at Screening). HIV testing at screening is not required unless considered clinically indicated by the treating physician. * Participants who have active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected at Screening); Note: Participants who have been vaccinated against Hepatitis B and who are positive only for the Hepatitis B surface antibody are permitted to participate in the study. Hepatitis B and C testing at screening is not required unless considered clinically indicated by the treating physician. * Participant has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug. The use of physiologic doses of corticosteroids may be approved after consultation with the Principal Investigator. * Participant has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis. * Participant has a history of interstitial lung disease. * Participant has an active infection requiring systemic therapy. * Participant has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. * Participant has not recovered (i.e., \> Grade 1 at Cycle 1, Day 1) from AEs due to a previously administered agent. * Participant has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. * Participants who are pregnant or breast feeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 5 months after the last dose of trial treatment. * Participants with electronic pacemakers or defibrillators * Participants who have received a live-virus vaccination within 30 days of the first dose of treatment. Seasonal flu vaccines that do not contain live virus are permitted * Participants who have received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including G-CSF, GM-CSF or recombinant erythropoietin) within 4 weeks prior to study Cycle 1, Day 1. * Previous treatment with anti-PD1 or anti-PDL1 immunotherapy. * Participation in another clinical study and systemic therapy within 30 days of Cycle 1, Day 1. * ECOG Performance Status: \>1 * Inadequate organ function as defined per protocol * Participant has severe hypersensitivity (≥Grade 3) to nivolumab and/or any of its excipients",NA,ALL,NA,"[{'measure': 'Pathologic Complete Response', 'description': 'For each subject, the study intervention consists of 3 phases: (1) Neoadjuvant Phase; (2) Surgery Phase; (3) Adjuvant Phase. Completion of all 3 phases is required for primary completion of the study. The study protocol requires that all subjects will be followed for 4 weeks after last dose of nivolumab at End of Study (EOS) visit. That is 4 weeks after the conclusion of the adjuvant phase. For the purpose of reporting the primary outcome measure, Pathologic Complete Response will be estimated based on the proportion of participants who have completed the study phases and were found to have no viable tumor on histologic assessment at definitive surgery after the 12- week Neoadjuvant phase. Surgery will then be scheduled 2-4 weeks after neoadjuvant phase. This will be followed by the adjuvant phase. Therefore, the proportion of participants who continue in Pathologic Complete Response following completion of the 3 study phases would be reported.', 'timeFrame': 'At least four weeks after the last dose of nivolumab at End of Study (EOS) visit'}]","[{'measure': 'Objective Response Rate', 'description': 'Preoperative ORR assessed by Investigator based on RECIST v1.1 at the conclusion of the Neoadjuvant phase.', 'timeFrame': 'Conclusion of the neoadjuvant phase.'}, {'measure': 'Relapse Free Survival', 'description': 'RFS assessed by Investigator based on RECIST v1.1 at least four weeks after the last dose of nivolumab at End of Study (EOS) visit.', 'timeFrame': 'At least four weeks after the last dose of nivolumab at End of Study (EOS) visit'}, {'measure': 'Overall Survival', 'description': 'Overall survival at 1 year after start of therapy.', 'timeFrame': 'At 1 year after start of therapy'}, {'measure': 'Risk of Surgical Delay', 'description': 'Definitive surgery will be planned at about 12 weeks. Participants will be monitored for surgical delay (either due to toxicity and/or tumor progression). Defined as the number of participants who had Surgery delayed due to progression.', 'timeFrame': 'Up to 16 weeks after start or therapy'}]" 219,NCT01879436,"{'fullName': 'Meir Medical Center', 'class': 'OTHER'}",The Effect of Human Placental Explants and Pregnant Women Sera on Cancer Cells,COMPLETED,"Maternal malignancy during pregnancy is estimated to occur in 1 out of 1000 pregnancies. Controversy exists regarding the effect of pregnancy on cancer prognosis. Gestational hormones and pregnancy-related growth factors may induce a more aggressive behavior in malignant cells. However, metastasis to the products of conception is rare. In the current study investigators wish to analyze the effect of placental explants on cancer cells (cervical, ovarian, thyroid, melanoma, lymphoma, leukemia and breast)phenotype (cell death, proliferation, migration , invasion), signaling pathway, mRNA, miRNA and protein expression.",['Cancer'],OBSERVATIONAL,"{'observationalModel': 'OTHER', 'timePerspective': 'OTHER'}",NA,"Inclusion Criteria: * Healthy women * Age 18-45. * Pregnant (6-9 weeks) and non pregnant women. Exclusion Criteria: • Placentae that were destroyed during pregnancy termination.",Healthy women Age 18-45. Pregnant (6-9 weeks) and non pregnant women.,FEMALE,PROBABILITY_SAMPLE,"[{'measure': 'Cancer cell phenotype (in the laboratory)', 'description': 'The measure of outcome is composite and includes several changes:\n\nChanges in:\n\n* cell death (% from tested cells)\n* cell cycle (% cells in G1, G2 and S phases)\n* cell migration (% closure in Scratch test)\n* cell invasion (% cells passing through membrane in Transwell assay)\n* RNA repertoire (Fold change)\n* miRNA repertoire (Fold change)', 'timeFrame': 'Baseline, 24 hours and 72 hours'}]",NA 220,NCT02571036,"{'fullName': 'Deciphera Pharmaceuticals, LLC', 'class': 'INDUSTRY'}","A Safety, Tolerability and PK Study of DCC-2618 in Patients With Advanced Malignancies",COMPLETED,"This is a Phase 1, open-label, first-in-human (FIH) dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of DCC-2618, administered orally (PO), in adult patients with advanced malignancies. The study consists of 2 parts, a dose-escalation phase, and an expansion phase. All active patients (from both dose-escalation and expansion phases) will then transition into an extension phase.","['Gastrointestinal Stromal Tumors', 'Advanced Systemic Mastocytosis', 'Advanced Cancers']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'DCC-2618', 'description': '50 mg formulated tablets', 'armGroupLabels': ['Expansion Cohort 1', 'Expansion Cohort 10', 'Expansion Cohort 2', 'Expansion Cohort 3', 'Expansion Cohort 4', 'Expansion Cohort 5', 'Expansion Cohort 6', 'Expansion Cohort 7', 'Expansion Cohort 8', 'Expansion Cohort 9', 'Extension Cohort'], 'otherNames': ['ripretinib']}, {'type': 'DRUG', 'name': 'DCC-2618', 'description': '10 mg and 50 mg formulated tablets', 'armGroupLabels': ['Escalation'], 'otherNames': ['ripretinib']}]","Inclusion Criteria (Escalation and Expansion Phases) Patients must meet the following criteria to be eligible to enroll in the study: 1. Male or female patients ≥18 years of age. 2. Patients must have histologically confirmed solid tumors or hematologic malignancies. Eligible patients include the following: 1. GIST patients must have a KIT and PDGFRA mutation and must have progressed on or had an intolerability to at least 1 line of systemic anticancer therapy. 2. SM patients must have a confirmed diagnosis of advanced SM according to 2016 World Health Organization (WHO) criteria for SM and must have documented KIT mutant disease. Patients with imatinib-sensitive KIT mutations must have progressed on or were intolerant to a tyrosine kinase inhibitor. Patients with advanced SM must present with at least 1 eligible C-Finding (organ damage) per 2013 International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) \& European Competence Network on Mastocytosis consensus response criteria; please see below for MCL exception. Advanced SM includes: i. Aggressive SM (ASM) ii. SM with associated hematologic neoplasm (SM-AHN), wherein the AHN does not require immediate alternative therapy. AHNs that are eligible include: low grade myelodysplastic syndrome (MDS) with a high SM burden who require treatment for SM only, myeloproliferative neoplasms (MPN), MDS/MPN, unclassifiable MDS, and HES/CEL. iii. MCL • Patients with histopathologically-confirmed MCL without a C-finding are eligible. iv. Symptomatic SSM • By definition, SSM patients must have at least 2 B-findings, and clinically significant symptom burden (eg, flushing, diarrhea, etc.) despite maximal treatment with approved agents to treat mediator symptoms, such as antihistamines and cromolyn sodium. v. Patients with hematologic malignancies featuring clonal expansion of eosinophils driven by genomic alterations of KIT or PDGFRA (eg, HES or CEL) are eligible if they have progressed on or are intolerant of imatinib therapy. Patients with de novo imatinib resistant mutations, such as but not limited to KIT D816V or PDGFRA D842V, are eligible without prior imatinib therapy. c. Malignant glioma patients with genomic alterations potentially conferring sensitivity to DCC-2618 including, but not limited to, amplification and/or mutations of PDGFRA and/or KIT. Other solid tumor patients that have alterations in genes encoding kinases that are targets of DCC-2618. This includes: * Melanoma * Soft tissue sarcoma patients (including but not limited to: malignant peripheral nerve sheath tumors (MPNST), desmoplastic small round cell tumors (DSRCT), and dermatofibrosarcoma protuberans tumors (DFSP) * Other solid tumor patients (non-melanoma, non-STS; specifically germ-cell, penile, and non-small cell lung carcinoma) * Renal impairment cohort 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤2. 4. Adequate organ function and bone marrow function. Exclusion Criteria (Escalation and Expansion Phases) Patients meeting any of the following criteria will be excluded from the study: 1. GIST patients with wild type or unknown KIT or PDGFRA status. 2. Patients with SM or other hematologic malignancies will be excluded if the following apply: 1. SM patients with neutropenia accompanied by fever or infection, or thrombocytopenia associated with clinically significant bleeding. • Patients with an infection that is well controlled with antibiotics are eligible if there is an immediate need for treatment. 2. SM-AHN patients diagnosed with: i. SM with MDS who require treatment for MDS. ii. Patients requiring immediate treatment for AHN. c. Patients with leukemias, with the exception of MCL and CEL, that have progressed after imatinib. d. Eosinophilic myeloproliferative neoplasm patients: i. Lacking a mutation that is a known target of DCC-2618. 3. Prior or concurrent malignancy whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of DCC-2618. Patients receiving adjuvant cancer treatment are not eligible if those medications are potentially active against GIST or excluded per protocol. 4. New York Heart Association class III and IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia requiring therapy, uncontrolled hypertension or congestive heart failure. 5. Arterial thrombotic or embolic events such as cerebrovascular accident (including ischemic attacks) or hemoptysis within 6 months before start of study drug. 6. Venous thrombotic events (eg, deep vein thrombosis) or pulmonary arterial events (eg, pulmonary embolism) within the 3 months before start of study drug. Patients with venous thrombotic events ≥3 months before start of study drug on stable anticoagulation therapy are eligible. 7. Baseline prolongation of the rate-corrected QT interval based on repeated demonstration of QT interval corrected by Fridericia's formula (QTcF) \>450 ms in males or \>470 ms in females or history of long QT interval corrected (QTc) syndrome. 8. Left ventricular ejection fraction (LVEF) \<50% or below the lower limit of normal (whichever is higher). 9. Major surgery within 4 weeks of the first dose of study drug; following major surgeries \>4 weeks prior to the first dose of study drug, all surgical wounds must be healed and free of infection or dehiscence. 10. Any other clinically significant comorbidities. 11. Illnesses that could affect oral absorption. 12. Known human immunodeficiency virus or active hepatitis C infection only if the patient is taking per protocol prohibited medications, active hepatitis B, or active hepatitis C infection. 13. If female, the patient is pregnant or lactating. 14. Known allergy or hypersensitivity to any component of the investigational drug product. Patients with history of Stevens-Johnson syndrome on a prior tyrosine kinase inhibitor (TKI) are excluded.",NA,ALL,NA,"[{'measure': 'Safety/tolerability of oral DCC-2618: incidence of adverse events', 'description': 'Dose limiting toxicities, AEs, SAEs, discontinuation of drug due to toxicity, physical exams and ECOG PS, ophthalmologic examinations, changes from baseline in laboratory parameters, electrocardiograms, LVEF, and vital signs.', 'timeFrame': 'Approximately 24 months'}, {'measure': 'Determination of the Maximum Tolerated Dose and the Recommended Phase 2 Dose', 'timeFrame': '18 months'}, {'measure': 'Expansion Phase: Assess Antitumor Activity of DCC-2618 in all diseases', 'description': 'Objective response rate (ORR); Disease control rate (DCR)', 'timeFrame': 'Approximately 24 months'}]","[{'measure': 'Determine the PK profile of oral DCC-2618', 'timeFrame': 'Predose and up to 24 hours postdose (Cycle = 28 Days)'}, {'measure': 'Escalation Phase: Assess Antitumor Activity of DCC-2618 in patients with advanced malignancies', 'description': 'Objective response rate (ORR); Disease control rate (DCR)', 'timeFrame': 'Approximately 24 months'}]" 221,NCT03179436,"{'fullName': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}",Study of Quavonlimab (MK-1308) in Combination With Pembrolizumab (MK-3475) in Advanced Solid Tumors (MK-1308-001),COMPLETED,"This study will assess the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of escalating doses of quavonlimab when used in combination with pembrolizumab in participants with advanced solid tumors.",['Advanced Solid Tumors'],INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'Quavonlimab', 'description': 'Quavonlimab is administered intravenously (IV) during the Dose Escalation Phase and Dose Confirmation Phase at either DL1 or DL2, and is administered IV during the Efficacy Expansion Phase at DL2.', 'armGroupLabels': ['Confirmation: DL 1 Quavonlimab Schedule 1 + Pembro (NSCLC): Arm A', 'Confirmation: DL 1 Quavonlimab Schedule 2 + Pembro (NSCLC): Arm B', 'Confirmation: DL 2 Quavonlimab Schedule 1 + Pembro (NSCLC): Arm E', 'Confirmation: DL 2 Quavonlimab Schedule 2 + Pembro (NSCLC): Arm C', 'Confirmation: DL 2 Quavonlimab Schedule 2 + Pembro (SCLC): Arm D', 'Escalation: DL 2 Quavonlimab + Pembro: Cohort 2', 'Escalation: DL 3 Quavonlimab + Pembro: Cohort 3', 'Escalation: Dose Level (DL) 1 Quavonlimab + Pembro: Cohort 1', 'Expansion: DL1 Quavonlimab Schedule 2 Monotherapy: Arm G', 'Expansion: DL1 Quavonlimab Schedule 2+PDL2 Pembro Schedule 2: Arm F'], 'otherNames': ['MK-1308']}, {'type': 'BIOLOGICAL', 'name': 'Pembrolizumab', 'description': 'Pembrolizumab is administered IV at PDL1 on Day 1 of each cycle starting Cycle 2 for the Dose Escalation Phase or starting Cycle 1 of the Dose Confirmation Phase. Pembrolizumab is administered IV at PDL2 on Day 1 of each cycle for the Efficacy Expansion Phase (Arm G).', 'armGroupLabels': ['Confirmation: DL 1 Quavonlimab Schedule 1 + Pembro (NSCLC): Arm A', 'Confirmation: DL 1 Quavonlimab Schedule 2 + Pembro (NSCLC): Arm B', 'Confirmation: DL 2 Quavonlimab Schedule 1 + Pembro (NSCLC): Arm E', 'Confirmation: DL 2 Quavonlimab Schedule 2 + Pembro (NSCLC): Arm C', 'Confirmation: DL 2 Quavonlimab Schedule 2 + Pembro (SCLC): Arm D', 'Escalation: DL 2 Quavonlimab + Pembro: Cohort 2', 'Escalation: DL 3 Quavonlimab + Pembro: Cohort 3', 'Escalation: Dose Level (DL) 1 Quavonlimab + Pembro: Cohort 1', 'Expansion: DL1 Quavonlimab Schedule 2+PDL2 Pembro Schedule 2: Arm F'], 'otherNames': ['Keytruda®']}, {'type': 'DRUG', 'name': 'Pembrolizumab/Quavonlimab', 'description': 'Pembrolizumab/Quavonlimab is a coformulated product composed of quavonlimab at DL1 in combination with pembrolizumab at dose level 2 (PDL2).', 'armGroupLabels': ['Coformulation Phase in China: Pembrolizumab/Quavonlimab Schedule 2: Arm K', 'Coformulation: Pembrolizumab/Quavonlimab Schedule 2: Arm I'], 'otherNames': ['MK-1308A']}]","Inclusion Criteria: For Dose Escalation Phase: * Have any histologically- or cytologically-confirmed advanced/metastatic solid tumor (except NSCLC for Cohorts 2 and 3) by pathology report and have received, been intolerant to, been ineligible for, or refused all treatment known to confer clinical benefit For Dose Confirmation Phase NSCLC Arms (A, B, C, and E): * Have newly diagnosed histologically or cytologically-confirmed stage IIIB/stage IV NSCLC. Epidermal growth factor receptor (EGFR)-and anaplastic lymphoma kinase (ALK) translocation-directed therapy is not indicated as primary therapy. Participant must not have received prior systemic treatment for advanced NSCLC or must have received previous neoadjuvant and adjuvant chemotherapies ≥6 months before dosing of study drug if prior systemic treatment was given for early stage disease For Dose Confirmation Phase SCLC Arm (Arm D): * Have histologically- or cytologically-confirmed metastatic (Stage III/IV) SCLC with progressive disease after ≥1 platinum-based chemotherapy regimen. Participants with platinum-sensitive disease are eligible * Have measurable disease by RECIST 1.1 as assessed by the local site investigator/radiology * Have Eastern Cooperative Oncology Group (ECOG) Performance Scale status of 0 or 1 * A female participant is eligible to participate if she is not pregnant or breastfeeding and at least 1 of the following conditions applies: * Is not a woman of child bearing potential (WOCBP) OR * Is a WOCBP and using a contraceptive method that is highly effective during the intervention period and for at least 120 days after the last dose of pembrolizumab or pembrolizumab/quavonlimab, whichever comes last * Female participants of childbearing potential must have negative urine or serum pregnancy test within 24 hours for urine and within 72 hours for serum prior to receiving the first dose of study treatment * Male participants with a female partner(s) of child-bearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study medication and refrain from donating sperm during this period * Must submit an evaluable baseline tumor sample for analysis (either a recent or archival tumor sample) For Efficacy Expansion Phase Arms F and G: * Have histologically/cytologically-confirmed unresectable Stage III or Stage IV melanoma per American Joint Committee on Cancer (AJCC) staging system version 8, not amenable to local therapy * Have at least 1 measurable lesion by CT or MRI per RECIST 1.1 by BICR. Cutaneous lesions and other superficial lesions are not considered measurable lesions for the purposes of this protocol, but may be considered as non-target lesions * Participants with unresectable Stage III or IV disease must have progressed on treatment with an anti-PD-1/L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies (combinations with anti-cytotoxic T-lymphocyte associated protein 4 \[CTLA-4\] agents will not be allowed) * Participants who receive anti-PD-1 therapy as adjuvant treatment following complete resection of Stage III or IV melanoma and have disease recurrence (unresectable loco-regional disease or distant metastases) while on active treatment or within 6 months of stopping anti-PD-1 are eligible * Have submitted pre-trial imaging and provided a baseline tumor sample * Proto-oncogene B-raf (BRAF) V600 mutation-positive melanoma participants should have received targeted therapy for advanced or metastatic disease (eg, BRAF/MEK inhibitor, alone or in combination) prior to enrolling on this study; however, they are not required to progress on this treatment prior to enrollment * BRAF V600E mutation-positive melanoma participants who have NOT received a BRAF inhibitor (either as adjuvant therapy or in the metastatic disease setting) with lactate dehydrogenase (LDH) \< local upper limit of normal (ULN), no clinically significant tumor-related symptoms, and absence of rapidly progressing metastatic melanoma. Approximately 10 participants each from Arms F and G will have 2 mandatory biopsies For Dose Coformulation Phase Arm I: * Have any histologically- or cytologically-confirmed advanced/metastatic solid tumor by pathology report and have received, been intolerant to, been ineligible for or refused all treatment known to confer clinical benefit * Meet all requirements for Dose Escalation Phase and Dose Confirmation Phase For the Coformulation Phase - Arm K (China only): * Have any histologically- or cytologically-confirmed advanced/metastatic solid tumor by pathology report and have received, been intolerant to, been ineligible for, or refused all treatment known to confer clinical benefit * Be a Chinese participant residing in China. Exclusion Criteria: * For all phases of the study: Has received previous treatment with another agent targeting cytotoxic T lymphocyte leukocyte antigen (CTLA)-4 For Dose Confirmation Phase: * Has received previous treatment with another agent targeting programmed cell death protein 1 (PD-1), programmed cell death ligand 1 (PD-L1), or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor * Has had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) prior to the first dose of study therapy, or has not recovered to Common Toxicity Criteria for Adverse Events (CTCAE) Grade 1 or better from any AEs that were due to cancer therapeutics administered more than 4 weeks earlier * Has received lung radiation therapy of \>30 Gray (Gy) within 6 months before the first dose of study treatment * Is currently participating and receiving study therapy in a study of an investigational agent or has participated and received study therapy in a study of an investigational agent or has used an investigational device within 28 days of administration of quavonlimab. * Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years For Dose Escalation Cohorts (1-3) and Dose Confirmation Arms (A-E): * Has known untreated central nervous system (CNS) metastases. Has known carcinomatous meningitis * Has received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse events (irAE) * Has had a severe hypersensitivity reaction to treatment with any monoclonal antibody or components of the study drug * Has any active infection requiring therapy * Has a history of interstitial lung disease, history of noninfectious pneumonitis that required steroids (or has current pneumonitis), or history of inflammatory bowel disease * Has an active autoimmune disease that has required systemic treatment in the past 2 years * Has clinically significant cardiac disease * Has received a live or live attenuated vaccine within 28 days of planned treatment start * Has known history of human immunodeficiency virus (HIV) and/or known active Hepatitis B or C infections, and/or known to be positive for hepatitis B surface antigen (HBsAg)/ hepatitis B virus (HBV) DNA * Has known psychiatric or substance abuse disorders that would interfere with the participant's ability to cooperate with the requirements of the trial * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with screening and for up to 120 days following cessation of pembrolizumab or pembrolizumab/quavonlimab * Has not fully recovered from any effects of major surgery without significant detectable infection For Arm F and G (Efficacy Expansion Phase) and Arm K (Coformulation Phase) ONLY: * Has known active CNS metastases and/or carcinomatous meningitis * Has not had resolution of anti-PD-1 antibody-related AEs, including immune-mediated AEs back to Grade ≤1 or baseline (not applicable to Arm K) * Has not discontinued steroid treatment for an irAE for at least 2 weeks prior to the first dose of study drug (not applicable to Arm K) * Has ocular melanoma (not applicable to Arm K) * Has mucosal melanoma (not applicable to Arm K) * Has had an allogenic tissue/solid organ transplant",NA,ALL,NA,"[{'measure': 'Percentage of Participants With ≥1 Dose Limiting Toxicity (DLT)', 'description': 'DLT was defined as toxicity that is possibly, probably, or definitely related to study therapy and may result in a change in the given dose. DLTs include Grade (Gr)4 non-hematologic toxicity (not laboratory); Gr 4 hematologic toxicity lasting ≥7 days (except thrombocytopenia); most non-hematologic AEs ≥ Gr 3 in severity; any Gr 3 or Gr 4 non-hematologic laboratory value that requires clinically significant medical intervention, leads to hospitalization, persists for \\>1 week, or results in a drug-induced liver injury; Gr 3 or Gr 4 febrile neutropenia; a prolonged delay in initiating Cycle 2 or 3 of Dose Escalation or Cycle 2 of Dose Confirmation due to treatment-related toxicity; any treatment-related toxicity that causes the participant to discontinue treatment during the DLT observation period, and Gr 5 toxicity.', 'timeFrame': 'Up to 6 weeks'}, {'measure': 'Number of Participants With ≥1 Adverse Event (AE)', 'description': 'An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, no analysis was planned for the cross over phase. The number of participants who experienced an AE are presented.', 'timeFrame': 'Up to approximately 77 months'}, {'measure': 'Number of Participants Discontinuing Study Treatment Due to an AE', 'description': 'An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment. Per protocol, no analysis was planned for the cross over phase. The number of participants who discontinued study treatment due to an AE are presented.', 'timeFrame': 'Up to approximately 26 months'}, {'measure': 'Efficacy Expansion: Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR) Based on Adjusted Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)', 'description': 'ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per adjusted Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR in the concurrent randomized subset as assessed by Blinded Independent Central Review (BICR) will be presented. Per protocol, only data for arms F and G were presented for this endpoint.', 'timeFrame': 'Up to approximately 72 months'}]","[{'measure': 'Area Under the Plasma Concentration Time Curve (AUC) of Pembrolizumab', 'description': 'AUC was defined as a measure of pembrolizumab exposure that was calculated as the product of plasma drug concentration and time after drug administration. AUC determined by blood samples collected pre-dose and at designated timepoints post-dose are presented. Per protocol, no analysis was planned for participants in arm G and cross over phase. AUC of pembrolizumab is presented. Blood sampling was taken for Cohorts 1-3: Predose and Postdose on Days 1, 8, 15 on Cycles 2 and 3. Arms A, B, C, D, E: Predose and Postdose on Days 1, 8, 15 on Cycles 1, 2, 3. Arm F: Predose and Postdose on Day 1 and 21 on Cycles 1, 2, 3. Arm I: Predose and Postdose on Day 1 and 21 on Cycles 1, 2, 3. Arm K: Predose and Postdose on Days 1, 2, 8, 15, 21 on Cycles 1, 2; Days 1, 21 on Cycle 3. Each cycle is 21 days.', 'timeFrame': 'At designated time points up to - Cohorts 1-3: Day 15 Cycle 3, Arms A, B, C, D, E: Day 15 Cycle 3, Arm F: Day 21 Cycle 3, Arm I: Day 21 Cycle 3, Arm K: Day 21 Cycle 3. Each cycle is 21 days.'}, {'measure': 'Maximum Concentration (Cmax) of Pembrolizumab', 'description': 'Cmax was defined as the maximum concentration of pembrolizumab observed in plasma. Cmax determined by blood samples collected pre-dose and at designated timepoints post-dose are presented. Per protocol, no analysis was planned for participants in arm G and cross over phase. Cmax of pembrolizumab is presented. Blood sampling was taken for Cohorts 1-3: Predose and Postdose on Days 1, 8, 15 on Cycles 2 and 3. Arms A, B, C, D, E: Predose and Postdose on Days 1, 8, 15 on Cycles 1, 2, 3. Arm F: Predose and Postdose on Day 1 and 21 on Cycles 1, 2, 3. Arm I: Predose and Postdose on Day 1 and 21 on Cycles 1, 2, 3. Arm K: Predose and Postdose on Days 1, 2, 8, 15, 21 on Cycles 1, 2; Days 1, 21 on Cycle 3. Each cycle is 21 days.', 'timeFrame': 'At designated time points up to - Cohorts 1-3: Day 15 Cycle 3, Arms A, B, C, D, E: Day 15 Cycle 3, Arm F: Day 21 Cycle 3, Arm I: Day 21 Cycle 3, Arm K: Day 21 Cycle 3. Each cycle is 21 days.'}, {'measure': 'Minimum Concentration (Cmin) of Pembrolizumab', 'description': 'Cmin was defined as the minimum or ""trough"" concentration of pembrolizumab observed after its administration and just prior to the administration of a subsequent dose. Cmin determined by blood samples collected pre-dose and at designated timepoints post-dose are presented. Per protocol, no analysis was planned for participants in arm G and cross over phase. Cmin of pembrolizumab is presented. Blood sampling was taken for Cohorts 1-3: Predose and Postdose on Days 1, 8, 15 on Cycles 2 and 3, Day 1 on Cycle 4. Arms A, B, C, D, E: Predose and Postdose on Days 1, 8, 15 on Cycles 1, 2, 3. Arm F: Predose and Postdose on Day 1 and 21 on Cycles 1, 2, 3. Arm I: Predose and Postdose on Day 1 and 21 on Cycles 1, 2, 3. Arm K: Predose and Postdose on Days 1, 2, 8, 15, 21 on Cycles 1, 2; Days 1, 21 on Cycle 3. Each cycle is 21 days.', 'timeFrame': 'At designated time points up to - Cohorts 1-3: Day 1 Cycle 4, Arms A, B, C, D, E: Day 15 Cycle 3, Arm F: Day 21 Cycle 3, Arm I: Day 21 Cycle 3, Arm K: Day 21 Cycle 3. Each cycle is 21 days.'}, {'measure': 'Area Under the Plasma Concentration Time Curve (AUC) of Quavonlimab (MK-1308)', 'description': 'AUC was defined as a measure of quavonlimab exposure that was calculated as the product of plasma drug concentration and time after drug administration. AUC determined by blood samples collected pre-dose and at designated timepoints post-dose are presented. Per protocol, no analysis was planned for the cross over phase. AUC of quavonlimab is presented. Blood sampling was taken for Cohorts 1-3: Predose and Postdose on Days 1, 8, 15 on Cycles 1, 2 and 3. Arms A, B, C, D, E: Days 1, 8, 15 on Cycles 1, 2, 3. Arms F, G and I: Predose and Postdose on Day 1 and 21 on Cycles 1, 2, 3. Arm K: Days 1, 2, 8, 15, 21 on Cycles 1, 2; Days 1, 21 on Cycle 3. Each cycle is 21 days.', 'timeFrame': 'At designated time points up to - Cohorts 1-3: Day 15 Cycle 3, Arms A, B, C, D, E: Day 15 Cycle 3, Arm F, G, I: Day 21 Cycle 3, Arm K: Day 21 Cycle 3. Each cycle is 21 days.'}, {'measure': 'Maximum Concentration (Cmax) of Quavonlimab', 'description': 'Cmax was defined as the maximum concentration of quavonlimab observed in plasma. Cmax determined by blood samples collected pre-dose and at designated timepoints post-dose are presented. Per protocol, no analysis was planned for the cross over phase. Cmax of quavonlimab is presented. Blood sampling was taken for Cohorts 1-3: Predose and Postdose on Days 1, 8, 15 on Cycles 1, 2 and 3. Arms A, B, C, D, E: Days 1, 8, 15 on Cycles 1, 2, 3. Arms F, G and I: Predose and Postdose on Day 1 and 21 on Cycles 1, 2, 3. Arm K: Days 1, 2, 8, 15, 21 on Cycles 1, 2; Days 1, 21 on Cycle 3. Each cycle is 21 days.', 'timeFrame': 'At designated time points up to - Cohorts 1-3: Day 15 Cycle 3, Arms A, B, C, D, E: Day 15 Cycle 3, Arm F, G, I: Day 21 Cycle 3, Arm K: Day 21 Cycle 3. Each cycle is 21 days.'}, {'measure': 'Minimum Concentration (Cmin) of Quavonlimab', 'description': 'Cmin was defined as the minimum or ""trough"" concentration of quavonlimab observed after its administration and just prior to the administration of a subsequent dose. Cmin determined by blood samples collected pre-dose and at designated timepoints post-dose are presented. Per protocol, no analysis was planned for the cross over phase. Cmin of quavonlimab is presented. Blood sampling was taken for Cohorts 1-3: Predose and Postdose on Days 1, 8, 15 on Cycles 1, 2 and 3. Arms A, B, C, D, E: Days 1, 8, 15 on Cycles 1, 2, 3. Arms F, G and I: Predose and Postdose on Day 1 and 21 on Cycles 1, 2, 3. Arm K: Days 1, 2, 8, 15, 21 on Cycles 1, 2; Days 1, 21 on Cycle 3. Each cycle is 21 days.', 'timeFrame': 'At designated time points up to - Cohorts 1-3: Day 15 Cycle 3, Arms A, B, C, D, E: Day 15 Cycle 3, Arm F, G, I: Day 21 Cycle 3, Arm K: Day 21 Cycle 3. Each cycle is 21 days.'}, {'measure': 'Number of Participants With Pembrolizumab Anti-drug Antibodies (ADAs)', 'description': 'Non-Treatment emergent (TE) ADA refers to presence of ADAs (as determined by assay) in the absence of treatment with pembrolizumab (i.e., at predose). Evaluable participants (used as the denominator for analysis) are the total number of negative, inconclusive, and positive participants (non-treatment emergent, treatment emergent and treatment boosted). Inconclusive participants are the number of participants with no positive ADA samples present and the drug concentration in the last sample above the drug tolerance level. ADA determined by blood samples collected pre-dose and at designated timepoints post-dose are presented. Per protocol, no analysis was planned for arm G and cross over phase.', 'timeFrame': 'Cohorts 1-3: Predose and day 1 of cycles 2, 3, 5, 6, 7, 9 and every 4 cycles up to 35 cycles. Arms A-E: Predose and day 1 of cycles 1-5, 6, 8 and every 4 cycles up to 35 cycles. Arms F, I, K: Predose and day 1 of cycles 1, 2, 3, 4. Each cycle is 21 days.'}, {'measure': 'Number of Participants With Quavonlimab Anti-drug Antibodies (ADAs)', 'description': 'Non-Treatment emergent (TE) ADA refers to presence of ADAs (as determined by assay) in the absence of treatment with quavonlimab (i.e., at predose). Evaluable participants (used as the denominator for analysis) are the total number of negative, inconclusive, and positive participants (non-treatment emergent, treatment emergent and treatment boosted (TB)). Inconclusive participants are the number of participants with no positive ADA samples present and the drug concentration in the last sample above the drug tolerance level. ADA determined by blood samples collected pre-dose and at designated timepoints post-dose are presented. Per protocol, no analysis was planned for the cross over phase.', 'timeFrame': 'Cohort 1-3: Predose and day 1 of cycles 2, 3, 5, 6, 7, 9 and every 4 cycles up to 35 cycles. Arms A-E: Predose and day 1 of cycle 1-5, 6, 8 and every 4 cycles up to 35 cycles. Arms F, G, I, K: Predose and day 1 of cycles 1, 2, 3, 4. Each cycle is 21 days.'}, {'measure': 'Dose Escalation, Dose Confirmation, Coformulation: ORR as Assessed by Investigator Based on Adjusted RECIST v1.1', 'description': 'ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented. Per protocol, no analysis was planned for the cross over phase.', 'timeFrame': 'Up to approximately 72 months'}, {'measure': 'Efficacy Expansion: Duration of Response (DOR) as Assessed by BICR Based on Adjusted RECIST v1.1', 'description': 'DOR was defined as the time from first documented evidence of complete response (CR: Disappearance of all target lesions) or confirmed partial response (PR: At least a 30% decrease in the sum of diameters of target lesions) until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by Blinded Independent Central Review (BICR) will be presented. Per protocol, only data for arms F and G were presented for this endpoint.', 'timeFrame': 'Up to approximately 72 months'}]" 222,NCT04852887,"{'fullName': 'NRG Oncology', 'class': 'OTHER'}","De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)",RECRUITING,This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.,['Stage I Breast Cancer'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'OTHER', 'name': 'Radiation and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)', 'description': ""Post lumpectomy radiation therapy will be external beam radiation to either the whole breast + boost, partial breast irradiation, or Accelerated Partial Breast Irradiation that must begin within 12 weeks of the last breast cancer surgery(including re-excision of margins).\n\nEndocrine therapy for a minimum of 5 years. The specific regimen of endocrine therapy is at the treating physician's discretion. The dose and schedule of the drug(s) used for endocrine therapy should be consistent with the instructions in the drug package insert(s). Endocrine therapy may be initiated before, during, or after completion of radiation therapy at the discretion of the investigator."", 'armGroupLabels': ['Arm 1: Breast Radiation Therapy + Endocrine Therapy']}, {'type': 'DRUG', 'name': 'Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)', 'description': ""Endocrine therapy for a minimum of 5 years. The specific regimen of endocrine therapy is at the treating physician's discretion. The dose and schedule of the drug(s) used for endocrine therapy should be consistent with the instructions in the drug package insert(s)."", 'armGroupLabels': ['Arm 2: No Breast Radiation Therapy + Endocrine Therapy']}]","Inclusion Criteria: * • The patient or a legally authorized representative must provide study-specific informed consent prior to pre-entry/Step 1 and, for patients treated in the U.S., authorization permitting release of personal health information. * The patient must have an ECOG performance status of 0 or 1. * The patient must have undergone a lumpectomy and the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS with no ink on tumor as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins. (Patients with margins positive for LCIS are eligible without additional resection.) * The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination. * Patient must have undergone axillary staging (sentinel node biopsy and/or axillary node dissection). * The following staging criteria must be met postoperatively according to AJCC 8th edition criteria: * By pathologic evaluation, primary tumor must be pT1 (less than or equal to 2 cm). * By pathologic evaluation, ipsilateral nodes must be pN0. (Patients with pathologic staging of pN0(i+) or pN0(mol+) are NOT eligible.) * Oncotype DX Recurrence Score of less than or equal to 18 on diagnostic core biopsy or resected specimen. \*\* For patients with a T1a tumor (less than or equal to 0.5 cm in size) or patients at Canadian provinces or approved international sites where Oncotype DX Recurrence Score testing would not be covered, who do not already have an Oncotype DX Recurrence Score at pre-entry/Step 1, a specimen (unstained blocks or slides) must be sent to the Genomic Health centralized laboratory. Tumor size sample must be greater than or equal to 0.2 cm for analysis. \*\*\* The Oncotype RS can be run on the biopsy core or surgical specimen. The patient cannot have initiated endocrine therapy prior to tissue collection. * An Oncotype RS is required for eligibility, however, for a patient whose tumor has already had a MammaPrint test completed as part of usual care when being considered for enrollment and is in the binary ""Low"" category will meet this eligibility criteria and an Oncotype RS does not need to be performed. * The tumor must have been determined to be ER and/or PgR positive assessed by current ASCO/CAP Guideline Recommendations for hormone receptor testing. Patients with greater than or equal to 1% ER or PgR staining by IHC are considered positive. * The tumor must have been determined to be HER2-negative by current ASCO/CAP guidelines. * Patients may be premenopausal or postmenopausal at the time of pre-entry/Step 1. For study purposes, postmenopausal is defined as: * Age 56 or older with no spontaneous menses for at least 12 months prior to pre-entry/Step 1; or a documented hysterectomy; or * Age 55 or younger with no spontaneous menses for at least 12 months prior to pre-entry/Step 1 (e.g., spontaneous or secondary to hysterectomy) and with a documented estradiol level in the postmenopausal range according to local institutional/laboratory standard; or Documented bilateral oophorectomy. * The interval between the last surgery for breast cancer (including re-excision of margins) and pre-entry/Step 1 must be no more than 70 days. * The patient must have recovered from surgery with the incision completely healed and no signs of infection. * Bilateral mammogram or MRI within 6 months prior to pre-entry/Step 1. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Patients must be intending to take endocrine therapy for a minimum 5 years duration (tamoxifen or aromatase inhibitor). The specific regimen of endocrine therapy is at the treating physician's discretion. Exclusion Criteria: * • Definitive clinical or radiologic evidence of metastatic disease. * pT1 mi and pT2 - pT4 tumors including inflammatory breast cancer. * Pathologic staging of pN0(i+) or pN0(mol+), pN1, pN2, or pN3 disease. * Patient had a mastectomy. * Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor. * Suspicious microcalcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign. * Non-epithelial breast malignancies such as sarcoma or lymphoma. * Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters. (Patients with multifocal carcinoma are eligible.) * Paget's disease of the nipple. * Any history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated or not treated. (Patients with synchronous or previous ipsilateral LCIS are eligible.) * Synchronous or previous contralateral invasive breast cancer or DCIS. (Patients with synchronous and/or previous contralateral LCIS are eligible.) * Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re- excision, the patient is eligible.) * Treatment plan that includes regional nodal irradiation. * Any treatment with radiation therapy, chemotherapy, or biotherapy, administered for the currently diagnosed breast cancer prior to pre-entry/Step 1. * History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to pre-entry/Step 1. * Current therapy with any endocrine therapy such as raloxifene (Evista®), tamoxifen, or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention. \*\* Patients are eligible for BR007 if they receive a short course of preoperative endocrine therapy of less than 6 weeks duration (prior to randomization/Step 2) for this diagnosis after the core biopsy (and can continue postoperatively if: * the Oncotype DX Recurrence Score is assessed on the biopsy core and is less than or equal to 18, AND * the patient had not initiated endocrine therapy prior to core biopsy tissue collection. \*\*\* This does not apply to adjuvant endocrine therapy recommended for this diagnosis which may start any time after surgery including prior to registration (Pre-entry/Step 1). * Patients intending to continue on oral, transdermal, or subdermal estrogen replacement (including all estrogen only and estrogen-progesterone formulas) are not eligible. Patients that discontinue oral, transdermal, or subdermal estrogen replacement prior to registration are eligible. * Prior breast or thoracic RT for any condition. * Active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma. * Pregnancy or lactation at the time of pre-entry/Step 1 or intention to become pregnant during treatment. (Note: Pregnancy testing according to institutional standards for women of childbearing potential must be performed within 2 weeks prior to pre-entry/Step 1.) * Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of study therapy or that may affect the interpretation of the results or render the patient at high risk from treatment complications. * Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements or interfere with interpretation of study results. * Use of any investigational product within 30 days prior to pre-entry/Step 1.",NA,ALL,NA,"[{'measure': 'Time to invasive or noninvasive IBTR.', 'description': 'Time from randomization to any invasive or noninvasive IBTR or last follow-up (expressed as % IBTR-free)', 'timeFrame': '5 years'}]","[{'measure': 'Percent of women with an intact index breast at report of the primary endpoint inclusive of salvage second breast conservation procedures.', 'description': 'Time from randomization to any breast procedure after the initial surgery or last follow-up (expressed as % with intact index breast)', 'timeFrame': 'Through study completion, an average of 15 years.'}, {'measure': 'Time from randomization to the first occurrence of invasive ipsilateral breast tumor recurrence.', 'description': 'Time from randomization to any invasive IBTR or last follow-up (expressed as percentage of invasive IBTR-free', 'timeFrame': '5 years'}, {'measure': 'Time from randomization to diagnosis of a local, regional or distant recurrence as a first cancer event.', 'description': 'Time from randomization to any breast cancer recurrence at a local, regional or distant site or last follow-up (expressed as percentage of recurrence-free)', 'timeFrame': '5 years'}, {'measure': 'Time from randomization to the first distant cancer event (either a recurrence or a secondary primary cancer).', 'description': 'Time from randomization to any cancer occurring at a distant site or last follow-up (expressed as percentage of distant disease-free)', 'timeFrame': '5 years'}, {'measure': 'Time from randomization to any death.', 'description': 'Time from randomization to any death or last follow-up (expressed as percent surviving)', 'timeFrame': '5 years'}]" 223,NCT00289016,"{'fullName': 'BioVex Limited', 'class': 'INDUSTRY'}",A Study of Talimogene Laherparepvec in Stage IIIc and Stage IV Malignant Melanoma,COMPLETED,The primary objective of the study was to assess the clinical efficacy of talimogene laherparepvec in terms of tumor response rates.,['Melanoma'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Talimogene Laherparepvec', 'description': 'Up to 4 mL of 10⁸ pfu/mL/per intratumoral injection', 'armGroupLabels': ['Talimogene Laherparepvec'], 'otherNames': ['OncoVEX^GM-CSF', 'T-VEC', 'IMLYGIC']}]","Inclusion Criteria: 1. Patients with histologically proven stage IIIc (including two or more palpable lymph nodes, extracapsular or in-transit metastases) or stage IV melanoma that is not eligible for curative surgery and who have one or more tumors that are accessible for direct injection. 2. Tumors 0.5 to 10 cm in the longest diameter that are suitable for injection (i.e. not bleeding or weeping). 3. Serum lactate dehydrogenase (LDH) levels ≤ 2.0 times the upper limit of normal. 4. Aged 18 years or more. 5. Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1. 6. Clinically immunocompetent. 7. Recovered from prior therapy with at least 4 weeks since the last exposure to chemotherapy or radiotherapy. 8. Total white cell count ≥ 3.0 x 10\^9/L, platelet count ≥ 80 x 10\^9/L. 9. Serum creatinine ≤ 0.2 mmol/L. 10. Bilirubin ≤ 1.5 times the upper limit of the normal range, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) equal to or less than twice the upper limit of the normal range and alkaline phosphatase equal to or less than twice the upper limit of the normal range. Exclusion Criteria: 1. Participation in any previous melanoma immunotherapy trial within one month prior to entry to this trial or any trial of any other investigational agent within the last month prior to entry to this trial. 2. Tumors to be injected lying in mucosal regions or close to an airway, major blood vessel or spinal cord that, in the opinion of the Investigators, could cause occlusion or compression in the case of tumor swelling or erosion into a major vessel in the case of necrosis. 3. Pregnancy, lactation or lack of effective contraception in women of child-bearing potential; lack of effective contraception in men if the partner is of child-bearing potential; women must have been practising an effective contraceptive method for at least three months prior to entry in to the trial (hormonal contraception or intrauterine device in conjunction with a barrier method OR surgically sterilised). Men must use a condom or be surgically sterilised. 4. Major surgery within the 14 days prior to entry to the trial. 5. Intercurrent serious infections within the 28 days prior to entry to the trial. 6. Life-threatening illness unrelated to cancer. 7. Treatment with antiviral agents within the 14 days prior to entry to the trial. 8. Uncontrolled congestive cardiac failure. 9. Clinically active autoimmune disease. 10. Dermatoses involving or near to the tumors to be injected. Limb tumors may not be injected if active dermatoses are present on the same limb. Trunk and head and neck tumors must not be injected if dermatoses are present within 50 cm of the tumor. 11. Known to test positive for human immunodeficiency virus (HIV), hepatitis B or C or syphilis. 12. Patient only has injectable tumors that are not potentially resectable in the case of tumor necrosis or swelling. 13. Previous history of malignancies of other types that have occurred or recurred within the previous 5 years with the exception of cone biopsied carcinoma of the cervix. 14. Corticosteroid use.",NA,ALL,NA,"[{'measure': 'Objective Tumor Response Rate', 'description': 'Objective response rate is defined as the percentage of participants with an overall best response of complete response or partial response. The objective response to treatment was assessed by computed tomography (CT) scanning or other clinical measurement using modified Response Evaluation Criteria In Solid Tumors (RECIST). Responses must have been confirmed on two visits not less than 4 weeks apart.\n\nTumor burden for a visit was calculated as the sum of the longest diameters of all tumors identified and measured up to that visit. Tumor response at each visit was derived from tumor burden, as follows:\n\n* Complete response (CR): zero tumor burden\n* Partial response (PR): a 30% or greater decrease in tumor burden\n* Progressive disease (PD): a 20% or greater increase in tumor burden\n* Stable disease (SD): none of the above (a \\< 30% decrease and \\< 20% increase in tumor burden)', 'timeFrame': 'From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days'}]","[{'measure': 'Overall Survival', 'description': 'Overall survival (OS) was calculated from the date of the first talimogene laherparepvec dose to the date of death. Median OS was estimated using the Kaplan-Meier method.', 'timeFrame': 'From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days'}, {'measure': 'Time to Progression', 'description': 'Time to progression was calculated from the date of the first talimogene laherparepvec dose to the first date of documented progressive disease (via clinical symptom or tumor burden assessment) that was not followed by a later response of CR, PR, or stable disease.\n\nMedian time to progression was calculated using the Kaplan-Meier method.', 'timeFrame': 'From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days.'}, {'measure': 'Time to Longest Continuous Response', 'description': ""Time to response was calculated from the date of the first talimogene laherparepvec dose to the initial date of the participant's last response interval."", 'timeFrame': 'From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days.'}, {'measure': 'Duration of Response', 'description': 'Duration of response was calculated from the initial date of response (CR or PR) until the date of progressive disease (or until last follow up that was CR or PR). Participants could have multiple response periods; in this situation, the last response interval was used for the calculation of duration of response.', 'timeFrame': 'From enrollment until the data cut-off date of 29 November 2008; Median duration of follow-up was 253 days.'}, {'measure': 'Number of Participants With Adverse Events', 'description': 'The severity of an adverse event (AE) was graded according to Common Toxicity Criteria for Adverse Events (CTCAE) Version 3 (1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death).\n\nSerious adverse events include death, life-threatening events, events requiring or prolonging hospitalization, result in persistent or significant disability/incapacity, or a congenital anomaly/birth defect, or otherwise important medical events that may jeopardise the patient or require intervention to prevent one of the above outcomes.', 'timeFrame': 'From first dose of talimogene laherparepvec until 30 days after the last dose; the median (minimum, maximum) duration of treatment was 82 (1, 346) days.'}]" 224,NCT00471133,"{'fullName': 'Ichor Medical Systems Incorporated', 'class': 'INDUSTRY'}",Safety and Immunogenicity of a Melanoma DNA Vaccine Delivered by Electroporation,COMPLETED,"The purpose of this study is to evaluate the safety and immunogenicity of a DNA vaccine encoding a melanosomal antigen in melanoma patients at risk for disease progression or recurrence. In this study, the vaccine will be administered intramuscularly using a device that applies brief electrical fields to the tissue at the site of injection (a technique known as electroporation). It is expected that this device will improve the delivery of the vaccine. This study is being performed to determine if this procedure can be administered safely and if it is capable of inducing immune responses to the vaccine.","['Melanoma (Skin)', 'Intraocular Melanoma']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'Xenogeneic Tyrosinase DNA Vaccine', 'armGroupLabels': ['Xenogeneic Tyrosinase']}, {'type': 'DEVICE', 'name': 'TriGrid Delivery System for Intramuscular Electroporation', 'armGroupLabels': ['Xenogeneic Tyrosinase']}]","Inclusion Criteria: * Patients must have documented, histologically confirmed malignant melanoma, American Joint Commission on Cancer (AJCC) Stage IIB- IV. Patients with stage IIb-III disease are only eligible after standard surgical care with wide local excision and appropriate lymph node sampling. Patients with stage IIb, IIc, or III melanoma who are free of disease after surgical resection are also eligible, only if they have refused high dose Interferon-alfa (INTRON A) or have had a recurrence while on Interferon-alfa. * Patients with choroidal melanoma may participate if they fulfill one of the following criteria: Basal diameter \>16mm; Height \>8mm or involvement of the ciliary body with tumor. * Patients must be at least 18 years of age and must be capable of understanding the consent form and giving informed consent. * Karnofsky Score \> 80 * Life Expectancy \> 6 months * HLA-A1, A2, A24, or B35+ as assessed by low resolution phenotyping * White blood cell count ≥ 2,000/mm3 * Platelet count ≥ 100,000/mm3 * Neutrophil count ≥ 1,000/mm3 * Hemoglobin ≥ 9.0 g/dL * Serum AST and ALT ≤ 2.5 times upper limit of normal (ULN) * Serum Bilirubin ≤ 2.0 mg/dL * Serum Creatinine ≤ 2.0 mg/dL * Serum Alkaline Phosphatase \< 2.5 times ULN * Serum Creatine phosphokinase (CPK) \< 2.5 times ULN Exclusion Criteria: * Documented metastases in brain * Clinical history of HIV, HepB, HepC, and/or HTLV I. * Active autoimmune disease other than vitiligo * Patients previously immunized using the tyrosinase DNA sequence, protein, or peptides. * Systemic immunosuppressive therapy (corticosteroids, or other immunosuppressive drugs) within the previous 28 days * Surgery and/or radiotherapy within the previous 28 days * Chemotherapy and/or biotherapy within the previous 28 days * Participation in an investigational study within previous 28 days * Patients with cardiac demand pacemakers. * Women who are pregnant or \< 3 months post partum or nursing. * Women of child-bearing potential and sexually active men must be using appropriate contraception during the course of this study. * Any other concurrent medical condition that in the opinion of the Principal Investigator or co-Principal Investigator's would preclude study compliance.",NA,ALL,NA,"[{'measure': 'Evaluate the safety and feasibility of electroporation mediated intramuscular delivery of a mouse tyrosinase plasmid DNA vaccine in patients with stage IIB, IIC, III, or IV melanoma.', 'timeFrame': 'one year'}]","[{'measure': 'Assess patients with measurable tumor for evidence of anti-tumor response following immunization.', 'timeFrame': '6 months'}, {'measure': 'Assess the magnitude and frequency of tyrosinase specific immunologic responses in the immunized patients', 'timeFrame': '6 months'}]" 225,NCT02459067,"{'fullName': 'TC Biopharm', 'class': 'INDUSTRY'}",ImmuniCell® in Patients With Advanced Cancers,TERMINATED,"To determine the safety, tolerability, maximum tolerated dose (MTD) and efficacy of ImmuniCell® in patients with melanoma, renal cell cancer (RCC) or non-small cell lung cancer (NSCLC). The study is an adaptive design that has 3 stages: Stage 1 - dose escalation, Stage 2 - efficacy, and Stage 3 - confirm efficacy in one of the tumor types.","['Malignant Melanoma', 'Non-small Cell Lung Cancer', 'Renal Cell Cancer']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'ImmuniCell®', 'description': 'Autologous γδ T Lymphocytes', 'armGroupLabels': ['ImmuniCell®']}]","Inclusion Criteria: 1. Male or female patients aged ≥18 years 2. Performance status Eastern Cooperative Oncology Group (ECOG) 0 or 1 3. Subjects with histological or cytological confirmation of advanced malignant melanoma, renal cell carcinoma or NSCLC which are refractory to current standard treatments or who have indolent disease for which immunotherapy may be beneficial 4. Measurable disease according to the irRC criteria 5. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted \<2 weeks prior to Cycle 1: * Creatinine ≤ 1.5 x upper limit of normal (ULN) OR a calculated creatinine clearance ≥ 50 ml/min * Total bilirubin ≤ 1.5 x ULN * Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 x ULN or ≤ 5 x ULN with liver metastases * Absolute lymphocyte count ≥1.0 x 10E9/L * Absolute Neutrophil Count (ANC) ≥1.5 x 10E9/L * Platelets ≥100 x 10E9/L * Haemoglobin ≥ 10 g/dL 6. Life expectancy of at least 3 months 7. Suitable increase in starting γδ T cell number to final γδ T cell number in the proliferation assay between 10 days in culture 8. Able to give informed, written consent 9. For female patients and female partners of male patients: must be surgically sterile, postmenopausal, or compliant with two forms of contraception (one of which must be a barrier method) during and for 6 months after the treatment period; female patients must have a negative urine pregnancy test at screening and must not be breast-feeding. Exclusion Criteria: 1. Other primary cancers apart from non-melanoma skin cancers, carcinoma - in situ of the cervix, or a prior cancer treated with curative intent more than 2 years ago without any evidence or recurrent disease 2. Uncontrolled systemic infection 3. Systemic steroid therapy or other immune-suppressants (except in cases where the patient is receiving treatment with replacement doses for adrenal insufficiency) 4. Treatment with bisphosphonates, for instance zoledronate, in the previous 3 months and throughout the trial 5. New York Heart Association (NYHA) functional class ≥3 or myocardial infarction within 6 months 6. Clinically-significant uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation not requiring therapy. 7. Ulcerative Colitis / Inflammatory bowel disease, Addison's disease 8. Pregnancy or lactation before or during the trial. A urine pregnancy test will be carried out at screening 9. Taking any other investigational medicinal product (IMP) or participation in another interventional clinical trial in the previous 30 days 10. Less than 4 weeks since systemic anti-cancer therapy (tyrosine kinase inhibitors, chemotherapy, immunotherapy, hormonal therapy, radiotherapy) and less than 6 weeks since mitomycin C and nitrosureas 11. Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the trial or evaluation of the trial results 12. Any other condition considered by a trial physician to be inappropriate for inclusion to the study such as contraindications to leukapheresis (contraindications to heparin which are: recent cerebral haemorrhage; peptic ulcer; recent surgery to eye or nervous system; hypersensitivity to heparin; past history of Type II heparin induced thrombocytopenia; past history of significant spontaneous haemorrhage; known haemophilia or other bleeding disorder). 13. Serological evidence of active infection",NA,ALL,NA,"[{'measure': 'Proportion of patients with drug-related > grade 3 toxicity (except for nausea, vomiting or grade 3 diarrhoea without maximal supportive therapy; anaemia, alopecia, or asymptomatic grade 3 laboratory findings that last for < 7 days)', 'timeFrame': '3 months'}, {'measure': 'Document the clinical response (immediate or delayed CR, PR, SD or PD) of the patients following ImmuniCell® treatment and assess the data for a response signal to guide the confirmatory stage', 'timeFrame': '12 months'}]","[{'measure': 'Changes in markers of immune response (such as IFN-γ, IL-2 and TNF-α) before the first and subsequent ImmuniCell® infusions', 'description': 'Changes in markers of immune response (such as IFN-γ, IL-2 and TNF-α) before the first and subsequent ImmuniCell® infusions', 'timeFrame': '12 months'}, {'measure': 'Changes in peripheral T lymphocyte counts before the first and subsequent ImmuniCell® infusions (optional)', 'timeFrame': '12 months'}]" 226,NCT00811200,"{'fullName': 'Leiden University Medical Center', 'class': 'OTHER'}",Treatment Of Radiation Retinopathy Trial,UNKNOWN,"The purpose of this study is to demonstrate a statistically significant improvement of visual acuity after treatment using either Lucentis® or Triamcinolone® compared to no treatment, in patients with radiation retinopathy.",['Uveal Melanoma'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}","[{'type': 'DRUG', 'name': 'ranibizumab', 'description': 'three initial monthly intra vitreal injections with 0.5 mg ranibizumab', 'armGroupLabels': ['1: Lucentis']}, {'type': 'DRUG', 'name': 'triamcinolone acetonide', 'description': 'at baseline one intra vitreal injection with 4.0 mg triamcinolone acetonide', 'armGroupLabels': ['2: Kenalog']}, {'type': 'OTHER', 'name': 'sham', 'description': 'at baseline one sham-injection', 'armGroupLabels': ['3: No treatment']}]","Inclusion Criteria: * The eye was previously irradiated for treatment of a uveal melanoma; * Decrease of visual acuity after irradiation therapy by more than 10 letters (ETDRS) and is now 20/40 or less; * Vision decrease is considered to be due to central radiation retinopathy with significant macular edema or optic disc edema; * Age 18 years or older; * The patient is fully competent; * Written informed consent to participate in the trial is given. * Patient is not pregnant (or not fertile) and is willing to use contraceptives for the duration of the trial (one year) * Patient is willing and able to return for follow-up. Exclusion Criteria: * Vision decrease is considered to be due to ischemic radiation retinopathy without macular edema or optic disc edema; * Other, approved therapy indicated for treatment of condition; * Presence of metastasis; * Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial; * Pre-existing retinopathy due to other disorders;",NA,ALL,NA,"[{'measure': 'To demonstrate a statistically significant superiority of intravitreal ranibizumab (0.5mg) or triamcinolone acetonide (4.0mg) to no treatment, in the mean change from baseline in best corrected visual acuity (BCVA)', 'timeFrame': 'one year'}]","[{'measure': 'To evaluate the time course of BCVA changes on ranibizumab (0.5 mg) and triamcinolone acetonide (4.0mg) relative to no treatment.', 'timeFrame': 'one year'}, {'measure': 'To evaluate the effects of ranibizumab (0.5 mg) and triamcinolone acetonide (4.0mg) on central retinal thickness, severity of retinopathy and other anatomical changes relative to no treatment', 'timeFrame': 'one year'}, {'measure': 'To demonstrate a possible relation between decreasing levels of angiogenic factors (such as VEGF) in the anterior chamber fluid and a good response to treatment with ranibizumab or triamcinolone acetonide, and radiation retinopathy', 'timeFrame': '4 weeks'}]" 227,NCT00082914,"{'fullName': 'National Cancer Institute (NCI)', 'class': 'NIH'}",Denileukin Diftitox in Treating Patients With Metastatic Melanoma or Metastatic Kidney Cancer,COMPLETED,"RATIONALE: Denileukin diftitox may be able to make the body build an immune response to kill tumor cells. PURPOSE: This phase II trial is studying how well denileukin diftitox works in treating patients with metastatic melanoma or metastatic kidney cancer.","['Kidney Cancer', 'Melanoma (Skin)']",INTERVENTIONAL,"{'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'denileukin diftitox'}]","DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Melanoma * Kidney cancer * Metastatic disease * Measurable disease * Documented disease progression while receiving standard therapy * No resectable local or regional disease PATIENT CHARACTERISTICS: Age * 16 and over Performance status * ECOG 0-2 Life expectancy * More than 3 months Hematopoietic * WBC ≥ 3,000/mm\^3 * Platelet count ≥ 90,000/mm\^3 * Lymphocyte count ≥ 500/mm\^3 * No concurrent coagulation disorders Hepatic * Bilirubin ≤ 2.0 mg/dL (\< 3.0 mg/dL for patients with Gilbert's syndrome) * AST and ALT \< 3 times normal * Albumin ≥ 2.5 g/dL * Hepatitis B surface antigen negative * Hepatitis C antibody negative Renal * Creatinine ≤ 2.0 mg/dL Cardiovascular * Normal thallium stress test\* * No prior myocardial infarction * No history of severe coronary artery disease * No major medical illness of the cardiovascular system NOTE: \*For patients \> 50 years of age OR who have a history of cardiovascular disease Pulmonary * No major medical illness of the respiratory system Immunologic * HIV negative * No active systemic infection * No presence of opportunistic infections * No primary or secondary immunodeficiency * No autoimmune disease * No other known immunodeficiency Other * No sensitivity to denileukin diftitox or any of its components (e.g., diphtheria toxin, interleukin-2, or excipients) * Willing to undergo leukapheresis * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Prior treatment with interleukin-2 allowed provided the patient's disease status required this therapy Chemotherapy * Recovered from prior chemotherapy Endocrine therapy * No concurrent systemic steroids Radiotherapy * Recovered from prior radiotherapy Surgery * Not specified Other * More than 3 weeks since prior systemic anticancer therapy * No other concurrent systemic anticancer therapy",NA,ALL,NA,[{'measure': 'Clinical response'}],"[{'measure': 'Changes in levels of CD4-positive CD25-positive lymphocytes in the peripheral blood'}, {'measure': 'Toxicity'}]" 228,NCT01339416,"{'fullName': 'ViiV Healthcare', 'class': 'INDUSTRY'}","HIV Cohort Study At Johns Hopkins University, University of North Carolina at Chapel Hill and Vanderbilt University",COMPLETED,"Human Immunodeficiency Virus (HIV) infected patients in the HIV registries of Johns Hopkins University, University of North Carolina and Vanderbilt University will be followed in the routine clinical care to estimate the rates of prespecified clinical events in this population.","['HIV', 'AIDS']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}",NA,"Inclusion Criteria: * HIV infection. Exclusion Criteria: * None.","HIV infected patients seeking treatment at Johns Hopkins University, Vanderbilt University and University of North Carolina at Chapel Hill",ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Incidence Rate of Malignancies', 'description': ""Incidence rate of malignancies was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Malignancies included acquired immunodeficiency syndrome (AIDS)-defining malignancies and non-AIDS defining malignancies. AIDS-defining malignancies included invasive cervical cancer, non-Hodgkin's lymphoma and kaposis sarcoma; non-AIDS defining malignancies included but not limited to Hodgkin's disease, lung cancer, liver cancer, anal cancer, melanoma of the skin, leukemia, renal cancer, and prostate cancer. Overall data for non-AIDS defining malignancies and individual data for AIDS-defining malignancies was reported. Incidence rate was computed as the number of events per 100 person-years."", 'timeFrame': 'Up to Week 626'}, {'measure': 'Incidence Rate of Acquired Immunodeficiency Syndrome (AIDS)-Defining Opportunistic Infections', 'description': 'Incidence rate of AIDS-defining opportunistic infections was calculated as the number of events divided by person-time. Only the first diagnosis of each event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Opportunistic infections were those that occurred on immune-compromised participants. AIDS-defining infections included: esophageal candidiasis; pneumocystes jiroveci; non-tuberculous mycobacterium infection; AIDS dementia complex; disseminated cryptococcosis; cytomegalovirus (all sites); wasting syndrome; toxoplasmosis; cytomegalovirus retinitis; mycobacterium tuberculosis; Progressive (Prog.) multifocal leukoencephalopathy; histoplasmosis; cryptosporidiosis; recurrent pneumonia; herpes simplex infection; extra-pulmonary coccidioidomycosis; salmonella septicemia; isosporiasis.', 'timeFrame': 'Up to Week 626'}, {'measure': 'Incidence Rate of Myocardial Infarction', 'description': 'Incidence rate of myocardial infarction (MI) was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.', 'timeFrame': 'Up to Week 626'}, {'measure': 'Incidence Rate of Liver Failure', 'description': 'Incidence rate of liver failure was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date.', 'timeFrame': 'Up to Week 626'}, {'measure': 'Incidence Rate of Viral Encephalitis', 'description': 'Incidence rate of viral encephalitis was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Viral encephalitis was defined as inflammation of the brain due to virus.', 'timeFrame': 'Up to Week 626'}]","[{'measure': 'Incidence Rate of Rhabdomyolysis', 'description': 'Incidence rate of rhabdomyolysis was calculated as the number of events divided by person-time. Only first diagnosis of the event per participant was included. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. Rhabdomyolysis was a condition of muscle fibers breakdown.', 'timeFrame': 'Up to Week 626'}, {'measure': 'Incidence Rate of Death', 'description': 'Incidence rate of death was calculated as the number of events divided by person-time. Person-time was calculated as the sum of all time contributed by each individual from the date of HIV care initiation at that institution or January 1, 2000 if in care prior to this date. All-cause mortality was used for the analyses.', 'timeFrame': 'Up to Week 626'}]" 229,NCT00553306,"{'fullName': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}",Laboratory-Treated T Cells and Aldesleukin After Cyclophosphamide in Treating Patients With Stage IV Melanoma,COMPLETED,"RATIONALE: Laboratory-treated T cells may be able to kill tumor cells when they are put back into the body. Aldesleukin and cyclophosphamide may stimulate the immune system in different ways and stop tumor cells from growing. Giving laboratory-treated T cells together with aldesleukin after cyclophosphamide may be an effective treatment for melanoma. PURPOSE: This phase I/II trial is studying the side effects of giving laboratory-treated T cells together with aldesleukin after cyclophosphamide and to see how well they work in treating patients with stage IV melanoma.","['Recurrent Melanoma', 'Stage IV Melanoma']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'therapeutic autologous lymphocytes', 'description': 'Given IV', 'armGroupLabels': ['Arm I'], 'otherNames': ['AL', 'Autologous Lymphocytes', 'autologous T cells']}, {'type': 'BIOLOGICAL', 'name': 'aldesleukin', 'description': 'Given subcutaneously', 'armGroupLabels': ['Arm I'], 'otherNames': ['IL-2', 'interleukin II', 'Proleukin', 'recombinant human interleukin-2', 'recombinant interleukin-2', 'TCGF, interleukin']}, {'type': 'DRUG', 'name': 'cyclophosphamide', 'description': 'Given IV', 'armGroupLabels': ['Arm I'], 'otherNames': ['CPM', 'CTX', 'Cytoxan', 'Endoxan', 'Endoxana', 'Enduxan']}, {'type': 'PROCEDURE', 'name': 'biopsy', 'description': 'Optional correlative studies', 'armGroupLabels': ['Arm I'], 'otherNames': ['biopsies']}, {'type': 'OTHER', 'name': 'immunohistochemistry staining method', 'description': 'Optional correlative studies', 'armGroupLabels': ['Arm I'], 'otherNames': ['immunohistochemistry']}, {'type': 'OTHER', 'name': 'flow cytometry', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I']}, {'type': 'GENETIC', 'name': 'polymerase chain reaction', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I'], 'otherNames': ['PCR']}]","Inclusion * Histopathologically documented metastatic melanoma * Karnofsky Performance status of at least 70% * Expected survival of greater than 16 weeks * WBC \> 2,500/uL (ANC \> 1,000 uL) * Platelet count \> 80,000 uL * HCT \> 28% * Patients whose tumor expresses targeted antigen and restricting allele against which CD4 and CD8 T cell clones can be generated * No CNS metastasis * Patient's whose tumor expresses an antigen and HLA type for which both an HLA Class I and HLA Class II epitope are listed, will be eligible for this study * CD4 and CD8 T cell clones do not necessarily have to target the same antigen to be eligible for the study, it is only necessary that the targeted antigen is expressed by the tumor and its epitope is restricted by an HLA allele expressed by the patient * Evidence of measurable residual disease by clinical exam or imaging studies Exclusion * Current central nervous system metastases; patients with history of CNS metastases that show no current evidence of active disease are eligible * Patients with active infections or oral temperature \> 38.2 C within 72 hours of study entry or systemic infection requiring chronic maintenance or suppressive therapy * Current treatment with steroids * Patients who are HIV seropositive (poor CD4 T cell generation due to low CD4 T cell recovery and likely HIV reservoir in stimulator cells used in vitro culture) * Prognosis less than 6 months * FOR T CELL INFUSION: * Pregnant women, nursing mothers of reproductive ability who are unwilling to use effective contraception or abstinence; women of childbearing potential must have a negative pregnancy test within two weeks prior to entry * Serum creatinine \> 2.0 mg/dL * Significant hepatic dysfunction (hepatic toxicity \>= grade 2 (NCICTC) of whatever origin * Clinically significant pulmonary dysfunction, as determined by medical history and physical exam; patients so identified will undergo pulmonary functions testing and those with FEV1 \< 60% of normal or DLco (corr for Hgb) \< 55% will be excluded * Significant cardiovascular abnormalities as defined by any one of the following: congestive heart failure, clinically significant hypotension, symptoms of coronary artery disease, presence of cardiac arrhythmias on EKG requiring drug therapy * Ejection fraction \< 50% excludes patients * Current central nervous system metastases; patients with history of CNS metastases that show no current evidence of active disease are eligible * Serum calcium \> 12 mg/dL * Chemotherapeutic agents (standard or experimental), radiation therapy, or other immunosuppressive therapies less than 4 weeks prior to T cell therapy; patients with bulky disease may undergo 1-2 courses of cytoreductive chemotherapy but treatment will be discontinued at least 4 weeks prior to T cell therapy; patients should have recovered fully from all previous treatment-related toxicities * History of seizures * Patients must not be receiving any other experimental drugs within 4 weeks of the initiation of the protocol and must have recovered from all side effects of such therapy * Patients with \>= Grade 2 hepatotoxicity are excluded * Patients with a history of autoimmune disease requiring active systemic therapy are excluded * The following agents are not allowed while on study: systemic corticosteroids (except as outlined for management of toxicity of nontransduced CTL), immunotherapy (for example, interleukins, interferons, melanoma vaccines, intravenous immunoglobulin, expanded polyclonal TIL or LAK therapy), pentoxifylline, or other investigational agents",NA,ALL,NA,"[{'measure': 'Safety and toxicity as assessed by NCI CTC version 3.0', 'timeFrame': '8 weeks post treatment'}, {'measure': 'Antitumor effects of CD4+ and CD8+ antigen-specific T-cells', 'timeFrame': '8 weeks post treatment'}, {'measure': 'Duration of in vivo persistence of adoptively transferred CD8+ antigen-specific T cell clones in the presence or absence of transferred CD4+ T cells', 'timeFrame': '8 weeks post treatment'}]","[{'measure': 'In vivo antitumor efficacy of the infused autologous antigen-specific CD4+ T cells', 'timeFrame': '8 weeks post treatment'}]" 230,NCT01425749,"{'fullName': 'University of Virginia', 'class': 'OTHER'}",Study to Assess Safety and Immune Response of Stage IIB-IV Resected Melanoma After Treatment With MAGE-A3 ASCI,COMPLETED,"The goals of this study are to 1) assess the safety of recombinant MAGE-A3 protein combined with AS15 Immunological Adjuvant System (recMAGE-A3 + AS15) as an Antigen-Specific Cancer Immunotherapeutic (MAGE-A3 ASCI) when administered in two different administration sites, intramuscular (IM) or intradermal/subcutaneous (ID/SC), and 2) to provide preliminary data on the immunological response to ASCI in the injection site microenvironment, in the node draining the vaccine site (sentinel immunized node) and in the blood and whether there are large differences in the magnitude, persistence, or type of immune response induced as a function of the ASCI injection. Evaluation of immune responses to the ASCI will include, amonth others antiMAGE-A3 antibody responses and CD4+ and CD8+ T cell responses.",['Melanoma'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'recMAGE-A3 + AS15 ASCI', 'description': 'Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.', 'armGroupLabels': ['Arm A', 'Arm B'], 'otherNames': ['recMAGE-A3 + AS15 ASCI IM', 'recMAGE-A3 + AS15 ASCI ID/SC']}]","Inclusion Criteria: * Histologically or cytologically proven melanoma that meets one of the following two criteria: * Stage IIB-IV melanoma rendered clinically free of disease by surgery, other therapy, or spontaneous remission within 6 months prior to registration. * Stage III or IV melanoma with disease. Patients may be eligible if there are definite or equivocal findings of persistent or metastatic disease as long as those findings do not meet RECIST criteria for measurable disease. * Expression of MAGE-A3 by the tumor (primary or metastasis). * Patients may have had multiple primary melanomas. * Patients may have had, or may have, a metastasis from a cutaneous, mucosal, unknown primary site. * Patients with brain metastases may be eligible if all of the following are true: * The total number of brain metastases ever is less than or equal to 3. * The brain metastases have been completely removed by surgery or have been treated completely by stereotactic radiotherapy. Stereotactic radiotherapy, such as gamma knife, can be used up to 1 week prior to study entry. * There has been no evident growth of any brain metastasis since treatment. * No treated brain metastasis is greater than 2 cm in diameter at the time of protocol entry. * Patients must have at least two intact axillary and/or inguinal lymph node basins. * The interferon education packet must be completed satisfactorily for those who are eligible for, but refuse, interferon therapy. * All patients must have: * ECOG performance status of 0 or 1. * Ability and willingness to give informed consent. * Laboratory parameters as follows: 1. ANC \> 1000/mm3, and Platelets \> 75,000/mm3 and Hgb \> 9 g/dL 2. Hepatic: AST and ALT up to 2.5 x upper limits of normal (ULN) Bilirubin up to 2.5 x ULN Alkaline phosphatase up to 2.5 x ULN LDH up to 2x ULN 3. Renal: Creatinine up to 1.5 x ULN 4. Serology: HIV negative (antibody screening), Hepatitis C negative 5. HGBA1C level of \< 7.5% * Patients must be 18 years or older at study entry Exclusion Criteria: * Patients with primary ocular melanoma. * Patients who have had brain metastases unless they meet the criteria outlined in the inclusion criteria * Patients who are currently receiving systemic cytotoxic chemotherapy, radiation, monoclonal antibody therapy, or other experimental therapy, or who have received this therapy within the preceding 4 weeks. Patients who are currently receiving nitrosoureas or who have received this therapy within the preceding 6 weeks. * Patients who have received isolated limb infusion (ILI) or isolated limb perfusion (ILP) for melanoma will not be eligible unless they have experienced tumor progression after the ILI/ILP, and the ILI/ILP was not performed within the prior 12 weeks. * Patients will not be eligible if there is clinically detectable melanoma deemed likely by the investigator to require intervention during the first 12 weeks of the study that would require premature discontinuation. * Patients with known or suspected allergies to any component of the MAGE-A3 ASCI. * Patients receiving the following medications at study entry or within the preceding 4 weeks are excluded, except as specified below: 1. Agents with putative immunomodulating activity, but with the exception of non-steroidal anti-inflammatory agents and topical steroids. 2. Antibodies to CTLA-4, PD-1, PD-L1, or CD137 may not have been received in the past 12 weeks, and patients will be eligible only if there has been melanoma progression since that therapy was administered. 3. Allergy desensitization injections. 4. Systemic corticosteroids, administered parenterally or orally. Inhaled steroids are not permitted. Topical corticosteroids are acceptable, including steroids with very low solubility administered nasally for local effects only. 5. Any growth factors (e.g. GM-CSF, G-CSF, erythropoietin). 6. Interferon therapy. 7. Interleukin-2 or other interleukins. 8. Targeted therapies designed to inhibit BRAF, MAPKinase, mTOR, or their signaling pathways. * Prior active immunotherapy or vaccines for melanoma may be an exclusion criterion in some circumstances. Exceptions to this exclusion criterion are as follows: 1. Patients who have recurred or progressed either after or during administration of a melanoma vaccine may be eligible to enroll in this study 12 weeks following their last vaccination. 2. Patients may not have been previously administered the synthetic MAGE-A3 protein, though prior vaccinations with up to 4 synthetic MAGE-A3 peptides (up to 16 amino acids in length, each) is allowed. * Pregnancy or the possibility of becoming pregnant during vaccine administration. Female patients of child-bearing potential must have a negative pregnancy test (urinary or serum beta-HCG) prior to administration of the first MAGE-A3 ASCI dose. Males and females must agree, in the consent form, to use effective birth control methods during the course of vaccination. Women must also not be breast feeding. This is consistent with existing standards of practice for vaccine and chemotherapy protocols. * Patients in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator. * Patients classified according to the New York Heart Association classification as having Class III or IV heart disease. * Patients with a body weight \< 110 lbs because of the amount and frequency with which blood will be drawn, and because of the biopsies required. * Patients must not have had prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. Patients with an active autoimmune disorder requiring these therapies are also excluded. The following will not be exclusionary: * Laboratory evidence of autoimmune disease (e.g. positive ANA titer) without symptoms * Clinical evidence of vitiligo * Other forms of depigmenting illness * Mild arthritis requiring NSAID medications",NA,ALL,NA,"[{'measure': 'Number of Participants With Treatment-related Adverse Events as a Measure of Safety and Tolerability', 'description': 'grade 2 treatment-related adverse events graded by CTCAE v4', 'timeFrame': 'Over 6 months'}, {'measure': 'Enumeration of CD4 and CD8 T Cell Responses to MAGE-A3 Epitopes in the Injection Site-draining Lymph Node (Sentinel Immunized Node, SIN) as a Measure of Immunogenicity.', 'description': 'Flow cytometry on in vitro stimulated lymphocytes. A positive immune response was identified as one with bifunctional CD4+ or CD8+ T cells, producing both TNF alpha and IFN-gamma after exposure to antigen.', 'timeFrame': 'One week after 3 doses of study drug, on day 22.'}]","[{'measure': 'Enumeration of CD4+ and CD8+ T Cells Reactive to MAGE-A3 Epitopes in Peripheral Blood as a Measure of Immunogenicity.', 'description': 'The analysis determined the proportion of CD4+ (and/or CD8+) T cells producing IFN-gamma or TNFα, or both, in response to MAGE-A3 peptide pools (with irrelevant peptide as negative control). T cell response was defined when T cells producing both IFNγ and TNFα in response to MAGE-A3 peptides exceeded (a) twice the maximum of 2 negative controls (PRAME peptides, media only), corrected for pre-existing response; and (b) exceeded the negative controls by at least 0.2% of the T cell population. These criteria also were used to define immunogenicity by ELIspot (IFNγ only). If the negative control values for a given sample were zero, a meaningful fold-increase could not be calculated; so, in those cases, we used the minimum detectable value among all similar assays (0.06%) as the negative control value for that sample.', 'timeFrame': 'Over 6 months'}, {'measure': 'Identification of Antibody Responses to MAGE-A3 After MAGE-A3 ASCI Administration as a Measure of Immunogenicity.', 'description': 'Antibody responses were assessed in serum by ELISA, assay for IgG. Seroconversion was defined as a detectable Ab response by ELISA (\\>20 EU/ml).', 'timeFrame': 'Over 6 months, typically weeks 1, 7, 13, 26'}, {'measure': 'Characterization of the Maturation and Activation of Dendritic Cell (DC) Populations in the Sentinel Immunized Node (SIN) After Treatment With MAGE-A3 ASCI.', 'description': 'Number of CD83+ cells (mature DC) and CD1a+ cells (immature DC/Langerhans cells) per mm\\^2 in cross-sections of sentinel immunized nodes', 'timeFrame': 'Over 3 weeks'}, {'measure': 'A Preliminary Evaluation of Cellular Components of the Injection Site Microenvironment for Cutaneous Immunization With MAGE-A3 ASCI (Activated T Cells, Th1,Th2, Th17 Infiltrating CD4 Cells, Regulatory T Cells, and Myeloid-derived Suppressor Cells).', 'description': 'Cells per mm\\^2 in the superficial dermis at the vaccine site microenvironment, by enumeration of immunohistochemically stained slides. Biopsies of the vaccine sites were taken at week 1 (1 week after the first vaccine) and week 7 (1 week after the 3rd vaccine). This only was evaluable in Arm B patients.', 'timeFrame': 'Over 6 months'}]" 231,NCT03638492,"{'fullName': 'Karolinska Institutet', 'class': 'OTHER'}",Trial of Surgical Excision Margins in Thick Primary Melanoma - 2,COMPLETED,"Objectives: The purpose of this study was to assess the long-term follow-up of the overall and melanoma-specific survival in the randomised, open-lable multicenter trial (NTC NCT01183936) comparing excision margin of 2 cm versus 4 cm for patients with primary cutaneous malignant melanoma (CMM) thicker than 2 mm. Study hypothesis: The hypothesis is that there is no difference between the two treatment arms measured as melanoma-specific survival and overall survival.","['Melanoma', 'Surgery', 'Treatment Outcome']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'PROCEDURE', 'name': '2-cm margin', 'description': 'Patients with CMM treated with a surgical safety margin of 2-cm in the surrounding skin and down to the fascia.', 'armGroupLabels': ['2 cm margin of excision']}, {'type': 'PROCEDURE', 'name': '4-cm margin', 'description': 'Patients with CMM treated with a surgical safety margin of 4-cm in the surrounding skin and down to the fascia.', 'armGroupLabels': ['4 cm margin of excision']}]","Inclusion Criteria: * Melanoma \>2 mm * Age ≤ 75 yr * Patients operated on with ≤ 2-cm at diagnosis * Final surgery planned within 8 weeks after date of diagnosis * Patient fit for surgery * Signed patient consent form Exclusion Criteria: * Melanoma on hand, foot, head-neck or ano-genital regions * The presence of in-transit- regional and/or distant spread of the disease * Illness making patient unfit for surgery * Previous malignancies except basal cell- and in-situ colli uteri cancer",NA,ALL,NA,"[{'measure': 'Melanoma-specific survival', 'description': 'Cause of death: cutaneous malignant melanoma', 'timeFrame': '24.9 years'}]","[{'measure': 'Overall survival', 'description': 'Cause of death: all death causes', 'timeFrame': '24.9 years'}]" 232,NCT03079232,"{'fullName': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}",First Optical Coherence Microscopy in Dermato-oncology,COMPLETED,"OCTAV is a medical device class I, not CE marked, based on a new technique for high-resolution imager (cell) internal microstructures of all types of biological tissues in vivo or ex vivo, to a depth of penetration 800 .mu.m. It allows to explore the epidermis, the dermo-epidermal junction and middle dermis in a totally non-invasive (direct contact with the tissue without sampling).",['Skin Cancer'],INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'One group of patients One group of non skin cancer patients', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DEVICE', 'name': 'OCTAV Patient', 'description': 'In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.', 'armGroupLabels': ['OCTAV Patient'], 'otherNames': ['OCTAV, DAMAE Medical, Paris, France']}, {'type': 'DEVICE', 'name': 'OCTAV Control group', 'description': 'In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.', 'armGroupLabels': ['OCTAV Control group'], 'otherNames': ['OCTAV, DAMAE Medical, Paris, France']}]","FOR PATIENT Inclusion Criteria: * Patient with a cutaneous lesion suspicious for melanoma, basal cell carcinoma, squamous cell carcinoma, requiring a surgical excision * Consent form signed * Major patient Exclusion Criteria: * Allergy or intolerance to immersion oil (used for microscopy) * If female, pregnant or breast-feeding * Patient unable to stand still for 60 seconds * Skin lesions located near patient eyes (\<3 cm) FOR CONTROL GROUP Inclusion Criteria: * Aged between 18 to 40 years * Consent form signed * Patient of the dermatology department with non-pathological forearm skin Exclusion Criteria: * Allergy or intolerance to immersion oil (used for microscopy) * If female, pregnant or breast-feeding * Patient unable to stand still for 60 seconds",NA,ALL,NA,"[{'measure': 'Sensitivity', 'description': 'Sensitivity measures the proportion of positive skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology)', 'timeFrame': 'Day 1'}, {'measure': 'Specificity', 'description': 'Specificity measures the proportion of negative skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology)', 'timeFrame': 'Day 1'}]","[{'measure': 'Measure of the thickness of the different skin layers (mm)', 'description': 'Only for the non skin cancer group. Theses measures will identify the different skin layers (Epidermis, Dermis, Subcutaneous tissue, Cross-section)', 'timeFrame': 'Day 1'}]" 233,NCT04169321,"{'fullName': 'Cytosite Biopharma Inc.', 'class': 'INDUSTRY'}",Granzyme B PET Imaging Drug as a Predictor of Immunotherapy Response to Checkpoint Inhibitors,COMPLETED,First in Human Safety of \[68Ga\]-NOTA-hGZP PET Imaging in subjects with cancer undergoing treatment with a checkpoint inhibitor either as a monotherapy of in combination I-O therapy,"['Solid Tumor, Unspecified, Adult', 'Lymphoma']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Multiple center, open label, non-randomized, single dose study, in subjects with cancer undergoing or treatment with a checkpoint inhibitor either as a monotherapy or in combination. subjects. Eligible subjects will receive an injection of \\[68Ga\\]-NOTA-hGZP pre checkpoint inhibitor administration and a second dose between 5 and 42 days post initial checkpoint inhibitor administration. Upon dosing each subject will undergo PET scans at 40, 60 and 90 minutes post dosing. The images will be analyzed for the distribution of radioactivity. Subjects will be followed for adverse events for approximately 4-6 hours post injection or until pembrolizumab injection plus a follow up phone call to assess adverse events 1-3 days after injection.', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Single Arm', 'description': '\\[68Ga\\]-NOTA-hGZP is a PET imaging agent.', 'armGroupLabels': ['Single Arm'], 'otherNames': ['[68Ga]-NOTA-hGZP', 'CSB-111']}]","Inclusion Criteria: 1. Subjects 18 years of age and older. 2. Subjects with proven metastatic cancer that is going to be treated with one or more checkpoint inhibitors under the licensed indications for the cancer type. Checkpoint inhibitors include PD-1, PD-L1, CTLA-4 and LAG-3 inhibitors. 3. Subjects must have at least one lesion ≥ 15 mm in diameter or with two lesions both ≥ 15mm in diameter, when an optional biopsy is planned. Lesion measurements are taken from a diagnostic quality CT or MR image. 4. ECOG performance status ≤ 2 (Karnofsky ≥ 60%) 5. Life expectancy of greater than 6 months. 6. Males and females willing to use adequate contraception prior to study and during study participation. 7. If female, not of childbearing potential or negative pregnancy test prior to radiotracer injection. 8. Willing and able to understand and sign a written informed consent document. 9. Willing and able to undergo all study procedures. 10. Cohort 3 only: have archival lesion tissue available within 90 days of enrollment either from biopsy or surgery. Exclusion Criteria: 1. Participants for whom adverse events due to agents administered more than 4 weeks earlier have not resolved to Grade 1 or less. 2. Has not received nor is expected to receive an investigational compound within 90 days prior to \[68Ga\]-NOTA-hGZP PET imaging. This includes checkpoint inhibitors that are not approved by the US FDA for the indications in this protocol. 3. Subjects who have received a prior checkpoint inhibitor. 4. Any acute or chronic inflammatory disease or medical conditions that in the investigator's opinion may interfere with the study procedures or the interpretation of the study results such as infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia. 5. Known brain metastases. 6. History of allergic reactions to compounds of similar chemical or biologic composition to \[68Ga\]-NOTA-hGZP or pembrolizumab. 7. If female, nursing. 8. Current treatment with systemic steroids, or immunosuppressive agents. Participants with a condition requiring systemic treatment with either corticosteroids (\< 10 mg daily prednisone equivalent) inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. 9. Subjects who have exclusion criteria that would prevent them from receiving a CT scan. 10. Laboratory values 1. Leukocytes \< 3000/mcL 2. Absolute neutrophil count \< 1500 mcL 3. Platelets \< 100,000 mCL 4. Total bilirubin \> 1.5 x ULN 5. AST/ALT \> 2.5 x ULN 6. Albumin \< 2 g/dL 7. Alkaline phosphatase \> 2.5 ULN 8. eGRF eGFR \< 45 mL/min/1.73 m2 Patients who are stable but have values outside the specified ranges may be included with approval of the study medical monitor.",NA,ALL,NA,"[{'measure': 'Number of participants with clinically meaningful changes in physical examination findings, vital signs or blood chemistry', 'description': 'Clinically significant changes from baseline in physical examination findings\n\nClinically significant changes from baseline to follow-up analysis in systolic and diastolic blood pressure (mmHg)\n\nClinically significant changes from baseline to follow-up analysis in heart rate (beats per minute)\n\nClinically significant changes in respiration rate.\n\nClinically significant changes from baseline to follow-up analysis in blood chemistry for:\n\n1. Leukocytes (/mcL),\n2. Absolute neutrophil count (mcL)\n3. Platelets (/mcL)\n4. Total bilirubin (mg/d)\n5. AST/ALT (unitless)\n6. Albumin (g/dL)\n7. Alkaline phosphatase (IU/L)\n8. eGRF (mL/min/1.73 m2)', 'timeFrame': 'up to 4 to 6 hours post-injection'}, {'measure': 'Number of participants with changes in ECG', 'description': 'Clinically significant changes from baseline to follow-up analysis in ECG change in QT (ms) Quantification of \\[68Ga\\]-NOTA-hGZP PET accumulation at tumor site in subjects after treatment with checkpoint inhibitor therapy as determined by region of interest analysis (SUVmean).', 'timeFrame': 'up to 4 to 6 hours post-injection'}, {'measure': 'Number of participants with treatment-related Adverse Events (AEs)', 'description': 'The absolute number of participants with AEs according to CTCAE 5.0', 'timeFrame': 'Between time of injection and 3 days post injection'}]","[{'measure': 'Evaluation of the accumulation of [68Ga]-NOTA-hGZP in tumor foci in participants receiving checkpoint inhibitor therapy (absolute number of avid lesions per subject)', 'description': 'Identification by the central reader of the number of avid lesions observed in each subject and the number of subjects with avid lesions seen on the PET images', 'timeFrame': 'up to one-hour post injection'}, {'measure': 'Quantification of accumulation of [68Ga]-NOTA-hGZP in tumor foci in participants receiving checkpoint inhibitor therapy.', 'description': 'To be determined by region of interest analysis the mean standardized uptake value (SUVmean) (SUV does not have any units)', 'timeFrame': 'up to one-hour post injection'}, {'measure': 'Evaluate the correlation of [68Ga]-NOTA-hGZP accumulation in tumor foci to 6-month outcome.', 'description': 'Compare quantified \\[68Ga\\]-NOTA-hGZP uptake to participant treatment response in individual lesions as assessed at 6-month clinical follow-up and/or CT assessments.\n\nThe number of lesions that were avid and the lesions that showed a decrease in size compared to those which increased in size.', 'timeFrame': '6 months'}, {'measure': 'Correlate uptake of [68Ga]-NOTA-hGZP tracer and granzyme B expression as assessed on optional excisional biopsy when available (melanoma only).', 'description': 'Compare granzyme B protein quantification from biopsied tissue to the \\[68Ga\\]-NOTA-hGZP PET uptake acquired at the same location.', 'timeFrame': 'up to one-hour post injection'}]" 234,NCT03565406,"{'fullName': 'NYU Langone Health', 'class': 'OTHER'}",A Phase 1b Study of the Selective HDAC Inhibitor Mocetinostat in Combination With Ipilimumab and Nivolumab in Patients With Unresectable Stage III or Stage IV Melanoma,TERMINATED,"This is a Phase 1b, open-label, dose-escalation cohort study. The study will consist of a dose escalation assessment of the safety and tolerability of Mocetinostat administered concurrently in combination with ipilimumab and nivolumab to patients with advanced melanoma. Treatment will be divided into induction and maintenance phases. It is anticipated that this clinical study will enable selection of the RP2D and dose schedule of this 3-drug combination for further clinical testing. The trial will include an assessment of the pharmacodynamic activity of Mocetinostat administered in combination with ipilimumab and nivolumab.",['Melanoma'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Mocetinostat Induction Phase + Ipilimumab + Nivolumab', 'description': 'Treatment Cycle 1: Mocetinostat at a dose of 90 mg PO TIW; ipilimumab will be administered IV at a dose of 1 mg/kg and nivolumab will be administered IV at a dose of 3 mg/kg during the 12-week induction period. The induction phase will last for 2 treatment cycles.\n\nTreatment Cycle 2: Mocetinostat at a dose of 70 mg PO TIW ipilimumab will be administered IV at a dose of 1 mg/kg and nivolumab will be administered IV at a dose of 3 mg/kg during the 12-week induction period. The induction phase will last for 2 treatment cycles.', 'armGroupLabels': ['Unresectable Stage III or Stage IV Melanoma']}, {'type': 'DRUG', 'name': 'Mocetinostat Maintenance Phase + Ipilimumab + Nivolumab', 'description': 'De-escalation Phase 1: Mocetinostat will be administered 50 mg PO TIW during each 84-day treatment cycle. Ipilimumab will be administered IV at a dose of 1 mg/kg and nivolumab will be administered IV at a dose of 3 mg/kg\n\nDe-escalation Maintenance Phase 2: Mocetinostat will be administered 40 mg PO TIW during each 84-day treatment cycle. Ipilimumab will be administered IV at a dose of 0.3 mg/kg and nivolumab will be administered IV at a dose of 1 mg/kg during period', 'armGroupLabels': ['Unresectable Stage III or Stage IV Melanoma']}]","Inclusion Criteria: * Patients must have signed and dated an Institutional Review Board/Independent Ethics Committee -approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal patient care * Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study. * All patients must be either Stage IIIb/c or Stage IV according to the American Joint Committee on Cancer (AJCC) (7th edition) and have histologically-confirmed melanoma that is felt to be surgically unresectable in order to be eligible. Please refer to the AJCC Cancer Staging Manual, 7th edition for a description of tumor, lymph node, metastasis and staging. * All melanomas, except ocular/uveal melanoma, regardless of primary site of disease will be allowed; mucosal melanomas are eligible. * Patients must not have received prior anticancer treatment for metastatic disease (for example, but not limited to, systemic, local, radiation, radiopharmaceutical). * Exceptions: Surgery for melanoma and/or postresection brain radiotherapy (RT) if central nervous system (CNS) metastases and/or prior treatment with adjuvant interferon (IFN) (as described in Exclusion Criterion 2). --All patients must have their disease status documented by a complete physical examination and imaging studies within 4 weeks prior to the first dose of study drug. Imaging studies must include computerized tomography (CT) scan of neck, chest, abdomen, pelvis, and all known sites of resected disease in the setting of Stage IIIb/c or Stage IV disease, and brain magnetic resonance imaging (\[MRI\], brain CT allowable if MRI is contraindicated). * The complete set of baseline radiographic images must be available before treatment initiation. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Tumor tissue from the resected site of disease must be provided for biomarker analyses * Prior treated CNS metastases must be without MRI evidence of recurrence for at least 4 weeks after treatment. Patients must be off immunosuppressive doses of systemic steroids (≥ 10 mg/day prednisone or equivalent) for at least 14 days prior to study drug administration, and must have returned to neurologic baseline status postoperatively * The 4-week period of stability is measured after the completion of the neurologic interventions (ie, surgery and/or radiation). * In addition to neurosurgery to treat CNS metastases, adjuvant radiation after the resection of CNS metastasis is allowed. Immunosuppressive doses of systemic steroids (doses ≥ 10 mg/day prednisone or equivalent) must be discontinued at least 14 days before study drug administration. * Prior surgery that required general anesthesia must be completed at least 4 weeks before study drug administration. Surgery requiring local/epidural anesthesia must be completed at least 72 hours before study drug administration. * All baseline laboratory requirements will be assessed and should be obtained within 14 days of first dose of study drug. Screening laboratory values must meet the following criteria: * White blood cells ≥ 2000/µL * Neutrophils ≥ 1500/µL * Platelets ≥ 100 × 10³/µL * Hemoglobin ≥ 9.0 g/dL * Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance \> 40 mL/minute (using Cockcroft/Gault formula) * Patient Re-enrollment: This study permits the re-enrollment of a patient that has discontinued the study as a screen failure (ie, patient has not been dosed/has not been treated). If re-enrolled, the patient must be re-consented. * Males and females ≥ 18 years of age. * Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin hormone) within 24 hours prior to the start of study drug.; Women must not be breastfeeding. * Women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of study drug plus 30 days (duration of ovulatory cycle). The half-lives of nivolumab and ipilimumab is up to 25 days and 18 days, respectively. Given the blinded nature of this study, WOCBP should therefore use an adequate method to avoid pregnancy for a total of 23 weeks posttreatment completion. * Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half lives of the study drug(s) plus 90 days (duration of sperm turnover). The half-lives of nivolumab and ipilimumab are up to 25 days and 18 days, respectively. Given the blinded nature of this study, men should therefore use an adequate method of contraception for a total of 31 weeks posttreatment completion. * Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, they must still undergo pregnancy testing as described in this section. Exclusion Criteria: * Patients with carcinomatosis meningitis or a history of ocular/uveal melanoma are excluded. * Patients with previous nonmelanoma malignancies are excluded unless a complete resection or remission was achieved at least 2 years prior to study entry and no additional therapy is required or anticipated to be required during the study period (exceptions include, but are not limited to, nonmelanoma skin cancers, in situ bladder cancer, in situ gastric cancer or gastrointestinal stromal tumor, in situ colon cancers, in situ cervical cancers/dysplasia, or breast carcinoma in situ). * Patients with active, known, or suspected autoimmune disease. Patients with type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. For any cases of uncertainty, it is recommended that the Principal Investigator be consulted prior to signing informed consent. * Patients with a condition requiring systemic treatment with either corticosteroids (≥ 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids are permitted in the absence of active autoimmune disease. * Prior therapy for melanoma with the following exceptions which are allowed: 1) surgery for the melanoma lesion(s), 2) adjuvant RT after neurosurgical resection for CNS lesions, and 3) prior adjuvant IFN (see qualifier below). Specifically, patients who received prior therapy with anti-PD-1, anti PD L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (including ipilimumab or any other antibody or drug specifically targeting T cell costimulation or checkpoint pathways) are not eligible. • Prior treatment with adjuvant IFN is allowed if completed ≥ 3 months prior to treatment. * Treatment directed against the melanoma (eg, chemotherapy, targeted agents, biotherapy, limb perfusion) that is administered after a prior complete resection other than adjuvant radiation after neurosurgical resection and IFN for resected melanoma. * Previous therapy with histone deacetylase inhibitor. * Any of the following laboratory abnormalities: * ANC \< 1,500/µL * Platelet count \< 100,000/µL * Hematologic growth factors are not allowed at screening or during the first cycle of treatment * Hemoglobin \< 9 g/dL (\< 5.5 mmol/L; previous red blood cell transfusion is permitted) * Creatinine \> 1.5 × ULN * AST or ALT \> 2.5 × ULN. For patients with liver metastasis, AST or ALT \> 5 × ULN * Serum total bilirubin \> 1.5 mg/dL or \> 3 × ULN for patients with hereditary benign hyperbilirubinemia * Corrected QT interval (QTc) using Fridericia's formula value \> 480 msec at screening; family or personal history of long QTc syndrome or ventricular arrhythmias including ventricular bigeminy at screening; previous history of drug induced QTc prolongation or the need for treatment with medications known or suspected of producing prolonged QTc intervals on electrocardiogram (ECG). * Congestive heart failure (New York Heart Association Class III or IV), myocardial infarction within 12 months before starting study treatment, or unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris. * Any serious or uncontrolled medical disorder or active infection that, in the opinion of the Investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the patient to receive protocol therapy. * Any positive test result for hepatitis B virus or hepatitis C virus indicating acute or chronic infection. * Known history of testing positive for human immunodeficiency virus or known acquired immunodeficiency syndrome. * History of Grade ≥ 3 allergy to human monoclonal antibodies. * Prisoners or patients who are involuntarily incarcerated. * Patients who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness. * Pregnant or nursing women. * Psychological, familial, sociological, or geographical conditions that potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.",NA,ALL,NA,"[{'measure': 'Number of Dose Limiting Toxicities (DLTs), defining the maximum tolerated dose (MTD)', 'timeFrame': '60 Months'}]","[{'measure': 'Maximum observed concentration (Cmax) of Mocetinostat administered in combination with ipilimumab and nivolumab', 'timeFrame': '60 Months'}]" 235,NCT03302637,"{'fullName': 'NYU Langone Health', 'class': 'OTHER'}",Oral Microbiome and Pancreatic Cancer,COMPLETED,"This is a prospective population based study to examine the relationship of oral and pancreatic microbiome, and their functions, to pancreatic cancer risk. The identification of specific oral bacteria and their functional relationship to pancreatic cancer will advance scientific knowledge on the etiology of pancreatic cancer. This could provide a new microbially-based research paradigm, possibly leading to new drug targets for this disease. Second, the oral bacteria may serve as a readily accessible, non-invasive biomarker for subsequent pancreatic cancer risk, which help to identify people at high risk of this disease. Finally, the identified oral bacteria may lead to microbial prophylactic preventions, with antibiotic therapy aimed at eradicating the specific species associated with increased cancer risk or, alternatively, combined with probiotics to introduce species that are associated with a decreased cancer risk. Thus, the study outcomes will lead to actionable means for pancreatic cancer prevention.",['Pancreatic Cancer'],OBSERVATIONAL,"{'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'OTHER', 'name': '16S rRNA gene sequencing assay', 'description': ""extraction of genomic DNA from oral samples using the Mobio DNA Isolation Kit. 16S rRNA amplicons covering variable regions V3 to V4 will be generated using primers (347F-5'GGAGGCAGCAGTRRGGAAT'-3' and 803R 5'-CTACCRGGGTATCTAATCC-3')66 incorporating adapters and a sample barcode sequence at PI's lab. Amplicons will be sequenced with the Roche 454 FLX Titanium sequencing system at the NYU genome technology center, following the manufacturer's specifications."", 'armGroupLabels': ['Cases', 'Control']}]","Inclusion Criteria: * DNA extracted from oral wash samples from NIH-PLCO and ACS-CPS cohorts Exclusion Criteria: \-","361 incident adenocarcinoma of pancreas and 371 matched controls from two prospective cohort studies, the American Cancer Society Cancer Prevention Study II and the National Cancer Institute Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial.",ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Presence or absence of bacterial taxa will be compared in oral and pancreatic samples.', 'description': 'For the taxa present at both sites, correlation between the abundance of taxa will be examined between the two sites. To adjust for confounders, multivariate linear regression will be used with abundance of oral taxa (exposure) and that of pancreas taxa (outcome).', 'timeFrame': '4 Years'}]",NA 236,NCT06090266,"{'fullName': 'OncoResponse, Inc.', 'class': 'INDUSTRY'}","A Study of OR502, a Monoclonal Antibody Targeting LILRB2, Alone and in Combination With Anticancer Agents",RECRUITING,"This is an open-label, multicenter, first-in-human dose-escalation and expansion Phase 1-2 study designed to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of OR502 administered as a monotherapy and in combination with cemiplimab in subjects with advanced solid tumors.","['Cancer', 'Tumor, Solid', 'Malignant Neoplasm', 'Metastatic Cancer', 'Advanced Solid Tumor', 'Cutaneous Melanoma', 'Non-small Cell Lung Cancer']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'OR502', 'description': 'IgG1 monoclonal antibody that binds specifically to the LILRB2 protein.', 'armGroupLabels': ['OR502 monotherapy and combination therapy dose-escalation phase (Part A)', 'OR502 monotherapy and combination therapy dose-expansion phase (Part B)']}, {'type': 'DRUG', 'name': 'Cemiplimab', 'description': 'IgG4 mAb that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2.', 'armGroupLabels': ['OR502 monotherapy and combination therapy dose-escalation phase (Part A)', 'OR502 monotherapy and combination therapy dose-expansion phase (Part B)']}]","Inclusion Criteria: 1. Informed consent signed by the subject prior to conducting study-specific procedures. 2. Male or female subjects ≥ 18 years of age. 3. Histological diagnosis as follows: 1. Parts A and B (Cohorts A1, A2, and B1): subjects must have a histological diagnosis of any type of carcinoma, sarcoma, or melanoma with progressive metastatic disease, or progressive locally advanced disease not amenable to local therapy with curative intent. 2. Part B (Expansion Cohorts B2-B3): subjects must have a histological diagnosis of the relevant tumor type (CSCC or PROC) with advanced/metastatic disease not amenable to local therapy with curative intent. 4. Prior therapies: a. Part A (dose-escalation) and Cohort B1 (monotherapy expansion) i. Subjects must have experienced progressive disease (PD) on an established standard systemic anti-cancer therapy for a given tumor type or have been intolerant to such therapy, or in the opinion of the Investigator have been considered ineligible for a particular form of standard therapy on medical grounds. Subjects must have no available proven curative or life prolonging therapies. b. Cohorts B4 and B5 (mini-expansion cohorts) i. Subjects must have received a PD-(L)1 inhibitor-based therapy, either alone or in combination with other anti-cancer agents, for at least 12 weeks. If subjects have received other lines of immunotherapy, including PD-(L)1-based therapy, they must have demonstrated clinical benefit on each prior immunotherapy. Subjects may also have received additional anti-cancer therapies after failure of a PD-(L)1 inhibitor, but 2nd line subjects are preferred. c. Cohorts B2 and B3 (dose-expansion) i. Cohort B2 subjects (CSCC) must have received a PD-(L)1 inhibitor. Subjects may not have received an additional immunotherapy. ii. Cohort B3 subjects (PROC) must have received platinum-based therapy and experienced disease progression on or within 6 months of completion of such therapy. Subjects may have received prior anti-PD-1 therapy. Subjects may have received additional therapies after failure of platinum-based therapy. 5. Subjects must have measurable disease per RECIST v1.1. 6. People of childbearing potential, if not postmenopausal (defined as no menses for at least 12 continuous months prior to study entry) or surgically sterile, must be willing to practice at least one of the highly effective methods of birth control described in Section 4.3 for at least a menstrual cycle (or partner's menstrual cycle, for male subjects) before and for 4 months after study medication administration. 7. Resolution of prior clinically significant therapy-related AEs (excluding alopecia and ≤ Grade 2 peripheral neuropathy) to ≤ Grade 1 per NCI-CTCAE version 5.0, and no treatment for these AEs for at least 2 weeks prior to the time of enrollment. Electrolyte and hormonal supplementation may be used to treat these AEs provided the subject is stable on these supplements. 8. Minimum of 2 weeks since the last dose of other hormone therapy and 3 weeks since the last dose of other systemic cancer therapy or radiotherapy (\> 4 weeks in case of nitrosoureas or radio-immuno conjugate therapy). Adjuvant hormonal therapy (e.g., tamoxifen) is allowed provided the original tumor diagnosis was more than 3 years before the first dose of study medication. Subjects with prostate cancer on stable doses of anti-hormone treatment may remain on therapy for this trial. 9. Subjects must have adequate organ function. 10. Biopsy specimens: 1. All subjects must be able to supply an archival tumor tissue specimen. If an archival specimen is not available, subjects may remain eligible with approval of the medical monitor. 2. Subjects in Cohort B1 must consent to pre- and on-treatment biopsies. Tissue obtained for the biopsy must not be previously irradiated. No systemic anti-neoplastic therapy may be received by the subject between the time of the biopsy and the first administration of study medication. 3. Subjects in all other cohorts will be asked to consent to pre- and on-treatment biopsies for biomarker analysis of the acquired tissue. These biopsies are optional and not required for study participation. Tissue obtained for the biopsy must not be previously irradiated. No systemic anti-neoplastic therapy may be received by the subject between the time of the biopsy and the first administration of study medication. 11. Subject is able and willing to comply with the protocol and the restrictions and assessments therein. 12. As required by local regulations or law, subjects must fulfill the obligation of affiliation or beneficiary of a social security or similar scheme. Exclusion Criteria: 1. Subject previously had a severe hypersensitivity reaction to treatment with another monoclonal antibody (mAb). 2. Life expectancy \< 12 weeks. 3. Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) \> 2. 4. Prior organ or stem cell transplant. 5. Subjects with symptomatic ascites or pleural effusion. Subjects who are clinically stable for at least 2 weeks following treatment for these conditions (including therapeutic thoraco- or paracentesis) are eligible. 6. Subject has a known active central nervous system (CNS) primary tumor or metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry, have no radiological evidence of new or enlarging brain metastases, and are off steroids or on a stable dose up to an equivalent of prednisone 10 mg/day for at least 15 days prior to first dose of study medication. Subjects who have symptoms consistent with CNS metastasis must have a negative magnetic resonance imaging (MRI) scan during the screening period. 7. Subject has a known history of a hematologic malignancy, malignant primary brain tumor, or another malignant primary solid tumor (other than that under study), unless the subject has undergone potentially curative therapy with no evidence of recurrent disease for at least 3 years before the start of treatment. 1. Subjects with a known history of AJCC Stage 1 cancer that has undergone potentially curative therapy with no evidence of recurrent disease for at least 1 year before the start of treatment may be eligible at the Investigator's discretion after consultation with the Sponsor. 2. Subjects who underwent successful definitive resection of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other in situ cancers at any time before the start of treatment, and have no evidence of recurrent disease, are eligible. 8. Recent or ongoing serious infection including the following: 1. Any uncontrolled Grade 3 or higher (per NCI-CTCAE version 5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of OR502. Routine antimicrobial prophylaxis is allowed. 2. Uncontrolled infection with human immunodeficiency virus (HIV). Subjects on stable highly active antiretroviral therapy (HAART) with undetectable viral load and normal CD4 counts for at least 6 months prior to study entry are eligible. Serological testing for HIV at screening is not required. 3. Known to be positive for hepatitis B virus (HBV) surface antigen, or any other positive test for hepatitis B indicating acute or chronic infection. Subjects who are or have received anti-HBV therapy and have undetectable HBV DNA for at least 6 months prior to study entry are eligible. Serological testing for hepatitis B at screening is not required. 4. Known active hepatitis C as determined by positive serology and confirmed by polymerase chain reaction (PCR). Subjects on or having received anti-retroviral therapy are eligible provided they are virus-free by PCR for at least 6 months prior to study entry. Serological testing for hepatitis C at screening is not required. 5. Known active or latent tuberculosis (testing at screening is not required). 9. Autoimmune disease or inflammatory condition requiring systemic anti-inflammatory therapy with exceptions as noted in Exclusion Criterion 10. Subjects on hormone replacement therapy for autoimmune-induced endocrinopathies are eligible. 10. Use of systemic corticosteroids within 15 days or other immunosuppressive drugs within 30 days prior to start of the study, with the exception of corticosteroids as replacement therapy up to an equivalent of prednisone 10 mg/day, which are allowed. 11. QTc interval ≥ 470 msec by electrocardiogram (ECG). 12. Subject has received an investigational product or been treated with an investigational device within 30 days prior to first administration of study medication. 13. Subject has received a live vaccine within 30 days prior to first administration of study medication. 14. For Cohorts A2, B1, B2, and B3 only: 1. Known hypersensitivity to cemiplimab or any of its excipients or contraindicated to cemiplimab per approved local labeling. 2. Interstitial lung disease. 3. Prior pneumonitis requiring systemic corticosteroid therapy. 4. Receiving immunosuppressive therapy, with exceptions as noted in Exclusion Criterion 10. 5. A history of severe immune-related adverse reactions from treatment with ipilimumab, defined as any Grade 4 toxicity or Grade 3 toxicity requiring corticosteroid treatment (\> 10 mg/day prednisone or equivalent) for more than 12 weeks. 15. Concurrent therapy with anti-cancer or anti-neoplastic drugs, with the exception of adjuvant hormonal therapy, which is allowed as outlined in Inclusion Criterion 8. 16. History or clinical evidence of any surgical or medical condition that the Investigator judges as likely to interfere with the results of the study or pose an additional risk in participating, e.g., rapidly progressive or uncontrolled disease involving a major organ system-vascular, cardiac, pulmonary, gastrointestinal, gynecologic, hematologic, neurologic, neoplastic, renal, endocrine, autoimmune or an immunodeficiency, or clinically significant active psychiatric or abuse disorders. 17. Subjects who, at the time of signing informed consent, had a recent history (within the last year) of chronic substance abuse. 18. Subject is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study. 19. Vulnerable persons: subjects under judicial safeguard, subjects deprived of their liberty by judicial or administrative decision, subjects under psychiatric care without their consent, subjects admitted to a health or social institution for purposes other than research, adults subject to a measure of legal protection (guardianship or curatorship), and subjects unable to express their consent.",NA,ALL,NA,"[{'measure': 'Dose-limiting Toxicity', 'description': 'The incidence of DLTs during the DLT assessment period.', 'timeFrame': 'First 21 days of treatment.'}, {'measure': 'Adverse Events and Serious Adverse Events', 'description': 'The nature, frequency, and severity of adverse events and serious adverse events graded by CTCAE v 5.0 as aggregated descriptive findings.', 'timeFrame': 'Screening to 90 days from last dose.'}, {'measure': 'Vital Signs', 'description': 'Assessment of changes in vital sign measurements (heart rate, pulse oximetry and blood pressure) as aggregated descriptive findings.', 'timeFrame': 'Screening to 90 days from last dose.'}, {'measure': 'Recommended Dose and Regimen (mono and combination therapy)', 'description': 'Determination of the recommended dose of OR502 for further development.', 'timeFrame': 'Screening to 90 days from last dose.'}]","[{'measure': 'Pharmacokinetics of OR502', 'description': 'Peak plasma concentration (Cmax).', 'timeFrame': 'Day 1 of dosing through 21 days post last dose.'}, {'measure': 'Pharmacokinetics of OR502', 'description': 'Area under the plasma concentration versus time curve (AUC).', 'timeFrame': 'Day 1 of dosing through 21 days post last dose.'}, {'measure': 'Objective Response Rate (ORR)', 'description': 'ORR according to RECIST v1.1.', 'timeFrame': 'Day 1 of dosing through 90 days after the last dose.'}, {'measure': 'Disease Control Rate (DCR)', 'description': 'The percentage of subjects with a complete response, partial response, or stable disease for at least 2 consecutive tumor assessments.', 'timeFrame': 'Day 1 of dosing through 90 days after the last dose.'}, {'measure': 'Progression Free Survival (PFS)', 'description': 'Time from the date of initiation of study therapy to the date measurement criteria are first met for PD or death from any cause, whichever occurs first.', 'timeFrame': 'Day 1 of dosing through 90 days after the last dose.'}]" 237,NCT02035956,"{'fullName': 'BioNTech SE', 'class': 'INDUSTRY'}",IVAC MUTANOME Phase I Clinical Trial,COMPLETED,"Clinical first-in-human study evaluating the safety, tolerability and immunogenicity of intra-nodal administration of a personalized vaccination with IVAC MUTANOME vaccine with or without initial treatment with RBL001/RBL002 vaccine in patients with advanced melanoma",['Melanoma'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'IVAC MUTANOME, RBL001/RBL002', 'description': 'Each patient will receive multiple repeated intranodal injections of IVAC MUTANOME vaccine with or without initial treatment with RBL001/RBL002.', 'armGroupLabels': ['IVAC MUTANOME RBL001/RBL002'], 'otherNames': ['cancer vaccine']}]","Inclusion Criteria: * Malignant Melanoma, resectable stage IIIA-C and IV (AJCC 2009 melanoma classification) * Patients with unresectable Malignant Melanoma stage IIIA-C in complete remission, partial remission or stable disease after treatment with vemurafenib or patients with slow progressive disease. * Malignant Melanoma, unresectable stage IV (AJCC 2009 melanoma classification) in complete remission, partial remission or stable disease after treatment with vemurafenib * All lines of treatment for malignant melanoma are accepted. * First line therapy for subjects not eligible or declining other first line therapies after all available treatment options have been transparently disclosed (to be documented in patient medical record). * ≥ 18 years of age * Written informed consent * ECOG performance status (PS) 0-1 (appendix G) * Life expectancy \> 6 months * WBC ≥ 3x109/L * Haemoglobin ≥ 10 g/dl * Platelet count ≥ 100,000/mm³ * LDH level \< 2.0 x ULN * Negative pregnancy test (measured by β-HCG) for females which are childbearing potential * Suitable lymph nodes for injection using ultrasound guidance Exclusion Criteria: * Pregnancy or breastfeeding * Primary ocular melanoma * History (\< 5 years) of a second malignancy other than squamous or basal cell carcinoma, non-active prostate cancer or cervical carcinoma in situ * Brain metastases * Known or symptomatic pleural effusions and/or ascites * Known hypersensitivity to the active substance or to any of the excipients * A serious local infection (e.g. cellulitis, abscess) or systemic infection (e.g. pneumonia, septicemia) which requires systemic antibiotic treatment within 2 weeks prior to the first dose of study medication * Positive test for acute or chronic active hepatitis B or C infection, acute EBV or acute CMV injection * Clinically relevant autoimmune disease * Systemic immune suppression: * HIV disease * Use of chronic oral or systemic steroid medication (topical or inhalational steroids are permitted) * Other clinical relevant systemic immune suppression * Symptomatic congestive heart failure (NYHA 3 or 4) * Unstable angina pectoris * Radiotherapy within two weeks, myelosuppressive chemotherapy, ipilimumab and major surgery within 4 weeks/28 days before the first treatment. Interferon and approved BRAF inhibitors will be allowed as concurrent treatment. * Any investigational drug within 4 weeks/28 days or 5 half-lives depending on what gives the longer range before the first treatment of this study * Minor surgery within 14 days before the first treatment of this study * Fertile males and females who are unwilling to use a highly effective method of birth control (less than 1% per year, e.g. condom with spermicide, diaphragm with spermicide, birth control pills, injections, patches or intrauterine device) during study treatment and 28 days after the last dose of study treatment * Presence of a serious concurrent illness or other condition (e.g. psychological, family, sociological, or geographical circumstances) that does not permit adequate follow-up and compliance with the protocol",NA,ALL,NA,"[{'measure': 'Safety and tolerability of repetitive doses', 'description': 'Number of Patients with adverse events, total number of adverse events', 'timeFrame': 'up to a maximum of 189 days'}]","[{'measure': 'Monitoring of vaccine-induced cellular immune response,', 'description': 'Determination of pharmacodynamic activity', 'timeFrame': '161 days'}]" 238,NCT01883323,"{'fullName': 'University Health Network, Toronto', 'class': 'OTHER'}",Tumor-Infiltrating Lymphocytes And Low-Dose Interleukin-2 Therapy Following Cyclophosphamide And Fludarabine In Patients With Melanoma,COMPLETED,"This is a phase II clinical study for patients with metastatic (the cancer has spread to other parts of the body) melanoma. Patients will receive an infusion (given by vein) of autologous tumor infiltrating lymphocytes (TILs). TILs are a type of white blood cells that recognizes tumor cells and enter them which causes the tumor cells to break down. Prior to the cell infusion, patients will receive a two drugs cyclophosphamide and fludarabine to prepare the body to receive the TILs. After cell infusion, patients will receive low-dose interleukin-2 therapy which is an approved drug to treat melanoma. This study will see how useful this regimen is in treating metastatic melanoma.","['Metastatic, Stage III or Stage IV, Melanoma']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Cyclophosphamide', 'description': 'i.v., 60mg/kg per day for 2 days', 'armGroupLabels': ['Cyclophosphamide and Fludarabine followed by TILs and IL-2'], 'otherNames': ['CYTOXAN, PROCYTOX']}, {'type': 'DRUG', 'name': 'Fludarabine', 'description': 'i.v., 25mg/m2 per day for 5 days', 'armGroupLabels': ['Cyclophosphamide and Fludarabine followed by TILs and IL-2'], 'otherNames': ['FLUDARA']}, {'type': 'BIOLOGICAL', 'name': 'Tumor-Infiltrating Lymphocytes', 'description': 'i.v., 1x10\\^10 - 1.6x10\\^11 cells', 'armGroupLabels': ['Cyclophosphamide and Fludarabine followed by TILs and IL-2']}, {'type': 'BIOLOGICAL', 'name': 'Low-Dose Interleukin', 'description': 'i.v., 125,000 IU/kg subcut per day, for 2 weeks (2 days rest between each week)', 'armGroupLabels': ['Cyclophosphamide and Fludarabine followed by TILs and IL-2'], 'otherNames': ['Aldesleukin, Proleukin, Recombinant Human Interleukin 2']}]","Inclusion Criteria (Eligibility for TIL Evaluation): * Must have measurable, unresectable stage III or stage IV melanoma * Suitable tumor for collection * If tumor is suitable for collection, patient must be suitable for surgery * Patient must be 18 years of age or older * Performance status of ECOG 0 or 1 * Life expectancy \> 5 months from date of consent of TIL evaluation * Willing to be tested for transmissible diseases * For patients with a history of allergy to penicillin, gentamycin, streptomycin, or anti-fungals, the ability to generate TILs will be confirmed with the cell manufacturing laboratory Inclusion Criteria (Eligibility for Treatment): * Signed and dated the informed consent * No brain metastases or stable brain metastases for 3 months following definitive treatment. * Life expectancy \> 3 months from the date of consent for TILs treatment * TILs are suitable for use as determined by laboratory * More than 30 days since any prior systemic therapy at the time of the cell infusion, or more than six weeks since prior nitrosurea therapy. For patients with prior ipilimumab therapy, at least six weeks must elapse between the last ipilimumab dose and the start of study treatment. All side effects from previous treatment must have recovered to an acceptable grade level. * Adequate organ function * Must have positive EBV titres * Women of child-bearing potential must have a negative pregnancy test. Patients of both genders must be willing to practice birth control during treatment and for 6 months post completion of IL-2 treatment. Exclusion Criteria: * Requiring systemic steroid therapy * HIV positive * With active hepatitis B or hepatitis C, syphilis, or HTLV * Must not have any active systemic infections, coagulation disorders or other active major medical illnesses of the cardiovascular, respiratory or immune system, uncontrolled psychiatric disorders, or other conditions that may affect following study procedures. * Have no active underlying cardiac illnesses defined by positive stress test, LVEF\<40% or ongoing life-threatening arrhythmias * Abnormal lung function test",NA,ALL,NA,"[{'measure': 'Clinical response to treatment', 'timeFrame': '6 weeks after treatment'}]","[{'measure': 'Number occurrences and severity of side effects', 'timeFrame': 'Starting at first dose of study treatment up to 10 years'}, {'measure': 'Number of patients with an immunity and no immunity to the study treatment', 'timeFrame': 'From start of study up to 10 years'}]" 239,NCT00707161,"{'fullName': 'University of Utah', 'class': 'OTHER'}",Radiation Therapy and Concurrent Cisplatin Chemotherapy for Locally Advanced or Metastatic Malignant Melanoma,TERMINATED,The study is a prospective phase II trial of radiation therapy concurrent with cisplatin chemotherapy in the treatment of locally advanced or metastatic melanoma in patients who are deemed to require radiation therapy by treating physicians for purposes of local control or palliation. Eligibility criteria include pathologically confirmed melanoma. Patients will undergo radiation therapy (20 treatments of 2.5 Gy for a total of 50 Gy) concurrent with cisplatin chemotherapy.,"['Cancer', 'Melanoma']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'RADIATION', 'name': 'Radiation Therapy', 'description': 'Radiation therapy will be delivered concurrent with cisplatin chemotherapy as outlined in table 2. Radiation therapy dose will be 50 Gy (2.5 Gy per day, 5 days per week, for 20 treatments).', 'armGroupLabels': ['All participants']}, {'type': 'DRUG', 'name': 'Cisplatin', 'description': 'Cisplatin dose will be 100 mg/m2 given i.v. every 3 weeks for a total of 2 doses (days 1 and 22) during radiation.', 'armGroupLabels': ['All participants'], 'otherNames': ['chemotherapy']}, {'type': 'PROCEDURE', 'name': 'Surgical resection', 'description': 'Surgical resection of residual (or recurrent) melanoma for cure or for palliation may be performed following chemoradiation if deemed appropriate by the treating physicians (surgical resection may be planned following pre-operative chemoradiation or may be performed for salvage due to inadequate response to chemoradiation or for relapse following chemoradiation). Surgical resection will not be performed until at least 4 weeks following chemoradiation (unless deemed emergent by the treating physicians).', 'armGroupLabels': ['All participants'], 'otherNames': ['surgery']}]","Inclusion criteria: * Signed study-specific consent form prior to registration. * Pathologically confirmed malignant melanoma. * Measurable melanoma lesion deemed to require radiation by treating physicians for purposes of local control or palliation. The lesion may be the primary melanoma, a nodal metastasis, or a distant metastasis. Recurrent lesions are allowed. * Lesion has to be measurable clinically or radiographically in 2 dimensions. * Karnofsky Performance Scale (KPS) \> 70. * Laboratory values * White blood cells (WBC) \> 3000/mm3 * Absolute granulocyte count \> 1,500 * Platelets \> 100,000/mm3 * Total bilirubin \< 2.0 x institutional upper limit of normal * AST or ALT (aminotransferase/alanine aminotransferase) \< 2.5 x institutional upper limit of normal * Serum calcium \< 1.3 x institutional upper limit of normal * Serum creatinine \< 1.5 mg/dL or Creatinine clearance \> 50 cc/min,calculated as follows: CCr = 0.85 x (140-age) x (weight in kg) 72 x serum creatinine in mg/dL Exclusion criteria: * Systemic therapy for malignant melanoma within one month preceding trial enrollment. * Prior irradiation to the planned field. * Concomitant chemotherapy (in addition to cisplatin) or biologic therapy is allowed. * Significant infection or other co-existent medical condition which would prevent the use of full dose chemotherapy. * Pre-existing sensory neuropathy (CTC 3.0 ≥ Grade II) * Pregnancy or lactation.",NA,ALL,NA,"[{'measure': 'Response Rate of Melanoma Lesions', 'description': 'Response rate of melanoma lesions was measured after treated with the trial agent.', 'timeFrame': '2005-2010'}]",NA 240,NCT01471054,"{'fullName': 'Wills Eye', 'class': 'OTHER'}",Dexamethasone Intravitreal Implant for Treatment of Macular Edema After Plaque Radiotherapy of Uveal Melanoma,TERMINATED,To evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex) and compare it with safety and efficacy of intravitreal bevacizumab in eyes with macular edema after plaque radiotherapy of uveal melanoma.,"['Macular Edema', 'Cystoid Macular Edema', 'Uveal Melanoma', 'Radiation Maculopathy', 'Radiation Retinopathy']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Ozurdex', 'description': 'Eyes in the Ozurdex group can have a maximum total of three Ozurdex insertions in the first 12 months after enrolling into the study. The criteria for retreatment with Ozurdex are:\n\ni.The study eye must have shown initial favorable response to prior Ozurdex implant (\\>10% decrease in central macular thickness with maintenance \\[change in BCVA of \\<=1 line\\] or improvement of visual acuity \\[increase of BCVA of \\>1 line\\]) ii. Interval since last Ozurdex implant should be \\> 4 and \\< 12 months. iii. The study eye must show definite evidence of recurrence of macular edema.', 'armGroupLabels': ['Ozurdex'], 'otherNames': ['Dexamethasone intravitreal implant']}, {'type': 'DRUG', 'name': 'Bevacizumab', 'description': 'Eyes in the Bevacizumab group can have a maximum total of twelve bevacizumab injections in the first year after enrolling into the study. All patients will receive 6 monthly injections after entering the study. After the sixth injection (at month 5) the interval between injections will be extended to 6 weeks if the study eye has shown initial favorable response to prior intravitreal bevacizumab.', 'armGroupLabels': ['Bevacizumab'], 'otherNames': ['Avastin']}]","* Inclusion criteria: 1. Patient age 18 years or more. 2. Uveal melanoma treated with I-125 plaque radiotherapy. 3. Visual acuity between 20/40 to 20/400 secondary to post-radiation macular edema. 4. Central subfield retinal thickness \> 300 micron. 5. Duration of macular edema \< 12 months. 6. No potential contributing causes of decreased vision other than macular edema. * Exclusion criteria: 1. Visual acuity worse than 20/400 or better than 20/40. 2. Monocular patient or poor vision in the non-study eye (\<20/80). 3. History of vitrectomy surgery. 4. Panretinal photocoagulation or intraocular surgery within 3 months of enrollment. 5. Concomitant or previous radiation optic neuropathy. 6. Use of periocular, intravitreal, or systemic steroids within 6 month of enrollment in the study eye. 7. Use of intravitreal VEGF antagonist within 6 weeks of enrollment. 8. History of ocular hypertension or glaucoma, or intraocular pressure (IOP)\>21 mmHg. 9. History of steroid-induced glaucoma in either eye. 10. Active ocular infection or history of herpetic eye infection. 11. Clinically significant epiretinal membrane in the study eye. 12. Iris neovascularization in the study eye. 13. Clinically significant media opacity preventing acquisition of good-quality optical coherence tomography (OCT) in the study eye. 14. Aphakia or anterior chamber intraocular lens. 15. Poorly controlled diabetes (Hemoglobin A1c level \>13%). 16. Poorly controlled hypertension (Systolic pressure \> 160 mm Hg or diastolic pressure \> 90 mm Hg). 17. Pregnancy (women of childbearing age should have negative pregnancy test and use contraception). 18. Presence of any ocular condition that in the opinion of one of the investigators will prevent at least 2 lines of improvement in best-corrected visual acuity. 19. Interval between plaque radiotherapy for uveal melanoma and intended date of dexamethasone intravitreal implant of less than 6 months. 20. Evidence of activity or inadequate regression of the treated uveal melanoma after plaque radiotherapy (based on the judgment of the study investigators). 21. Known allergy or hypersensitivity to any of the study medications or their components. 22. History of prior myocardial infarction or stroke.",NA,ALL,NA,"[{'measure': 'Number of Participants for Whom Study Eye Showed >=2 Lines of Improvement in Best-corrected Visual Acuity', 'description': 'The number of participants that developed 2 or more lines of visual acuity improvement in the study eye. Visual acuity was measured with Snellen eye chart placed 10 feet away from the patient.', 'timeFrame': 'At 12 months'}]","[{'measure': 'Change in Central Subfield Retinal Thickness', 'description': 'Increase or decrease in central subfield retinal thickness in microns based on spectral-domain optical coherence tomography measurement', 'timeFrame': 'At 12 months'}, {'measure': 'Development of Glaucoma', 'description': 'Intraocular pressure more than 21 mm Hg as measured with applanation tonometry.', 'timeFrame': 'At 12 months'}, {'measure': 'Development of Cataract', 'description': 'Development of visually-significant lens opacity based on judgement of examining physician.', 'timeFrame': 'At 12 months'}, {'measure': 'Development of Retinal Detachment', 'description': 'Development of rhegmatogenous retinal detachment in the study eye.', 'timeFrame': 'At 12 months'}, {'measure': 'Development of Vitreous Hemorrhage', 'description': 'Development of hemorrhage in the vitreous cavity detectable with slit lamp examination or dilated funduscopy.', 'timeFrame': 'At 12 months'}]" 241,NCT02697591,"{'fullName': 'Incyte Corporation', 'class': 'INDUSTRY'}",A Study of INCAGN01876 in Participants With Advanced or Metastatic Solid Tumors,COMPLETED,"This was an open-label, non-randomized Phase 1/2 safety study of INCAGN01876 in participants with advanced or metastatic solid tumors that was conducted in 2 parts. Part 1 is dose escalation and safety expansion which determines the optimal dose and maximum number of tolerated doses. Part 2 is dose expansion in which Part 1 recommended dose will be evaluated.","['Advanced Malignancies', 'Metastatic Cancer']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'INCAGN01876', 'description': 'Initial cohort dose of INCAGN01876 monotherapy at the protocol-defined starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose will be taken forward into expansion cohorts.', 'armGroupLabels': ['Phase 1: 0.03 mg/kg Q2W', 'Phase 1: 0.1 mg/kg Q2W', 'Phase 1: 0.3 mg/kg Q2W', 'Phase 1: 1.0 mg/kg Q2W', 'Phase 1: 10.0 mg/kg Q2W', 'Phase 1: 20.0 Milligram Per Kilograms (mg/kg) Every 2 Weeks (Q2W)', 'Phase 1: 3.0 mg/kg Q2W', 'Phase 1: 400 mg/kg Every 4 Weeks (Q4W)', 'Phase 1: 5.0 mg/kg Q2W', 'Phase 2: 300 mg/kg Q2W']}]","Inclusion Criteria: * Locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent. * Part 1: Participants with advanced or metastatic solid tumors. * Part 2: Participants with advanced or metastatic adenocarcinoma of endometrium, melanoma, non-small cell lung cancer, and renal cell carcinoma. * Participants who have disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment, or participants who refuse standard treatment. * Presence of measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. Exclusion Criteria: * Laboratory and medical history parameters not within the protocol-defined range. * Receipt of anticancer medications or investigational drugs within protocol-defined intervals before the first administration of study drug. * Has not recovered to ≤ Grade 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting therapy. * Receipt of a live vaccine within 30 days of planned start of study therapy. * Active autoimmune disease. * Prior treatment with any tumor necrosis factor super family agonist. * Known active central nervous system metastases and/or carcinomatous meningitis. * Evidence of active, non-infectious pneumonitis or history of interstitial lung disease. * Evidence of hepatitis B virus or hepatitis C virus infection or risk of reactivation.",NA,ALL,NA,"[{'measure': 'Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) and as Per the Severity', 'description': 'AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. A treatment-emergent AE is any AE either reported for first time or worsening of a pre-existing event after the first dose of study drug. Grade 1 AEs is defined as Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 AEs is defined as Moderate; minimal, local, or non-invasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3 AEs is defined as the severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living and Grade 4 AEs as life-threatening consequences; urgent intervention indicated. Data is reported for Grade 3 and higher severity for this outcome measure.', 'timeFrame': 'From screening through 60 days after end of treatment, up to Month 15'}]","[{'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': 'Day 1 of Cycles 1 and 6 post-dose'}, {'measure': 'Time to Maximum Concentration (Tmax)', 'timeFrame': 'Day 1 of Cycles 1 and 6 post-dose'}, {'measure': 'Minimum Observed Plasma Concentration Over the Dose Interval (Cmin)', 'timeFrame': 'Day 1 of Cycles 2, 3, 4, 6, and 7 post-dose'}, {'measure': 'Area Under the Plasma Time Curve From Time = 0 to the Last Measurable Concentration (AUC0-t)', 'timeFrame': 'Day 1 of Cycles 1 and 6 post-dose'}, {'measure': 'Objective Response Rate (ORR) Per RECIST v1.1 and Modified RECISTv1.1 (mRECIST)', 'description': 'ORR is defined as the percentage of participants having complete response (CR) or partial response (PR), as determined by investigator assessment of radiographic disease assessments. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm.', 'timeFrame': 'Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter up to 15 months'}, {'measure': 'Duration of Response (DOR) Per RECIST and mRECIST', 'description': 'DOR is defined as the time from earliest date of disease response (CR or PR) until earliest date of disease progression, as determined by investigator assessment of radiographic disease assessments per RECIST v1.1 and mRECIST, or death due to any cause if occurring sooner than progression. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm.', 'timeFrame': 'Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter up to 15 months'}, {'measure': 'Duration of Disease Control Per RECIST and mRECIST', 'description': 'Duration of disease control (CR, PR, and stable disease \\[SD\\]), as measured from first report of SD or better until disease progression, as determined by investigator assessment of radiographic disease assessments per RECIST v1.1 and mRECIST, or death due to any cause if occurring sooner than progression. PR: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. CR: Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \\< 10 mm. Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.', 'timeFrame': 'Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter up to 15 months'}, {'measure': 'Progression Free Survival (PFS) Per RECIST and mRECIST', 'description': 'PFS is defined as the time from date of first dose of study drug until the earliest date of disease progression, as determined by investigator assessment of objective radiographic disease assessments per RECIST v1.1 and mRECIST, or death due to any cause if occurring sooner than progression. Progression is defined by RECIST and mRECIST as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and an absolute lesion increase of at least 5 mm or the appearance of new lesions.', 'timeFrame': 'Baseline and every 8 weeks for the first 12 months and then every 12 weeks thereafter up to 15 months'}]" 242,NCT01006980,"{'fullName': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}",A Study of Vemurafenib (RO5185426) in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3),COMPLETED,"This randomized, open-label study evaluated the efficacy, safety and tolerability of vemurafenib (RO5185426) as compared to dacarbazine in previously untreated patients with metastatic melanoma. Patients were randomized to receive either vemurafenib 960 mg orally twice daily or dacarbazine 1000 mg/m2 intravenously every 3 weeks. Study treatment was continued until disease progression or unacceptable toxicity occurred. The data and safety monitoring board recommended that patients in the dacarbazine group be allowed to cross over to receive vemurafenib, and the protocol was amended accordingly on January 14, 2011, as both overall survival and progression-free survival endpoints had met the prespecified criteria for statistical significance in favor of vemurafenib.",['Malignant Melanoma'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Vemurafenib', 'description': '960 mg (as 240 mg tables) orally twice daily', 'armGroupLabels': ['Vemurafenib'], 'otherNames': ['Zelboraf®', 'RO5185426']}, {'type': 'DRUG', 'name': 'Dacarbazine', 'description': '1000 mg/m2 intravenously every 3 weeks', 'armGroupLabels': ['Dacarbazine']}]","Inclusion Criteria: * adults, \>/=18 years of age * metastatic melanoma, stage IIIC or IV (AJCC) * treatment-naïve (no prior systemic anticancer therapy) * positive for BRAF V600E mutation * measurable disease by RECIST criteria * negative pregnancy test and, for fertile men and women, effective contraception during treatment and for 6 months after completion Exclusion Criteria: * active central nervous system metastases * history of carcinomatous meningitis * severe cardiovascular disease within 6 months prior to study drug administration * previous malignancy within 5 years prior to study, except for basal or squamous cell carcinoma of the skin, melanoma in-situ, or carcinoma in-situ of the cervix",NA,ALL,NA,"[{'measure': 'Overall Survival', 'description': 'An Overall survival event was defined as death due to any cause. The number of participants with overall survival events is reported.', 'timeFrame': 'From randomization (initiated January 2010) to December 30 2010. Median follow-up time in the vemurafenib group was 3.75 months (range 0.3 to 10.8) and in the dacarbazine group was 2.33 months (range <0.1 to 10.3).'}, {'measure': 'Progression-free Survival', 'description': 'A progression-free survival (PFS) event was defined as disease progression or death due to any cause. Tumor response (progression) was assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 criteria using computed tomography (CT) scans or magnetic resonance imaging (MRI).', 'timeFrame': 'From randomization (initiated January 2010) to December 30 2010.'}]","[{'measure': 'Participants With a Best Overall Response (BOR) of Complete Response or Partial Response', 'description': 'BOR was defined as a complete response (CR) or partial response (PR) confirmed per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Participants who never received study treatment and treated participants without any post-baseline tumor assessments were considered as non-responders. CR: Disappearance of all target lesions, all non-target lesions and no new lesion. Any pathological lymph nodes must have had reduction in the short axis to \\<10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, no progression in non-target lesion and no new lesion.', 'timeFrame': 'From randomization (initiated January 2010) until December 30, 2010'}, {'measure': 'Duration of Response', 'description': 'Duration of response was defined as the time between the date of the earliest qualifying response and the date of disease progression or death due to any cause. Duration of response was calculated only for participants who had a best overall response of Complete Response or Partial Response and was estimated using the Kaplan-Meier method.', 'timeFrame': 'From randomization (initiated in January 2010) until December 30, 2010.'}, {'measure': 'Time to Confirmed Response', 'description': 'Time to response was defined as the time from randomization to confirmed response (complete response or partial response).', 'timeFrame': 'From randomization (initiated January 2010) until December 30, 2010.'}, {'measure': 'Time to Treatment Failure', 'description': 'Treatment failure was defined as a secondary endpoint in the protocol, defined as death, disease progression or premature withdrawal of study treatment. This endpoint was not included in the Statistical analysis plan; therefore no analyses of time to treatment failure were performed.', 'timeFrame': 'approximately 3 years'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'description': 'The intensity of AEs was graded according to the NCI Common Terminology Criteria for Adverse Events v 4.0 (CTCAE) on a five-point scale (Grade 1 to 5: Mild, Moderate, Severe, Life-threatening and Death). A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution, for example is life-threatening, requires hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or requires intervention to prevent one or other of the outcomes listed above.', 'timeFrame': 'From randomization (initiated January 2010) until December 30, 2010.'}, {'measure': 'Pre and Post-dose Plasma Vemurafenib Concentration by Study Day', 'description': 'The pharmacokinetics of vemurafenib were assessed at the beginning of each 21-day cycle using pre-dose and 2-4 hours post-dose sampling.', 'timeFrame': 'Plasma samples were collected before the morning dose (troughs) and 2-4 hours after the morning dose at the beginning of each cycle (Days 1, 22, 43, 64, 106, 148 and 190).'}]" 243,NCT03820986,"{'fullName': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}",Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advance Melanoma (MK-7902-003/E7080-G000-312/LEAP-003),COMPLETED,"The purpose of this study is to assess the safety and efficacy of pembrolizumab (MK-3475) combined with lenvatinib (MK-7902/E7080) compared to pembrolizumab alone (with placebo for lenvatinib) as first-line treatment in adults with no prior systemic therapy for their advanced melanoma. The primary study hypotheses are that: 1) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), and 2) The combination of pembrolizumab and lenvatinib is superior to pembrolizumab and placebo as assessed by Overall Survival (OS). For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.",['Malignant Melanoma'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}","[{'type': 'BIOLOGICAL', 'name': 'Pembrolizumab', 'description': 'IV infusion', 'armGroupLabels': ['Pembrolizumab+Lenvatinib', 'Pembrolizumab+Placebo'], 'otherNames': ['MK-3475', 'KEYTRUDA®']}, {'type': 'DRUG', 'name': 'Lenvatinib', 'description': 'Oral capsule', 'armGroupLabels': ['Pembrolizumab+Lenvatinib'], 'otherNames': ['MK-7902', 'E7080', 'LENVIMA®']}, {'type': 'DRUG', 'name': 'Placebo for lenvatinib', 'description': 'Oral capsule', 'armGroupLabels': ['Pembrolizumab+Placebo']}]","Inclusion Criteria: * Has histologically or cytologically confirmed melanoma. * Has unresectable Stage III or Stage IV melanoma, as per American Joint Committee on Cancer guidelines, not amenable to local therapy. * Has been untreated for advanced or metastatic disease except as follows: 1. Proto-oncogene B-Raf (BRAF) V600 mutation-positive melanoma may have received standard of care targeted therapy as first-line therapy for advanced or metastatic disease. Participants that do not have a BRAF V600 mutation but did receive BRAF or BRAF/mitogen-activated extracellular signal-regulated kinase 1/2 Inhibitor (MEKi) therapy are eligible to participate in this study after discussion with the medical monitor. 2. Prior adjuvant or neoadjuvant therapy, with targeted therapy or immunotherapy (such as anti-cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], anti-programmed cell death 1 \[anti-PD-1\] therapy or interferon) will only be permitted if relapse did not occur during active treatment or within 6 months of treatment discontinuation. * Have documentation of BRAF V600-activating mutation status or consent to BRAF V600 mutation testing during the Screening period (participants with BRAF mutation-positive melanoma as well as BRAF wild-type or unknown are eligible). * Has an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1. * Has the presence of ≥1 measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST 1.1. * Provides a tumor biopsy. Participants must submit tumor sample during Screening for confirmation of adequacy of tumor tissue at a central pathology laboratory. Participants who do not submit a tumor tissue sample will not be randomized. The tumor biopsy may not be obtained from a lone target lesion. Confirmation of presence of tumor tissue is not required prior to randomization. * Has resolution of toxic effect(s) of the most recent prior therapy to Grade 1 or less (except alopecia). If participant received major surgery or radiation therapy of \>30 Gray (Gy), they must have recovered from the toxicity and/or complications from the intervention. * Male participants must agree to use contraception during the treatment period and for at least 7 days after the last dose of study treatment and refrain from donating sperm during this period. Please note that 7 days after lenvatinib/placebo is stopped, if the participant is on pembrolizumab only, no male contraception measures are needed. Contraception use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed. * Female participants must not be pregnant, not breastfeeding, and ≥1 of the following conditions applies: 1. Not a woman of childbearing potential (WOCBP). OR 2. A WOCBP who agrees to use study-approved contraception during the treatment period and for at least 120 days after the last dose of study treatment. * The participant (or legally acceptable representative) has provided documented informed consent for the study. * Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mmHg at screening and no change in antihypertensive medications within 1 week before Cycle 1 Day 1. * Has adequate organ function. Exclusion Criteria: * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days before the first dose of study treatment. * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1, non-ulcerated primary melanoma \<1 mm in depth with no nodal involvement) treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy. * Has known active central nervous system metastases and/or carcinomatous meningitis. * Has ocular melanoma. * Has known hypersensitivity to active substances or any of their excipients including previous clinically significant hypersensitivity reaction to treatment with another monoclonal antibody. * Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. * Has an active infection requiring systemic therapy. * Has known history of human immunodeficiency virus (HIV) infection * Has known history of or is positive for hepatitis B virus or hepatitis C virus infection. * Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * Has a history of active tuberculosis (Bacillus tuberculosis). * Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib. * Has had a major surgery within 3 weeks prior to first dose of study intervention. Note: Adequate wound healing after major surgery must be assessed clinically independent of time elapsed for eligibility. * Has a preexisting Grade ≥3 gastrointestinal or non-gastrointestinal fistula. * Has radiographic evidence of encasement or invasion of major blood vessel, or of intratumoral cavitation. * Has active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study treatment. * Has clinically significant cardiovascular disease from 12 months of the first dose of study treatment including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability. * Has urine protein ≥1 g/24-hour. Note: Participants with ≥2+ (≥100 mg/dL) proteinuria on urine dipstick testing (or urinalysis) will undergo 24-hour urine collection for quantitative assessment of proteinuria. * Prolongation of QTcF interval to \>480 ms. Note: If the QTcF is prolonged to \>480 ms in the presence of a pacemaker, contact the Sponsor to determine eligibility. * Has left ventricular ejection fraction (LVEF) below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram. * Has received prior therapy in the adjuvant setting. Note: Targeted therapy, anti-CTLA-4, or anti-PD-1 may be allowed. * Has received prior systemic treatment for unresectable or metastatic melanoma other than targeted therapy as noted in Inclusion Criteria above * Has received prior therapy with a monoclonal antibody, chemotherapy, or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer) before administration of study treatment or not recovered (≤Grade 1 or at Baseline) from adverse events due to previously administered agents. Exception to this rule would be use of denosumab, which is not excluded. Note: Participants with alopecia and ≤Grade 2 neuropathy are an exception and may enroll. * Has received prior radiotherapy within 2 weeks of first dose of study treatment (Cycle 1 Day 1). Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. * Has received live vaccine within 30 days before the first dose of study treatment. * Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment. * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator. * Has had an allogeneic tissue/solid organ transplant. * Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.",NA,ALL,NA,"[{'measure': 'Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) Per Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)', 'description': 'PFS is defined as the time from date of randomization to the date of the first documentation of progressive disease (PD) or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD. For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The final analysis for this outcome is presented here.', 'timeFrame': 'Up to approximately 34 months'}, {'measure': 'Overall Survival (OS)', 'description': 'OS is defined as the time from date of randomization to date of death from any cause. The final analysis for this outcome is presented here.', 'timeFrame': 'Up to approximately 46 months'}]","[{'measure': 'Objective Response Rate (ORR) as Assessed by BICR Per RECIST 1.1', 'description': 'ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The final analysis for this outcome is presented here.', 'timeFrame': 'Up to approximately 46 months'}, {'measure': 'Duration of Response (DOR) as Assessed by BICR Per RECIST 1.1', 'description': 'For participants who demonstrated CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions), DOR is defined as the date of the first documented evidence of CR or PR until disease progression or death from any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD. For this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The final analysis for this outcome is presented here.', 'timeFrame': 'Up to approximately 46 months'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'description': 'An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The final analysis for this outcome is presented here.', 'timeFrame': 'Up to approximately 67 months'}, {'measure': 'Number of Participants Who Discontinue Study Treatment Due to Adverse Events (AEs)', 'description': 'An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinued any study treatment due to an AE is presented. The final analysis for this outcome is presented here.', 'timeFrame': 'Up to approximately 63 months'}, {'measure': 'Change From Baseline in European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire-Core 30 [QLQ-C30] Global Health Status (GHS)/Quality of Life (QoL) Score', 'description': 'The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The GHS/QoL combined score consists of participant responses to the questions ""How would you rate your overall health during the past week?"" and ""How would you rate your overall quality of life during the past week?"" GHS/QoL responses range in score from 0 to 100, with a higher score indicating a better outcome. The final analysis for this outcome is presented here.', 'timeFrame': 'Baseline and Week 21'}, {'measure': 'Change From Baseline in European Organization for Research and Treatment of Cancer [EORTC] Quality of Life Questionnaire-Core 30 [QLQ-C30] Physical Function (PF) Score', 'description': 'The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The PF Score consists of participant responses to questions regarding PF (5 questions about daily activities \\[strenuous activities, long walks, short walks, bed/chair rest and needing help with eating, dressing, washing themselves or using the toilet\\]). For PF, responses range in score from 0 to 100, with a higher score indicating a better outcome. The final analysis for this outcome is presented here.', 'timeFrame': 'Baseline and Week 21'}, {'measure': 'Time to True Deterioration (TTD) Based on Change From Baseline in EORTC QLQ-C30 GHS/QoL Score', 'description': 'TTD is defined as the time from Baseline to 1st onset of a ≥10-point negative change (decrease) in EORTC-QLQ-C30 GHS Score. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The GHS/QoL Score consists of participant responses to the questions ""How would you rate your overall health during the past week?"" and ""How would you rate your overall quality of life during the past week?"" GHS/QoL responses range in score from 0 to 100, with a higher score indicating a better outcome. A longer TTD indicates a better outcome. The final analysis for this outcome is presented here.', 'timeFrame': 'Up to approximately 30 months'}, {'measure': 'Time to True Deterioration (TTD) Based on Change From Baseline in EORTC QLQ-C30 in Physical Function (PF) Score', 'description': 'TTD is defined as the time from Baseline to 1st onset of a ≥10-point negative change (decrease) in EORTC-QLQ-C30 PF Score. The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. The PF Score consists of participant responses to questions regarding PF (5 questions about daily activities \\[strenuous activities, long walks, short walks, bed/chair rest \\& needing help with eating, dressing, washing themselves or using the toilet\\]. For PF, responses range in score from 0 to 100, with a higher score indicating a better outcome. The final analysis for this outcome is presented here.', 'timeFrame': 'Up to approximately 30 months'}]" 244,NCT06640582,"{'fullName': 'Essen Biotech', 'class': 'OTHER'}",TIL Therapy Combined With Pembrolizumab for Advanced Brain Cancer Including Gliomas and Meningiomas,RECRUITING,"This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with Advanced Brain Cancer including Gliomas and Meningiomas . Lifileucel (Amtagvi), the first FDA-approved TIL therapy, has demonstrated significant success in treating unresectable or metastatic melanoma by utilizing the patient's own immune cells to combat cancer. This study aims to apply a similar approach to Brain cancer. TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody targeting the PD-1 receptor on T cells, will be administered to enhance the immune response. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to offer a novel, personalized treatment option for patients with limited therapeutic alternatives.","['Brain Tumor', 'Brain Metastases', 'Brain Cancer', 'Glioma', 'Gliomas, Malignant', 'Glioblastoma', 'Meningioma']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'Tumor Infiltrating Lymphocytes (TIL)', 'description': 'Tumor Infiltrating Lymphocytes (TIL) IV', 'armGroupLabels': ['Biological Tumor Infiltrating Lymphocytes (TIL) Therapy with Immunotherapy']}, {'type': 'DRUG', 'name': 'Cyclophosphamide', 'description': 'Cyclophosphamide will be administered as an intravenous (IV) infusion for two days.', 'armGroupLabels': ['Biological Tumor Infiltrating Lymphocytes (TIL) Therapy with Immunotherapy']}, {'type': 'DRUG', 'name': 'Fludarabine', 'description': 'Fludarabine will be administered as an intravenous (IV) infusion for five days.', 'armGroupLabels': ['Biological Tumor Infiltrating Lymphocytes (TIL) Therapy with Immunotherapy']}, {'type': 'DRUG', 'name': 'Interleukin-2', 'description': 'After TIL infusion, IL-2 will be started as a bolus administration every eight hours, for a maximum of eight doses.', 'armGroupLabels': ['Biological Tumor Infiltrating Lymphocytes (TIL) Therapy with Immunotherapy']}, {'type': 'DRUG', 'name': 'Pembrolizumab', 'description': 'Intravenous (IV) infusion', 'armGroupLabels': ['Biological Tumor Infiltrating Lymphocytes (TIL) Therapy with Immunotherapy']}]","Inclusion Criteria: * Age: 16 years to 90 years * Histologically diagnosed as primary/relapsed/metastasized brain glioma * Expected life span more than 3 months * Karnofsky≥60% or ECOG score 0-2 * Test subjects have failed standard treatment regimens, or there are no standard treatment regimens available. * Test subjects must have tumor regions eligible for biopsy or resection, or malignant body fluid where TILs can be isolated * At least 1 evaluable tumor lesion * Hematology and Chemistry（within 7 days prior to enrollment）: * Absolute count of white blood cells≥2.5×10\^9/L * Absolute count of neutropils≥1.5×10\^9/L * Absolute count of lymphocytes ≥0.7×109/L * Platelet count≥100×10\^9 * hemoglobin≥90 g/L * Activated partial thromboplastin time (APTT) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days) * International normalized ratio (INR) ≤1.5xULN (Unless received anticoagulant therapy within the previous 3 days) * Serum creatinine ≤1.5mg/dL(or ≤132.6μmol/L), or clearance rate≥50mL/min * Serum ALT/AST ≤3×ULN(subjects with liver metastasis ≤3×ULN) * Totol bilirubin≤1.5×ULN * No absolute or relative contraindications to operation or biopsy * Test subjects with child-bearing potential must be willing to practice approved highly effective methods of contraception at the time of informed consent and continue within 1 year after the completion of lymphodepletion * Any malignant tumor-targeting therapies, including radiotherapy, chemotherapy, and biologics must cease 28 days before obtaining TILs * Be able to understand and sign the informed consent document; * Be able to stick to follow-up visit plan and other requirements in the agreement. Exclusion Criteria: * Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment * Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40% * Significant cardiovascular anomalies according to any of the following definitions: * New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant * Low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrioventricular conductive block, etc. * Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive. * Severe physical or mental diseases; * Have a systemic active infection requiring treatment, or have positive blood cultures(or imaging evidence of infection). * Having been treated within a month or being treated now with other medicines, or other biologic therapy, chemo-or radiotherapy. * History of allergy to chemical compounds consisting of chemical and biological substances resembling cell therapy. * Having received immunotherapy and developed an irAE level greater than Level 3. * Previous anti-tumor treatment AE did not return to CTCAE5.0 version grade 1 or below (toxicity considered by the investigator as non-safety concerns like alopecia excluded). * Females in pregnancy or lactation. History of organ transplantation, allogeneic stem cell transplantation, and renal replacement therapy. * Researchers consider the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.",NA,ALL,NA,"[{'measure': 'Adverse Events', 'description': 'To characterize the safety profile of (TIL) and natural autologous TIL in patients with advanced solid tumors who were failed to standard treatment as assessed by incidence of adverse events.', 'timeFrame': '6 months'}]","[{'measure': 'Objective Response Rate (ORR)', 'description': 'Proportion of patients with response per Response Evaluation Criteria in Solid Tumors', 'timeFrame': 'Up to 36 months'}, {'measure': 'Disease Control Rate (DCR）', 'description': 'Percentage of patients that meet CR, PR and SD criteria set in this study', 'timeFrame': 'Up to 36 months'}, {'measure': 'Duration of Response (DOR)', 'description': 'The time length between the first confirmed objective response to the treatment and the subsequent disease progression', 'timeFrame': 'Up to 36 months'}, {'measure': 'Progression-Free Survival (PFS)', 'description': 'The time length between TIL infusion and confirmed subsequent disease progression', 'timeFrame': 'Up to 36 months'}]" 245,NCT06608420,"{'fullName': 'Fundacion Clinic per a la Recerca Biomédica', 'class': 'OTHER'}",Precision Medicine for L/GCMN and Melanoma 1,RECRUITING,"The primary objective of this study is to create a highly multidimensional and multicentric database for melanoma that encompasses cohorts of children, adolescent and young adults. This database will be used to perform survival analysis and evaluate sentinel lymph node (SLNB) positivity in CAYA. The secondary objectives to be met are the following: * Adaptation and optimization of algorithms: work on optimizing existing precision medicine algorithms, which are currently being used in adult patient care, for their application within pediatric and young adult populations. * Implementation of transfer learning: given the limitations associated with pediatric and young adult data, the investigators intend to utilize transfer learning techniques. The study will employ a sequential waterfall methodology, whereby machine learning models trained on adult patient data will be fine-tuned using the more limited data from younger cohorts. * Integration of expert medical opinion: to integrate physician's scientific domain knowledge into the decision support system. This will be facilitated through the comprehensive examination of existing literature, as well as the evaluation of variable risk contributions within each patient group. * AI-based prognostic models: to develop artificial intelligence-based models for the quantitative prognosis of melanoma across the three age groups: adults, young adults, and children.","['Melanoma (Skin Cancer)', 'Nevi and Melanomas']",OBSERVATIONAL,"{'observationalModel': 'OTHER', 'timePerspective': 'RETROSPECTIVE'}","[{'type': 'OTHER', 'name': 'Gradient Boosting Survival Analysis (GBSA),', 'description': 'It is a non-deep learning method that effectively addresses data scarcity issues. GBSA adapts the gradient boosting machine algorithm for survival analysis, particularly accommodating censored data. In survival analysis, patients are represented by a triplet (xi, δi, Ti), where xi is the feature vector, Ti is the time to event, and δi indicates whether the observation is censored. Our goal is to estimate the survival function S(t), representing the probability of a patient surviving beyond time t, and the hazard function λ(t), indicating the instantaneous probability of an event occurring at time t.', 'armGroupLabels': ['Melanoma patients']}, {'type': 'OTHER', 'name': 'Concordance index', 'description': 'The survival model performance will be evaluated using the concordance index (c-index), a metric particularly suited for survival analysis. The c-index assesses the predictive accuracy of our model by comparing predicted and observed event times. A high c-index indicates that our model effectively predicts the order of patient hazard given its input features.', 'armGroupLabels': ['Melanoma patients']}]","Inclusion Criteria: \- Melanoma patients of any age with histopathological confirmed melanoma Exclusion Criteria: * Not having a melanoma diagnosis * Not having signed the informed consent * Records prior to the year 2012 (as data might not accurately reflect current practices and treatment outcomes)","Review and/or analysis of pre-existing medical records, biological samples and data collected from patients that have been visited at our hospital.",ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Patient prognosis curves', 'description': 'The main outcome of the study will be to obtain prognosis indicators, mainly survival curves and sentinel lymph node (SLNB) positivity, by training artificial intelligence-based models using tabular clinical data in children, adolescents and young adults (CAYA).', 'timeFrame': '24 months'}]",NA 246,NCT04250246,"{'fullName': 'Italian Network for Tumor Biotherapy Foundation', 'class': 'OTHER'}",A Study of NIVO Plus IPI and Guadecitabine or NIVO Plus IPI in Melanoma and NSCLC Resistant to Anti-PD1/PDL1,UNKNOWN,"This is a run-in, randomized, non-comparative, phase II study designed according to a two stages optimal design by Simon. This phase II design will be preceded by a safety evaluation after the first cohort of 6 patients to preserve a high-grade of overlapping and/or unexpected toxicity rate. The study will assess the immune-objective response rate (iORR) (assessed using iRECIST criteria) of nivolumab combined with ipilimumab and guadecitabine or nivolumab combined with ipilimumab, in Melanoma and non-small cell lung cancer (NSCLC) patients resistant to anti-PD-1/PD-L1 therapy. Immune biologic correlates to treatment will be assessed as exploratory endpoints.","['Melanoma', 'Non Small Cell Lung Cancer']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, non-comparative, phase II study designed according to a two stages optimal design by Simon', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Ipilimumab plus nivolumab plus guadecitabine', 'description': 'Cohort A Melanoma ARM A Guadecitabine: 30-45 mg/m2 s.c./day 1-5 q21 x 4 cycles and from W13 q28 x 6 cycles Ipilimumab: 3 mg/Kg i.v. plus nivolumab 1 mg/Kg i.v. on W1, 4, 7 and 10 and from W14 nivolumab 480 mg i.v. q4 wks for 2 years\n\nCohort B NSCLC ARM A Guadecitabine: 30-45 mg/m2 s.c./day 1-5 q21 x 4 cycles and from W13 q28 x 6 cycles Ipilimumab: 1 mg/Kg i.v.q 6wks plus nivolumab 3 mg/Kg i.v. q2 wks until W13, then ipilimumab: 1 mg/Kg i.v. q 6wks plus nivolumab 480mg i.v. q4wks for 2 years', 'armGroupLabels': ['Ipilimuamb plus nivoluamb plus guadecitabine'], 'otherNames': ['ipilimumab (Yervoy)', 'nivolumab (Opdivo)', 'guadecitabine (SGI-110)']}, {'type': 'DRUG', 'name': 'Ipilimumab plus nivolumab', 'description': 'Cohort A Melanoma ARM B Ipilimumab: 3 mg/Kg i.v. plus nivolumab 1 mg/Kg i.v. on W1, 4, 7 and 10 and from W14 nivolumab 480 mg i.v. q4 wks for 2 years\n\nCohort B NSCLC ARM B Ipilimumab: 1 mg/Kg i.v. q 6wks plus nivolumab 3 mg/Kg i.v. q2 wks until W13, then ipilimumab: 1 mg/Kg i.v. q6 wks plus nivolumab 480mg i.v. q4wks for 2 years.', 'armGroupLabels': ['Ipilimumab plus nivolumab'], 'otherNames': ['ipilimumab (Yervoy)', 'nivolumab (Opdivo)']}]","Inclusion Criteria: 1. Target Population Melanoma cohort A 1. Histologic diagnosis of malignant melanoma 2. Unresectable Stage III/Stage IV melanoma patients with resistance to anti-PD-1/PD-L1 and measurable lesions by CT or MRI per iRECIST/RECIST criteria that can be amenable to biopsy 3. Only one line of immunotherapy for advanced (unresectable Stage III or Stage IV) disease with anti-PD-1/PD-L1 and its combinations; if BRAF mutant one line of targeted therapy is allowed prior to anti-PD-1/PD-L1therapy. 2. Target Population NSCLC cohort B 1. Histologic or cytologic diagnosis of NSCLC lackingEGFR-sensitizing mutation and/or ALK/ROS1 translocation. 2. Stage IV NSCLC patients with primary resistance to anti-PD-1/PD-L1 and measurable lesions by CT or MRI per iRECIST/RECIST criteria that can be amenable to biopsy. 3. Only one line of immunotherapy for advanced (unresectable Stage III or Stage IV) disease with anti-PD-1/PD-L1 or its combinations; one line of chemotherapy is allowed prior to anti-PD-1/PDL-1 therapy. 3. confirmed PD 4. 4 weeks or greater since last treatment and 5. Must have recovered from any acute toxicity associated with prior therapy 6. Life expectancy greater than 16 weeks 7. Subjects with adequate organ function defined as: 1. WBC ≥3500/uL 2. ANC ≥2000/uL 3. Platelets ≥ 100 x 103/uL 4. Hemoglobin ≥ 9 g/dL 5. Creatinine \< or \<= 2.5 x ULN 6. AST * \< or \<= 2.5 x ULN for patients without liver metastasis * \< or \<= 5 x ULN for patients with liver metastasis 7. Bilirubin * \< or \<= 3 x ULN for patients with liver metastasis * \<3.0 mg/mL for patients with Gilbert's Syndrome * 1.5 x ULN for patients without liver metastasis 8. Negative screening tests for HIV, HepB, and HepC. If positive results are not indicative of true active or chronic infection, the patient can enter the study after discussion and agreement between the Investigator and the Medical Monitor. 9. Women of child-bearing potential must not be pregnant or breastfeeding, must have a negative pregnancy test at Screening and all men must be practicing two medically acceptable methods of birth control. Men should not father a child while receiving treatment with guadecitabine+ ipilimumab, and for 2 months following completion of treatment. Men with female partners of childbearing potential should use effective contraception during this time. Exclusion Criteria: 1. Sex and Reproductive Status 1. Women who are pregnant or breastfeeding; 2. WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 23 weeks after the study; 3. Women with a positive pregnancy test on enrollment or prior to investigational product administration; 4. Sexually active fertile men not using effective birth control if their partners are WOCBP 2. Target Disease Exceptions 1. Any malignancy from which the patient has been disease-free for less than 2 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix 2. Primary ocular melanoma. 3. Medical History and Concurrent Diseases 1. Symptomatic brain metastases requiring immediate local intervention (radiotherapy (RT) and/or surgery); 2. Leptominingeal involvement by disease; 3. Autoimmune disease: Patients with a documented history of Inflammatory Bowel Disease, including ulcerative colitis and Crohn's disease are excluded from this study as are patients with a documented history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], Systemic Lupus Erythematosus, autoimmune vasculitis \[e.g., Wegener's Granulomatosis\] and autoimmune hepatitis. Subjects with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome) are also excluded from this study; 4. Any underlying medical condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent diarrhea. 4. Prohibited Treatments and/or Therapies 1. Concomitant therapy with any anti-cancer agent; immunosuppressive agents; any non-oncology vaccine therapy used for prevention of infectious diseases (for up to 1 month prior to or after any dose of study drug); surgery or radiotherapy (except palliative surgery and/or radiotherapy to treat a non-target symptomatic lesion or to the brain after Sponsor approval); other investigational anti-cancer therapies; or chronic use of systemic corticosteroids (used in the management of cancer or non-cancer-related illnesses); 2. Previous treatment with other investigational products, including cancer immunotherapy, within 30 days; 3. Prior treatment with anti-CTLA-4, except in adjuvant setting Other Exclusion Criteria 1. Prisoners or subjects who are involuntarily incarcerated; 2. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness. Eligibility criteria for this study have been carefully considered to ensure the safety of the study subjects and to ensure that the results of the study can be used. It is imperative that subjects fully meet all eligibility criteria.",NA,ALL,NA,"[{'measure': 'Immune-related Objective Response Rate (iORR)', 'description': 'Immune-related Objective Response Rate (iORR) is the proportion of treated subjects with an iBOR of confirmed iCR or confirmed iPR.', 'timeFrame': '24 weeks'}]","[{'measure': 'Safety of guadecitabine in combination with ipilimumab and nivolumab', 'description': 'Reporting of safety, extent of exposure, concomitant medications and discontinuation of study therapy will be based on all treated subjects; for on-study laboratory test results, all treated subjects with at least one on-study laboratory measurement available will be included in the analysis. The reporting period for safety data will be from the date of first dose received on this study to 100 days after the last dose is received. Serious adverse events are reported from the time of consent forward for all subjects. All subjects who received at least one dose of study treatment will be evaluated for safety parameters', 'timeFrame': '2 years'}, {'measure': 'Obiective Response Rate (ORR)', 'description': 'Objective Response Rate (ORR) is the proportion of treated subjects with a BOR of CR or PR per RECIST 1.1.', 'timeFrame': '24 weeks'}, {'measure': 'Disease Control Rate (DCR)', 'description': 'Disease Control Rate (DCR) is the proportion of treated subjects with a BOR of confirmed CR, confirmed PR or SD, based on RECIST 1.1 and iRECIST.', 'timeFrame': '24 weeks'}, {'measure': 'Duration of response (DoR)', 'description': 'Duration of Response (DoR) for the subjects whose BOR is CR or PR will be defined as the time between the date of response of confirmed CR or confirmed PR (whichever occurs first) and the date of PD or death (whichever occurs first), based on RECIST 1.1 and iRECIST.', 'timeFrame': '2 years'}, {'measure': 'Time to response (TTR)', 'description': 'Time to Response (TTR) is defined as the time from first dosing date until the measurement criteria are first met for overall response of PR or CR (whichever status comes first, and provided it is subsequently confirmed), , based on RECIST 1.1 and iRECIST.', 'timeFrame': '24 weeks'}, {'measure': 'Progression Free Survival (PFS)', 'description': 'Progression free survival (PFS) per RECIST 1.1 and iRECISTwill be defined as the time between the date of randomization and the date of progression and or confirmed PD (according to RECIST 1.1 and iRECIST) or death, whichever occurs first.', 'timeFrame': '2 years'}, {'measure': 'Overall Survival (OS)', 'description': 'Overall Survival (OS) is defined as the time from randomization until the date of death. For those subjects who have not died, OS will be censored at the recorded last date of subject contact, and for subjects with a missing recorded last date of contact, OS will be censored at the last date the subject was known to be alive. Any efforts will be made to know the date of death.', 'timeFrame': '2 years'}]" 247,NCT04303403,"{'fullName': 'National Cancer Centre, Singapore', 'class': 'OTHER'}",Study of Trametinib and Ruxolitinib in Colorectal Cancer and Pancreatic Adenocarcinoma,UNKNOWN,"The purpose of this research study to find out if the drug trametinib in combination with ruxolitinib is safe, tolerable and has beneficial effects in people who has certain type of cancers including the type that you have. Patients with RAS mutant colorectal cancer and pancreatic adenocarcinoma are invited to participate in this study. This is the first time that both trametinib and ruxolitinib are studied in combination. Trametinib is marketed in several countries with the brand name Mekinist® for the treatment of melanoma (a type of skin cancer). Trametinib has been studied extensively in cancer and has been tested in many patients. Ruxolitinib is an oral inhibitor of JAK1 and JAK2 tyrosine kinases and is approved for treatment of adult polycythemia vera and myelofibrosis. Ruxolitinib has been studied extensively in many patients.","['Colorectal Cancer', 'Pancreatic Adenocarcinoma']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'The first part of this study will be a standard 3+3 dose-escalating', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Trametinib', 'description': 'Taken orally once daily', 'armGroupLabels': ['Dose Escalation and Expansion'], 'otherNames': ['Mekinist']}, {'type': 'DRUG', 'name': 'Ruxolitinib', 'description': 'Taken orally twice daily', 'armGroupLabels': ['Dose Escalation and Expansion'], 'otherNames': ['Jakafi']}]","Inclusion Criteria: * Patients (male or female) ≥ 21. * Patients with histological diagnosis of RAS mutant advanced colorectal and pancreatic adenocarcinoma having received at least 1 prior line of systemic therapy. Pancreatic cancer patients with KRAS mutation detected on plasma profiling having received at least 1 prior line of systemic therapy. * Patients must have at least one measurable lesion according to Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1. * Life expectancy of at least 3 months. * Written informed consent that is consistent with ICH-GCP guidelines. * Eastern Cooperative Oncology Group (ECOG) performance score ≤ 2. * Have adequate organ and hematologic function, as determined by: * Absolute neutrophil count (ANC) ≥ 1,500/μl. * Platelets ≥ 100,000/μl. * Haemoglobin ≥ 9g/dL. * Aspartate Amino Transferase (AST)/ Alanine Amino Transferase (ALT) ≤ 2.5 x upper limit of normal (ULN ≤ 5 x ULN is acceptable if liver metastases are present). * Total bilirubin ≤1.5 x ULN (\< 3 ULN for patients with Gilbert syndrome). * Creatinine clearance ≥ 60ml/min. * Prothrombin time and activated partial thromboplastin time ≤ 1.5 x upper limit of normal (ULN) per institutional laboratory normal range. * Ejection fraction ≥ 50% with no symptoms attributable to heart failure. * Have normal QT interval on screening electrocardiogram (ECG) evaluation, defined as QT interval corrected (Fridericia) (QTcF) of ≤450 ms in males or ≤470 ms in females. * For female patients of childbearing potential, a negative pregnancy test must be documented prior to enrolment. * Female and male patients who are fertile must agree to use a highly effective form of contraception with their sexual partners throughout study participation. * Have the willingness and ability to comply with scheduled visits and study procedures. Exclusion Criteria: * Received cytotoxic chemotherapy, investigational agents, or radiation within 14 days of study drug commencement, or 5 half-lives, whichever is shorter, and with recovery of clinically significant toxicities from that therapy. * Received monoclonal antibodies or had surgery within 30 days of the first dose of study drug. * Have been diagnosed with another primary malignancy within the past 3 years of study drug commencement (except for adequately treated non-melanoma skin cancer, cervical cancer in situ, or prostate cancer). * Have CNS metastases that are symptomatic, neurologically unstable, or requiring an increasing dose of corticosteroids. * Have meningeal involvement or spinal cord compression. * Have significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to: * Myocardial infarction (MI) within 6 months prior to the first dose. * Unstable angina within 6 months prior to first dose. * History of congestive heart failure (CHF). * History of clinically significant atrial arrhythmia. * Any history of ventricular arrhythmia. * Cerebrovascular accident or transient ischemic attack within 6 months prior to first dose. * Have history or the presence of pulmonary interstitial disease or drug related pneumonitis. * Have an ongoing or active infection. * Patients with active HBV and HCV are excluded unless they are undergoing treatment for HBV and HCV. * Have a history of or active significant gastrointestinal (GI) bleeding within 3 months of the first dose. * Patients who are on immunosuppressive therapy. * Patients who have retinal vein occlusion and retinal pigment epithelial detachment. * On medications which are potent and moderate inhibitor and inducers of CYP3A4. * Patients with moderate to severe hepatic impairment (Child Pugh B and C). * Patients with history of severe allergic skin reactions or current skin conditions.",NA,ALL,NA,"[{'measure': 'Maximum Tolerated Dose', 'description': 'Highest dose level at which less than one-third of the patients in the dose level experienced dose limiting toxicities (DLTs) during the first cycle of treatment', 'timeFrame': '28 days (1 cycle)'}]","[{'measure': 'Frequency and severity of treatment-emergent Adverse Events and Serious Adverse Events', 'description': 'To assess the safety of the drug combination. During the dose escalation phase, this includes the incidences of dose limiting toxicities during the first 2 cycles of treatment.', 'timeFrame': 'From time of first study drug administration until 30 days after last dose of study drug'}, {'measure': 'Changes between baseline and post-baseline hematology laboratory parameters during treatment - Haemoglobin', 'description': 'Unit of measure: g/dL. To assess the safety of the drug combination', 'timeFrame': 'From time of first study drug administration until 30 days after last dose of study drug'}, {'measure': 'Changes between baseline and post-baseline hematology laboratory parameters during treatment - White blood count, Platelets, Absolute neutrophil count', 'description': 'Unit of measure: x 10\\^9/L. To assess the safety of the drug combination.', 'timeFrame': 'From time of first study drug administration until 30 days after last dose of study drug'}, {'measure': 'Changes between baseline and post-baseline hematology laboratory parameters during treatment - Neutrophils', 'description': 'Unit of measure: Percentage component of white blood cells. To assess the safety of the drug combination.', 'timeFrame': 'From time of first study drug administration until 30 days after last dose of study drug'}, {'measure': 'Changes between baseline and post-baseline biochemistry laboratory parameters during treatment - Urea, Sodium, Potassium, Chloride, Bicarbonate, Glucose, Magnesium, Calcium, Phosphate, Total cholesterol, High and low density lipoprotein, Triglycerides', 'description': 'Unit of measure: mmol/L. To assess the safety of the drug combination', 'timeFrame': 'From time of first study drug administration until 30 days after last dose of study drug'}, {'measure': 'Changes between baseline and post-baseline biochemistry laboratory parameters during treatment - Uric acid, Creatinine, Total bilirubin', 'description': 'Unit of measure: umol/L. To assess the safety of the drug combination', 'timeFrame': 'From time of first study drug administration until 30 days after last dose of study drug'}, {'measure': 'Changes between baseline and post-baseline biochemistry laboratory parameters during treatment - Total protein, Albumin', 'description': 'Unit of measure: g/L. To assess the safety of the drug combination', 'timeFrame': 'From time of first study drug administration until 30 days after last dose of study drug'}, {'measure': 'Changes between baseline and post-baseline biochemistry laboratory parameters during treatment - Alkaline phosphatase, Alanine transaminase, Aspartate transaminase, Lactate dehydrogenase, Beta-human chorionic gonadotrophin', 'description': 'Unit of measure: U/L. To assess the safety of the drug combination', 'timeFrame': 'From time of first study drug administration until 30 days after last dose of study drug'}, {'measure': 'Frequency of dose interruptions', 'description': 'To assess the tolerability of the drug combination.', 'timeFrame': 'From time of first study drug administration until 30 days after last dose of study drug'}, {'measure': 'Frequency of dose reductions', 'description': 'To assess the tolerability of the drug combination', 'timeFrame': 'From time of first study drug administration until 30 days after last dose of study drug'}, {'measure': 'Pharmacokinetics (PK): Trough concentrations of trametinb', 'description': 'Trough concentrations of trametinb at different cycles of combination treatment with ruxolitinib', 'timeFrame': 'From cycle 1-6 of study (each cycle is 28 days)'}, {'measure': 'Tumour Markers: CEA and CA 19-9 in blood samples', 'description': 'Changes from baseline tumour markers (CEA and CA 19-9) in blood samples', 'timeFrame': 'From cycle 1 up to last cycle of treatment (each cycle is 28 days)'}, {'measure': 'Overall Response Rate', 'description': 'The best overall response is the best response recorded from the start of the treatment until disease progression (PD)/ recurrence (taking as reference for PD the smallest measurements recorded since the treatment started).', 'timeFrame': 'From time of first study drug administration until first occurrence of disease progression, up to 2 years'}, {'measure': 'Disease Control Rate', 'description': 'Percentage of patients who have achieved complete response, partial response and stable disease in accordance to RECIST 1.1.', 'timeFrame': 'From time of first study drug administration until best overall response, first occurence of disease progression, up to 2 years'}, {'measure': 'Progression Free Survival', 'description': 'Time elapsed between treatment initiation and tumour progression or death from any cause, with censoring of patients who are lost to follow-up.', 'timeFrame': 'From time of first study drug administration until first occurence of disease progression, or death from any cause, up to 2 years'}, {'measure': 'Overall Survival', 'description': 'Time elapsed between treatment initiation and death from any cause, with censoring of patients who are lost to follow-up.', 'timeFrame': 'From time of first study drug administration to death from any cause, up to 2 years'}]" 248,NCT00002754,"{'fullName': 'Duke University', 'class': 'OTHER'}",Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Melanoma or Brain Tumors,COMPLETED,"RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to determine the effectiveness of monoclonal antibody therapy in treating patients who have primary or metastatic melanoma or brain tumors.","['Brain and Central Nervous System Tumors', 'Melanoma (Skin)', 'Metastatic Cancer']",INTERVENTIONAL,{'primaryPurpose': 'TREATMENT'},"[{'type': 'BIOLOGICAL', 'name': ""monoclonal antibody Me1-14 F(ab')2""}]","DISEASE CHARACTERISTICS: Histologically confirmed primary or metastatic malignant melanoma OR Histologically confirmed supratentorial malignant brain tumor Newly diagnosed or recurrent primary or metastatic tumor Eligible primary histologies, including but not limited to: Glioblastoma multiforme Mixed anaplastic glioma Anaplastic astrocytoma Other astrocytoma Gliosarcoma Anaplastic oligodendroglioma The following excluded: Diffusely infiltrating tumors Multifocal tumors Infratentorial tumors Subependymal spread No measurable enhancing lesion extending more than 1 cm beyond margins of surgical cavity on contrast-enhanced CT or MRI performed within 72 hours after resection Intralesional catheter placed at resection Patency of catheter demonstrated by radiolabeled albumin flow Reactivity of neoplastic cells with intact Me1-14 IgG2a or Me1-14 F(ab')2 demonstrated by immunohistology with polyclonal rabbit antibody or monoclonal mouse antibody PATIENT CHARACTERISTICS: Age: 3 and over Performance status: Karnofsky 50%-100% Hematopoietic: Absolute neutrophil count greater than 1,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST less than 1.5 times normal Alkaline phosphatase less than 1.5 times normal Renal: Creatinine less than 1.2 mg/dL Other: Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks since antineoplastic chemotherapy unless unequivocal tumor progression Endocrine therapy: Concurrent corticosteroids allowed at lowest possible dose and stable for at least 10 days prior to entry Radiotherapy: At least 3 months since radiotherapy to site of measurable disease within the nervous system unless unequivocal tumor progression Surgery: See Disease Characteristics",NA,ALL,NA,NA,NA 249,NCT05180851,"{'fullName': 'Shanghai Fengxian District Central Hospital', 'class': 'OTHER'}",Safety and Efficacy of Recombinant Oncolytic Adenovirus L-IFN Injection in Relapsed/Refractory Solid Tumors Clinical Study,UNKNOWN,"This is an open-label, dose escalation study of the safety and tolerability of Recombinant oncolytic adenovirus L-IFN injection（YSCH-01） when administered via intratumoral injection in patients with advanced solid tumors. The purpose of this study is to assess the safety and tolerability of Recombinant L-IFN adenovirus injectionand to determine the recommended phase 1 dose for further study. The study will also evaluate antitumor activity, objective response rate, pharmacokinetics and virus shedding of Recombinant L-IFN adenovirus injection","['Head and Neck Cancer', 'Melanoma', 'Breast Cancer', 'Bladder Cancer', 'Ovarian Carcinoma', 'Cervical Carcinoma', 'Lung Cancer']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Recombinant L-IFN adenovirus injection', 'description': 'Before use, dilute the product with normal saline according to the size of the tumor to an appropriate volume (10-30% of the total volume of the tumor), or adjust appropriately according to the specific tumor situation, inject directly into the tumor or inject under the guidance of B ultrasound /CT, inject the drug solution into the tumor edge and tumor evenly', 'armGroupLabels': ['Safety and efficacy of recombinant L-IFN adenovirus injection in relapsed/refractory solid tumors'], 'otherNames': ['(YSCH-01)', 'Cancer targetting gene-virotherapy(CTGVT) virus (YSCH-01)', 'Replicative adenovirus', 'Oncolytic virus', 'Oncolytic adenovirus']}]","Inclusion Criteria: 1. Male or female aged ≥ 18 and ≤ 75 years; 2. Patients with advanced malignant solid tumors, histologically or cytologically confirmed, who have failed standard therapy, have no standard therapy, are not eligible for standard therapy at this stage, or have refused standard therapy； 3. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), the length of non-lymph node lesion ≥10 mm or the short diameter of lymph node lesion ≥15 mm according to CT or MRI cross-sectional images;CT scan of the longest axis of measurable lesions ≥10 mm (CT scan thickness ≤5 mm)； 4. There were injectable tumor lesions that met the requirements of the current dose group, including superficial lesions and deep lesions that could be injected under the guidance of B-ultrasound /CT； 5. ECOG score of 0 \~ 2; 6. Sufficient hematopoietic capacity: ANC ≥1.0 ×10\^9/L (no short-acting albino within 1 week, no long-acting albino within 2 weeks), platelet count ≥75 ×10\^9/L, HGB \> 80 g/L (no blood transfusion within 2 weeks)； 7. Adequate liver and kidney function: AST and ALT ≤3 times ULN in patients without liver metastasis, ≤5 times ULN in patients with liver metastasis; Total bilirubin ≤1.5 ULN (excluding hyperbilirubinemia or hyperbilirubin of non-liver origin);Creatinine ≤2.0 ULN and creatinine clearance and creatinine clearance ≥40 mL/min; 8. Eligible and fertile patients (male and female) must agree to use a reliable contraceptive method during the trial and for at least 90 days after the last dose; Women of childbearing age (15-49 years) must have a negative pregnancy test within 7 days before starting treatment; 9. PT or INR \<1.5 ULN, and APTT \<1.5 ULN； 10. Expect to live at least 12 weeks； Exclusion Criteria: 1. Received any antineoplastic therapy within 2 weeks prior to initial treatment； 2. Systemic diseases that have not been stably controlled after treatment, such as diabetes, serious organic cardiovascular and cerebrovascular diseases, cardiac insufficiency, hypertension, heart block above ⅱ degree, myocardial infarction within 6 months, cerebral infarction within 6 months, etc. 3. Pregnancy or lactation; 4. Uncontrolled infectious diseases, such as baseline HBV DNA≥2000 IU/ml, anti-HIV positive, HCV-RNA positive; 5. Other active infections of significant clinical significance; 6. Subjects with other active malignancies within the past 5 years, such as basal or squamous skin cancer, superficial bladder cancer, or breast cancer in situ, that have been completely cured and do not require follow-up treatment are excluded; 7. Severe autoimmune diseases such as ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, autoimmune vasculitis, or Wegener's granuloma require long-term (more than 2 months) systemic immunosuppressive therapy, but subjects with the following conditions are admitted: Autoimmune hypothyroidism requiring only hormone replacement therapy; Skin disorders that do not require systemic treatment (e.g., eczema, a rash of less than 10% of the body surface); 8. Subjects with allergic constitution, allergy to immunotherapy or related drugs; 9. Organ failure; Coronary heart: grades ⅲ and ⅳ;Or hypertension that cannot be controlled by standard treatment, a history of myocarditis or myocardial infarction within one year; Gallo liver: achieves grade C on the Child-Turcotte-Pugh liver function scale; Gallonic kidney: renal failure and uremia; Lung: symptoms of severe respiratory failure; Brain unconsciously: people with consciousness disorder have active brain metastases; 10. Patients with active bleeding and thrombotic diseases requiring treatment; 11. Patients with uncontrollable pleural and abdominal effusion requiring clinical treatment or intervention; 12. Subjects requiring systemic corticosteroids (equivalent to \>10 mg prednisone/day) within 14 days prior to enrollment or during the study period; The following conditions are allowed to join the group: Allow subjects to use topical or inhaled corticosteroids; Allows short-term (≤7 days) use of glucocorticoids for the prevention or treatment of non-autoimmune allergic diseases; 13. Subject suffering from any mental illness, including dementia, altered mental state, that may affect informed consent and understanding of the relevant questionnaire; 14. Participated in clinical trials of other drugs or medical devices within 4 weeks; 15. If the investigator determines that they have a serious and uncontrollable disease or other conditions that may affect their acceptance of this study, they are not considered suitable for this study.",NA,ALL,NA,"[{'measure': 'Dose Limiting Toxicities (DLT)', 'description': 'To define the maximum tolerated dose (MTD) of intratumoral administration of Recombinant L-IFN adenovirus injection in humans with malignant tumors.', 'timeFrame': 'Up to 28 days'}, {'measure': 'Safety and tolerability assessed by Adverse Events (AEs)', 'description': 'An AE is any untoward medical occurrence in a subject administered an investigational product (IP), and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP whether or not considered related to the IP', 'timeFrame': 'Time Frame: Up to 6 months'}]","[{'measure': 'Number of participants with vital sign abnormalities and /or adverse event', 'description': 'Number of participants with potentially clinically significant laboratory values', 'timeFrame': 'Up to 6 months'}, {'measure': 'Number of participants with laboratory value abnormalities and/or adverse events', 'description': 'Number of participants with potentially clinically significant laboratory values', 'timeFrame': 'Up to 6 months'}, {'measure': 'Presence of neutralizing antibodies of antidrug antibodies (ADAs) development', 'description': 'To evaluate the immunogenicity of Recombinant L-IFN adenovirus injection given as single agent post injection', 'timeFrame': 'Up to 6 months'}]" 250,NCT04164082,"{'fullName': 'National Cancer Institute (NCI)', 'class': 'NIH'}","Testing the Addition of an Anti-cancer Drug, Pembrolizumab, to the Usual Intravesical Chemotherapy Treatment (Gemcitabine) for the Treatment of BCG-Unresponsive Non-muscle Invasive Bladder Cancer",ACTIVE_NOT_RECRUITING,"This phase II trial studies the effect of adding pembrolizumab to gemcitabine in treating patients with non-muscle invasive bladder cancer whose cancer does not respond to Bacillus Calmette-Guerin (BCG) treatment. Chemotherapy drugs, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the patient's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Adding pembrolizumab to gemcitabine may delay the return of BCG-unresponsive bladder cancer for longer period compared to gemcitabine alone.","['Bladder Flat Urothelial Carcinoma In Situ', 'Non-Muscle Invasive Bladder Urothelial Carcinoma', 'Stage 0a Bladder Cancer AJCC v8', 'Stage 0is Bladder Cancer AJCC v8', 'Stage I Bladder Cancer AJCC v8']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'PROCEDURE', 'name': 'Biopsy Procedure', 'description': 'Undergo bladder biopsy', 'armGroupLabels': ['Treatment (pembrolizumab, gemcitabine hydrochloride)'], 'otherNames': ['Biopsy', 'BIOPSY_TYPE', 'Bx']}, {'type': 'PROCEDURE', 'name': 'Biospecimen Collection', 'description': 'Undergo urine and blood sample collection', 'armGroupLabels': ['Treatment (pembrolizumab, gemcitabine hydrochloride)'], 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Sample Collection', 'Specimen Collection']}, {'type': 'PROCEDURE', 'name': 'Computed Tomography', 'description': 'Undergo CT', 'armGroupLabels': ['Treatment (pembrolizumab, gemcitabine hydrochloride)'], 'otherNames': ['CAT', 'CAT Scan', 'Computed Axial Tomography', 'Computerized Axial Tomography', 'Computerized axial tomography (procedure)', 'Computerized Tomography', 'Computerized Tomography (CT) scan', 'CT', 'CT Scan', 'Diagnostic CAT Scan', 'Diagnostic CAT Scan Service Type', 'tomography']}, {'type': 'PROCEDURE', 'name': 'Cystoscopy', 'description': 'Undergo cystoscopy', 'armGroupLabels': ['Treatment (pembrolizumab, gemcitabine hydrochloride)'], 'otherNames': ['CS']}, {'type': 'DRUG', 'name': 'Gemcitabine Hydrochloride', 'description': 'Given intravesically', 'armGroupLabels': ['Treatment (pembrolizumab, gemcitabine hydrochloride)'], 'otherNames': ['dFdCyd', 'Difluorodeoxycytidine Hydrochloride', 'Gemcitabine HCI', 'Gemzar', 'LY 188011', 'LY-188011', 'LY188011']}, {'type': 'PROCEDURE', 'name': 'Magnetic Resonance Imaging', 'description': 'Undergo MRI', 'armGroupLabels': ['Treatment (pembrolizumab, gemcitabine hydrochloride)'], 'otherNames': ['Magnetic Resonance', 'Magnetic Resonance Imaging (MRI)', 'Magnetic resonance imaging (procedure)', 'Magnetic Resonance Imaging Scan', 'Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance', 'MR', 'MR Imaging', 'MRI', 'MRI Scan', 'MRIs', 'NMR Imaging', 'NMRI', 'Nuclear Magnetic Resonance Imaging', 'sMRI', 'Structural MRI']}, {'type': 'BIOLOGICAL', 'name': 'Pembrolizumab', 'description': 'Given IV', 'armGroupLabels': ['Treatment (pembrolizumab, gemcitabine hydrochloride)'], 'otherNames': ['BCD-201', 'GME 751', 'GME751', 'Keytruda', 'Lambrolizumab', 'MK 3475', 'MK-3475', 'MK3475', 'Pembrolizumab Biosimilar BCD-201', 'Pembrolizumab Biosimilar GME751', 'Pembrolizumab Biosimilar QL2107', 'Pembrolizumab Biosimilar RPH-075', 'Pembrolizumab Biosimilar SB27', 'QL2107', 'RPH 075', 'RPH-075', 'RPH075', 'SB 27', 'SB-27', 'SB27', 'SCH 900475', 'SCH-900475', 'SCH900475']}, {'type': 'PROCEDURE', 'name': 'Transurethral Resection of Bladder Tumor', 'description': 'Undergo TURBT', 'armGroupLabels': ['Treatment (pembrolizumab, gemcitabine hydrochloride)'], 'otherNames': ['Transurethral resection (TURBT)', 'TURBT']}]","Inclusion Criteria: * High grade Ta, T1 or CIS urothelial carcinoma. Accrual of patients with Ta or T1 disease may be closed to ensure adequate patients enrollment to meet the primary endpoint * Persistent disease (defined as not achieving disease free status) after completing therapy with at least induction BCG (\>= 5 doses) and the first round of maintenance or second induction course (\>= 2 doses). The subsequent round of BCG, either maintenance or repeat induction, must be given within 6 months of initial induction BCG * Persistent high risk NMIBC (T1, high grade Ta and/or CIS) must be within 9 months of the last BCG instillation despite having received adequate BCG as defined above. * Registration must be within 12 months of last BCG instillation * High grade T1 after completing therapy with at least induction BCG (\>= 5 doses) or after completing therapy with at least induction BCG (\>= 5 doses) and first round of maintenance or second induction course (\>= 2 doses). The subsequent round of BCG, either maintenance or repeat induction, must be given within 6 months of initial induction BCG * Disease recurrence (T1) must be within 9 months of the last BCG instillation despite having received adequate BCG as defined above * Registration must be within 12 months of last BCG instillation * Mixed variant histology (adenocarcinoma, squamous cell carcinoma) is eligible, but pure variant histology is ineligible * Patients who are disease free at 6 months after starting BCG but have high grade recurrence (T1, Ta, CIS) while on maintenance therapy would be eligible * The recurrence must be within 6 months of the last BCG dose. * Registration must be within 12 months of last maintenance BCG instillation * Patients must be deemed unfit for radical cystectomy by the treating physician or refuse radical cystectomy * All patients must have histologically confirmed urothelial cancer of the bladder within 60 days prior to registration * All visible tumor must be completely resected 60 days prior to registration (residual pure CIS is permitted) * All patients must have had a cystoscopy (or TURBT with complete resection) without papillary tumor and negative urinary cytology within 28 days of registration (positive cytology is allowed in patients with CIS) * All patients with T1 tumors must undergo a re-staging transurethral resection of bladder tumor (TURBT) within 60 days of registration * There must be uninvolved muscularis propria present in the re-staging TURBT. The initial TURBT prior to re-staging TURBT may be greater than 60 days prior to registration * Patients must have had imaging with CT or MRI abdomen/pelvis within 90 days of registration demonstrating no evidence of metastasis * Patients cannot have had a history of urothelial carcinoma in the ureters or prostatic urethra 24 months prior to registration * Patients must not be currently participating in or have participated in a study of an investigational agent or have used an investigational device within 4 weeks prior to study registration * Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been more than 4 weeks after the last dose of the previous investigational agent at time of registration * Patients must not have prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) * Patients must not have undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years prior to registration. (Participants who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of graft versus host disease \[GVHD\]) * Patients must not have received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment * Note: Participants must have recovered from all adverse events (AEs) due to previous therapies to =\< grade 1 or baseline. Participants with =\< grade 2 neuropathy may be eligible * Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment * Patients must not have received prior radiotherapy within 2 weeks of study registration. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis * Patients must not have received radiation therapy to the lung that is \> 30 Gy within 6 months prior to trial registration * Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects * Women and men of reproductive potential should agree to use an appropriate method of birth control throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial. Include as applicable: Appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives or double barrier method (diaphragm plus condom) * A woman of childbearing potential (WOCBP) must not have a positive urine pregnancy test within 7 days prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * Patients must not be pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with registration through the last dose of treatment * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Hemoglobin \>= 9.0 g/dL * Creatinine =\< 1.5 x upper limit of normal (ULN) * In patients with creatinine \> 1.5 x ULN, if measured or calculated creatinine clearance \> 30 mL/min, then patient is eligible * Total bilirubin =\< 1.5 x ULN * In patients with a total bilirubin \> 1.5 x ULN, if direct bilirubin \< 1.0 X ULN, then patient is eligible * Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) =\< 2.5 x ULN * Patients must not have had an active autoimmune disease requiring systemic treatment within 24 months prior to registration. Autoimmune diseases include, but not limited to, lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis * Patients must not have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to registration * Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed * Patients must not have a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study * Patients must not have active tuberculosis * Patients must not have been treated with antibiotics for an active infection within 14 days prior to registration. Prophylactic antibiotics are permitted. Treatment for a urinary tract infection (UTI) is allowed but must be deemed adequately treated by the treating physician prior the start of cycle 1 (C1) day 1 (D1) * Patients must not have a history of idiopathic pulmonary fibrosis or organizing pneumonia * Patients must not have a history of (non-infectious) pneumonitis that required steroids or have current pneumonitis * Patients with human immunodeficiency virus (HIV) are eligible with the following: * On effective anti-retroviral therapy with undetectable viral load within 6 months of registration * HIV-infected participants must not have a history of Kaposi sarcoma and/or multicentric Castleman disease * Patients must not have a known additional malignancy that has had progression or has required active treatment in the last three years. Exceptions include basal or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. A history of prostate cancer that was treated with definitive intent is allowed, provided that the prostate-specific antigen (PSA) is undetectable for at least 1 year while off androgen deprivation therapy * Patients must not have known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment * Patients must not have severe hypersensitivity (\>= grade 3) to pembrolizumab and/or any of its excipients * Patients must not have an active infection requiring systemic therapy * Patients must not have a known history of hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known active hepatitis C virus (defined as hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] is detected) infection * Note: No testing for hepatitis B and hepatitis C is required unless mandated by a local health authority * Patients must not have received live vaccines within 30 days of study drug administration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guerin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. COVID-19 vaccinations are permitted",NA,ALL,NA,"[{'measure': 'Complete response rate in the carcinoma in situ (CIS) subpopulation', 'description': 'A complete response, only for patients with a CIS component, is a cystoscopy without evidence of bladder tumor and negative biopsy (including directed biopsies to any suspicious areas and in addition random bladder biopsies including trigone, left lateral wall, right lateral wall, posterior bladder, dome of bladder, and the prostatic urethra in men), and negative cytology for high grade disease.', 'timeFrame': 'At 6 months (end of cycle 8, week 25)'}, {'measure': 'Event-free survival at 18 months', 'description': 'For patients without a documented event and who are still alive, they will be censored at last disease assessment. For patients who start any subsequent ant-cancer therapy without any reported events will be censored at their last disease assessment. will be obtained with a Kaplan-Meier estimator (using the Greenwood formula to estimate the variance) for the entire 153 patient group consisting of patients with CIS, CIS with Ta/T1 or Ta or T1 disease. A 90% confidence interval will be generated for the 18-month EFS estimate.', 'timeFrame': 'From the date of study registration to the first documentation of an event or death whichever comes first, assessed up to 18 months'}]","[{'measure': 'Incidence of adverse events', 'description': 'Adverse events will be assessed based on the National Cancer Institute common toxicity criteria (Common Terminology Criteria for Adverse Events version 5.0).', 'timeFrame': 'Up to 5 years post treatment'}, {'measure': 'Duration of response (DOR)', 'description': 'Analysis will only include those patients in the CIS population who achieve a response. Patients who are alive and without a documented progression at the time of analysis will be censored at the time of the last disease status evaluation. The Kaplan-Meier product-limit estimator will be used to estimate DOR, medians and 95% confidence intervals (CI).', 'timeFrame': 'From the time a patient had a documented response (the time would start at the time a response was first noted) until disease-progression, assessed up to 5 years'}, {'measure': 'Progression-free survival (PFS)', 'description': 'Surviving patients without any documented progressions will be censored at the date of last known contact. Progression will be defined as the development of muscle invasive bladder cancer or metastatic urothelial cancer (nodal and/or distant). The Kaplan-Meier product-limit estimator will be used to estimate PFS, medians and 95% CI.', 'timeFrame': 'From the date of study registration to the date of progression or death due to any cause, whichever occurs first, assessed up to 5 years'}, {'measure': 'Overall survival (OS)', 'description': 'Surviving patients will be censored at the date of last known contact. The Kaplan-Meier product-limit estimator will be used to estimate OS, medians and 95% CI.', 'timeFrame': 'From the date of study registration to date of death due to any cause, assessed up to 5 years'}, {'measure': 'Cystectomy-free survival', 'description': 'The Kaplan-Meier product-limit estimator will be used to estimate cystectomy-free survival, medians and 95% CI.', 'timeFrame': 'From the date of study registration to the date of cystectomy for all patients'}, {'measure': 'Recurrence free survival (RFS)', 'description': 'Surviving patients without any documented recurrence will be censored at the date of last known contact. Recurrence will be defined as the development of high-grade bladder cancer for patients with a CIS component only and those without a CIS component. The Kaplan-Meier product-limit estimator will be used to estimate RFS, medians and 95% CI.', 'timeFrame': 'From the date of study registration to the first documentation of recurrence or death due to any cause, assessed up to 5 years'}]" 251,NCT05054062,"{'fullName': 'Zuyderland Medisch Centrum', 'class': 'OTHER'}",Sentinel Lymph Node Mapping Using Magtrace and MRI in Healthy Subjects for Potential Use in Melanoma Patients,COMPLETED,"Sentinel lymph node biopsy (SLNB) is crucial in the management of malignant melanoma treatment and is currently performed by pre-operatively inject a colloid nanomaterial labeled with Technetium (99mTc) as radioactive tracer. Intra-operatively, Patent Blue (PB) will be injected to improve the visualization of the lymphatic tract. However, current pre-operative SLN mapping technique, is associated with disadvantages as radiation exposure for both patients and health care personnel and logistic challenges, because of time constraints due to short half-live time of 99mTc. Superparamagnetic iron oxide (SPIO) is novel, non-radioactive technique using a magnetic tracer (Magtrace® (Endomagnetics Ltd.)) and several studies showed that SPIO is non-inferior to dual tracing with 99mTc and PB in breast cancer patients. SPIO is expected to be non-inferior to dual tracing with 99mTc and PB in melanoma patients. However, further research is needed to demonstrate the use of SPIO in pre-operative Magnetic Resonance Imaging (MRI) scanning. Guidance on pre-operative MRI use is rather limited, though fundamental in the intended research process. Hence, the aim of this subprotocol study, which includes healthy subjects, is to develop a pre-operative MRI protocol for melanoma patients. The acquired knowledge will be used to design a feasibility study, including a larger group of melanoma patients.",['Melanoma'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DIAGNOSTIC_TEST', 'name': 'Sentinel node mapping using MRI', 'description': 'Sentinel lymph node mapping in melanoma patients using a magnetic tracer and MRI', 'armGroupLabels': ['Healthy participants']}]","Inclusion Criteria: * Healthy participants; * Participants should be ≥18 years of age at the time of consent; * Participants should be willing to provide informed consent. Exclusion Criteria: * Known intolerance/hypersensitivity to iron, dextran compounds or Magtrace® itself; * Standard MRI exclusion criteria: * Implantable (electrical) devices (e.g. pacemaker, cochlear implants, neurostimulator); * Any other metal implants; * Claustrophobia; * MR-incompatible prosthetic heart valves; * Tattoos inked with metallic dye. * Participants who refuse to provide informed consent.",NA,ALL,NA,"[{'measure': 'SPIO dosage in milliliters', 'description': 'SPIO dosage in milliliters will be assessed to develop a pre-operative MRI protocol. Testing will be perform in healthy subjects.', 'timeFrame': 'Three weeks'}, {'measure': 'Massage duration in seconds', 'description': 'Massage duration in seconds will be assessed to develop a pre-operative MRI protocol. Testing will be perform in healthy subjects.', 'timeFrame': 'Three weeks'}, {'measure': 'Time to artefact appearance in minutes', 'description': 'Time to artefact appearance in minutes will be assessed to develop a pre-operative MRI protocol. Testing will be perform in healthy subjects.', 'timeFrame': 'Three weeks'}]",NA 252,NCT06781983,"{'fullName': 'Innate Pharma', 'class': 'INDUSTRY'}",Safety and Tolerability of IPH4502 in Patients With Advanced Solid Tumors,RECRUITING,"This is a first-in-human, open-label, multicenter, Phase 1 study to evaluate the safety, tolerability and preliminary efficacy of IPH4502 and to determine the recommended Phase 2 dose (RP2D) in advanced solid tumors that are known to express Nectin-4",['Advanced or Metastatic Solid Tumors'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'IPH4502', 'description': 'Part 1 (dose escalation) and Part 2 (dose optimization)', 'armGroupLabels': ['IPH4502 Monotherapy']}]","Main Inclusion Criteria: * Histologically confirmed, unresectable, locally advanced or metastatic solid tumors that are known to express Nectin-4 * Prior systemic treatment for locally advanced or metastatic disease, yet no therapy with demonstrated clinical benefit for the tumor type is available. * Measurable disease according to RECIST 1.1. * Archival tumor tissue obtained within 4 months of screening and since the last anticancer therapy prior to the study or agree to undergo a tumor biopsy at baseline. * Adequate organ function and hematological function. Main Exclusion Criteria: * Known or suspected brain metastases. * Participants with an active infection, Any other infection requiring systemic treatment or latent infection. * Participants with clinically significant comorbidity(s). * History of treatment for, or suspicion or confirmed interstitial lung disease (ILD) at baseline. * Condition being treated with systemic corticosteroids or immunosuppressive therapy during IPH4502 treatment. * Thromboembolic event requiring anticoagulation therapy ≤14 days prior to the first dose of IPH4502. * Clinically significant cardiovascular disease and/or cardiac repolarization abnormality. * Participants with symptomatic heart failure, Acute coronary syndromes * Participant is receiving or has received anticancer therapy prior to enrolment that may have impact on the assessment of IPH4502. * Major surgery ≤28 days and minor surgery ≤7 days prior to first dose of IPH4502 or 6 months for coronary artery bypass surgery. * Concomitant medications or vaccines : Live-attenuated vaccines ≤ 6 weeks prior to first dose of IPH4502; systemic corticosteroids or other immunosuppressive agents within 14 days prior to the first dose of IPH4502; systemic use of moderate or strong CYP 3A4 inhibitors; systemic use of moderate or strong CYP 3A4 inducers.",NA,ALL,NA,"[{'measure': 'Safety and Tolerability', 'description': 'To evaluate the incidence of AEs, SAEs, TEAEs, and DLTs.', 'timeFrame': 'From time of first dose through treatment period, including the follow-up: up to 24 months'}]","[{'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'description': 'To characterize and evaluate the pharmacokinetic profile of IPH4502.', 'timeFrame': 'From time of informed consent through treatment period, including the follow-up: up to 24 months'}, {'measure': 'Area Under the Plasma Concentration (AUC)', 'description': 'To characterize and evaluate the pharmacokinetic profile of IPH4502.', 'timeFrame': 'From time of informed consent through treatment period, including the follow-up: up to 24 months'}, {'measure': 'Incidence of antidrug antibodies (ADA) against IPH4502', 'description': 'To evaluate the immunogenicity of IPH4502.', 'timeFrame': 'From time of informed consent through treatment period, including the follow-up: up to 24 months'}, {'measure': 'Objective Response Rate (ORR)', 'description': 'To investigate any preliminary antitumor activity of IPH4502.', 'timeFrame': 'From time of informed consent through treatment period, including the follow-up: up to 24 months'}, {'measure': 'Duration Of Response (DoR)', 'description': 'To investigate any preliminary antitumor activity of IPH4502.', 'timeFrame': 'From time of informed consent through treatment period, including the follow-up: up to 24 months'}, {'measure': 'Progression Free Survival (PFS)', 'description': 'To investigate any preliminary antitumor activity of IPH4502.', 'timeFrame': 'From time of informed consent through treatment period, including the follow-up: up to 24 months'}]" 253,NCT01480154,"{'fullName': 'National Cancer Institute (NCI)', 'class': 'NIH'}","Akt Inhibitor MK2206 and Hydroxychloroquine in Treating Patients With Advanced Solid Tumors, Melanoma, Prostate or Kidney Cancer",ACTIVE_NOT_RECRUITING,"This phase I trial studies the side effects and the best dose of Akt inhibitor MK2206 together with hydroxychloroquine in treating patients with advanced solid tumors, melanoma, prostate or kidney cancer. Akt inhibitor MK2206 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as hydroxychloroquine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving Akt inhibitor MK2206 together with hydroxychloroquine may kill more tumor cells than giving either drug alone.","['Advanced Malignant Solid Neoplasm', 'Stage III Cutaneous Melanoma AJCC v7', 'Stage III Prostate Cancer AJCC v7', 'Stage III Renal Cell Cancer AJCC v7', 'Stage IIIA Cutaneous Melanoma AJCC v7', 'Stage IIIB Cutaneous Melanoma AJCC v7', 'Stage IIIC Cutaneous Melanoma AJCC v7', 'Stage IV Cutaneous Melanoma AJCC v6 and v7', 'Stage IV Prostate Cancer AJCC v7', 'Stage IV Renal Cell Cancer AJCC v7']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Akt Inhibitor MK2206', 'description': 'Given PO', 'armGroupLabels': ['Treatment (Akt inhibitor MK2206, hydroxychloroquine)'], 'otherNames': ['MK 2206', 'MK-2206', 'MK-2206 FREE BASE', 'MK2206']}, {'type': 'DRUG', 'name': 'Hydroxychloroquine', 'description': 'Given PO', 'armGroupLabels': ['Treatment (Akt inhibitor MK2206, hydroxychloroquine)']}]","Inclusion Criteria: * Patients with histologically or cytologically proven advanced solid cancer and have undergone treatment with at least one regimen of standard therapy, either cytotoxic chemotherapy, a molecularly targeted agent, or immunotherapy, or have a form of cancer for which no standard therapy exists; patients with prostate cancer may continue on androgen-deprivation therapy if they are currently receiving it * Patient must have recovered from toxicity of prior chemotherapy, molecularly targeted agents and/or radiotherapy; patient may not have received chemotherapy in the prior 4 weeks (6 weeks for nitrosoureas or mitomycin C); patients may have not received a molecularly targeted agent within the past 4 weeks or 5 half lives (whichever is less); patients may not have received radiotherapy in the prior 3 weeks * Patients must be willing and able to sign informed consent * Leukocytes \>= 3,000/mcL (obtained within 7 days of treatment initiation) * Absolute neutrophil count \>= 1,500/mcL (obtained within 7 days of treatment initiation) * Platelets \>= 100,000/mcL (obtained within 7 days of treatment initiation) * Total serum bilirubin within normal institutional limits (obtained within 7 days of treatment initiation) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normal (obtained within 7 days of treatment initiation) * Creatinine =\< grade 1 OR creatinine clearance \>= 40 mL/min/1.73 m\^2 for patients with creatinine (Cr) above normal institutional limits; a calculated creatinine clearance by Cockcroft-Gault Formula is acceptable in lieu of a measured value (obtained within 7 days of treatment initiation) * All patients must have measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) criteria * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 * Estimated life expectancy of at least 12 weeks * Women must: have a negative serum or urine pregnancy test within 7 days prior to study entry if she is a woman of child-bearing potential (WOCBP), or be at least one year post-menopausal, OR be surgically sterile * The effects of MK-2206 on the developing human fetus are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and for 6 months after study participation; acceptable methods of contraception include hormonal, barrier methods, intrauterine device, tubal ligation/vasectomy or abstinence; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; acceptable methods of contraception include hormonal, barrier methods, intrauterine device, tubal ligation/vasectomy or abstinence; women should not breast feed while on treatment with MK-2206 and hydroxychloroquine * Patients must not have a history of any condition (social or medical) that, in the opinion of the investigator, might interfere with the patient's ability to comply with the protocol or pose additional or unacceptable risk to the patient * Approval for hydroxychloroquine treatment by an eye doctor, based on a screening eye exam; examples of disqualifying baseline conditions may include macular degeneration and other retinal disease such as cataracts that would interfere with required funduscopic examinations, or severe baseline visual impairment, retinopathy or visual field changes; all patients must undergo a screening eye exam prior to enrollment * Patients must be able to swallow whole tablets; nasogastric or gastrostomy (G) tube administration is not allowed; tablets must not be crushed or chewed Exclusion Criteria: * Failure to recover fully (as judged by the investigator) from prior surgical procedures, or failure to recover from adverse events (grade =\< 1) due to agents administered more than 4 weeks earlier * Concurrent treatment with an investigational agent other than the investigational agent(s) used in this study OR treatment within 4 weeks of study entry with any investigational agent(s) or device(s) * Patients with corrected QT interval (QTc) prolongation greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 (\> 480 msec); in addition, patients should not be receiving non-study medications known to prolong QTc * Patients on treatment for rheumatoid arthritis or systemic lupus erythematosus * History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study * Patient has uncontrolled diabetes, defined as a fasting serum glucose \> 150 mg/dl or glycosylated hemoglobin (hemoglobin A1c \[HbA1c\]) \> 7% at screening * Diabetic patients requiring insulin for glucose control at the time of study entry * Patient must not have ongoing ventricular cardiac dysrhythmias of grade \>= 2 as described by the Cancer Therapy Evaluation Program (CTEP) version 4.0 of the National Cancer Institute (NCI) CTCAE * Any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous \[IV\] alimentation, prior surgical procedures affecting absorption, ulcerative colitis, inflammatory bowel disease, a partial or complete small bowel obstruction, or active peptic ulcer disease) that impairs their ability to swallow and retain MK-2206 or hydroxychloroquine tablets * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would affect safety or limit compliance with study requirements * Pregnant and nursing women are excluded from this study because developmental and reproductive toxicity studies of MK-2206 have not been performed * Known human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with MK-2206 or HCQ used in this study * Because MK-2206 is metabolized primarily by the cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) liver enzyme, the eligibility of patients taking medications that are potent inducers or inhibitors of that enzyme will be determined following a review of their case by the principal investigator; every effort should be made to switch patients taking such agents or substances to other medications * Patients with active central nervous system (CNS) metastases are excluded; patients with CNS metastases that have been treated must be off steroid treatment for \> 2 months and be asymptomatic; patients that have symptoms to suggest CNS metastases should have a brain magnetic resonance imaging (MRI) within 28 days of enrollment to confirm the absence of CNS metastases; contrast computed tomography (CT) is acceptable for patients who are unable to undergo a brain MRI * Must not have psoriasis or porphyria * Must not have known hypersensitivity to 4-aminoquinoline compound * Must not have retinal or visual field changes from prior 4-aminoquinoline compound use * Must not have known glucose-6-phosphate dehydrogenase (G-6PD) deficiency * Patients with liver disease such as cirrhosis, chronic active hepatitis, or chronic persistent hepatitis * Must not be taking hydroxychloroquine for treatment or prophylaxis of malaria * Current treatment on another clinical trial; participation in non-therapeutic clinical trials is permissible",NA,ALL,NA,"[{'measure': 'Maximum tolerated dose of Akt inhibitor MK-2206', 'description': 'Will be assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.', 'timeFrame': '21 days'}, {'measure': 'Dose-limiting toxicity rate', 'description': 'Will be assessed by CTCAE version 4.0.', 'timeFrame': '21 days'}]","[{'measure': 'Changes in expression pattern of markers Beclin1, LC3, and p62', 'description': 'Will be assessed by immunohistochemistry (IHC), Western blotting, and number of autophagosomes by electron microscope (EM). Spaghetti plots or boxplots at time points will be produced for each marker and for EM. Appropriate transformations of the measurements will be carried out to normalize the data. Descriptive summary statistics will be provided for each type of measure at each time point.', 'timeFrame': 'Baseline to 4 weeks'}, {'measure': 'Change in autophagy activity induced by hydroxychloroquine', 'description': 'Will be measured by the amount of autophagosomes by EM. Student t-test and Wilcoxon nonparametric tests will be conducted.', 'timeFrame': 'Baseline to 4 weeks'}, {'measure': 'Validation of Beclin1, LC3, and p62 as markers for autophagy', 'description': 'Will be measured by EM. Linear mixed models will be fitted to the data, EM as the independent variable, the 3 markers and time points as fixed effects, plus a subject-specific random effect. A backward variable selection will be carried out for the 3 markers until a final model is selected. An ROC curve will be produced. The log-transformed ratio of LC3-II/LC3-I and difference in the log-transformed ratios of LC3-II./LC3-I pre-post treatment between high autophagy activity (HA, \\>= 6 AV/cell) and low autophagy activity (LA, \\< 6 AV/cell) will be analyzed for evaluating treatment effect using a two sided paired t-test.', 'timeFrame': 'Up to 4 weeks'}]" 254,NCT02437305,"{'fullName': 'Northwestern University', 'class': 'OTHER'}",Melanoma Perception and Health Literacy in People of Color,COMPLETED,"This study will examine the effectiveness of a targeted, health literate educational intervention for people of color compared to a standard melanoma education pamphlet for increasing knowledge and promoting early melanoma detection. It is hypothesized that people of color are less aware of their risk for developing melanoma and that a targeted educational intervention will help increase knowledge and promote early melanoma detection especially in individuals with low health literacy.",['Melanoma'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BEHAVIORAL', 'name': 'ABCDEs of Melanoma Skin Cancer', 'description': 'Modified melanoma educational intervention that is targeted towards people of color.', 'armGroupLabels': ['ABCDEs of Melanoma Skin Cancer']}, {'type': 'BEHAVIORAL', 'name': 'ABCDEs of Melanoma', 'description': 'Conventional melanoma educational intervention.', 'armGroupLabels': ['ABCDEs of Melanoma']}]","Inclusion Criteria: * English-speaking * Self-identifies with one of the following races/ethnicities: African American, Asian/Pacific Islander, American Indian and Alaskan Native, or Hispanic Exclusion Criteria: * Not proficient in English * Unable to give informed consent * Does not self-identify with the following races/ethnicities: African American, Asian/Pacific Islander, American Indian and Alaskan Native, or Hispanic",NA,ALL,NA,"[{'measure': 'Number of Participants That Performed Regular Self-Skin Examinations', 'description': 'The subject will complete 3 questionnaires: one pre-intervention, one immediately post-intervention and one 2 months post-intervention. 5 questions will assess whether or not the patient has completed skin-self examinations and knows which areas of the skin to pay attention to. The pre-intervention and 2 month post-intervention questionnaire will be evaluated to determine the number of participants that performed regular self-skin examinations.', 'timeFrame': '2 months post-intervention'}, {'measure': 'Number of Participants With Correct Answers on Melanoma Perception Pre-intervention and 2 Months Post-intervention', 'description': 'The subject will complete 3 questionnaires: one pre-intervention, one post-intervention, and one 2 months post-intervention. Several questions will assess the participants knowledge of general melanoma, what it looks like and what are its risk factors. To determine participant retention, the pre-intervention and 2 month post-intervention questionnaires will be evaluated.', 'timeFrame': '2 months post-intervention'}]",NA 255,NCT04557956,"{'fullName': 'National Cancer Institute (NCI)', 'class': 'NIH'}","Testing the Addition of the Anti-cancer Drug, Tazemetostat, to the Usual Treatment (Dabrafenib and Trametinib) for Metastatic Melanoma That Has Progressed on the Usual Treatment",ACTIVE_NOT_RECRUITING,"This phase I/II trial investigates the best dose, possible benefits and/or side effects of tazemetostat in combination with dabrafenib and trametinib in treating patients with melanoma that has a specific mutation in the BRAF gene (BRAFV600) and that has spread from where it first started (primary site) to other places in the body (metastatic). Tazemetostat, dabrafenib, and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving tazemetostat in combination with dabrafenib and trametinib may stabilize BRAFV600 mutated melanoma.","['Clinical Stage IV Cutaneous Melanoma AJCC v8', 'Metastatic Melanoma']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Phase I single-arm trial followed by randomized two-arm phase II trial with cross-over', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'PROCEDURE', 'name': 'Biopsy Procedure', 'description': 'Undergo tumor biopsy', 'armGroupLabels': ['Phase I; Phase II Arm 2 (tazemetostat, dabrafenib, trametinib)'], 'otherNames': ['Biopsy', 'BIOPSY_TYPE', 'Bx']}, {'type': 'PROCEDURE', 'name': 'Computed Tomography', 'description': 'Undergo CT scan', 'armGroupLabels': ['Phase I; Phase II Arm 2 (tazemetostat, dabrafenib, trametinib)', 'Phase II, Arm 1 (tazemetostat)'], 'otherNames': ['CAT', 'CAT Scan', 'Computed Axial Tomography', 'Computerized Axial Tomography', 'Computerized axial tomography (procedure)', 'Computerized Tomography', 'Computerized Tomography (CT) scan', 'CT', 'CT Scan', 'Diagnostic CAT Scan', 'Diagnostic CAT Scan Service Type', 'tomography']}, {'type': 'DRUG', 'name': 'Dabrafenib Mesylate', 'description': 'Given PO', 'armGroupLabels': ['Phase I; Phase II Arm 2 (tazemetostat, dabrafenib, trametinib)'], 'otherNames': ['Dabrafenib Methanesulfonate', 'GSK2118436 Methane Sulfonate Salt', 'GSK2118436B', 'Tafinlar']}, {'type': 'PROCEDURE', 'name': 'Echocardiography Test', 'description': 'Undergo ECHO', 'armGroupLabels': ['Phase I; Phase II Arm 2 (tazemetostat, dabrafenib, trametinib)'], 'otherNames': ['EC', 'Echocardiography']}, {'type': 'PROCEDURE', 'name': 'Magnetic Resonance Imaging', 'description': 'Undergo MRI', 'armGroupLabels': ['Phase I; Phase II Arm 2 (tazemetostat, dabrafenib, trametinib)', 'Phase II, Arm 1 (tazemetostat)'], 'otherNames': ['Magnetic Resonance', 'Magnetic Resonance Imaging (MRI)', 'Magnetic resonance imaging (procedure)', 'Magnetic Resonance Imaging Scan', 'Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance', 'MR', 'MR Imaging', 'MRI', 'MRI Scan', 'MRIs', 'NMR Imaging', 'NMRI', 'Nuclear Magnetic Resonance Imaging', 'sMRI', 'Structural MRI']}, {'type': 'PROCEDURE', 'name': 'Multigated Acquisition Scan', 'description': 'Undergo MUGA', 'armGroupLabels': ['Phase I; Phase II Arm 2 (tazemetostat, dabrafenib, trametinib)'], 'otherNames': ['Blood Pool Scan', 'Equilibrium Radionuclide Angiography', 'Gated Blood Pool Imaging', 'Gated Heart Pool Scan', 'MUGA', 'MUGA Scan', 'Multi-Gated Acquisition Scan', 'Radionuclide Ventriculogram Scan', 'Radionuclide Ventriculography', 'RNV Scan', 'RNVG', 'SYMA Scanning', 'Synchronized Multigated Acquisition Scanning']}, {'type': 'DRUG', 'name': 'Tazemetostat Hydrobromide', 'description': 'Given PO', 'armGroupLabels': ['Phase I; Phase II Arm 2 (tazemetostat, dabrafenib, trametinib)', 'Phase II, Arm 1 (tazemetostat)'], 'otherNames': ['EPZ-6438 Monohydrobromide', 'Tazemetostat Monohydrobromide', 'TAZVERIK']}, {'type': 'DRUG', 'name': 'Trametinib Dimethyl Sulfoxide', 'description': 'Given PO', 'armGroupLabels': ['Phase I; Phase II Arm 2 (tazemetostat, dabrafenib, trametinib)'], 'otherNames': ['Mekinist', 'Meqsel', 'Spexotras']}]","Inclusion Criteria: * Patient must have a diagnosis of BRAF\^V600E/K-mutated metastatic melanoma * Patient must have had documented radiographic or clinical evidence of progressive disease while on combination BRAF/MEK inhibitor therapy. For Phase 2 only, no more than one intervening therapy since progression on BRAF/MEK inhibitor therapy is allowed. Subjects who have evidence of progression while on, or within 4 weeks of completing, combination BRAF/MEK inhibitor therapy in the adjuvant setting will be eligible * PHASE 2 ONLY: Patient must have EZH2 alteration (somatic mutation or copy number alteration). Can be performed on either archival or fresh specimen. EZH2 alterations need to be documented by a Clinical Laboratory Improvement Act (CLIA)/Clinical Laboratory Improvement Program (CLIP)-certified next generation sequencing platform (Foundation One, Tempus, Guardant360, etc.) * PHASE 2 ONLY: Patient must have measurable disease * PHASE 2 ONLY: Patient must have at least one tumor lesion amenable to biopsy. If possible, this lesion should be different from the lesion used for following tumor measurements but is not required * PHASE 2 ONLY: Patient must agree to planned pre-treatment and planned on-treatment biopsy. A pre-treatment biopsy will be optional if patient has an archival tissue block or 5 formalin-fixed paraffin-embedded (FFPE) slides available from specimen used to document presence of eligible EZH2 alteration that is deemed adequate for evaluation * Patient must be \>= 18 years * Because no dosing or adverse event data are currently available on the use of tazemetostat in combination with dabrafenib and trametinib in patients \< 18 years of age, children are excluded from this study * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 50%) * Patients with symptomatic central nervous system (CNS) metastases are eligible if previously treated with surgery and/or radiation with no evidence of radiologic CNS recurrence or progression for 4 weeks and on a stable/tapering dose of steroid for at least one week prior to start of study drug. Patients with new or progressive asymptomatic CNS metastases are eligible * Hemoglobin \>= 9 g/dL * Albumin \>= 2.5 g/dL * Leukocytes \>= 3,000/mcL * Absolute neutrophil count \>= 1,500/mcL * Platelets \>= 100,000/mcL * Serum bilirubin =\< 1.5 x institutional upper limit of normal (ULN) except subjects with known Gilbert's syndrome * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN * Creatinine =\< 1.5 mg/dL OR calculated creatinine clearance (Cockcroft-Gault formula) \>= 50 mL/min * Glomerular filtration rate (GFR) \>= 60 mL/min/1.73 m\^2 * Patients with a prior (or concurrent, if enrolling in Phase 1) malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Patient must be able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels * Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =\< 1.3 x institutional ULN. Prophylactic low dose warfarin may be given to maintain central catheter patency * The effects of tazemetostat, and the combination of tazemetostat, dabrafenib and trametinib on the developing human fetus are unknown. Women of childbearing potential and all male patients must agree to the following: * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \< 1% per year during the treatment period, for 6 months after tazemetostat discontinuation, or for 6 months after discontinuation of the combination of tazemetostat, dabrafenib and trametinib. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately * A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (\>= 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus) * Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices * Due to the potential of enzyme induction with tazemetostat, female subjects who use hormonal contraceptives should use an additional barrier method of birth control while on study treatment and for 6 months after discontinuation of tazemetostat or the combination of tazemetostat, dabrafenib and trametinib * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post ovulation methods) and withdrawal are not acceptable methods of contraception * Women of childbearing potential must have a negative urine or serum pregnancy test at screening * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm, as defined below: * With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 4 months after the last dose of study drug. Men must refrain from donating sperm during this same period. In addition, female partners of male subjects should adhere to the following: * Intrauterine device (IUD) (must provide medical documentation of IUD) * Hormonal contraceptive (partner must be on a stable dose of the same hormonal contraceptive product for at least 4 weeks before receiving study drug) AND a condom (hormonal contraceptives must be supplemented with condoms) * The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. Periodic abstinence and withdrawal are not acceptable methods of contraception * Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and/or family member available will also be eligible * Have progressed on, been intolerant to, is ineligible for, or has refused prior standard of care anti-PD-1 based immunotherapy Exclusion Criteria: * Previous therapy with a demethylating agent (i.e. decitabine) or previous therapy with an EZH2 inhibitor * History of second malignancy not treated with curative intent * History of life-threatening toxicity, including hypersensitivity, related to BRAF or MEK inhibitor therapy, or known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the study treatments, their excipients, and/or dimethyl sulfoxide (DMSO) * Active infection requiring intravenous therapy * Presence of untreated or progressive symptomatic CNS melanoma metastases. Diffuse leptomeningeal carcinomatosis or metastases causing spinal cord compression are exclusionary. Previously treated lesions should be stable for \>= 4 weeks (must be documented by imaging). Subjects on a stable dose of corticosteroids for \> 1 week can be enrolled. Subjects must also be off of enzyme-inducing anticonvulsants for \> 4 weeks * Radiation therapy in the last 14 days. Palliative radiation to a localized area without residual toxicity requires a washout of at least 7 days * Prior systemic anti-cancer therapy (chemotherapy, targeted therapy, immunotherapy, biologic therapy, or vaccine therapy) within the 2 weeks preceding the first dose of study treatment. For Phase 2 only, prior chemotherapy regimens are not permitted * Use of other investigational drugs within 21 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of study treatment and during the study * Unresolved toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0) grade 2 or higher from previous anti-cancer therapy, except alopecia and other toxicities that have resolved to grade 1 or well controlled with medical management (i.e.: hypothyroidism, adrenal insufficiency, type 1 diabetes, etc.), at the time of randomization * Current use of a prohibited medication. Patients must not be treated with any medications or substances that are strong or moderate inhibitors or inducers of CYP3A or strong inhibitors or inducers of CYP2C8 within 14 days prior to the first treatment through the end of the study. Current use of, or intended ongoing treatment with: herbal remedies (e.g., St. John's wort), or strong inhibitors or inducers of P-glycoprotein (Pgp) or breast cancer resistance protein 1 (Bcrp1) should also be excluded * Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with dabrafenib * A history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (with the exception of cleared HBV and HCV infection, which will be allowed) * History of interstitial lung disease or pneumonitis * Clinically significant bleeding diathesis or coagulopathy, including known platelet function disorders. Patients on anticoagulation with low molecular weight heparin or low dose warfarin are allowed * History of myeloid malignancies, including myelodysplastic syndrome (MDS) * Has abnormalities known to be associated with MDS (e.g. del 5q, chr 7 abn) and multiple primary neoplasms (MPN) (e.g. JAK2 V617F) observed in cytogenetic testing and deoxyribonucleic acid (DNA) sequencing * History of T-lymphoblastic lymphoma (T-LBL)/T-cell acute lymphoblastic leukemia (T-ALL) * Patients with history of RAS mutation-positive tumors are not eligible regardless of interval from the current study. Note: Prospective RAS testing is not required. However, if the results of previous RAS testing are known, they must be used in assessing eligibility * History or evidence of cardiovascular risks including any of the following: * QT interval corrected for heart rate using Fridericia's formula (QT corrected by Fridericia \[QTcF\]) \>= 450 msec * History of acute coronary syndromes (including myocardial infarction or unstable angina), coronary angioplasty, or stenting within the past 24 weeks prior to randomization * History or evidence of current class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system * Intra-cardiac defibrillators * Abnormal cardiac valve morphology (\>= grade 2) documented by ECHO; (subjects with grade 1 abnormalities \[i.e., mild regurgitation/stenosis\] can be entered on study). Subjects with moderate valvular thickening should not be entered on study * History or evidence of current clinically significant uncontrolled cardiac arrhythmias; clarification: Subjects with atrial fibrillation controlled for \> 30 days prior to dosing are eligible * Treatment refractory hypertension defined as a blood pressure of systolic \> 140 mmHg and/or diastolic \> 90 mm Hg which cannot be controlled by anti-hypertensive therapy * Left ventricular ejection fraction (LVEF) \< institutional lower limit of normal (LLN) by ECHO or MUGA * Known cardiac metastases * Patients with uncontrolled intercurrent illness * Patients with psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study because of the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with tazemetostat / dabrafenib / trametinib, breastfeeding should be discontinued prior to treatment * Patients with uncontrolled diabetes * Patients with a history of retinal vein occlusion (RVO), retinal pigment epithelial detachment (RPED) or other ophthalmologic toxicity",NA,ALL,NA,"[{'measure': 'Recommended phase 2 dose (Phase I)', 'description': 'Data analysis will be descriptive in nature, and will be determined using the standard 3+3 algorithm. Toxicities by grade, number of cycles administered, and response to treatment will be listed for each dose level.', 'timeFrame': 'Up to 30 days'}, {'measure': 'Median progression-free survival (PFS) (Phase II)', 'description': 'Median PFS in each arm will be assessed using Kaplan-Meier product limit methods and the randomized arms will be compared using log-rank test (at 0.15 one-sided significance level) when 36 PFS events are observed.', 'timeFrame': 'At 6 and 12 months'}]","[{'measure': 'Overall response rates (complete response, partial response)', 'description': 'Assessed by Response Evaluation Criteria in Solid Tumors 1.1, and 95% confidence intervals will be calculated.', 'timeFrame': 'Up to 3 years'}, {'measure': 'Overall survival', 'description': 'Will be estimated in each arm using Kaplan-Meier product limit methods, and its 95% confidence interval will be calculated.', 'timeFrame': 'Up to 3 years'}, {'measure': 'Incidence of adverse events', 'description': 'Toxicity evaluation will be descriptive, and standard toxicity definitions and criteria will be used as outlined in the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The number and percentage of subjects experiencing each type of adverse event will be tabulated by severity. If appropriate, confidence intervals will be used to characterize the precision of the estimate. A complete listing of adverse events will also be tabulated, and will provide details including severity, relationship to treatment, onset, duration, and outcome. Laboratory data measured on a continuous scale will be characterized by summary statistics (mean and standard deviation).', 'timeFrame': 'Up to 3 years'}]" 256,NCT01877382,"{'fullName': 'Daiichi Sankyo', 'class': 'INDUSTRY'}",A Multiple Ascending Dose Study of Milademetan in Subjects With Advanced Solid Tumors or Lymphomas,COMPLETED,"This will be a Phase 1, open-label study of milademetan to assess its safety and tolerability, identify a maximum tolerated dose (MTD)/tentative recommended phase 2 dose (RP2D), and assess its pharmacokinetic (PK)/ pharmacodynamic (PDy) properties in participants with advanced solid tumors or lymphomas. Approximately 5 US sites are planned for Part 1 (Dose Escalation) and Part 2 (Dose Expansion). The same sites are planned to participate for both parts.","['Advanced Solid Tumor', 'Lymphoma']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Milademetan', 'description': 'DS-3032b will be administered as an oral capsule. It will be supplied in 5, 20, 80, and/or 200 mg capsules individually packaged in desiccant-embedded aluminum blisters.', 'armGroupLabels': ['Part 1, Milademetan Alone']}, {'type': 'DRUG', 'name': 'Milademetan', 'description': 'Milademetan will be administered as a single oral capsule or as a combination of multiple oral capsules containing 5, 20, 80, and/or 200 mg. An alternate combination of 30 and/or 100 mg capsules of milademetan may be utilized.', 'armGroupLabels': ['Part 2, Milademetan Alone']}]","Inclusion Criteria: Dose Escalation Cohorts (Part 1) * Has a histologically or cytologically documented advanced solid tumor or lymphoma that has relapsed from or is refractory to standard treatment, or for which no standard treatment is available. * Participants with melanoma who are ineligible to receive or have declined ipilimumab treatment or who are refractory or intolerant to ipilimumab may enroll. * Participants with certain tumor types such as those with high prevalence of MDM2 amplification or overexpression (eg, well-differentiated \[WD\]/dedifferentiated \[DD\] liposarcoma) may be preferentially enrolled in Part 1. Dose Expansion Cohort (Part 2) * Has a histologically or cytologically documented advanced melanoma or diffuse large B cell lymphoma (DLBCL), with measurable disease that is refractory to standard treatment or for which no standard treatment is available. * Participants with melanoma who are ineligible to receive or have declined ipilimumab treatment or who are refractory or intolerant to ipilimumab may enroll. * Participants with DLBCL who have failed, been deemed ineligible for, or refused autologous stem cell transplantation may enroll. * Man or woman ≥ 18 years old. * Has an Eastern Cooperative Oncology Group (ECOG) performance status 0-1. * Has adequate bone marrow function, defined as: * Platelet count ≥ 100 x 10\^9/L * Hemoglobin ≥ 9.0 g/dL * Absolute neutrophil count ≥ 1.5 x 10\^9/L. * Has adequate renal function, defined as creatinine clearance ≥ 60 mL/min, as calculated using the modified Cockcroft Gault equation, (\[{140 - age in years} × {actual weight in kg}\] divided by \[{72 × serum creatinine in mg/dL} multiply by 0.85 if female\]), OR creatinine ≤ 1.5 x ULN. * Has adequate hepatic function, defined as: * AST/ALT levels ≤ 3 x ULN (if liver metastases are present, ≤ 5 x ULN) * Bilirubin ≤ 1.5 x ULN. * Has adequate blood clotting function, defined as International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN. * Participant should be able to provide written informed consent, comply with protocol visits and procedures, be able to take oral medication, and not have any active infection or comorbidity that would interfere with therapy. * Participant (male and female) of childbearing/reproductive potential must agree to use double-barrier contraceptive measures or avoid intercourse during the study and for 90 days after the last dose of study drug. * Participant must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must sign and date an IRB \[Institutional Review Board\]-approved Informed consent Form \[ICF\] (including Health Insurance Portability and Accountability Act authorization, if applicable) before performance of any study specific procedures or tests. * Is willing to provide and there is confirmed availability of pre-existing diagnostic or resected tumor samples, such as paraffin-embedded sections. Providing fresh tumor biopsy is optional for participants in Dose Escalation cohorts. * Is willing to undergo tumor genotyping for TP53 mutation, insertion, or deletion at screening. Confirmation of TP53 nonmutant status is encouraged, but not required prior to milademetan dosing. * Is willing to provide additional archived samples for comprehensive genomic and/or proteomic analyses if the participant has a partial response/complete response to milademetan treatment. * Is willing to undergo pre-treatment tumor biopsies (Part 2 only) Exclusion Criteria: * Has a tumor that contains an inactivating mutation, insertion, or deletion in the TP53 gene determined previously or at screening. * Has a history of primary central nervous system malignancy. * Has gastrointestinal conditions that could affect the absorption of milademetan in the opinion of the Investigator. * Has an uncontrolled infection requiring intravenous antibiotics, antivirals, or antifungals, known human immunodeficiency virus infection, or active hepatitis B or C infection. * Has received an allogeneic bone marrow or allogeneic stem cell transplant. * Has a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor. * Has clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Participants with treated brain metastases that are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 4 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment (2 weeks for stereotactic radiotherapy). * Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to NCI-CTCAE v4, grade ≤ 1 or baseline. Participants with chronic grade 2 toxicities may be eligible per the discretion of the Investigator and Sponsor (eg, grade 2 chemotherapy-induced neuropathy). * Had an autologous transplant within 3 months of starting study drug treatment. * Is receiving concomitant treatment with a strong inducer of CYP3A. * Had systemic treatment with anticancer therapy, antibody-based therapy, retinoid therapy, or hormonal therapy within 3 weeks before study drug treatment; or treatment with nitrosoureas or mitomycin C within 6 weeks before study drug treatment; or treatment with small-molecule targeted agents within 2 weeks before study drug treatment. Previous and concurrent use of hormone replacement therapy, the use of gonadotropin releasing hormone modulators for prostate cancer, and the use of somatostatin analogs for neuroendocrine tumors are permitted if such therapy has not been changed within 8 weeks before study drug treatment. * Had therapeutic radiation therapy or major surgery within 4 weeks before study drug treatment or palliative radiation therapy within 2 weeks before study drug treatment. * Participated in a therapeutic clinical study within 3 weeks before study drug treatment, or current participation in other therapeutic investigational procedures. * Prolongation of corrected QT interval by Fridericia's method (QTcF) at rest, where the mean QTcF interval is \> 450 milliseconds (ms) for males and \> 470 ms for females based on triplicate ECG. * Pregnant or breastfeeding. * Substance abuse or medical, psychological, or social conditions that, in the opinion of the Investigator, may interfere with the participant's participation in the clinical study or evaluation of the clinical study results. * Prior treatment with an MDM2 inhibitor.",NA,ALL,NA,"[{'measure': 'Number of Participants With Treatment-emergent Adverse Events (≥10% Overall) in Participants Receiving Milademetan', 'description': 'A treatment-emergent adverse event (TEAE) was defined as an adverse event (AE) that emerged during the treatment period (from first dose date until 30 days after the last dosing date), having been absent at pretreatment; or reemerged during treatment, having been present at baseline, but stopped prior to treatment; or worsened in severity after starting treatment relative to the pretreatment state, when the AE was continuous.', 'timeFrame': 'Screening until end of treatment visit, up to approximately 7 years 2 months'}, {'measure': 'Number of Participants With Dose-Limiting Toxicities In Participants Receiving Milademetan by Preferred Term and Worst Grade by NCI CTCAE', 'description': ""A dose-limiting toxicity (DLT) was defined as any treatment-emergent AE (TEAE) not attributable to the participant's disease or a disease-related processes that occurred during the observation period (Cycle 1) in each dose-level cohort and was Grade 3 or higher according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.0, with a few exceptions."", 'timeFrame': 'Cycle 1, Day 1 to Day 28 (each cycle, 28 days)'}, {'measure': 'Number of Participants With Melanoma and Diffuse Large B Cell Lymphoma Who Achieved Objective Response', 'description': 'Tumor response was assessed using RECIST Version 1.1 (in solid tumor participants with measurable disease) or treatment response using the revised International Working Group criteria 7 (in participants with lymphoma). For RECIST, complete response (CR) was defined as a disappearance of all target lesions, partial response (PR) was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions. Objective response rate (ORR) was the sum of CR and PR rates.', 'timeFrame': 'Screening up to Cycle 3 and beyond, Day 1 (each cycle, 28 days)'}]","[{'measure': 'Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of Milademetan In Participants Receiving Milademetan', 'description': 'Plasma pharmacokinetic parameters of DS-3032a were calculated using noncompartmental methods.', 'timeFrame': 'Escalation:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,6-8 hours(h);Cycle 2,Day 1 Predose,1,3,6-8h,30 days after last dose; Expansion:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,4,6,8h;Cycle 2,Day 1 Predose,1,2,3,4,6,8h and Day 2 (each cycle, 28 days)'}, {'measure': 'Pharmacokinetic Parameter Area Under the Curve (AUC) of Milademetan In Participants Receiving Milademetan', 'description': 'Area under the curve from time 0 to 24 hours (AUC0-24), time 0 to infinity (AUCinf), and to the last measurable concentration (AUClast). Plasma pharmacokinetic parameters of DS-3032a were calculated using noncompartmental methods.', 'timeFrame': 'Escalation:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,6-8 hours(h);Cycle 2,Day 1 Predose,1,3,6-8h,30 days after last dose; Expansion:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,4,6,8h;Cycle 2,Day 1 Predose,1,2,3,4,6,8h and Day 2 (each cycle, 28 days)'}, {'measure': 'Pharmacokinetic Parameter Time to Reach Maximum Plasma Concentration (Tmax) of Milademetan In Participants Receiving Milademetan', 'description': 'Plasma pharmacokinetic parameters of DS-3032a were calculated using noncompartmental methods.', 'timeFrame': 'Escalation:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,6-8 hours(h);Cycle 2,Day 1 Predose,1,3,6-8h,30 days after last dose; Expansion:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,4,6,8h;Cycle 2,Day 1 Predose,1,2,3,4,6,8h and Day 2 (each cycle, 28 days)'}, {'measure': 'Pharmacokinetic Parameter Apparent Clearance (CL/F) of Milademetan In Participants Receiving Milademetan', 'description': 'Plasma pharmacokinetic parameters of DS-3032a were calculated using noncompartmental methods.', 'timeFrame': 'Escalation:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,6-8 hours(h);Cycle 2,Day 1 Predose,1,3,6-8h,30 days after last dose; Expansion:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,4,6,8h;Cycle 2,Day 1 Predose,1,2,3,4,6,8h and Day 2 (each cycle, 28 days)'}, {'measure': 'Pharmacokinetic Parameter Elimination Terminal Half Life Half-Life (T1/2) of Milademetan In Participants Receiving Milademetan', 'description': 'Plasma pharmacokinetic parameters of DS-3032a were calculated using noncompartmental methods.', 'timeFrame': 'Escalation:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,6-8 hours(h);Cycle 2,Day 1 Predose,1,3,6-8h,30 days after last dose; Expansion:Cycle 1,Days 1,2,8,15,18-21 Predose,0.5,1,2,3,4,6,8h;Cycle 2,Day 1 Predose,1,2,3,4,6,8h and Day 2 (each cycle, 28 days)'}, {'measure': 'Mean Fold Change From Baseline in Serum MIC-1 Levels in Participants Receiving Milademetan', 'description': 'Mean fold change in macrophage inhibitory cytokine-1 (MIC-1) levels in serum from baseline are summarized using descriptive statistics by cohort.', 'timeFrame': 'Cycle 1, Day 15 and Cycle 1, Days 18 to 21 (each cycle is 28 days)'}]" 257,NCT02755233,"{'fullName': 'University of Zurich', 'class': 'OTHER'}",Ipilimumab-induced Lung Toxicity: Observational Study,COMPLETED,"Serial spirometries and measurements of CO-diffusion capacity (DLCO) in patients with MM before and during treatment with ipilimumab are performed. A reduction from baseline of forced vital capacity (FVC) of ≥10%, or ≥15% of DLCO was defined clinically meaningful, thus indicative for pulmonary toxicity.",['Metastatic Melanoma'],OBSERVATIONAL,"{'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'OTHER', 'name': 'Pulmonary Function', 'description': ""Spirometry and DLCO were measured according to performance standards based on the statements from the American Thoracic Society (ATS) and the European Respiratory Society (ERS). Values of DLCO were adjusted for the patient's current hemoglobin value, and the patients were asked to withhold cigarette smoking at least four hours before pulmonary function testing. Lung volumes and DLCO were measured with a commercial ZAN300 CO Diffusion system (nSpire Health GmbH, Oberthulba, Germany)"", 'armGroupLabels': ['Pulmonary function'], 'otherNames': ['Spirometry and CO-diffusion capacity measurement']}]","Inclusion Criteria: * Established diagnosis of metastatic melanoma Exclusion Criteria: * Acute pulmonary infection at enrolment",Patients in whom a treatment with ipilimumab due to metastatic melanoma is indicated,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Relative reduction of DLCO of more than 15% from the baseline value during follow-up', 'description': 'A relative reduction of ≥15% from baseline of DLCO was chosen as clinically meaningful, thus indicative of a possible interstitial lung disease as a consequence of ipilimumab induced pulmonary toxicity', 'timeFrame': '9 weeks'}]","[{'measure': 'Relative reduction of FVC of more than 10% from the baseline value during', 'description': 'A relative reduction of FVC of ≥10% from baseline was chosen as clinically meaningful, thus indicative of a possible interstitial lung disease as a consequence of ipilimumab induced pulmonary toxicity', 'timeFrame': '9 weeks'}]" 258,NCT01318161,"{'fullName': 'Örebro University, Sweden', 'class': 'OTHER'}",Epidural Versus Patient-controlled Analgesia for Reduction in Long-term Mortality Following Colorectal Cancer Surgery,TERMINATED,"Colorectal cancer is one of the most common cancers in the industrialized world (12% of all cancers). In Sweden, 6000 new cases of colorectal cancer are reported each year, and almost half of these cases result in death. Several recently published retrospective studies show that regional anaesthesia (RA) can reduce cancer-related mortality following surgical treatment of colorectal, breast and prostate cancers and malignant melanoma. If these results are true, then the choice of perioperative pain management is as beneficial, or even better, than the current oncological therapies. This theory needs to be investigated in a prospective, randomized and controlled trail.","['Colorectal Cancer', 'Pain', 'Other Complications']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Ropivacaine + opioid epidurally', 'description': 'Epidural analgesia with local anesthetic + opioid', 'armGroupLabels': ['Epidural anesthesia and analgesia']}, {'type': 'DRUG', 'name': 'Morphine', 'description': 'Morphine via PCA pump', 'armGroupLabels': ['Patient controlled analgesia']}]","Inclusion Criteria: * ASA status 1-3 * Age group 40-80 years old * Undergoing elective surgery for colorectal cancer Exclusion Criteria: * All contraindications to epidural analgesia * Chronic opiate medication/drug abuse * Allergy to morphine",NA,ALL,NA,"[{'measure': 'Long-term (up to 5 yrs) all-cause mortality', 'description': 'Cancer specific as well as all-cause mortality would be recorded.', 'timeFrame': '7 years from start of enrollment'}]","[{'measure': 'Cancer recurrence detected by MRI; perioperative complications', 'description': 'All complications during the perioperative period including cancer recurrence detected by MRI examination once each year would be recorded.', 'timeFrame': '7 years following start of enrollment'}]" 259,NCT02986373,"{'fullName': 'AbbVie', 'class': 'INDUSTRY'}",A Study to Investigate Safety With Risankizumab in Psoriatic Arthritis Subjects Who Have Completed Week 24 Visit of Study M16-002 (NCT02719171),COMPLETED,"This is an open-label extension (OLE) study to assess the efficacy, safety and tolerability of risankizumab in participants with psoriatic arthritis (PsA).",['Psoriatic Arthritis'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'risankizumab', 'description': 'Risankizumab administered by subcutaneous injection.', 'armGroupLabels': ['Risankizumab'], 'otherNames': ['ABBV-066', 'BI 655066', 'SKYRIZI']}]","Inclusion Criteria: * Participants who have completed all doses of study drug and Week 24 visit of the lead-in study. * Women of childbearing potential who are sexually active, must agree to use at least one accepted method of contraception throughout the study, including 20 weeks after last dose of study drug is given. * Women of childbearing potential must have a negative urine pregnancy test at Baseline (Week 0/V1). * Participants must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any study specific procedures. * Participant is judged to be in good health as determined by the Investigator. Exclusion Criteria: * Female participant who is pregnant, breastfeeding or is considering becoming pregnant during study participation, including 20 weeks after the last dose of study drug is given. * Premature discontinuation of the study drug in the lead-in study for any reason. * Use of a biologic treatment other than risankizumab since first dose of study drug in the lead-in study. * Time elapsed is \> 8 weeks since the Week 24 visit in the lead-in study. * Active systemic infections during the last 2 weeks (exception: common cold) prior to the first dose, as assessed by the investigator.",NA,ALL,NA,"[{'measure': 'Number of Participants With Adverse Events', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs) are defined as an AE that began or worsened in severity after initiation of study drug and 20 weeks (140 days) after last dose. Abbreviations: NMSC=non-melanoma skin cancer', 'timeFrame': 'From the first dose of study drug in this study until 20 weeks after the last dose of study drug (up to 56 weeks).'}]","[{'measure': 'Modified Total Sharp Score (mTSS): Change From Baseline (in the Lead-in Study) to Week 24 in the Lead-in Study', 'description': 'The mTSS is a measure of change in joint health. X-rays of hands, wrists, and feet (including distal interphalangeal joints) were obtained at Week 24 and Week 48. Totals for hands and feet for erosion scores (range 0 to 320) and joint space narrowing scores (range 0 to 208) were calculated and added to obtain the mTSS (range = 0 \\[normal\\] to 528 \\[maximal disease\\]). An increase in mTSS from Baseline represents disease progression and/or joint worsening; no progression was defined as a change of ≤0.5. Baseline is defined as baseline in the lead-in study.', 'timeFrame': 'Baseline (Lead-in Study), Week 24 (Lead-in Study)'}, {'measure': 'mTSS: Change From Baseline (in the Lead-in Study) to Week 24', 'description': 'The mTSS is a measure of change in joint health. X-rays of hands, wrists, and feet (including distal interphalangeal joints) were obtained at Week 24 and Week 48. Totals for hands and feet for erosion scores (range 0 to 320) and joint space narrowing scores (range 0 to 208) were calculated and added to obtain the mTSS (range = 0 \\[normal\\] to 528 \\[maximal disease\\]). An increase in mTSS from Baseline represents disease progression and/or joint worsening; no progression was defined as a change of ≤0.5. Baseline is defined as baseline in the lead-in study.', 'timeFrame': 'Baseline (Lead-in Study), Week 24'}, {'measure': 'mTSS: Change From Baseline (in the Lead-in Study) to Week 48', 'description': 'The mTSS is a measure of change in joint health. X-rays of hands, wrists, and feet (including distal interphalangeal joints) were obtained at Week 24 and Week 48. Totals for hands and feet for erosion scores (range 0 to 320) and joint space narrowing scores (range 0 to 208) were calculated and added to obtain the mTSS (range = 0 \\[normal\\] to 528 \\[maximal disease\\]). An increase in mTSS from Baseline represents disease progression and/or joint worsening; no progression was defined as a change of ≤0.5. Baseline is defined as baseline in the lead-in study.', 'timeFrame': 'Baseline (Lead-in Study), Week 48'}, {'measure': 'Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Week 0', 'description': ""Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 0: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity visual analog scale (VAS), Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, Health Assessment Questionnaire Disability Index (HAQ-DI), and acute phase reactant value (C-reactive protein). Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study."", 'timeFrame': 'Week 0'}, {'measure': 'Percentage of Participants Achieving ACR20 Response at Week 4', 'description': ""Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 4: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity VAS, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, HAQ-DI, and acute phase reactant value (C-reactive protein). Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study."", 'timeFrame': 'Week 4'}, {'measure': 'Percentage of Participants Achieving ACR20 Response at Week 12', 'description': ""Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 12: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity VAS, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, HAQ-DI, and acute phase reactant value (C-reactive protein). Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study."", 'timeFrame': 'Week 12'}, {'measure': 'Percentage of Participants Achieving ACR20 Response at Week 24', 'description': ""Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 24: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity VAS, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, HAQ-DI, and acute phase reactant value (C-reactive protein). Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study."", 'timeFrame': 'Week 24'}, {'measure': 'Percentage of Participants Achieving ACR20 Response at Week 36', 'description': ""Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 36: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity VAS, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, HAQ-DI, and acute phase reactant value (C-reactive protein). Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study."", 'timeFrame': 'Week 36'}, {'measure': 'Percentage of Participants Achieving ACR20 Response at Week 48', 'description': ""Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 48: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity VAS, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, HAQ-DI, and acute phase reactant value (C-reactive protein). Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study."", 'timeFrame': 'Week 48'}, {'measure': 'Percentage of Participants Achieving ACR20 Response at Week 52', 'description': ""Response defined by ACR20 criteria (improvement from baseline in the lead-in study) at Week 52: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 out of the following 5 parameters: Patient's Assessment of Pain Intensity VAS, Patient's Global Assessment of Disease Activity, Investigator's Global Assessment of Disease Activity, HAQ-DI, and acute phase reactant value (C-reactive protein). Baseline is defined as the last non missing pre-treatment observation prior to first dose in the lead-in study."", 'timeFrame': 'Week 52'}, {'measure': 'Health Assessment Questionnaire Disability Index (HAQ-DI): Change From Baseline (in the Lead-in Study) to Week 0', 'description': 'The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of \\< 0.5. Negative change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.', 'timeFrame': 'Baseline (Lead-in Study), Week 0'}, {'measure': 'HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 4', 'description': 'The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of \\< 0.5. Negative change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.', 'timeFrame': 'Baseline (Lead-in Study), Week 4'}, {'measure': 'HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 12', 'description': 'The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of \\< 0.5. Negative change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.', 'timeFrame': 'Baseline (Lead-in Study), Week 12'}, {'measure': 'HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 24', 'description': 'The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of \\< 0.5. Negative change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.', 'timeFrame': 'Baseline (Lead-in Study), Week 24'}, {'measure': 'HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 36', 'description': 'The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of \\< 0.5. Negative change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.', 'timeFrame': 'Baseline (Lead-in Study), Week 36'}, {'measure': 'HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 48', 'description': 'The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of \\< 0.5. Negative change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.', 'timeFrame': 'Baseline (Lead-in Study), Week 48'}, {'measure': 'HAQ-DI: Change From Baseline (in the Lead-in Study) to Week 52', 'description': 'The HAQ-DI is a patient-reported questionnaire specific for rheumatoid arthritis that consists of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability. HAQ remission indicating normal physical function is defined by HAQ-DI score of \\< 0.5. Negative change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study.', 'timeFrame': 'Baseline (Lead-in Study), Week 52'}, {'measure': 'Short Form Health Survey 36 (SF-36) Physical Component Summary (PCS) Score: Change From Baseline (in the Lead-in Study) to Week 0', 'description': ""The SF-36 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study."", 'timeFrame': 'Baseline (Lead-in Study), Week 0'}, {'measure': 'SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 4', 'description': ""The SF-36 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study."", 'timeFrame': 'Baseline (Lead-in Study), Week 4'}, {'measure': 'SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 12', 'description': ""The SF-36 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study."", 'timeFrame': 'Baseline (Lead-in Study), Week 12'}, {'measure': 'SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 24', 'description': ""The SF-36 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study."", 'timeFrame': 'Baseline (Lead-in Study), Week 24'}, {'measure': 'SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 36', 'description': ""The SF-36 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study."", 'timeFrame': 'Baseline (Lead-in Study), Week 36'}, {'measure': 'SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 48', 'description': ""The SF-36 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study."", 'timeFrame': 'Baseline (Lead-in Study), Week 48'}, {'measure': 'SF-36 PCS Score: Change From Baseline (in the Lead-in Study) to Week 52', 'description': ""The SF-36 Health determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study."", 'timeFrame': 'Baseline (Lead-in Study), Week 52'}, {'measure': 'SF-36 Mental Component Summary (MCS) Score: Change From Baseline (in the Lead-in Study) to Week 0', 'description': ""The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study."", 'timeFrame': 'Baseline (Lead-in Study), Week 0'}, {'measure': 'SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 4', 'description': ""The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study."", 'timeFrame': 'Baseline (Lead-in Study), Week 4'}, {'measure': 'SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 12', 'description': ""The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study."", 'timeFrame': 'Baseline (Lead-in Study), Week 12'}, {'measure': 'SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 24', 'description': ""The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study."", 'timeFrame': 'Baseline (Lead-in Study), Week 24'}, {'measure': 'SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 36', 'description': ""The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study."", 'timeFrame': 'Baseline (Lead-in Study), Week 36'}, {'measure': 'SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 48', 'description': ""The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study."", 'timeFrame': 'Baseline (Lead-in Study), Week 48'}, {'measure': 'SF-36 MCS Score: Change From Baseline (in the Lead-in Study) to Week 52', 'description': ""The SF-36 determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 5-8 comprise the mental component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement. Baseline is defined as baseline in the lead-in study."", 'timeFrame': 'Baseline (Lead-in Study), Week 52'}]" 260,NCT03025256,"{'fullName': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}",Intravenous and Intrathecal Nivolumab in Treating Patients With Leptomeningeal Disease,ACTIVE_NOT_RECRUITING,"This phase I/Ib trial studies the side effects and best dose of intrathecal nivolumab, and how well it works in combination with intravenous nivolumab in treating patients with leptomeningeal disease. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.","['Acral Lentiginous Melanoma', 'Central Nervous System Melanoma', 'Clinical Stage IV Cutaneous Melanoma AJCC v8', 'Leptomeningeal Neoplasm', 'Melanocytoma', 'Metastatic Lung Non-Small Cell Carcinoma', 'Metastatic Melanoma', 'Metastatic Mucosal Melanoma', 'Metastatic Uveal Melanoma', 'Stage IV Lung Cancer AJCC v8']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'PROCEDURE', 'name': 'Biospecimen Collection', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (nivolumab)'], 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection']}, {'type': 'PROCEDURE', 'name': 'Computed Tomography', 'description': 'Undergo CT', 'armGroupLabels': ['Treatment (nivolumab)'], 'otherNames': ['CAT', 'CAT Scan', 'Computed Axial Tomography', 'Computerized Axial Tomography', 'Computerized Tomography', 'CT', 'CT Scan', 'tomography']}, {'type': 'PROCEDURE', 'name': 'Lumbar Puncture', 'description': 'Undergo lumbar puncture for cerebrospinal fluid collection', 'armGroupLabels': ['Treatment (nivolumab)'], 'otherNames': ['LP', 'Spinal Tap']}, {'type': 'PROCEDURE', 'name': 'Magnetic Resonance Imaging', 'description': 'Undergo MRI of brain and spine', 'armGroupLabels': ['Treatment (nivolumab)'], 'otherNames': ['Magnetic Resonance Imaging Scan', 'Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance', 'MR', 'MR Imaging', 'MRI', 'MRI Scan', 'NMR Imaging', 'NMRI', 'Nuclear Magnetic Resonance Imaging']}, {'type': 'BIOLOGICAL', 'name': 'Nivolumab', 'description': 'Given IV or IT', 'armGroupLabels': ['Treatment (nivolumab)'], 'otherNames': ['BMS-936558', 'CMAB819', 'MDX-1106', 'NIVO', 'Nivolumab Biosimilar CMAB819', 'ONO-4538', 'Opdivo']}, {'type': 'PROCEDURE', 'name': 'Positron Emission Tomography', 'description': 'Undergo PET', 'armGroupLabels': ['Treatment (nivolumab)'], 'otherNames': ['Medical Imaging, Positron Emission Tomography', 'PET', 'PET Scan', 'Positron Emission Tomography Scan', 'Positron-Emission Tomography', 'proton magnetic resonance spectroscopic imaging']}]","Inclusion Criteria: * Patients must have radiographic and/or CSF cytological evidence of LMD. For patient with melanoma: Must have a confirmed diagnosis of primary central nervous system (CNS) melanoma, melanocytomas or metastatic melanoma (cutaneous, acral-lentiginous, uveal and mucosal in origin), based on histological analysis of metastatic tissue and/or cancer cells, archival tissue permitted. For patients with lung cancer: non-small cell, based on histological analysis of metastatic tissue and/or cancer cells, archival tissue permitted * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of =\< 2 * Patients may receive steroids to control symptoms related to CNS involvement, but the dose must be =\< 4 mg per 24 hours of dexamethasone (or the equivalent). Physiologic replacement doses for adrenal insufficiency is allowed on this protocol * Patients who have received radiation to brain and/or spine, including whole brain radiation, stereotactic radiosurgery, or stereotactic body radiation therapy (SBRT), are eligible, but must have completed radiation treatment at least 7 days prior to the start of treatment * Patients who have been treated with an approved targeted therapy (BRAF inhibitor and/or MEK inhibitor) will be allowed to remain on concurrent approved targeted therapy. No other concomitant intrathecal therapy with another agent will be allowed. For patients that have received other systemic therapies, the minimum wash out period is as follows: * Patients that received previous IT therapy must have received their last treatment \>= 7 days prior to the start of treatment * Patients who have received systemic chemotherapy must have received their last treatment \>= 14 days prior to the start of treatment * Patients who have received an approved systemic biologic therapy (e.g. anti-PD-1, anti-CTLA4, IL2, interferon) must have received their last treatment \>= 2 weeks prior to the start of treatment * Patients who have received any other investigational agents must have received their last treatment \>= 14 days prior to the start of treatment * For patients with lung cancer: * For chemotherapy: patients do not require a washout period, and can continue with chemotherapy during treatment with IT/IV nivolumab * Patients who have received an approved systemic biologic therapy (e.g. anti-PD-1, anti-CTLA4, IL2, interferon) must have received their last treatment \>= 2 weeks prior to the start of treatment * Patients who have received any other investigational agents must have received their last treatment \>= 14 days prior to the start of treatment * No other concomitant intrathecal therapy with another agent will be allowed * Patients who are receiving treatment to tyrosine kinase inhibitors or other targeted therapy agents do not require a washout period, and can continue with tyrosine kinase inhibitors or other targeted therapy agents during treatment with IT/IV nivolumab * Age \>= 18 years * Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form * Absolute neutrophil count (ANC) \>= 1.5 X 10\^9/L * Hemoglobin \>= 9.0 g/dL * Platelets \>= 75 X 10\^9/L * Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) =\< 1.5 X upper limit of normal (ULN) * Total bilirubin: =\< 1.5 X ULN (isolated bilirubin \> 1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 X ULN * Albumin \>= 2.5 g/dL * Creatinine OR =\< 2 x ULN; calculated creatinine clearance OR \>= 50 mL/min; 24-hour urine creatinine clearance \>= 50 mL/min * Absence of contraindication for Ommaya reservoir * Women are eligible to participate if: * Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) \> 40 MlU/mL and estradiol \< 40 pg/mL (\<140 pmol/L) is confirmatory\] * A Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal. Menopause is defined as 12 months of amenorrhea in a woman over age 45 years in the absence of other biological or physiological causes. In addition, females under the age of 55 years must have a serum follicle stimulating hormone, (FSH) level \> 40mIU/mL to confirm menopause * Females treated with hormone replacement therapy, (HRT) are likely to have artificially suppressed FSH levels and may require a washout period in order to obtain a physiologic FSH level. The duration of the washout period is a function of the type of HRT used. The duration of the washout period below are suggested guidelines and the investigators should use their judgment in checking serum FSH levels. If the serum FSH level is \>40 mIU/ml at any time during the washout period, the woman can be considered postmenopausal: * 1 week minimum for vaginal hormonal products (rings, creams, gels) * 4 week minimum for transdermal products * 8 week minimum for oral products * Other parenteral products may require washout periods as long as 6 months * A Women of childbearing potential agrees to use method(s) of contraception. For a teratogenic study drug and/or when there is insufficient information to assess teratogenicity (preclinical studies have not been done), a highly effective method(s) of contraception (failure rate of less than 1% per year) is required. The individual methods of contraception and duration should be determined in consultation with the investigator. Women of childbearing potential (WOCBP) must follow instructions for birth control when the half-life of the investigational drug is greater than 24 hours, contraception should be continued for a period of 30 days plus the time required for the investigational drug to undergo five half-lives. The half-life of nivolumab is up to 25 days. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational product * Women must not be breastfeeding * Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year The investigator shall review contraception methods and the time period that contraception must be followed. Men who are sexually active with WOCBP must follow instructions for birth control when the half-life of the investigational drug is greater than 24 hours, contraception should be continued for a period of 90 days plus the time required for the investigational drug to undergo five half-lives. The half-life of nivolumab is up to 25 days. Therefore, men who are sexually active with WOCBP must continue contraception for 31 weeks (90 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug * Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile and azoospermic men do not require contraception Exclusion Criteria: * Patients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment * Subjects with a condition requiring systemic treatment with either corticosteroids (\> 4 mg daily dexamethasone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Tocilizumab and vedolizumab are permitted, as are inhaled or topical steroids and adrenal replacement doses in the absence of active autoimmune disease * Subjects that require premedication with corticosteroids for a contrast allergy are excluded from this restriction and can proceed with enrollment * Patients who have previously received alpha-PD-1 and/or anti-CTLA-4 will be eligible, unless they have ongoing \> grade 2 adverse event (AE) side effects of such therapy. Ongoing physiologic replacement doses for adrenal and thyroid insufficiency are allowed on protocol * Currently receiving cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug (concurrent treatment with approved targeted therapies is allowed.) * Pregnant or lactating female * Subjects with major medical, neurologic or psychiatric condition who are judged as unable to fully comply with study therapy or assessments should not be enrolled * Patients with a history of pneumonitis * Evidence of active infections =\< 7 days prior to initiation of study drug therapy (does not apply to viral infections that are presumed to be associated with the underlying tumor type required for study entry) * Use of non-oncology vaccines containing live virus for prevention of infectious diseases within 12 weeks prior to study drug * Any positive test for hepatitis B virus or hepatitis C virus indicating acute or chronic infection * Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) even if fully immunocompetent on antiretroviral therapy (ART)-due to the unknown effects of HIV on the immune response to combined nivolumab or the unique toxicity spectrum of these drugs in patients with HIV * History of allergy to study drug components * History of severe hypersensitivity reaction to any monoclonal antibody * Prisoners or subjects who are involuntarily incarcerated * Subjects who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness",NA,ALL,NA,"[{'measure': 'Incidence of adverse events', 'description': 'Safety and tolerability of treatment will be assessed by vital signs, laboratory assessments, adverse events, and serious adverse events for the safety population. Adverse events will be graded by the Common Terminology Criteria for Adverse Events version 4.0. Categorical measures will be summarized using frequencies and percentages while continuous variables will be summarized using mean, standard deviation, median, minimum, and maximum.', 'timeFrame': 'Up to 2 years'}, {'measure': 'Recommended dose of combined intrathecal (IT) and intravenous (IV) nivolumab defined as the highest dose for which the posterior probability of toxicity is closest to 30% (dose escalation part)', 'description': 'The Bayesian modified toxicity probability interval method will be used to find the recommended dose.', 'timeFrame': 'Up to 28 days'}, {'measure': 'Overall survival (OS) in patients treated with IT and IV nivolumab (dose expansion part)', 'timeFrame': 'Up to 2 years'}]","[{'measure': 'OS', 'description': 'The Kaplan-Meier method will be used to estimate the distribution of OS from the start of study treatment, and Cox proportional hazard regression will be used to assess the relationship between OS and various covariates of interest, including but not limited to patient demographics, tumor characteristics, disease characteristics, and the expression of biomarkers.', 'timeFrame': 'Up to 2 years'}, {'measure': 'Immunological effects of nivolumab', 'timeFrame': 'Up to 2 years'}]" 261,NCT06212388,"{'fullName': 'Xijing Hospital', 'class': 'OTHER'}",Allogeneic Gammadelta T Cells Combined With Interferon-α1b or PD-1 Monoclonal Antibody in Stage III-IV Amenable to Surgical Resection Melanoma,NOT_YET_RECRUITING,The purpose of this study is to evaluate the efficacy and safety of allogeneic γδ T cells combined with recombinant human interferon-α1b (IFN-α1b) or PD-1 monoclonal antibody in neoadjuvant treatment of patients with Stage III-IV resectable melanoma.,['Melanoma'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'Ex-vivo expanded allogeneic γδ T cells', 'description': 'Cells will be extracted from a healthy donor by apheresis, followed by ex-vivo expansion and activation. The ex-vivo expanded γδT cells from donors will be adoptively transfused.', 'armGroupLabels': ['group A: IFN-α1B+ γδ T cells', 'group B: Palizizumab+ γδ T cells']}, {'type': 'DRUG', 'name': 'Recombinant human interferon α1b', 'description': 'Recombinant human interferon α1b is a protein with potent antiviral, antiproliferative and immunomodulatory properties.', 'armGroupLabels': ['group A: IFN-α1B+ γδ T cells']}, {'type': 'DRUG', 'name': 'Pembrolizumab', 'description': 'Pembrolizumab is a recombinant, humanized programmed death receptor (PD-1) monoclonal antibody that binds to PD- and prevents binding of PD-1 with programed death ligands 1 (PD-L1) and PD-L2. It can function to activate cytotoxic T lymphocytes and inhibit tumor growth.', 'armGroupLabels': ['group B: Palizizumab+ γδ T cells']}]","Inclusion Criteria: * 1\. Aged 18-75. 2. ECOG performance status of 0 or 1 3. Life expectancy ≥ 3 months; 4. Histologically or cytologically confirmed diagnosis of resectable stage III-IV melanoma by the American Joint Committee on Cancer (AJCC) (the 8th Edition). (Note: uveal melanoma cases are excluded) 5. Adequate organ and marrow function (within 4 weeks prior to study treatment initiation): 6. A negative urine or plasma β-HCG test result is required at screening for female patients of childbearing potential. 7\. Contraception is required for patients and their partners throughout the trial and within 1 year after the last dose of study treatment. 8\. Capable of understanding and complying with the study protocol requirements ( including follow-up visit and examinations). 9\. Be willing to signed a written informed consent document before enrollment. Exclusion Criteria: * 1\. History of allergic reactions attributed to compounds of similar chemical or biologic composition to ex-vivo expanded allogeneic γδ T cells, recombinant human interferon-α1b and PD-1 monoclonal antibody. 2\. Patients accepted other anti-tumor clinical trials within 4 weeks prior to study entry. 3\. Patients accepted anti-tumor radiotherapy within 4 weeks prior to study entry. 4\. Disease improved by in response to anti-tumor therapies within 4 weeks including perioperative chemotherapy, molecularly targeted therapy, PD-1/PD-L1/CTLA-4 immune therapy, anti-angiogenesis therapy, interferon, herbal supplements, and other cell therapies including NK, CIK, DC, CTL and stem cell therapy etc. 5\. Plan to take other systemic or local anti-tumor therapy during the current study 6. Systemic treatment with either corticosteroid (\> 10 mg /kg prednisone equivalents) or other immunosuppressive medications prior to 2 weeks prior to study dose initiation 7. Known hematologic malignancy, primary brain tumor, sarcoma or any other primary solid tumor unless the disease-free period is over 5 years. 8\. Imaging confirmed of central nervous system (CNS) metastases with or without meningeal carcinomatosis 9. Known severe hypersensitivity reaction of another adoptive immune cell therapy. 10\. Known active autoimmune disease requiring systemic treatment (such as corticosteroids or immunosuppressive medications) or related replacement therapies (such as thyroid hormone for hypothyroidism, insulin for diabetes or physiological glucocorticoid replacement therapy for adrenal or pituitary insufficiency) in the past 2 years. 11\. Surgery history within past 4 weeks, except for melanoma removal or partial removal. 12\. Major organs dysfunction. 13. Acute infections and any condition has potential risk of gastrointestinal bleeding or perforation, such as active gastrointestinal ulcer, known intra luminal metastases,inflammatory bowel disease; known abdominal fistula, gastrointestinal perforation or intraperitoneal abscess 4 weeks prior to entry of the study entry. 14\. Other diseases that may affect compliance or interfere with results interpretation including active opportunistic infections or progressing or severe infections , uncontrolled diabetes or pulmonary diseases including interstitial pneumonia, obstructive pulmonary disease and symptomatic bronchospasm. 15\. Known HIV or AIDS-related illness, or active HBV, HCV and tuberculosis. 16. A history of getting a live vaccine within 4 weeks prior to the first dose; a history of hematopoietic stimulating factor therapy such as colony-stimulating factor (CSF) and erythropoietin (EPO) within 2 weeks prior to the first dose; a history of major surgeon except for diagnosis within 4 weeks prior to the first dose. 17\. Diagnosis of a psychiatric or substance abuse disorder. 18. Individuals who are pregnant or breast-feeding or plan to conceive during the study period 19. Any other illness, laboratory abnormality, or situations that in the opinion of the principal investigator would compromise the patients' ability to tolerate treatment or would limit compliance with study requirements.",NA,ALL,NA,"[{'measure': 'Rate of Pathological Complete Response (pCR)', 'description': 'Investigators will measure the rate of pCR after surgery.', 'timeFrame': 'at 12 weeks'}, {'measure': 'Rate of Major Pathological Response (mPR)', 'description': 'Investigators will measure the rate of mPR after surgery.', 'timeFrame': 'at 12 weeks'}, {'measure': 'Rate of Partial Pathological Response (pPR)', 'description': 'Investigators will measure the rate of pPR after surgery.', 'timeFrame': 'at 12 weeks'}, {'measure': 'Overall Response Rate(ORR)', 'description': 'ORR will be measured after neoadjuvant therapy (for participants who have measurable disease per RECIST 1.1 at start of neoadjuvant therapy).', 'timeFrame': 'up to 12 weeks'}]","[{'measure': 'Event Free survival(EFS)', 'description': 'EFS is defined as time from randomization to melanoma progression (irresectable stage III or stage IV disease), melanoma recurrence, treatment-related death, or melanoma-related death, whichever occurs first. Occurrence of a new primary melanoma during treatment/follow-up is also regarded as an event. Presurgical resectable progression to stage III disease is not defined as an event, even as death to another reason than melanoma or the study treatment.', 'timeFrame': 'From randomization up to 3 years after surgery'}, {'measure': 'Relapse Free Survival (RFS)', 'description': 'RFS is defined as time from surgery until disease relapse.', 'timeFrame': 'After surgery up to 3 years'}, {'measure': '3 Year Overall Survival (OS)', 'description': 'The 3 years after surgery OS rate of patients with γδ T cells plus IFN-α1B or γδ T cells plus pembrolizumab，From date of enrollment until the date of death from any cause.', 'timeFrame': 'After surgery up to 3 years'}, {'measure': 'Incidence of Adverse Events (AEs)', 'description': ""Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)."", 'timeFrame': 'After surgery up to 13 months'}]" 262,NCT00379769,"{'fullName': 'GlaxoSmithKline', 'class': 'INDUSTRY'}",RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes,COMPLETED,"This study is a phase 3b, multicentre, randomised, open label, parallel group study. A 4-week run-in period will be followed by a median of 6 years of treatment with study medication in addition to continuation of background glucose lowering therapy. Patients inadequately controlled on background metformin will be randomised to receive, in addition to metformin, either rosiglitazone or a sulfonylurea(glibenclamide, gliclazide or glimepiride) in a ratio of 1:1. Patients inadequately controlled on background SU will be randomised to receive, in addition to SU, either rosiglitazone or metformin in a ratio of 1:1. Equal numbers of patients receiving background metformin and SU at entry will be entered into the study.","['Diabetes Mellitus, Type 2']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Rosiglitazone', 'description': 'Rosiglitazone maximum 8 mg per day', 'armGroupLabels': ['rosiglitazone in addition to background metformin', 'rosiglitazone in addition to background sulfonylurea']}, {'type': 'DRUG', 'name': 'Sulfonylurea', 'description': 'Sulfonylurea (SU) maximum permitted daily dose', 'armGroupLabels': ['Metformin in addition to background sulfonylurea', 'Sulfonylurea in addition to background metformin', 'rosiglitazone in addition to background sulfonylurea']}, {'type': 'DRUG', 'name': 'Metformin', 'description': 'Metformin maximum permitted daily dose .', 'armGroupLabels': ['Metformin in addition to background sulfonylurea', 'Sulfonylurea in addition to background metformin', 'rosiglitazone in addition to background metformin']}]","Inclusion Criteria: * Patients with type II diabetes mellitus as defined by 1999 World Health Organisation criteria. * Glycated haemoglobin (HbA1c) \>7.0 % to = 9.0 % at visit 1. * Use of an oral glucose lowering agent for a minimum of 6 months prior to screening and unchanged for 2 months prior to screening. * Body mass index \>25.0 kg/m2. Exclusion Criteria: * Patients receiving any other glucose lowering therapy which is not metformin or a sulfonylurea. * Patients with systolic blood pressure \>180 mmHg or diastolic blood pressure \>105 mmHg. * Patients who have required the use of insulin for glycaemic control at any time in the past. * Hospitalisation for any major cardiovascular event in the last 3 months.",NA,ALL,NA,"[{'measure': 'Number of Participants With Cardiovascular Death/Cardiovascular Hospitalisation Events', 'description': 'The number of participants with cardiovascular death events (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation events (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) was recorded.', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)'}, {'measure': 'Independent Re-adjudication Outcome: Number of Participants Who Died Due to Any Cause', 'description': 'All deaths identified during the original record study and discovered after the re-adjudication efforts began were included.', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)'}, {'measure': 'Independent Re-adjudication (IR) Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Original RECORD Endpoint Definitions', 'description': 'IR was based on original RECORD endpoint definitions. CV death= no unequivocal non-CV cause (sudden death, death from acute vascular events, heart failure, acute MI, other CV causes, and deaths adjudicated as unknown cause). MI event=hospitalization + elevation of specific cardiac biomarkers above the upper limit of normal + cardiac ischemia symptoms/new pathological electrocardiogram findings. Stroke event=hospitalization + rapidly developed clinical signs of focal/global disturbance of cerebral function for more than 24 hours, with no apparent cause other than a vascular origin.', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)'}, {'measure': 'Independent Re-adjudication Outcome: Number of Participants With a First Occurrence of a Major Adverse Cardiovascular Event (MACE) Defined as CV (or Unknown) Death, Non-fatal MI, and Non-fatal Stroke Based on Contemporary Endpoint Definitions', 'description': 'Independent re-adjudication was based on the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions. CV death included death resulting from an acute MI; sudden cardiac death and death due to heart failure, stroke, and to other CV causes. Deaths of unknown cause were counted as CV deaths. MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia. Stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)'}, {'measure': 'Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Original RECORD Endpoint Definitions', 'description': 'The number of participants with a CV death (or unknown) as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. CV death was defined as any death for which an unequivocal non-CV cause could not be established. CV death included death following heart failure, death following acute myocardial infarction (MI), sudden death, death due to acute vascular events, and other CV causes. Deaths due to unknown causes were classified as ""unknown deaths,"" but were counted as CV deaths for the analysis of this endpoint.', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)'}, {'measure': 'Independent Re-adjudication Outcome: Number of Participants With a CV (or Unknown) Death, Based on Contemporary Endpoint Definitions', 'description': 'The number of participants with a CV (or unknown) death as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. CV death included death resulting from an acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, and death due to other CV causes. Deaths of unknown cause were counted as CV deaths.', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)'}, {'measure': 'Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions', 'description': 'The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. An event of MI was defined as hospitalization plus elevation of cardiac biomarkers troponin (TN) I and/or TNT above the upper limit of normal (ULN) or creatinine kinase (CK) MB (M=muscle type; B=brain type) isoenzyme \\>= 2x the ULN or CK \\> 2x the ULN plus typical symptoms of cardiac ischemia or new pathological electrocardiogram findings, or cause of death adjudicated as MI.', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)'}, {'measure': 'Independent Re-adjudication Outcome: Number of Participants With an Event of Myocardial Infarction (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions', 'description': 'The number of participants with an MI (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of MI was defined as evidence of myocardial necrosis in a clinical setting consistent with myocardial ischemia.', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)'}, {'measure': 'Independent Re-adjudication Outcome: Number of Participants (Par.) With an Event of Stroke (Fatal and Non-fatal), Based on Original RECORD Endpoint Definitions', 'description': 'Par. with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the original RECORD endpoint definitions was recorded. A stroke event=hospitalization plus rapidly developed clinical signs of focal (or global) disturbance of cerebral function lasting more than 24 hours (unless interrupted by thrombolysis, surgery, or death), with no apparent cause other than a vascular origin, including par. presenting clinical signs/symptoms suggestive of subarachnoid haemorrhage/intracerebral haemorrhage/cerebral ischemic necrosis or cause of death adjudicated as stroke.', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)'}, {'measure': 'Independent Re-adjudication Outcome: Number of Participants With an Event of Stroke (Fatal and Non-fatal), Based on Contemporary Endpoint Definitions', 'description': 'The number of participants with a stroke (fatal or non-fatal) event as determined by independent re-adjudication using the Standard Data Collection for Cardiovascular Trials Initiative (draft October 2011) endpoint definitions was recorded. An event of stroke was defined as an acute episode of neurological dysfunction caused by focal or global brain, spinal cord, or retinal vascular injury.', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)'}]","[{'measure': 'Number of Participants With Cardiovascular Events and All-cause Deaths', 'description': 'Composites of participants with first cardiovascular (CV) hospitalisations and CV death or all-cause death and individual first events of acute myocardial infarction (MI) , stroke, congestive heart failure (CHF), CV death, and all-cause death.', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)'}, {'measure': 'Total Number of Cardiovascular Hospitalisations and Cardiovascular Deaths', 'description': 'The total number of events for individual components of cardiovascular (CV) hospitalisations and cardiovascular deaths were recorded. MI, myocardial infarction.', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)'}, {'measure': 'Number of Participants With First Cardiovascular Hospitalisations/Cardiovascular Deaths by Stratum', 'description': 'Participants with first cardiovascular death (death due to cardiovascular causes or deaths with insufficient information to rule out a cardiovascular cause) and cardiovascular hospitalisation (hospitalisation for a cardiovascular event, excluding planned admissions not associated with a worsening of the disease/condition of the participant) were recorded by study stratum.', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)'}, {'measure': 'Number of Participants With CV/Microvascular Events', 'description': 'The number of participants with first cardiovascular or microvascular events (renal, foot, eye) were recorded.', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)'}, {'measure': 'Number of Participants With Glycaemic Failure Events', 'description': 'Failure of glycaemic control was defined as two consecutive HbA1c values of ≥8.5 percent, or HbA1c ≥8.5percent at a single visit, after which the subject was either moved to the post-randomised treatment phase or triple therapy was started.', 'timeFrame': 'Baseline through to end of randomised dual therapy'}, {'measure': 'Number of Participants With Addition of Third Oral Agent/Switch to Insulin', 'description': 'The number of participants with addition of a third oral agent or switch to insulin from randomised dual combination treatment were recorded.', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)'}, {'measure': 'The Number of Participants Starting Insulin at Any Time During the Study', 'description': 'The number of participants starting insulin at any time during the study was recorded.', 'timeFrame': 'Baseline through End of Study (up to 7.5 years)'}, {'measure': 'Model Adjusted Change From Baseline in HbA1c at Month 60', 'description': 'Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in HbA1c was calculated as the value at Month 60 minus the Baseline value.', 'timeFrame': 'Baseline and Month 60 of randomised dual therapy treatment period'}, {'measure': 'Model Adjusted Change From Baseline in Fasting Plasma Glucose at Month 60', 'description': 'Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in fasting plasma glucose was calculated as the value at Month 60 minus the Baseline value.', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment period'}, {'measure': 'Model Adjusted Mean Change From Baseline in Insulin and Pro-insulin at Month 60', 'description': 'Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in insulin and pro-insulin was calculated as the value at Month 60 minus the Baseline value.', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment period'}, {'measure': 'Number of HbA1c and Fasting Plasma Glucose (FPG) Responders at Month 60', 'description': 'Number of responders, i.e., participants meeting glycaemic targets (HbA1c less than or equal to 7 percent, FPG less than or equal to 7 mmol/L)', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment period'}, {'measure': 'Model Adjusted Ratio to Baseline (Expressed as a Percentage) Homeostasis Model Assessment (HOMA) Beta Cell Function and Insulin Sensitivity at Month 60', 'description': 'The model adjusted (adjusted for any imbalances in the baseline \\[BL\\] values between within stratum treatment groups) ratio to BL in HOMA beta-cell function and insulin sensitivity was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\\*\\[GM\\^-1\\]).', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase'}, {'measure': 'Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC), Low-density Lipoprotein (LDL) Cholesterol, High-density Lipoprotein (HDL) Cholesterol, Triglycerides, and Free Fatty Acids (FFAs) at Month 60', 'description': 'The model adjusted (adjusted for any imbalances in the baseline \\[BL\\] values between within stratum treatment groups) ratio to BL in TC, LDL cholesterol, HDL cholesterol, triglycerides, and FFAs was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\\*\\[GM\\^-1\\]).', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase'}, {'measure': 'Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Total Cholesterol (TC):High-density Lipoprotein (HDL) Cholesterol and Low-density Lipoprotein (LDL) Cholesterol:HDL Cholesterol Ratios at Month 60', 'description': 'The model adjusted (adjusted for any imbalances in the baseline \\[BL\\] values between within stratum treatment groups) ratio to BL in TC:HDL cholesterol and LDL cholesterol:HDL cholesterol was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\\*\\[GM\\^-1\\]).', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment period'}, {'measure': 'Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Apolipoprotein B (Apo-B) at Month 60', 'description': 'The model adjusted (adjusted for any imbalances in the baseline \\[BL\\] values between within stratum treatment groups) ratio to BL in Apo-B was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\\*\\[GM\\^-1\\]).', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment period'}, {'measure': 'Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Urinary Albumin Creatinine Ratio at Month 60', 'description': 'The model adjusted (adjusted for any imbalances in the baseline \\[BL\\] values between within stratum treatment groups) ratio to BL in urinary albumin creatinine ratio was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\\*\\[GM\\^-1\\]).', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase'}, {'measure': 'Model Adjusted Change From Baseline in Body Weight at Month 60', 'description': 'Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in body weight was calculated as the value at Month 60 minus the Baseline value.', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase'}, {'measure': 'Model Adjusted Change From Baseline in Alanine Aminotransferase at Month 60', 'description': 'Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in alanine aminotransferase was calculated as the value at Month 60 minus the Baseline value.', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase'}, {'measure': 'Model Adjusted Change From Baseline in Waist Circumference at Month 60', 'description': 'Model adjusted (adjusted for any imbalances in the baseline values between within stratum treatment groups) change from baseline in waist circumference was calculated as the value at Month 60 minus the Baseline value.', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase'}, {'measure': 'Model Adjusted Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Month 60', 'description': 'Model adjusted (adjusted for any imbalances in the baseline values between within treatment groups) change from baseline in SBP and DBP was calculated as the value at Month 60 minus the Baseline value.', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase'}, {'measure': 'Model Adjusted Ratio to Baseline (Expressed as a Percentage) for C-Reactive Protein at Month 60', 'description': 'The model adjusted (adjusted for any imbalances in the baseline \\[BL\\] values between within stratum treatment groups) ratio to BL in C-Reactive Protein was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\\*\\[GM\\^-1\\]).', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase'}, {'measure': 'Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Fibrinogen at Month 60', 'description': 'The model adjusted (adjusted for any imbalances in the baseline \\[BL\\] values between within stratum treatment groups) ratio to BL in fibrinogen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\\*\\[GM\\^-1\\]).', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase'}, {'measure': 'Model Adjusted Ratio to Baseline (Expressed as a Percentage) for Plasminogen Activator Inhibitor-1 (PAI-1) Antigen at Month 60', 'description': 'The model adjusted (adjusted for any imbalances in the baseline \\[BL\\] values between within stratum treatment groups) ratio to BL in plasminogen activator inhibitor-1 (PAI-1) antigen was calculated as the ratio of the Month 60 value to the BL value and was expressed as percent change from BL. For each treatment group, the model-adjusted mean change from BL at Month 60 was determined on the log scale. This mean was then back transformed to give a geometric mean (GM) of the ratio of the Month 60 value to BL on the original scale. The GM was expressed as a percentage (100\\*\\[GM\\^-1\\]).', 'timeFrame': 'Baseline to Month 60 of the randomised dual therapy treatment phase'}, {'measure': 'Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Main Study + Observational Follow-up Combined', 'description': ""The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE."", 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)'}, {'measure': 'Number of Participants With the Indicated Type of Neoplasm/Cancer Event Reported as a Serious Adverse Event (SAE) or Death: Observational Follow-up', 'description': ""The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE."", 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)'}, {'measure': 'Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Main Study + Observational Follow-up Combined', 'description': 'The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.', 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)'}, {'measure': 'Number of Participants With the Indicated Type of Malignant Neoplasms/Cancer Events Reported as an SAE or Death by Location (Including Location of Special Interest): Observational Follow-up', 'description': 'The observational follow-up (OFU) was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. The neoplasms/cancer events of bladder, breast, colon, liver, pancreatic, prostate cancer, and melanoma were pre-specified as cancers of interest for the OFU. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.', 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)'}, {'measure': 'Number of Participants Who Died Due to the Indicated Cancer-related Event: Main Study + Observational Follow-up Combined', 'description': ""The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE."", 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)'}, {'measure': 'Number of Participants Who Died Due to the Indicated Cancer-related Event: Observational Follow-up', 'description': ""The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE."", 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)'}, {'measure': 'Number of Participants With a Bone Fracture Event - Overall and by Gender: Main Study and Observational Follow-up Combined', 'description': ""The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant."", 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)'}, {'measure': 'Number of Participants With a Bone Fracture Event - Overall and by Gender: Observational Follow-up', 'description': ""The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant."", 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)'}, {'measure': 'Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Main Study + Observational Follow-up Combined', 'description': 'The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.', 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)'}, {'measure': 'Number of Participants With a Bone Fracture Event Reported as the Indicated Serious Adverse Event (by Higher Level Group Term) or Death: Observational Follow-up', 'description': 'The OFU was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the OFU. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE.', 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)'}, {'measure': 'Number of Participants With an Event of Death Due to a Bone Fracture-related Event: Main Study + Observational Follow-up Combined', 'description': ""The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant."", 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)'}, {'measure': 'Number of Participants With the Indicated Bone Fracture by Fracture Site: Main Study + Observational Follow-up Combined', 'description': ""The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant."", 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)'}, {'measure': 'Number of Participants With the Indicated Bone Fracture by Fracture Site: Observational Follow-up', 'description': ""The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date that had the same Higher Level Group Term (HLGT) for fracture location, per participant."", 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)'}, {'measure': 'Number of Participants With Potentially High Morbidity Fractures: Main Study + Observational Follow-up Combined', 'description': ""The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown)."", 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)'}, {'measure': 'Number of Participants With Potentially High Morbidity Fracture Events and Non-high Morbidity Fracture Events, in Participants With Prior Hand/Upper Arm/Foot Fractures (H/UA/FF): Main Study + Observational Follow-up Combined', 'description': ""The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The following bone fractures were grouped and were identified as potentially high morbidity bone fractures: hip, pelvis, upper leg, vertebral (lumbar spine, thoracic spine, cervical spine, spine - site unknown)."", 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)'}, {'measure': 'Number of Participants With Bone Fracture Events of the Indicated Cause: Main Study + Observational Follow-up Combined', 'description': ""The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant."", 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)'}, {'measure': 'Number of Participants With Bone Fracture Events of the Indicated Cause: Observational Follow-up', 'description': 'The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator\'s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included ""Unknown"" as a category. Fracture events with missing outcome data were reported as ""Data unavailable.""', 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)'}, {'measure': 'Number of Bone Fracture Events With the Indicated Outcome: Main Study + Observational Follow-up Combined', 'description': 'The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator\'s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included ""Unknown"" as a category. Fracture events with missing outcome data were reported as ""Data unavailable.""', 'timeFrame': 'From the beginning of the main study through the end of the observational follow-up (up to 11.4 years)'}, {'measure': 'Number of Bone Fracture Events With the Indicated Outcome: Observational Follow-up', 'description': 'The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator\'s discretion. A bone fracture event is defined as one or more fractured bones occurring on the same date and that had the same Higher Level Group Term (HLGT) for fracture location, per participant. The indicated fracture outcome was pre-specified in the CRF and included ""Unknown"" as a category. Fracture events with missing outcome data were reported as ""Data unavailable.""', 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)'}, {'measure': 'Number of Participants With the Indicated Serious Adverse Event: Observational Follow-up', 'description': ""The observational follow-up was designed to collect data concerning cancer and bone fractures in RECORD participants during a 4-year period after the end of the main RECORD study. At the end of the main study, all study medication was stopped. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion. An SAE is defined as any event that is fatal; life threatening; disabling/incapacitating; results in hospitalization (excluding elective surgery or routine clinical procedures); prolongs a hospital stay; is associated with a congenital abnormality; cancer; is associated with an overdose. In addition, any event that the investigator regards as serious or that would suggest any significant hazard, contraindication, side effect, or precaution that may be associated with the study procedures should be reported as an SAE."", 'timeFrame': 'From the end of the RECORD study through the end of the observational follow-up (up to 4.0 years)'}]" 263,NCT05662202,"{'fullName': 'Biofrontera Inc.', 'class': 'INDUSTRY'}","Study to Evaluate the Safety, Tolerability and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis (AK) on the Extremities and Neck/Trunk With Photodynamic Therapy (PDT) Using a RhodoLED Lamp",COMPLETED,"The aim of this study is to test the safety. tolerability and efficacy of field-directed photodynamic therapy (PDT) with 10% aminolevulinic acid gel (Ameluz®, BF-200 ALA) in combination with one of the narrow spectrum red light RhodoLED lamps in comparison to vehicle treatment for actinic keratosis (AK) on the extremities and neck/trunk.",['Actinic Keratoses'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}","[{'type': 'COMBINATION_PRODUCT', 'name': 'BF-200 ALA and red light LED lamp', 'description': 'Up to two PDTs using a RhodoLED lamp (RhodoLED® XL or BF-RhodoLED®) (ALA-PDT, Ameluz®-PDT):\n\nTopical application of up to 3 tubes BF-200 ALA on the expanded treatment field (up to 240 cm²), followed by red light illumination with a RhodoLED lamp after 3 h incubation of study medication under occlusive dressing.\n\nPDT-1 will be performed at Visit 2. Clinical clearance will be assessed 12 weeks after PDT-1 (Visit 4). In case of remaining lesions at Visit 4, PDT-2 will be performed at the same visit.', 'armGroupLabels': ['BF-200 ALA']}, {'type': 'COMBINATION_PRODUCT', 'name': 'Vehicle and red light LED lamp', 'description': 'Up to two PDTs using a RhodoLED lamp (RhodoLED® XL or BF-RhodoLED®) (Vehicle-PDT):\n\nTopical application of up to 3 tubes vehicle on the expanded treatment field (up to 240 cm²), followed by red light illumination with a RhodoLED lamp after 3 h incubation of study medication under occlusive dressing.\n\nPDT-1 will be performed at Visit 2. Clinical clearance will be assessed 12 weeks after PDT-1 (Visit 4). In case of remaining lesions at Visit 4, PDT-2 will be performed at the same visit.', 'armGroupLabels': ['Vehicle']}]","Inclusion Criteria: 1. Willingness and ability of subjects to provide informed consent and sign the Health Insurance Portability and Accountability Act (HIPAA) form. A study-specific informed consent and HIPAA form must be obtained in writing prior to starting any study procedures. 2. 4 - 15 mild to moderate clinically confirmed AK lesions according to Olsen either on the extremities or on the neck/trunk with a diameter of ≥ 4 mm that must be present in the treatment field (defined as AK target lesions). In addition, non-target AK lesions may be present in the treatment field, including up to two severe AK lesions ≥ 4 mm. For each severe AK lesion (≥ 4 mm), a biopsy must be taken for confirmation of diagnosis. The treatment field (continuous or in several patches) totaling approx. either 80 cm², 160 cm² or 240 cm2 must be within one effective illumination area of the BF-RhodoLED® XL but may require up to three illuminations with the BF-RhodoLED®. All AK target lesions and, if applicable, severe AK lesions ≥ 4 mm located in the treatment field should be clearly distinguishable, without restrictions on the distance between lesions, and should have a minimal distance of 1 cm to the border of the treatment field. 3. All sexes, ≥ 18 years of age. 4. Willingness to undergo a 2 mm punch biopsy for each (up to two) severe AK lesion ≥ 4 mm, if applicable, at the screening visit. 5. Willingness and ability to comply with study procedures, particularly willingness to receive up to 2 PDTs within approximately 12 weeks. 6. Subjects with good general health or with clinically stable medical conditions will be permitted to be included in the study. 7. Willingness to stop the use of moisturizers and any other non-medical topical treatments within the treatment field at least 24 h prior to the next clinical visit. 8. Acceptance to abstain from extensive sunbathing and the use of a solarium or tanning beds during the treatment phase. 9. For female subjects with reproductive potential: Negative serum pregnancy test. 10. For female subjects with reproductive potential: Effective contraception at screening visit and throughout the treatment phase of the study (until Visit 4 or Visit 6). Exclusion Criteria: 1. Any known history of hypersensitivity to ALA, porphyrins, or excipients of BF-200 ALA. 2. History of soy or peanut allergy. 3. Sunburn or other possible confounding skin conditions (e.g., wounds, irritations, bleeding, or skin infections) inside or in close proximity (\< 2 cm distance) to the treatment field. 4. Clinically significant (cs) medical conditions making implementation of the protocol or interpretation of the study results difficult or impairing subject's safety such as: 1. Presence of photodermatoses or porphyria 2. Metastatic tumor or tumor with high probability of metastasis 3. Infiltrating skin neoplasia (suspected or known) 4. Unstable cardiovascular disease (New York Heart Association class III, IV) 5. Unstable hematologic (including myelodysplastic syndrome), hepatic, renal, neurologic, or endocrine condition 6. Unstable collagen-vascular condition 7. Unstable gastrointestinal condition 8. Immunosuppressive condition 9. Presence of clinically significant inherited or acquired coagulation defect 5. Clinical diagnosis of atopic dermatitis, Bowen´s disease (BD), basal cell carcinoma (BCC), eczema, psoriasis, rosacea, squamous cell carcinoma (SCC), other malignant or benign tumors inside or in close proximity (\< 2 cm distance) to the treatment field. 6. Presence of strong artificial pigmentation (e.g., tattoos) or any other abnormality that may impact lesion assessment or light penetration in the treatment field. 7. Any physical therapy such as cryotherapy, laser therapy, electrodessication, microdermabrasion, surgical removal of lesions, curettage, or treatment with chemical peels such as trichloroacetic acid inside or in close proximity (\< 10 cm distance) to the treatment field within 4 weeks prior to screening. 8. Any of the topical treatments defined below within the designated periods prior to screening: 1. Topical treatment with ALA or ALA esters (e.g., methyl aminolevulinic acid (MAL)) inside the treatment field within 3 months. 2. Topical treatment with immunomodulatory, cytostatic, or cytotoxic drugs inside or in close proximity (\< 10 cm distance) to the treatment field within 3 months. 3. Start of topical administration of a medication with hypericin or other drugs with phototoxic or photoallergic potential inside or in close proximity (\< 10 cm distance) to the treatment field within 4 weeks. Subjects may, however, be eligible if such medication was applied for more than 4 weeks prior to screening without evidence of an actual phototoxic/photoallergic reaction. 9. Any use of the systemic treatments within the designated periods prior to screening: 1. Cytostatic or cytotoxic drugs within 6 months. 2. Immunosuppressive therapies or ALA or ALA esters (e.g., MAL) within 12 weeks. 3. Drugs known to have major organ toxicity within 8 weeks. 4. Interferon or glucocorticosteroids within 6 weeks. 5. Start of intake of medication with hypericin or drugs with phototoxic or photoallergic potential within 8 weeks prior to screening. Subjects may, however, be eligible if such medication was taken in for more than 8 weeks prior to the screening visit without evidence of an actual phototoxic/photoallergic reaction. 10. Breast feeding women. 11. Suspicion of drug or alcohol abuse. 12. Subjects unlikely to comply with protocol, e.g., inability to return for visits, unlikely to complete the study, or inappropriate in the opinion of the investigator. 13. A member of study site staff or sponsor staff directly involved in the conduct of the protocol or a close relative thereof. 14. Receipt of any investigational drug or medical product within 8 weeks before screening or simultaneous participation in another clinical study. Reassessment of subjects is allowed once in case exclusion criterion 3 is met and eligibility can be achieved within 4 weeks. Reassessment can be done on the day of the actual treatment. Dosing day exclusion criteria: At Visit 2 (baseline, PDT-1) Subjects with sunburn or other possibly confounding skin conditions (e.g., wounds, irritations, bleeding, or skin infections) inside or in close proximity (\< 2 cm distance) to the treatment field. Reassessment of subjects is allowed once if the sunburn or other confounding skin conditions is/are expected to resolve within 2 weeks. At Visit 4 (PDT-2) Subjects with sunburn or other possibly confounding skin conditions (e.g., wounds, irritations, bleeding, or skin infections) inside or in close proximity (\< 2 cm distance) to the treatment field. Rescheduling of PDT-2 can be performed once at the earliest possibility after resolution, but rescheduling should not exceed 2 weeks.",NA,ALL,NA,"[{'measure': 'Overall subject complete response rate', 'description': 'Percentage of subjects with all AK target lesions clinically cleared after last PDT', 'timeFrame': '12 weeks after the last PDT (Visit 4 or Visit 6)'}]","[{'measure': 'Overall subject complete response rate for subjects with lesions treated on extremities', 'description': 'Percentage of subjects with all AK target lesions on extremities clinically cleared after last PDT', 'timeFrame': '12 weeks after the last PDT (Visit 4 or Visit 6)'}, {'measure': 'Overall subject complete response rate for subjects with lesions treated on neck/trunk', 'description': 'Percentage of subjects with all AK target lesions on neck/trunk clinically cleared after last PDT', 'timeFrame': '12 weeks after the last PDT (Visit 4 or Visit 6)'}, {'measure': 'Lesion complete response rate', 'description': 'Percentage of clinically cleared individual AK target lesions in relation to total number of AK target lesions at baseline (Visit 2) after the last PDT, overall and stratified by treatment area and AK severity at baseline (according to Olsen)', 'timeFrame': '12 weeks after the last PDT (Visit 4 or Visit 6)'}, {'measure': 'Complete response rate for severe lesions', 'description': 'Percentage of clinically cleared individual severe AK lesions in relation to total number of severe AK lesions at baseline (according to Olsen; Visit 2) after the last PDT, overall and stratified by treatment area', 'timeFrame': '12 weeks after the last PDT (Visit 4 or Visit 6)'}, {'measure': 'Subject complete response rate after PDT-1', 'description': 'Percentage of subjects with all AK target lesions clinically cleared after PDT-1, overall and stratified by AK baseline parameters', 'timeFrame': '12 weeks after PDT-1 (Visit 4)'}, {'measure': 'Lesion complete response rate after PDT-1', 'description': 'Percentage of clinically cleared individual AK target lesions in relation to total number of AK target lesions at baseline (Visit 2) after PDT-1, overall and stratified by treatment area and AK severity at baseline (according to Olsen \\[mild, moderate, severe\\])', 'timeFrame': '12 weeks after PDT-1 (Visit 4)'}, {'measure': 'Complete response rate for severe lesions after PDT-1', 'description': 'Percentage of clinically cleared individual severe AK lesions in relation to total number of severe AK lesions at baseline (according to Olsen \\[mild, moderate, severe\\]; Visit 2) after PDT-1, overall and stratified by treatment area', 'timeFrame': '12 weeks after PDT-1 (Visit 4)'}, {'measure': 'Esthetic appearance at the end of treatment phase assessed by the investigator', 'description': 'The esthetic appearance after the last PDT as assessed by the investigator as assessed by the subject according to a 4-point scale ranging from 0 (=very good) to 3 (=unsatisfactory); overall and stratified by treatment area', 'timeFrame': 'On final visit of the treatment phase, 12 weeks after the last PDT (Visit 4 or Visit 6)'}, {'measure': 'Esthetic outcome at the end of treatment phase assessed by the subject', 'description': 'The esthetic outcome after the last PDT as assessed by the subject according to a 4-point scale ranging from 0 (=very good) to 3 (=unsatisfactory); overall and stratified by treatment area', 'timeFrame': 'On final visit of the treatment phase, 12 weeks after the last PDT (Visit 4 or Visit 6)'}, {'measure': 'Satisfaction with PDT at the end of treatment phase', 'description': 'Satisfaction with PDT treatment after the last PDT as assessed by the subject via questionnaire, 1. if they would chose PDT treatment in the future in case of recurrence or similar disease (yes/no) and 2. how they would rate the PDT treatment in comparison to other treatment modalities, if applicable (better than/ similar/ worse). The treatment modalities should be documented, if applicable); overall and stratified by treatment area', 'timeFrame': 'On final visit of the treatment phase, 12 weeks after the last PDT (Visit 4 or Visit 6)'}, {'measure': 'Frequency and extent of adverse events (AEs), AEs of Special Interest (AESIs), serious AEs (SAEs) and treatment-emergent AEs (TEAEs) during treatment phase', 'description': 'Frequency and extent of AEs, AESIs, SAEs, and TEAEs, overall and stratified by demographics, skin type class (I-III and IV-VI), size of the treatment field, and treatment area.\n\nTEAEs (including application site skin reactions and discomfort) are defined as all AEs with onset or worsening after treatment with IMP.', 'timeFrame': 'Entire study duration, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)'}, {'measure': 'New lesions inside the treatment field during treatment phase', 'description': ""New lesions: AK, non-melanoma skin cancer \\[NMSC, including Basal Cell Carcinoma (BCC), Squamous Cell Carcinoma (SCC) or Bowen's Disease (BD)\\] or melanoma"", 'timeFrame': 'All clinical visits throughout entire study duration, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)'}, {'measure': 'Assessment of application site reactions', 'description': 'Application site reactions (bleeding, burning, discharge, edema, erosion, erythema, exfoliation, hyperalgesia, induration, irritation, paraesthesia, pruritus, pustules, scabbing, or vesicles) will be assessed on a 4-point scale: grade 0 = none, grade 1 = mild, grade 2 = moderate, grade 3 = severe.', 'timeFrame': 'All visits (except screening, Visit 1) throughout entire study duration, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)'}, {'measure': 'Application site pain during illumination', 'description': 'Reported by the subjects assessed on an 11-point numeric rating scale ranging from 0 (no pain) to 10 (worst imaginable pain); overall and stratified by size of the treatment field and treatment area', 'timeFrame': 'During treatment (illumination) on treatment day for PDT-1 (Visit 2, up to 4 weeks after screening) and during treatment (illumination) on treatment day for PDT-2 (Visit 4; if applicable; 12 weeks after PDT-1)'}, {'measure': 'Number of patients with significant changes of vital signs', 'description': 'Number of patients with changes in blood pressure (systolic and diastolic) \\[mmHg\\] and changes in pulse rate \\[beats/min\\]. Findings which differ from reference range and are considered to be clinically significant are to be reported.', 'timeFrame': 'All clinical visits throughout entire study duration, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)'}, {'measure': 'Number of patients with significant changes in safety laboratory', 'description': 'Changes in clinical chemistry, in hematology and urinalysis parameters as defined in the protocol. Findings which differ from reference range and are considered to be clinically significant are to be reported.', 'timeFrame': 'All clinical visits throughout entire study duration, approx. 16 weeks for subjects requiring 1 PDT (until Visit 4) and approx. 28 weeks for subjects with 2 PDTs (until Visit 6)'}, {'measure': 'Number of patients with abnormal findings in physical examination', 'description': 'Physical examination of head, neck, skin, lymph nodes, thorax including heart and lungs, abdomen, and musculoskeletal, peripheral vascular and nervous system status will be performed. Abnormal findings, considered to be clinically significant, are to be reported.', 'timeFrame': 'At screening (up to 4 weeks before treatment) and 12 weeks after the last PDT (Visit 4 or Visit 6)'}]" 264,NCT06546553,"{'fullName': 'Pfizer', 'class': 'INDUSTRY'}",A Study to Learn About How Different Amounts of the Study Medicine PF-07826390 Act in the Body of People With Cancer When Taken Alone or With Other Anti-cancer Medicines.,TERMINATED,"The purpose of this study is to learn about the: * safety (the effect of the study medicine on the participant's body), * effects of the study medicine alone or in combination with sasanlimab - * the best amount of the study medicine. This study is seeking participants who have solid tumors (An abnormal mass of tissue) that: * have advanced (cancer that does not disappear or stay away with treatment) or * are metastatic (has spread to other parts of the body). This includes (but limited to) the following cancer types: * Non-Small Cell Lung Cancer (NSCLC): It's a type of lung cancer where the cells grow slowly but often spread to other parts of the body. * Colorectal Cancer (CRC): This is a disease where cells in the colon or rectum grow out of control. * Renal Cell Carcinoma (RCC): This is a cancer that starts in the kidney. All participants in this study will receive the study medication (PF-07826390) as an IV infusion (given directly into a vein) at the study once every four weeks in 28 day cycles. The study participants depending on the group enrolled in, will receive the study medication (PF-07826390 alone or in combination with other anti-cancer medications (sasanlimab). Sasanlimab is given as a shot under the skin every 4 weeks. Participants can continue to take the study medication (PF-07826390) until their cancer is no longer responding. Participants who are taking sasanlimab may receive it for up to 2 years. The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and effective. Participants will be involved in this study for up to 4 years. During this time, participants will have a study visit every week. The participants after stopping the study medicine (at about 2 years) will be followed for another two years to see how the participants are doing.","['Neoplasms', 'Non-small-cell Lung Cancer', 'Squamous Cell Carcinoma of the Head and Neck', 'Renal Cell Carcinoma', 'Colorectal Carcinoma', 'Ovarian Carcinoma']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'PF-07826390', 'description': 'PF-07826390 is a novel, fully humanized bispecific IgG1 that targets the leukocyte immunoglobulin-like receptor, LILRB1 and LILRB2 (B1 and B2) cell-surface receptors', 'armGroupLabels': ['Part 1A: PF-07826390 Monotherapy', 'Part 1B: PF-07826390 + sasanlimab', 'Part 2A (Arm 1): PF-07826390 + sasanlimab', 'Part 2A (Arm 2): PF-07826390 + sasanlimab', 'Part 2A (Arm 3): PF-07826390 + sasanlimab', 'Part 2B: PF-07826390', 'Part 2C: PF-07826390 + SOC'], 'otherNames': ['LILRB1/2']}, {'type': 'BIOLOGICAL', 'name': 'sasanlimab', 'description': 'A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/L2', 'armGroupLabels': ['Part 1B: PF-07826390 + sasanlimab', 'Part 2A (Arm 1): PF-07826390 + sasanlimab', 'Part 2A (Arm 2): PF-07826390 + sasanlimab', 'Part 2A (Arm 3): PF-07826390 + sasanlimab'], 'otherNames': ['PF-06801591']}, {'type': 'OTHER', 'name': 'SOC (anti-PD-1 + platinum -based chemo)', 'description': 'Standard of Care (anti-PD-1 + platinum -based chemo)', 'armGroupLabels': ['Part 2C: PF-07826390 + SOC']}]","Inclusion Criteria: * Histological or cytological diagnosis of advanced, unresectable, and/or metastatic or relapsed/refractory solid tumor * Part 1A: Participants with solid tumors where anti-PD-(L)1 is an established treatment. Participants must have progressed on or following prior anti-PD-(L)1 therapy if approved, available, tolerable, and eligible * Part 1B: Participants either meeting Part 1A criterion, or participants with ""cold"" solid tumors where anti-PD-(L)1 therapy is not an established treatment * Part 2: Participants with NSCLC (2A Arm 1 and 2B) must have received platinum-based chemotherapy and anti-PD-(L)1 or have intolerability to or refusal of standard therapies. Participants with NSCLC who have not been previously treated with a prior anti-pd-(L) will be enrolled in Part 2C. * Participants with MSS CRC (Part 2A Arm 2) must have received fluoropyrimidine-, oxaliplatin, and irinotecan-based chemotherapy, an anti-VEGF agent and anti-EGFR inhibitor (if RAS wildtype) and/or other molecularly targeted therapy if appropriate. Participants with RCC (Part 2A Arm 3) must have received prior tyrosine kinase inhibitor (TKI), anti-PD-(L)1 (if not receiving anti-PD-1 on protocol), anti-CTLA-4 (optional), hypoxia-inducible factor 2 alpha (HIF2a) inhibitor, or mTOR inhibitor or have documented intolerance to the standard therapy. * At least 1 measurable lesion based on RECIST 1.1 that has not been previously irradiated (Part 1 exceptions permitted after review and approval) * Able to provide pre-treatment (and optional on-treatment) tumor tissue Exclusion Criteria: * Treatment with any systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to planned first dose * Active or history of clinically significant autoimmune disease or other medical condition that required chronic systemic immunosuppressive therapy within recent 2 years * Prior treatment with another LILRB1 (ILT2), LILRB2 (ILT4), and/or LILRB1/2 (B1 and B2) antagonist antibodies or pathway targeting agents, including HLA conformers and HLA-G antibodies. * Lack of adequate organ (bone marrow, renal, liver) function * History of severe immune-mediated adverse event or cytokine release syndrome that was considered related to prior immune modulatory therapy that required immunosuppressive therapy",NA,ALL,NA,"[{'measure': 'PART 1: Number of participants with Dose-limiting toxicities (DLT)', 'description': 'Any of the prespecified AEs that are attributable to one, the other, or both study treatments, occurring in the DLT observation period are considered DLTs, excluding toxicities clearly due to underlying disease or extraneous causes.', 'timeFrame': 'First cycle, Day 1 up to Day 28'}, {'measure': 'PART 1 & 2: Incidence of Adverse Events (AE)s', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship to it. SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. AEs included both serious and all non-serious AEs.', 'timeFrame': 'From start of the treatment and up to 90 days after last dose or start of new anticancer therapy, whichever occurred first.'}, {'measure': 'PART 1 & 2: Number of participants with laboratory abnormalities', 'description': 'Number of participants with laboratory test abnormalities. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy).', 'timeFrame': 'From start of the treatment and up to 90 days after last dose or start of new anticancer therapy, whichever occurred first.'}, {'measure': 'Part 2: Objective Response - Number of Participants With Objective Response', 'description': 'Percentage of participants with objective response-based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by the Investigator.', 'timeFrame': 'Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years.'}]","[{'measure': 'Objective Response - Number of Participants with Objective Response', 'description': 'Percentage of participants with objective response-based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) assessed by the Investigator', 'timeFrame': 'Baseline and every 8 to 12 weeks through time of confirmed disease progression, death, unacceptable toxicity, or through study completion, approximately 2 years'}, {'measure': 'Time to event endpoints: duration of response (DOR) by RECIST v1.1', 'description': 'Time to event: DOR according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as assessed by the Investigator.', 'timeFrame': 'Baseline to confirmed disease progression, up to 2 years after the last dose of study treatment'}, {'measure': 'Time to event endpoints: progression-free survival (PFS) by RECIST v1.1', 'description': 'Time to event: PFS according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) as assessed by the Investigator.', 'timeFrame': 'Baseline to confirmed disease progression, up to 2 years after the last dose of study treatment'}, {'measure': 'Part 1: Maximum Observed Serum Concentration (Cmax)', 'description': 'Cycle 1: Pre-dose, 1, 4, 8, 24, 48, 168, 336 and 504 hours post dose. Cycle 2: Pre-dose and 336 hours post dose. Cycle 3: Pre-dose, 1, 4, 24, 168 and 336 hours post dose. Cycle 3 and beyond Pre-dose only.', 'timeFrame': 'Cycle 1 Day 1, 2, 3, 8, 15 and 22; Cycle 2 Day 1 and 15; Cycle 3+ Day 1 (each cycle is 28 days)'}, {'measure': 'Part 1: Time to Reach Maximum Serum Concentration (Tmax) of PF-07826390', 'description': 'Cycle 1: Pre-dose, 1, 4, 8, 24, 48, 168, 336 and 504 hours post dose. Cycle 2: Pre-dose and 336 hours post dose. Cycle 3: Pre-dose, 1, 4, 24, 168 and 336 hours post dose. Cycle 3 and beyond Pre-dose only.', 'timeFrame': 'Cycle 1 Day 1, 2, 3, 8, 15 and 22; Cycle 2 Day 1 and 15; Cycle 3+ Day 1 (each cycle is 28 days)'}, {'measure': 'Part 1: Serum Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-07826390', 'description': 'Cycle 1: Pre-dose, 1, 4, 8, 24, 48, 168, 336 and 504 hours post dose. Cycle 2: Pre-dose and 336 hours post dose. Cycle 3: Pre-dose, 1, 4, 24, 168 and 336 hours post dose. Cycle 3 and beyond Pre-dose only.', 'timeFrame': 'Cycle 1 Day 1, 2, 3, 8, 15 and 22; Cycle 2 Day 1 and 15; Cycle 3+ Day 1 (each cycle is 28 days)'}, {'measure': 'Part 1: Serum Area Under the Curve From Time Zero to Last Time Zero to clearance (CL/F) of PF-07826390', 'description': 'Cycle 1: Pre-dose, 1, 4, 8, 24, 48, 168, 336 and 504 hours post dose. Cycle 2: Pre-dose and 336 hours post dose. Cycle 3: Pre-dose, 1, 4, 24, 168 and 336 hours post dose. Cycle 3 and beyond Pre-dose only.', 'timeFrame': 'Cycle 1 Day 1, 2, 3, 8, 15 and 22; Cycle 2 Day 1 and 15; Cycle 3+ Day 1 (each cycle is 28 days)'}, {'measure': 'Part 1: Serum under the curve apparent volume of distribution during terminal phase (Vz/F) of PF-07826390', 'description': 'Cycle 1: Pre-dose, 1, 4, 8, 24, 48, 168, 336 and 504 hours post dose. Cycle 2: Pre-dose and 336 hours post dose. Cycle 3: Pre-dose, 1, 4, 24, 168 and 336 hours post dose. Cycle 3 and beyond Pre-dose only.', 'timeFrame': 'Cycle 1 Day 1, 2, 3, 8, 15 and 22; Cycle 2 Day 1 and 15; Cycle 3+ Day 1 (each cycle is 28 days)'}, {'measure': 'Part 1: Serum under the curve terminal elimination half life (T ½) of PF-07826390', 'description': 'Cycle 1: Pre-dose, 1, 4, 8, 24, 48, 168, 336 and 504 hours post dose. Cycle 2: Pre-dose and 336 hours post dose. Cycle 3: Pre-dose, 1, 4, 24, 168 and 336 hours post dose. Cycle 3 and beyond Pre-dose only.', 'timeFrame': 'Cycle 1 Day 1, 2, 3, 8, 15 and 22; Cycle 2 Day 1 and 15; Cycle 3+ Day 1 (each cycle is 28 days)'}, {'measure': 'Part 1 and Part 2: Serum Concentrations of PF-07826390 in combination (Part 1B, 2A and 2C)', 'description': 'Day 1 (all cycles) and EOT.', 'timeFrame': 'Prior to dosing at Cycle 1+ Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)'}, {'measure': 'Part 1 and Part 2: Incidence and titers of antidrug antibodies (ADA) against PF-07826390', 'description': 'Day 1 (all cycles) and end of treatment', 'timeFrame': 'Prior to dosing at Cycle 1+ Day 1 up to end of study treatment, approximately 2 years (each cycle is 28 days)'}, {'measure': 'Part 1 and Part 2: Paried Tumor Biopsies', 'description': 'Pre-dose and C2 Day 15', 'timeFrame': 'Baseline through Cycle 2 Day 15 (each cycle is 28 days)'}, {'measure': 'Part 2: Time to Reach Maximum Serum Concentration (Tmax) of PF-07826390', 'description': 'Cycle 1, 2 and 3: Pre-dose, 1, 24, and 336 hours post dose. Cycle 4 and beyond Pre-dose only.', 'timeFrame': 'Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)'}, {'measure': 'Part 2: Maximum Observed Serum Concentration (Cmax) of PF-07826390', 'description': 'Cycle 1, 2 and 3: Pre-dose, 1, 24, and 336 hours post dose. Cycle 4 and beyond Pre-dose only.', 'timeFrame': 'Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)'}, {'measure': 'Part 1: Pharmacodynamic blood samples: Receptor occupancy', 'description': 'Cycle 1: Pre-dose, 48, 168 and 336 hours post dose. Cycle 2: Pre-dose and 336 hours post dose. Cycle 3 and beyond pre-dose only.', 'timeFrame': 'Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)'}, {'measure': 'Part 2: Pharmacodynamic blood samples Receptor Occupancy', 'description': 'Cycle 1: Pre-dose, 24 and 336 hours post dose, Cycle 2: Pre-dose, 24 and 336 hours post dose. Cycle 3 and beyond pre-dose only.', 'timeFrame': 'Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)'}, {'measure': 'Part 2: Serum Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-07826390', 'description': 'Cycle 1, Cycle 2 and Cycle 3: Pre-dose, 1, 24 and 336 hours post dose.', 'timeFrame': 'Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)'}, {'measure': 'Part 2: Serum Area Under the Curve From Time Zero to clearance (CL/F) of PF-07826390', 'description': 'Cycle 1, Cycle 2 and Cycle 3: Pre-dose, 1, 24 and 336 hours post dose.', 'timeFrame': 'Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)'}, {'measure': 'Part 2: Serum under the curve apparent volume of distribution during terminal phase (Vz/F) of PF-07826390', 'description': 'Cycle 1, Cycle 2 and Cycle 3: Pre-dose, 1, 24 and 336 hours post dose.', 'timeFrame': 'Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)'}, {'measure': 'Part 2: Serum under the curve terminal elimination half life (T ½) of PF-07826390', 'description': 'Cycle 1, Cycle 2 and Cycle 3: Pre-dose, 1, 24 and 336 hours post dose.', 'timeFrame': 'Cycle 1 Day 1 until last dose of study treatment, approximately 2 years (each cycle is 28 days)'}]" 265,NCT01274533,"{'fullName': 'Columbia University', 'class': 'OTHER'}",Lenalidomide in HTLV-1 Adult T-Cell Leukemia,COMPLETED,"This is a research study for subjects who have been diagnosed with Adult T cell Leukemia/Lymphoma, a rare and aggressive peripheral T cell neoplasm caused by the virus HTLV1. Currently, there is no accepted standard therapy for this disease. The purpose of this research study is to evaluate the use of the investigational drug lenalidomide in the treatment of Adult T cell Leukemia/Lymphoma. Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental.",['Adult T Cell Leukemia/Lymphoma'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Lenalidomide', 'description': '25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle', 'armGroupLabels': ['Lenalidomide'], 'otherNames': ['Revlimid']}]","Inclusion Criteria: * Age ≥18 years at the time of signing the informed consent form. * Able to adhere to the study visit schedule and other protocol requirements. * Relapsed or refractory HTLV-1 associated Adult T-cell Leukemia/Lymphoma (Acute and lymphoma subtypes) * All previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study. * ECOG performance status of ≤ 2 at study entry (see Appendix C). * Laboratory test results within these ranges: * Absolute neutrophil count ≥ 1000/mm³ * Platelet count ≥ 50,000 /mm³ * Calculated creatinine clearance of ≥ 30 mL/min by Cockcroft-Gault formula (Appendix J). Patients with calculated creatinine clearance ≥ 30 mL/min and \< 60 mL/min will have a reduced starting dose of lenalidomide (see Section 5.4.2). * Total bilirubin ≤ 1.5 x ULN * AST (SGOT) and ALT (SGPT) ≤ 3 x ULN. * Disease free of prior malignancies for ≥ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma ""insitu"" of the cervix or breast. * Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days prior to and again within 24 hours of starting lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. See Appendix A: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods, AND also Appendix B: Education and Counseling Guidance Document. * Patients at high risk for DVT/PE must be able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low molecular weight heparin). Exclusion Criteria: * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. * Pregnant or breast feeding females. (Lactating females must agree not to breast feed while taking lenalidomide). * Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. * Evidence of laboratory TLS by Cairo-Bishop Definition of Tumor Lysis Syndrome (see Appendix H). Subjects may be enrolled upon correction of electrolyte abnormalities. * Use of any other experimental drug or therapy within 28 days of baseline. * Known hypersensitivity to thalidomide. * The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs. * Any prior use of lenalidomide. * Concurrent use of other anti-cancer agents or treatments. * Known positive for HIV or infectious hepatitis, type B or C. * Recent DVT/PE requiring dose adjustments of anticoagulation within past 90 days",NA,ALL,NA,"[{'measure': 'Response Rate (CR + Cru + PR)', 'description': 'Peripheral blood, CT or MRI', 'timeFrame': '28 days'}]","[{'measure': 'Safety of Lenalidomide Monotherapy', 'timeFrame': '28 days'}]" 266,NCT02405338,"{'fullName': 'Medigene AG', 'class': 'INDUSTRY'}",DC Vaccination for Post-remission Therapy in AML,COMPLETED,"This is a multi-centre, open label, prospective, non-randomized phase I/II trial in 20 patients including a safety-run in phase I part comprising 6 patients. Trial subjects will receive repeated immunotherapies with autologous Dendritic Cells (DCs), presenting two leukemia-associated antigens.",['Acute Myeloid Leukemia'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'WT1/PRAME vaccination', 'armGroupLabels': ['WT1/PRAME vaccination']}]","Inclusion Criteria: * Diagnosis of Acute Myeloid Leukemia (AML) * Age 18 - 75 years * Morphologic remission (CR) with or without hematological recovery (CRi) following induction chemotherapy * WT1 with or without PRAME positivity by qPCR * Negative pregnancy test in women of childbearing potential (within 7 days before the first vaccination). Women of childbearing potential and sexually active male participants must use reliable methods of contraception during the whole treatment period and 3 months after the last trial drug dose * Negative HIV 1 and 2 test, Hepatitis B and C test and negative Syphilis test at screening * Informed consent signed prior to any trial related activities Exclusion Criteria: * Patients suitable for allogeneic stem cell transplantation * AML M3 (acute promyelocytic leukemia) * Patients not in complete remission (CR or CRi), bone marrow blast count ≥ 5 % * Active immunodeficiency syndromes * Concurrent active second malignancy other than non-melanoma skin cancers * Clinically relevant autoimmune disease * Prior immunotherapy * Severe organ dysfunction precluding the apheresis procedure: * Creatinine \> 200 mmol/l * Bilirubin, ALAT and ASAT \> 3 x upper normal limit * Respiratory insufficiency with pO2 \< 60 mmHg * Clinically relevant coronary heart disease of ventricular arrhythmia, congestive heart failure \> grade II NYHA * Recent cerebral hemorrhage * Known allergies to substances used in the generation of DCs * Other severe acute or chronic medical psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or the administration of the investigational product * Use of corticosteroids * Active CMV infection (Antibody-positivity due to previous, now inactive infection is accepted) * Inability to comply with the trial protocol * Participation in other clinical trials that, according to the investigator's discretion, may interfere with this trial",NA,ALL,NA,"[{'measure': 'Percentage of patients in whom treatment with the scheduled number of immunotherapies is feasible', 'timeFrame': '2 years'}, {'measure': 'Percentage of grade I/II, grade III/IV and grade ≥III toxicities in patients having received at least 1 immunotherapy', 'timeFrame': '2 years'}]","[{'measure': 'Overall survival', 'timeFrame': '2 years'}, {'measure': 'Relapse/Progression free survival', 'timeFrame': '2 years'}, {'measure': 'Time to progression (TTP).', 'timeFrame': '2 years'}, {'measure': 'Control of minimal residual disease (MRD)', 'timeFrame': '2 years'}, {'measure': 'ECOG performance status', 'timeFrame': '2 years'}, {'measure': 'Cellular immune responses to applied antigens', 'timeFrame': '2 years'}]" 267,NCT06160115,"{'fullName': 'Assiut University', 'class': 'OTHER'}",The Role of NK Cells to Detect Blood Infection in ALL.,UNKNOWN,"1. Assess possibility of prediction of blood stream infections in ALL patients by profiling of NK cells using flow cytometry. 2. Assess the role of NK cells in development of drug resistance post chemotherapy.","['Acute Lymphoblastic Leukemia', 'Bloodstream Infection']",OBSERVATIONAL,"{'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'DEVICE', 'name': 'Flow cytometry', 'description': '1. Profiling of NK cells using flow cytometry on peripheral blood and bone marrow aspirate samples.\n2. Isolation and identification of pathogens causing BSI and bacterial drug susceptibility testing using VITEK compact fully automatic microbial identification instrument.', 'otherNames': ['Microbial identification instrument']}]","Inclusion Criteria: * Patients aged less than 17 years diagnosed as Acute Lymphoblastic Leukemia and on chemotherapy, who are positive for blood stream infection. Exclusion Criteria: 1. Patients over 17 years of age. 2. Presence of other hematological malignancies or history of other malignancies.",Primary care clinic.,ALL,PROBABILITY_SAMPLE,"[{'measure': 'Number of participants who test positive for bloodstream infection and NK cells profile', 'description': 'Assess the number of participants who are positive for bloodstream infection in microbial identification instrument, then comparison of Flow cytometry results for CD16 and CD56 to identify role of NK cells.', 'timeFrame': 'Baseline'}]",NA 268,NCT07469592,"{'fullName': 'University of Miami', 'class': 'OTHER'}",eHealth Mindfulness-based Music Therapy Intervention for Patients Undergoing Stem Cell Transplantation,NOT_YET_RECRUITING,The goal of this study is to test an electronic health (eHealth) mindfulness-based music therapy intervention to improve health-related quality of life and reduce symptom burden and disease activity in patients undergoing stem cell transplantation.,"['Stem Cell Transplantation', 'Myelodysplastic Syndromes', 'Leukemia, Myeloid, Acute', 'Precursor Cell Lymphoblastic Leukemia-Lymphoma', 'Lymphoma, Non-Hodgkin']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BEHAVIORAL', 'name': 'eHealth Mindfulness-based Music Therapy (eMBMT)', 'description': 'Participants will receive 8 music therapy sessions that will last approximately 60 minutes in length. A Music therapist will conduct the sessions. These sessions will be in person and/or virtual depending on patient status and the time between sessions will vary based on patient response to treatment.', 'armGroupLabels': ['eHealth Mindfulness-based Music Therapy (eMBMT)']}, {'type': 'BEHAVIORAL', 'name': 'eHealth Mindfulness Meditation (eMM)', 'description': 'Participants will receive 8 mindfulness meditation sessions that will last approximately 60 minutes in length. These sessions will be participant led virtually.', 'armGroupLabels': ['eHealth Mindfulness Meditation (eMM)']}]","Inclusion Criteria: * ≥ 18 years of age * have a primary diagnosis of a hematologic malignancy (e.g., myelodysplastic syndrome \[MDS\], acute myeloid leukemia \[AML\], acute lymphoblastic leukemia \[ALL\], or non Hodgkin's Lymphoma \[NHL\]) * have a treatment plan for a hematopoietic stem cell transplant * Speak English or Spanish Exclusion Criteria: * history of severe psychiatric illness (e.g., psychosis, active suicidality, inpatient treatment in the past 12 months) * severe cognitive impairment (per the short portable mental status questionnaire) * hearing impairment * active alcohol or substance dependence within the past six months * participated in the prior pilot MBMT R61 phase * participated in music therapy or mindfulness programs in the past six months",NA,ALL,NA,"[{'measure': 'Change in Health Related Quality of Life Scores as Measures by Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT)', 'description': 'Health Related Quality of Life will be measured using the Functional Assessment of Cancer Therapy Bone Marrow Transplant (FACT-BMT), a validated 47-item patient-reported outcome measure. It includes the FACT-G core questionnaire (Physical, Social/Family, Emotional, and Functional Well-Being) plus a Bone Marrow Transplant Subscale. Each item is rated on a 5-point Likert scale (0 = not at all; 4 = very much). Subscale scores are summed up to produce a total score, with higher scores indicating better quality of life. Change from baseline will be analyzed using mixed-effects models adjusted for baseline score. FACT-BMT total score (range: 0 to 176)', 'timeFrame': 'Baseline (T1), up to 18 months'}, {'measure': 'Change in Pain as Measured by patient reported outcome measures (PROMIS®) pain scale.', 'description': '(PROMIS®) pain scale is scored on a range of 3 to 15 with higher scores indicating higher pain.', 'timeFrame': 'Baseline (T1), up to 18 months'}, {'measure': 'Change in Fatigue as Measured by patient reported outcome measures (PROMIS®) Fatigue scale.', 'description': '(PROMIS®) Fatigue scale is scored on a range of 8 to 40. Higher scores indicate higher fatigue.', 'timeFrame': 'Baseline (T1), up to 18 months'}, {'measure': 'Change in Cognitive Function Scores as Measured by The Fast Cognitive Evaluation (FaCE).', 'description': 'The Fast Cognitive Evaluation (FaCE) scores range from 0 to 27 with higher scores indicating better cognitive functioning.', 'timeFrame': 'Baseline (T1), up to 18 months'}, {'measure': 'Change in Sleep Quality Scores as Measured by Pittsburgh Sleep Quality Index', 'description': 'Pittsburgh Sleep Quality Index score range from 0 to 21. Higher score indicate worse sleep quality.', 'timeFrame': 'Baseline (T1), up to 18 months'}, {'measure': 'Number of Days to Engraftment Measured from Infusion to Engraftment.', 'description': 'To measure the number of days to engraftment we will extract from the electronic medical record (EMR) days from infusion to engraftment.', 'timeFrame': 'Up to 18 months'}, {'measure': 'Number of Days of Hospitalization Measured from Admission to Engraftment.', 'description': 'To measure the number of days of hospitalization we will extract from the electronic medical record (EMR) days of hospitalization from admission to engraftment.', 'timeFrame': 'Up to 18 months'}, {'measure': 'Number of Hospital Readmissions after Hospital Discharge', 'description': 'To measure the number of hospital readmissions we will extract from the electronic medical record (EMR) the number of hospital readmissions from hospital discharge.', 'timeFrame': 'Up to 100 days'}, {'measure': 'Number of Infections from Hospital Admission', 'description': 'To measure the number of infections we will extract from the electronic medical record (EMR) the number of infections from hospital admission measure up to 100 days post infusion.', 'timeFrame': 'up to 100 Days Post-Infusion Day'}, {'measure': 'Changes in Depression Scores as measured with the patient health questionnaire (PHQ-9)', 'description': 'PHQ-9 (patient health questionnaire) scores range is from 0 to 27; higher scores are associated with more severe depression.', 'timeFrame': 'Baseline (T1), up to 18 months'}, {'measure': 'Changes in Anxiety Scores as measured with the Generalized Anxiety Disorder scale-7 (GAD-7).', 'description': 'GAD-7 scores range from 0 to 21; higher scores are associated with more severe anxiety.', 'timeFrame': 'Baseline (T1), up to 18 months'}, {'measure': 'Change in Cancer-specific Distress Scores as Measured by the Impact of Events Scale-Revised', 'description': 'Impact of Events Scale-Revised range is 0 to 88; higher score is associated with more effect caused by events.', 'timeFrame': 'Baseline (T1), up to 18 months'}, {'measure': 'Change in Serum Cortisol as Measured by ELISA', 'description': 'Serum cortisol levels are measured via ELISA. Serum Cortisol normal levels morning range: 10-20 mcg/dL ; afternoon range: 3-10 mcg/dL. Any values outside of the range are associated with higher stress and inflammation', 'timeFrame': 'Baseline (T1), up to 18 months'}, {'measure': 'Change in Pro- and Anti-Inflammatory Cytokine Concentrations as Measured by Multiplex Immunoassay', 'description': 'Cytokines levels are measured in pg/mL. Plasma concentrations of 10 cytokines (GM-CSF, IFN-γ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, TNF-α) are measured via the Novex Life Technologies Human Cytokine 10-Plex Kit on the Magpix Luminex platform (ThermoFisher). Assay sensitivity is 0.5-5 pg/mL per analyte with a \\>3-log dynamic range. Elevated pro-inflammatory cytokines (e.g., IL-1β, IL-6, TNF-α) and suppressed anti-inflammatory cytokines (e.g., IL-10) are associated with immune dysregulation and chronic stress.', 'timeFrame': 'Baseline (T1), up to 18 months'}, {'measure': 'Change in Immunocompetence as Measured by Thymic Function', 'description': 'Thymic function T-cell receptor excision circles (TRECs) measured by TRECs/microliter.', 'timeFrame': 'Baseline (T1), up to 18 months'}, {'measure': 'Change in Immunocompetence as Measured by Regulatory T cells', 'description': 'Regulatory T cells measured as cells/mm\\^3', 'timeFrame': 'Baseline (T1), up to 18 months'}]",NA 269,NCT06412692,"{'fullName': 'Izmir Katip Celebi University', 'class': 'OTHER'}",Motivational Interviewing in Adolescents With Epilepsy,UNKNOWN,"Epilepsy is the most common serious neurodevelopmental disorder of childhood characterized by recurrent seizures, affecting approximately 0.9% of children and adolescents worldwide. Although epileptic seizures are an important element of epilepsy in children, there are many neurological, mental health and cognitive comorbidities in childhood epilepsy that increase the burden of the disease and cause a decrease in quality of life. Motivational interviewing has been found to have a positive effect on the treatment and prevention of chronic diseases; It is a patient-centered counseling that explores, strengthens, and directs the individual's motivation for change.",['Pediatric ALL'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In our study; The motivational interview technique will be applied to the intervention group individually by the researcher at 2-week intervals, including a preliminary interview and 6 motivational interview sessions.', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Randomized', 'whoMasked': ['OUTCOMES_ASSESSOR']}}","[{'type': 'OTHER', 'name': 'The Motivational Interviewing Technique', 'description': 'Motivational interviewing technique applied to adolescents with epilepsy; It is thought that it will be effective in reducing social anxiety and increasing the quality of life of adolesce.', 'armGroupLabels': ['The Motivational Interviewing Technique']}]","Inclusion Criteria: * Be between the ages of 12-15 * Having epilepsy for at least six months * Having a high score on the Social Anxiety Scale for Adolescents * Having a low score on the General Child Life Quality Scale * Low scores on the KINDL Epilepsy Quality of Life Module for Children * No mental disability * Able to communicate (can speak and understand Turkish, has no speech disorder) * Being literate * Not having any other chronic disease * Being willing to participate in the study Exclusion Criteria: -Not attending at least one of the interviewing",NA,ALL,NA,"[{'measure': '""Social Anxiety Scale for Adolescents"" [Time Frame: After the motivational interviewing technique]', 'description': 'A high score on the Social Anxiety Scale for Adolescents indicates high anxiety.', 'timeFrame': '3 months'}, {'measure': ""''KINDL Epilepsy Quality of Life Module for Children'' [Time Frame: After the motivational interviewing technique]"", 'description': 'A high score on the KINDL Epilepsy Quality of Life Module for Children indicates good healthy quality of life.', 'timeFrame': '3 months'}, {'measure': '""Children\'s General Quality of Life Scale\'\' [Time Frame: After the motivational interviewing technique]', 'description': ""A high score on the Children's General Quality of Life Scale for Children indicates good healthy quality of life."", 'timeFrame': '3 months'}, {'measure': '""Social Anxiety Scale for Adolescents"" [Time Frame: 1 month after the Motivational Interviewing Technique]', 'description': 'A high score on the Social Anxiety Scale for Adolescents indicates high anxiety.', 'timeFrame': '1 months'}, {'measure': ""''KINDL Epilepsy Quality of Life Module for Children'' [Time Frame: 1 month after the Motivational Interviewing Technique]"", 'description': 'A high score on the KINDL Epilepsy Quality of Life Module for Children indicates good healthy quality of life.', 'timeFrame': '1 months'}, {'measure': '""Children\'s General Quality of Life Scale"" [Time Frame: 1 month after the Motivational Interviewing Technique]', 'description': ""A high score on the Children's General Quality of Life Scale for Children indicates good healthy quality of life."", 'timeFrame': '1 months'}]",NA 270,NCT06287944,"{'fullName': 'City of Hope Medical Center', 'class': 'OTHER'}","225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome",RECRUITING,"This phase I trial tests the safety, side effects, best dose, and effectiveness of 225Ac-DOTA-Anti-CD38 daratumumab monoclonal antibody in combination with fludarabine, melphalan and total marrow and lymphoid irradiation (TMLI) as conditioning treatment for donor stem cell transplant in patients with high-risk acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS). Daratumumab is in a class of medications called monoclonal antibodies. It binds to a protein called CD38, which is found on some types of immune cells and cancer cells. Daratumumab may block CD38 and help the immune system kill cancer cells. Radioimmunotherapy is treatment with a radioactive substance that is linked to a monoclonal antibody, such as daratumumab, that will find and attach to cancer cells. Radiation given off by the radioisotope my help kill the cancer cells. Chemotherapy drugs, such as fludarabine and melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. TMLI is a targeted form of body radiation that targets marrow, lymph node chains, and the spleen. It is designed to reduce radiation-associated side effects and maximize therapy effect. Actinium Ac 225-DOTA-daratumumab combined with fludarabine, melphalan and TMLI may be safe, tolerable, and/or effective as conditioning treatment for donor stem cell transplant in patients with high-risk AML, ALL, and MDS.","['Acute Lymphoblastic Leukemia', 'Acute Myeloid Leukemia', 'Myelodysplastic Syndrome']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'Actinium Ac 225-DOTA-Daratumumab', 'description': 'Given IV', 'armGroupLabels': ['Treatment ( Actinium Ac 225-DOTA-Daratumumab)'], 'otherNames': ['225Ac-DOTA-Daratumumab', '[225Ac]-DOTA-Daratumumab']}, {'type': 'PROCEDURE', 'name': 'Biospecimen Collection', 'description': 'Undergo blood sample collection', 'armGroupLabels': ['Treatment ( Actinium Ac 225-DOTA-Daratumumab)'], 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection']}, {'type': 'PROCEDURE', 'name': 'Bone Marrow Aspiration', 'description': 'Undergo bone marrow biopsy and aspiration', 'armGroupLabels': ['Treatment ( Actinium Ac 225-DOTA-Daratumumab)']}, {'type': 'PROCEDURE', 'name': 'Bone Marrow Biopsy', 'description': 'Undergo bone marrow biopsy and aspiration', 'armGroupLabels': ['Treatment ( Actinium Ac 225-DOTA-Daratumumab)'], 'otherNames': ['Biopsy of Bone Marrow', 'Biopsy, Bone Marrow']}, {'type': 'PROCEDURE', 'name': 'Computed Tomography', 'description': 'Undergo CT', 'armGroupLabels': ['Treatment ( Actinium Ac 225-DOTA-Daratumumab)'], 'otherNames': ['CAT', 'CAT Scan', 'Computed Axial Tomography', 'Computerized Axial Tomography', 'Computerized axial tomography (procedure)', 'Computerized Tomography', 'CT', 'CT Scan', 'tomography']}, {'type': 'BIOLOGICAL', 'name': 'Daratumumab', 'description': 'Given IV', 'armGroupLabels': ['Treatment ( Actinium Ac 225-DOTA-Daratumumab)'], 'otherNames': ['Daratumumab Biosimilar HLX15', 'Daratumumab-fihj', 'Darzalex', 'HLX15', 'HuMax-CD38', 'JNJ-54767414']}, {'type': 'PROCEDURE', 'name': 'Echocardiography', 'description': 'Undergo echocardiography', 'armGroupLabels': ['Treatment ( Actinium Ac 225-DOTA-Daratumumab)'], 'otherNames': ['EC']}, {'type': 'DRUG', 'name': 'Fludarabine', 'description': 'Given IV', 'armGroupLabels': ['Treatment ( Actinium Ac 225-DOTA-Daratumumab)'], 'otherNames': ['Fluradosa']}, {'type': 'PROCEDURE', 'name': 'Hematopoietic Cell Transplantation', 'description': 'Undergo SCT', 'armGroupLabels': ['Treatment ( Actinium Ac 225-DOTA-Daratumumab)'], 'otherNames': ['HCT', 'Hematopoietic Stem Cell Infusion', 'Hematopoietic Stem Cell Transplantation', 'HSCT', 'SCT', 'Stem Cell Transplant', 'stem cell transplantation', 'Stem Cell Transplantation, NOS']}, {'type': 'BIOLOGICAL', 'name': 'Indium In 111-DOTA-Daratumumab', 'description': 'Given IV', 'armGroupLabels': ['Treatment ( Actinium Ac 225-DOTA-Daratumumab)'], 'otherNames': ['111In-DOTA-Daratumumab', '[111In]-DOTA-Daratumumab']}, {'type': 'DRUG', 'name': 'Melphalan', 'description': 'Given IV', 'armGroupLabels': ['Treatment ( Actinium Ac 225-DOTA-Daratumumab)'], 'otherNames': ['Alanine Nitrogen Mustard', 'CB-3025', 'L-PAM', 'L-Phenylalanine Mustard', 'L-Sarcolysin', 'L-Sarcolysin Phenylalanine mustard', 'L-Sarcolysine', 'Melphalanum', 'Phenylalanine Mustard', 'Phenylalanine Nitrogen Mustard', 'Sarcoclorin', 'Sarkolysin', 'WR-19813']}, {'type': 'PROCEDURE', 'name': 'Multigated Acquisition Scan', 'description': 'Undergo MUGA', 'armGroupLabels': ['Treatment ( Actinium Ac 225-DOTA-Daratumumab)'], 'otherNames': ['Blood Pool Scan', 'Equilibrium Radionuclide Angiography', 'Gated Blood Pool Imaging', 'Gated Heart Pool Scan', 'MUGA', 'MUGA Scan', 'Multi-Gated Acquisition Scan', 'Radionuclide Ventriculogram Scan', 'Radionuclide Ventriculography', 'RNVG', 'SYMA Scanning', 'Synchronized Multigated Acquisition Scanning']}, {'type': 'PROCEDURE', 'name': 'Radionuclide Imaging', 'description': 'Undergo nuclear scan', 'armGroupLabels': ['Treatment ( Actinium Ac 225-DOTA-Daratumumab)'], 'otherNames': ['NM', 'Nuclear Medicine', 'nuclear medicine scan', 'radioimaging', 'Radionuclide Scanning', 'Scan', 'Scintigraphy']}, {'type': 'PROCEDURE', 'name': 'Single Photon Emission Computed Tomography', 'description': 'Undergo SPECT scan', 'armGroupLabels': ['Treatment ( Actinium Ac 225-DOTA-Daratumumab)'], 'otherNames': ['Medical Imaging, Single Photon Emission Computed Tomography', 'Single Photon Emission Tomography', 'Single-Photon Emission Computed', 'single-photon emission computed tomography', 'SPECT', 'SPECT imaging', 'SPECT SCAN', 'SPET', 'ST', 'tomography, emission computed, single photon', 'Tomography, Emission-Computed, Single-Photon']}, {'type': 'DRUG', 'name': 'Sirolimus', 'description': 'Given sirolimus', 'armGroupLabels': ['Treatment ( Actinium Ac 225-DOTA-Daratumumab)'], 'otherNames': ['AY 22989', 'RAPA', 'Rapamune', 'Rapamycin', 'SILA 9268A', 'WY-090217']}, {'type': 'DRUG', 'name': 'Tacrolimus', 'description': 'Given tacrolimus', 'armGroupLabels': ['Treatment ( Actinium Ac 225-DOTA-Daratumumab)'], 'otherNames': ['FK 506', 'FK-506', 'Fujimycin', 'Hecoria', 'Prograf', 'Protopic', 'Tacforius']}, {'type': 'RADIATION', 'name': 'Total Marrow and Lymphoid Irradiation', 'description': 'Undergo TMLI', 'armGroupLabels': ['Treatment ( Actinium Ac 225-DOTA-Daratumumab)'], 'otherNames': ['TMLI']}]","Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * ≥ 60 years. Note: Patients ≥ 18 years and \< 60 years with HCT-comorbidity index (CI) ≥ 2 are also included * Karnofsky performance status ≥ 70 * Eligible patients will have a histopathological confirmed diagnosis of hematologic malignancy in one of the following categories : * Acute myelogenous leukemia: * Patients with de novo or secondary disease in unfavorable risk group including poor risk cytogenetics according to National Comprehensive Cancer Network (NCCN) guidelines for AML i.e., monosomal karyotype, -5,5q-,-7,7q-,11q23-non t(9;11), inv (3), t(3;3), t(6;9), t(9;22) and complex karyotypes (≥ 3 unrelated abnormalities), or all patient in intermediate risk groups accept patients with FLT3-NPM1+ disease, OR * Patients with a complete morphological remission (CR) with minimal residual disease (MRD)-positive status by flow cytometry (≥ 0.1% by flow cytometry) or cytogenetic after at least 2 prior induction therapies, OR * Patients with chemosensitive active disease defined as at least 50% reduction in their blast count after last treatment * Myelodysplastic syndrome in high-intermediate (int-2) and high-risk categories per Revised International Prognostic Scoring System- (IPSS-R) * Acute lymphocytic leukemia * Patients with de novo or secondary disease according to NCCN guidelines for ALL hypoploidy (\< 44 chromosomes); t(v;11q23): MLL rearranged; t(9;22) (q34;q11.2); complex cytogenetics (5 or more chromosomal abnormalities); high white blood cell (WBC) at diagnosis (≥ 30,000 for B lineage or ≥ 50,000 for T lineage); iAMP21loss of 13q, and abnormal 17p, OR * Patients with a complete response (CR) with MRD-positive status by flow cytometry (≥ 0.1% by flow cytometry) or cytogenetics after at least 2 prior induction therapies, OR * Patients with chemosensitive active disease defined as at least 50% reduction in their blast count after last treatment * A pretreatment measured creatinine clearance (absolute value) of ≥ 60 ml/minute (To be performed within 30 days prior to day 1 of protocol therapy unless otherwise stated) * Patients must have a serum bilirubin ≤ 2.0 mg/dl (To be performed within 30 days prior to day 1 of protocol therapy unless otherwise stated) * Patients must have a serum glutamic oxaloacetic transaminase (SGOT) ≤ 2.5 times the institutional upper limits of normal (To be performed within 30 days prior to day 1 of protocol therapy unless otherwise stated) * Patients must have a serum glutamic pyruvic transaminase (SGPT) ≤ 2.5 times the institutional upper limits of normal (To be performed within 30 days prior to day 1 of protocol therapy unless otherwise stated) * Ejection fraction measured by echocardiogram or multigated acquisition scan (MUGA) ≥ 50% (To be performed within 30 days prior to day 1 of protocol therapy unless otherwise stated) * Diffusion capacity of the lung for carbon monoxide (DLCO) \> 50% predicted (To be performed within 30 days prior to day 1 of protocol therapy unless otherwise stated) * Forced expiratory volume in 1 second (FEV1) \> 50% predicted (To be performed within 30 days prior to day 1 of protocol therapy unless otherwise stated) * Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only) * DONOR SPECIFIC CRITERIA: All candidates for this study must have an human leukocyte antigen (HLA) (A, B, C, and DR) identical sibling who is willing to donate mobilized peripheral blood stem cells (preferred) or bone marrow, or have a 10/10 (A, B, C, DR and DQ) allele matched unrelated donor. DQ or DP mismatch is allowed per discretion of the principal investigator. City of Hope (COH) standards of practice (SOP) (B.001.11) will be used for allogeneic donor evaluation, selection, and consent. Donor screening will be in compliance with all requirements of Food and Drug Administration (FDA) regulation 21 CFR Part 1271 including donor screening for COVID-19 exposure or infection Exclusion Criteria: * Patients who had a prior allogeneic transplant * Patients who have had prior radiotherapy * Patients who have received prior radiopharmaceutical therapy * Inclusion of other patients with previous radiation exposure will be determined based on the radiation oncologist medical doctor (MD) principal investigator (PI) evaluation and judgement * For patients with leukemia or MDS: Patients may not have received more than 3 prior regimens, where the regimen intent was to induce remission * Receiving any other investigational agents or concurrent biological, intensive chemotherapy or radiation therapy for the previous 2 weeks from conditioning * Patients should have discontinued all previous intensive therapy, chemotherapy, or radiotherapy for 2 weeks prior to commencing therapy on this study. Note: Low dose chemotherapy or maintenance chemotherapy given within 7 days of planned study enrollment is permitted. These include hydroxyurea, 6-meraptopurine, oral methotrexate, vincristine, oral etoposide, and tyrosine kinase inhibitors (TKIs). FLT-3 inhibitors can also be given up to 3 days before conditioning regimen * History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent * Patients with other active malignancies are ineligible for this study, other than non-melanoma skin cancers * Patients should not have any uncontrolled illness including ongoing or active bacterial, viral or fungal infection * The recipient has a medical problem or neurologic/psychiatric dysfunction which would impair his/her ability to be compliant with the medical regimen and to tolerate transplantation or would prolong hematologic recovery which in the opinion of the investigator (treating physician) would place the recipient at unacceptable risk * Females only: Pregnant or breastfeeding * Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)",NA,ALL,NA,"[{'measure': 'Incidence of adverse events (CTCAE)', 'description': 'Toxicity will be scored on the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5 scale. Toxicity will be recorded in each patient and will include the type, severity, and probable association with the study regimen.', 'timeFrame': 'Up to 2 years post-transplant'}, {'measure': 'Incidence of adverse events (Bearman)', 'description': 'Toxicity will be scored on the Bearman Scale. Toxicity will be recorded in each patient and will include the type, severity, and probable association with the study regimen.', 'timeFrame': 'Up to 2 years post-transplant'}, {'measure': 'Dose limiting toxicity (DLT)', 'description': 'DLT will be graded using the NCI CTCAE v5 scale.', 'timeFrame': 'Up to 30 days post-stem cell infusion'}, {'measure': 'Maximum tolerated dose/recommended phase II dose (MTD/RP2D)', 'description': 'MTD/RP2D will be defined as the highest dose where 6 patients have been treated and at most on patient experiences a DLT.', 'timeFrame': 'Up to 30 days post stem cell infusion'}]","[{'measure': 'Overall survival (OS)', 'description': 'OS will be defined as the time from start of protocol therapy to death or last follow-up whichever comes first. OS will be calculated using the Kaplan-Meier method.', 'timeFrame': 'At start of protocol therapy to death or last follow-up up to 2 years post transplant'}, {'measure': 'Event-free survival (EFS)', 'description': 'EFS will be defined as the time from start of protocol therapy to death, relapse/progression or last follow-up, whichever comes first. EFS will be calculated using the Kaplan-Meier method.', 'timeFrame': 'At start of protocol therapy to death, relapse/progression or last follow-up up to 2 years post-transplant'}, {'measure': 'Cumulative incidence of relapse/progression (CIR)', 'description': 'CIR will be measured from start of therapy. Death without relapse/progression is considered a competing risk.', 'timeFrame': 'At start of therapy up to 2 years post transplant'}, {'measure': 'Graft versus host disease and relapse free survival (GRFS)', 'description': 'GRFS will be measured from the start of therapy. GRFS will be calculated using the Kaplan-Meier method.', 'timeFrame': 'At start of therapy up to 2 years post-transplant'}, {'measure': 'Complete remission (CR) proportion', 'description': 'CR will be defined as the time from start of therapy to the time of biopsy proven CR.', 'timeFrame': 'At start of therapy up to day 30'}, {'measure': 'Non-relapse mortality (NRM)', 'description': 'NRM will be defined as the time from start of therapy until non-disease related death, or last follow-up, whichever comes first. NRM will be calculated as competing risks.', 'timeFrame': 'At start of therapy until non-disease related death or last follow-up up to 2 years post-transplant'}, {'measure': 'Incidence of infection', 'description': 'Microbiologically documented infections will be reported by site of disease, date of onset, severity and resolution, if any.', 'timeFrame': 'At day 0 up to 100 days post-transplant'}, {'measure': 'Neutrophil recovery rate', 'description': 'Neutrophil recovery rate will be measured from stem cell infusion to the first to three consecutive days with neutrophil count greater than 0.5 x 10\\^9/L.', 'timeFrame': 'At stem cell infusion up to the first to three consecutive days with neutrophil count greater than 0.5 x 10^9/L up to 2 years post-transplant'}, {'measure': 'Incidence of grade 2-4 and 3-4 acute graft-versus-host disease (GVHD)', 'description': 'Documented/biopsy proven acute GVHD will be graded according to the Consensus Grading. Acute GVHD will be measured from date of stem cell infusion to document/biopsy proven acute GVHD onset date (within the first 100 days post-transplant) and will be used to estimate the cumulative incidence. GVHD will be calculated as competing risks.', 'timeFrame': 'At date of stem cell infusion to document/biopsy proven acute GVHS onset (within first 100 days post-transplant)'}, {'measure': 'Incidence of chronic GVHD (cGVHD)', 'description': 'Documented/biopsy proven cGVHD is scored according to National Institutes of Health Consensus Staging. CGVHD is measured from approximately 80-100 days post-transplant to the documented/biopsy proven cGVHD onset date and will be used to estimate the cumulative incidence. The incidence of cGVHD will be calculated as competing risks.', 'timeFrame': 'At 80-100 days post-transplant to documented/biopsy proven cGVHD onset date up to 2 years post-transplant'}]" 271,NCT04014764,"{'fullName': 'Notable Labs', 'class': 'INDUSTRY'}",Collect and Assess Tissue Samples From Subjects With Hematologic Malignancy,COMPLETED,"This is a prospective, multicenter observational study to collect clinically annotated biospecimens in order to assess the correlation between ex vivo data generated by the Notable assay platform and clinical outcome.","['Acute Myelogenous Leukemia', 'Multiple Myeloma', 'Myelodysplastic Syndromes', 'Lymphoma', 'Acute Lymphoblastic Leukemia', 'Chronic Myelogenous Leukemia', 'Myeloproliferative Neoplasm']",OBSERVATIONAL,"{'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'OTHER', 'name': 'This is a non-interventional study', 'description': ""N/A. This is a non-interventional study. Following consent, the subject will have biospecimen samples taken during routine standard of care procedures, and provided to Sponsor for analysis. Optional research blood draws may occur at treating physician's discretion to obtain additional tissue samples."", 'armGroupLabels': ['Single group']}]","Inclusion Criteria: * Provide written informed consent; * Age ≥ 18 years, male or female, of any race; * Documented hematologic malignancy (any of the below) in need of starting an active anti-cancer therapy: * Acute myelogenous leukemia (AML) * Multiple myeloma (MM) * Myelodysplastic syndrome (MDS) * Lymphoma * Acute lymphocytic leukemia (ALL) * Chronic lymphocytic leukemia (CLL) * Chronic myelogenous leukemia (CML) * Neoplasm (MPN) * Other (upon review and approval by medical monitor) Note: \*Supportive care agents including erythropoiesis-stimulating agents (ESAs) such as EPO, Procrit, Aranesp, etc; granulocyte colony stimulating factor (G-CSF); hydroxyurea (Hydrea); and luspatercept (Reblozyl) are not considered anti-cancer therapy for this study * Intent to start anti-cancer therapy within 21 days of biospecimen collection •≥7 days from last anti-cancer therapy; * Any number of prior therapies * Subject cohort is currently open Exclusion Criteria: * Unwilling or unable to give consent * Subject's disease is in remission * Subject cohort is not open at time of consent * Subject is restarting an ongoing treatment regimen after a dose interruption",Approximately 1000 Subjects with diagnosed with a hematological malignancy will be enrolled to provide at least 1000 biospecimen samples.,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Clinical response to treatment', 'description': 'Collect clinical responses to treatment and outcomes in patients who have provided samples to the biobank', 'timeFrame': '3 years'}]","[{'measure': 'Type of clinical treatment responses', 'description': 'Correlate ex vivo drug sensitivity data on patient samples with clinical treatment responses.', 'timeFrame': '3 years'}, {'measure': 'Types of somatic tumor mutations', 'description': 'Determine genotype and/or phenotype relationships between ex vivo and clinical responses with somatic tumor mutations.', 'timeFrame': '3 years'}]" 272,NCT01578109,"{'fullName': 'National Cancer Institute (NCI)', 'class': 'NIH'}",Sorafenib Tosylate Before and After Donor Bone Marrow Transplant in Treating Patients With Acute Myeloid Leukemia,COMPLETED,This pilot clinical trial studies the side effects of sorafenib tosylate before and after donor bone marrow transplantation in treating patients with acute myeloid leukemia. Sorafenib tosylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.,['Acute Myeloid Leukemia With FLT3/ITD Mutation'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'PROCEDURE', 'name': 'Bone Marrow Transplantation', 'description': 'Undergo BMT', 'armGroupLabels': ['Treatment (sorafenib tosylate and transplant)'], 'otherNames': ['Blood and Bone Marrow Transplant', 'BMT', 'Bone Marrow Grafting', 'Bone Marrow Transplant', 'Marrow Transplantation']}, {'type': 'DRUG', 'name': 'Sorafenib', 'description': 'Given PO', 'armGroupLabels': ['Treatment (sorafenib tosylate and transplant)'], 'otherNames': ['BA4 43 9006', 'BAY 43-9006', 'Bay-439006']}, {'type': 'DRUG', 'name': 'Sorafenib Tosylate', 'description': 'Given PO', 'armGroupLabels': ['Treatment (sorafenib tosylate and transplant)'], 'otherNames': ['BAY 43-9006 Tosylate', 'BAY 54-9085', 'Nexavar', 'sorafenib']}]","Inclusion Criteria: * Acute myeloid leukemia with a FLT3-internal tandem duplication (ITD) who are in a complete remission or partial remission (less than 10% blasts in marrow) as documented by bone marrow biopsy and who plan to undergo a bone marrow transplantation * Patients who have had count recovery (absolute neutrophil count \[ANC\] \> 500,000/mm\^3; non transfused platelet count over 30,000/mm\^3) and are at least 30 days after induction and/or transplantation but no more than 120 days post transplant * Patients may have received any prior therapy deemed necessary for induction of remission except for patients whom have progressed while on sorafenib; patients who have responded to sorafenib previously are eligible for enrollment on the protocol * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%) * Life expectancy of greater than four months * Total bilirubin less than 2 x upper limit of normal * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 5 x institutional upper limit of normal * Creatinine =\< 1.5 x upper limit of normal OR creatinine clearance \>= 60 mL/min/1.73 m\^2 for patients with creatinine levels \> 1.5 x upper limit of normal * The effects of sorafenib on the developing human fetus are unknown; for this reason and because tyrosine kinase inhibiting agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately; contraception should continue for at least 30 days after the last dose of sorafenib * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients who have had chemotherapy or radiotherapy within 2 weeks except for intrathecal chemotherapy (i.e., methotrexate, cytarabine, or thiotepa) * Patients may not be receiving any other investigational agents * Patients with uncontrolled hypertension (i.e., persistent grade 3 while undergoing treatment) * History of allergic reactions attributed to compounds of similar chemical or biologic composition to sorafenib * Patients with active and/or untreated central nervous system (CNS) leukemia will not be eligible * Patients must not have any evidence of bleeding diathesis or be on any therapeutic anticoagulation such as low molecular weight (LMW) heparin or warfarin for deep vein thrombosis (DVT) treatment * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant women are excluded from this study because sorafenib is chemotherapeutic agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with sorafenib, breastfeeding should be discontinued if the mother is treated sorafenib * Human immunodeficiency virus (HIV)-positive patients are excluded because management of these patients in the hematopoietic cell transplant setting has not yet been well defined and is currently the subject of investigation in other studies addressing this issue * Patients with active acute GVHD who have been initiated on therapy or had therapy escalation within 21 days are not eligible * Patients with lack of engraftment (less than 90% donor deoxyribonucleic acid \[DNA\] in bone marrow or peripheral blood) after bone marrow transplant as evidence by RFLP (restriction fragment length polymorphism) are not eligible * Patients who are unable to swallow pills are not eligible * Patients taking strong cytochrome P450 family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors including enzyme-inducing anti-epileptic drugs (phenytoin, carbamazepine, or phenobarbital), rifampin, grape fruit juice, or St. John's wort are not eligible",NA,ALL,NA,"[{'measure': 'Proportion of patients removed from the study in each cohort due to toxicity', 'description': 'Will be reported with exact binomial proportions and 95% confidence intervals. All toxicities by type and grade will be reported. The proportion of patients with graft failure in each cohort will also be reported with exact binomial proportions and 95% confidence intervals.', 'timeFrame': 'Up to 24 months'}]","[{'measure': 'Cumulative incidence of non-relapse mortality and relapse', 'description': ""Estimated by competing risks analysis using Grey's method."", 'timeFrame': 'Up to 2 years'}, {'measure': 'Disease-free survival (DFS)', 'description': 'Standard life table methods with Kaplan-Meier (KM) plots will be used to analyze DFS. Reported with 90% confidence intervals overall and by cohort.', 'timeFrame': 'Up to 2 years'}, {'measure': 'Overall survival (OS)', 'description': 'Standard life table methods with KM plots will be used to analyze OS. Reported with 90% confidence intervals overall and by cohort.', 'timeFrame': 'Up to 2 years'}, {'measure': 'Change in minimal residual disease (MRD)', 'description': 'Will be assessed by flow cytometry. Box plots will be used.', 'timeFrame': 'Baseline to day 365'}, {'measure': 'Change in FLT3 suppression', 'description': 'Will be assessed by plasma inhibitory assay and western blotting. Box plots will be used.', 'timeFrame': 'Baseline to day 365'}, {'measure': 'Pharmacodynamic parameters of sorafenib tosylate', 'description': 'Samples will be collected to assess sorafenib tosylate and the N-oxide metabolite (total and unbound) exposure to correlate with pharmacodynamic endpoints using non-parametric statistics.', 'timeFrame': 'Up to 2 years post-transplant'}]" 273,NCT06702098,"{'fullName': 'Guangzhou Ruixin Biotechnological Co., LTD', 'class': 'INDUSTRY'}",Induced Pluripotent Stem Cells Derived Natural Killer Cells Therapy for Refractory and Relaps Acute Myelogenous Leukemia,NOT_YET_RECRUITING,This is a clinical study on the use of iNK cells for the treatment of refractory relapsed acute myeloid leukemia.,['Acute Myeloid Leukemia (AML)'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'iNK cells', 'description': 'Induced pluripotent stem cells derived NK cells.', 'armGroupLabels': ['Cell therapy group']}]","Inclusion Criteria: Patients must satisfy the following criteria to be enrolled in the study. 1. Patient is ≥ 18 and ≤ 80 years of age at the time of signing the Study informed consent form (ICF). 2. Patient understands and voluntarily signs the Study ICF prior to any study-related assessments/procedures are conducted. 3. Patient has eligible disease status: 3.1 Primary or Secondary acute myeloid leukemia (AML) Patients in first of second Morphological Complete Remission (CR), Morphological Complete Remission with incomplete hematologic recovery (CRi), or Morphologic Leukemia-free State (MLFS) as defined by the European LeukemiaNet (ELN) recommendations for AML Response Criteria (Dohner, 2017). 3.2 R/R diagnosis based on confirmed diagnosis with local pathology report following any reinduction/ salvage therapy ELN guidelines. 3.2.1 Relapsed AML are defined as having relapsed after achieving ≥ 1 CR, including relapse after allogeneic stem cell transplantation (≥ 2 months after transplant). 3.2.2 Refractory AML, defined as not achieving CR, CRi, or MLFS after 2 or more cycles of induction therapy (primary refractory) or not achieving CR after treatment for relapsed AML. 3.2.3 Secondary AML (MDS transformation): Secondary AML patients are eligible to participate if they have received a minimum of one prior line of treatment for AML. 3.2.4 Treatment-related AML: Treatment-related AML patients are eligible to participate if they have received a minimum of one prior line of treatment for AML. 4. No active infection. 5. No heart , liver and kidney functioninsufficiency. 6. No central nervous system leukemia. Exclusion Criteria: 1. Subject meets one of the following criteria. 1.1History of CAR-T treatment with third degree CRS. 1.2 History of NK cell and CIK cell immunotherapy. 2. Serious cardiovascular and cerebrovascular diseases. 2.1 Severe heart rhythm or conduction abnormalities, corrected QT interval (QTc)≥480 ms. 2.2 Complete left bundle branch block, second- or third-degree atrioventricular block; 2.3 Severe, uncontrolled cardiac arrhythmias requiring medication. 2.4 New York Heart Association (NYHA) class II or above congestive heart failure. 2.5 Left ventricular ejection fraction (LVEF) \<50% in color Doppler echocardiography. 2.6 History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, severe pericardial disease, ECG evidence of acute ischemic or active conduction system abnormalities within 6 months prior to recruitment. 3. Previous or present concomitant other malignancies (except for basal cell carcinoma of the skin, non-melanoma and non-melanoma, carcinoma in situ of the breast/cervix that have been effectively controlled, and other malignancies that have been effectively controlled without treatment in the past five years). 4. Uncontrollable systemic disease(e.g. uncontrolled hypertension, diabetes, etc). 5. Pregnant women, lactating females, patients who refuse to use effective contraception during the study. 6. history of severe neurological or psychiatric illness. 7. Positive for hepatitis B surface antigen. 8. Patients who are judged by the investigator to be unsuitable for participating in this study.",NA,ALL,NA,"[{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': '12 months'}, {'measure': 'MRD negative rate', 'timeFrame': '12 months'}, {'measure': 'Progression-free Survival', 'timeFrame': '12 months'}, {'measure': 'Overall survival', 'timeFrame': '12 months'}]","[{'measure': 'Determination of chimerism of iNK cells in peripheral blood of subject.', 'timeFrame': '12 months'}]" 274,NCT06235398,"{'fullName': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}",Upfront Related Donor Transplantation in Patients With Myelodisplatic Syndrome : a Phase 2 Trial,NOT_YET_RECRUITING,"Three recent prospective ""transplant/no transplant"" studies concluded to an advantage of OS with transplantation in patients with high or intermediate-2 IPSS risk (not significant in Kröger's study). No prospective randomized trial has assessed the pre-transplant therapy in MDS patients yet but some information can be extracted from these 3 recent studies. In the French study (n=162), 72% patients with a donor received HSCT, previously treated by hypomethylating agent (HMA) in 71% of them. There was a trend to a better survival in patients achieving a complete remission with pre-graft therapy (HR: 0.55, p=0.088) and higher risk of death in unresponsiveness patients transformed into AML (HR: 2.36, p=0.008). In Nakamura's study (n=384), 83% of patients with a donor were transplanted, previously treated by HMA in 68%2. The multivariable Cox model for Overall Survival (OS) and Leukemia-free survival showed an excess risk in patients treated by HMA. Moreover, responders still have a higher risk of mortality as compared to patients who did not receive any pre-graft therapy (HR: 2.417, p=0.0054). In the German study, the aim was to initiate azacytidine at inclusion and to transplant patients after 4 cycles if a donor was identified1. Among 170 registered patients, 162 initiated 5-aza but 36% of them were ""lost during this pre-graft therapy"" before allocation to ""donor"" or ""no-donor"" arm, for different reasons including death (n=12). After 4 cycles of 5-aza, 79/81 patients ""donor arm"" were transplanted. The multivariable analysis showed remission status did not influence OS. Those 3 previous clinical trials thus suggest that a substantial number of patients planned for transplantation are not transplanted nowadays while no evidence of HMA benefit before HSCT has been clearly identified. This phase 2 study aim to assess the feasibility of upfront HSCT in patients with high risk MDS in order to increase the probability to be transplanted and to achieve a subsequent remission and better survival.",['Myelodysplastic Syndromes'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'Hematopoietic stem-cell transplantation', 'description': 'Upfront related donor transplantation', 'armGroupLabels': ['Adults with Myelodysplasic Syndrome diagnosis']}]","Inclusion Criteria: * Age ≥ 50 and ≤ 70 years * An HLA (Human Leukocyte Antigen) matched sibling donor or familial haplo-identical donor has been identified * The disease fulfills at least one of the following criteria: * Intermediate-2 or high risk according to classical International Prognostic Scoring System (IPSS) * Intermediate-1 risk if marrow fibrosis \> grade I or poor risk cytogenetics according to R IPSS or classified high or very high risk according to Revised International Prognostic Scoring System (R IPSS) or if the MDS is therapy-related neoplasm * Usual criteria for Hematopoietic Stem Cell Transplantation (HSCT): * Eastern Cooperative Oncology Group Score (ECOG) ≤ 2 * No severe and uncontrolled infection * Cardiac function compatible with high dose of cyclophosphamide Left Ventricular Function (LVF) \> 50% * Adequate organ function: ASAT and ALAT ≤ 2.5N, total bilirubin ≤ 2N, creatinine clearance ≥ 30 ml/min (according to Cockroft formula) * In case of transplantation with a haploidentical donor, absence of donor specific antibody (DSA) detected in the patient with a MFI \>1000 (antibodies directed towards the distinct haplotype between donor and recipient) * Contraception methods must be prescribed for women of childbearing age during all the study. If cyclophosphamide is used, effective contraceptive methods for men during all their participation in the study * With health insurance coverage * With a written informed consent signed Exclusion Criteria: * Marrow blast \> 15% at time of inclusion * MDS with excess blast \>10% and NPM1 mutation or a recurrent genetic abnormality related to Acute Myeloid Leukemia (AML) (WHO 2022) * Chemotherapy (AML like intensive chemotherapy or demethylating agent) to treat MDS at the current stage * Disponibility of an unrelated donor 10/10 (MUD) in absence of geno-identical donor * Patient with uncontrolled infection * Cancer in the last 5 years (except basal cell carcinoma of the skin or ""in situ"" carcinoma of the cervix * Renal failure with creatinine clearance \<30ml / min (according to Cockroft formula) * With contraindications to treatments used during the research * Uncontrolled coronary insufficiency, recent myocardial infarction \<6 month, current manifestations of heart failure, uncontrolled cardiac rhythm disorders, ventricular ejection fraction \<50% * With heart failure according to NYHA (II or more) * Patient with seropositivity for HIV or HTLV-1 or active hepatitis B or C defined by a positive PCR Hepatitis B Virus or Hepatitis C Virus * Yellow fever vaccine or any alive vaccine within 2 months before transplantation * Pregnancy (β-HCG positive) or breast-feeding * Who have any debilitating medical or psychiatric illness, which would preclude giving well understand informed consent or optimal treatment and follow-up * Under protection by law (tutorship or curatorship)",NA,ALL,NA,"[{'measure': 'Disease-free survival', 'timeFrame': '2 years after transplantation'}]","[{'measure': 'Overall survival', 'timeFrame': '2 years after transplantation'}, {'measure': 'Non-relapse mortality', 'timeFrame': '2 years after transplantation'}, {'measure': 'Cumulative incidence of transformation into acute myeloid leukemia from inclusion', 'timeFrame': '2 years after inclusion'}, {'measure': 'Incidence of acute Graft versus Host Disease (GvHD) and grading', 'timeFrame': '100 days after transplantation'}, {'measure': 'Incidence of chronic GvHD and grading', 'timeFrame': '2 years after transplantation'}, {'measure': 'Percentage of engraftment', 'description': 'Engraftment is defined by hematological recovery and donor chimerism \\> 95%', 'timeFrame': '3 months after transplantation'}, {'measure': 'Percentage of graft failure', 'description': 'Graft failure is defined by acute or late rejection and non-engraftment', 'timeFrame': '2 years after transplantation'}, {'measure': 'Incidence of severe infections', 'description': 'Severe infections are defined by Common Terminology of Adverse Events (CTAE) grade 3-4', 'timeFrame': '3 months after transplantation'}, {'measure': 'Incidence of severe infections', 'description': 'Severe infections are defined by Common Terminology of Adverse Events grade 3-4', 'timeFrame': '6 months after transplantation'}, {'measure': 'Incidence of severe infections', 'description': 'Severe infections are defined by Common Terminology of Adverse Events grade 3-4', 'timeFrame': '12 months after transplantation'}, {'measure': 'Incidence of severe infections', 'description': 'Severe infections are defined by Common Terminology of Adverse Events grade 3-4', 'timeFrame': '24 months after transplantation'}, {'measure': 'Incidence of cardiac events', 'description': 'CTAE grade 2-4', 'timeFrame': '1 month after transplantation'}, {'measure': 'Incidence of cardiac events', 'description': 'CTAE grade 2-4', 'timeFrame': '3 months after transplantation'}]" 275,NCT01366898,"{'fullName': 'PETHEMA Foundation', 'class': 'OTHER'}",Protocol For the Treatment Acute Lymphoblastic Leukemia With Ph 'Negative in Elderly Patients (> 55 Years),UNKNOWN,"The protocol objective is providing adequate treatment and based on broad consensus in elderly patients with Acute Lymphoblastic Leukemia (ALL). Apply uniform treatment that enables a joint analysis of results strong enough to make conclusions on specific subgroups of patients (genotypic subtypes, particularly LAL Bcr/abl positive, phenotype, or strata of age or associated diseases). Provide results of a treatment to consider standard against which to compare the results of phase II trials of experimental drugs that undoubtedly will be activated in the coming years",['Acute Lymphoblastic Leukemia'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Dexamethasona, Idarubicine, ARA-C, Methotrexate', 'armGroupLabels': ['Chemotherapy']}]","Inclusion Criteria: Adults over 55 years diagnosed with ALL with chromosome Ph 'negative and naïve Exclusion Criteria: 1. L3 ALL with mature B phenotype or cytogenetic abnormalities ALL characteristics of Burkitt type (t \[8, 14\], t \[2, 8\], t \[8, 22\]). 2. Biphenotypic acute leukemias and bilinear 3. Acute undifferentiated leukemia The criteria for exclusion from treatment (but not patient record) any of the following: 4. Patients with a history of severe and uncontrolled disease, including: * Coronary artery disease, valvular or hypertensive heart disease. * Chronic liver disease (active viral or alcoholic). * Chronic respiratory failure. * Renal failure not due to the ALL. * Serious neurological disorder not due to the ALL. f. Improperly controlled diabetes. 5. General condition affected (grades 3 and 4 of the WHO scale, see Appendix II), not attributable to the LAL. 6. LAL chromosome Ph 'positive (must register even if you follow a specific protocol). 7. Lack of consent by the patient to use their medical records.",NA,ALL,NA,"[{'measure': 'Efficacy in terms of response rate', 'timeFrame': '5 years'}]","[{'measure': 'Efficacy in terms disease free survival', 'timeFrame': '5 years'}, {'measure': 'Efficacy in terms of global survival', 'timeFrame': '10 years'}]" 276,NCT04691648,"{'fullName': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}",A Study to Assess the Safety of Xospata in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-Like Tyrosine Kinase 3 (FLT3) Mutation,COMPLETED,The objective of this study is to describe the observed safety profile of Xospata® 40 mg tablet when administered in patients with relapsed or refractory AML with FLT3 mutation in routine clinical practice in Korea.,['Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation'],OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'DRUG', 'name': 'Gilteritinib Exposure', 'description': 'Oral', 'armGroupLabels': ['Xospata'], 'otherNames': ['Xospata']}]","Inclusion Criteria: * Patients who receive Xospata® 40 mg tablet according to the drug label approved at the time of marketing authorization in routine clinical practice. * Patients who voluntarily signed the written informed consent form. Exclusion Criteria: * Patients who meet the section 'Do not administer to the following patients' in the precautions for use given at the time of marketing authorization. * Patients who use the drug for an off-label purpose.",Patients receiving Xospata® 40 mg tablet according to the drug label for 54 months from the start date of marketing in Korea.,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Number of participants with Adverse Drug Reactions (ADRs) related to important identified and/or potential risks', 'description': 'An Adverse Drug Reaction refers to any unfavorable and unintended reaction occurring with a normal administration or use of the medicinal product that a causal relationship to the medicinal product cannot be ruled out. Number of ADRs related to important identified risks such as posterior reversible encephalopathy syndrome (PRES), QT prolongation, differentiation syndrome, and/or important potential risks such as pancreatitis, embryo-fetal lethality, suppressed fetal growth and teratogenicity, will be recorded.', 'timeFrame': 'Up to a maximum of 54 months (until 30 days after the last dose)'}, {'measure': 'Number of participants with serious ADRs related to important identified and/or potential risks', 'description': 'An ADR refers to any unfavorable and unintended reaction occurring with a normal administration or use of the medicinal product that a causal relationship to the medicinal product cannot be ruled out. Number of ADRs related to important identified risks such as posterior reversible encephalopathy syndrome (PRES), QT prolongation, differentiation syndrome, and/or important potential risks such as pancreatitis, embryo-fetal lethality, suppressed fetal growth and teratogenicity, will be recorded. An ADR is considered ""serious"" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires inpatient hospitalization or prolongation of hospitalization, or other medically important event.', 'timeFrame': 'Up to a maximum of 54 months (until 30 days after the last dose)'}]","[{'measure': 'Number of participants with ADRs related to identified risks and considered not important', 'description': 'An ADR refers to any unfavorable and unintended reaction occurring with a normal administration or use of the medicinal product that a causal relationship to the medicinal product cannot be ruled out. Number of ADRs related to identified risks but considered not important, such as other ADRs described by the Korean package insert, will be recorded. An ADR is considered ""serious"" if, in the view of either the investigator or Sponsor, it results in any of the following outcomes: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires inpatient hospitalization or prolongation of hospitalization, or other medically important event.', 'timeFrame': 'Up to a maximum of 54 months (until 30 days after the last dose)'}, {'measure': 'Number of participants with AEs', 'description': 'An AE is defined as any untoward medical occurrence in a subject administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE is considered ""serious"" if, in the view of either the investigator or Sponsor, it results in any of the following outcomes: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires inpatient hospitalization or prolongation of hospitalization, or other medically important event. Causal relationship between the study drug is judged by medically qualified investigator either as certain, probable/likely, possible, unlikely, conditional/unclassified or unassessable/unclassifiable.', 'timeFrame': 'Up to a maximum of 54 months (until 30 days after the last dose)'}]" 277,NCT00145626,"{'fullName': ""St. Jude Children's Research Hospital"", 'class': 'OTHER'}",HLA-Nonidentical Stem Cell and Natural Killer Cell Transplantation for Children Less the Two Years of Age With Hematologic Malignancies,COMPLETED,"Recent studies of conventional chemotherapy for infants with high-risk hematologic malignancies show that the long-term disease-free survival is low. Although blood and marrow stem cell transplantation using an HLA identical sibling has improved the outcome for these children, less than 25% have this donor source available. Another option is haploidentical transplantation using a partially matched family member donor (i.e. parental donor). Although haploidentical transplantation has proven curative for some patients, this procedure has been hindered by significant complications, primarily regimen-related toxicity including infection and graft versus host disease (GVHD). Building on prior institutional trials, this study will provide patients a haploidentical graft depleted of T lymphocytes using the investigational device, CliniMACS selection system. One week after the transplant procedure, patients will also receive an infusion of additional donor derived white blood cells called Natural Killer (NK) cells in an effort to decrease risks for rejection of the graft, disease relapse, and regimen related toxicity. The primary objective of the study is to evaluate 1 year survival in infants with high risk hematologic malignancies who receive this study treatment.","['Acute Myeloid Leukemia', 'Acute Lymphocytic Leukemia', 'Myelodysplasia', 'Chronic Myeloid Leukemia', 'Histiocytosis']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Chemotherapy and antibodies', 'description': 'Study participants will receive a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants will receive an infusion of additional donor derived cells called NK cells.', 'armGroupLabels': ['Study Participants'], 'otherNames': ['Cyclophosphamide', 'Fludarabine', 'Thiotepa', 'Melphalan', 'OKT3']}, {'type': 'DEVICE', 'name': 'Miltenyi Biotec CliniMACS', 'description': 'Stem cell selection device', 'armGroupLabels': ['Study Participants']}, {'type': 'PROCEDURE', 'name': 'Allogeneic stem cell transplantation', 'description': 'Allogeneic natural killer (NK)cell infusion', 'armGroupLabels': ['Study Participants'], 'otherNames': ['Haploidentical stem cell transplantation', 'Allogeneic stem cell transplant', 'Immunotherapy', 'Mismatched family member donor transplant', 'NK cell infusions']}]","Inclusion Criteria: Must have one of the following diagnosis: * AML in remission or relapse (e.g., FAB M7 or biphenotypic leukemia) * High-risk ALL in first remission (e.g., poor responder to prednisone, Ph+ ALL) * ALL beyond first remission * Secondary leukemia * Primary myelodysplasia (including RAEB, RAEB-T, CMML, JCML, and JMML) * Chronic myeloid leukemia * Histiocytoses (including multi-system Langerhans' cell histiocytosis and hemophagocytic lymphohistiocytosis Inclusion criteria Donor research participants * HIV negative (date). * Hepatitis B surface antigen negative (date). * Hepatitis C antibody negative (date). * Syphilis negative (date). * Donor is equal to or greater than 3 on 6 HLA match (date). * Not pregnant (negative pregnancy test). * Not lactating. * At least 18 years of age. Exclusion Criteria * Patients greater than 24 months of age at the time of transplant. * HLA-identical sibling donor is available. * Cardiac function: shortening fraction \<25%. * Pulse oximetry oxygen saturation \<92% on room air. * Glomerular filtration rate less than 40 ml/min/1.73 m2 (may use Technetium-99 result for GFR). * Direct bilirubin \> 3 mg/dl. * SGPT \> 500 U/L. * Patients with previous allergy to mouse proteins. * Patients with previous allergy to rabbit serum products. * Patients with Down's syndrome",NA,ALL,NA,"[{'measure': 'One-year Survival', 'description': 'The one-year survival of infants with high-risk hematologic malignancies who receive a haploidentical transplant procedure using a total body irradiation (TBI)-excluding conditioning regimen followed by an HLA-nonidentical family donor hematopoietic stem cell (HSC) graft depleted of T cells ex vivo using the CliniMACS CD34+ selection system, with a subsequent infusion of donor NK cells purified ex vivo using the CliniMACS CD3+ depletion and CD56+ enrichment system.\n\nThe Kaplan-Meier estimate for one-year survival is reported.', 'timeFrame': 'One year after transplant'}]","[{'measure': 'Number of Transplant-Related Adverse Outcomes: Regimen-Related Mortality', 'description': 'The cumulative incidences of regimen-related mortality will be estimated using method of Kalbfleisch and Prentice.', 'timeFrame': '100 days post-transplantation'}, {'measure': 'Number of Transplant-Related Adverse Outcomes: Engraftment Failure', 'description': 'Engraftment failure is defined as \\<10% donor cell chimerism at any time point between 28 and 100 days after transplant with no evidence of disease relapse or requiring stem cell boost.', 'timeFrame': '100 days post-transplantation'}, {'measure': 'Number of Transplant-Related Adverse Outcomes: Fatal Acute Graft-Versus Host Disease (GVHD)', 'description': 'The cumulative incidence estimate for occurrence of fatal acute GVHD by the end of the first 100 days post-transplant was calculated using method of Kalbfleisch and Prentice.', 'timeFrame': '100 days post-transplantation'}, {'measure': 'Number of Incidences of Chronic GVHD.', 'description': ""Chronic GVHD was graded according to Seattle Criteria: limited or extensive. Limited is defined as localized skin and/or hepatic dysfunction. Extensive is defined as one or more of the following:\n\n* generalized skin involvement\n* liver histology showing chronic aggressive hepatitis, bridging necrosis or cirrhosis\n* eye dryness with Schirmer's test \\<5 mm wetting\n* oral: involvement of salivary glands or oral mucosa\n* other: another target organ involvement"", 'timeFrame': 'Up to 5 years after transplant'}, {'measure': 'Factors Affecting One-year Survival: Median Age of Donor at HSCT', 'description': 'Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).', 'timeFrame': 'Up to one year after transplant'}, {'measure': 'Factors Affecting One-year Survival: Median Dose of CD34', 'description': 'Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).', 'timeFrame': 'Up to one year after transplant'}, {'measure': 'Factors Affecting One-year Survival: Median Dose of NK Cells', 'description': 'Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).', 'timeFrame': 'Up to one year after transplant'}, {'measure': 'Factors Affecting One-year Survival: Disease Status at HSCT', 'description': 'Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).', 'timeFrame': 'Up to one year after transplant'}, {'measure': 'Factors Affecting One-year Survival: Donor Type', 'description': 'Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).', 'timeFrame': 'Up to one year after transplant'}, {'measure': 'Factors Affecting One-year Survival: Match N/6 HLA Loci', 'description': 'HLA typing determined the degree of match by looking at 6 different HLA loci. The results indicate the number of the 6 loci that matched for each participant. Due to small sample size (n=14) and total number of events (n=7), the analysis to check the various factors that affect the one-year survival was not performed (using logistic and cox model).', 'timeFrame': 'Up to one year after transplant'}, {'measure': 'Factors Affecting One-year Survival: Minimal Residual Disease (MRD)', 'description': 'Detection of leukemia blasts in bone marrow by flow cytometry', 'timeFrame': 'Up to one year after transplant'}, {'measure': 'Incidence of and Risk Factors for Organ Dysfunction.', 'description': 'The organ dysfunction will be summarized using summary statistics and assessed in a longitudinal manner and analyzed accordingly.', 'timeFrame': 'Up to 5 Years after transplant'}, {'measure': 'Incidence of and Risk Factors for Long-term Neurocognitive Deficit.', 'description': 'The long-term neurocognitive deficit will be summarized using summary statistics and assessed in a longitudinal manner and analyzed accordingly.', 'timeFrame': 'Up to 5 Years after transplant'}, {'measure': 'Frequency of and Clinical Relevance of Minimal Residual Disease (MRD) Before and After Transplantation', 'description': 'The presence or absence of MRD before and after the bone marrow transplant (BMT) and its frequency distribution will be obtained for each time point separately.', 'timeFrame': 'Baseline before HSCT, 1 year post HSCT, and up to 5 years post HSCT'}, {'measure': 'Kinetics of Lymphohematopoietic Reconstitution', 'description': 'The lymphohematopoietic reconstitution will be summarized using summary statistics and assessed in a longitudinal manner and analyzed accordingly.', 'timeFrame': 'From 0-3 months after HSCT through 4-5 years after HSCT'}]" 278,NCT06861530,"{'fullName': ""University Children's Hospital Basel"", 'class': 'OTHER'}",A Swiss Assessment of Hypothalamic-pituitary-adrenal Axis Suppression After Glucocorticoid Therapy for Leukemia and Lymphoblastic Lymphoma in Children,RECRUITING,"Plain Language Summary: Background Glucocorticoids are stress hormones produced by the human body to control inflammation and regulate the immune system. Cortisol is the most well-known example of a glucocorticoid. These stress hormones are essential for the bodys healthy functioning. To treat certain types of cancer, such as leukemia (blood cancer) in children, glucocorticoids are administered as medications in large quantities. This helps rapidly reduce the number of cancer cells in the body but also leads to the suppression of the body's natural glucocorticoid production, causing a deficiency. This deficiency can be particularly dangerous for children with leukemia, as their immune defenses are already weakened by chemotherapy, leading to an increased risk of infections. Moreover, the signs of glucocorticoid deficiency in children with leukemia are often indistinguishable from the side effects of chemotherapy, making the deficiency harder to detect. Objectives The aim of the study is to understand how frequently and for how long the body's natural glucocorticoid production is impaired in children treated for lymphoblastic leukemia and lymphoblastic lymphoma. Additionally, the goal is to identify which children are at particularly high risk. By gaining a better understanding, this study may help to improve the detection and treatment of glucocorticoid deficiency in children with blood cancer. Methods Regular low-dose ACTH tests will be conducted to assess the bodys natural glucocorticoid production during and after treatment. To avoid placing additional burden on children who are already heavily affected by the disease, these tests will only be performed when there is already a venous access established and the children are in the hospital for treatment reasons.","['Adrenal Insufficiency', 'Leukemia, Lymphoblastic, Acute, Pediatric', 'Lymphoma, Lymphoblastic']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}",NA,"Inclusion Criteria: * diagnosed with ALL or LBL * treated for at least 21 sequential days with glucocorticoids between the 01.07.2024 and the 30.06.2027 at the Childrens University Hospital of Basel or at the Childrens Hospital of Aarau * lnformed consent can be obtained from the patient\'s legal representatives (and the patient if at least 14 years of age) within week 2 of treatment with glucocorticoids Exclusion Criteria: \- Contraindication to the administration of intravenous synthetical ACTH (Synacthen®): extremely rare cases of known or suspected hypersensitivity to Synacthen®.","Children aged 0-17 years who are: Diagnosed with ALL or LBL, and who are treated for at least 21 sequential days with glucocorticoids between the 01.07.2024 and the 30.06.2027 at the Childrens University Hospital of Basel or at the Childrens Hospital of Aarau",ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Occurence of Adrenal Insufficiency', 'description': 'The primary outcome of this study is he measurement of the occurrence of HPA axis suppression. The outcome is binary (yes/no) and is considered yes, if a HPA axis suppression occurs at 1 test or more. HPA axis suppression is commonly defined as stimulated cortisol levels below 500nmol/l (below 18μg/dl) in the low-dose ACTH stimulation test, i.e. a measurement of cortisol 30 minutes and 60 minutes after the stimulation with 1 μg of synthetical ACTH (Synacthen®).\n\nFor further analyses the following subgroups may be considered:\n\n\\- Morning cortisol according to current norm values from our laboratory: suppressed if below 66nmol/l (1-11 years) / below 100nmol/l (12-18 years)\n\n* Stimulated peak cortisol 300-500nmol/l = partially suppressed; below 300nmol/l = suppressed\n* Increment of cortisol after stimulation (basal to peak):\n\nbelow 100nmol/l = suppressed, 100-200nmol/l = partially suppressed, above 200nmol/l = normal', 'timeFrame': 'Study enrollment until 3 months after the last dose of glucocorticoid treatment'}]","[{'measure': 'Duration of Adrenal Insufficiency', 'description': 'The measurement of the duration of HPA axis suppression. The outcome is continuous (in weeks). lf there is no occurrence of HPA axis suppression (primary outcome, then this secondary outcome is 0 weeks.\n\nThe cut-off values are specified under the primary outcome section.', 'timeFrame': 'Study enrollment until 3 months after the last dose of glucocorticoid treatment'}]" 279,NCT02432911,"{'fullName': 'ChineseAMS', 'class': 'UNKNOWN'}",Treatment of Elderly Chinese Acute Myeloid Leukemia Patients Aged 65 to 75 Years Old,UNKNOWN,This study focus on the comparison of CAG regimen to the low dose cytarabine therapy in elderly AML patients who are unfit or unwilling to receive intensive chemotherapy.,['Acute Myeloid Leukemia'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'CAG regimen (Aclacinomycin, cytarabine, with/w/o G-CSF)', 'description': 'Aclacinomycin 20mg/d for 4 days combined with cytarabine 20mg bid for 10 days with/without G-CSF 6ug/m2 from 1 day before therapy to day 10 of therapy.', 'armGroupLabels': ['CAG regimen']}, {'type': 'DRUG', 'name': 'low dose cytarabine', 'description': 'cytarabine 20mg bid for 10 days.', 'armGroupLabels': ['Low dose cytarabine'], 'otherNames': ['cytarabine']}]","Inclusion Criteria: * Acute myeloid leukemia except APL * ECOG PS：0-3 * Unfit or unwilling to receive intensive therapy Exclusion Criteria: * The one who has already received induction therapy no matter what the outcome is. * Active cancer patients who are needed to receive treatment; * Serious uncontrolled infectious diseases(eg.tuberculosis or invasive pulmonary aspergillosis）； * Active heart disease",NA,ALL,NA,"[{'measure': 'overall survival', 'timeFrame': '3 years'}]","[{'measure': 'complete remission rate', 'timeFrame': '4 months'}, {'measure': 'relapse free survival', 'timeFrame': '3 years'}, {'measure': 'treatment-related mortality', 'timeFrame': '2 months'}]" 280,NCT06564493,"{'fullName': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}","A Prospective, Open-label, Randomized Controlled, Multicenter Clinical Study of MSD-HSCT Using a TBI or TMLI Conditioning Regimen for Pediatric ALL",RECRUITING,"This study aims to compare the effects of two different conditioning regimens on patients with acute lymphoblastic leukemia (ALL) undergoing matched sibling donor hematopoietic stem cell transplantation (MSD-HSCT): Total Body Irradiation (TBI) and Total Marrow, Central Nervous System and Lymphoid Irradiation (TMLI). Both regimens are supported and recommended by literature; however, there is no definitive evidence favoring one over the other. We hypothesize that the TMLI regimen, compared to the TBI regimen, may more effectively eliminate leukemia cells in the bone marrow and lymphoid tissues, thereby reducing the risk of relapse, while also minimizing damage to normal tissues, thus reducing conditioning-related toxicity and transplant-related mortality. This study aims to provide evidence for the optimal conditioning regimen for MSD-HSCT in pediatric ALL patients, with the goal of improving patient quality of life and survival outcomes.","['Acute Lymphoblastic Leukemia, Pediatric']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'RADIATION', 'name': 'TBI', 'description': 'The total dose of TBI is 12 Gy, administered on days -7, -6, and -5, with 2 Gy per fraction, twice daily, for a total of 6 fractions.', 'armGroupLabels': ['TBI conditioning group']}, {'type': 'RADIATION', 'name': 'TMLI', 'description': 'The total dose of TMLI is 12 Gy, administered on days -7, -6, and -5, with 2 Gy per fraction, twice daily, for a total of 6 fractions.', 'armGroupLabels': ['TMLI conditioning group']}, {'type': 'DRUG', 'name': 'Cyclophosphamide', 'description': 'The total dose of cyclophosphamide is 120 mg/kg, administered over 2 days on days -4 and -3.', 'armGroupLabels': ['TBI conditioning group', 'TMLI conditioning group'], 'otherNames': ['CTX']}]","Inclusion Criteria: 1. Informed Consent: Participants or guardians must voluntarily sign a written informed consent form. 2. Age and Gender: Participants should be male or female, aged 1-17 years, inclusive. 3. Diagnosis: Participants must be diagnosed with acute lymphoblastic leukemia (ALL) according to World Health Organization (WHO) criteria, and the diagnosis must apply to pediatrics aged 1-17 years. 4. Remission Status: The participant's leukemia must be in hematologic remission (complete remission, CR) prior to transplantation. 5. Donor Availability: There must be a suitable matched sibling donoravailable, and the participant must consent to undergo MSD hematopoietic stem cell transplantation (MSD-HSCT). 6. Karnofsky Performance Status: The participant must have a Karnofsky score of 70 or higher, indicating that they are capable of caring for themselves and carrying out normal activities. Additionally, they must not have significant organ dysfunction, defined by the following: * Cardiac Function: New York Heart Association (NYHA) classification of class II or lower. * Liver Function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be no more than 2.5 times the upper limit of normal. Bilirubin levels should be no more than 2 times the upper limit of normal. * Renal Function: Serum creatinine levels should be no more than 1.5 times the upper limit of normal, or the creatinine clearance rate should be at least 60 ml/min. o Pulmonary Function: Participants should not experience significant dyspnea, should not require oxygen therapy, should not have interstitial lung disease, and should not have any active pulmonary infections. Exclusion Criteria: To be eligible for inclusion in the study, participants must not meet any of the following criteria: 1\. The patient has not achieved hematologic remission before transplantation. 2. The patient has chosen a non-MSD donor. 3\. The patient has severe cardiac, hepatic, renal, or pulmonary diseases that make them unable to tolerate the conditioning regimen. 4\. The patient has an active or refractory infection, or other life-threatening complications. 5\. The patient has a history of other malignant tumors, psychiatric disorders, or HIV infection. 6\. The patients or guardians refuses to sign the informed consent form, is unwilling to comply with clinical follow-up required by the study, or does not consent to the use of their data to support future research, project presentations, and clinical practices. 7\. The investigator deems the patient unsuitable for participation in the study for any other reason.",NA,ALL,NA,"[{'measure': 'Relapse-free survival (RFS)', 'description': 'RFS is defined as the time from transplantation to the first relapse or death, with RFS is defined as the time from transplantation to the first relapse or death, with the date of the last follow-up as the endpoint.', 'timeFrame': '2 years'}, {'measure': 'acute Graft Versus Host Disease (aGVHD)', 'description': 'The incidence of aGVHD within 100 days post-transplant.', 'timeFrame': '100 days'}, {'measure': 'Overall Survival (OS)', 'description': 'OS is defined as the time from transplantation to death, with the date of the last follow-up as the endpoint.', 'timeFrame': '2 years'}]","[{'measure': 'Transplantation Related Mortality (TRM)', 'description': 'The incidence of TRM in 2 years.', 'timeFrame': '2 years'}, {'measure': 'Relapse Rate (RR)', 'description': 'The incidence ratio of leukemia relapse in 2 years.', 'timeFrame': '2 years'}, {'measure': 'Conditioning-related Adverse Events (CRAE)', 'description': 'Based on CTCAE v5.0.', 'timeFrame': '30 days'}]" 281,NCT04013685,"{'fullName': 'Orca Biosystems, Inc.', 'class': 'INDUSTRY'}",Precision-T: A Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies,ACTIVE_NOT_RECRUITING,"This study will evaluate the safety, tolerability, and efficacy of Orca-T, an allogeneic stem cell and T-cell immunotherapy biologic manufactured for each patient (transplant recipient) from the mobilized peripheral blood of a specific, unique donor. It is composed of purified hematopoietic stem and progenitor cells (HSPCs), purified regulatory T cells (Tregs), and conventional T cells (Tcons) in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation for hematologic malignancies.","['Acute Myeloid Leukemia', 'Acute Lymphoid Leukemia', 'Myelodysplastic Syndromes', 'Acute Leukemia', 'Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)', 'Chronic Myeloid Leukemia']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'Orca-T', 'description': 'an allogeneic stem cell and T-cell immunotherapy biologic', 'armGroupLabels': ['Subjects with Acute Leukemia or Myelodysplastic Syndrome, or BPDCN']}]","Key Inclusion Criteria: Recipients must meet all of the following criteria: 1. Patients must be diagnosed with 1 of the following histopathologically confirmed diseases, for which a myeloablative hematopoietic stem cell transplant (HCT) is planned: A) Acute myeloid, lymphoid, or mixed phenotype/undifferentiated leukemia who are not in CR or CRi (active disease) and/or MDS with \>10% to \<20% bone marrow blast burden (ages 18 to 75 years) B) Acute leukemia in CR/CRi or MDS that is DRI intermediate to high risk (ages 66 to 75 years) C) BPDCN (ages 18 to 65 years) D) Participants aged 18 to 65 who would be eligible for the Phase 3 component of Precision-T except for mild impairments of renal and/or hepatic function as defined by an eGFR of 50 to \<60 mL/min and/or a total bilirubin of \>ULN to ≤2 x ULN and diagnosed with either of the following: i. Acute myeloid, lymphoid, or mixed phenotype/undifferentiated leukemia that is in CR/CRi and DRI intermediate to high risk a) MDS that is DRI intermediate to high risk E) Acute or chronic leukemia in remission that is DRI low risk (ages 18 to 65 years), including the following: i. CML in chronic phase but with a history of accelerated phase or blast crisis or who are resistant to or intolerant of more than 1 first- and second-generation tyrosine kinase inhibitors ii. Acute myeloid leukemia (AML) with inv(16) without accompanying complex cytogenetics 2. Patients must be matched to a 8/8 HLA-matched related or unrelated donor 3. Estimated glomerular filtration rate (eGFR) \>50 mL/minute 4. Cardiac ejection fraction at rest ≥45% or shortening fraction of ≥27% by echocardiogram or radionuclide scan (MUGA) 5. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥50% 6. Total bilirubin \<2 times upper limit of normal (ULN) (patients with Gilbert's syndrome may be included where hemolysis has been excluded) and ALT/AST \<3 times ULN Key Exclusion Criteria: Recipients meeting any of the following exclusion criteria will not be eligible: 1. History of prior allogeneic HCT 2. Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg/day are allowed. 3. Pre-planned donor lymphocyte infusion (DLI) 4. Planned pharmaceutical in vivo or ex vivo T cell depletion 5. Positive for anti-donor HLA antibodies against an allele in the selected donor 6. Karnofsky performance score \<70% 7. Hematopoietic cell transplantation-specific Comorbidity Index (HCT-CI) \>4 8. Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment 9. Seropositive for HIV-1 or -2 antibody, HTLV-1 or -2 antibody, Hepatitis B sAg, or Hepatitis C antibody 10. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment 11. Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected 12. Women who are pregnant or breastfeeding",NA,ALL,NA,"[{'measure': 'The incidence of primary graft failure', 'description': 'The incidence of primary graft failure', 'timeFrame': '365 days'}, {'measure': 'The incidence of grade 3 or 4 aGVHD', 'description': 'The incidence of grade 3 or 4 aGVHD', 'timeFrame': '180 days'}]","[{'measure': '1-year overall survival (OS)', 'description': '1-year overall survival (OS)', 'timeFrame': '365 days'}, {'measure': '1 year graft-versus-host-disease-free and relapse-free survival (GRFS)', 'description': '1 year graft-versus-host-disease-free and relapse-free survival (GRFS)', 'timeFrame': '365 days'}, {'measure': 'incidence and severity of acute and chronic graft vs host disease (GvHD)', 'description': 'incidence and severity of acute and chronic graft vs host disease (GvHD)', 'timeFrame': '365 days'}, {'measure': 'incidence of serious infections', 'description': 'incidence of serious infections', 'timeFrame': '365 days'}, {'measure': 'incidence of engraftment', 'description': 'incidence of engraftment of platelets and neutrophils', 'timeFrame': '28 days'}]" 282,NCT05969821,"{'fullName': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}",Clonal Hematopoiesis of Immunological Significance,NOT_YET_RECRUITING,"Ambispective, national, multicenter observational cohort study aimed at characterizing the satellite dysimmune manifestations of clonal hematopoiesis, including Vexas (Vacuoles, E1 enzyme, X-linked, Autoinflammatory and Somatic) syndrome.","['Immune System Diseases', 'Autoimmune Diseases', 'Inflammation', 'Autoinflammatory Diseases', 'Vexas Syndrome', 'Hematopoiesis Clonal', 'Clonal Hematopoiesis of Indeterminate Potential', 'Hematologic Diseases', 'Myelodysplastic-Myeloproliferative Diseases', 'Leukemia Myelomonocytic Chronic', 'Myelodysplastic Syndromes', 'Myeloproliferative Disorders', 'Lymphoproliferative Disorders', 'Lymphoma', 'Leukemia', 'Monoclonal Gammopathy of Undetermined Significance']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'OTHER'}","[{'type': 'OTHER', 'name': 'observational cohort study', 'description': 'observational cohort study', 'armGroupLabels': ['Dysimmune manifestations with or without clonal hematopoiesis']}]","Inclusion Criteria: * Age \>=18 years old; * Confirmed dysimmune manifestations: clinical or biological abnormality or systemic disease; * Presence or absence of myeloid or lymphoid blood disease according to World Health Organization (WHO) classification Exclusion Criteria: * Persons benefiting from special protection: adults under guardianship and curatorship; * People hospitalized without their consent and not protected by law; persons deprived of liberty; * Persons not affiliated to the social security system","The research concerns : * patients whose inflammatory disease without or with haemopathy is already known when the cohort is set up, and for whom data will be collected retrospectively and then prospectively * incident cases identified after the cohort was set up.",ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Incidence of dysimmune manifestations associated with hematological disorders', 'description': 'Number of new cases', 'timeFrame': 'Baseline'}]","[{'measure': 'VEXAS syndrome', 'description': 'Number of patients with VEXAS syndrome', 'timeFrame': '10 years'}, {'measure': 'Dysimmune manifestations other than VEXAS syndrome', 'description': 'Number of patients with dysimmune manifestations other than VEXAS syndrome', 'timeFrame': '10 years'}, {'measure': 'Myeloid hemopathy', 'description': 'Number of patients with myeloid hemopathy', 'timeFrame': '10 years'}, {'measure': 'Lymphoid hemopathy', 'description': 'Number of patients with lymphoid hemopathy', 'timeFrame': '10 years'}, {'measure': 'Clonal hematopoiesis of undeterminate potential', 'description': 'Number of patients with clonal hematopoiesis of undeterminate potential', 'timeFrame': '10 years'}, {'measure': 'Skin involvement', 'description': 'Number of patients with skin involvement', 'timeFrame': '10 years'}, {'measure': 'Musculoskeletal involvement', 'description': 'Number of patients with musculoskeletal involvement', 'timeFrame': '10 years'}, {'measure': 'Ocular involvement', 'description': 'Number of patients with ocular involvement', 'timeFrame': '10 years'}, {'measure': 'Vascular involvement', 'description': 'Number of patients with vascular involvement', 'timeFrame': '10 years'}, {'measure': 'Neurological involvement', 'description': 'Number of patients with neurological involvement', 'timeFrame': '10 years'}, {'measure': 'Digestive system involvement', 'description': 'Number of patients with digestive system involvement', 'timeFrame': '10 years'}, {'measure': 'Cardiac involvement', 'description': 'Number of patients with cardiac involvement', 'timeFrame': '10 years'}, {'measure': 'Pulmonary involvement', 'description': 'Number of patients with pulmonary involvement', 'timeFrame': '10 years'}, {'measure': 'Renal involvement', 'description': 'Number of patients with renal involvement', 'timeFrame': '10 years'}, {'measure': 'Therapeutic interventions received', 'description': 'Type and duration of therapeutic interventions received', 'timeFrame': '10 years'}, {'measure': 'Progression to acute myeloid leukemia', 'description': 'Number of patients who progressed to acute myeloid leukemia', 'timeFrame': '10 years'}, {'measure': 'Overall mortality', 'description': 'Overall mortality rate from all causes', 'timeFrame': '10 years'}]" 283,NCT05398614,"{'fullName': 'Hebei Senlang Biotechnology Inc., Ltd.', 'class': 'INDUSTRY'}",SENL101 Autologous T Cell Injection in Adults With Relapsed or Refractory CD7+ Hematolymphoid Malignancies,UNKNOWN,To evaluate the tolerability and safety of SENL101 in patients with relapsed or refractory CD7+ hematolymphoid malignancies.,"['T-ALL', 'Lymphoma, T-Cell']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'SENL101', 'description': 'Patients will be treated with CD7 CAR-T cells', 'armGroupLabels': ['CD7 CAR-T']}]","The subjects of this study were patients with recurrent or refractory hematocratic malignancies of CD7+. Inclusion Criteria: 1. Subjects diagnosed with refractory/relapsing T-cell leukaemia/lymphoma met one of the following criteria: relapse: disease recurrence after complete remission with at least two prior regiments or complete remission with stem cell transplantation; Refractory: patients who have received at least two previous treatment regimens and failed to achieve a complete or partial response after the last treatment (leukemia patients), or failed to achieve a response after stem cell transplantation or develop disease progression; 2. The tumor cells detected by bone marrow flow cytometry were CD7+ and/or extramedullary lesions were diagnosed as CD7+ by pathological immunohistochemistry at the time of enrollment and screening; 3. If tumor cells were detected in peripheral blood during enrollment and screening, it was required to meet the requirement that the surface immunophenotype of tumor cells was CD4 and CD8 double negative by flow cytometry. If the surface phenotype of peripheral blood tumor cells was not CD4 and CD8 double negative, the proportion of tumor cells in peripheral blood was ≤1%; 4. Life expectancy greater than 12 weeks; 5. ECOG 0-2; 6. Age 18-65 (upper and lower limits included); 7. HGB at least 70g/L,PLT 20x109/L, can be transfused; 8. Liver and kidney functions The cardiopulmonary functions meet the following requirements: Oxygen saturation under air ≥ 92%; LVEF≥45%; Total bilirubin \<3×ULN; ALT/AST\<5×ULN; Creatinine \<1.5×ULN; 9. Informed consent explained to, understood by and signed by patient/ guardian. Exclusion Criteria: Those who meet any of the following criteria are not eligible to join the group: 1. New York Heart Association (NYHA) classification ≥ grade III heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris or other clinically prominent heart disease within one year before signing the informed consent form, Or QTc interval \>480ms at screening (QTc interval calculated by Fridericia formula); 2. If the patient has a history of hematopoietic stem cell transplantation, 6 months after the patient received allogeneic hematopoietic stem cell transplantation; 3. Those with active GvHD or those who require immunosuppressive therapy; 4. Malignancy other than T-cell acute lymphoblastic leukemia/lymphoma within 5 years prior to screening, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer after radical surgery, radical surgery ductal carcinoma in situ; 5. Active or uncontrollable infection requiring systemic treatment within 7 days prior to screening (except for mild urogenital infections and upper respiratory tract infections); 6. History of autoimmune disease (eg, rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease) requiring systemic immunosuppressive/systemic disease modulating medication within the past 2 years; 7. When screening, if the hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HbcAb) is positive, and the peripheral blood hepatitis B virus (HBV) DNA is higher than the detection limit, it needs to be excluded; if the hepatitis C virus (HCV) antibody is positive, the peripheral blood HCV Those with positive RNA need to be excluded; those with positive human immunodeficiency virus (HIV) antibody; those with positive cytomegalovirus (CMV) DNA test; those with positive test for Treponema pallidum specific antibody (TPPA) need to be excluded; 8. Participate in other clinical trials within 4 weeks before the informed consent is signed, or the date of the informed consent is signed and the last medication of the drug is still within 5 half-lives of the drug (whichever is longer); 9. History of severe allergy to biological products; 10. Unstable systemic disease as judged by the investigator: including but not limited to severe liver, kidney or metabolic disease requiring drug therapy; 11. Pregnant or breastfeeding women, and female subjects planning pregnancy within 2 years of cell infusion or male subjects whose partner is planning pregnancy within 2 years of cell infusion; 12. Subjects who have received CAR-T therapy or other gene-modified cell therapy prior to screening; 13. Circumstances that the investigator believes may increase the risk to the subject or interfere with the results of the trial.",NA,ALL,NA,"[{'measure': 'Safety: Incidence and severity of adverse events', 'description': 'The incidence and severity of adverse events and adverse reactions from infusion to withdrawal or before the safety follow-up period', 'timeFrame': '24 months post CAR-T cells infusion'}]",NA 284,NCT00858806,"{'fullName': 'Università degli Studi di Brescia', 'class': 'OTHER'}",Intermittent Imatinib Treatment in Chronic Myeloid Leukemia and Philadelphia Chromosome (Ph+CML) Patients Who Achieved a Complete Cytogenetic Response (CCgR) on Standard Imatinib Therapy,COMPLETED,"Standard therapy with Imatinib (IM) significantly prolongs the survival of Ph+CML patients who obtain a complete cytogenetic response (CCgR). Elderly patients (i.e., at least 65 years) have similar cytogenetic responses and survival, but they usually show a low compliance. The aim of the study is to evaluate the percentage of elderly patients who maintain a CCgR with intermittent imatinib therapy with respect to standard daily administration.",['Chronic Myeloid Leukemia'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Imatinib', 'description': 'Intermittent Imatinib administration.\n\n* 1 week on / 1 week off for the 1st month(weeks 1-4)\n* 2 weeks on / 2 weeks off for the 2nd and the 3rd month (weeks 5-12)\n* 1 month on / 1 month off from the 4th month thereafter (weeks 13 on)', 'armGroupLabels': ['Intermittent Imatinib'], 'otherNames': ['glivec']}]","Inclusion Criteria: 1. Patients with confirmed diagnosis of Ph+ CML in CP 2. Age ≥ 65 years old 3. Stable CCgR after at least 2 years of treatment with standard (daily administration) IM therapy documented by 2 consecutive cytogenetic analysis over the last 12 month 4. Karnofsky performance status \>50% 5. Written informed consent prior to any study procedures being performed. Exclusion Criteria: 1. Patients with Ph+ CML in accelerated/blastic phase (AP/BP), or in late CP, previously treated (i.e. IFN alpha+/- low dose Ara-C, Hydroxyurea, allogeneic stem cell transplantation, etc etc.) 2. Age \< 65 years old 3. No stable CCgR after at least 2 years of treatment with standard (daily administration) IM therapy documented by 2 consecutive cytogenetic analysis over the last 12 month 4. Karnofsky performance status \<50% 5. No written informed consent prior to any study procedures being performed.",NA,ALL,NA,"[{'measure': 'The proportion of patients who remain in CCgR with INTERIM given for one year.', 'timeFrame': '1 year'}]","[{'measure': 'Variation of BCR-ABL transcript level', 'timeFrame': '1 year'}]" 285,NCT01795716,"{'fullName': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}",Bioequivalence Study of Mesylate Imatinib Capsule in Chronic Myeloid Leukemia Body,COMPLETED,"1. purpose: To conduct the relative bioavailability study of a single dose and multiple doses of imatinib mesylate capsule (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus Glivec (Novartis Pharma Stein AG). 2. Experimental Design： Two-period crossover design 3. Test drug: imatinib mesylate capsule Reference drug: Glivec 4. Sample size：20",['Chronic Myeloid Leukemia'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'mesylate imatinib capsule', 'description': 'Single and multiple oral mesylate imatinib capsule 400mg qd', 'armGroupLabels': ['mesylate imatinib capsule'], 'otherNames': ['111201']}, {'type': 'DRUG', 'name': 'Glivec', 'description': 'Single and multiple oral Glivec 400mg qd', 'armGroupLabels': ['Glivec'], 'otherNames': ['Mesylate Imatinib tablet']}]","Inclusion Criteria: * Patients with chronic myeloid leukemia; * Age: 18-65 years,gender:both. * Weight: standard weight ± 20% within, and avoid weight disparity is too large; * No previous radiation therapy, chemotherapy, or surgery within 1 weeks before treatment with imatinib; * Performance status 0 to 3 (WHO scale); Life expectancy greater than 3 months; * No other malignancy; * Adequate hepatic, renal, and bone marrow function (WBC≥3.0×109/L，ANC≥1.5×109/L，PLT≥80×109/L. Serum bilirubin≤1.5×the institutional upper limit of normal, ALT、ALP≤2.5×the institutional upper limit of normal, creatinine≤1.5×the institutional upper limit of normal); * Ability to understand objectives of the study, the study procedure, the pharmacological properties of the drug and possible adverse reactions and the willingness to sign a written informed consent. Exclusion Criteria: * Suffering from heart, liver, kidney disease or severe acute and chronic gastrointestinal diseases; * Pregnant or lactating women and be sensitive to drug; * Subjects are thought unsuitable for the study by investigators; * Inability to comply with protocol or study procedures in the opinion of the investigator; * Attending other clinical trials or attended other clinical trials 3 months ago.",NA,ALL,NA,"[{'measure': 'Area Under Curve (AUC) Time Frame: Predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours Post-dose', 'timeFrame': 'predose, 0.5,1,1.5,2,3,5,8,12,24,48,72hours post-dose'}]",NA 286,NCT04670016,"{'fullName': 'University of Calgary', 'class': 'OTHER'}",HRQL and Symptom Assessment for Patients With DIPG or Recurrent and Re-irradiated Brain Tumours and Their Caregivers,COMPLETED,"Although many children with brain tumours are successfully cured of their disease, a substantial proportion of patients suffer disease recurrence and require further treatment. This therapy may involve a repeat course of radiation (RT2). Based on retrospective data, re-irradiation may provide palliative and even potentially curative benefit. However, such retrospective data are subject to bias, which may over-report survival and under-report toxicity. Furthermore, we do not know how re-irradiation affects patients' HRQOL. The goal of this research is to prospectively describe the HRQOL of patients diagnosed with DIPG and recurrent brain tumors and their families before and after re-irradiation to more accurately assess the benefit versus the toxicity of this treatment. In addition, if we are able to demonstrate the feasibility of collecting HRQOL information on a routine basis we will be able to justify the need to conduct this research further and implement HRQOL screening as a standard of care for these patients. Re-irradiation for children with DIPG and recurrent brain tumours will not cure these children from their disease but may improve neurological function and wellbeing. We postulate that the opportunity of more time to say the final good bye and creating memories will facilitate bereavement and prevent psychological dysfunction of parents and siblings. A greater understanding of what helps these families may enable clinicians to better support these children and their families in this difficult disease course. Ultimately our goal is to improve the psychological experience of these patients and their families.","['DIPG', 'Brain Tumor, Pediatric, Recurrent', 'Brain Tumor, DIPG', 'Radiation Toxicity', 'Radiation Exposure', 'Brain Tumor, Pediatric']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'OTHER', 'name': 'This study does not include an intervention.', 'description': 'This study does not include an intervention.', 'armGroupLabels': ['Patient/Caregiver dyad diagnosed with DIPG', 'Patient/Caregiver dyad with re-RT for a recurrent brain tumour']}]","Inclusion Criteria: 1. Patient aged \>2 and \<21 years treated with a repeat course of radiation for DIPG or other recurrent or progressive brain tumour. 2. Radiation for the first tumour must be a primary brain neoplasm (i.e. not leukemia). 3. Enrollment within 14 days of starting re-irradiation (RT2). 4. Patients with malignant transformation of the first tumour are eligible. 5. There are no restrictions on histology or RT1/RT2 dose-fractionation or RT2 body site. In other words, RT2 may be directed at a different location to RT1. 6. The patient is treated at a site where the study is approved by the local ethics board 7. Consent, and, if applicable, assent, has been obtained according to institutional standards Exclusion Criteria: 1\. Inability to complete questionnaires in English or French.","Up to 30 patients diagnosed with DIPG and up to 32 patients diagnosed with another recurrent or progressive brain tumor will be enrolled in this study. There will be no registration on study for screening purposes only. Eligible patients who consent to this study therapy will be registered at the PI's institution, specifically with the PI's research coordinator. A study subject number will be assigned to the patient upon registration.",ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Health-related quality of life (HRQOL) for children diagnosed with DIPG and in children treated with re-irradiation for a recurrent brain tumour', 'description': 'Health-related quality-of-life will be measured using the Pediatric Quality of Life Inventory (PedsQL) General Core Scales', 'timeFrame': '2 months after the second radiation'}]","[{'measure': 'HRQOL disease specific modules and family impact', 'description': 'PedsQL Brain Tumor and Family Impact Module', 'timeFrame': '2 months after the second radiation]'}, {'measure': 'Symptom burden for children diagnosed with DIPG and in children treated with re-irradiation for a recurrent brain tumour', 'description': 'Symptom Screening in Pediatrics (SSPEDI)', 'timeFrame': '2 months after the second radiation]'}, {'measure': 'Caregiver HRQOL', 'description': 'Short Form 36 (SF-36)', 'timeFrame': '2 months after the second radiation]'}, {'measure': 'Anxiety, Depression and Pain Interference', 'description': 'Patient Reported Outcomes Measurement Information System (PROMIS): Anxiety, Depression and Pain Interference Short Forms', 'timeFrame': '2 months after the second radiation]'}, {'measure': 'Radiation necrosis (RN), local control, progression-free survival and overall survival after re-irradiation.', 'description': 'Radiation necrosis without obvious tumour progression', 'timeFrame': '12 months'}]" 287,NCT04965649,"{'fullName': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}",Is There an Association Between Innate CD8+ T Cells and the Evolution of Tyrosine Kinase Inhibitor Resistance Mutations in Phi+ Hematological Malignancies.,COMPLETED,"The aim of this project is to test whether low levels of BcrAbl1, despite the presence of resistance mutations, are related to high levels of innate CD8+ T cells, in the hypothesis that these cells have an anti-tumor role. This research aims to investigate: * An association between the rate of innate CD8+ T cells and the evolution of Phi+ pathologies (Chronic Myeloid Leukemia and Philadelphia chromosome-positive Acute lymphocytic leukemia (Phi+ ALL) carrying a resistance mutation, according to the ELN 2013 and Phi LMC recommendations. * An association between the level of innate CD8+ T cells and the expansion of TKI resistance clones, assessed as the number of BcrAbl1 copies carrying the mutation relative to the number of Abl1 copies.","['Leukemia', 'Myelogenous Leukemia', 'Chronic Leukemia', 'BCR-ABL Positive Acute Myeloid Leukemia']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}","[{'type': 'GENETIC', 'name': 'Phenotyping of total and innate CD8+T cells by flow cytometry', 'description': 'Blood samples from patients in the active file of the Clinical Cytology and Cytogenetics Laboratory at Nîmes University Hospital will be analyzed (diagnosis already known). Samples will be representative of the different stages of the pathology.\n\nFor patients with a confirmed diagnosis of Chronic Myeloid Leukemia and Philadelphia+ Acute Lymphoblastic Leukemia), the remaining whole blood sample taken as part of the usual management will be sent for phenotyping of CD8+ TL (total and innate) by flow cytometry. Phenotyping will be performed on samples pooled at the end of the recruitment period.', 'armGroupLabels': ['Chronic Myeloid Leukemia', 'Philadelphia+ Acute Lymphoblastic Leukemia'], 'otherNames': ['Evaluation of clinical evolution of the pathology and response to treatment according to ELN 2013 criteria.']}]","Inclusion Criteria: * Chronic Myeloid Leukemia or Phi+ ALL patients with TKI resistance mutations being monitored by the Clinical Cytology and Cytogenetics Laboratory at Nîmes University Hospital. * Pathology resulting from a BcrAbl1 fusion gene (CML or Phi+ ALL) and presence of a TKI resistance mutation. * Patients affiliated to or beneficiaries of a health insurance scheme. * Adult patients over18 years of age. Exclusion Criteria: * Blast crisis stage pathology (according to WHO 2017 criteria (Table2.01, p33, WHO classification of tumours of haematopoietic and lymphoid tissues, IARC 2017). * Patients Under 18 years of age",Patients suffering from Philadelphia+malignant hemopathies (Chronic Myeloid Leukemia and Philadelphia+ Acute Lymphoblastic Leukemia ) followed by the Clinical and Cytogenetic Cytology Laboratory at Nîmes University Hospital.,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Association between innate CD8+ T cell population levels and the rate of progression of TKI resistance mutations in Chronic Myeloid Leukemia: mutated BcrAbl1', 'description': 'The number of copies of mutated BcrAbl1 / 1000 copies of Abl1 will be measured.', 'timeFrame': '1-6 months after collecting last sample'}, {'measure': 'Association between innate CD8+ T cell population levels and the rate of progression of TKI resistance mutations in Chronic Myeloid Leukemia: % of BcrAbl1', 'description': 'The percentage of BcrAbl1 will be measured against total Abl1', 'timeFrame': '1-6 months after collecting last sample'}, {'measure': 'Association between innate CD8+ T cell population levels and the rate of progression of TKI resistance mutations in Chronic Myeloid Leukemia: % of innate CD8+ T cells', 'description': 'The percentage of innate CD8+ T cells will be measured against total CD8+ T cells.', 'timeFrame': '1-6 months after collecting last sample'}, {'measure': 'Association between innate CD8+ T cell population levels and the rate of progression of TKI resistance mutations in Philadelphia+ Acute Lymphoblastic Leukemia:mutated BcrAbl1', 'description': 'The number of copies of mutated BcrAbl1 / 1000 copies of Abl1 will be measured.', 'timeFrame': '1-6 months after collecting last sample'}, {'measure': 'Association between innate CD8+ T cell population levels and the rate of progression of TKI resistance mutations in Philadelphia+ Acute Lymphoblastic Leukemia:% of BcrAbl1', 'description': 'The percentage of BcrAbl1 will be measured against total Abl1', 'timeFrame': '1-6 months after collecting last sample'}, {'measure': 'Association between innate CD8+ T cell population levels and the rate of progression of TKI resistance mutations in Philadelphia+ Acute Lymphoblastic Leukemia:% of innate CD8+ T cells', 'description': 'The percentage of innate CD8+ T cells will be measured against total CD8+ T cells', 'timeFrame': '1-6 months after collecting last sample'}]","[{'measure': 'Association between the rate of innate CD8+ T cells and the molecular response during Chronic myeloid Leukemia.', 'description': 'In patients with Chronic Myeloid Leukemia, data from the patient file will be used to qualitatively analyse the nature of BcrABl1 transcripts.', 'timeFrame': '1-6 months after collecting last sample'}, {'measure': 'Association between the rate of innate CD8+ T cells and the molecular response during Philadelphia + Acute Lymphoblastic Leukemia', 'description': 'In patients with Philadelphia + Acute Lymphoblastic Leukemia data from the patient file will be used to qualitatively analyse the nature of BcrABl1 transcripts.', 'timeFrame': '1-6 months after collecting last sample'}]" 288,NCT00795548,"{'fullName': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}",Safety Study of 5-Azacitidine and Standard Donor Lymphocyte Infusion (DLI) to Treat Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) Relapsing After Allogeneic Stem Cell Transplantation,COMPLETED,This open label phase-II trial evaluates hematological response of an additional treatment with 5-Azacitidine to common DLI in patients with MDS or AML relapsing after allogeneic stem cell transplantation.,"['Myelodysplastic Syndrome', 'Acute Myeloid Leukemia']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': '5-Azacitidine', 'description': '5-Aza will be administered at doses of 100mg/m2 via subcutaneous injection over a period of 5 days. The total amount per treatment cycle, consisting of 5 days, is 500mg/m². Each treatment cycle is repeated every 28 days, with a treatment pause of 23 days between each 5-Aza cycle, to a total of 6 (optional 8 cycles) cycles.\n\nDLI will be transfused on day +34 with a total count of CD3+ cells of DLI 1-5x10E6CD3+/kg bodyweight. In absence of GvHD DLI transfusion is repeated on day +90 with DLI 1-5x10E7CD3+/kg bodyweight and on day +142 with DLI 1-5x10E8CD3+/kg bodyweight. Additional DLI may be given.', 'armGroupLabels': ['5-Azacitidine'], 'otherNames': ['Vidaza']}]","Inclusion Criteria: \- Primary and secondary MDS, AML after MDS, and de novo AML relapsing after allogeneic stem cell transplantation * Eligibility for Donor Lymphocyte Infusions * Performance status according to the WHO scale: 0, 1 or 2. * Adequate renal and liver function: bilirubin \< 1.5 times the upper limit of normal and a GFR \> 50 ml/min * Absence of severe cardiovascular disease, i.e., arrhythmias requiring chronic treatment, congestive heart failure (NYHA Class III or IV) or symptomatic ischemic heart disease, where New-York Heart Association (NYHA) * HIV negative and HBs-Ag negative. * Absence of active uncontrolled infection (Septicaemia). * No prior history or current evidence of central nervous system and psychiatric disorders requiring hospitalization. * Age at least 18 years. * Negative pregnancy test for women with reproductive potential. * Signed written informed consent must be given according to national/local regulations. Exclusion Criteria: \- Have malignant hepatic tumors. * Severe liver dysfunction CHILD B and C. * Renal insufficiency with a GFR \< 50 ml/min * Radiation therapy, chemotherapy, or cytotoxic therapy, given to treat conditions other than MDS, AML or applied for conditioning prior allogeneic stemcell transplantation. * Psychiatric illness that would prevent granting of informed consent. * Treatment with androgenic hormones during the previous 14 days prior Day 1. * Active viral infection with known human immunodeficiency virus (HIV) or viral Hepatitis B or C. * Hypersensitivity to Mannitol or 5-Azacitidine. * Treatment with other investigational drugs following relapse after allogeneic stemcell transplantation or ongoing adverse events from previous treatment with investigational drugs regardless of time period.",NA,ALL,NA,"[{'measure': 'Best response', 'timeFrame': 'within the 6 months of treatment'}]","[{'measure': 'Safety and Toxicity of 5-Azacitidine for patients relapsing after allo-SCT', 'timeFrame': 'within 3 years'}, {'measure': 'Response rate', 'timeFrame': 'within 6 months'}, {'measure': 'Duration of remissions', 'timeFrame': 'within 3 years'}, {'measure': 'Incidence of acute and chronic GvHD', 'timeFrame': '3 years'}, {'measure': 'Achievement of complete chimerism', 'timeFrame': '6 month'}, {'measure': 'Toxicity', 'timeFrame': 'wtihin 3 years'}]" 289,NCT01258816,"{'fullName': 'Clavis Pharma', 'class': 'INDUSTRY'}",The Pharmacokinetics and Cardiac Properties of Elacytarabine (CP-4055),COMPLETED,The purpose of the study is to investigate the pharmacokinetics (PK) and cardiac properties of elacytarabine in patients with relapsed or refractory Acute Myeloid Leukaemia (AML). The efficacy and tolerability of elacytarabine will also be assessed.,['Relapsed/Refractory AML'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Elacytarabine for infusion', 'description': 'Elacytarabine 2000 mg/m2/d will be administered as a continuous intravenous infusion (CIV) in a d 1-5 q3w schedule.', 'otherNames': ['CP-4055']}]","Inclusion¨Criteria: 1. Patients must have relapsed / refractory AML according to WHO classification (excluding acute promyelocytic leukaemia) 2. Patients must have ECOG Performance Status (PS) of 0 - 2 3. Patients must be 18 years of age or older 4. Women of child-bearing potential must have a negative serum or urine pregnancy test within two weeks prior to treatment start 5. Male and female fertile patients must use adequate contraception for the duration of the study, and males also for 3 months after the last elacytarabine dose 6. Patients must be capable of understanding and complying with protocol requirements, and they must be able and willing to sign a written informed consent Exclusion Criteria: 1. A history of allergic reactions to egg. A history of CTCAE grade 3 or 4 allergic reactions to ara-C of 2. A history of cancer that according to the investigator might confound the assessment of the endpoints of the clinical study 3. Known positive status for human immunodeficiency virus (HIV) 4. Pregnant and nursing patients 5. Uncontrolled inter-current illness including, but not limited to, uncontrolled infection, or psychiatric illness/social situations that will limit compliance with study requirements 6. Impairment of hepatic or renal function to such an extent that the patient, in the opinion of the investigator, will be exposed to an excessive risk if entered into the clinical study 7. Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medications, or uncontrolled congestive heart failure. Any NYHA grade 3 or 4 8. A history of familial long QT syndrome 9. Patients with history of serious ventricular arrhythmia (VT or VT) 10. ECG criteria at the eligibility visit: QTc ≥ 480 msec calculated using Fridericia's correction (QTcF = QT/RRO,33) or bradycardia (\<50bpm) or criteria for left ventricular hypertrophy 11. treatment with any medications known to produce QT prolongations 12. Treatment with hydroxyurea or 6-mercaptopurine within the last 12 hours prior to treatment on this protocol or any other investigational or standard cytotoxic treatment within the last 14 days 9\. Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities",NA,ALL,NA,"[{'measure': 'Characterise the pharmacokinetics of elacytarabine in patients with relapsed/refractory Acute Myeloid Leukaemia', 'description': 'Collection of pheripheral blood samples at specified time points during first week of the treatment course for PK analyses', 'timeFrame': 'During first week of treatment course'}]","[{'measure': 'Investigate the activity of elacytarabine measured as remission rate (CR + CRi)', 'description': 'Bone marrow and/or blood examination', 'timeFrame': 'After each course'}, {'measure': 'Number of patients with Adverse Events as a measure of safety and tolerability', 'timeFrame': 'Continuously during study'}, {'measure': 'Evaluate the cardiac safety of elacytarabine with focus on the QT/QTc intervals', 'description': 'Triplicate 12-lead ECG assessments will be done at specified time points before, during and after infusion', 'timeFrame': 'During the first week of treatment'}]" 290,NCT00697684,"{'fullName': 'Beth Israel Deaconess Medical Center', 'class': 'OTHER'}","Reduced Intensity Conditioning With Clofarabine, Antithymocyte Globulin (ATG), Total Lymphoid Irradiation (TLI) Followed by Allogeneic Stem Cell Transplant",COMPLETED,"This study will examine the safety of clofarabine, TLI and ATG as a reduced conditioning regimen prior to allogeneic transplantation. The impact of the conditioning regimen on the presence of the circulating regulatory as compared to activated T cell populations will be assessed.The recovery of DC populations post-transplant will be examined, along with the effect of the regimen on disease free and overall survival.","['Acute Myeloid Leukemia', 'Myelodysplastic Syndrome', 'Acute Lymphocytic Leukemia', 'Relapsed/Refractory Chronic Lymphocytic Leukemia', ""Relapsed/Refractory Non Hodgkin's Lymphoma"", 'Hodgkins Disease', 'Relapsed Refractory Multiple Myeloma']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Antithymocyte Globulin', 'armGroupLabels': ['Cohort 2', 'Cohort 3', 'Cohort 4']}, {'type': 'DRUG', 'name': 'Clofarabine', 'description': 'Transplant conditioning will begin day -11 with 5 days of TLI at a dose of 80 cGy per day administered in conjunction with rabbit ATG at a dose of 1.5 mg/kg per day (day -11 to -7). Clofarabine will be given at 20mg/m2/d IV infused over 1 hour x 5 days (day -6 to -2), for a total dose of 100 mg/m(2). TLI will be completed at 80 cGy per day (day -4 to 0) for a total of 10 fractions (800 cGy).', 'armGroupLabels': ['Cohort 2', 'Cohort 3', 'Cohort 4']}, {'type': 'DRUG', 'name': 'Clofarabine', 'description': 'Transplant conditioning will begin day -11 with 5 days of TLI at a dose of 80 cGy per day administered in conjunction with rabbit ATG at a dose of 1.5 mg/kg per day (day -11 to -7). Clofarabine will be given at 30mg/m2/d IV infused over 1 hour x 5 days (day -6 to -2), for a total dose of 150 mg/m(2). TLI will be completed at 80 cGy per day (day -4 to 0) for a total of 10 fractions (800 cGy).', 'armGroupLabels': ['Cohort 2', 'Cohort 3', 'Cohort 4']}, {'type': 'DRUG', 'name': 'Clofarabine', 'description': 'Transplant conditioning will begin day -11 with 5 days of TLI at a dose of 80 cGy per day administered in conjunction with rabbit ATG at a dose of 1.5 mg/kg per day (day -11 to -7). Clofarabine will be given at 40mg/m2/d IV infused over 1 hour x 5 days (day -6 to -2), for a total dose of 200 mg/m(2). TLI will be completed at 80 cGy per day (day -4 to 0) for a total of 10 fractions (800 cGy).', 'armGroupLabels': ['Cohort 2', 'Cohort 3', 'Cohort 4']}]","Inclusion Criteria: 1. Patients with a)acute myeloid leukemia exclusive of patients in first complete remission with good risk cytogenetics (translocation 8,21,translocation 15, 17 or inversion 16); B)myelodysplastic syndrome; c)acute lymphocytic leukemia exclusive of patients in first remission without negative prognostic markers; d) relapsed or refractory nonHodgkin's lymphoma or Hodgkin's disease; e)relapsed or refractory multiple myeloma or f)relapsed or refractory chronic lymphocytic leukemia. 2. Patients who are considered appropriate for reduced intensity transplantation must present with at least one of the following: A. Age over 50 B. History of a prior hematopoietic stem cell transplant C. Patient with compromised organ function or comorbid conditioning such that a standard ablative transplant would be considered high risk. D. Patient with low grade Lymphoma or CLL for which reduced intensity transplant would be the optimal therapy compared to an ablative regimen 3. Patients will have a related or unrelated donor matched at 5/6 or 6/6 HLA loci. 4. Patients must be greater than or equal to 18 years old, and younger than or equal to 75 years old to participate in the study. 5. Patients must have ECOG performance status of 0-2 6. Pulmonary function tests demonstrate DLCO (adjusted for Hgb)\>50% predicted 7. Cardiac ejection fraction \>40% 8. Laboratories: * Bilirubin less than or equal to 1.5mg/dL x ULN * AST/ALT/Alkaline Phosphatase less than or equal to 2.5x ULN * Serum creatinine less than or equal to 1.0mg/dL; if serum creatinine \> 1.0MG/dL, then the estimated glomerular filtration rate (GFR) must be \>60mL/min/1.73m\^2 as calculated by the Modification of Diet in Renal Disease equation where Predicted GRF (ml/min/1.73m\^2)=186x (serum creatinine)\^1.154x(age in years)\^-0.203x(0.742 if patient is female) x (1.212 if patient is black) 9. Patients with serologic evidence of hepatitis B or C exposure will undergo liver biopsy to assess for presence of active hepatitis or fibrosis and quantification of risk of proceeding with transplant. 10\. All patients must be capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent. All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines. 11\. Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment. 12\. Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment Exclusion Criteria: 1. Patients who are HIV+ will be excluded. 2. Patients must not have serious intercurrent illness such as uncontrolled systemic infection or significant organ compromise which significantly increases the risk of undergoing allogeneic transplantation. 3. Pregnant and lactating women will be excluded.",NA,ALL,NA,"[{'measure': 'To assess the toxicity and donor engraftment following treatment with a reduced intensity preparative regimen consisting of clofarabine, rabbit antithymocyte globulin (ATG), and total lymphoid irradiation followed by the infusion of allogeneic stem cells', 'timeFrame': '30 days'}]","[{'measure': 'To determine the incidence of acute and chronic graft versus host disease following clofarabine, rabbit ATG, total lymphoid irradiation, and allogeneic transplantation.', 'timeFrame': '1 year'}, {'measure': '2. To evaluate the nature of immunologic reconstitution in patients treated clofarabine, rabbit ATG, total lymphoid irradiation, and allogeneic transplantation. The impact of the regimen on the phenotypic and functional characteristics of dendritic cell', 'timeFrame': '1 year'}, {'measure': 'To determine the disease free survival and overall survival of patients undergoing allogeneic transplantation following following clofarabine, rabbit ATG, and total lymphoid irradiation.', 'timeFrame': 'Patient lifetime'}]" 291,NCT05222984,"{'fullName': 'City of Hope Medical Center', 'class': 'OTHER'}","Navitoclax, Venetoclax, and Decitabine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Previously Treated With Venetoclax",ACTIVE_NOT_RECRUITING,"This phase Ib trial is to find the side effect and best dose of navitoclax when given together with venetoclax and decitabine in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory) after previous treatment with venetoclax. Chemotherapy drugs, such as navitoclax, venetoclax, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.","['Recurrent Acute Myeloid Leukemia', 'Refractory Acute Myeloid Leukemia']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Decitabine', 'description': 'Given IV', 'armGroupLabels': ['Treatment (navitoclax, venetoclax, decitabine)'], 'otherNames': [""5-Aza-2'-deoxycytidine"", 'Dacogen', 'Decitabine for Injection', 'Deoxyazacytidine', 'Dezocitidine']}, {'type': 'BIOLOGICAL', 'name': 'Navitoclax', 'description': 'Given PO', 'armGroupLabels': ['Treatment (navitoclax, venetoclax, decitabine)'], 'otherNames': ['A-855071.0', 'ABT-263', 'BcI-2 Family Protein Inhibitor ABT-263']}, {'type': 'DRUG', 'name': 'Venetoclax', 'description': 'Given PO', 'armGroupLabels': ['Treatment (navitoclax, venetoclax, decitabine)'], 'otherNames': ['ABT-0199', 'ABT-199', 'ABT199', 'GDC-0199', 'RG7601', 'Venclexta', 'Venclyxto']}]","Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * For participants under the age of 18 years, documentation of adolescent assent by the participant and consent of both parents or guardian * Adults aged \>= 18 years * Adolescent patients aged \>= 16 years and \< 18 years weighing at least 45 kg who have no other standard-of-care option for treatment * Eastern Cooperative Oncology Group (ECOG) =\< 2 * Patients with histologically confirmed AML, according to World Health Organization (WHO) criteria, with refractory/relapsed (R/R) disease following a venetoclax-containing regimen who are ineligible for therapies known to be effective for treatment of their AML. * Patients with extramedullary disease may be included if they also have marrow involvement * Patients with acute promyelocytic leukemia (APL) will not be eligible * Fully recovered from the acute toxic effects (except alopecia) to =\< grade 1 of prior anti-cancer therapy * Ability to swallow pills * Absolute neutrophil count (ANC) \>= 750/mm\^3 (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated) * NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement * White blood cell (WBC) =\< 25 x 10\^9/L prior to initiation of study therapy. Cytoreduction with hydroxyurea prior to treatment and/or during cycle 1 may be required (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated) * Platelets \>= 75,000/mm\^3 * NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement * Total bilirubin =\< 1.5 X upper limit of normal (ULN) (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated) * Aspartate aminotransferase (AST) =\< 3.0 x ULN (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated) * Alanine aminotransferase (ALT) =\< 3.0 x ULN (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated) * Creatinine clearance of \>= 45 ml/min per 24-hour urine test or the Cockcroft-Gault formula (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated) * If in the absence of anticoagulants: International normalized ratio (INR) OR prothrombin (PT) =\< 1.5 x ULN (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated) * If in the absence of anticoagulants: Activated partial thromboplastin time (aPTT) =\< 1.5 x ULN (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated) * Left ventricular ejection fraction (LVEF) \>= 50% * Note: To be performed within 28 days prior to day 1 of protocol therapy * Corrected QT interval (QTc) =\< 480 ms * Note: To be performed within 28 days prior to day 1 of protocol therapy * Seronegative for human immunodeficiency virus (HIV) antigen (Ag)/antibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative), and syphilis (RPR) (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated) * If positive, Hepatitis C RNA quantitation must be performed * Meets other institutional and federal requirements for infectious disease titer requirements * Note Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy * Women of child-bearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required (performed within 14 days prior to day 1 of protocol therapy unless otherwise stated) * Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months (males) and 6 months (females) after the last dose of protocol therapy * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only) Exclusion Criteria: * Hematopoietic stem cell transplant within 100 days prior to day 1 of protocol therapy * Chemotherapy, radiation therapy, biological therapy, or immunotherapy within 14 days or 5 half-lives, whichever is shorter, prior to day 1 of protocol therapy with the following exceptions: * Subjects will be allowed to have been on venetoclax at screening and remain on it through treatment start. * Hydroxyurea is allowed prior to treatment and through cycle 1 for control of rapidly progressing leukemia * Strong or moderate CYP3A4 inducers within 14 days prior to day 1 of protocol therapy * Grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or star fruit consumed within 3 days prior to the first dose of study drug * Immunosuppressants (steroids =\< 10 mg/day of oral prednisone or equivalent is allowed) within the last 28 days * Hematopoietic growth factors in the last 14 days * Must not have received or planning to receive live vaccine while being on study or 4 weeks before and after completion of treatment * Herbal medications known to affect platelet function within 14 days of therapy initiation * History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent * Active graft-versus-host-disease (GVHD) * Active central nervous system (CNS) disease * No measurable disease in the bone marrow * Active diarrhea * Gastrointestinal disorder that interferes with oral drug absorption such as malabsorption syndrome * Clinically significant cardiac morbidities (class III/IV cardiovascular disability according to the New York Heart Association classification, arrhythmia not stable on medical management, acute cardiovascular ischemic event within 6 months of enrollment, etc.) * Clinically significant uncontrolled illness * Active infection requiring antibiotics * Active/uncontrolled HIV infection, acquired immunodeficiency syndrome (AIDS), or currently taking contraindicated medications for HIV control * Diagnosis of Gilbert's disease * Any other active malignancy at time of enrollment. Exceptions include basal/squamous cell carcinoma, in situ adequately treated breast and uterine cancer * Females only: Pregnant or breastfeeding * Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)",NA,ALL,NA,"[{'measure': 'Incidence of adverse events', 'description': 'Will be assessed and graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5.0.', 'timeFrame': 'Up to 1 year'}]","[{'measure': 'Overall response rate', 'description': 'Will be calculated as the percent of evaluable patients that have confirmed complete response (CR) or complete response with incomplete hematopoiesis or partial response. Assessment of disease response will be made according to European LeukemiaNet criteria.', 'timeFrame': 'Up to 1 year'}, {'measure': 'Progression Free Survival (PFS)', 'description': 'From the start of study treatment to the time of disease relapse, progression or death from any cause, whichever comes first. assessed up to 1 year', 'timeFrame': 'Assessed up to 1 year'}, {'measure': 'Overall Survival (OS)', 'description': 'Time from the start of study treatment to death from any cause.', 'timeFrame': 'Assessed up to 1 year'}, {'measure': 'Dose Limiting Toxicity (DLT)', 'description': 'DLT will be evaluated in the first 35 days of treatment in the safety cohort to determine any dose limiting toxicities at this dose.', 'timeFrame': 'Up to 35 days (1 cycle)'}]" 292,NCT01241552,"{'fullName': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}","A Study of MK-3415, MK-6072, and MK-3415A in Participants Receiving Antibiotic Therapy for Clostridium Difficile Infection (MK-3415A-001)",COMPLETED,"This study will investigate whether: 1) treatment with MK-3415A in addition to standard of care (SOC) antibiotic therapy will decrease Clostridium difficile infection (CDI) recurrence as compared to treatment with MK-6072 or MK-3415, 2) treatment with MK-3415A, MK-6072, or MK-3415, in addition to SOC antibiotic therapy will decrease CDI recurrence as compared to placebo, and 3) MK-3415A, MK-6072, and MK-3415 will be generally well tolerated in participants receiving SOC therapy for CDI as compared to placebo.",['Clostridium Difficile Infection'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}","[{'type': 'BIOLOGICAL', 'name': 'MK-3415', 'description': 'A single IV infusion of MK-3415 (10 mg/kg of monoclonal antibody to Clostridium difficile Toxin A)', 'armGroupLabels': ['MK-3415 + SOC']}, {'type': 'BIOLOGICAL', 'name': 'MK-6072', 'description': 'A single infusion of MK-6072 (10 mg/kg of monoclonal antibody to Clostridium difficile Toxin B)', 'armGroupLabels': ['MK-6072 + SOC']}, {'type': 'BIOLOGICAL', 'name': 'MK-3415A', 'description': 'A single IV infusion of MK-3415A (10 mg/kg of monoclonal antibody to Clostridium difficile Toxin A and 10mg/kg of monoclonal antibody to Clostridium difficile Toxin B)', 'armGroupLabels': ['MK-3415A + SOC']}, {'type': 'BIOLOGICAL', 'name': 'Placebo', 'description': 'A single IV infusion of normal saline (0.9% sodium chloride)', 'armGroupLabels': ['Placebo + SOC']}, {'type': 'DRUG', 'name': 'SOC', 'description': 'Standard of care (SOC) for CDI will be prescribed for 10 to 14 days and can begin on the day of study drug infusion; but the first dose must have been administered prior to or within a few hours following study drug infusion. SOC is defined as the receipt of oral metranidazole, oral vancomycin, IV metronidazole concurrent with oral vancomycin, oral fidaxomicin, or oral fidaxomicin concurrent with IV metronidazole.', 'armGroupLabels': ['MK-3415 + SOC', 'MK-3415A + SOC', 'MK-6072 + SOC', 'Placebo + SOC']}]","Inclusion Criteria: * participant has a confirmed diagnosis of CDI as defined by: a. diarrhea, as defined by passage of 3 or more loose stools in 24 or fewer hours, AND b. A positive test for toxigenic C. difficile from a stool collected no more than 7 days before study infusion. * participant must be receiving SOC therapy for CDI. SOC therapy is defined as the receipt of oral metronidazole, oral vancomycin, IV metronidazole concurrent with oral vancomycin, oral fidaxomicin, or oral fidaxomicin concurrent with IV metronidazole. * participant is highly unlikely to become pregnant or to impregnate a partner since they meet at least one of the following criteria: a. A female participant who is not of reproductive potential is eligible without requiring the use of contraception. A female participant who is not of reproductive potential is defined as: one who has either (1) reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels in the postmenopausal range as determined by the local laboratory, or 12 months of spontaneous amenorrhea); (2) 6 weeks post surgical bilateral oophorectomy with or without hysterectomy; or (3) bilateral tubal ligation. Spontaneous amenorrhea does not include cases for which there is an underlying disease that causes amenorrhea (e.g. anorexia nervosa). b. A participant who is of reproductive potential agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control starting at enrollment and through the 12 Week study period. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy and any registered and marketed hormonal contraceptives that contain an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents) * participant or legal representative must have voluntarily agreed to participate by providing written informed consent after the nature of the study has been fully explained. Exclusion Criteria: * participant with an uncontrolled chronic diarrheal illness such that their normal 24-hour bowel movement habit is 3 or more loose stools. * participant with a planned surgery for CDI within 24 hours. * participant has a positive pregnancy test in the 48 hours before the infusion or is unwilling to undergo pregnancy testing if a pre-menopausal female who is not sterilized and therefore has the potential to bear a child. * participant is breast-feeding or plans to breast-feed prior to the completion of the 12-week study period. * A female participant who plans to donate ova prior to the completion of the 12-week study period, or a male participant who is planning to impregnate or provide sperm donation prior to the completion of the 12-week study period. * participant has previously participated in this study, has previously received MK-3415 or MK- 6072 (either alone or in combination), has received a C. difficile vaccine, or has received another experimental monoclonal antibody against C. difficile toxin A or B. * participant plans to donate blood and/or blood products within 6 months following the infusion. * participant has received immune globulin within 6 months prior to receipt of the infusion or is planning to receive immune globulin prior to the completion of the 12-week study period. * treatment with SOC therapy is planned for longer than 14 days. * participant has received more than a 24-hour regimen of cholestyramine, colestimide, rifaximin, or nitazoxanide within 14 days prior to receipt of the infusion or is planning to receive these medications prior to the completion of the 12-week study period. * participant plans to take medications that are given to decrease gastrointestinal peristalsis, such as loperamide (Imodium™) or diphenoxylate hydrochloride/atropine sulfate (LOMOTIL™), at any time during the 14 days following infusion. Participants receiving opioid medications at the onset of diarrhea may be included if they are on a stable dose or if there is anticipation of a dose decrease or cessation of use. * participant plans to take the probiotic Saccharomyces boulardii or receive fecal transplant therapy, or any other therapies that have been demonstrated to decrease CDI recurrences at any time following infusion (Day 1) and through the completion of the 12-week study period. * participant has received another investigational study agent within the previous 30 days, or is currently participating in or scheduled to participate in any other clinical trial with an investigational agent during the 12-week study period. * participant is not expected to survive for 72 hours. * participant has any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the participant participating in the study, would make it unlikely for the participant to complete the study, or would confound the results of the study.",NA,ALL,NA,"[{'measure': 'Percentage of Participants With Clostridium Difficile Infection (CDI) Recurrence', 'description': 'CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic Clostridium (C.) difficile following clinical cure of the initial CDI episode', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Percentage of Participants With One or More Adverse Events (AEs) During 4 Weeks Following Infusion', 'description': ""An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specific procedure, whether or not considered related to the medicinal product or protocol specific procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE."", 'timeFrame': 'Up to 28 days'}, {'measure': 'Percentage of Participants With Any Drug-related AE During 4 Weeks Following Infusion', 'description': ""An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specific procedure, whether or not considered related to the medicinal product or protocol specific procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. A drug-related AE was an AE determined by the investigator to be related to the drug."", 'timeFrame': 'Up to 28 days'}, {'measure': 'Percentage of Participants With Any Serious Adverse Events (SAEs) During 4 Weeks Following Infusion', 'description': ""A SAE is any AE occurring at any dose or during any use of Sponsor's product that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer, or is associated with an overdose (whether accidental or intentional); or is other important medical events."", 'timeFrame': 'Up to 28 days'}, {'measure': 'Percentage of Participants With Any Serious Drug-related Adverse Events During 4 Weeks Following Infusion', 'description': ""A SAE is any AE occurring at any dose or during any use of Sponsor's product that: results in death; or is life threatening; or results in a persistent or significant disability/incapacity; or results in or prolongs an existing inpatient hospitalization; or is a congenital anomaly/birth defect; or is a cancer, or is associated with an overdose (whether accidental or intentional); or is other important medical events. A serious drug-related AE was a SAE determined by the investigator to be related to the drug."", 'timeFrame': 'Up to 28 days'}, {'measure': 'Percentage of Participants Who Discontinued Study Medication Due to an AE During 4 Weeks Following Infusion', 'description': ""An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended signs (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specific procedure, whether or not considered related to the medicinal product or protocol-specific procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE."", 'timeFrame': 'Up to 28 days'}, {'measure': 'Percentage of Participants With Infusion-specific AEs', 'description': 'Infusion-specific AEs included local infusion site AEs; and systemic AEs which include nausea, vomiting, chills, fatigue, feeling hot, infusion site conditions (bruising, coldness, erythema, extravasation, pain, phlebitis, pruritus), pyrexia, arthralgia, musculoskeletal pain, myalgia, dizziness, headache, dysphonia, nasal congestion, pruritus, rash, pruritic rash, urticaria, flushing, hot flush, hypertension, and hypotension.', 'timeFrame': 'Up to 24 hours'}]","[{'measure': 'Percentage of Participants With Global Cure', 'description': 'Global Cure is defined as the clinical cure of the initial CDI episode and no CDI recurrence through Week 12. Clinical cure is defined as participants who received ≤ 14 day regimen of SOC therapy and have no diarrhea (≤2 loose stools per 24 hours) for two consecutive days following completion of SOC therapy for the initial CDI episode.', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Percentage of Participants With CDI Recurrence in Those With Clinical Cure of the Initial CDI Episode', 'description': 'CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode. Clinical cure is defined as participants who received ≤ 14 day regimen of SOC therapy and have no diarrhea (≤2 loose stools per 24 hours) for two consecutive days following completion of SOC therapy for the baseline CDI episode.', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Percentage of Participants ≥ 65 Years of Age at Study Entry With CDI Recurrence', 'description': 'CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Percentage of Participants With a History of CDI in the 6 Months Prior to Enrollment With CDI Recurrence', 'description': 'CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Percentage of Participants With Clinically Severe CDI at Study Entry With CDI Recurrence', 'description': 'CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode. Clinically severe CDI is defined as a Zar Score ≥ 2 based on the presence of 1 or more of the following: 1) age \\>60 years old (1 point); 2)body temperature \\>38.3°C (\\>100°F) (1 point); 3) albumin level ˂2.5 mg/dL (1 point); 4) peripheral white blood cell count \\>15,000 cells/mm\\^3 within 48 hours (1 point); 5) endoscopic evidence of pseudomembranous colitis (2 points); and 6) treatment in Intensive Care Unit (2 points).', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Percentage of Participants With the B1/NAP1/027 Strain of C. Difficile at Study Entry With CDI Recurrence', 'description': 'CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Percentage of Participants With an Epidemic Strain of C. Difficile (Ribotypes 027, 014, 002, 001, 106, and 020) at Study Entry With CDI Recurrence', 'description': 'CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode.', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Percentage of Participants With Compromised Immunity at Study Entry With CDI Recurrence', 'description': 'CDI recurrence is defined as the development of a new episode of diarrhea (3 or more loose stools in 24 or fewer hours) and a positive local or central lab stool test for toxigenic C. difficile following clinical cure of the initial CDI episode. Compromised immunity is defined as follows: an active hematological malignancy (including leukemia, lymphoma, multiple myeloma), an active malignancy requiring recent cytotoxic chemotherapy, receipt of a prior hematopoietic stem cell transplant, receipt of a prior solid organ transplant, asplenia, or neutropenia/pancytopenia due to other conditions.', 'timeFrame': 'Up to 12 weeks'}]" 293,NCT04709458,"{'fullName': 'Taiga Biotechnologies, Inc.', 'class': 'INDUSTRY'}",Safety and Early Efficacy Study of TBX-2400 in Patients With AML or Myelofibrosis,UNKNOWN,"This is a study of allogeneic stem cell transplantation with TBX-2400 in adult subjects with Acute Myelogenous Leukemia (AML) or Myelofibrosis (MF). The donor cells are exposed to a protein that has been shown in the laboratory to improve the ability of the donor cells to make blood and immune cells after transplant. Exposure of the donor cells to this protein does not modify the genes in the cells in any way. This study has two goals. The first goal is to find out if transplant with TBX-2400 is safe. The second goal is to find out what effects TBX-2400 stem cells have on time to engraftment in adult subjects with AML or MF. The study hypothesis is that TBX-2400 cells will shorten the time to immune reconstitution after transplant.","['Myelofibrosis', 'Acute Myelogenous Leukemia']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'TBX-2400', 'description': 'Hematopoietic stem cells transplantation', 'armGroupLabels': ['TBX-2400 treatment']}]","Inclusion Criteria: 1. For crAML: AML with ≥5% blasts (either by morphology or by multi-parameter flow cytometry \[MFC\]) in a marrow aspirate obtained within 21 days of enrollment in the trial, and following the administration of at least two prior courses of chemotherapy; 2. For MF: primary MF or MF that has progressed from a myeloproliferative disease. Dynamic International Prognostic Scoring System (DIPSS)-plus to be utilized to support the inclusion of MF subjects at screening; 3. Subject undergoing allogeneic stem cell transplantation on the decision of transplanting physician; 4. Signed informed consent of donor and recipient; 5. Subjects of ≥ 18 years of age (no upper age limit); 6. Donor agrees to donate bone marrow-derived or mobilized peripheral blood stem cells; 7. Subjects with Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2; 8. Adequate pulmonary function with Diffusing Capacity for Carbon Monoxide (DLCO) \> 50; 9. Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception (e.g. sterilization, hormone implants, hormone injections, intrauterine devices, or vasectomized partner with combined use of condom and/or birth control pills) from screening until 6 months after TBX-2400 transplantation; 10. Able to adhere to all trial treatments and procedures. Exclusion Criteria: 1. Previous stem cell transplantation; 2. For MF: Blasts \> 10% in a marrow aspirate obtained within 30 days of screening; 3. Renal function: serum creatinine \> 1.5 x Upper Limit of Normal (ULN); 4. Hepatic function: impaired synthetic function as indicated by a serum fibrinogen below the normal limit. Aspartate transaminase/alanine transaminase (AST/ALT) \> 3.0 x ULN. Bilirubin, \> 1.5 x ULN; 5. Cardiac function: ejection fraction \< 45% as determined by echocardiography; 6. Prior malignancy active within previous three years - except for locally curable cancers such as cutaneous basal or squamous cell cancer, superficial bladder cancer, carcinoma in situ of cervix or breast, or carcinoma in situ of the prostate; 7. Positive pregnancy test or breastfeeding for women of childbearing age; 8. Serologic evidence of chronic Hepatitis B virus infection or Hepatitis C exposure; 9. Known history of positive test for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS); 10. Hypersensitivity to any trial medication (including the preparative regimen, TBX-2400 treatment and any prophylaxis or other medication planned); 11. Presence of a serious or uncontrolled medical disorder that, in the opinion of the Investigator, may increase the risk associated with trial participation or trial drug administration, impair the ability of the participant to receive protocol therapy, or interfere with interpretation of trial results.",NA,ALL,NA,"[{'measure': 'Incidence of adverse events according to NCI-CTCAE Version 5.0', 'description': 'Adverse events from subject reporting or other assessments', 'timeFrame': 'Two years'}, {'measure': 'Transplant engraftment', 'description': 'Assessment of transplant engraftment will include absolute neutrophil count, untransfused platelet count and donor chimerism', 'timeFrame': '1 year'}]","[{'measure': 'Immune reconstitution as measured by CD3+ cell count', 'description': 'Immune reconstitution as measured by CD3+ cell count \\> 300/μL', 'timeFrame': 'Up to Day 360'}, {'measure': 'Immunoglobulin (IgA) levels', 'timeFrame': 'Up to Day 360'}, {'measure': 'Immunoglobulin (IgM) levels', 'timeFrame': 'Up to Day 360'}, {'measure': 'T-cell Engraftment', 'description': 'CD45 RA versus RO at 3, 6, 9 and 12 months', 'timeFrame': 'Up to Day 360'}, {'measure': 'Disease-free survival', 'timeFrame': 'Two years'}, {'measure': 'Incidence of secondary graft failure', 'timeFrame': 'Two years'}, {'measure': 'Transplant-Related Mortality (TRM)', 'timeFrame': '100 Days'}, {'measure': 'Quality of life using the World Health Organisation Five Wellbeing Index', 'description': 'QoL assessed at 3, 6, 9 and 12 months (World Health Organization \\[WHO\\] Five Wellbeing Index).', 'timeFrame': 'Up to day 360'}]" 294,NCT04361058,"{'fullName': 'SCRI Development Innovations, LLC', 'class': 'OTHER'}",Nivolumab for High-Risk MDS/AML Patients After Allogeneic Stem Cell Transplant With Post-Transplant Cyclophosphamide,WITHDRAWN,"There are no strategies developed post-stem cell transplant (SCT) for patients who receive allogenic SCT with a significant amount of blasts prior SCT. Novel strategies to treat relapsed AML/MDS and to reduce the incidence of relapse after allogeneic SCT are needed. This study is being done in patients with high-risk MDS or AML who undergo an allogeneic SCT. The study will have two arms, participants who receive an HLA-matched unrelated donor SCT (Arm A) or HLA- haploidentical SCT (Arm B). Following myeloablative conditioning (MAC), GVHD prophylaxis with post-transplantation cyclophosphamide (PTCy), tacrolimus and mycophenolate mofetil will be given per standard of care. At 40-60 days post SCT, If the patient has not had any evidence of Grade II-IV acute graft-versus-host-disease (aGVHD), Nivolumab will be given intravenously every 2 weeks for 4 cycles of consolidation or treatment with Nivolumab. Dose-escalation of Nivolumab will follow the standard 3+3 design where a maximum of three dose levels will be evaluated, with a maximum of 18 patients treated with nivolumab per arm. As the maximum tolerated dose (MTD) of Nivolumab may differ between Arm A and Arm B, dose escalation of nivolumab in each arm will be followed separately following allogeneic SCT. Immunosuppression with tacrolimus will be continued during the cycles of PD-1 blockade to provide a moderate level of GVHD prophylaxis during consolidation or treatment with nivolumab.","['Leukemia, Myeloid, Acute', 'Myelodysplastic Syndromes', 'Myelodysplastic Syndrome Acute Myeloid Leukemia']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Nivolumab', 'description': 'At Day +50 (±10 days) post-allogeneic SCT, participants will be treated with Nivolumab. Nivolumab will be administered intravenously once every two weeks for a total of 4 treatments. Participants will initially receive nivolumab at a significantly reduced starting dose of 0.25 mg/kg. This dose was determined based on the incidence of increased aGVHD, which was noted after treatment post-SCT in previous studies. Nivolumab IV will be given every 2 weeks for 4 cycles. One dose of nivolumab is equivalent to one cycle. The first administration will be at Day +50 (±10 days), assuming the participant has not had any evidence of Grade II-IV aGVHD after allogeneic SCT and does not have any current evidence of any grade of aGVHD at the day of first application of nivolumab. Depending on emerging safety data, dose escalation cohorts will explore higher dose levels of nivolumab at 0.5 mg/kg and 1 mg/kg.', 'armGroupLabels': ['Arm A - HLA-matched unrelated donor SCT treated with Nivolumab', 'Arm B - HLA-haploidentical donor SCT treated with Nivolumab'], 'otherNames': ['Opdivo']}]","Inclusion Criteria for initial enrollment: * Written informed consent form (ICF), according to local guidelines, signed by the patient or by a legal guardian prior to the performance of any study-related screening procedures (i.e., prior to conditioning). * Male and female patients between ≥18 and ˂66 years-of-age * Patients with high-risk AML defined as: AML with ≥5% bone marrow blast burden prior to allogeneic SCT who failed ≥2 lines of cytoreductive anti-leukemic therapy * Patients with high risk MDS defined as: MDS with ≥10% bone marrow blasts prior to allogeneic SCT despite 1 line of prior cytoreductive anti-leukemic treatment with chemotherapy or hypomethylating agent * Patients will receive a MAC MUD or MAC haploidentical SCT followed by PTCy as treatment for AML or MDS. * A 10/10 HLA-match is required for patients that will receive a MUD SCT. * A 5/10 HLA-match or greater is required for patients that will receive a haploidentical SCT. * Patients must be able to swallow and retain oral medication. * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or Inclusion Criteria after SCT, prior to start of nivolumab: * Patients who have achieved a CR post-allogeneic SCT * Patients who have persistent disease post-allogeneic SCT * Greater than 50% PB donor T cell chimerism * Adequate renal function defined as serum creatinine ≤2.0 mg/dL or creatinine clearance ≥40 mL/min measured or calculated by Cockcroft-Gault equation. * Females of childbearing potential must have a negative serum or urine pregnancy test result within 72 hours prior to the first dose of nivolumab and must agree to follow instructions for method(s) of contraception, using two forms of acceptable contraception, including one barrier method, for the duration of treatment with nivolumab and for 7 months following their last dose of the study drug. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy. * Male patients with female partners of childbearing potential are required to use contraceptive methods, during their participation in the study and for 7 months following the last dose of study drug. Male patients must also refrain from donating sperm during their participation in the study and for 7 months following the last dose of study drug. * Ability to understand the nature of this study and to comply with study and follow-up procedures. Exclusion Criteria for initial enrollment: * Prior allogeneic SCT * Pregnant or lactating women * Evidence of active uncontrolled bacterial, fungal, parasitic, or viral infection. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of active infection progression are present. This is assessed by the site clinicians including consulting physicians from infectious disease regarding adequacy of therapy. These infections include, but are not limited to: * Known human immunodeficiency virus (HIV) infection * Active tuberculosis infection * History of autoimmune pneumonitis within the last 5 years * Prior diagnosis of an inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis) * History of severe hypersensitivity reactions to monoclonal antibodies * Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol. Exclusion Criteria after SCT, prior to start of nivolumab: * Current evidence of any grade of active aGVHD at Day 40-60 at the time of study enrollment * Prior history of Grade II or higher aGVHD (Appendix E) * Prior or concurrent treatment with DLI * Use of a study drug ≤21 days or 5 half-lives (whichever is shorter) prior to the first dose of nivolumab, except antimicrobial drugs. For study drugs for which 5 half-lives is ≤21 days, a minimum of 10 days between termination of the study drug and administration of nivolumab is required, except antimicrobial drugs. * Evidence of active uncontrolled bacterial, fungal, parasitic, or viral infection. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of infection progression are present. * Active autoimmune disease that has persisted or recurred after allogeneic SCT, except vitiligo or resolved childhood asthma/atopy. * Inadequate organ function: * Clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months of enrollment, New York Heart Association Class III or IV congestive heart failure (Appendix B), circulatory collapse requiring vasopressor or inotropic support, or arrhythmia that requires therapy. If the patient does not meet the minimum criteria and/or receive cardiotoxic agents, cardiology consultation and clearance is recommended. * Significant respiratory disease that requires mechanical ventilation support or a resting O2 saturation \<90% by pulse oximetry. FEV1/FVC/DLCO \<50%. If the patient does not meet the minimum criteria, pulmonary consultation and clearance is recommended. * Serum creatinine ≥2.0 mg/dL. If the patient does not meet the minimum criteria, nephrology consultation and clearance is recommended. * Serum bilirubin \>2.5 mg/dL (except for hemolysis or Gilbert's syndrome) and transaminases ≥3 upper limit of normal (ULN). If the patient does not meet minimum criteria, hepatology consultation and clearance should be considered. If warranted, a liver biopsy should be performed prior to transplant. * Any corticosteroid therapy for indications other than GVHD at doses \>1 mg/kg/day methylprednisolone or equivalent within 7 days of start of nivolumab. * Any corticosteroid therapy for prior GVHD including topicals, budesonide and beclomethasone PO at any dose within 7 days of start of nivolumab.",NA,ALL,NA,"[{'measure': 'Incidence of dose limiting toxicities as a determinant of the Maximum Tolerated Dose (MTD)', 'description': 'Defined as the highest dose at which ≤ 1 of 6 participants experience a DLT. Certain toxicities will be considered dose-limiting unless clearly attributable to an extraneous cause, such as underlying disease. If 2 or more patients in a dosing group of ≤6 patients experience a DLT, the MTD has been exceeded. If 2 or more patients in a dosing group of up to 6 patients experience a DLT and only 3 patients were evaluated at the previous dose (i.e. next lower). Then, an additional 3 patients will be evaluated at this next lower dose, and if zero or one have DLTs, then this previous dose level is declared the MTD. Dose level -1 will be tested if dose level 1 exceeds the MTD.', 'timeFrame': 'After the first dose of Nivolumab treatment for up to 28 days.'}]","[{'measure': 'Progression-free survival (PFS)', 'description': 'Defined as the time from the first day of study drug administration until the date of relapse, progression, or death from any cause; patients not known to have relapsed/progressed or died at last follow-up are censored on the date they were last examined. Progression is defined as evidence for an increase in bone marrow blast percentage and/or increase of absolute blast counts in the blood: \\>50% increase in marrow blasts over baseline (min 15% increase is required in cases with \\<30% blasts at baseline); or persistent marrow blast percentage of \\>70% over at least 3 months; without at least a 100% improvement in absolute neutrophil count (ANC) to an absolute level \\[\\>0.5 x 109/L (500/μL), and/or platelet count to \\>50 x 109/L (50,000/μL) non-transfused\\]; or \\>50% increase in peripheral blasts (WBC x % blasts) to \\>25 x 109/L (\\>25,000/μl) (in the absence of differentiation syndrome); or New extramedullary disease.', 'timeFrame': 'PFS will be assessed for up to 3 years post-SCT'}, {'measure': 'Overall survival (OS)', 'description': 'Defined as the time from the first day of study drug administration to death on study from any cause or study discontinuation.', 'timeFrame': 'OS will be assessed for up to 3 years post-SCT'}, {'measure': 'Number of participants that experience Non-relapse mortality', 'description': 'Defined as death in the absence of recurrent or progressive malignancy after stem cell transplant (SCT).', 'timeFrame': 'Will be assessed throughout study treatment, when study treatment ends, and for up to 3 years'}, {'measure': 'Number of participants with evidenceof cGVHD', 'description': 'Number of participants with evidence/cumulative incidence of chronic GVHD (\\>0 cGVHD symptoms on the chronic GVHD activity assessment form) at 1 year and up to 3 years post-SCT.', 'timeFrame': 'Will be assessed throughout study treatment, when study treatment ends, and for up to 3 years'}, {'measure': 'Number of participants that experience Nivolumab-related mortality', 'description': 'Number of participants with mortality directly related to nivolumab leading to Grade III-IV aGVHD or non-GVHD immune-mediated toxicity leading to death.', 'timeFrame': 'Will be assessed throughout study treatment, when study treatment ends, and for up to 3 years'}, {'measure': 'Number of participants who relapse (CIR)', 'description': 'Number of participants (cumulative incidence) who achieve a complete remission (CR) or CR with incomplete hematologic recovery (CRi) who later relapse (Bone marrow blasts ≥5%; or reappearance of blasts in the blood; or development of extramedullary disease) measured from the date of achievement of a remission until the date of relapse.', 'timeFrame': 'Will be assessed throughout study treatment, when study treatment ends, and for up to 3 years'}, {'measure': 'Relapse free survival (RFS)', 'description': 'Defined as the time measured from the date of achievement of a remission until the date of relapse (bone marrow blasts ≥5%; or reappearance of blasts in the blood; or development of extramedullary disease) or death from any cause; only for patients achieving complete remission (CR), or CR with incomplete hematologic recovery (CRi); patients not known to have relapsed or died at last follow-up are censored on the date they were last examined.', 'timeFrame': 'Will be assessed for up to 3 years'}]" 295,NCT03132948,"{'fullName': ""Connecticut Children's Medical Center"", 'class': 'OTHER'}",Quality of Life in Pediatric Patients With Acute Lymphoblastic Leukemia Receiving Maintenance Chemotherapy,SUSPENDED,The purpose of the study is to evaluate the impact of exercise on physical activity levels and quality of life in children with acute lymphoblastic leukemia (ALL) receiving maintenance chemotherapy.,['Quality of Life'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BEHAVIORAL', 'name': 'Physical Activity', 'description': 'Nintendo WII fit console, Xbox console, sport activities (soccer, basketball, yoga, walking and other physical games)', 'armGroupLabels': ['Physical Activity']}]","Inclusion Criteria: * Pediatric oncology patients with ALL in the maintenance phase of chemotherapy during the time of study * Ages 8-18 years of either gender (age limits due to reliability and validity of outcome assessment surveys) * Have no documented or observable psychiatric or neurological disorders that would interfere with study participation * Capable of speaking and reading English * Having no contraindications to participate in moderate physical exercise as determined by the research staff and the patient's pediatric oncologist * Currently living with their parents/legal guardians * Consent obtained from legal guardians and assent obtained from patients to participate in the study Exclusion Criteria: * Not a pediatric oncology patient with ALL in maintenance * Not receiving chemotherapy during the time of study * Age less than 8 years or greater than 18 years * Not English-speaking Since not all outcome measures have been validated in Spanish and other languages, only English-speaking patients will be included.",NA,ALL,NA,"[{'measure': 'Quality of Life Outcomes', 'description': 'PedsQL', 'timeFrame': '1 year'}]","[{'measure': 'Physical Activity', 'description': 'Actigraphy', 'timeFrame': '1 year'}, {'measure': 'Sleep', 'description': 'Diary', 'timeFrame': '1 year'}, {'measure': 'Fatigue', 'description': 'Childhood Fatigue Scale', 'timeFrame': '1 year'}]" 296,NCT00555048,"{'fullName': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}","Alemtuzumab, Busulfan, and Cyclophosphamide Followed By a Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer",TERMINATED,"RATIONALE: Monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving chemotherapy drugs, such as busulfan and cyclophosphamide, before a donor stem cell transplant helps stop the growth of cancer cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving tacrolimus and methotrexate after the transplant may stop this from happening. PURPOSE: This phase I/II trial is studying the best dose of alemtuzumab when given together with busulfan and cyclophosphamide followed by a donor stem cell transplant and to see how well it works in treating patients with hematologic cancer.","['Graft Versus Host Disease', 'Leukemia', 'Myelodysplastic Syndromes', 'Myelodysplastic/Myeloproliferative Diseases']",INTERVENTIONAL,{'primaryPurpose': 'TREATMENT'},"[{'type': 'BIOLOGICAL', 'name': 'alemtuzumab', 'armGroupLabels': ['Alemtuzumab']}, {'type': 'DRUG', 'name': 'busulfan', 'armGroupLabels': ['Alemtuzumab']}, {'type': 'DRUG', 'name': 'cyclophosphamide', 'armGroupLabels': ['Alemtuzumab']}, {'type': 'DRUG', 'name': 'methotrexate', 'armGroupLabels': ['Alemtuzumab']}, {'type': 'DRUG', 'name': 'tacrolimus', 'armGroupLabels': ['Alemtuzumab']}, {'type': 'PROCEDURE', 'name': 'allogeneic hematopoietic stem cell transplantation', 'armGroupLabels': ['Alemtuzumab']}, {'type': 'PROCEDURE', 'name': 'peripheral blood stem cell transplantation', 'armGroupLabels': ['Alemtuzumab']}]","DISEASE CHARACTERISTICS: * Confirmed diagnosis of one of the following: * Primary acute myeloid leukemia (AML) meeting any of the following criteria: * First complete remission (CR; defined as \< 5% blasts in marrow) with high-risk features as defined by failure to achieve remission by day 21 after induction chemotherapy, or the presence of chromosomal abnormalities involving any of the following: * -5/del(5q) * -7/del(7q) * Inversion 3q * Abnormalities of 11q23, 20q, 21q, del(9q), * Translocation 6;9 * Translocation 9;22 * Abnormalities of 17p * Complex karyotype with ≥ 3 abnormalities * Second CR or subsequent in remission * Refractory or relapsed disease * Secondary AML in remission or relapse * Chronic myelogenous leukemia (CML) in accelerated or blast phase meeting the following criteria: * Accelerated phase is defined by any one of the following: * Blasts 10% to 19% of peripheral blood white cells or bone marrow cells * Peripheral blood basophils ≥ 20% * Persistent thrombocytopenia (\< 100,000/mm³) unrelated to therapy, or persistent thrombocytosis (\> 1,000,000/mm³) unresponsive to therapy * Increasing spleen size and increasing WBC count unresponsive to therapy * Cytogenetic evidence of clonal evolution (i.e., the appearance of an additional genetic abnormality that was not present in the initial specimen at the time of diagnosis of chronic phase CML) * Blast phase is defined by any of the following: * Blasts ≥ 20% of peripheral blood white cells or bone marrow cells * Extramedullary blast proliferation * Large foci or clusters of blasts in bone marrow biopsy * Primary myelodysplastic syndromes (MDS) with an IPSS score \> 1.5 * Secondary MDS with any IPSS score * Primary acute lymphoblastic leukemia meeting any of the following criteria: * First CR (\< 5% blasts in marrow) with high-risk features as defined by 1 of the following: * Failure to achieve remission after first induction chemotherapy * Presence of chromosomal abnormalities including hypodiploidy or abnormalities of 11q23 or translocation 9;22 * Second CR or subsequent in remission * Refractory or relapsed disease * No patients for whom a suitable HLA genotypically identical sibling or fully matched HLA-A, -B, -C, and -DRB1 unrelated donor is available * No active CNS involvement with disease * Donors must meet the following criteria: * Unrelated volunteer donors who are mismatched for more than one HLA-class I alleles or antigens or for one HLA-class I antigen, but matched by high-resolution typing at HLA-DRB1 and -DQB1, OR who are mismatched for one or more HLA-class II alleles or antigens, but matched by high-resolution typing at HLA-A, -B, and -C * No two-antigen mismatch at a single HLA-A, -B, or -C locus * No mismatching of class I and class II HLA * Matching must be based on results of high-resolution typing at HLA-A, -B, -C, - DRB1, and -DQB1 PATIENT CHARACTERISTICS: * Karnofsky performance status 50-100% * No symptomatic coronary artery disease or symptomatic congestive heart failure * No hepatic disease with transaminases or bilirubin \> 2 times upper limit of normal except for isolated hyperbilirubinemia attributed to Gilbert's syndrome * No severe hypoxemia with room air P\_AO\_2 \< 70, supplemental oxygen-dependence, or DLCO \< 60% predicted * No impaired renal function with creatinine \> 2 times upper limit of normal or creatinine clearance \< 50% normal * Not HIV seropositive * Not pregnant or breast-feeding * Fertile patients must use effective contraception * No active infections that are untreated or failing to respond to appropriate therapy PRIOR CONCURRENT THERAPY: Inclusion criteria: * See Disease Characteristics Exclusion criteria: * Prior allogeneic or autologous bone marrow, peripheral blood stem cell, or umbilical cord blood transplantation using a high-dose total-body irradiation regimen",NA,ALL,NA,"[{'measure': 'Lowest Dose of Alemtuzumab Associated With Transplant-related Mortality', 'description': 'Lowest dose of alemtuzumab associated with transplant-related mortality at day 180', 'timeFrame': 'Up to day 180'}]","[{'measure': 'Life-threatening Infection', 'timeFrame': 'Up to 180 days'}, {'measure': 'Grades III-IV Acute Graft-vs-host Disease (GVHD)', 'timeFrame': 'Up to 100 days'}, {'measure': 'Overall Survival', 'description': 'Count of surviving participants at 1 year', 'timeFrame': 'Up to 1 year'}, {'measure': 'Disease Relapse', 'description': 'Count of participants with disease relapse at 1 year', 'timeFrame': 'Up to 1 year'}, {'measure': 'Extensive Chronic GVHD', 'description': 'Count of participants with extensive chronic GVHD at 1 year', 'timeFrame': 'Up to 1 year'}, {'measure': 'Graft Failure', 'description': 'Count of participants with graft failure at day 100', 'timeFrame': 'Up to day 100'}]" 297,NCT01755325,"{'fullName': 'Ruijin Hospital', 'class': 'OTHER'}",Phase III Study of Compound Formula Realgar-Indigo Naturalis Plus Imatinib Versus Placebo Plus Imatinib in Adult CML-CP Patients With Ph+,SUSPENDED,"It is an open-label, randomized, double blind, placebo-controlled parallel-group, multi-center study to evaluate the efficacy and safety of Compound realgar formula Realgar-Indigo naturalis Tablet combined with Imatinib will be compared with imatinib alone in adult patients with diagnosed Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia in the chronic phase (CML-CP).",['Chronic Myelogenous Leukemia'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}","[{'type': 'DRUG', 'name': 'Compound realgar natural indigo Tablet', 'description': 'Compound realgar natural indigo Tablet, 65mg/kg/d, from day1 to day14,every 4 weeks.\n\nimatinib,0.4g,qd', 'armGroupLabels': ['Compound realgar natural indigo Tablet']}, {'type': 'DRUG', 'name': 'placebo', 'armGroupLabels': ['placebo']}]","Inclusion Criteria: 1. Male or female patients, age \>= 18 years and \<= 75 years. 2. Eastern Cooperative Oncology Group （ECOG） performance status (PS) score 0, 1, or 2. 3. Diagnosis of chronic myelogenous leukemia in chronic phase with confirmation of Philadelphia chromosome positive.(Ph+ CML-CP) 4. Ph+ Chronic myelogenous leukemia in chronic phase patients within the first 12 months of diagnosis. 5. Adequate end organ function as defined by: (1). Alanine transaminase（ALT）, Aspartate transaminase（AST） \<=2.5 x upper limit of normal（ULN）. (2). Total bilirubin \<= 1.5 x ULN. (3).Cr \<= 1.5 x ULN. (4). Serum amylase and lipase \<= 1.5 x ULN. 6. Signed informed consent. Exclusion Criteria: 1\. Previously received or be receiving any of the following medical treatment for CML: 1. . Treatment with Busulfan within 1 day prior to study entry. 2. . Treatment with interferon-alpha within 2 days prior to study entry. 3. . Treatment with hydroxyurea within 1 day prior to study entry. 4. . Treatment with homoharringtonine within 14 days prior to study entry. 5. . Treatment with Cytosine arabinoside within 28 days prior to study entry. 6. . Surgery (Including hematopoietic stem cell transplantation therapy) 7. . Treatment with anthracyclines, or etoposide within 21 days prior to study entry. 2\. Treatment with any tyrosine kinase inhibitor(s) or arsenic reagent prior to study entry 3. Patients who are: (a) pregnant, (b) breast feeding, (c) female or male of childbearing potential unwilling to use contraceptive precautions throughout the trial. 4\. Major surgery within 4 weeks prior to randomization or who have not recovered from prior surgery. 5\. Patients who have not recovered from toxic reaction of prior similar treatment evaluated by investigators. 6\. Impaired cardiac function including any one of the following: 1. LVEF \< 45%. 2. . Complete left bundle branch block. 3. . Use of a ventricular-paced pacemaker. 4. . Congenital long QT syndrome. 5. . History or presence of ventricular, clinically significant atrial tachyarrhythmias 6. . History or presence of clinically significant bradyarrhythmia.(heart rate persistently less than 50/min) 7. . QTcF \> 450 msec for male or 470 msec for female. 8. . History of clinically documented myocardial infarction or unstable angina (during the last 12 month). 9. .Any other severe heart disease. 7. Patients with active, uncontrolled psychiatric disorders, without insight and the ability of exact expression. 8\. Uncontrolled medical conditions: 1. .Uncontrolled diabetes with fasting blood-glucose \>200mg/dl (11.1mmol/L),or with combined symptoms (nephropathy, peripheral neuropathy). 2. . Uncontrolled hypertension. 3. . Active or uncontrolled infection (persistent fever and worsening of the clinical symptoms) 9. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the tested drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery). 10\. History of chronic pancreatitis or history of acute pancreatitis within 1 year of study entry. 11\. Acute or chronic uncontrolled liver disease or severe renal disease considered unrelated to CML. 12\. Patients actively receiving therapy with strong CYP3A4 inhibitors, strong CYP3A4 inducers or any medications being potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. 13\. Treatment with other investigational agents (defined as not used in accordance with the approved indication) within 4 weeks prior to randomization. 14\. Known to be allergic to the study drugs, including crude drug or adjuvant. 15. As investigators evaluate, the patients do not fit to join the study (such as with severe complications) .",NA,ALL,NA,"[{'measure': 'To compare the rate of Major molecular response（MMR） at 12 months', 'timeFrame': '12 months of follow-up from the start of treatment'}]",NA 298,NCT03881826,"{'fullName': 'Université Catholique de Louvain', 'class': 'OTHER'}",Investigation of the Gut Microbiota in Patients With Acute Myeloid Leukemia,COMPLETED,"This cohort study aims to investigate the composition and activity of the gut microbiota of patients newly diagnosed for acute myeloid leukemia (AML), in relationship with their food habits and cachectic hallmarks. The recruitment for this study is currently ongoing with the help of clinicians, nurses and data managers at the Saint-Luc clinics, University Hospital Leuven (Campus Gasthuisberg) and University Hospital Gent. Primary Objective •To assess the composition and activity of the gut microbiota in patients with acute myeloid leukemia (AML) compared to matched control subjects. Secondary Objectives * To investigate correlations between the gut microbiota, cachectic hallmarks and gut microbiota-related markers in the blood (gut permeability markers, microbial compounds, microbial metabolites). * To characterize the changes in the gut microbial ecosystem that are induced by chemotherapy and associated with colitis. * To assess whether the composition of the gut microbiota can predict the severity of chemotherapy-related colitis. Study Design This is an academic multi-centric prospective study. The study is composed of two cohorts (Fig. 1). In Cohort A, patients are included before any chemotherapy. Biological samples (urine, feces, blood) are collected, alongside information on nutritional habits, appetite and medical records. Muscle strength and body composition are also measured. Only patients receiving a standard chemotherapy are included in Cohort B. In Cohort B, biological samples are collected and body composition, muscle strength and appetite are evaluated at 2 different time points, at the end of the chemotherapy (T1) and at discharge (T4).","['Acute Myeloid Leukemia', 'Cachexia']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'OTHER', 'name': 'collection of clinical data and biological samples', 'description': '* nutritional assessement\n* cachexia symptoms\n* urine, feces and blood samples', 'armGroupLabels': ['Haematological patients', 'Healthy volunteers']}]","Inclusion Criteria: * Patients with * A diagnosis of AML and related precursor neoplasms according to WHO 2008 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antecedent hematological disease (e.g. MDS) and therapy-related AML) * Acute leukemia's of ambiguous lineage according to WHO 2008 * A diagnosis of refractory anemia with excess of blasts (MDS REAB) 2 and IPSS (International Prognostic Scoring System)-R score \> 2. * World Health Organization performance status 0, 1 or 2 * Sampled bone marrow and/ blood cells at diagnosis with molecular analysis. * Written informed consent * Good command of the French or Dutch language Exclusion Criteria: * Age \< 18 years * Age \> 75 years * Pregnancy * Antibiotics consumption during the last 30 days before inclusion * Recent chemotherapy (\< 3 months), with exclusion of hydroxyurea * BMI \>30 * Any history of chronic intestinal affections (Crohn disease, inflammatory bowel disease, gluten intolerance) * Gastric bypass * Current treatment with antidiabetic or hypoglycemic drugs",NA,ALL,NA,"[{'measure': 'Description of gut microbiota composition in patients with acute myeloid leukemia and control subjects', 'description': ""Sequencing DNA extracts from patients' feces (both patients with acute myeloid leukemia and control subjects matched for BMI, sex and age) to obtain the description of gut microbiota composition in those patients"", 'timeFrame': 'Day 0 i.e.: feces sampling is done at time of diagnosis before any chemotherapy'}, {'measure': 'Measure of metabolites production by the gut microbiota in patients with acute myeloid leukemia and control subjects', 'description': ""1H-NMR metabolomics performed on patients' feces (both patients with acute myeloid leukemia and control subjects matched for BMI, sex and age) to report the metabolites produced by the gut microbiota of those patients"", 'timeFrame': 'Day 0 i.e.: feces sampling is done at time of diagnosis before any chemotherapy'}]","[{'measure': 'Changes in muscle strength', 'description': 'Measure of muscle strength with Jamar dynamometer (in kg)', 'timeFrame': 'at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);'}, {'measure': 'Changes in body composition', 'description': 'Measure of body composition by bio-electric impedance (in kg)', 'timeFrame': 'at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);'}, {'measure': 'Changes in appetite', 'description': 'Measure of appetite with the SNAQ questionnaire (score from 5 to 20)', 'timeFrame': 'at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);'}, {'measure': 'Changes in gut microbiota-related markers in the blood (gut permeability markers and microbial compounds)', 'description': 'ELISA (in pg/ml)', 'timeFrame': 'at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);'}, {'measure': 'Changes in gut microbiota-related markers in the blood (microbial metabolites)', 'description': '1H-NMR metabolomics', 'timeFrame': 'at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);'}, {'measure': 'Changes in gut microbiota-related markers in urine (gut permeability markers, microbial compounds, microbial metabolites)', 'description': 'ELISA and 1H-NMR metabolomics', 'timeFrame': 'at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);'}, {'measure': 'Changes in gut microbiota composition in patients with acute myeloid leukemia before, during and after chemotherapy', 'description': ""Sequencing DNA extracts from patients' feces to obtain the description of gut microbiota composition in those patients."", 'timeFrame': 'at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);'}, {'measure': 'Changes in metabolites production by the gut microbiota in patients with acute myeloid leukemia before, during and after chemotherapy.', 'description': ""1H-NMR metabolomics performed on patients' feces to report the metabolites produced by the gut microbiota of those patients."", 'timeFrame': 'at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);'}, {'measure': 'Changes in number of participants with treatment related-related adverse events as assessed by CTCAE v4.0', 'description': 'CTCAE (common terminology criteria for adverse event version 4)', 'timeFrame': 'at day 0 (i.e.: feces sampling is done at time of diagnosis before any chemotherapy);'}]" 299,NCT06661915,"{'fullName': 'National Cancer Institute (NCI)', 'class': 'NIH'}",A Randomized Study of ASTX727 With or Without Iadademstat in Advanced Myeloproliferative Neoplasms (MPNs),SUSPENDED,"This phase II trial compares the effect of ASTX727 in combination with iadademstat to ASTX727 alone in treating patients with accelerated or blast phase Philadelphia chromosome negative myeloproliferative neoplasms (MPNs). ASTX727 is a combination of two drugs, cedazuridine and decitabine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Iadademstat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving ASTX727 in combination with iadademstat may be more effective than ASTX727 alone in treating patients with accelerated or blast phase Philadelphia chromosome negative MPNs.","['Accelerated Phase Myeloproliferative Neoplasm', 'Blast Phase Myeloproliferative Neoplasm', 'Essential Thrombocythemia', 'Myelodysplastic/Myeloproliferative Neoplasm', 'Myeloproliferative Neoplasm, Not Otherwise Specified', 'Polycythemia Vera', 'Primary Myelofibrosis', 'Secondary Myelofibrosis']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'PROCEDURE', 'name': 'Biospecimen Collection', 'description': 'Undergo buccal swab and blood sample collection', 'armGroupLabels': ['Arm I (ASTX727)', 'Arm II (ASTX727, iadademstat)'], 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Sample Collection', 'Specimen Collection']}, {'type': 'PROCEDURE', 'name': 'Bone Marrow Aspiration', 'description': 'Undergo bone marrow aspiration and biopsy', 'armGroupLabels': ['Arm I (ASTX727)', 'Arm II (ASTX727, iadademstat)']}, {'type': 'PROCEDURE', 'name': 'Bone Marrow Biopsy', 'description': 'Undergo bone marrow aspiration and biopsy', 'armGroupLabels': ['Arm I (ASTX727)', 'Arm II (ASTX727, iadademstat)'], 'otherNames': ['Biopsy of Bone Marrow', 'Biopsy, Bone Marrow']}, {'type': 'DRUG', 'name': 'Decitabine and Cedazuridine', 'description': 'Given PO', 'armGroupLabels': ['Arm I (ASTX727)', 'Arm II (ASTX727, iadademstat)'], 'otherNames': ['ASTX 727', 'ASTX-727', 'ASTX727', 'C-DEC', 'CDA Inhibitor E7727/Decitabine Combination Agent ASTX727', 'Cedazuridine/Decitabine Combination Agent ASTX727', 'Cedazuridine/Decitabine Tablet', 'DEC-C', 'Inaqovi', 'Inqovi']}, {'type': 'DRUG', 'name': 'Iadademstat', 'description': 'Given PO', 'armGroupLabels': ['Arm II (ASTX727, iadademstat)'], 'otherNames': ['ORY 1001', 'ORY-1001', 'RG 6016', 'RG6016', 'RO 7051790', 'RO7051790', 'trans-N1-((1R,2S)-2-Phenylcyclopropyl)-1,4-cyclohexanediamine']}]","Inclusion Criteria: * Patients must have morphologically confirmed diagnosis of Philadelphia-chromosome negative MPN in accelerated-phase (10-19% myeloid blasts) or blast-phase (≥ 20% myeloid blasts) arising from polycythemia vera, essential thrombocythemia, primary myelofibrosis, secondary myelofibrosis, or MPN not otherwise specified, as per the World Health Organization (WHO) 2016 classification OR myelodysplastic syndrome (MDS)/MPN overlap syndromes (e.g., chronic myelomonocytic leukemia \[CMML\]) with ≥ 10% blasts * Patients must not have received prior DNMTi. Previous use of janus kinase (JAK) inhibition, hydroxyurea, and interferon is allowed. There is no required washout period * Age ≥ 18 years * Because no dosing or adverse event data are currently available on the use of ASTX727 (35 mg decitabine + 100 mg cedazuridine) in combination with iadademstat in patients \< 18 years of age, children are excluded from this study * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3 (Karnofsky ≥ 30) * Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (unless elevated due to Gilbert's syndrome, thought to be related to MPN-AP/BP, or due to extrasvascular hemolysis. In these cases conjugated bilirubin should be ≤ 2.0 x ULN) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x institutional ULN * Glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m\^2 by Modification of Diet in Renal Disease (MDRD) * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial * Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better * The effects of ASTX727 (35 mg decitabine + 100 mg cedazuridine) and/or iadademstat on the developing human fetus are unknown. For this reason and because DNMT inhibitor and LSD1 inhibitor agents are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation and 6 months after completion of ASTX727 (35 mg decitabine + 100 mg cedazuridine) and/or iadademstat administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception for the duration of study participation and 6 months after completion of ASTX727 (35 mg decitabine + 100 mg cedazuridine) and/or iadademstat administration * Women of child-bearing potential must agree not to donate or freeze egg(s) during the course of this study or within 180 days after receiving their last dose of study drug. Male patients must agree not to donate sperm during the course of this study or within 180 days after receiving their last dose of study drug * Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants * Patient is able to swallow oral medications * Patients must have a body weight of at least 50 kg due to the use of flat doses. If a patient is on continued treatment and is receiving benefit, but falls below 50 kg, they may stay on the study per investigator discretion. Otherwise, they will have to come off the study * Peripheral white blood cell (WBC) count \<25 x 10\^9/L on day 1 prior to treatment initiation. Hydroxyurea is allowed for cytoreduction until 24 hours prior to study treatment Exclusion Criteria: * Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia * Patients who are receiving any other investigational agents or had received any investigational products within 3 weeks or 5 half-lives (whichever is shorter) prior to first dose of study treatment * Patients with a Fridericia's corrected QT interval (QTcF) \> 450 ms * History of allergic reactions attributed to compounds of similar chemical or biologic composition to ASTX727 (35 mg decitabine + 100 mg cedazuridine) or iadademstat * Patients medicated with anti-depressants reported to have KDM1A/LSD1 inhibitory activity: tranylcypromine or phenelzine * Patients with IDH1-mutated MPN blast phase (≥ 20% blasts). Patients with an IDH1-mutation with MPN-AP (10-19%) blasts are eligible for this study * Iadademstat concomitant medication considerations: Patients are not allowed to receive prophylactic hematopoietic colony stimulating factors, any complementary or alternative medicine \[any of various systems of healing or treating disease (as non-prescription supplements, herbal medicine and homeopathy)\]. Of note, patients may receive granulocyte colony-stimulating factor for management of febrile neutropenia or for prolonged neutropenia * Patients may not receive administration of live or live-attenuated vaccines. Administration of non-live vaccines included ribonucleic acid (RNA)-based vaccines is allowed and is recommended for pneumococcal, coronavirus, and influenza vaccines * Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous * Pregnant women are excluded from this study because iadademstat is an LSD1 inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with iadademstat, breastfeeding should be discontinued if the mother is treated with iadademstat. These potential risks also apply to the ASTX727 (35 mg decitabine + 100 mg cedazuridine) used in this study * Patients who require treatment while on study with concomitant drugs that target the 5HT2B receptor or the sigma nonspecific receptor (e.g., escitalopram, fluoxetine, sertraline) except for drugs that are considered absolutely essential for the care of the patient and with appropriate treatment monitoring",NA,ALL,NA,"[{'measure': 'Acute leukemia response-complete (ALR-C) rate', 'description': ""ALR-C rates will be compared between the two treatment arms using Fisher's exact test at the one-sided, alpha = 0.15 significance level."", 'timeFrame': 'Within 4 cycles (cycle length = 28 days)'}]","[{'measure': 'Event-free survival', 'description': 'Treatment failure is defined as not achieving ALR-C by four cycles of therapy. Hematological relapse is defined as ≥ 5% blasts in bone marrow or peripheral blood or development of myeloid sarcoma after achievement of ALR-C or better. Kaplan-Meier curves will be generated and the two treatment arms will be compared using a stratified log rank test. Cox regression modeling, including treatment arm and dichotomized blast percentage as covariates, will also be performed to estimate the hazard ratio, along with a 90% confidence interval.', 'timeFrame': 'From day 1 of randomization to the date of treatment failure, hematological relapse from ALR-C, or death from any cause up to 2 years'}, {'measure': 'Overall survival (OS)', 'description': 'Kaplan-Meier curves will be generated, and the two treatment arms will be compared using a stratified log rank test. Cox regression modeling including treatment arm and dichotomized blast percentage as covariates, will also be performed to estimate the hazard ratio, along with a 90% confidence interval.', 'timeFrame': 'From randomization to the time of death due to any cause up to 2 years'}, {'measure': 'Percentage of allogeneic hematopoietic stem cell transplantation (allo-HCT)', 'description': ""Descriptive statistics will be utilized for analysis and will be broken down by which treatment arm to which a patient is assigned. The number receiving allo-HCT will be compared between the two treatment arms using Fisher's exact test."", 'timeFrame': 'Up to 2 years'}]" 300,NCT00552825,"{'fullName': 'Sheba Medical Center', 'class': 'OTHER_GOV'}",Pulmonary Function at Presentation and Follow-up in Hemato-Oncology 3-7 Years Old Children,COMPLETED,The aim of this study was to investigate the occurrences of respiratory symptoms risk factors and abnormalities in lung function in young children (3-6 years old) with hemato-oncologic diseases at presentation (before treatment) and up to 3 years follow-up (study period).,"['Acute Lymphoblastic Leukemia', 'Acute Myeloblastic Leukemia', 'Solid Tumors,', ""Hodgkin's Disease"", 'Non-Malignant']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}",NA,"Inclusion Criteria: * All pediatric patients (age 3-7 years) with hemato-onclogic diseases that were treated at the Hemato-Oncology Department, and were sent to the pediatric pulmonary unit.","All pediatric patients (age 3-7 years) with hemato-onclogic diseases that were treated at the Hemato-Oncology Department, and were sent to the pediatric pulmonary unit at the Safra children's hospital, Sheba medical center, Ramat-Gan, Israel, to perform lung function tests, as a part of a 3-year follow-up study.",ALL,NON_PROBABILITY_SAMPLE,NA,NA 301,NCT05665114,"{'fullName': 'Zhejiang University', 'class': 'OTHER'}",Natural Killer(NK) Cell Therapy in r/r AML,UNKNOWN,"This is an open-label, Phase I study of QN-030a (allogeneic NK cell therapy) in relapse/refractory Acute Myeloid Leukemia (AML). This clinical study is to evaluate the safety, tolerability and preliminary efficacy of QN-030a in patients with r/r AML, where a ""3+3"" enrollment schema will be utilized at dose escalation stage. Up to 18 patients will be enrolled.","['AML, Adult']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'QN-030a', 'description': 'NK cell therapy', 'armGroupLabels': ['QN-030a']}, {'type': 'DRUG', 'name': 'Cyclophosphamid', 'description': 'Lympho-conditioning Agent', 'armGroupLabels': ['QN-030a']}, {'type': 'DRUG', 'name': 'Fludarabine', 'description': 'Lympho-conditioning Agent', 'armGroupLabels': ['QN-030a']}, {'type': 'DRUG', 'name': 'Cytarabine', 'description': 'Lympho-conditioning Agent', 'armGroupLabels': ['QN-030a']}, {'type': 'DRUG', 'name': 'VP-16', 'description': 'Lympho-conditioning Agent', 'armGroupLabels': ['QN-030a']}]","Key Inclusion Criteria: * Provision of signed and dated informed consent form (ICF) * ≥18 years old * Diagnosis of r/r AML * Eastern Cooperative Oncology Group (ECOG) performance status ≤1 * Adequate organ function as defined in the protocol * Donor specific antibody (DSA) to QN-030a: MFI \<= 2000 Key Exclusion Criteria: * Allergic to drug used in this study * Accept other anti-tumor drugs/therapies within certain time of day 0 (first QN-030a dose infusion), time window and drug defined in the protocol. * received systemic immunosuppressive therapy within 7 days of day 0, or likely to require systemic immunosuppressive therapy * Acute Promyelocytic Leukemia (APL) * Central nervous system Leukemia. * Uncontrolled, active clinically significant infection * Clinically significant cardiovascular disease as defined in the protocol * Known HIV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection * History of central nervous system (CNS) disease such as stroke, epilepsy. * Females are pregnant or lactating * Investigator-assessed presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject",NA,ALL,NA,"[{'measure': 'Incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': 'Up to approximately 2 years after last dose of QN-030a'}, {'measure': 'Incidence of dose adjustment or discontinuation due to NK cell toxicities', 'timeFrame': 'Up to approximately 2 years after last dose of QN-030a'}, {'measure': 'Incidence of subjects with Dose Limiting Toxicities within each dose level cohort', 'timeFrame': '28 Days from first dose of QN-030a'}, {'measure': 'Determine the Maximum tolerated dose (MTD) and RP2D', 'timeFrame': '28 Days from first dose of QN-030a'}]","[{'measure': 'Overall Response Rate(ORR) of QN-030a in r/r AML', 'description': 'Proportion of subjects who achieve a CR, CRi, CRMRD-, MLFS, or PR, as determined by investigator.', 'timeFrame': 'Up to approximately 2 years after last dose of QN-030a'}, {'measure': 'Relapse-free survival (RFS) of QN-030a in r/r AML', 'timeFrame': 'Up to approximately 2 years after last dose of QN-030a'}, {'measure': 'Time to Response (TTR) of QN-030a in r/r AML', 'timeFrame': 'Up to approximately 2 years after last dose of QN-030a'}, {'measure': 'Event-free survival (EFS) of QN-030a in r/r AML', 'timeFrame': 'Up to approximately 2 years after last dose of QN-030a'}, {'measure': 'Overall Survival (OS) of QN-030a in r/r AML', 'timeFrame': 'Up to approximately 2 years after last dose of QN-030a'}, {'measure': 'Determination of the pharmacokinetics (PK) of QN-030a cells in peripheral blood', 'description': 'The PK of QN-030a in peripheral blood will be reported as the relative percentage of product (QN-030a) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points', 'timeFrame': 'Up to approximately 2 years after last dose of QN-030a'}, {'measure': 'Evaluate the immunogenicity features of QN-030a', 'description': 'The Donor specific antibody (DSA) and T cell receptor (TCR) will be measured.', 'timeFrame': 'Up to approximately 2 years after last dose of QN-030a'}]" 302,NCT02900716,"{'fullName': 'Zhejiang DTRM Biopharma', 'class': 'INDUSTRY'}","Safety Study of BTK Inhibitor, DTRMWXHS-12, Used Singly or in Combination, in CLL and B-cell Lymphomas",COMPLETED,"This study will evaluate the safety, antitumor activity and preliminary pharmacokinetics of an investigational drug product, DTRMWXHS-12, in patients with chronic lymphocytic leukemia or other B-cell lymphomas. DTRMWXHS-12 will be evaluated as a single agent, and in combination. This study will be conducted in two parts: phase Ia and Ib. Both parts will explore escalating doses of DTRMWXHS-12. The phase Ia study will evaluate DTRMWXHS-12 monotherapy. The phase Ib study will evaluate DTRMWXHS-12 combinations.","['Chronic Lymphocytic Leukemia', 'B-Cell Lymphoma']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'DTRMWXHS-12', 'description': 'DTRMWXHS-12', 'armGroupLabels': ['Phase Ia']}, {'type': 'DRUG', 'name': 'DTRM-505', 'description': 'DTRMWXHS-12 and everolimus', 'armGroupLabels': ['Phase Ib, DTRM-505']}, {'type': 'DRUG', 'name': 'DTRM-555', 'description': 'DTRMWXHS-12 and everolimus and pomalidomide', 'armGroupLabels': ['Phase Ib, DTRM-555']}]","Inclusion Criteria: * Patients with a diagnosis of chronic lymphocytic leukemia (CLL) or other B-cell neoplasms including small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) and follicular B-cell non-Hodgkin's lymphoma (FL) who have no available approved therapies. * Age \> 18 years. * Life expectancy greater than 12 weeks. * Patients must have an ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1. * Patients must provide written informed consent. * Ability to swallow and retain capsules. * Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions. * Women of child-bearing potential must have a negative serum or urine pregnancy test. * Women of child-bearing potential must agree to use 2 reliable methods of contraception beginning 4 weeks prior to the initiation of treatment, during therapy, and for at least 4 weeks after the last drug administration. * Men must agree to use a latex or synthetic condom during sexual contact with a pregnant female or a female who can become pregnant, for the duration of the study and for at least 4 weeks after the last drug administration, even if they have undergone a successful vasectomy. Exclusion Criteria: * Received previous chemotherapy, immunotherapy, radiotherapy or any other investigational therapy within 21 days or 5 half-lives for targeted therapies prior to this study entry. * Patients with active infections requiring intravenous (IV) antibiotic/antiviral therapy are not eligible for entry onto the study until resolution of the infection; patients on prophylactic antibiotics, antifungals or antivirals are acceptable * Pregnant or lactating individuals. * Impaired hepatic or renal function as demonstrated by any of the following laboratory values: 1. AST or ALT \> 2.5 x ULN 2. Total bilirubin \> 1.5 x ULN (Patients with a history of Gilbert's syndrome may participate if total bilirubin is less than or equal to 1.5 x ULN and the AST/ALT and alkaline phosphatase meet the protocol-specified levels for eligibility) 3. Alkaline phosphatase \> 2.5 x ULN 4. Glomerular filtration rate (GFR) \< 50 mL/min, as assessed using the standard methodology at the investigating center (i.e. Cockroft-Gault), or serum creatinine \> 1.5 x ULN * INR \> 1.5 or other evidence of impaired hepatic synthesis function. * Persisting (\> 8 weeks) severe pancytopenia due to hematologic disorder or due to previous therapy rather than disease (ANC \< 0.5 x 109/L or platelets \< 30 x 109/L) - to be confirmed via bone marrow biopsy, as part of normal clinical care, prior to signing of consent. * Previous allogeneic bone marrow transplant are restricted, unless there is no evidence of acute or chronic graft versus host disease. * CNS involvement with malignancy. * Current malignancies of another type, with the exception of adequately treated in situ cervical cancer and basal cell skin cancer, squamous cell carcinoma of the skin or other malignancies with no evidence of disease for 2 years or more. * Known history of HIV, HBV or HCV infection. * Documented or known bleeding disorder. * Requirement for anticoagulation treatment that increases INR or aPTT above the normal range (low molecular weight heparin and heparin line flush allowed). * Patient is receiving any azole. * Patients with a significant cardiovascular disease or condition, including: * Myocardial infarction within 6 months of study entry * NYHA Class III or IV heart failure, or reduced LVEF \<50% * Uncontrolled dysrhythmias or poorly controlled angina. * History of serious ventricular arrhythmia (VT or VF, ≥ 3 beats in a row) and/or risk factors (e.g., heart failure, hypokalemia, family history of Long QT Syndrome) * Baseline prolongation of QT/QTc interval (repeated demonstration of QTc ≥ 450 msec for men and 470 msec for women, or LVEF ≤ 40% by MUGA or ECHO).",NA,ALL,NA,"[{'measure': 'Number of patients with adverse events', 'description': 'Safety and tolerability', 'timeFrame': 'Starting from date of first dose up to 30 days after last dose'}]","[{'measure': 'Plasma concentration over time', 'description': 'Pharmacokinetics', 'timeFrame': 'Days 1-28 (first treatment cycle)'}]" 303,NCT00498316,"{'fullName': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}",Cord Blood Expansion on Mesenchymal Stem Cells,COMPLETED,"The goal of this clinical research study is to learn if combining cord blood units will be safe and result in the cells ""taking"" faster in recipients. The cord blood units will have their cell number increased in the lab using cells from a family member or they will be collected from an unrelated healthy donor.","['Myelodysplastic Syndrome', 'Leukemia']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'PROCEDURE', 'name': 'Cord Blood Infusion', 'description': 'Cord blood transplantation performed on day 0.', 'armGroupLabels': ['Cord Blood Infusion']}, {'type': 'DRUG', 'name': 'Busulfan', 'description': '32 mg/m2 by vein as an outpatient before Day -14 or as an inpatient on Day -9, and AUC of 4,000 microMol.min-1 by vein on Days -7 to -4 for patients with ALL, AML, NHL, CLL, CML, HD, and MM who are \\>1 and \\< 55 years old. Patients \\>55 but \\< 65 years who have a Performance Status of 0 or 1 and no comorbidities may receive the myeloablative regimen 4 at the discretion of the investigator(s).', 'armGroupLabels': ['Cord Blood Infusion'], 'otherNames': ['Busulfex', 'Myleran']}, {'type': 'DRUG', 'name': 'Fludarabine', 'description': '10 mg/m2 by vein on Days -7 to -4 for patients with ALL, AML, NHL, CLL, CML, HD, and MM who are \\>1 and \\< 55 years old. Patients \\>55 but \\< 65 years who have a Performance Status of 0 or 1 and no comorbidities may receive the myeloablative regimen 4 at the discretion of the investigator(s).\n\n40 mg/m2 by vein on Days -6 to -3 for patients with AML, ALL, NHL, CLL,CML, HD and MM who are \\> 55 and \\< 80 years old or of any age with co-morbid condition that in the opinion of the investigators would preclude myeloablative therapy.\n\n40 mg/m2 by vein on Days -5 to -2 for patients with AML, ALL, NHL, CLL, CML, and HD who are \\>1 and \\< 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy and who cannot receive Total Body Irradiation (TBI) may receive the reduced intensity treatment regimen 3.', 'armGroupLabels': ['Cord Blood Infusion'], 'otherNames': ['Fludarabine Phosphate', 'Fludara']}, {'type': 'DRUG', 'name': 'Rituximab', 'description': '375 mg/m2 by vein on Day -9 for patients with AML, ALL, NHL, CLL,CML, HD and MM who are \\> 55 and \\< 80 years old or of any age with co-morbid condition that in the opinion of the investigators would preclude myeloablative therapy.', 'armGroupLabels': ['Cord Blood Infusion'], 'otherNames': ['Rituxan']}, {'type': 'OTHER', 'name': 'ATG', 'description': '1.25 mg/Kg by vein on Day -4 and 1.75 mg/Kg by vein on Day -3 for patients with AML, ALL, NHL, CLL,CML, HD and MM who are \\> 55 and \\< 80 years old or of any age with co-morbid condition that in the opinion of the investigators would preclude myeloablative therapy.\n\n1.25 mg/kg by vein on Day -3 and 1.75 mg/kg by vein on Day -2 for patients with AML, ALL, NHL, CLL, CML, and HD who are \\>1 and \\< 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy and who cannot receive Total Body Irradiation (TBI) may receive the reduced intensity treatment regimen 3.', 'armGroupLabels': ['Cord Blood Infusion'], 'otherNames': ['Antithymocyte Globulin', 'Thymoglobulin']}, {'type': 'DRUG', 'name': 'Cyclophosphamide', 'description': '50 mg/kg by vein on Day -6 for patients with AML, ALL, NHL, CLL,CML, HD and MM who are \\> 55 and \\< 80 years old or of any age with co-morbid condition that in the opinion of the investigators would preclude myeloablative therapy.', 'armGroupLabels': ['Cord Blood Infusion'], 'otherNames': ['Cytoxan', 'Neosar']}, {'type': 'DRUG', 'name': 'Clofarabine', 'description': '30 mg/m2 by vein on Days -7 to -4 for patients with ALL, AML, NHL, CLL, CML, HD, and MM who are \\>1 and \\< 55 years old. Patients \\>55 but \\< 65 years who have a Performance Status of 0 or 1 and no comorbidities may receive the myeloablative regimen 4 at the discretion of the investigator(s).', 'armGroupLabels': ['Cord Blood Infusion'], 'otherNames': ['Clofarex', 'Clolar']}, {'type': 'RADIATION', 'name': 'Total Body Irradiation (TBI)', 'description': '200 cGy at 25 cGy/minute delivered on Day -3.', 'armGroupLabels': ['Cord Blood Infusion'], 'otherNames': ['TBI', 'XRT']}, {'type': 'DRUG', 'name': 'Melphalan', 'description': '140 mg/m2 by vein on Day -2 for patients with AML, ALL, NHL, CLL, CML, and HD who are \\>1 and \\< 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy and who cannot receive Total Body Irradiation (TBI) may receive the reduced intensity treatment regimen 3.', 'armGroupLabels': ['Cord Blood Infusion'], 'otherNames': ['Alkeran']}, {'type': 'DRUG', 'name': 'Tacrolimus', 'description': '0.03 mg/kg by vein daily starting on D-2, to be changed to oral dosing when tolerated. Tacrolimus is to be tapered around Day +180, if no GVHD is present.', 'armGroupLabels': ['Cord Blood Infusion'], 'otherNames': ['Prograf']}, {'type': 'DRUG', 'name': 'Mycophenolate Mofetil', 'description': '1 gram by vein twice a day Days -3 through Day 100.', 'armGroupLabels': ['Cord Blood Infusion'], 'otherNames': ['MMF', 'CellCept']}, {'type': 'DRUG', 'name': 'G-CSF', 'description': '5 mcg/kg/day subcutaneously beginning on day 0, and continuing until the absolute neutrophil count (ANC) is \\> 2.5 x 109/L.', 'armGroupLabels': ['Cord Blood Infusion'], 'otherNames': ['Filgrastim', 'Neupogen']}]","Inclusion Criteria: 1. Patients must have one of the following hematologic malignancies: Acute Myelogenous Leukemia (AML), induction failure, high-risk for relapse first remission (with intermediate-risk or high-risk cytogenetics, flt3 mutation positive and/or evidence of minimal residual disease by flow cytometry), secondary leukemia from prior chemotherapy and/or arising from MDS, Langerhan's cell histiocytosis, any disease beyond first remission; or, 2. Myelodysplastic Syndrome (MDS): Primary or therapy related; or, 3. Acute Lymphoblastic Leukemia (ALL): induction failure, primary refractory to treatment (do not achieve complete remission after first course of therapy) or are beyond first remission including second or greater remission or active disease. 4. #3, continued: Patients in first remission are eligible if they are considered high risk, defined as any of the following detected at any time: with translocations 9;22 or 4;11, hypodiploidy, complex karyotype, secondary leukemia developing after cytotoxic drug exposure, and/or evidence of minimal residual disease, or acute biphenotypic leukemia, or double hit non-Hodgkin's lymphoma; or, 5. Non-Hodgkin's Lymphoma (NHL) in second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant). Double hit lymphomas in first remission or more advanced disease; or, 6. Small Lymphocytic Lymphoma (SLL), or Chronic Lymphocytic Leukemia (CLL) with progressive disease following standard therapy; or, 7. CML second chronic phase or accelerated phase; or, 8. Hodgkin's Disease (HD): Induction failures, second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant); or, 9. Multiple Myeloma: stage II or III, symptomatic, secretory Multiple Myeloma requiring treatment. 10. Age greater than or equal to 1 year but less than or equal to 55 years (Myeloablative Regimen 4). Eligibility for pediatric patients will be determined in conjunction with an MD Anderson Cancer Center (MDACC) pediatrician. Patients \>55 but \< 65 years who have a Performance Status of 0 or 1 and no comorbidities may receive the myeloablative regimen 4 at the discretion of the investigator(s). 11. Age greater than 55 years and less than or equal to 80 years (Nonmyeloablative Regimen 2) 12. Age greater than or equal to 1 but less than or equal to 80 years old that in the opinion of the investigator(s) would preclude myeloablative therapy and who cannot receive Total Body Irradiation (TBI) may receive reduced intensity regimen 3. 13. Performance score of at least 60% by Karnofsky or PS less than 3 (ECOG) (age greater than or equal to 12 years), or Lansky Play-Performance Scale of at least 60% or greater (age \<12 years) 14. Left ventricular ejection fraction of at least 40% (Myeloablative Regimen 4, Reduced Intensity Regimen 3) or 30% (Nonmyeloablative Regimen 2) 15. Pulmonary function test demonstrating a diffusion capacity of least 50% predicted (Myeloablative Regimen 4, Reduced Intensity Regimen 3) or at least 40% predicted (Nonmyeloablative Regimen 2). For children \< 7 years of age who are unable to perform pulmonary function test (PFT), oxygen saturation \> 92% on room air by pulse oximetry. 16. Creatinine \< 1.6 mg/dL (Myeloablative Regimen 4, Reduced Intensity Regimen 3) or \< 3.0 mg/dL (Nonmyeloablative Regimen 2). 17. Serum glutamate pyruvate transaminase (SGPT)/bilirubin \< / = to 2.0 x normal (Myeloablative Regimen 4, Reduced Intensity Regimen 3) or \< / = 4.0 x normal (Nonmyeloablative Regimen 2) 18. Negative Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization and willing to use an effective contraceptive measure while on study. 19. Unrelated Cord Blood will be used as a source of hematopoietic support if a 5 or 6/6 related or 6/6 unrelated bone marrow donor is not available, or if the tempo of a patient's disease dictates it is not in the patient's best interest to wait for an unrelated marrow donor to be procured. 20. Patients must have two Cord Blood units available which are matched with the patient at 4, 5, or 6/6 HLA class I (serological) and II (molecular) antigens. Each cord must contain at least 10 million total nucleated cells/Kg recipient body weight (pre-thaw) 21. Patients must have a family member who is matched at 2, 3, or 4 HLA antigens typed as described above and willing to donate 80-100 ml or bone marrow for MSC generation or the Angioblast Mesenchymal Precursor Cells will be used for the cord blood co-cultures. Patients that are high risk for relapse are eligible to use the Angioblast ""off-the-shelf"" Mesenchymal Precursor Cells. 22. Have identified a back-up cell source in case of engraftment failure. The source can be autologous, related, or unrelated. Exclusion Criteria: 1. HIV positive 2. Positive beta HCG in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization or breast-feeding. 3. Uncontrolled serious medical condition such as persistent septicemia despite adequate antibiotic therapy, decompensated congestive heart failure despite cardiac medications or pulmonary insufficiency requiring intubation. (excluding primary disease for which CB transplantation is proposed), or psychiatric condition that would limit informed consent. 4. Active central nervous system (CNS) disease in patient with history of CNS malignancy. 5. Availability of appropriate, willing, HLA-matched related marrow donor.",NA,ALL,NA,"[{'measure': 'Engraftment and Time to Engraftment', 'description': 'Engraftment defined as a sustained ANC \\> 0.5 x 109/L for 3 consecutive days and evidence of donor chimerism or autologous reconstitution by D+42', 'timeFrame': '100 days after transplant, then every 3 months thereafter'}]",NA 304,NCT00003938,"{'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}",Liposomal Amphotericin B in Treating Granulocytopenia and Persistent Unexplained Fever in Cancer Patients,COMPLETED,"RATIONALE: Liposomal amphotericin B may be effective in controlling fever and granulocytopenia. It is not yet known which regimen of liposomal amphotericin B is more effective in treating cancer patients who have these conditions. PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of liposomal amphotericin B in treating granulocytopenia and fever in cancer patients.",['Cancer'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'primaryPurpose': 'SUPPORTIVE_CARE'}","[{'type': 'DRUG', 'name': 'liposomal amphotericin B'}]","DISEASE CHARACTERISTICS: * Hematologic malignancy or solid tumor * Must be undergoing remission induction and/or consolidation therapy for hematologic malignancy only OR * Must be undergoing allogeneic or autologous bone marrow transplantation * Granulocyte count less than 500/mm\^3 and profound granulocytopenia expected to last for greater than 5 days * Fever (greater than 38.5 degrees C) refractory for greater than 72 hours and less than 84 hours to broad spectrum antimicrobials, after exclusion of current bacterial, fungal, viral, parasitic, and mycobacterial infections * Peripheral blood cultures and central venous catheter cultures negative for infections * No microbiological documentation of a bacterial infection (e.g., abscess at catheter site) * No invasive fungal infection * No probable noninfectious cause of fever PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Karnofsky 40-100% OR * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics Hepatic: * Not specified Renal: * Not specified Other: * No prior anaphylactic reaction to amphotericin B * No psychological, familial, sociological, or geographical conditions that would prevent compliance * Not pregnant or nursing * Normal chest X-ray or normal high resolution CT scan of the lungs PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics Chemotherapy: * See Disease Characteristics Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * No concurrent active systemic antifungal agents or antifungal prophylaxis (e.g., azoles or polyenes) * No prior IV amphotericin B during same neutropenic episode * No change in antibacterial regimen within 48 hours prior to study",NA,ALL,NA,NA,NA 305,NCT02885038,"{'fullName': 'Etablissement Français du Sang', 'class': 'OTHER'}",Effect of Product Related Factors on Platelet Concentrate Transfusion Response in Patients With Hematologic Malignacies,COMPLETED,"Platelet concentrates (PCs) characteristics, such as storage duration, ABO compatibility, dose and source, may have an impact on transfusion responses and outcomes. Because of the relative scarcity of PCs the selection of a specific PC for issue to the patient remains a challenging process. Regulatory agencies do not fully address these characteristics in their recommendations for prophylactic transfusions. The aim of the study was to analyse the effect of product-related factors in a real life setting, in order to determine which ones are the most relevant when selecting PCs for patients in prophylactic conditions. Two different endpoints are studied: the corrected count increment and the platelet transfusion time intervals.","['Lymphoma', 'Multiple Myeloma', 'Lymphocytic Leukemia', 'Hodgkin Disease']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}","[{'type': 'OTHER', 'name': 'Platelet concentrate transfusion'}]","Inclusion Criteria: * Inpatients in the hematology department between January 2001 and December 2012 * Hematologic malignancy * At least one platelet transfusion (with platelet count ≤ 25 G/L) * Age 18 and over at time of first transfusion Exclusion Criteria: * More than one hematologic malignancy * Non-malignant haematological disorder",All patients with hematologic malignancies treated at the university hospital of Besançon who received at least one prophylactic platelet transfusion,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Corrected count increment', 'description': 'Platelet increment corrected for platelet dose and body surface area', 'timeFrame': '24 hours post transfusion'}]","[{'measure': 'Transfusion interval', 'description': 'Time interval to following platelet transfusion in days', 'timeFrame': '7 days'}]" 306,NCT00655343,"{'fullName': 'Neovii Biotech', 'class': 'INDUSTRY'}",Acute Graft-Versus-Host Disease (aGvHD) Prophylaxis With ATG-Fresenius in Matched Unrelated Donor-Stem Cell Transplantation (MUD-SCT),COMPLETED,The study aim is to evaluate the influence of the anti-T-lymphocyte globulin ATG-Fresenius S given pre-transplant in addition to standard GvHD prophylaxis with cyclosporine A and a short course of methotrexate with respect to efficacy and safety.,['Graft vs Host Disease'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'ATG-Fresenius S', 'description': '20 mg rabbit immunoglobulin (IgG) in 1 ml of sterile solution\n\n20 mg/kg body weight per day diluted in 500 ml physiological saline, slow intravenous infusion at days -3, -2, -1 prior to transplantation', 'armGroupLabels': ['ATG-F'], 'otherNames': ['ATG-Fresenius', 'Anti-T-Lymphocyte globulin']}]","Inclusion Criteria: Participation of patients in simultaneous diagnostic and comprehensive therapeutical trials for certain entities is allowed. * Patients 18-60 years of age; * Patients suffering from one of the following diseases: * AML: 1st complete remission (CR1) or beyond 1st remission (CR2, CR3), in relapse, not in remission (primary refractory, induction failure); * ALL: 1st complete remission (CR1) or beyond 1st remission (CR2, CR3), in relapse, not in remission (primary refractory, induction failure); * MDS, if transplantation is medically indicated: RA (with poor risk factors as classified by the International Prognostic Scoring System of MDS), RARS, RAEB, RAEB-t, CMML; * CML: beyond 1st chronic phase (CP1): accelerated phase, blast crisis, chronic phase (CP2, CP3); * OMF, if transplantation is medically indicated: Osteomyelofibrosis; * Patients designated to undergo allogeneic bone marrow transplantation or allogeneic peripheral blood stem cell transplantation; * Patients with a HLA-A, -B (DNA-based, 2 digits), HLA-DRB1, -DQB1 (DNA-based 4 digits) matched (8 out of 8 alleles) unrelated donor; serological typing is not required * Patients with a Karnofsky Performance Score (KPS): \> 60%; * Patients who underwent all obligatory screening examinations (special examinations within the last 4 weeks); * Patients who have given their written informed consent to participate in the study. Exclusion Criteria: * Patients with significant cardiac (e.g. ejection fraction \<50%), pulmonary (e.g. FEV1 \<50%), renal (e.g. creatinine \> 1.5 mg/dl), metabolic (e.g. bilirubin \> 2.0 mg/dl) and/or CNS disease, currently uncontrolled by treatment, which may interfere with the completion of the study; * Patients with any bacterial, viral, or fungal infections not under adequate antimicrobial control; * Patients who are known to have serum hepatitis or who are carriers of the Hepatitis B surface antigen (HBs-Ag), or Hepatitis C antibody, or who are known to have a positive result to the test of HIV antibodies; * Patients with any additional concurrent or previous malignant disease; * Patients with known hypersensitivity to rabbit immunoglobulin antibodies in past patient history or with known allergy to any substance chemically related to the study medication; * Pregnant (β-HCG test) or lactating women; * Patients who formerly underwent transplantation including previous autologous transplants; * Patients who cannot communicate reliably with the investigator or who are not likely to cope with the requirements of the study.",NA,ALL,NA,"[{'measure': 'Primary: Early treatment failure defined by the occurrence of severe acute GvHD (°III-°IV) or early mortality within 100 days post transplantation.', 'timeFrame': '100 days'}]","[{'measure': 'Time to onset of acute GvHD, incidence and severity of infections until day +100, time to engraftment, incidence of cGvHD, disease free survival, relapse, death without relapse, overall survival, safety, tolerability.', 'timeFrame': '24 months'}]" 307,NCT00093743,"{'fullName': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}",Low-Dose Total-Body Irradiation and Fludarabine Phosphate Followed by Unrelated Donor Stem Cell Transplant in Treating Patients With Fanconi Anemia,COMPLETED,"Based on success in other diseases, the Fred Hutchinson Cancer Research Center (FHCRC) has developed a transplant procedure for Fanconi anemia (FA), which does not completely destroy the patient's remaining bone marrow. It should also be less harmful (toxic). Researchers wish to test whether this approach can overcome the graft failure often seen when bone marrow or peripheral blood stem cells from an unrelated donor are used. Researchers also will look at whether the procedure is less toxic than a conventional bone marrow transplant (BMT).","['Adult Acute Myeloid Leukemia in Remission', 'Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities', 'Adult Acute Myeloid Leukemia With Del(5q)', 'Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)', 'Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)', 'Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)', 'Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)', 'Childhood Acute Myeloid Leukemia in Remission', 'Childhood Myelodysplastic Syndromes', 'Fanconi Anemia', 'Previously Treated Myelodysplastic Syndromes']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'fludarabine phosphate', 'description': 'Given IV', 'armGroupLabels': ['Treatment (allogeneic bone marrow or PBSC transplantation)'], 'otherNames': ['2-F-ara-AMP', 'Beneflur', 'Fludara']}, {'type': 'DRUG', 'name': 'cyclosporine', 'description': 'Given IV or PO', 'armGroupLabels': ['Treatment (allogeneic bone marrow or PBSC transplantation)'], 'otherNames': ['ciclosporin', 'cyclosporin', 'cyclosporin A', 'CYSP', 'Sandimmune']}, {'type': 'RADIATION', 'name': 'total-body irradiation', 'description': 'Undergo TBI', 'armGroupLabels': ['Treatment (allogeneic bone marrow or PBSC transplantation)'], 'otherNames': ['TBI']}, {'type': 'PROCEDURE', 'name': 'allogeneic bone marrow transplantation', 'description': 'Undergo allogeneic bone marrow transplantation', 'armGroupLabels': ['Treatment (allogeneic bone marrow or PBSC transplantation)'], 'otherNames': ['bone marrow therapy, allogeneic', 'bone marrow therapy, allogenic', 'transplantation, allogeneic bone marrow', 'transplantation, allogenic bone marrow']}, {'type': 'PROCEDURE', 'name': 'allogeneic hematopoietic stem cell transplantation', 'description': 'Undergo allogeneic PBSC transplantation', 'armGroupLabels': ['Treatment (allogeneic bone marrow or PBSC transplantation)']}, {'type': 'PROCEDURE', 'name': 'peripheral blood stem cell transplantation', 'description': 'Undergo allogeneic PBSC transplantation', 'armGroupLabels': ['Treatment (allogeneic bone marrow or PBSC transplantation)'], 'otherNames': ['PBPC transplantation', 'PBSC transplantation', 'peripheral blood progenitor cell transplantation', 'transplantation, peripheral blood stem cell']}, {'type': 'DRUG', 'name': 'mycophenolate mofetil', 'description': 'Given PO or IV', 'armGroupLabels': ['Treatment (allogeneic bone marrow or PBSC transplantation)'], 'otherNames': ['Cellcept', 'MMF']}]","Inclusion Criteria: * Any patient with marrow failure and increased chromosome fragility as determined in the diepoxybutane (DEB) or mitomycin C test * Any patient with Fanconi anemia (FA) with marrow failure meeting the following criteria: * Granulocyte count \< 0.2 x 10\^9/L * Platelet count \< 20 x 10\^9/L * Hemoglobin \< 8 g/dl * Corrected reticulocyte count \<1% * Any patient with FA as determined by DEB fragility, who has life-threatening marrow failure involving a single hematopoietic lineage * Any patient with FA and pre-existing cytogenetic abnormality including hematopoietic malignancy (myelodysplastic syndromes \[MDS\] or acute myeloid leukemia \[AML\]) in remission * DONOR: Unrelated Donors who are prospectively: Matched for human lymphocyte antigen (HLA)-DRB1 and DQB1 alleles (must be defined by high resolution typing); only a single allele disparity will be allowed for HLA -A, B, or C as defined by high resolution typing * DONOR: HLA typing will be performed at the highest level of resolution available at the time of transplant Exclusion Criteria: * Evidence for hematopoietic malignancy in relapse * Heart or lung disease that would prevent compliance with conditioning and GvHD regimen or would severely limit the probability of survival * Human immunodeficiency virus (HIV) seropositive patients * Females who are pregnant or breastfeeding, or unwilling to use contraceptive techniques during and for the 12 months following treatment * DONOR: Donors who by DEB testing are found to have FA * DONOR: Donors who test positive in the lymphocytotoxic crossmatch assay * DONOR: Donors who are HIV positive * DONOR: Donors who for other medical or psychological reasons are not suitable as donors",NA,ALL,NA,"[{'measure': 'Engraftment, defined as donor chimerism (mixed or complete)', 'description': 'Mixed chimerism is defined as presence of 5-95%, complete chimerism as \\> 95% donor derived cells in the peripheral blood. Patient data will be summarized using standard statistical methods.', 'timeFrame': 'Day 28'}, {'measure': 'Engraftment, defined as donor chimerism (mixed or complete)', 'description': 'Mixed chimerism is defined as presence of 5-95%, complete chimerism as \\> 95% donor derived cells in the peripheral blood. Patient data will be summarized using standard statistical methods.', 'timeFrame': 'Day 56'}, {'measure': 'Engraftment, defined as donor chimerism (mixed or complete)', 'description': 'Mixed chimerism is defined as presence of 5-95%, complete chimerism as \\> 95% donor derived cells in the peripheral blood. Patient data will be summarized using standard statistical methods.', 'timeFrame': 'Day 84'}, {'measure': 'Engraftment, defined as donor chimerism (mixed or complete)', 'description': 'Mixed chimerism is defined as presence of 5-95%, complete chimerism as \\> 95% donor derived cells in the peripheral blood. Patient data will be summarized using standard statistical methods.', 'timeFrame': 'Day 180'}, {'measure': 'Regimen toxicity assessed using the Bearman scale', 'description': 'Patient data will be summarized using standard statistical methods.', 'timeFrame': 'Up to day 100'}, {'measure': 'Acute GvHD defined using the Seattle criteria', 'description': 'For the evaluation of GvHD, time of onset, severity, and treatment will be recorded. Patient data will be summarized using standard statistical methods.', 'timeFrame': 'Day 84'}]",NA 308,NCT01292135,"{'fullName': 'Pharmacyclics LLC.', 'class': 'INDUSTRY'}",Safety and Tolerability Study of PCI-32765 Combined With Fludarabine/Cyclophosphamide/Rituximab (FCR) and Bendamustine/Rituximab (BR) in Chronic Lymphocytic Leukemia (CLL),COMPLETED,The purpose of this study is to establish the safety of orally administered PCI-32765 in combination with fludarabine/cyclophosphamide/rituximab (FCR) and bendamustine/rituximab (BR) in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma(SLL).,"['B-cell Chronic Lymphocytic Leukemia', 'Small Lymphocytic Lymphoma']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'PCI-32765', 'description': '420 mg daily', 'armGroupLabels': ['PCI-32765 plus bendamustine/rituximab (BR)', 'PCI-32765 plus fludarabine/cyclophosphamide/rituximab (FCR)']}]","Inclusion Criteria: 1. Histologically confirmed CLL or SLL and satisfying at least 1 of the following criteria for requiring treatment: * Progressive splenomegaly and/or lymphadenopathy identified by physical examination or radiographic studies * Anemia (\<11 g/dL) or thrombocytopenia (\<100,000/μL) due to bone marrow involvement * Presence of unintentional weight loss \> 10% over the preceding 6 months * NCI CTCAE Grade 2 or 3 fatigue * Fevers \> 100.5° or night sweats for \> 2 weeks without evidence of infection * Progressive lymphocytosis with an increase of \> 50% over a 2 month period or an anticipated doubling time of \< 6 months 2. 1 to 3 prior treatment regimens for CLL/SLL 3. ECOG performance status of ≤ 1 4. ≥ 18 years of age 5. Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty 6. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations) Exclusion Criteria: 1. Any chemotherapy, therapeutic antineoplastic antibodies (not including radio- or toxin immunoconjugates), radiation therapy, or experimental antineoplastic therapy within 4 weeks of first dose of study drug 2. Radio- or toxin-conjugated antibody therapy within 10 weeks of first dose of study drug 3. Concomitant use of medicines known to cause QT prolongation or torsades de pointes 4. Transformed lymphoma or Richter's transformation Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of PCI-32765 PO, or put the study outcomes at undue risk 5. Any of the following laboratory abnormalities: oAbsolute neutrophil count (ANC) \< 1000 cells/mm3 (1.0 x 109/L) oPlatelet count \< 50,000/mm3 (50 x 109/L) oSerum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≥ 3.0 x upper limit of normal (ULN) oCreatinine \> 2.0 x ULN or creatinine clearance \< 40 mL/min",NA,ALL,NA,"[{'measure': 'Incidence of Prolonged Hematologic Toxicity Started in Cycle 1', 'timeFrame': 'From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.'}]","[{'measure': 'Incidence of Adverse Events Requiring Dose Delay or Discontinuation of Ibrutinib', 'timeFrame': 'From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.'}, {'measure': 'Overall Incidence of Grade ≥3 Adverse Events (AEs) Per NCI CTCAE V4.0', 'timeFrame': 'From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.'}, {'measure': 'Overall Incidence of Serious Adverse Events (SAEs)', 'timeFrame': 'From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.'}, {'measure': 'Overall Response Rate (Complete Response [CR] + Complete Response With Incomplete Marrow Recovery [CRi] + Nodular Partial Response [nPR] + Partial Response [PR])', 'description': 'Response criteria are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. response requires 50% reduction in lymph node size. Assessment of response to treatment will be done every 2 cycles for the first 6 months and then every 3 months thereafter until disease progression or prior to the administration of a new anticancer therapy and at follow-up visits.', 'timeFrame': 'From first response assessment to last response assessment. Participants were followed with a median follow-up time of 15.8 months.'}, {'measure': 'Sustained Hematologic Improvement in Subjects With Neutropenia, Anemia, or Thrombocytopenia at Baseline', 'timeFrame': 'From first response assessment to last response assessment. Participants were followed with a median follow-up time of 15.8 months.'}, {'measure': 'Progression Free Survival Rate at 12 Months', 'description': 'Criteria for progression are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. progression defined as a 50% increase in lymph node size.', 'timeFrame': 'From first dose of any study medication to 12 months after first dose to progressive disease or death or the last clinical assessment before receiving new anticancer therapy or loss to follow-up, whichever occured the earliest.'}]" 309,NCT06050850,"{'fullName': 'University of Kansas Medical Center', 'class': 'OTHER'}",Healthy Weight Intervention Families During ALL Treatment: NOURISH-ALL,NOT_YET_RECRUITING,"The purpose of this study is to conduct a single arm pilot of the NOURISH-ALL (Nourishing Our Understanding of Role modeling to Improve Support and Health in Acute Lymphoblastic Leukemia) intervention focused on three components of participant engagement. This is a single arm intervention study that involves participation in a 6-session family intervention and three time points of multimethod data collection. The primary outcome is participant engagement, measured as recruitment, retention, and intended dose received. This study will be conducted over 5 years in three phases: * Aim 1a: Adapting the NOURISH-ALL Intervention for Families of Youth with ALL (Year 1) * Aim 1b: Iteratively Refining the NOURISH-ALL Intervention (Year 2) * Aim 2: Pilot Single-Arm Trial of NOURISH-ALL Focused on Participant Engagement (Years 3-5)","['ALL, Childhood', 'Behavior, Health']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BEHAVIORAL', 'name': 'NOURISH-ALL', 'description': 'Our NOURISH-ALL intervention will build on this existing NOURISH-T family based behavioral intervention with families of cancer survivors. The intervention, NOURISH-ALL, will adapt these family-based health promotion strategies to the early ALL treatment context.', 'armGroupLabels': ['Aim 2: Pilot Single-Arm Trial of NOURISH-ALL Focused on Participant Engagement (Years 3-5)']}]","Inclusion Criteria: * Children ages 2-12 years old and their primary caregiver ages 18-90 * Child diagnosed with acute lymphoblastic leukemia (ALL) * Child completed induction phase of therapy and not yet in maintenance phase of therapy * Primary caregiver and child English language proficient * Primary caregiver able to provide permission for child to participate in research * Primary caregiver identifies as being involved with child's oncology care * Primary caregiver lives with child at least 50% of the time * Primary oncology provider confirms child is eligible to participate Exclusion Criteria: * Primary oncology provider identifies safety concerns regarding the child's participation in the study.",NA,ALL,NA,"[{'measure': 'Recruitment Rate', 'description': 'Measured by # enrolled / # eligible', 'timeFrame': 'Baseline (Week 0)'}, {'measure': 'Retention Rate', 'description': 'Measured by # completed intervention / # enrolled', 'timeFrame': 'Post-Intervention (Week 6), Follow-Up (Month 6)'}, {'measure': 'Intended dose received', 'description': 'Measured by # sessions attended / # sessions offered', 'timeFrame': 'Post-Intervention (Week 6), Follow-Up (Month 6)'}]","[{'measure': 'Child Body Mass Index (BMI)', 'description': 'Measured by child height and weight', 'timeFrame': 'Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)'}, {'measure': 'Child Physical Activity', 'description': 'Measured by Actigraph wGT3x+ activity monitor', 'timeFrame': 'Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)'}, {'measure': 'Child Sleep', 'description': 'Measured by Actigraph wGT3x+ activity monitor', 'timeFrame': 'Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)'}, {'measure': 'Child Dietary Intake', 'description': 'Total calories, % calories from fat, and other nutrition variables will be measured by Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)', 'timeFrame': 'Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)'}, {'measure': 'Family Stress Measures', 'description': 'Measured by Psychosocial Assessment Tool v3.0 (PAT 3.0)', 'timeFrame': 'Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)'}, {'measure': 'Family Distress', 'description': 'Measured by Distress Thermometer (DT)', 'timeFrame': 'Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)'}, {'measure': 'Body Composition - Bioelectrical Impedance Analysis', 'description': 'Measured by InBody Scale bioelectrical impedance analysis', 'timeFrame': 'Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)'}, {'measure': 'Body Composition', 'description': 'Measured by dual energy x-ray absorptiometry (DXA) scan', 'timeFrame': 'Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)'}, {'measure': 'Subcutaneous fat', 'description': 'Skinfold thickness measurement', 'timeFrame': 'Baseline (Week 0), Post-Intervention (Week 6), Follow-Up (Month 6)'}]" 310,NCT00083213,"{'fullName': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}",Intravenous VEGF Trap in Treating Patients With Relapsed or Refractory Advanced Solid Tumors or Non-Hodgkin's Lymphoma,COMPLETED,"RATIONALE: VEGF Trap may stop the growth of solid tumors or non-Hodgkin's lymphoma by stopping blood flow to the tumor. PURPOSE: This phase I trial is studying the side effects and best dose of intravenous VEGF Trap in treating patients with relapsed or refractory advanced solid tumors or non-Hodgkin's lymphoma.",['Cancer'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'ziv-aflibercept'}]","DISEASE CHARACTERISTICS: * Histologically confirmed diagnosis of one of the following: * Non-Hodgkin's lymphoma * Primary or metastatic solid tumor located, by radiography, in at least one of the following sites: * Liver * Soft tissue * Pelvis * Other site that is suitable for delayed contrast-enhanced MRI (e.g., peripheral lung field) * Relapsed or refractory (including unresectable) disease * Patients with solid tumors must have failed all curative chemotherapeutic regimens * Patients with non-Hodgkin's lymphoma must be refractory to at least 2 standard chemotherapeutic regimens and rituximab * Not amenable to available conventional therapies AND no standard therapy exists * Measurable disease * No prior or concurrent CNS metastases (brain or leptomeningeal) * No primary intracranial tumor by MRI or CT scan * No histologically confirmed squamous cell carcinoma of the lung PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * WBC ≥ 3,500/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Hemoglobin ≥ 9.0 g/dL * Platelet count ≥ 100,000/mm\^3 * No severe or uncontrolled hematologic condition Hepatic * Bilirubin ≤1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN * PT and PTT normal * INR normal * Hepatitis B surface antigen negative * Hepatitis C antibody negative Renal * Creatinine ≤ ULN * Urine protein/creatinine ratio ≤ 1 * No severe or uncontrolled renal condition Cardiovascular * No clinically significant acute electrocardiographic abnormalities * LVEF normal by echocardiogram or MUGA within the past 12 months if there was prior exposure to anthracyclines * No untreated or uncontrolled hypertension * No blood pressure \> 150/100 mm Hg (despite treatment) * No isolated systolic hypertension (i.e., systolic blood pressure \> 180 mm Hg on at least 2 determinations \[on separate days\] within the past 3 months) * No New York Heart Association class II - IV heart disease * No active coronary artery disease requiring acute medical management * No angina requiring acute medical management * No congestive heart failure requiring acute medical management * No ventricular arrhythmia requiring acute medical management * No stroke or transient ischemic event within the past 6 months * No prior or concurrent peripheral vascular disease * No angiographically or ultrasonographically documented arterial or venous occlusive event * No symptomatic claudication * No symptomatic orthostatic hypotension * No other severe or uncontrolled cardiovascular condition Pulmonary * No severe or uncontrolled pulmonary condition * No pulmonary embolism within the past 6 months Immunologic * HIV negative * No severe or uncontrolled immunologic condition * No active current infection requiring antibiotics * No prior hypersensitivity reaction to any recombinant proteins, including VEGF Trap Other * No severe or uncontrolled gastrointestinal or musculoskeletal condition * No psychiatric condition or adverse social circumstance that would preclude study participation * No other condition that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective double-barrier contraception during and for 3 months after study treatment PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * No prior participation in a VEGF Trap, interleukin-1 Trap, or interleukin-4/13 Trap clinical trial * At least 3 weeks since prior immunotherapy and recovered * No concurrent epoetin alfa, filgrastim (G-CSF), or sargramostim (GM-CSF) Chemotherapy * See Disease Characteristics * At least 3 weeks since prior chemotherapy and recovered Endocrine therapy * No concurrent adrenal corticosteroids except low-dose replacement therapy * No concurrent systemic hormonal contraceptive agents Radiotherapy * At least 3 weeks since prior radiotherapy and recovered Surgery * At least 3 weeks since prior major or laparoscopic surgery and recovered * More than 6 months since prior surgical procedure for correction or prophylaxis of peripheral vascular insufficiency or cerebral ischemic events Other * More than 30 days since prior investigational drugs * No concurrent anticoagulant or antiplatelet drugs (e.g., warfarin, heparin, or aspirin) other than low-dose (1 mg) warfarin for maintaining patency of venous access devices * No concurrent non-steroidal anti-inflammatory drugs, including cyclo-oxygenase-2 (COX-2) inhibitors * No other concurrent anticancer investigational agents * No other concurrent anticancer therapy",NA,ALL,NA,NA,NA 311,NCT01700413,"{'fullName': 'Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias', 'class': 'OTHER'}","Efficacy and Toxicity of Increasing Doses of Idarubicin, Cytarabine and G-CSF in Acute Myeloid Leukemia",COMPLETED,"While several studies have been reported with increasing doses of daunorubicin in the first line treatment of Acute Myeloid Leukemia (AML), there is no similar experience with idarubicin as initial treatment of AML. As idarubicin is the most common treatment used for AML, it is needed to find the optimal dose for the combination of idarubicin, cytarabine and G\_CSF, to explore if this combination improves the outcomes of current treatments for AML. The aim of this dose-finding study is to find the optimal dose for the combination of idarubicin, cytarabine and G-CSF that could improve the response rate, reduce relapse and improve survival of patients with primary acute myeloid leukemia. This could be a significant advance in a field where treatment outcomes have stabilized in the last 15 years. This study will be the basis for further prospective, randomized, multicenter trial comparing idarubicin maximum tolerated dose, compared to standard treatment with idarubicin and cytarabine, including raising both arms in G-CSF. The dose of 12 mg/m2 will be administered as control arm in this future randomized study, which will investigate the benefit of enhanced dose identified as optimal in this phase II pilot study.",['Di Novo Acute Myeloid Leukemia'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Idarubicin', 'armGroupLabels': ['Idarubicin']}]","Inclusion Criteria: Informed consent signature Patients with newly diagnosed AML, classified according to WHO criteria. Age more than or equal to 18 and less than or equal to 70 years. Exclusion Criteria: Patients previously treated with chemotherapy for their AML other than hydroxyurea. Acute promyelocytic leukemia with t (15; 17). Blast crisis of chronic myeloid leukemia. Leukemias that appear after other myeloproliferative neoplasms. Leukemias ensuing myelodysplastic syndromes after more than 6 months. Presence of other malignancies in activity. AML secondary to chemo-radiotherapy treatment for other malignancies. Abnormal renal and hepatic function, with creatinine value and / or bilirubin 2 times the normal limit value, except where the alterations are attributable to leukemia. Patients with markedly reduced ejection fraction (less than 45%), symptomatic heart failure, or both of the normal value of the center. Patients with serious concomitant psychiatric or neurological disease. HIV-positive. Pregnancy or breastfeeding",NA,ALL,NA,"[{'measure': 'Rate of complete remissions (CR)', 'description': 'Identify the highest dose of idarubicin in combination with cytarabine and G-CSF that produces a CR rate equal to or greater than 65% with tolerable toxicity.', 'timeFrame': 'From 28 up to 56 days after first induction'}]","[{'measure': 'Rate of patients with adverse events as a measure of safety and tolerability', 'description': 'Hematologic toxicity Gastrointestinal and liver toxicity Cardiac Toxicity Fever and infection Pulmonary complications Duration of hospitalization Mortality and causes of death induction.', 'timeFrame': 'Weekly during treatment, and on months 3 and 6 after complete response'}, {'measure': 'Duration of hospitalization', 'description': 'Number of days in which the patient is hospitalized.', 'timeFrame': 'From the inclusion until 9 months after inclusion.'}, {'measure': 'Mortality (as rate) related to study treatment', 'description': 'Causes of death, mortality related treatment, mortality in induction.', 'timeFrame': 'Weekly during treatment, 3 months after complete remission, 6 months after complete remission and 9 months after complete remission'}, {'measure': 'Relapse at 6 months', 'description': 'Rate of patients that have relapsed within 6 months after complete remission.', 'timeFrame': '6 months from complete remission, expected to be within 9 months from inclusion.'}, {'measure': 'Survival at 9 months from diagnosis', 'description': 'Rate of patients alive at 9 months after diagnosis.', 'timeFrame': '9 months after diagnoses'}]" 312,NCT02167360,"{'fullName': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}",Study of Efficacy and Safety of CTL019 in Adult ALL Patients,WITHDRAWN,"This is a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of CTL019 in adult patients with r/r B-cell ALL. The study will have the following sequential phases: Screening, Pre-Treatment, Treatment and Primary Follow-up, Secondary Follow-up (Relapse Follow-up) and Survival Follow-up. The total duration of the primary follow-up is 1 year from cell infusion. Safety will be assessed until the end of the treatment and primary follow-up phase.","['B-cell Acute Lymphoblastic Leukemia', 'Relapsed B-cell Acute Lymphoblastic Leukemia', 'Refractory B-cell Acute Lymphoblastic Leukemia']",INTERVENTIONAL,{'primaryPurpose': 'TREATMENT'},"[{'type': 'DRUG', 'name': 'CTL019', 'description': 'A dose of CTL019 transduced cells will consist of a single infusion of 2 to 10 x 108 CTL019 transduced cells.', 'armGroupLabels': ['Single Arm']}]","Inclusion Criteria: * Relapsed or refractory adult B-cell ALL a. First or greater Bone Marrow (BM) relapse OR b. Any BM relapse after allogeneic stem cell transplantation (SCT) and must be \> 6 months from SCT at the time of CTL019 infusion OR c. Refractory as defined by not achieving a CR (morphology \<5% blasts) after 2 cycles of a standard chemotherapy regimen OR d. Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are intolerant to or have failed tyrosine kinase inhibitor therapy (TKI), or if TKI therapy is contraindicated. * For relapsed patients, documentation of CD19 tumor expression in bone marrow or peripheral blood by flow cytometry within 3 months of screening * Adequate organ function defined as: a. Renal function defined as: i. A serum creatinine of \<1.5 x ULN OR ii. Calculated creatinine clearance or radioisotope Glomerular Filtration Rate (GFR) \> 60 mL/min/1.73 m2 b. Alanine Aminotransferase (ALT) \< 5 times the upper limit of normal (ULN) c. Bilirubin \< 2.0 mg/dL d. Must have a minimum level of pulmonary reserve defined as ≤Grade 1 dyspnea and pulse oxygenation \> 91% on room air e. Left Ventricular Ejection Fraction (LVEF) ≥ 45% confirmed by echocardiogram or Multiple Uptake Gated Acquisition (MUGA) * Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening * Age \> 18 years * A ECOG Performance Status that is either 0 or 1 at screening * Signed written informed consent must be obtained prior to any study procedures * Once all other eligibility criteria are confirmed, must have an apheresis product of non-mobilized cells received and accepted by the manufacturing site. Note: Apheresis product will not be assessed for acceptance by the manufacturing site until documented confirmation of all other eligibility criteria. * Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) must agree to use highly effective methods of contraception during the entire study period (1 year after the CTL019 infusion). Highly effective contraception methods include: 1. Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are NOT acceptable methods of contraception) 2. Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment 3. Male sterilization (at least 6 months prior to screening). For female patients on the study the vasectomized male partner should be the sole partner for that patient 4. BOTH of the following forms of contraception must be utilized: * Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate \<1%), for example hormone vaginal ring or transdermal hormone contraception * Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository 5. Use of intrauterine devices (IUD) are excluded due to increased risks of infection and bleeding in this population 6. In case of use of oral contraception, women must be stable on the same pill for a minimum of 3 months before taking study treatment Women who are not of reproductive potential (defined as post-menopausal for at least 24 consecutive months (i.e. have had no menses) or have undergone hysterectomy, salpingotomy, and/or bilateral oophorectomy) are eligible without requiring the use of contraception. Acceptable documentation includes written or oral documentation communicated by clinician or clinician's staff of one of the following: 1. Physician report/letter 2. Operative report or other source documentation in the patient record 3. Discharge summary 4. Follicle stimulating hormone measurement elevated into the menopausal range. Exclusion Criteria: * Isolated extra-medullary disease relapse * Patients with concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome. * Patients with Burkitt's lymphoma/leukemia (i.e. patients with mature B-cell ALL, leukemia with B-cell \[surface Immunoglobulin (sIg) positive and kappa or lambda restricted positivity\] ALL, with French, American, British \[FAB\] L3 morphology and /or a MYC translocation) * Prior malignancy, unless treated with curative intent and with no evidence of active disease present for \> 5 years before screening * Treatment with any prior gene therapy product * Has had treatment with any prior anti-CD19/anti-CD3 therapy, or any other anti-CD19 therapy * Active or latent hepatitis B or active hepatitis C, or any uncontrolled infection at screening 8. Human Immunodeficiency Virus (HIV) infection at screening 9. Presence of grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD) 10. The following medications are excluded: a. Steroids: Therapeutic doses of steroids must be stopped \> 72 hours prior to CTL019 infusion. However, the following physiological replacement doses of steroids are allowed: \< 6-12 mg/m2/day hydrocortisone or equivalent. Topical steroids are permitted. b. Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed \> 6 weeks prior to CTL019 infusion c. GVHD therapies: Any drug used for GVHD must be stopped \> 4 weeks prior to CTL019 infusion (e.g. calcineurin inhibitors, methotrexate or other chemotherapy drugs, mycophenolyate, University of Pennsylvania Page 20 of 138 Oncology Protocol Protocol No. UPCC#07414/CCTL019B2207J V00.1 04-02-2014 steroids \[see above\], rapamycin, thalidomide, or immunosuppressive antibodies such as rituximab, anti-tumor necrosis factor \[anti-TNF\] , anti-interleukin 6 \[anti-IL6\] or anti-interleukin 6 receptor \[anti-IL6R\]) d. Chemotherapy: i. The following drugs must be stopped \>1 week prior to CTL019 infusion: hydroxyurea, vincristine, 6-mercaptopurine, 6-thioguanine, methotrexate \<25 mg/m2, cytosine arabinoside \<10 mg/m2/day, asparaginase ii. The following drugs must be stopped \>4 weeks prior to CTL019 infusion: salvage chemotherapy (e.g. clofarabine, cytosine arabinoside \>100mg/m2, anthracyclines, cyclophosphamide), excluding the required lymphodepleting chemotherapy drugs e. CNS disease prophylaxis i. CNS prophylaxis treatment must be stopped \> 1 week prior to CTL019 infusion (e.g. intrathecal methotrexate). 11\. Active Central Nervous System (CNS) involvement by malignancy, defined as CNS-3 per National Comprehensive Cancer Network (NCCN) guidelines. Note: Patients with history of CNS disease that has been effectively treated will be eligible. 12\. Patient has received an investigational medicinal product within the last 30 days prior to screening 13. Pregnant or nursing (lactating) women. NOTE: female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion",NA,ALL,NA,"[{'measure': 'Number of Adverse Events', 'timeFrame': '12 months'}]",NA 313,NCT00006721,"{'fullName': 'SWOG Cancer Research Network', 'class': 'NETWORK'}",S0016 Combination Chemotherapy With Monoclonal Antibody Therapy in Newly Diagnosed Non-Hodgkin's Lymphoma,COMPLETED,"RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver radioactive tumor-killing substances to them without harming normal cells. It is not yet known which monoclonal antibody plus combination chemotherapy regimen is more effective in treating non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is comparing 2 different monoclonal antibodies given together with combination chemotherapy to see how well they work in treating patients with newly-diagnosed non-Hodgkin's lymphoma.",['Lymphoma'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'rituximab', 'description': 'Given IV', 'armGroupLabels': ['Arm II (CHOP + rituximab)'], 'otherNames': ['rituxan']}, {'type': 'DRUG', 'name': 'cyclophosphamide', 'description': 'Given IV', 'armGroupLabels': ['Arm I (CHOP only)', 'Arm II (CHOP + rituximab)', 'Arm III (CHOP + tositumomab)'], 'otherNames': ['cytoxan']}, {'type': 'DRUG', 'name': 'doxorubicin', 'description': 'Given IV', 'armGroupLabels': ['Arm I (CHOP only)', 'Arm II (CHOP + rituximab)', 'Arm III (CHOP + tositumomab)'], 'otherNames': ['adriamycin']}, {'type': 'DRUG', 'name': 'prednisone', 'description': 'Given orally', 'armGroupLabels': ['Arm I (CHOP only)', 'Arm II (CHOP + rituximab)', 'Arm III (CHOP + tositumomab)'], 'otherNames': ['steroid']}, {'type': 'DRUG', 'name': 'vincristine', 'description': 'Given IV', 'armGroupLabels': ['Arm I (CHOP only)', 'Arm II (CHOP + rituximab)', 'Arm III (CHOP + tositumomab)'], 'otherNames': ['oncovin']}, {'type': 'RADIATION', 'name': 'tositumomab', 'description': 'Given IV', 'armGroupLabels': ['Arm III (CHOP + tositumomab)']}]","DISEASE CHARACTERISTICS: * Histologically confirmed previously untreated bulky stage II or stage III or IV follicular non-Hodgkin's lymphoma * Grade I-III disease * Cluster of differentiation antigen 20 (CD20) antigen positive * Fewer than 5,000/mm\^3 circulating lymphoid cells on a white blood cell (WBC) differential count * Bidimensionally measurable disease * Bone marrow aspiration and biopsy within the past 42 days * No clinical evidence of central nervous system (CNS) involvement by lymphoma PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0-2 Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics * Granulocyte count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No impaired cardiac status, including: * Severe coronary artery disease * Cardiomyopathy * Congestive heart failure * Serious arrhythmia * Ejection fraction at least lower limit of normal by Multi Gated Acquisition Scan (MUGA) or 2-D echocardiogram for questionable cardiac history Other: * No hypersensitivity to iodine * Not pregnant or nursing * Fertile patients must use effective contraception during and for 6 months after study participation * HIV negative * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior monoclonal antibodies for cancer Chemotherapy: * No prior chemotherapy for lymphoma * Prior prednisone for non-lymphoma related illnesses allowed Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy for lymphoma Surgery: * See Disease Characteristics",NA,ALL,NA,"[{'measure': 'Progression-free Survival at 2 Years', 'description': 'Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date', 'timeFrame': '0-2 years'}, {'measure': 'Progression-free Survival at 5 Years', 'description': 'Measured from time of registration to date of of first observation of progression/relapse, or death due to any cause, or last contact date', 'timeFrame': '0-5 years'}, {'measure': 'Overall Survival at 2 Years', 'description': 'Measured from date of registration to date of death due to any cause', 'timeFrame': '0-2 years'}, {'measure': 'Overall Survival at 5 Years', 'description': 'Measured from date of registration to date of death due to any cause', 'timeFrame': '0-5 years'}]","[{'measure': 'Objective Response (Confirmed and Unconfirmed Complete and Partial Responses)', 'description': 'Complete Response(CR) is a complete disappearance of all disease with the exception of nodes. No new lesions. previously enlarged organs must have regressed and not be palpable. Bone marrow(BM) must be negative if positive at baseline. Normalization of markers. CR Unconfirmed (CRU) does not qualify for CR above, due to a residual nodal mass or an indeterminate BM. Partial Response(PR) is a 50% decrease in the sum of products of greatest diameters (SPD) for up to 6 identified dominant lesions, including spleenic and hepatic nodules from baseline. No new lesions and no increase in the size of liver, spleen or other nodes.', 'timeFrame': 'Assessed 200 days and 365 days after initiation of therapy and then every 6 months until death'}, {'measure': 'Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug', 'description': 'Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 2.0. For each patient, worst grade of each event type is reported. Grade 3 = Severe, Grade 4 = Life-threatening, Grade 5 = Fatal', 'timeFrame': 'Patients were assessed for adverse events at end of cycle 1-6 of CHOP or R-CHOP, the end of cycle 1-6 of CHOP and once 2 weeks after the completion of I-131 treatment. For either arm, once 3 months after removal from protocol treatment'}]" 314,NCT02560025,"{'fullName': 'Massachusetts General Hospital', 'class': 'OTHER'}",Phase II Trial of Alisertib With Induction Chemotherapy in High-risk AML,COMPLETED,"This research study is studying a targeted therapy (a form of treatment that uses drugs or other substances to identify and attack specific types of cancer cells with less harm to normal cells) as a possible treatment for high-risk acute myeloid leukemia. The names of the study interventions involved in this study are: * Alisertib / MLN8237 * Cytarabine / Cytosine Arabinoside * Idarubicin / Idarubicin hydrochloride * Daunorubicin (Can be used in place of idarubicin)",['Acute Myeloid Leukemia'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Alisertib', 'armGroupLabels': ['Alisertib / MLN8237'], 'otherNames': ['MLN8237']}, {'type': 'DRUG', 'name': 'Cytarabine', 'armGroupLabels': ['Alisertib / MLN8237'], 'otherNames': ['Cytosine Arabinoside']}, {'type': 'DRUG', 'name': 'Idarubicin', 'armGroupLabels': ['Alisertib / MLN8237'], 'otherNames': ['Idarubicin hydrochloride']}, {'type': 'DRUG', 'name': 'Daunorubicin', 'description': 'Can be used in place of idarubicin', 'armGroupLabels': ['Alisertib / MLN8237'], 'otherNames': ['Cerubidine®']}]","Inclusion Criteria: * Participants must have pathologically confirmed, newly diagnosed high-risk acute myeloid leukemia, as defined by at least one of the following criteria * Age greater than or equal to 65 years * Poor risk karyotype, as per Leukemianet criteria * Antecedent or underlying myelodysplastic syndrome or myeloproliferative neoplasm * AML with MDS-related changes * Adults, age 18 years or older at the time of diagnosis, eligible for standard induction chemotherapy according to their treating physician. * ECOG performance status 0-2 (Karnofsky ≥60%, see Appendix A) * Left ventricular ejection fraction \> 50% as measured by echocardiogram or MUGA scan * Must not have received systemic antineoplastic therapy including radiation therapy within 14 days of the study enrollment, except hydroxyurea or 6-mercaptopurine for the purposes of cytoreduction. Patients may also have received all-trans retinoic acid (ATRA) if there is an early suspicion of acute promyelocytic leukemia (APL, M3-AML), although if confirmed to have APL these patients will be excluded from the study. * Adequate renal function as defined by: calculated creatinine clearance ≥40 mL/min (Cockcroft-Gualt Formula) * Direct bilirubin \< 2.0 x upper limit of normal (ULN), SGOT (AST) and SGPT (ALT)\< 2.5 x ULN. AST and/or ALT may be up to 5X ULN if thought to be secondary to leukemia. * The effects of alisertib on the developing human fetus are unknown. For this reason and because other chemotherapeutic agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception for the duration of study participation, and 6 months after completion of therapy. * Subject must be able to take oral medication and to maintain a fast as required for 2 hours before and 1 hour after alisertib administration. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Patients will be excluded from this study if they do not otherwise fulfill criteria mentioned in bullet 3.1.1, and are found to harbor ""intermediate"" or ""favorable"" risk cytogenetics 41: * In such patients, a sample to evaluate patient cytogenetics will be sent at the time of diagnosis per standard clinical care and the absence of favorable or intermediate-risk cytogenetics must be confirmed by Day 8. If the cytogenetic analysis reveals that the patient harbors non-poor risk cytogenetics, or if the cytogenetic results are not received prior to Day 8, the participant will be removed from the study. * Patients with acute bilineal/biphenotypic leukemia * Participants who have had chemotherapy or radiotherapy within 14 days prior to entering the study, except for hydroxyurea or 6-MP as noted. * Participants who are receiving or have received any other investigational agents within 14 days of enrollment. * Chemo-, hormono-, radio- or immunotherapy or therapy with monoclonal antibodies or small tyrosine kinase inhibitors within the past 4 weeks prior to treatment with the trial drug * Persistence of clinically relevant therapy related toxicity from previous anti-cancer therapy * Prior allogeneic bone marrow or organ transplantation * Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin. * Current clinical central nervous system (CNS) symptoms deemed by the investigator to be related to leukemic CNS involvement (no lumbar puncture required, clinical assessment per investigator's judgment is sufficient). * If applicable, patient with ≥Grade 2 peripheral neuropathy within 14 days before enrollment * Prior treatment with alisertib * Known history of hepatitis C infection or suspected currently active hepatitis C infection. Known or suspected history of hepatitis B infection will be excluded when any of the following conditions are met: * Received hematopoietic stem cell transplantation (either allogenic or autologous), or * Received any rituximab-containing treatment regimen in the last 12 months before entering the study, or * Tested positive for the presence of at least 1 of the following 3 markers in blood (evaluated at screening): hepatitis B surface antigen (HBsAG), antibodies against hepatitis B core antigen (anti-HBc), or hepatitis B viral load (HBV DNA). * Current or history of congestive heart failure New York Heart Association (NYHA) class 3 or 4, or any history of documented diastolic or systolic dysfunction (LVEF \<50%, as measured by MUGA scan or echocardiogram). Prior to study entry, any ECG abnormality at screening has to be documented by the investigator as not medically relevant * Known hypersensitivity to the trial drugs or other contraindication to standard ""7+3"" induction chemotherapy. * Known history of uncontrolled sleep apnea syndrome, or sleep apnea requiring supplemental oxygen, and other conditions that could result in excessive daytime sleepiness. * A medical condition requiring use of proton pump inhibitors (PPIs); or histamine 2 (H2) receptor antagonists. Patients who intermittently use these medications, must meet the following criteria: * No use of PPIs within 5 days before the first dose of alisertib * No use of H2 antagonist or pancreatic enzymes within 24 hours before the first dose of alisertib * Patients with mental deficits or psychiatric conditions that preclude them from giving informed consent or following protocol. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring intravenous antibiotics, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Known GI disease or GI procedures that could interfere with the oral absorption or tolerance of alisertib. Examples include, but are not limited to partial gastrectomy, history of small intestine surgery, and celiac disease. * Pregnant women are excluded from this study because alisertib, along with standard induction chemotherapy, carries the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with alisertib as well as cytarabine and idarubicin, breastfeeding should be avoided. Confirmation that the subject is not pregnant must be established by a negative serum ß-human chorionic gonadotropin ( ß-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women. * Although not absolute exclusion criteria, because of known drug-drug interactions, below are issues that should be considered during enrollment: * Treatment with clinically significant enzyme-inducing drugs, including known P-glycoprotein inducers (including St John's wort and rifampicin) should be used only if absolutely necessary and considered to be the best available choice for the patient. If possible, it is recommended that alternatives to known substrates, inhibitors or inducers of P-glycoprotein be considered. Cases should be discussed with the principal investigator, and may be allowed as per his/her discretion. * Patients with psychological, familial, social, or geographic factors that otherwise preclude them from giving informed consent, following the protocol, or potentially hamper compliance with study treatment and follow-up. * Patients who are otherwise felt unable to comply with the protocol, in the opinion of the investigator.",NA,ALL,NA,"[{'measure': 'Number of Participants That Achieved Complete Remission', 'description': 'The number of participants that achieved a best overall response of complete remission while on study.\n\nComplete remission (CR): Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/μL and a platelet count of 100,000/μL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, existing extramedullary disease. If possible, at least one bone marrow biopsy should be performed to confirm CR.', 'timeFrame': 'From the start of treatment until the end of study treatment, up to approximately 10 months'}, {'measure': 'Number of Participants That Achieved Complete Remission With Incomplete Blood Count Recovery (CRi)', 'description': 'The number of participants that achieved a best overall response of CRi while on study.\n\nComplete Remission with Incomplete Blood Count Recovery (CRi): Same as for CR but without achievement of ANC at least 1000/uL (CRi) and/or platelet count of 100,000/uL (CRp).', 'timeFrame': 'From the start of treatment until the end of study treatment, up to approximately 10 months'}]","[{'measure': '1 Year Overall Survival Rate', 'description': 'The percentage of participants alive at one year', 'timeFrame': '1 Year'}, {'measure': 'Median Relapse Free Survival', 'description': 'The median amount of time from achieving a complete remission to the first of disease recurrence or death. RFS applies only to the subset of patients who achieve a CR+CRi at the end of induction therapy.\n\n* Complete remission (CR): Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/μL and a platelet count of 100,000/μL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, existing extramedullary disease. If possible, at least one bone marrow biopsy should be performed to confirm CR.\n* Complete remission with incomplete blood count recovery (CRi): Same as CR but without achievement of specified ANC and/or platelet count\n* Recurrence/ morphologic relapse: reappearance of leukemic blasts in the peripheral blood or \\>5% blasts in the bone marrow not attributable to any other cause', 'timeFrame': 'From the time of treatment response until death or disease progression (up to about one year)'}, {'measure': 'Median Duration of Remission', 'description': 'The median amount of time from first achieving remission to disease progression (with patients censored at death).\n\n* Complete remission (CR): Bone marrow showing less than 5% myeloblasts with normal maturation of all cell lines, an ANC of at least 1000/μL and a platelet count of 100,000/μL, absence of blast in peripheral blood, absence of identifiable leukemic cells in the bone marrow, existing extramedullary disease. If possible, at least one bone marrow biopsy should be performed to confirm CR.\n* Complete remission with incomplete blood count recovery (CRi): Same as CR but without achievement of specified ANC and/or platelet count\n* Recurrence/ morphologic relapse: reappearance of leukemic blasts in the peripheral blood or \\>5% blasts in the bone marrow not attributable to any other cause', 'timeFrame': 'From the time of first remission to disease progression or death, median duration of 12.8 months'}, {'measure': 'Number of Participants With Serious Adverse Events', 'description': 'Adverse events were assessed using Common Terminology Criteria for Adverse Events (CTCAE 4). Adverse events were considered to be Serious Adverse Events (SAE) if they were grade 3 or greater and deemed to be possibly, probably, or definitely related to the study treatment.', 'timeFrame': 'From the start of treatment until 30 days after the last dose of a study drug is received, up to approximately 11 months'}]" 315,NCT00520208,"{'fullName': 'CytRx', 'class': 'INDUSTRY'}","Safety, Efficacy, & Pharmacokinetic Study of Tamibarotene to Treat Patients With Relapsed or Refractory APL",COMPLETED,"This is a Phase II, open-label, non-randomized study to evaluate the safety, efficacy, and pharmacokinetics of tamibarotene in adult patients with relapsed or refractory acute promyelocytic leukemia (APL) following treatment with all-trans-retinoic acid (ATRA) and arsenic trioxide (ATO). Patients must have received and failed therapy with ATRA and ATO. Treatment may have been administered either as combination therapy or sequentially as single agents. Patients who are intolerant to either drug are eligible for this study.",['Acute Promyelocytic Leukemia'],INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Tamibarotene', 'description': 'For induction therapy, tamibarotene will be self-administered via tablets on an outpatient basis at a dose of 6 mg/m2 per day, taken orally, in two divided doses approximately one hour after breakfast and dinner. Induction therapy will continue for a maximum of 56 days until either a morphologic leukemia-free state or complete response (CR) has been achieved. For patients who achieve a CR with induction therapy, consolidation therapy will commence 4 to 8 weeks after the end of induction therapy. For patients who have a morphologic leukemia-free state after induction therapy but who fail to achieve a CR, consolidation therapy will commence 8 weeks after the end of induction therapy.', 'otherNames': ['Amnolake']}]","Patients must meet all of the following criteria for admission into the study: 1. Have a diagnosis of either relapsed and/or refractory APL: * Refractory disease is defined as a confirmed diagnosis of APL and a myeloblast plus promyelocyte count of \> 10% in the bone marrow in patients who have failed to respond to induction therapy in the first or second line setting. Induction therapy must have included ATRA- and ATO-based therapy given either sequentially or in combination. * Relapsed disease is defined as a confirmed diagnosis of APL and a myeloblast plus promyelocyte count of \> 10% in the bone marrow following a documented complete remission or positive RT-PCR assay for PML/RAR-α in two consecutive tests separated by at least one month, after treatment with ATRA- and ATO-based therapy given either sequentially or in combination. 2. Confirmation of diagnosis and relapsed/refractory APL must be obtained in blood or bone marrow mononuclear cells by at least one of the following methods: * Conventional cytogenetics showing the translocation t(15:17), * Positive RT-PCR assay for PML/RAR-α, or * Fluorescence in situ hybridization (FISH) analysis showing evidence of the PML/RAR-α translocation. 3. Patients must have received and failed therapy with ATRA and ATO either within the same or separate induction/consolidation schedule(s). Treatment must have been administered for a minimum of 28 days for each agent. Treatment may have been administered either as combination therapy or sequentially as single agents. Patients who failed to complete a course of induction/consolidation therapy, as specified, due to drug intolerance are eligible for the study. 4. Patients in whom ATO is contraindicated (for example due to congenital long QT syndrome) are eligible for inclusion on study if they have received and failed ATRA therapy as defined in (3). 5. Be able to provide written informed consent prior to enrollment into the study. 6. Be ≥ 18 years old. 7. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2. 8. Have an estimated life expectancy of ≥ 12 weeks. 9. Be male or a non-pregnant, non-lactating female. Fertile patients must agree to use an effective barrier method of contraception (e.g., latex condom, diaphragm, or cervical cap) to avoid pregnancy while on therapy and for 90 days following the discontinuation of the study drug. \[In countries where double barrier contraception is required by Regulatory Authorities, patients who are fertile must agree to use 2 forms of barrier method contraception (e.g., latex condom AND a diaphragm or cervical cap) while on therapy and for 90 days following the discontinuation of the study drug.\] A non-fertile female is defined as: * Postmenopausal (amenorrheic for ≥ 12 months) * Undergone a complete oophorectomy or hysterectomy. 10. Have a negative serum or urine pregnancy test within 10 days prior to the first dose of study drug (if patient is a female of childbearing potential). 11. Have adequate organ function. Patients who meet any of the following criteria will be excluded from study admission: 1. Extramedullary leukemia. 2. Patients on a vitamin A preparation or patients with hypervitaminosis A. 3. Have received cytotoxic therapy ≤ 2 weeks from the start of therapy. If the patient needs these agents due to urgent medical care within 2 weeks prior to starting tamibarotene, a waiver may be granted by the INNOVIVE Medical Monitor. 4. Have a history of myelodysplastic syndromes (MDS). 5. Have impaired cardiac function or clinically significant heart disease including: * Myocardial infarction within 3 months, unstable angina pectoris, congenital long QT syndrome and clinically significant resting bradycardia (\< 50 beats per minute), uncontrolled congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with antihypertensive medication. 6. Have an active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment. 7. Have clinically significant acute or chronic liver or renal disease considered unrelated to leukemia. 8. Have uncontrolled hyperlipidemia. 9. Have uncontrolled or poorly controlled diabetes mellitus. 10. Have impaired gastrointestinal function that may significantly alter drug absorption (e.g., uncontrolled vomiting, ulcerative colitis, malabsorption, or small bowel resection). 11. Are pregnant or lactating. 12. Have psychiatric disorder(s) that would interfere with consent, study participation, or follow-up. 13. Have not recovered from acute toxicities of all previous therapy prior to enrollment. 14. Have any other severe concurrent disease and/or uncontrolled medical conditions, which, in the judgment of the investigator, could predispose patients to unacceptable safety risks or compromise compliance with the protocol. 15. Have a history of another primary malignancy that has been actively treated in the last 24 months. 16. Are unwilling or unable to comply with the protocol.",NA,ALL,NA,"[{'measure': 'To determine the rate of durable complete response for tamibarotene therapy when administered as a single agent to adult patients with relapsed or refractory APL.', 'timeFrame': 'Minimum 28 days'}]","[{'measure': '(1) To determine the rates of morphologic leukemia-free state, partial response, cytogenetic complete response, and molecular complete response for tamibarotene therapy in the indicated patient population.', 'timeFrame': 'Minimum 28 days'}, {'measure': '(2) To determine the safety profile and tolerability of tamibarotene in the indicated patient population.', 'timeFrame': 'Up to 32 weeks'}, {'measure': '(3) To determine the pharmacokinetic (PK) profile of tamibarotene when administered in the indicated patient population.', 'timeFrame': 'One year'}]" 316,NCT07150676,"{'fullName': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}",Harmonized Clinical and Biological Database for Integrated Research Into the Management of Pediatric Acute Myeloid Leukemia,NOT_YET_RECRUITING,"The aim of this project is to study the different diagnostic, predictive, and prognostic profiles, as well as their interrelationships (clinical, biological, genetic) in children with Acute Myeloid Leukemia (AML). Despite numerous research projects on separate cohorts, the prognosis for pediatric AML has not improved. The project therefore consists of pooling research data and existing clinical and biological data from healthcare in a health data warehouse to increase its power. As these diseases are rare and genetic subgroups even rarer, it is crucial to combine all these data sets into a single database to statistically validate our observations. The ultimate goal of this project is to reduce the relapse rate and improve the survival rate of pediatric AML by identifying rare, uncharacterized patient subgroups at high risk of relapse, for whom clinical characteristics and outcomes will be compared with omics data, Leukemia Stem Cells signatures, and drug responses to establish accurate and in-depth profiles.","['Acute Myeloid Leukemia (AML)', 'Pediatric Acute Myeloid Leukemia']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'CROSS_SECTIONAL'}","[{'type': 'OTHER', 'name': 'Long term follow-up', 'description': 'Long term follow-up as part of standard of care', 'armGroupLabels': ['All children/young adults (<25 years old) with LAM diagnosed in participating French centers']}]",All patients under the age of 25 diagnosed with AML in the participating centers in France.,Patients already included in a protocol or newly included,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Overall survival', 'timeFrame': 'Up to 27 years'}]","[{'measure': 'Event Free Survival', 'description': 'Event is defined as : relapse, secondary cancer', 'timeFrame': 'Up to 27 years'}, {'measure': 'Cumulative incidence of relapse', 'timeFrame': 'Up to 27 years'}, {'measure': 'Cumulative incidence of second cancer', 'timeFrame': 'Up to 27 years'}, {'measure': 'Incidence of long-term sequelae', 'description': 'Heart failure, kidney failure, endocrine failure, or any other medical condition covered at 100% by French Social Security', 'timeFrame': 'Up to 27 years'}]" 317,NCT01333358,"{'fullName': 'Central Texas Neurology Consultants', 'class': 'OTHER'}",Evaluating Alemtuzumab as a Treatment in Stabilizing Neurocognitive Function In Relapsing Remitting Multiple Sclerosis Patients,UNKNOWN,"The main purpose of this research study is to investigate how well a medicine (alemtuzumab) works in treating MS-related cognitive problems (e.g., attention, memory, speed of thinking). This study will include 30 subjects from six research sites. Alemtuzumab is approved and sold under the brand names Campath and MabCampath to treat some types of leukemia. As a leukemia treatment, it is given more often and at much higher doses than in this study.",['Multiple Sclerosis'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Alemtuzumab', 'description': 'Alemtuzumab 12mg given intravenously each day for five days and again twelve months later for an additional three days', 'otherNames': ['Campath Mabcampath']}]","Inclusion Criteria: 1. Signed informed consent form (ICF) 2. Age 18 to 55 years old (inclusive) as of the date the ICF is signed 3. Diagnosis of MS per McDonald criteria (2005 update). 4. Onset of MS symptoms (as determined by a neurologist, at present or retrospectively) within 10 years of the date the ICF is signed 5. EDSS score 0.0 to 5.0 (inclusive) at Screening 6. ≥ 2 MS attacks (first episode or relapse) occurring in the 24 months prior to the date the ICF is signed, with ≥ 1 attack in the 12 months prior to the date the ICF is signed, with objective neurological signs confirmed by a physician, nurse practitioner, or other sponsor-approved health-care provider. The objective signs may be identified retrospectively. 7. ≥ 1 MS attack (relapse) during treatment with a beta interferon therapy or glatiramer acetate after having been on that therapy for ≥ 6 months within 10 years of the date the ICF is signed 8. MRI scan demonstrating white matter lesions attributable to MS and meeting at least 1 of the following criteria, as determined by the neurologist or a radiologist * ≥ 9 T2 lesions at least 3 mm in any axis * a gadolinium-enhancing lesion at least 3 mm in any axis plus \> 1 brain T2 lesions * a spinal cord lesion consistent with MS plus \> 1 brain T2 lesions 9. Corrected vision of subjects must be no worse than 20/50. 10. Participants must have at least 10 years of education. 11. Participants must be capable of writing and pressing the buttons on a computer mouse. 12. Participants must be capable of understanding and following all test instructions. Exclusion Criteria: Patients will be excluded from enrollment in this study if they meet any of the following criteria: 1. Previous treatment with alemtuzumab 2. Current participation in another clinical study or previous participation in CAMMS323 3. Treatment with natalizumab, methotrexate, azathioprine, or cyclosporine in the past 6 months. Patients who received one of these medications more than 6 months before the date the ICF is signed may be eligible for study entry if approval is granted by the sponsor 4. Previous treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab or any other immunosuppressant or cytotoxic therapy (other than steroids) 5. Previous treatment with any investigational medication (drug has not been approved at any dose or for any indication) unless prior approval is granted by the sponsor and the patient completes any required washout. Use of an investigational medication that was subsequently licensed and nonstandard use of a licensed medication (eg, using a dose other than the dose that is stated in the licensed product labeling or using a licensed therapy for an alternative indication) is not exclusionary. Prior treatment with herbal medications or nutritional supplements is also permitted. 6. Any progressive form of MS 7. History of malignancy, except basal skin cell carcinoma 8. Any disability acquired from trauma or another illness that, in the opinion of the Investigator, could interfere with evaluation of disability due to MS 9. Previous hypersensitivity reaction to any immunoglobulin product 10. Known allergy or intolerance to interferon beta, human albumin, or mannitol 11. Intolerance of pulsed corticosteroids, especially a history of steroid psychosis 12. Inability to self-administer SC injections or receive SC injections from caregiver 13. Inability to undergo MRI with gadolinium administration 14. Confirmed platelet count \< the lower limit of normal (LLN) of the evaluating laboratory at Screening or documented at \<100,000/μL within the past year on a sample without platelet clumping 15. Absolute neutrophil count \< LLN at Screening; if abnormal cell count returns to within normal limits, eligibility may be reassessed 16. Known bleeding disorder (eg, dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrand's disease, disseminated intravascular coagulation \[DIC\], fibrinogen deficiency, clotting factor deficiency) 17. Seropositivity for human immunodeficiency virus (HIV) 18. Significant autoimmune disease including but not limited to: immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis. 19. Active infection, eg, deep-tissue infection, that the Investigator considers sufficiently serious to preclude study participation 20. In the Investigator's opinion, is at high risk for infection (eg, indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent urinary tract infection) 21. Latent tuberculosis unless effective anti-tuberculosis therapy has been completed, or active tuberculosis. 22. Infection with hepatitis C virus 23. Past or present hepatitis B infection (positive hepatitis B serology) 24. Of childbearing potential with a positive serum pregnancy test, pregnant, or lactating 25. Unwilling to agree to use a reliable and acceptable contraceptive method throughout the study period (fertile patients only). Reliable and effective contraceptive method(s) include: intrauterine device (IUD), hormonal based contraception, surgical sterilization, abstinence, or double-barrier contraception (condom and occlusive cap (diaphragm or cervical cap with spermicide). 26. Major psychiatric disorder that is not adequately controlled by treatment 27. Epileptic seizures that are not adequately controlled by treatment 28. Major systemic disease or other illness that would, in the opinion of the Investigator, compromise patient safety or interfere with the interpretation of study results, e.g., current peptic ulcer disease, or other conditions that may predispose to hemorrhage 29. Medical, psychiatric, cognitive, or other conditions that, in the Investigator's opinion, compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study 30. Prior history of invasive fungal infections 31. Cervical high risk human papillomavirus (HPV) positivity or abnormal cervical cytology other than abnormal squamous cells of undetermined significance (ASCUS). The patient may be eligible after the condition has resolved (e.g., follow-up HPV test is negative or cervical abnormality has been effectively treated). 32. Any other illness or infection (latent or active) that, in the Investigator's opinion, could be exacerbated by either study medication 33. Any hepatic or renal function value grade 2 or higher at Screening, with the exception of hyperbilirubinemia due to Gilbert's syndrome, unless, in the Investigator's opinion, the abnormality is due to a condition that has resolved (eg, recent interferon treatment subsequently discontinued) and levels return to within normal limits. See Table below, drawn from the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events v3.0 (CTCAE), published 09 August 2006. * Hepatic * Bilirubin \> 1.5 × ULN * SGOT/AST \> 2.5 × ULN * SGPT/ALT \> 2.5 × ULN * Alkaline phosphatase \> 2.5 × ULN * Renal * Creatinine \> 1.5 × ULN 34. Participants with upper extremity dysfunction which prohibits them from using a computer mouse. 35. Participants who are colorblind. 36. Participants with current alcohol/substance abuse. 37. Participants taking medications with notable adverse CNS effects such as excessive sedation.",NA,ALL,NA,"[{'measure': 'The primary study objective is to demonstrate whether treatment with alemtuzumab is effective in stabilizing overall neurocognitive functioning in relapsing-remitting multiple sclerosis over time.', 'description': 'To determine the rate of change in cognitive scores for RRMS participants taking alemtuzumab over time. The data from participants in this trial will be compared to data from normal controls and RRMS patients receiving Rebif® in a parallel trial conducted by Wilken et al (in preparation).', 'timeFrame': 'Four years'}]",NA 318,NCT01470248,"{'fullName': 'Emory University', 'class': 'OTHER'}",Study of Arsenic Trioxide in Small Cell Lung Cancer,COMPLETED,"The purpose of this study is to study the effect of an anticancer drug, Arsenic Trioxide, in patients with small cell lung cancer who have failed at least one standard chemotherapy regimen as well as patients who are unable to tolerate the standard treatment for their cancer. The investigators seek to establish the safety of and efficacy of Arsenic Trioxide in this patient group. The study will include up to 36 participants with small cell lung cancer. The investigators want to find out what effects, good or bad, that the study drug has on your cancer. This study will also look at specific biomarkers in your blood and in the tumor tissue which may help the investigators to determine if the levels of these biomarkers are related to tumor response to treatment. Arsenic Trioxide, also known by the brand name, Trisenox, is a chemotherapy drug approved by the Food and Drug Administration (FDA) for the treatment of a specific type of blood cancer called Acute Promyelocytic Leukemia. It works in part by making cancer cells become more mature thereby stopping them from growing in number and more likely to die off.","['Lung Cancer', 'Cancer of Lung', 'Pulmonary Cancer', 'Pulmonary Neoplasms', 'Carcinoma, Small Cell']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Arsenic Trioxide', 'description': 'Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects', 'armGroupLabels': ['Arsenic Trioxide Treatment'], 'otherNames': ['Trisenox', 'ATO']}]","Inclusion Criteria: * Patients must have histologically or cytologically confirmed small cell lung cancer * Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as \>20 mm with conventional techniques or as \> 10 mm with spiral CT scan. * Patient must have failed or found to be intolerant of standard frontline platinum-based regimens. There is no limit on the number of prior regimens provided the patient meets all the other eligibility criteria. * Adult patients 18 years or older. Because no dosing or adverse event data are currently available on the use of arsenic trioxide in patients \< 18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable. * Life expectancy of greater than 3 months * Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2 * Patients must have normal organ and marrow function as defined below: * absolute neutrophil count \> 1,500/mL * platelets \> 100,000/mL * total bilirubin ≤ 1.5 X institutional upper limits of normal * aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \< 2.5 X institutional upper limit of normal * creatinine ≤ 1.5 X institutional upper limits of normal OR * creatinine clearance \> 40 mL/min/1.73 m² for patients with * creatinine levels above institutional normal. * Negative serum pregnancy test within 48 hours before starting study treatment in women with childbearing potential * Ability to understand and the willingness to sign a written informed consent document. * No history of QTc prolongation syndrome or any other cardiac conduction abnormality evidenced by normal baseline EKG (QTc ≤ 450 in males and ≤ 470 in females) * Both men and women and members of all races and ethnic groups are eligible for this trial. Exclusion Criteria: * Need for treatment with chemotherapy (within 4 weeks; 6 weeks for nitrosoureas or mitomycin C); radiotherapy or biologic agents (within 2 weeks) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. * Patients may not be receiving any other investigational agents. * Patients with uncontrolled symptomatic brain metastases. Patients with no known brain metastasis are not required to undergo screening prior to enrolment. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to arsenic trioxide. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women are excluded from this study because Trisenox is a category D agent with the potential to cause fetal harm. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Trisenox, breastfeeding should be discontinued if the mother is treated with Trisenox. * HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with Trisenox. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated. * Patients who require ongoing treatment with any hematopoietic colony-stimulating growth factors (e.g., granulocyte-colony stimulating factor \[G-CSF\], granulocyte-macrophage colony-stimulating factor \[GM-CSF\]) ≤ 2 weeks prior to starting study drug. * Patients who are currently receiving treatment with medication that has the potential to prolong the QT interval or inducing Torsades de Pointes and the treatment cannot either be discontinued or switched to a different medication prior to starting study drug * Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy * History of another malignancy within 3 years, except curatively treated basal cell carcinoma of the skin, ductal carcinoma in situ (DCIS), early stage prostate cancer without detectable prostate-specific antigen (PSA) or excised carcinoma in situ of the cervix * Patient is unable or unwilling to abide by the study protocol",NA,ALL,NA,"[{'measure': 'Response Rate (RR)', 'description': 'Response rate (complete response \\[CR\\]+ partial response \\[PR\\]) was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).\n\n* Complete response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\< 10 mm.\n* Partial response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.\n* Progressive disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.\n* Stable disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.', 'timeFrame': 'Every 8 weeks'}, {'measure': 'Clinical Benefit Rate (CBR)', 'description': 'Sum of complete response (CR), partial response (PR) and stable disease (SD) in patients eligible for efficacy analysis.', 'timeFrame': 'After completing at least 1 cycle (8 weeks) of treatment'}]","[{'measure': 'Progression-free Survival', 'description': 'Defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Progression was evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1).\n\nProgressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.', 'timeFrame': 'Every 8 weeks'}, {'measure': 'Overall Survival', 'description': 'Duration of time from enrollment on study until death', 'timeFrame': 'From enrolment till death on average up to 2 years'}]" 319,NCT00887926,"{'fullName': 'Eli Lilly and Company', 'class': 'INDUSTRY'}",Study of IMC-EB10 in Participant With Leukemia,TERMINATED,"The purpose of this study is to determine if IMC-EB10 is safe for participants with leukemia, and also to determine the best dose of IMC-EB10 to give to participants.",['Myeloid Leukemia'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'IMC-EB10', 'description': 'Cohort 1 will receive IMC-EB10 intravenously for 3 weekly infusions, followed by a 1-week observation period. The starting dose in Cohort 1 will be 5 mg/kg. After all participants in Cohort 1 complete the first cycle of therapy, dose escalation for subsequent cohorts will proceed as follows: Cohort 2 - 10 mg/kg, Cohort 3 - 20 mg/kg, Cohort 4 - 30 mg/kg. Participants who experience a dose-limiting toxicity (DLT) will not receive further IMC-EB10 treatment, but will continue to be followed on the protocol. Participants may continue to receive IMC-EB10 therapy, in the absence of treatment failure, treatment intolerance, or other withdrawal criteria for additional 28-day cycles at the same dose that they initially received. Dosing for Cycle 2 and beyond will be administered on Days 1, 8, 15, and 22 of a 28-day treatment cycle', 'armGroupLabels': ['IMC-EB10 5 milligrams/kilogram (mg/kg)'], 'otherNames': ['LY3012218']}]","Inclusion Criteria: 1. The participant has acute myeloid leukemia in the bone marrow or blood that has relapsed with or without a prior complete remission 2. The participant is not regarded to be a candidate for a potentially curative, higher priority treatment for acute myeloid leukemia 3. The participant has resolution of all clinically significant toxic effects of any prior antitumor therapy and any other study-specific clinical or laboratory parameter specified in the entry criteria 4. The participant has not had major surgery, an open biopsy, a significant injury, and/or prior antitumor therapy (except antileukemia therapy) within 21 days prior to the first infusion of IMC-EB10 5. The participant has an Eastern Cooperative Oncology Group (ECOG)performance status of 0, 1, or 2 at study entry. 6. The participant is age 18 years or older 7. The participant has a life expectancy of \>3 months 8. The participant has adequate liver and kidney function, as defined in the entry criteria 9. The participant is using an effective contraception (per the institutional standard), if procreative potential exists 10. The participant is able to give written informed consent 11. The participant is willing and able to comply with study procedures, scheduled visits, and treatment plans Exclusion Criteria: 1. The participant has had prior allogenic or autologous stem cell transplant within \<3 months of the first infusion of IMC-EB10 2. The participant has had an organ transplant (nonhematologic) within 3 years of study entry 3. The participant has active central nervous system leukemia 4. The participant has extramedullary disease without peripheral/and or bone marrow involvement 5. The participant is disease-free from a previous or concurrent malignancy for a period ≤ 1 year. A participant who has basal cell carcinoma or carcinoma in situ of the cervix will not be excluded from the study 6. The participant is currently receiving antileukemia therapy. Concurrent treatment with hydroxyurea is permitted 7. The participant has uncontrolled intercurrent illness as specified in the study entry criteria 8. The participant is receiving chronic steroid or other immunosuppressive medications. Occasional use of steroid-containing medications for, for example (e.g.), asthma exacerbation or for skin lesions, is permitted 9. The participant is receiving full-dose heparin (including low molecular weight heparin) or warfarin. \[The participant is permitted to use low-dose warfarin to maintain patency of preexisting, permanent, indwelling intravenous (I.V.) catheters.\] 10. The participant is pregnant (confirmed by urine or serum pregnancy test) or breast feeding 11. The participant has received treatment with monoclonal antibodies within 6 weeks prior to first infusion of IMC-EB10 12. The participant has a history of clinically significant allergic reactions to monoclonal antibodies or other therapeutic proteins",NA,ALL,NA,"[{'measure': 'Maximum Tolerate Dose (MTD) of IMC-EB10', 'description': 'MTD is defined as the dose preceding the dose level at which 2 participants experienced a dose limiting toxicity (DLT) during Cycle 1. DLT is defined using National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI-CTCAE v 3.0): (1) any Grade 3 or 4 toxicity that is clearly not attributable to leukemia \\[for example (e.g.) a type of end-organ failure that is infrequently encountered in acute myeloid leukemia (AML)\\] and is possibly, probably, or definitely attributable to IMC-EB10 in the judgment of the investigator; and (2) any Grade 3 or 4 toxicity that is clearly not attributable to a co-medication (e.g., prolonged neutropenia that is not attributable to hydroxyurea).', 'timeFrame': 'Cycle 1 (28-day cycle)'}]","[{'measure': 'Pharmacokinetic (PK): Maximum Concentration (Cmax)', 'timeFrame': 'Cycle 1 Week 1: predose, immediately after infusion, and 1.5, 2, 4, 8, 24, 96, and 168 h after infusion ends, and Cycle 1 Week 3: predose, immediately after infusion, and 1.5, 2, 4, 8, 24, 48, 96,168, 240 and 336 h after infusion ends (28-day cycles)'}, {'measure': 'PK: Area Under the Concentration Versus Time Curve From Time Zero to Last Measurable Concentration [AUC(0-last)]', 'timeFrame': 'Cycle 1 Week 1: predose, immediately after infusion, and at 1.5, 2, 4, 8, 24, 96 and 168 h after infusion ends (28-day cycle)'}, {'measure': 'PK: Area Under the Concentration Time Curve During the Dosing Interval (AUCtau) Where Tau is 168 Hours', 'timeFrame': 'Cycle 1 Week 3: predose, immediately after infusion and at 1.5, 2, 4, 8, 24, 48, 96,168, 240 and 336 h after infusion ends (28-day cycle)'}, {'measure': 'Number of Participants With Adverse Events (AEs) (Safety Profile of IMC-EB10)', 'description': 'Clinically significant events were defined as serious adverse events (SAEs) and other non-serious AEs regardless of causality. A summary of SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module', 'timeFrame': '8 weeks and 30-day post-treatment follow-up'}, {'measure': 'Number of Participants With Anti-IMC-EB10 Antibodies', 'description': 'A participant is considered positive for antibodies against IMC-EB10 if their blood sample exhibited a post-treatment antibody level that exceeds the positive upper cut point determined from the anti-IMC-EB10 level in healthy untreated individuals. A participant was considered to have an anti-IMC-EB10 response if there are 2 consecutive positive samples or if the final sample tested is positive.', 'timeFrame': 'Cycle 1, Weeks 1 and 3 and Cycle 2, Week 1: predose (28-day cycles)'}, {'measure': 'Number of Participants With Antileukemic Complete Response (CR) or Partial Response (PR)', 'description': 'Assessment of antileukemic response was based on hematologic response criteria. PR defined as \\>1000/microliter (µL) neutrophils and ≥100000/µL platelets in peripheral blood; a decrease of ≥50% in the pretreatment percentage of blasts to 5% to 25% in the bone marrow aspirate or a value of ≤5% blasts if Auer rods are present. Cytogenetic CR defined as normal cytogenetic findings. Molecular CR defined as negative findings for minimal residual disease by automated quantitative Reverse-Transcription-Polymerase Chain Reaction (RT-PCR) and multidimensional flow cytometry. Morphologic CR with incomplete blood count recovery defined as ≤5% blasts (containing no Auer rods) in a bone marrow aspirate with spicules; neutrophil count \\< 1000/µL or platelets \\<100000/mL in peripheral blood or no extramedullary leukemia present.', 'timeFrame': '4 weeks'}, {'measure': 'Number of Participants With Feline McDonough Sarcoma (FMS)-Like Tyrosine Kinase 3 (FLT3) Response', 'description': 'FLT3 response to IMC-EB10 is defined as wild type, internal tandem duplications (ITD) mutations and other mutations.', 'timeFrame': 'Week 4 and Week 8'}]" 320,NCT04002115,"{'fullName': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}",Clofarabine Pre-conditioning Followed by Stem Cell Transplant for Non-remission AML,TERMINATED,"The Investigators would like to study the incidence of complete remission (CR) at day +30 after Clofarabine followed by haploidentical transplant. The conditioning regimen used is Fludarabine, Busulfan (2 doses) or cyclophosphamide (2 doses) and Total Body Irradiation (TBI) with post transplant cyclophosphamide for patients with Acute Myeloid Leukemia (AML) who are not in remission prior to considering allogeneic transplant with haploidentical donors.",['Acute Myeloid Leukemia'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Dose de-escalation: Enrollment will begin at 30 mg/m2 to analyze any grade 4-5 organ toxicities as defined in Section 12.2. If the trial is stopped due to excessive toxicities, then dose de-escalation to 20 mg/m2 will occur for the next cohort of participants. For each participant, the observation period is from start of treatment through post-transplant day +30. Adverse effects will be continuously monitored as patients are enrolled. The trial will be stopped when the toxicity rate exceeds 20% with a posterior probability of 80% and a margin of no more than 5%. This leads to the following stopping rule: the trial will be stopped if 2 of the first 3 subjects experience grade 4-5 organ toxicity, or 3 out of 6, 4 out 9, 5 out of 12, 6 out of 16, or 7 out 19.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Clofarabine', 'description': 'Clofarabine to be administered pre-stem cell transplant infusion (""Day 0"") once a day for 5 days total.', 'armGroupLabels': ['Clofarabine 30 mg/m^2'], 'otherNames': ['Clolar']}, {'type': 'DRUG', 'name': 'Fludarabine', 'description': 'Fludarabine will be administered once a day for 4 days as part of the transplant conditioning regimen.', 'armGroupLabels': ['Clofarabine 30 mg/m^2'], 'otherNames': ['Fludara']}, {'type': 'DRUG', 'name': 'Busulfan', 'description': 'Busulfan will be administered once a day for 2 days as part of the transplant conditioning regimen.', 'armGroupLabels': ['Clofarabine 30 mg/m^2'], 'otherNames': ['Busulfex']}, {'type': 'PROCEDURE', 'name': 'Total Body Irradiation (TBI)', 'description': 'TBI will be administered at a dose of 200cGys on Day -1 prior to transplant', 'armGroupLabels': ['Clofarabine 30 mg/m^2'], 'otherNames': ['TBI']}, {'type': 'DRUG', 'name': 'Cyclophosphamide', 'description': 'Cyclophosphamide will be given once a day for 2 days after the transplant infusion.', 'armGroupLabels': ['Clofarabine 30 mg/m^2'], 'otherNames': ['Cytoxan']}, {'type': 'DRUG', 'name': 'Granulocyte Colony-Stimulating Factor', 'description': 'G-CSF will be administered to subjects starting on Day +5 and will continue as clinically indicated', 'armGroupLabels': ['Clofarabine 30 mg/m^2'], 'otherNames': ['Filgrastim G-CSF']}, {'type': 'DRUG', 'name': 'Tacrolimus', 'description': 'Tacrolimus will be administered to subjects starting on Day +5 and will continue as clinically indicated', 'armGroupLabels': ['Clofarabine 30 mg/m^2'], 'otherNames': ['Prograf']}, {'type': 'DRUG', 'name': 'Cellcept', 'description': 'Mycophenolate Mofetil will be administered to subjects starting on Day +5 and will continue as clinically indicated', 'armGroupLabels': ['Clofarabine 30 mg/m^2'], 'otherNames': ['Mycophenolate Mofetil (MMF)']}]","Inclusion Criteria: 1. Diagnostic criteria of AML, induction failure without having achieved remission after at least 2 attempts at induction chemotherapy, or relapsed after any complete remission (CR). 2. 18 to 75 years of age. 3. Planned or scheduled to receive an allogeneic HSCT from haploidentical related donors, matched and mismatched unrelated donors. 4. All organ function testing should be done within 28 days of study registration. * Performance status: Karnofsky ≥ 70% (Appendix A). * Cardiac: LVEF ≥ 50% by MUGA or echocardiogram. * Pulmonary: FEV1 and FVC ≥ 50% predicted, DLCO (corrected for hemoglobin) ≥ 50% of predicted. * Renal: Creatinine clearance (CrCl) ≥ 60 mL/min/1.73 m2 * Hepatic: Serum bilirubin ≤1.5 x upper limit of normal (ULN); (AST)/(ALT) ≤ 2.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN. 5. Both men and women need to use an approved method of birth control and/or abstinence due to unknown risks to the fetus. Exclusion Criteria: 1. Acute promyelocytic leukemia (APL) 2. Known history of non-compliance with medication regimens, scheduled clinic visits, or self-care. 3. In the opinion of the investigator, no appropriate caregivers identified. 4. HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive 5. Active Hepatitis B and Hepatitis C orepatitis positive serology including HBsAg, hepatitis B core antibody, and hepatitis C antibody. Hepatitis B surface antibody positive due to vaccination or natural immunity are permitted. 6. In the opinion of the physician investigator, uncontrolled medical or psychiatric disorders. 7. Uncontrolled infections requiring treatment within 14 days of registration. 8. Active central nervous system (CNS) leukemia. 9. Cord blood transplant excluded. 10. Prior allogeneic HSCT within last 6 months. 11. Patients with \>= grade 2 acute GVHD. 12. Patients with \>=moderate chronic GVHD. 13. Pregnant or Breastfeeding. Women of child bearing potential (WCBP) are required to have a negative serum or urine pregnancy test prior to initiation of conditioning regimen. 14. Haploidentical related donors who are positive for DSA ≥ 5000 MFI by solid phase microarray method (Luminex). 15. Any patient with steroid dose more than 10 mg/day within a week of registration . 16. Autoimmune disorder requiring any active immunosuppression therapy.",NA,ALL,NA,"[{'measure': 'Complete Remission (CR) Rate at Day 30 Post HSCT', 'description': 'The CR rate at 30 days (Day +30) post stem cell transplant infusion', 'timeFrame': '30 days'}]","[{'measure': 'Non-relapse Related Mortality', 'description': 'Determine the rate of non-relapse related mortality at 100 days post transplant (Day +100)', 'timeFrame': '100 days'}, {'measure': 'Neutrophil Engraftment', 'description': 'Rates of engraftment, defined as the first day of Absolute Neutrophil Count (ANC) greater than 500 for the first of three consecutive days', 'timeFrame': '1 year'}, {'measure': 'Rate of Acute Graft-versus-host Disease (GVHD)', 'description': 'The rate of any grade (1-4) of acute GvHD as measured from day of transplantation to Day +100 using the Glucksberg criteria.', 'timeFrame': '100 days'}, {'measure': 'Severity of Acute Graft-versus-host Disease (GVHD)', 'description': 'The highest grade (1-4) of acute GvHD experienced by participants as measured from day of transplantation to Day +100 using the Glucksberg criteria', 'timeFrame': '100 days'}, {'measure': 'Rate of Chronic GVHD', 'description': 'The rate of any grade (1-4) of Chronic GvHD as measured from Day +100 to Year 1 post-transplantation using the Glucksberg criteria.', 'timeFrame': '1 year'}, {'measure': 'Severity of Chronic GVHD', 'description': 'The highest overall grade (1-4) of chronic GvHD experienced by participants as measured from Day +100 to Year 1 post-transplantation using the Glucksberg criteria', 'timeFrame': '1 year'}]" 321,NCT07029217,"{'fullName': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}",A Study of Reduced Dose Radiation Therapy for People With B-Cell Lymphomas,RECRUITING,"The researchers are doing this study to find out whether a very low dose of radiation therapy (VLDRT) is an effective treatment for people with follicular lymphoma (FL) or marginal zone lymphoma (MZL) and works as well as the standard dose of radiation therapy. The researchers will see if VLDRT works against cancer in the area that is currently affected by cancer and if the therapy prevents new spots of lymphoma from developing. The researchers will also compare VLDRT with the standard dose of radiation therapy to see if VLDRT causes fewer side effects. Radiation therapy uses beams of intense energy to kill cancer cells. Standard doses of radiation therapy can cause short- and long-term side effects. Researchers think VLDRT may be as effective as standard doses, and, because VLDRT uses less radiation, researchers think VLDRT may cause fewer side effects than standard doses.","['Follicular Lymphoma', 'Marginal Zone Lymphoma']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This a phase III, randomized, multi-center non-inferiority trial.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'RADIATION', 'name': 'Radiation (Standard)', 'description': '24 Gy in 12 fractions', 'armGroupLabels': ['Standard dose of Radiation']}, {'type': 'RADIATION', 'name': 'Radiation (Very low dose)', 'description': '4 Gy in 1-2 consecutive daily fractions', 'armGroupLabels': ['Very low dose of Radiation']}]","Inclusion Criteria: (Arms 1\&2) * Patients must be diagnosed with a follicular lymphoma or marginal zone lymphoma. Of note, there are now two widely-utilized pathology classification criteria used for mature B-cell lymphomas, the World Health Organization (WHO) 5th Edition Classification of Lymphoid Neoplasms and the International Consensus Classification (ICC) of Mature Lymphoid Neoplasms. Either criteria is acceptable and for the purposes of this protocol, the following diagnoses are included: * Follicular lymphoma * WHO 5th Edition * Classic follicular lymphoma (cFL) * Follicular lymphoma with uncommon features (uFL) * Pediatric type follicular lymphoma * Duodenal type follicular lymphoma * ICC * Follicular lymphoma, grades 1-2 or 3A * BCL2 rearrangement negative, CD23 positive follicle center lymphoma * Pediatric type follicular lymphoma * Duodenal type follicular lymphoma * Marginal zone lymphoma * WHO 5th Edition and ICC * Nodal marginal zone lymphoma * Pediatric nodal marginal zone lymphoma * Extranodal marginal zone lymphoma of mucosa associated lymphoid tissue (MALT) * Patients must have stage I or II disease (with stage I defined as involvement of one nodal region and stage II as two or more nodal regions involved on the same side of the diaphragm) * Patients should be newly diagnosed or previously observed with no prior lymphoma-directed therapy * If the patient is referred for localized gastric MALT lymphoma, there should be documented negative H. Pylori testing within 6 months prior to proposed radiotherapy * Age at the time of enrollment of ≥18 years * Patients must be able to start radiation within 2 months from time of randomization Exclusion Criteria: * Prior radiation to site(s) needing treatment * Follicular lymphoma, grade 3B (ICC) or Follicular large B cell lymphoma (FLBL by WHO 5th edition criteria) * Patients planned to receive concurrent systemic therapy (including oral steroids) for their lymphoma * Patient has cutaneous only iNHL defined as primary cutaneous B-cell lymphoma, primary cutaneous follicle center lymphoma, cutaneous marginal zone lymphoma or unspecified indolent lymphoma of the skin * Gross total resection of all disease * Tumor size measuring ≥5 cm in maximum diameter on any modality diagnostic imaging * Patients with any concurrent medical or psychiatric condition or disease which, in the investigator's judgment, would make them inappropriate candidates for entry into this study",NA,ALL,NA,"[{'measure': 'progression-free survival', 'description': 'Progression will be defined as either PD as per Lugano criteria (either treated or non-treated lesions) OR\n\n* Receipt of any additional radiotherapy for lymphoma to an initially involved site outside of the protocol mandated treatment OR\n* Death from any cause', 'timeFrame': '2 years'}]","[{'measure': 'radiographic response', 'description': 'using Lugano criteria', 'timeFrame': '6 months'}]" 322,NCT00003440,"{'fullName': 'National Cancer Institute (NCI)', 'class': 'NIH'}","Paclitaxel With or Without Trastuzumab in Treating Patients With or Without HER-2/Neu Breast Cancer That is Inoperable, Recurrent, or Metastatic",COMPLETED,"This randomized phase III studies how well two different regimens of paclitaxel with or without trastuzumab works in treating patients with or without HER-2/Neu breast cancer that is inoperable, recurrent, or metastatic. Drugs used in chemotherapy, such as paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known what regimen of paclitaxel is more effective with or without trastuzumab in treating patients with breast cancer.","['HER2-negative Breast Cancer', 'HER2-positive Breast Cancer', 'Recurrent Breast Cancer', 'Stage IIIC Breast Cancer', 'Stage IV Breast Cancer']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}","[{'type': 'DRUG', 'name': 'paclitaxel', 'description': 'Given IV over 1 hour or 3 hours', 'armGroupLabels': ['Am E (paclitaxel, trastuzumab)', 'Arm A (paclitaxel)', 'Arm B (paclitaxel)', 'Arm C (paclitaxel, trastuzumab)', 'Arm D (paclitaxel, trastuzumab)', 'Arm F (paclitaxel, trastuzumab)'], 'otherNames': ['Anzatax', 'Asotax', 'TAX', 'Taxol']}, {'type': 'BIOLOGICAL', 'name': 'trastuzumab', 'description': 'Given IV', 'armGroupLabels': ['Am E (paclitaxel, trastuzumab)', 'Arm C (paclitaxel, trastuzumab)', 'Arm D (paclitaxel, trastuzumab)', 'Arm F (paclitaxel, trastuzumab)'], 'otherNames': ['anti-c-erB-2', 'Herceptin', 'MOAB HER2']}, {'type': 'PROCEDURE', 'name': 'quality-of-life assessment', 'description': 'Ancillary studies', 'armGroupLabels': ['Am E (paclitaxel, trastuzumab)', 'Arm A (paclitaxel)', 'Arm B (paclitaxel)', 'Arm C (paclitaxel, trastuzumab)', 'Arm D (paclitaxel, trastuzumab)', 'Arm F (paclitaxel, trastuzumab)'], 'otherNames': ['quality of life assessment']}, {'type': 'OTHER', 'name': 'laboratory biomarker analysis', 'description': 'Correlative studies', 'armGroupLabels': ['Am E (paclitaxel, trastuzumab)', 'Arm A (paclitaxel)', 'Arm B (paclitaxel)', 'Arm C (paclitaxel, trastuzumab)', 'Arm D (paclitaxel, trastuzumab)', 'Arm F (paclitaxel, trastuzumab)']}]","Inclusion Criteria: * Histologically confirmed adenocarcinoma of the female breast which is inoperable, recurrent or metastatic * HER-2/neu status must be known at the time of protocol registration; HER-2/neu assessment will be based on FISH analysis of either the primary tumor or a metastatic site; a scoring of 0 or 1+ by immunohistochemistry (IHC) is considered negative; 2+ is considered negative unless confirmed by FISH positivity, in which case it should be considered positive; 3+ by IHC is considered positive; for centers using FISH only, a positive FISH assay by itself is sufficient to determine HER-2 positivity * Patients with the following prior therapy are eligible: * Patients with 0-1 prior chemotherapy regimens for metastatic or locally advanced breast cancer, with the following exception: no prior taxane for metastatic/locally advanced breast cancer * Patients with 0-1 prior chemotherapy regimens in the adjuvant setting; if adjuvant regimen included a taxane, patient must have been disease free for at least 12 months from completion of adjuvant therapy until relapse * Patients must be \> 2 weeks from prior surgery, other than simple biopsy or placement of venous access device; patients must be \> 4 weeks from prior chemotherapy; patients must be \>6 weeks from nitrosoureas, melphalan, or mitomycin * Patients must be \> 4 weeks from prior hormonal therapy unless tumor measurements document clear progression while on treatment; if progression is documented and toxicity from hormonal regimen has resolved, patients may be placed on study \> 1 week from prior hormonal therapy * Prior Herceptin therapy is not allowed * Patients with central nervous system metastases are eligible only if the patient has completed cranial irradiation at least 6 months prior, is currently asymptomatic, and is not currently receiving corticosteroids for this condition; patients with leptomeningeal carcinoma (carcinomatous meningitis) are not eligible * MESURABLE DISEASE: Any mass reproducibly measurable in two perpendicular dimensions, examples include: * Pulmonary nodules * Hepatic lesions * Skin nodules (if two measurements can be assigned) * Lymph nodes * The following lesions do not qualify as measurable: * Central nervous system (CNS) lesions * Bone disease only; lytic lesions should be documented and followed * Lymphangitic pulmonary metastases (patients with lymphangitic metastases are eligible if there are other sites of metastatic disease which can be measured) * Lesions which have been irradiated unless there is definite documentation of progression since radiotherapy * A baseline assessment of left ventricular ejection fraction within 8 weeks of registration is required (echocardiogram or resting multi gated acquisition scan \[MUGA\] (radionuclide cineangiography \[RNCA\]) nuclear scintigraphy); patients with a left ventricular ejection fraction (LVEF) \< 45% are ineligible * Granulocytes \>= 1500/ul * Platelet count \>= 100,000/ul * Creatinine =\< 2.0 mg/dl * Bilirubin within institutional normal limits * Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\])",NA,FEMALE,NA,"[{'measure': 'Response rate (complete response [CR]) and partial response [PR])', 'description': ""Multivariate logistic regression will be used to relate patient characteristics and pretreatment clinical variables with tumor response (complete or partial). Interim analyses will use a chi square statistic to compare response incidence by treatment arm with two-sided bounds constructed from the O'Brien-Fleming approach"", 'timeFrame': 'Up to 5 years'}]","[{'measure': 'Overall survival', 'description': 'Kaplan-Meier curves will be plotted for each of the arms. Sets of curves will be compared using the logrank statistic. A Cox proportional hazards regression model will be used to relate length of survival with paclitaxel dose schedule, HER-2/neu status, Herceptin use (for HER-2/neu negatives), number of sites of metastases at baseline, ER status,', 'timeFrame': 'Up to 5 years'}, {'measure': 'Time to disease progression:', 'description': 'Kaplan-Meier curves will be plotted for each combination of therapy. Sets of curves will be compared using the logrank statistic. A Cox proportional hazards regression model will be used to relate length of survival with paclitaxel dose schedule, HER-2/neu status, Herceptin use (for HER-2/neu negatives), number of sites of metastases at baseline, ER status, CALGB performance status, prior adjuvant chemotherapy, and prior radiotherapy.', 'timeFrame': 'Up to 5 years'}, {'measure': 'Duration of response', 'description': 'For patients who achieve response within each arm, Kaplan-Meier curves will be used to estimate probability distributions for duration of response. Distributions will be compared using the logrank statistic.', 'timeFrame': 'Length of time between response and disease progression, assessed up to 5 years'}, {'measure': 'Cardiac toxicity as measured by changes in LVEF', 'description': 'Cardiac toxicity will be evaluated using multivariate logistic regression.', 'timeFrame': 'From baseline to up to 5 years'}, {'measure': 'Toxicity as assessed by CALGB Expanded Common Toxicity Criteria', 'description': 'Toxicity frequency will be tabulated by most severe occurrence.', 'timeFrame': 'Up to 5 years'}, {'measure': 'Change in quality of life (QOL)', 'description': 'EORTC Breast Cancer Module QLQ-BR23, Changes in Function (C-616), Centers for Epidemiologic Studies-Depression (CES-d) Short Form (C-617), MOS Social Support Questionnaire (C-249), Spirituality Subscale (C-613) will be used to assess QOL. Multiple regression will be used to examine whether sociodemographic characteristics (age, gender, education, marital status, ethnicity, employment status); treatment (chemotherapy dose, Herceptin usage); clinical factors (HER2 status, performance status); and pre-treatment QOL, social support and spirituality, are significant predictors of survival.', 'timeFrame': 'From baseline to up to 9 months'}, {'measure': 'Correlation between ErbB2 and response to treatment', 'description': 'Correlation will be assessed using contingency tables for two dichotomous variables, point biserial correlation for one dichotomous and one continuous variable and Pearson correlation for two dichotomous variables.', 'timeFrame': 'Up to 5 years'}]" 323,NCT00004189,"{'fullName': 'National Cancer Institute (NCI)', 'class': 'NIH'}",Rebeccamycin Analog and Cisplatin With or Without Filgrastim in Treating Patients With Advanced Cancer,COMPLETED,Phase I trial to study the effectiveness of rebeccamycin analog and cisplatin with or without filgrastim in treating patients who have advanced cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.,"['Lymphoma', 'Small Intestine Cancer', 'Unspecified Adult Solid Tumor, Protocol Specific']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'filgrastim', 'armGroupLabels': ['Arm I']}, {'type': 'DRUG', 'name': 'becatecarin', 'armGroupLabels': ['Arm I']}, {'type': 'DRUG', 'name': 'cisplatin', 'armGroupLabels': ['Arm I']}]","DISEASE CHARACTERISTICS: * Histologically or cytologically proven advanced malignancy that is refractory to prior therapy or unlikely to benefit from standard therapy (e.g., chemotherapy, radiotherapy, and surgery) * Part I: Previously untreated OR minimally pretreated * Ineligible for part I and considered heavily pretreated if: * Prior radiotherapy to wide ports involving the pelvis or at least 25% of bone marrow * Greater than 6 courses of prior combination chemotherapy including alkylating agent * Prior nitrosoureas or mitomycin * Widespread bone metastases with bone marrow involvement by bone marrow biopsy (positive bilateral bone marrow biopsy for lymphoma patients) * Part II: Heavily pretreated as defined above * Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * SWOG 0-2 Life expectancy: * At least 3 months Hematopoietic: * Absolute neutrophil count greater than 1,500/mm\^3 * Hemoglobin greater than 9 mg/dL * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin less than 1.5 mg/dL Renal: * Creatinine less than 1.5 mg/dL Cardiovascular: * No uncontrolled hypertension * No angina pectoris * No clinically significant, multifocal, uncontrolled cardiac dysrhythmias Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active serious infection * No clinically severe peripheral neuropathy (grade 1 or worse) * No nonmalignant medical condition that would preclude compliance or increase risk of participation in study * No hypersensitivity to E. coli derived drug preparations PRIOR CONCURRENT THERAPY: Biologic therapy: * No other concurrent colony stimulating factors for prophylactic purposes Chemotherapy: * At least 3 weeks since prior chemotherapy (6 weeks since prior nitrosoureas and mitomycin) and recovered Endocrine therapy: * No chronic oral corticosteroids * No concurrent corticosteroids except as prophylactic antiemetic Radiotherapy: * At least 3 weeks since prior radiotherapy and recovered Other: * At least 1 month since prior investigational agent * No prophylactic oral or IV antibiotics for neutropenia unless fever present * No other concurrent anticancer treatment or investigational agent",NA,ALL,NA,NA,NA 324,NCT00002818,"{'fullName': 'Virginia Commonwealth University', 'class': 'OTHER'}",High-Dose Cytarabine Plus Deoxycytidine in Treating With Acute Myelogenous Leukemia or Other Hematologic Malignancies,COMPLETED,"RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Deoxycytidine may protect patients from the side effects of high-dose cytarabine. PURPOSE: Phase I trial to study the effectiveness of high-dose cytarabine given with deoxycytidine in treating patients who have refractory acute myelogenous leukemia or other lymphoma or leukemia.","['Drug/Agent Toxicity by Tissue/Organ', 'Leukemia', 'Lymphoma', 'Multiple Myeloma and Plasma Cell Neoplasm']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'cytarabine'}, {'type': 'DRUG', 'name': 'deoxycytidine'}]","DISEASE CHARACTERISTICS: One of the following histologically documented hematologic malignancies: Acute myelogenous leukemia Failed or relapsed following conventional dose chemotherapy (e.g., doxorubicin, cytarabine) or high dose cytarabine (HD ARA-C) Chronic myelogenous leukemia in blast crisis that has failed at least 1 conventional antileukemic regimen Acute lymphoblastic leukemia (ALL) that is relapsed following or initially refractory to conventional therapy Failed at least 1 salvage regimen for ALL Disease refractory to conventional HD ARA-C allowed Primarily refractory or relapsed Hodgkin's or non-Hodgkin's lymphoma Failed at least 1 conventional second or third generation regimen (e.g., ProMACE-CytaBOM) Refractory multiple myeloma Not eligible for protocols of higher priority and no alternative forms of therapy available that offer a reasonable chance of palliation or cure PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 50-100% Life expectancy: At least 8 weeks Hematopoietic: Not specified Hepatic: Bilirubin less than 3 mg/dL Renal: Creatinine clearance at least 40 mL/min Pulmonary: Pulse oximetry greater than 88% in patients with a history of pulmonary disease Other: No major concurrent disease that renders patient a poor medical risk No uncontrolled infection Disease related fever allowed at investigator's discretion No mental incapacity that precludes informed consent No incarcerated patients Not pregnant Effective contraception required of fertile women PRIOR CONCURRENT THERAPY: Not specified Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior chemotherapy (24 hours since hydroxyurea) and recovered Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to 30% or more of bone marrow At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified",NA,ALL,NA,NA,NA 325,NCT01011998,"{'fullName': 'New Mexico Cancer Research Alliance', 'class': 'OTHER'}",A Study of Imatinib and Valproic Acid in Patients With Chronic Myelogenous Leukemia (CML),WITHDRAWN,The aim of this study is to test the effect of the combination of valproate in combination with imatinib with an aim of achieving a maximal molecular response as the primary goal.,['Chronic Myelogenous Leukemia'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Gleevec (imatinib), valproic acid', 'description': 'Valproic acid: 250 mg three times per day and then adjusted according to attain a therapeutic level.\n\nGleevec will be continued at the dose the patient was taking at the time of entry onto the study.', 'otherNames': ['Valproic acid', 'Imatinib', 'Gleevec']}]","Inclusion Criteria: * All patients, 18 years of age or older, with a diagnosis of CML. * Patients must have a life expectancy of at least 12 weeks. * Patients must have an ECOG performance status of 0-2. * Patients must sign an informed consent. * Patients should have adequate hepatic function with a total bilirubin \< 2 mg/dl and SGOT or SGPT \< two times the upper limit of normal, and adequate renal function as defined by a serum creatinine \< 1.5 x upper limit of normal. * Patients with CML in chronic phase on imatinib as first line therapy who fulfill the following criteria: * The patient has at least two tests for quantitative reverse transcriptase polymerase chain reaction (RT-PCR) for bcr-abl (peripheral blood or bone marrow aspirate). The results of these tests should demonstrate a relative plateau in the effect of imatinib on the detected level of the transcript (i.e. there should less than a ½ log difference between the last two values). Note: Patients will be eligible if the more recent study is greater than the previous study by any value. * The last two quantitative RT-PCR studies should be at least 3 months apart. * The patient should have received at least 9 months of imatinib since the diagnosis of CML. * The patient is tolerating imatinib without any grade 3 or greater toxicity. Exclusion Criteria: * Pregnant women or nursing mothers are not eligible for this trial. Patients of child bearing potential must use adequate contraception. * Patients may receive no other concurrent chemotherapy or radiation therapy during this trial. * Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial. * Patients who have a hypersensitivity to valproic acid, derivatives, or any component of the formulation. Patients with hepatic disease or significant impairment, or urea cycle disorders",NA,ALL,NA,"[{'measure': 'To measure the effect of the combination of valproate in combination with imatinib with an aim of achieving a maximal molecular response as the primary goal.', 'timeFrame': '6 months'}]",NA 326,NCT04358393,"{'fullName': 'Ascentage Pharma Group Inc.', 'class': 'INDUSTRY'}","A Study of APG-115 Alone or Combined With Azacitidine in Patients With AML, CMML, or MDS",UNKNOWN,"This is a two Part study in patients with relapsed/refractory acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), or high risk myelodysplastic syndrome (MDS) that will initially evaluate the safety and tolerability of APG-115 as a single agent in Part 1, followed by a combination of APG-115 + 5-azacitidine (5-AZA) in Part 2.","['AML', 'Acute Myeloid Leukemia', 'Chronic Myelomonocytic Leukemia', 'CMML', 'Myelodysplastic Syndromes', 'High-risk Myelodysplastic Syndrome', 'MDS']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'APG-115', 'description': 'APG-115 given once daily on day 1-5 of every 28 day cycle', 'armGroupLabels': ['APG-115 + 5-azacitidine combination', 'APG-115 monotherapy']}, {'type': 'DRUG', 'name': '5-azacitidine', 'description': '5-AZA is given at 75 mg/m˄2/d subcutaneously daily on Day 1-7 every 28 days', 'armGroupLabels': ['APG-115 + 5-azacitidine combination'], 'otherNames': ['Vidaza', 'Azadine']}]","Inclusion Criteria: 1. Patients with a diagnosis of histologically confirmed relapsed or refractory AML, CMML, or high-risk MDS (overall revised international prognostic scoring system (IPSS-R) score \> 3, including intermediate, high, or very high risk) by World Health Organization (WHO) classification for which no available standard therapies are indicated or anticipated to result in a durable response. 2. Adequate organ function as defined below: 1. Liver function (total bilirubin \< or = 1.5 x upper limit of normal (ULN), aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \<3 x ULN 2. Kidney function (defined as a calculated creatinine clearance ≥ 60 mL/min; determined via urine collection for 24-hour creatinine clearance or by the Cockcroft Gault formula) 3. Known cardiac ejection fraction of \> or = 45% within the past 3 months 3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 4. A negative serum pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial. 5. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or legally authorized representative is required prior to their enrollment on the protocol. 6. Subject must have a projected life expectancy of at least 12 weeks. 7. Subject has a white blood cell count \< 25 × 10˄9/L. Note: Hydroxyurea is permitted to meet this criteria. Exclusion: 1. Pregnant women are excluded. 2. Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 3. Have had leukemia therapy for 14 days prior to starting investigational drug. However, patients with rapidly proliferative disease may receive hydroxyurea as needed until 24 hours prior to starting therapy on this protocol and during the first cycle of study. 4. Have acute promyelocytic leukemia. 5. Active infection requiring systemic antibiotic/antifungal medication, known clinically active hepatitis B or C, or HIV infection. 6. Have received allogeneic hematopoietic stem cell transplant (HSCT) within 12 months prior to the first dose, or who have active/ongoing graft-versus host disease (GVHD), or require continued treatment with systemic immunosuppressive agents (calcineurin inhibitors within 4 weeks prior to the first dose), or received autologous hematopoietic stem cell transplantation within 6 months prior to the first dose. 7. Documented hypersensitivity to any of the components of the therapy program 8. Active, uncontrolled central nervous system (CNS) leukemia will not be eligible. 9. Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use at least 1 form of barrier birth control (such as condom) prior to study entry and for the duration of study participation. 10. Any prior systemic MDM2-p53 inhibitor treatment 11. Any other condition or circumstance that would, in the opinion of the investigator, make the patient unsuitable for participation in the study. 12. History of other malignancies within 2 years prior to study entry, with the exception of: 1. Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of breast 2. Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin 3. Previous malignancy confined and surgically resected (or treated with other modalities) with curative intention: requires discussion with sponsor 13. Failure to have recovered (Grade \> 1) from prior treatment (including chemotherapy, targeted therapy, immunotherapy, experimental agents, radiation, or surgery) 14. Significant screening electrocardiogram (ECG) abnormalities including left bundle branch block, 2nd degree atrioventricular (AV) block type II, 3rd degree block, or corrected QT interval (QTc) ≥470 msec",NA,ALL,NA,"[{'measure': 'Maximum Tolerated Dose', 'description': 'Part I is to assess the safety and tolerability of APG-115 by assessing the dose-limiting toxicity (DLT) of APG-115. End points include: Incidence of DLTs during the first 3 weeks of treatment of each dose cohort; Severity and frequency of any adverse event(s) (AE) and serious adverse event(s) (SAE) based on NCI CTCAE 5.0', 'timeFrame': '28 days'}]",NA 327,NCT02981784,"{'fullName': 'Hospices Civils de Lyon', 'class': 'OTHER'}",Comparative Evaluation of Results of Allogeneic Hematopoietic Stem Cells Versus Ponatinib in CML Patients Carrying a Mutation T315I,COMPLETED,Effective treatment options for chronic myeloid leukemia (CML) or Philadelphia-positive (Ph+) acute lymphoblastic leukemia (ALL) patients with the T315I mutation are few. This study compared overall survival (OS) between CML and Ph+ ALL patients treated with ponatinib versus allogeneic stem cell transplantation (allo-SCT).,['Leukemia'],OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}","[{'type': 'DRUG', 'name': 'Ponatinib (Iclusig®)', 'description': 'Novel tyrosine kinase inhibitor active in patients with an ABL T315I mutation compared to conventional or reduced intensity allogeneic stem cell transplantation.', 'armGroupLabels': ['Ponatinib (PACE trial)']}, {'type': 'PROCEDURE', 'name': 'allogeneic stem cell transplantation', 'armGroupLabels': ['Allogenis stem cell transplantation (EBMT registry)']}]","Inclusion Criteria: * CML any phase with T315I mutation * Ph+ ALL with a T315I mutation * Being treated in the PACE trial according to the criteria of this phase II trial * Or being allogeneic stem cell transplanted with any source of allogeneic cells and after any conditioning regimen. Exclusion Criteria: * Ph negative patients * Patients under 18 years",All 128 T315I+ patients from PACE comprised the ponatinib group of this study. Fifty-six patients from the EBMT database comprised the allo-SCT group,ALL,PROBABILITY_SAMPLE,"[{'measure': 'Overall survival after either allogeneic stem cell transplantation or Ponatinib initiation. (Time between therapeutic intervention and death, in months)', 'timeFrame': 'From date of inclusion until the date of death, assessed up to 180 months'}]",NA 328,NCT02192333,"{'fullName': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}",Survivorship Care in Reducing Symptoms in Young Adult Cancer Survivors,COMPLETED,"This randomized clinical trial studies survivorship care in reducing symptoms in young adult cancer survivors. Survivorship care programs that identify the needs of young adult cancer survivors and ways to support them through the years after treatment may help reduce symptoms, such as pain, fatigue, sleep disturbance, depression, and distress, in young adult cancer survivors.","['Breast Carcinoma', 'Cancer Survivor', 'Depression', 'Fatigue', 'Leukemia', 'Lymphoma', 'Malignant Bone Neoplasm', 'Malignant Digestive System Neoplasm', 'Malignant Female Reproductive System Neoplasm', 'Malignant Male Reproductive System Neoplasm', 'Pain', 'Sleep Disorder', 'Soft Tissue Sarcoma']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'PROCEDURE', 'name': 'Management of Therapy Complications', 'description': 'Receive survivorship care', 'armGroupLabels': ['Arm II (survivorship care)']}, {'type': 'OTHER', 'name': 'Quality-of-Life Assessment', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm II (survivorship care)'], 'otherNames': ['Quality of Life Assessment']}, {'type': 'OTHER', 'name': 'Questionnaire Administration', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm II (survivorship care)']}, {'type': 'BEHAVIORAL', 'name': 'Telephone-Based Intervention', 'description': 'Receive phone-based booster intervention', 'armGroupLabels': ['Arm II (survivorship care)']}]","Inclusion Criteria: * Patients enrolled on phase 1 of the study are eligible (and/or if recruited from tumor registry or clinic follow-up schedules) * Diagnosed with invasive malignancy including: breast, gastrointestinal track, female or male genitourinary system, sarcoma of bone or soft-tissue, leukemia and lymphoma * Treated at one of the Survivorship Centers of Excellence or their community affiliates * Received a therapeutic intervention with at least one of the following modalities: surgery, cytotoxic chemotherapy, biological or targeted agents, radiation therapy (any modality) * Currently between 1.0 and 4.99 years from the completion of active cancer-directed therapy (cytotoxic chemotherapy, radiation therapy and/or definitive surgical intervention) * Patient must still be in active follow-up: seen for a follow-up visit in the participating center at least once in the 3 years prior to enrollment and/or scheduled to be seen for follow-up in the next 6 months (i.e. in active follow-up) * May be receiving ""maintenance"" therapy that has a goal of prevention of recurrence but there should be no expectations for further active treatment * Able to read and speak English adequate to complete the patient-reported outcomes (PRO) assessment Exclusion Criteria: * Prior visit to a survivorship clinic or previously provided with a treatment summary and care plan",NA,ALL,NA,"[{'measure': 'Mean of the two z scores of the two highest scores for the symptoms that determined the participant\'s eligibility as ""high need"" assessed using patient-reported outcomes (PRO) survey', 'description': 'Mean scores for the primary outcome measures will be compared between the study using standard methods. Two-sided significance levels will be set at an alpha level of 0.05.', 'timeFrame': 'At 6 months'}]","[{'measure': 'Barriers to health care assessed using the patient-reported outcomes (PRO) survey', 'description': 'Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Change in depression assessed using the patient-reported outcomes (PRO) survey', 'description': 'Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available. The mean differences in other continuous valued outcomes will be evaluated using standard t-tests or linear regression models, as appropriate.', 'timeFrame': 'Baseline to up to 12 months'}, {'measure': 'Change in distress assessed using the patient-reported outcomes (PRO) survey', 'description': 'Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available. The mean differences in other continuous valued outcomes will be evaluated using standard t-tests or linear regression models, as appropriate.', 'timeFrame': 'Baseline to up to 12 months'}, {'measure': 'Change in fatigue assessed using the patient-reported outcomes (PRO) survey', 'description': 'Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available. The mean differences in other continuous valued outcomes will be evaluated using standard t-tests or linear regression models, as appropriate.', 'timeFrame': 'Baseline to up to 12 months'}, {'measure': 'Change in pain assessed using the patient-reported outcomes (PRO) survey', 'description': 'Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available. The mean differences in other continuous valued outcomes will be evaluated using standard t-tests or linear regression models, as appropriate.', 'timeFrame': 'Baseline to up to 12 months'}, {'measure': 'Change in sleep assessed using the patient-reported outcomes (PRO) survey', 'description': 'Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available. The mean differences in other continuous valued outcomes will be evaluated using standard t-tests or linear regression models, as appropriate.', 'timeFrame': 'Baseline to up to 12 months'}, {'measure': 'Confidence in survivorship information assessed using the patient-reported outcomes (PRO) survey', 'description': 'Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.', 'timeFrame': 'Up to 12 months'}, {'measure': 'General health assessed using the patient-reported outcomes (PRO) survey', 'description': 'Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Health behaviors assessed using the patient-reported outcomes (PRO) survey', 'description': 'Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Health care utilization assessed using the patient-reported outcomes (PRO) survey', 'description': 'Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Medications assessed using the patient-reported outcomes (PRO) survey', 'description': 'Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Mood and worries assessed using the patient-reported outcomes (PRO) survey', 'description': 'Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Musculoskeletal symptoms assessed using the patient-reported outcomes (PRO) survey', 'description': 'Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Neuropathy assessed using the patient-reported outcomes (PRO) survey', 'description': 'Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Post-traumatic stress assessed using the patient-reported outcomes (PRO) survey', 'description': 'Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Quality of life assessed using the patient-reported outcomes (PRO) survey', 'description': 'Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Reclassification of subject from high need to low need', 'description': 'Reclassification of subject from high need to low need is defined as the high need subject no longer has scores above the cut-off level on 2 or more symptoms scales (depression, distress, insomnia, fatigue, pain) assessed using the PRO survey. The 5 symptom scales are categorized based on the following cut points to define ""high need"": pain score \\>= 5, fatigue score \\>= 3, insomnia score of no insomnia, distress score \\> 1.1, and depression score \\>= 10.', 'timeFrame': 'At 6 months'}, {'measure': 'Reproductive health assessed using the patient-reported outcomes (PRO) survey', 'description': 'Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Sexual function assessed using the patient-reported outcomes (PRO) survey', 'description': 'Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.', 'timeFrame': 'Up to 12 months'}, {'measure': 'Social support assessed using the patient-reported outcomes (PRO) survey', 'description': 'Will be examined in an exploratory manner, utilizing similar methods as those described for the primary endpoints for dichotomized versions of the outcomes, using standard cutoff values, where available.', 'timeFrame': 'Up to 12 months'}]" 329,NCT07605949,"{'fullName': 'UNC Lineberger Comprehensive Cancer Center', 'class': 'OTHER'}","Revumenib, Azacitidine, and VENetoclax in Newly Diagnosed KMT2A-Rearranged AML",NOT_YET_RECRUITING,"This study is testing a new treatment combination called RAVEN, which includes revumenib, azacitidine, and venetoclax, in patients who are newly diagnosed with a specific type of acute myeloid leukemia (AML) called KMT2A- translocated AML. People with this type of AML often have poor outcomes, so new treatments are needed that may work better and cause fewer side effects. The study has two parts: 1. Induction Phase: Patients will receive treatment for up to 3 cycles. Each cycle lasts 28 days. The goal is to help the leukemia go into remission. 2. Continuation Phase: After remission and blood count recovery, patients will continue treatment until the leukemia returns, side effects become too severe, the patient receives a stem cell transplant, or another reason to stop treatment occurs. Patients who receive an allogeneic stem cell transplant (stem cells from a donor) may also join a separate part of the study to test revumenib as maintenance treatment after transplant.",['Leukemia Acute Myeloid'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The study uses a structured, stepwise design. All participants begin with induction therapy. Patients who do not respond discontinue treatment, while those who achieve remission proceed to the continuation phase. During continuation therapy, patients may either remain on treatment until relapse/progression or proceed to allogeneic stem cell transplant.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Azacitidine', 'description': 'Subcutaneous or IV over 10-40 minutes on Days 1-7 or days 1-5, 8-9, in every 28 days, for 3 cycles.', 'armGroupLabels': ['KMT2A-translocated (KMT2Ar) acute myeloid leukemia (AML)']}, {'type': 'DRUG', 'name': 'Venetoclax', 'description': 'Per oral, daily in combination with posaconazole for 1- 28 days, for 3 cycles.', 'armGroupLabels': ['KMT2A-translocated (KMT2Ar) acute myeloid leukemia (AML)']}, {'type': 'DRUG', 'name': 'Revumenib', 'description': 'Per oral,12 hours in combination with posaconazole for 1- 28 days , for 3 cycles.', 'armGroupLabels': ['KMT2A-translocated (KMT2Ar) acute myeloid leukemia (AML)']}]","Inclusion Criteria: * Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. * Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee. * Age 18-65 years at the time of consent. * Untreated AML based on 2022 WHO or ICC criteria with KMT2A translocation by local standard diagnostic testing by cytogenetics/karyotype or FISH Exclusion Criteria: * Isolated myeloid sarcoma (patients must have blood or marrow involvement with AML to enter study) * Active central nervous system (CNS) involvement by AML. Of note, patients are eligible if CNS leukemia is in remission at the time of study entry. * Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).",NA,ALL,NA,"[{'measure': 'Complete remission rate', 'description': 'Complete remission (CR) rate will be determined as defined in the protocol Response Criteria. Bone marrow blasts \\< 5%; absence of circulating blasts; absence of extramedullary disease; ANC \\> 1.0 × 109/L (1,000/μL); platelet count ≥ 100 × 109/L (100 000/μL)', 'timeFrame': 'Up to 3 months'}]","[{'measure': 'Composite Complete remission', 'description': 'Composite Complete remission (CCr) rate defined as complete remission (CR) + complete remission with incomplete recovery (CRi) + complete remission with partial hematologic recovery (CCr)= CR + CRi + CRh.\n\nCR: Bone marrow blasts \\< 5%; absence of circulating blasts; absence of extramedullary disease; ANC \\> 1.0 × 109/L (1,000/μL); platelet count ≥ 100 × 109/L (100 000/μL) CRi = All CR criteria except for residual neutropenia \\<1.0 × 109/L (1,000/μL) or thrombocytopenia \\< 100× 109/L (100 000/μL CRh: ANC ≥ 0.5 × 109/L (500/μL) and platelet count ≥50 × 109/L (50 000/μL), otherwise all other CR criteria met.', 'timeFrame': 'Up to 3 months'}, {'measure': 'Duration of complete remission (DOCR)', 'description': 'Duration of complete remission (DOCR) will be defined as the time from the first complete remission to hematological relapse or death from any cause. CR: Bone marrow blasts \\< 5%; absence of circulating blasts; absence of extramedullary disease; ANC \\> 1.0 × 109/L (1,000/μL); platelet count ≥ 100 × 109/L (100 000/μL)', 'timeFrame': 'Up to 2 years'}, {'measure': 'Event-free survival', 'description': 'Event-free survival will be determined as time until treatment failure (lack of CRc), relapse or death.', 'timeFrame': 'Up to 2 years'}, {'measure': 'The number of treatment-emergent adverse events', 'description': 'The number of treatment-emergent special interest (AESIs) and serious adverse events (SAEs), and clinically significant test results will be submitted.', 'timeFrame': 'Up to 2 years'}, {'measure': 'Relapse-free survival', 'description': 'Relapse-free survival will be determined as time to relapse or death after achieving CR.', 'timeFrame': 'Up to 2 years'}, {'measure': 'Overall survival', 'description': 'Overall survival will be determined as time until date of death from any cause.', 'timeFrame': 'Up to 2 years'}, {'measure': 'MRD-Negative (MRD<0.02%) complete remission', 'description': 'MRD-Negative (MRD\\<0.02%) complete remission rate will be assessed from bone marrow samples using Hematologics Flow MRD assay after 2 cycles of RAVEN treatment', 'timeFrame': 'Up to 3 months'}]" 330,NCT03446638,"{'fullName': 'University of Florida', 'class': 'OTHER'}",iCare 2: Personalized Genomic Mutation Informed Treatment of Patients With Myelodysplastic Syndromes,WITHDRAWN,"This open-label, randomized, parallel group phase II study will investigate the efficacy of computational biology-informed treatment vs. standard of care treatment for patients with relapsed or refractory myelodysplastic syndromes (MDS).",['Myelodysplastic Syndromes'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'FDA-approved drug or combination of drugs', 'description': 'Patients assigned to this arm will receive an FDA-approved drug or combination of drugs. Dosing and treatment schedule will follow the package insert for the selected drug(s).', 'armGroupLabels': ['Computational Biology-Informed Treatment']}, {'type': 'DRUG', 'name': 'FLAG induction', 'description': 'Patients will receive 30 mg/m2 per day intravenously of fludarabine for 5 days and 2000 mg/m2 per day intravenously of cytarabine for 5 days. 5 mg/kg per day of granulocyte colony stimulating factor (G-CSF) may be given subcutaneously beginning on Day 1 of each treatment until absolute granulocyte count \\> 500/ microliter for 3 days.', 'armGroupLabels': ['Standard of Care Treatment']}, {'type': 'DRUG', 'name': '7 + 3 induction', 'description': 'Patients will receive 100-200 mg/m2 per day intravenously of cytarabine for 7 days, plus either 45-60 mg/m2 per day intravenously of daunorubicin or 9-12 mg/m2 per day intravenously of idarubicin for 3 days.', 'armGroupLabels': ['Standard of Care Treatment']}, {'type': 'DRUG', 'name': 'Low-dose cytarabine', 'description': 'Patients will receive 20 mg/m2 per day subcutaneously of cytarabine for 10 days every 28 days.', 'armGroupLabels': ['Standard of Care Treatment']}, {'type': 'OTHER', 'name': 'Supportive care alone', 'description': 'Patients will receive one or more of the following: blood product transfusions, antibiotics, granulocyte colony-stimulating factor (G-CSF), erythropoietic stimulating factors, and iron chelation.', 'armGroupLabels': ['Standard of Care Treatment']}, {'type': 'DEVICE', 'name': 'Computational biology simulations software', 'description': ""Genetic testing results for each patient randomized to this arm will be used by a computational biology simulations software program to generate a personalized map of dysregulated metabolic pathways contributing to the patient's disease. This map will then be used to digitally screen for potentially therapeutic FDA-approved drugs or drug combinations to target the dysregulated metabolic pathways."", 'armGroupLabels': ['Computational Biology-Informed Treatment']}]","Inclusion Criteria: * Provide written informed consent * Must be at least 18 years of age * Diagnosis of MDS, as defined by World Health Organization (WHO) 2008, that has relapsed after any duration of time from last best response or is refractory to induction therapy (defined as 4 cycles of treatment with a hypomethylating agent, 2 cycles of lenalidomide, 1 cycle of low intensity chemotherapy, or 1 cycle of high intensity chemotherapy) * ECOG performance status of 0-2 * Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) may participate, provided they meet the following conditions: 1. Must agree to use physician-approved contraceptive methods (e.g., abstinence, intrauterine device, oral contraceptive, double barrier device) throughout the study and for 3 months following the last dose of study treatment; and 2. Must have a negative serum or urine pregnancy test within 7 days prior to beginning treatment on this trial * Males with female partners of child-bearing potential must agree to use physician approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for 6 months following the last dose of study treatment. Exclusion Criteria: * Must not have acute myeloid leukemia (AML), as defined by WHO 2008 * Pregnant and nursing subjects are excluded because the effects of study treatments on a fetus or nursing child are unknown * Must not have had treatment with any anti-cancer therapy (investigational or standard) within the previous 21 days prior to the first dose of study drug or less than full recovery (no worse than CTCAE v4.0 grade 1) from the clinically significant toxic effects of that treatment.",NA,ALL,NA,"[{'measure': 'Difference in overall response, as measured by International Working Group (IWG) 2006 criteria for response in MDS', 'description': 'Difference in overall response (number of patients who achieve complete response, partial response, stable disease, or hematologic improvement per IWG 2006 criteria) between patients treated with computational biology-informed therapy vs. those treated with standard of care regimens', 'timeFrame': '4 months'}]","[{'measure': 'Difference in safety and feasibility, as measured by CTCAE v4.0 criteria', 'description': 'Difference in safety and feasibility, as measured by CTCAE v4.0 criteria, between patients treated with computational biology-informed treatment and those who receive a standard of care regimen', 'timeFrame': '5 months'}, {'measure': 'Difference in time to death between patients treated with computational biology-informed therapy and those treated with standard of care regimens', 'timeFrame': '3 years'}, {'measure': 'Difference in time to progression to acute myeloid leukemia (AML), as measured by IWG 2006 criteria for response in MDS, between patients treated with computational biology-informed therapy and those treated with standard of care regimens', 'timeFrame': '4 months'}, {'measure': 'Difference in time to disease relapse, as measured by IWG 2006 criteria for response in MDS, between patients treated with computational biology-informed therapy and those treated with standard of care regimens', 'timeFrame': '4 months'}, {'measure': 'Difference in time to best response, as measured by IWG 2006 criteria for response in MDS, between patients treated with computational biology-informed therapy and those treated with standard of care regimens', 'timeFrame': '4 months'}, {'measure': 'Difference in change in myeloblast percentage between patients treated with computational biology-informed therapy and those treated with standard of care regimens', 'timeFrame': '4 months'}, {'measure': 'Difference in blood transfusion rate between patients treated with computational biology-informed therapy and those treated with standard of care regimens', 'timeFrame': '7 months'}]" 331,NCT06440135,"{'fullName': 'Massachusetts General Hospital', 'class': 'OTHER'}",Ziftomenib Maintenance Post Allo-HCT,RECRUITING,"The purpose of this study is to test the safety, effects, and recommended dose of an investigational drug, ziftomenib, in addition to the standard treatment on blood cancer with Allogeneic Hematopoietic Cell Transplantation (allo-HCT). This study plans to learn more about ziftomenib, which targets and inhibits negative interactions within cancer cells related to AML, when given after allo-HCT, to determine if it improves outcomes following allo-HCT. The name of the study drug involved in this study is: • Ziftomenib","['Acute Myeloid Leukemia', 'Acute Myeloid Leukemia in Remission', 'NPM1 Mutation', 'KMT2A Rearrangement']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Ziftomenib', 'description': 'Taken orally once per day', 'armGroupLabels': ['Ziftomenib'], 'otherNames': ['KO-539']}]","Inclusion Criteria: * 18 years or older. * Pathologically confirmed diagnosis of acute myeloid leukemia (AML). * Complete remission (CR) or complete remission with incomplete count recovery (CRi) at screening. * Complete remission (CR): * no circulating blasts in peripheral blood and \<5% blasts in bone marrow * no extramedullary disease * platelet count ≥100 x 10(9)/L and/or absolute neutrophil count ≥1000/µL * Complete remission with incomplete count recovery (CRi): * no circulating blasts in peripheral blood and \<5% blasts in bone marrow * no extramedullary disease * platelet count \<100 x 10(9)/L and/or absolute neutrophil count \<1000/µL * Presence of at least one of the following molecular mutations: * KMT2A rearrangement * Eligibility and enrollment will be based on local mutational testing. * The presence of a KMT2A rearrangement (excluding partial tandem duplication \[PTD\]) at the time of initial diagnosis or any other time thereafter is sufficient. * Participants may receive additional treatment for AML between consent and transplant. * NPM1 mutation * Eligibility and enrollment will be based on local mutational testing. * For participants being transplanted in CR1, the presence of a NPM1 mutation at screening is necessary for the purposes of eligibility. * For participants being transplanted in greater than or equal to CR2, the presence of a NPM1 mutation at the time of consent is not necessary for eligibility and its presence at the time of initial diagnosis or any other time thereafter is sufficient. * Participants may receive additional treatment for AML between consent and transplant. * Treatment with a menin inhibitor prior to transplant is permitted. However, patients who experienced AML relapse or progression while being treated with a menin inhibitor prior to transplant are ineligible. * Will undergo first allogeneic HCT for their malignancy. * Transplantation will be performed with the use of conventional myeloablative (MAC) or reduced intensity conditioning (RIC). * HCT Donor will be one of the following: * 5/6 or 6/6 (HLA-A, B, DR) matched related donor * 7/8 or 8/8 (HLA-A, B, DR, C) matched unrelated donor. Matching in the unrelated setting must be at the allele level. * Haploidentical related donor, defined as ≥ 3/6 (HLA-A, B, DR) matched * ≥ 4/6 (HLA-A, B, DR) umbilical cord blood (UCB). Matching in the UCB setting is at the antigen level. Recipients may receive either one or two UCB units. In the case of 2 UCB units, both units must have been at least 4/6 matched with the recipient. * Any non-investigational GVHD prophylaxis regimen is allowed. * Eastern Cooperative Oncology Group (ECOG) performance status 0-2. * Participants must have normal organ and function as defined below: * AST (SGOT), ALT (SGPT) and Alkaline phosphatase \< 3x institutional upper limit of normal (ULN) * Total bilirubin \< 1.5 x institutional ULN (with the exception of subjects with a history of Gilbert's syndrome, for which the total bilirubin must be \< 5 x ULN) * Calculated creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula) * LVEF must be ≥50%, as measured by MUGA scan or echocardiogram. * Female patients of childbearing potential must have a negative pregnancy test, as measured by serum or urine testing. * The effects of ziftomenib on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during the entire study treatment period and through 6 months after the last dose of treatment. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * History of other malignancy(ies) unless * the participant has been disease-free for at least 2 years and is deemed by the investigator to be at low risk of recurrence of that malignancy, or * the cancer has been deemed indolent with no progression over the last 2 years, and deemed by the investigator to be at low risk for further progression during the course of study and follow-up * the only prior malignancy was cervical cancer in situ and/or basal cell or squamous cell carcinoma of the skin * Known diagnosis of active hepatitis B or hepatitis C * Current or history of congestive heart failure New York Heart Association (NHYA) class 3 or 4, or any history of documented diastolic or systolic dysfunction (LVEF \< 50%, as measured by multigated acquisition (MUGA) scan or echocardiogram) * Current or history of ventricular or life-threatening arrhythmias or diagnosis of long-QT syndrome * Systemic uncontrolled infection * Known dysphagia, short-gut syndrome, gastroparesis, or other condition(s) that limits the ingestion or gastrointestinal absorption of drugs administered orally * Uncontrolled hypertension (systolic blood pressure \[BP\] \> 180 mmHg or diastolic BP \> 100 mmHg) * QTc interval (i.e., Friderica's correction \[QTcF\]) ≥ 480 ms or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) at screening * Uncontrolled intercurrent illness that would limit compliance with study requirements. * Persons who are pregnant or lactating.",NA,ALL,NA,"[{'measure': 'Maximum Tolerated Dose (Dose Escalation)', 'description': 'Defined as the highest dose level at which 1 or 0 of 6 patients experience a Dose Limiting Toxicity (DLT). Toxicities will be graded and documented according to NCI CTCAE version 5.0.\n\nA non-hematologic DLT is any grade 3 adverse event (AE) lasting \\>72 hours or any grade greater than or equal to 4 AE that is at least possibly related to the study drug with exceptions.\n\nAny ≥ grade 2 non-hematologic toxicity that the participant finds intolerable or renders the participant unable to take 75% or more of the assigned doses (e.g. multiple dose interruptions) during the first cycle will be considered a DLT.', 'timeFrame': '28 days'}]","[{'measure': 'Occurrence of ziftomenib-related toxicities', 'description': 'Defined as ziftomenib-related toxicities detected and categorized according to severity. Toxicities will be graded and documented according to NCI CTCAE version 5.0.', 'timeFrame': 'Day 0 to last treatment dose, up to 336 days'}, {'measure': 'Incidence of acute Graft versus Host Disease (GVHD) during treatment', 'description': 'Defined as cumulative incidence of acute GVHD from start of ziftomenib in subjects receiving maintenance therapy after allogeneic HCT. Clinical stage and grade of acute graft-versus-host-disease (GVHD) is based on MAGIC Criteria (Harris 2016). The incidence of acute GVHD grade II-IV and grade III-IV will be estimated for each treatment group using the cumulative incidence estimate, treating death prior to acute GVHD as a competing event.', 'timeFrame': 'Day 0 to end of treatment visit, up to 366 days (336 days of treatment + 30 days end of treatment)'}, {'measure': 'Incidence of chronic Graft versus Host Disease (GVHD) during treatment', 'description': 'The incidence of chronic GVHD will be estimated for each treatment group using the cumulative incidence estimate, treating death prior to chronic GVHD as a competing event. Chronic GVHD will be assessed as per the 2014 National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease (Jagasia 2015).', 'timeFrame': 'Day 0 to end of treatment visit, up to 366 days (336 days of treatment + 30 days end of treatment)'}, {'measure': 'Non-relapse mortality (NRM)', 'description': 'The incidence of non-relapse mortality will be estimated for each treatment group using the cumulative incidence estimate, treating disease relapse or progression as a competing event. AML treatment response is based on 2022 ELN recommendations (Dohner 2022).', 'timeFrame': 'Day 0 to end of treatment visit, up to 1086 days (336 days of treatment + 30 days end of treatment + 24 months follow-up))'}, {'measure': 'Leukemia-Free Survival (LFS)', 'description': 'Leukemia-Free Survival is defined as the time from first dose of study drug to the earlier of leukemia relapse or death due to any cause. Participants alive and leukemia-free are censored at the date of last disease evaluation. AML treatment response is based on 2022 ELN recommendations (Dohner 2022).', 'timeFrame': 'Day 0 to end of treatment visit, up to 1086 days (336 days of treatment + 30 days end of treatment + 24 months follow-up))'}, {'measure': 'Overall Survival (OS)', 'description': 'Overall Survival is defined as the time from first dose of study drug to the date of death due to any cause. Participants who are alive at the analysis / cutoff date will be censored at the last contact date.', 'timeFrame': 'Day 0 to end of treatment visit, up to 1086 days (336 days of treatment + 30 days end of treatment + 24 months follow-up))'}, {'measure': 'GVHD-free, relapse-free survival (GRFS)', 'description': 'GVHD, relapse-free survival is defined as the time from first dose of study drug to the earlier of grade III-IV acute GVHD, chronic GVHD requiring systemic immune suppression, leukemia relapse or death due to any cause. Participants alive and without one of these three events are censored at the date of last disease evaluation. AML treatment response is based on 2022 ELN recommendations (Dohner 2022).', 'timeFrame': 'Day 0 to end of treatment visit, up to 1086 days (336 days of treatment + 30 days end of treatment + 24 months follow-up))'}, {'measure': 'Proportion of successfully screened that do not reach study treatment', 'description': 'Defined as proportion of subjects who successfully screen for study prior to transplantation but who do not reach the maintenance phase due to transplant-related morbidity or mortality.', 'timeFrame': '30 days (Screening to Day 0)'}, {'measure': 'Plasma Concentration of ziftomenib and metabolites', 'description': 'Characterize the pharmacokinetics (PK) of ziftomenib and metabolites when ziftomenib is given as maintenance therapy after allogeneic HCT by measuring the plasma concentration of ziftomenib and metabolites.', 'timeFrame': 'Up to 62 days (Cycle 1 Day 1 - Cycle 3 Day 1 (+/- 5 days)'}, {'measure': 'Plasma Concentration of oral immunosuppressive agents and ziftomenib', 'description': 'Assess PK drug-drug interaction between ziftomenib and oral systemic immunosuppressive agents performed by measuring plasma concentrations.', 'timeFrame': 'Up to 34 days (Day -7 to -14 after HCT prior to co-administration and on Cycle 1 Day 1 and Day 15 (+/- 5 days) of co-administration)'}, {'measure': 'Number of Participants with Treatment-Related Adverse Events', 'description': ""The severity/intensity of adverse events will be graded based upon the subject's symptoms according to the current active minor version of the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0). All participants will be followed and assessed for adverse events 30 days after removal from protocol therapy or until death, whichever occurs first."", 'timeFrame': 'Day 0 to end of treatment visit, up to 366 days (336 days of treatment + 30 days end of treatment)'}]" 332,NCT01743989,"{'fullName': 'Novartis', 'class': 'INDUSTRY'}",A Randomized Phase III Study to Assess the Effect of a Longer Duration of Consolidation Treatment With Nilotinib on TFR in CP CML.,COMPLETED,"This study aimed to assess the optimal duration of nilotinib 300 mg twice daily (BID) consolidation treatment in patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML), in order that patients remained in treatment-free remission (≥MR4.0) without molecular relapse 12 months after starting the Treatment-Free Remission (TFR) phase.",['Philadelphia Chromosome Positive (PH+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'All participants received 24 months of study treatment. After 24 months of treatment, eligible participants (i.e. those deemed to have achieved sustained molecular response) were randomized to one of the two study arms on a continued open-label basis.\n\nParticipants not achieving sustained molecular response after 24 months of treatment were not randomized but remained in the study until the 5-year study period was completed (Not randomized arm).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Nilotinib', 'description': 'Participants received a daily oral nilotinib dose of 300 mg BID, given as two 150 mg capsules BID.', 'armGroupLabels': ['Nilotinib 24-month treatment', 'Nilotinib 36-month treatment', 'Not randomized'], 'otherNames': ['AMN107']}]","Key Inclusion Criteria: * Confirmed diagnosis of chronic phase Ph+ CML * Previous first-line treatment with imatinib for a minimum of 2 years; * Patient in complete cytogenetic response; Key Exclusion Criteria: * Previous achievement of MR4.0 at study entry; * Previous treatment with other target cells inhibitors other than imatinib; * Patients with any history of detectable atypical Leukemia transcripts or patients with detectable atypical leukemia transcripts at screening; * Previous anticancer agents for Chronic myeloid leukemia other than imatinib except for cytoreduction; * Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol; * History of other active malignancies within the 5 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively; * Patients who have not recovered from prior surgery; * Treatment with other investigational agents within 4 weeks of Day 1; * Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug Other inclusion/exclusion criteria might apply.",NA,ALL,NA,"[{'measure': 'Percentage of Participants Who Remained in Treatment Free Remission (TFR) Without Molecular Relapse 12 Months After Entering the TFR Phase', 'description': 'Number of participants who remained in TFR (≥molecular response (MR) 4.0) without molecular relapse 12 months after entering the TFR phase (without re-starting nilotinib therapy) divided by the number of participants who entered the TFR phase and multiplied by 100.\n\nMolecular relapse during TFR is defined as the loss of major molecular response (MMR), or the confirmed loss of MR4.0 (defined by 3 consecutive tests less than MR4.0 assessed at 3 consecutive visits during TFR phase). Participants dropping out early from the study during the TFR phase were considered as unsuccessful TFR.\n\nConfidence intervals were calculated based on the Exact Clopper-Pearson method. MMR is defined as≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1% BCR-ABL.\n\nMR4.0 is defined as either detectable disease≤0.01% BCR-ABL or undetectable disease in cDNA with≥10,000 ABL transcripts', 'timeFrame': '12 months after entering the TFR phase, which is after 36 months from study treatment start for Nilotinib 24-month treatment arm and after 48 months from study treatment start for Nilotinib 36-month treatment arm'}]","[{'measure': 'Cumulative Incidence of MMR During the Pre-randomization Induction/Consolidation Phase Among Participants Without That Response at Study Entry', 'description': 'Number of participants who were in MMR during pre-randomization induction/consolidation phase divided by the number of participants without that response at baseline and multiplied by 100.\n\nConfidence intervals were calculated based on the Exact Clopper-Pearson method. MMR is defined as ≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1% BCR-ABL.', 'timeFrame': 'From baseline up to 24 months after study treatment start'}, {'measure': 'Cumulative Incidence of MMR During the Post-randomization Consolidation Phase Among Participants Without That Response at Study Entry', 'description': 'Number of participants who were in MMR during post-randomization consolidation phase divided by the number of participants without that response at baseline and multiplied by 100. Post-randomization consolidation phase corresponded to the 12-month additional treatment (after randomization) for Nilotinib 36-month treatment arm.\n\nConfidence intervals were calculated based on the Exact Clopper-Pearson method. MMR is defined as ≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1% BCR-ABL.', 'timeFrame': 'From randomization (month 24 after study treatment start) up to 36 months after study treatment start'}, {'measure': 'Cumulative Incidence of MR4.0 During the Pre-randomization Induction/Consolidation Phase Among Participants Without That Response at Study Entry', 'description': 'Number of participants who were in MR4.0 during the pre-randomization induction/consolidation phase divided by the number of participants without that response at baseline and multiplied by 100.\n\nConfidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.0 is defined as either detectable disease ≤0.01% BCR-ABL IS or undetectable disease in cDNA with ≥10,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL)', 'timeFrame': 'From baseline up to 24 months after study treatment start'}, {'measure': 'Cumulative Incidence of MR4.0 During the Post-randomization Consolidation Phase Among Participants Without That Response at Study Entry', 'description': 'Number of participants who were in MR4.0 during the post-randomization consolidation phase divided by the number of participants without that response at baseline and multiplied by 100. Post-randomization consolidation phase corresponded to the 12-month additional treatment (after randomization) for Nilotinib 36-month treatment arm.\n\nConfidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.0 is defined as either detectable disease ≤0.01% BCR-ABL IS or undetectable disease in cDNA with ≥10,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL)', 'timeFrame': 'From randomization (month 24 after study treatment start) up to 36 months after study treatment start'}, {'measure': 'Cumulative Incidence of MR4.5 During the Pre-randomization Induction/Consolidation Phase Among Participants Without That Response at Study Entry', 'description': 'Number of participants who were in MR4.5 during the pre-randomization induction/consolidation phase divided by the number of participants without that response at baseline and multiplied by 100.\n\nConfidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.5 is defined as either detectable disease ≤ 0.0032% BCR-ABL IS; or undetectable disease within cDNA with ≥ 32,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL)', 'timeFrame': 'From baseline up to 24 months after study treatment start'}, {'measure': 'Cumulative Incidence of MR4.5 During the Post-randomization Consolidation Phase Among Participants Without That Response at Study Entry', 'description': 'Number of participants who were in MR4.5 during the post-randomization consolidation phase divided by the number of participants without that response at baseline and multiplied by 100. Post-randomization consolidation phase corresponded to the 12-month additional treatment (after randomization) for Nilotinib 36-month treatment arm.\n\nConfidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.5 is defined as either detectable disease ≤ 0.0032% BCR-ABL IS; or undetectable disease within cDNA with ≥ 32,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL)', 'timeFrame': 'From randomization (month 24 after study treatment start) up to 36 months after study treatment start'}, {'measure': 'Cumulative Incidence of MMR During the Pre-randomization Induction/Consolidation Phase', 'description': 'Number of participants who were in MMR during the pre-randomization induction/consolidation phase divided by the number of enrolled participants and multiplied by 100.\n\nConfidence intervals were calculated based on the Exact Clopper-Pearson method. MMR is defined as ≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1% BCR-ABL.', 'timeFrame': 'From baseline up to 24 months after study treatment start'}, {'measure': 'Cumulative Incidence of MMR During the Post-randomization Consolidation Phase', 'description': 'Number of participants who were in MMR during the post-randomization consolidation phase divided by the number of enrolled participants and multiplied by 100. Post-randomization consolidation phase corresponded to the 12-month additional treatment (after randomization) for Nilotinib 36-month treatment arm.\n\nConfidence intervals were calculated based on the Exact Clopper-Pearson method. MMR is defined as ≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1% BCR-ABL.', 'timeFrame': 'From randomization (month 24 after study treatment start) up to 36 months after study treatment start'}, {'measure': 'Cumulative Incidence of MR4.0 During the Pre-randomization Induction/Consolidation Phase', 'description': 'Number of participants who were in MR4.0 during the pre-randomization induction/consolidation phase divided by the number of enrolled participants and multiplied by 100.\n\nConfidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.0 is defined as either detectable disease ≤0.01% BCR-ABL IS or undetectable disease in cDNA with ≥10,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL)', 'timeFrame': 'From baseline up to 24 months after study treatment start'}, {'measure': 'Cumulative Incidence of MR4.0 During the Post-randomization Consolidation Phase', 'description': 'Number of participants who were in MR4.0 during the post-randomization consolidation phase divided by the number of enrolled participants and multiplied by 100. Post-randomization consolidation phase corresponded to the 12-month additional treatment (after randomization) for Nilotinib 36-month treatment arm.\n\nConfidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.0 is defined as either detectable disease ≤0.01% BCR-ABL IS or undetectable disease in cDNA with ≥10,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL)', 'timeFrame': 'From randomization (month 24 after study treatment start) up to 36 months after study treatment start'}, {'measure': 'Cumulative Incidence of MR4.5 During the Pre-randomization Induction/Consolidation Phase', 'description': 'Number of participants who were in MR4.5 during the pre-randomization induction/consolidation phase divided by the number of enrolled participants and multiplied by 100.\n\nConfidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.5 is defined as either detectable disease ≤ 0.0032% BCR-ABL IS; or undetectable disease within cDNA with ≥ 32,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL)', 'timeFrame': 'From baseline up to 24 months after study treatment start'}, {'measure': 'Cumulative Incidence of MR4.5 During the Post-randomization Consolidation Phase', 'description': 'Number of participants who were in MR4.5 during the post-randomization consolidation phase divided by the number of enrolled participants and multiplied by 100. Post-randomization consolidation phase corresponded to the 12-month additional treatment (after randomization) for Nilotinib 36-month treatment arm.\n\nConfidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.5 is defined as either detectable disease ≤ 0.0032% BCR-ABL IS; or undetectable disease within cDNA with ≥ 32,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL)', 'timeFrame': 'From randomization (month 24 after study treatment start) up to 36 months after study treatment start'}, {'measure': 'Percentage of Participants Who Were in MMR During TFR Phase', 'description': 'Number of participants who were in MMR at selected timepoints divided by the number of participants in the TFR phase and multiplied by 100. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotinib 24-month treatment arm had a maximum of 36 months of TFR phase.\n\nConfidence intervals were calculated based on the Exact Clopper-Pearson method. MMR is defined as ≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1% BCR-ABL.', 'timeFrame': 'From Month 1 after entering TFR phase up to 24 months after entering TFR phase for Nilotinib 36-month treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-month treatment arm'}, {'measure': 'Percentage of Participants Who Were in MR4.0 During the TFR Phase', 'description': 'Number of participants who were in MR4.0 at selected timepoints divided by the number of participants in the TFR phase and multiplied by 100. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotinib 24-month treatment arm had a maximum of 36 months of TFR phase.\n\nConfidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.0 is defined as either detectable disease ≤0.01% BCR-ABL IS or undetectable disease in cDNA with ≥10,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL)', 'timeFrame': 'From Month 1 after entering TFR phase up to 24 months after entering TFR phase for Nilotininb 36-months treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-months treatment arm'}, {'measure': 'Percentage of Participants Who Were in MR4.5 During the TFR Phase', 'description': 'Number of participants who were in MR4.5 at selected timepoints divided by the number of participants in the TFR phase and multiplied by 100. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotinib 24-month treatment arm had a maximum of 36 months of TFR phase.\n\nConfidence intervals were calculated based on the Exact Clopper-Pearson method. MR4.5 is defined as either detectable disease ≤ 0.0032% BCR-ABL IS; or undetectable disease within cDNA with ≥ 32,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL)', 'timeFrame': 'From Month 1 after entering TFR phase up to 24 months after entering TFR phase for Nilotininb 36-month treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-month treatment arm'}, {'measure': 'BCR-ABL Ratio (Expressed as a Percentage) During the Induction/Consolidation Phase', 'description': 'BCR-ABL transcript ratio by international scale (IS) (expressed as a percentage) during the induction/consolidation phase. Participants randomized to Nilotinib 36-month treatment arm had 12-month additional consolidation phase (post-randomization).', 'timeFrame': 'From baseline up to 24 months after study treatment start for Nilotinib 24-month treatment arm and Not randomized participants; and up to 36 months after study treatment start for Nilotinib 36-month treatment arm.'}, {'measure': 'BCR-ABL Ratio (Expressed as a Percentage) During the TFR Phase', 'description': 'BCR-ABL/control gene (ABL) transcript ratio by international scale (IS) (expressed as a percentage) during the TFR phase. BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes.\n\nParticipants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotinib 24-month treatment arm had a maximum of 36 months of TFR phase.', 'timeFrame': 'From Month 1 after entering TFR phase up to 24 months after entering TFR phase for Nilotinib 36-month treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-month treatment arm'}, {'measure': 'BCR-ABL Ratio (Expressed as a Percentage) During the Nilotinib Re-treatment Phase', 'description': 'BCR-ABL/control gene (ABL) transcript ratio by international scale (IS) (expressed as a percentage) during the nilotinib re-treatment phase. BCR-ABL is the fusion gene from breakpoint cluster region and Abelson genes.', 'timeFrame': 'From Day 1 after entering the re-treatment phase up to 24 months after entering re-treatment phase for Nilotinib 36-month treatment arm and 36 months after entering the re-treatment phase for Nilotinib 24-month treatment arm'}, {'measure': 'Progression-free Survival (PFS) During the TFR Phase of the Study.', 'description': 'PFS is defined as the time from the date of start of the nilotinib TFR phase to the date of acelerated phase/blast crisis (AP/BC) or death, whichever came first. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotini 24-month treatment arm had a maximum of 36 months of TFR phase.\n\nPatients not known to have recurred or died on or before the cut-off date for PFS analysis were censored at the date of their last assessment (cytogenetic, hematology or extramedullary) for patients who were on study, and at the date of last contact for patients who were in follow-up.', 'timeFrame': 'From the start of the TFR phase to progression to AP/BC or death up to 24 months after entering TFR phase for Nilotininb 36-month treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-month treatment arm'}, {'measure': 'Treatment -Free Survival (TFS) During the TFR Phase of the Study', 'description': 'TFS is defined as the time from the start of the TFR phase to the date of the earliest of the following: loss of MMR, confirmed loss of MR4.0,re-start of nilotinib treatment, progression to AP/BC, or death from any cause. Patients not known to have had any of the events on or before the cut-off date were censored at the earlier of the date of their last assessment for patients who were still on study and the date of last contact for patients who were in follow-up. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotinib 24-month treatment arm had a maximum of 36 months of TFR phase. MMR is defined as ≥3.0 log reduction in BCR-ABL transcripts compared to the standardized baseline or ≤0.1%BCR-ABL.\n\nMR4.0 is defined as either detectable disease ≤0.01%BCR-ABL IS or undetectable disease in cDNA with ≥10,000 ABL transcripts (numbers of ABL transcripts in the same volume of cDNA used to test for BCR-ABL)', 'timeFrame': 'From the start of the TFR phase to the date of occurrence of treatment-free survival event, up to 24 months after entering TFR phase for Nilotinib 36-month treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-month treatment arm'}, {'measure': 'Overall Survival (OS) Rate During the TFR Phase of the Study.', 'description': 'OS is defined as the time from start of the TFR phase to the time of death due to any cause. Participants randomized in Nilotinib 36-month treatment arm had a maximum of 24 months of TFR phase, whereas participants randomized in Nilotini 24-month treatment arm had a maximum of 36 months of TFR phase.\n\nFor participants without any event on or before the cut-off date, survival time will be censored at the date of their last assessment for patients who are still on study, and at the date of last contact for patients who are in follow-up.', 'timeFrame': 'From the start of the TFR phase to death due to any cause, assessed up to 24 months after entering TFR phase for Nilotinib 36-month treatment arm and up to 36 months after entering TFR phase for Nilotinib 24-month treatment arm'}]" 333,NCT04813263,"{'fullName': 'AbbVie', 'class': 'INDUSTRY'}",Study of Oral Venetoclax Tablets to Evaluate Adverse Events and Change in Disease Activity in Participants of Any Age With Acute Myeloid Leukemia,COMPLETED,"Acute Myeloid Leukemia (AML) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections) and is the most common acute leukemia in adults. This study will assess how safe and effective oral venetoclax is in participants with AML. Adverse events and change in disease activity will be monitored under routine clinical practice. Venetoclax is an approved drug to treat Acute Myeloid Leukemia (AML). Around 400 participants of any age who are treated with oral venetoclax tablets for AML in accordance with the approved label will be enrolled in the study across Japan. Participants will be followed up to 52 weeks following the first dose of oral venetoclax tablets. There is expected to be no additional burden for participants in this study. Data will be collected by information provided by participating physicians based on routine medical records.",['Acute Myeloid Leukemia (AML)'],OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}",NA,"Inclusion Criteria: \- All participants who are administered venetoclax for treatment of AML. Exclusion Criteria: None",Participants who are prescribed venetoclax for the treatment of Acute Myeloid Leukemia (AML) in routine clinical practice across Japan.,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Percentage of Participants With ≥ Grade 3 Neutropenia of Venetoclax Regimens With Unfit Acute Myeloid Leukemia (AML)', 'description': 'Percentage of participants with a high grade (≥ Grade 3) protocol specified neutropenia during and after treatment with venetoclax.', 'timeFrame': 'Up to 52 weeks.'}]","[{'measure': 'Percentage of Participants With Febrile Neutropenia and Thrombocytopenia', 'description': 'Percentage of participants with protocol specified febrile neutropenia and thrombocytopenia during and after treatment with venetoclax.', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Percentage of Participants With Tumor Lysis Syndrome (TLS)', 'description': 'Percentage of participants with protocol specified TLS during and after treatment with venetoclax.', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Percentage of Participants Reported >= Grade 3 Adverse Events (AE)/Adverse Drug Reactions (ADR)', 'description': 'Grade 3 and above AE/ADR are serious adverse event (SAE) that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Percentage of Participants Reported Adverse Events (AE)/Adverse Drug Reaction (ADR)', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either definitely related, probably related, possibly related or unrelated.', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Percentage of Participants With AE/ADR When Used Concomitantly With CYP3A Inhibitors or Growth Colony Stimulating Factor (G-CSF)', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either definitely related, probably related, possibly related or unrelated.', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Percentage of Participants With Composite Complete Remission Rate (CR + CRi)', 'description': 'Composite Complete remission (CRc) is defined as Complete Remission (CR) + CRi (CR with incomplete blood count recovery) based on protocol criteria.', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Median Time to Best Response', 'description': 'Time to Best Response is measured as the time in months from the first dose of study treatment to the date of first documented documentation of a confirmed response of partial response (PR) or better.', 'timeFrame': 'Up to 52 weeks.'}, {'measure': 'Median Treatment Duration', 'description': 'Median time for duration of oral venetoclax treatment in participants with Acute Myeloid Leukemia.', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Median Overall Survival', 'description': 'Time from the date of first oral Venetoclax intake to the date of death from any cause.', 'timeFrame': 'Up to 52 weeks'}, {'measure': 'Median Duration of Composite Complete Remission', 'description': 'Time from the date of first oral Venetoclax intake and the date of the assessment having documented Complete Remission with incomplete Hematologic recovery (CRi).', 'timeFrame': 'Up to 52 weeks'}]" 334,NCT01652014,"{'fullName': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}",Single or Double Donor Umbilical Cord Blood Transplant in Treating Patients With High-Risk Hematologic Malignancies,WITHDRAWN,"This study will determine the safety and applicability of experimental forms of umbilical cord blood (UCB) transplantation for patients with high risk hematologic malignancies who might benefit from a hematopoietic stem cell transplant (HSCT) but who do not have a standard donor option (no available HLA-matched related donor (MRD), HLA-matched unrelated donor (MUD)), or single UCB unit with adequate cell number and HLA-match).","['Accelerated Phase Chronic Myelogenous Leukemia', 'Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome', 'Adult Acute Lymphoblastic Leukemia in Remission', 'Adult Acute Myeloid Leukemia in Remission', 'Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities', 'Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)', 'Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)', 'Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)', 'Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)', 'Adult Nasal Type Extranodal NK/T-cell Lymphoma', 'Anaplastic Large Cell Lymphoma', 'Angioimmunoblastic T-cell Lymphoma', 'Blastic Phase Chronic Myelogenous Leukemia', 'Cutaneous B-cell Non-Hodgkin Lymphoma', 'de Novo Myelodysplastic Syndromes', 'Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue', 'Hepatosplenic T-cell Lymphoma', 'Intraocular Lymphoma', 'Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable', 'Nodal Marginal Zone B-cell Lymphoma', 'Noncutaneous Extranodal Lymphoma', 'Peripheral T-cell Lymphoma', 'Post-transplant Lymphoproliferative Disorder', 'Previously Treated Myelodysplastic Syndromes', 'Recurrent Adult Acute Lymphoblastic Leukemia', 'Recurrent Adult Acute Myeloid Leukemia', 'Recurrent Adult Burkitt Lymphoma', 'Recurrent Adult Diffuse Large Cell Lymphoma', 'Recurrent Adult Diffuse Mixed Cell Lymphoma', 'Recurrent Adult Diffuse Small Cleaved Cell Lymphoma', 'Recurrent Adult Grade III Lymphomatoid Granulomatosis', 'Recurrent Adult Hodgkin Lymphoma', 'Recurrent Adult Immunoblastic Large Cell Lymphoma', 'Recurrent Adult Lymphoblastic Lymphoma', 'Recurrent Adult T-cell Leukemia/Lymphoma', 'Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma', 'Recurrent Grade 1 Follicular Lymphoma', 'Recurrent Grade 2 Follicular Lymphoma', 'Recurrent Grade 3 Follicular Lymphoma', 'Recurrent Mantle Cell Lymphoma', 'Recurrent Marginal Zone Lymphoma', 'Recurrent Mycosis Fungoides/Sezary Syndrome', 'Recurrent Small Lymphocytic Lymphoma', 'Refractory Chronic Lymphocytic Leukemia', 'Refractory Hairy Cell Leukemia', 'Refractory Multiple Myeloma', 'Relapsing Chronic Myelogenous Leukemia', 'Secondary Acute Myeloid Leukemia', 'Secondary Myelodysplastic Syndromes', 'Small Intestine Lymphoma', 'Splenic Marginal Zone Lymphoma', 'T-cell Large Granular Lymphocyte Leukemia', 'Testicular Lymphoma', 'Waldenström Macroglobulinemia']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'cyclophosphamide', 'description': 'Given IV over 1 hour on Day -6; after pre-hydration', 'armGroupLabels': ['Arm I', 'Arm II'], 'otherNames': ['CPM', 'CTX', 'Cytoxan', 'Endoxan', 'Endoxana']}, {'type': 'DRUG', 'name': 'fludarabine phosphate', 'description': 'Given IV daily over 30 minutes for 5 days (Days -6 to -2)', 'armGroupLabels': ['Arm I', 'Arm II'], 'otherNames': ['2-F-ara-AMP', 'Beneflur', 'Fludara']}, {'type': 'DRUG', 'name': 'mycophenolate mofetil', 'description': 'Given PO 1.0 g BID Day 1-30', 'armGroupLabels': ['Arm I', 'Arm II'], 'otherNames': ['Cellcept', 'MMF']}, {'type': 'PROCEDURE', 'name': 'allogeneic hematopoietic stem cell transplantation', 'description': 'Undergo double-unit allogeneic UCB transplant', 'armGroupLabels': ['Arm I']}, {'type': 'PROCEDURE', 'name': 'umbilical cord blood transplantation', 'description': 'Undergo single allogeneic UCB transplant', 'armGroupLabels': ['Arm II'], 'otherNames': ['cord blood transplantation', 'transplantation, umbilical cord blood', 'UCB transplantation']}, {'type': 'PROCEDURE', 'name': 'double-unit umbilical cord blood transplantation', 'description': 'Undergo double-unit allogeneic UCB transplant', 'armGroupLabels': ['Arm I']}, {'type': 'RADIATION', 'name': 'total-body irradiation', 'description': 'Undergo TBI', 'armGroupLabels': ['Arm I', 'Arm II'], 'otherNames': ['TBI']}, {'type': 'DRUG', 'name': 'tacrolimus', 'description': 'Given IV 0.03 mg/kg/d as continuous infusion over 24 hours starting Day -3 with dose adjustments to maintain level of 8-20 mg/ml', 'armGroupLabels': ['Arm I', 'Arm II'], 'otherNames': ['FK 506', 'Prograf']}, {'type': 'PROCEDURE', 'name': 'allogeneic hematopoietic stem cell transplantation', 'description': 'Undergo single allogeneic UCB transplant', 'armGroupLabels': ['Arm II']}, {'type': 'PROCEDURE', 'name': 'peripheral blood stem cell transplantation', 'description': 'Undergo irradiated allogeneic peripheral blood stem cell transplant', 'armGroupLabels': ['Arm II'], 'otherNames': ['PBPC transplantation', 'PBSC transplantation', 'peripheral blood progenitor cell transplantation', 'transplantation, peripheral blood stem cell']}]","Inclusion Criteria: * Patients with histologically proven hematologic malignancy with anticipated 2 year survival \< 20% with standard therapy; patients age \<18 are excluded by virtue of the policies and procedures of the allogeneic hematopoietic stem cell transplant (HSCT) program (Cancer Institute of New Jersey \[CINJ\]/Robert Wood Johnson University Hospital \[RWJUH\] is not an approved Pediatric Transplant Center); patients \> age 65 are generally not considered candidates for experimental unrelated allogeneic HSCT, as utilized in this study by virtue of the anticipated delayed immune reconstitution, high risk of GVHD, and known negative impact of age on outcomes * Patients eligible for this trial will have high risk diseases that include, but are not limited to: * Acute myeloid leukemia (AML) in second complete remission (CR2) or greater or early relapse with \< 5% marrow blasts and no circulating blasts * AML in first complete remission (CR1) with high risk cytogenetics (complex, monosomy 5, monosomy 7, 11q23 (not t(9;11)), t(6;9), chromosome 3, monosomy phenotype and other karyotypes estimated to have =\< 20% disease free survival at 3 years) or secondary/transformed AML without favorable cytogenetics; * Acute lymphoblastic leukemia (ALL) with t(9;22), 11q23 abnormality or early relapse (\< 5% marrow blasts) or CR2 or greater; * Chronic myeloid leukemia (CML) resistant/refractory to all commercially available Abelson (abl) kinase inhibitors (e.g. imatinib mesylate, dasatinib, nilotinib) or predicted to be so based upon clinical course or abl kinase domain mutation analysis; or in accelerated phase or blast crisis; * High intermediate to high international prognostic score myelodysplasia; * Non-Hodgkin lymphoma (NHL)/Hodgkin lymphoma (HL)/other lymphoproliferative diseases resistant/refractory to standard therapies and for whom an autologous transplant is considered to be inappropriate (e.g. bone marrow involvement, chemotherapy refractory disease, prior transplant); * Chronic lymphocytic leukemia (CLL) resistant/refractory to standard therapies (e.g. fludarabine) or high risk cytogenetics/fluorescence in situ hybridization (FISH) (e.g. 17p-); * Myeloproliferative disorders with progressive disease or cytopenias or clinical symptoms refractory to standard therapy (e.g. hypomethylating agents) * Relapsed or refractory multiple myeloma after (or not eligible for) high dose chemotherapy/autologous hematopoietic stem cell rescue and following salvage therapy with thalidomide, lenalidomide or bortezomib/other Food and Drug Administration (FDA)-approved multiple myeloma salvage therapies; * Other hematologic malignancies/disorders with anticipated 2 year survival \< 20%, as established by available data bases, medical literature and the documented consensus of the Hematologic Malignancies Tumor Study Group * Patients must be an allogeneic HSCT candidate but have no standard donor (matched related donor \[MRD\], human leukocyte antigen \[HLA\]-matched unrelated donor \[MUD\] or single UCB unit of appropriate size and HLA type) available * Patients must have available UCB unit(s) * Patients considered for Arm 2 must not be eligible for Arm 1 and must have an HLA-haploidentical sibling, parent, child, or other relative (uncle, aunt, first cousin, niece or nephew) who meets donor requirements as outlined in Donor Eligibility criteria * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Left ventricular (LV) ejection fraction \>= 50% * Diffusion capacity of carbon monoxide (DLCO) corrected for hemoglobin \> 60% * Total bilirubin within normal institutional limits unless the patient has Gilbert's disease * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) =\< 2.5 X institutional upper limit of normal (ULN) * Measured or estimated creatinine clearance \> 50 ml/min * Hematopoietic stem cell co-morbidity index =\< 2 * There must be a negative pregnancy test for women of childbearing potential within 1 week of therapy; there must be willingness to avoid pregnancy and undergo counseling about contraceptive techniques throughout the course of treatment * There must be no uncontrolled infections or active acute or chronic illnesses such as diabetes, angina/myocardial ischemia, cardiac arrhythmia, venous thrombosis/embolism, cerebrovascular disease, seizure disorder, psychiatric illness or other intercurrent illness that is not well controlled or is anticipated to be difficult to control during the proposed therapy * The patient must be aware of the high risk and experimental nature of the treatment and provide informed consent * The patient must have clearance for HSCT after psychosocial evaluation * The patient must have adequate insurance or other support to meet the anticipated financial burden imposed by the costs of therapy * DONOR (for allogeneic lymphocytes, Arm 2 only): Relative (parent, child, sibling, first cousin, uncle aunt, nephew, niece) with appropriate HLA match (\>= 3/6 HLA A, B, DR match) * DONOR (for allogeneic lymphocytes, Arm 2 only): Age \>= 18 years old * DONOR (for allogeneic lymphocytes, Arm 2 only): Normal hemogram; potential donors not having a normal hemogram may be utilized at the discretion of the Principal Investigator * DONOR (for allogeneic lymphocytes, Arm 2 only): Not pregnant or lactating * DONOR (for allogeneic lymphocytes, Arm 2 only): Not human immunodeficiency virus (HIV)-1, HIV-2, hepatitis C (HCV), Hepatitis B core or human T-lymphotropic virus (HTLV)-I/II seropositive; hepatitis B surface antigen (HB Sag)(-); must meet other infectious disease screening criteria utilized by New Brunswick Affiliated Hospital (NBAH) Blood Center * DONOR (for allogeneic lymphocytes, Arm 2 only): No uncontrolled infections, other medical or psychological/social conditions, or required medications that might increase the likelihood of patient or donor adverse effects or poor outcomes * DONOR (for allogeneic lymphocytes, Arm 2 only): Meet other blood bank criteria for blood product donation (as determined by NBAH Blood Center screening history) * DONOR (for allogeneic lymphocytes, Arm 2 only): Donors must be informed of the investigational nature of this study, understand the requirements, potential benefits and potential risks of the experimental treatment, and give written informed consent in accordance with institutional and federal guidelines Exclusion Criteria: * Prior extensive radiation therapy that the radiation oncologist feels precludes additional TBI * Patients with known human immunodeficiency virus (HIV) are excluded due to side effects of the therapy on the immune system * Patients with known active central nervous system (CNS) disease will be excluded from this clinical trial because they often develop progressive neurologic dysfunction unresponsive to HSCT therapy",NA,ALL,NA,"[{'measure': 'Engraftment of white blood cells (WBC) (absolute neutrophil count > 500/mm^3)', 'timeFrame': '3 years'}, {'measure': 'Non-relapse mortality', 'timeFrame': '40 months'}]","[{'measure': 'Platelet engraftment rate (non-transfusion dependent)', 'timeFrame': 'At 100 days'}, {'measure': 'Transplant related mortality', 'timeFrame': 'At 1 year'}, {'measure': 'Rates of infection requiring hospitalization or prolongation of hospitalization', 'timeFrame': 'Up to 2 years'}, {'measure': 'Incidence of steroid-refractory acute GVHD', 'description': 'GVHD will be staged per standard guidelines of the American Society for Blood and Bone Marrow Transplantation.', 'timeFrame': 'at 100 days'}, {'measure': 'Incidence of extensive chronic GVHD', 'description': 'GVHD will be staged per standard guidelines of the American Society for Blood and Bone Marrow Transplantation.', 'timeFrame': 'up to 2 years'}, {'measure': 'Total time on immunosuppressive therapy', 'timeFrame': 'Up to 2 years'}, {'measure': 'Time to CD4 count > 200/mm^3', 'timeFrame': 'Up to 2 years'}]" 335,NCT06830733,"{'fullName': 'Fundacion Clinic per a la Recerca Biomédica', 'class': 'OTHER'}","Study to Evaluate the Safety and Efficacy of ARI0002h, for the Initial Treatment of Patients With Primary Plasma Cell Leukaemia",NOT_YET_RECRUITING,"Phase II, pilot, open-label, prospective, multicenter, non-randomized study to evaluate the safety and efficacy of ARI0002h (cesnicabtagene autoleucel) in 20 patients with newly diagnosed primary plasma cell leukemia (PCL). The study population is patients between 18 and 75 years of age with newly diagnosed primary plasma cell leukemia (pPCL), with a life expectancy of more than 3 months. The primary objective is to assess the safety and efficacy of CARTBCMA ARI0002h (cesnicabtagene autoleucel) after initial treatment to induce response in patients with newly diagnosed primary plasma cell leukaemia.","['Leukemia, Plasma Cell']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'GENETIC', 'name': 'ARI0002h', 'description': '* Treatment with ARI0002h cells\n* Other names: CARTBCMA\\_J22.9-h:CD8TM:4-1BB:CD3. Adult differentiated autologous T cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-BCMA (TNFRSF17) specificity conjugated to the 4-1BB co-stimulatory domain and the CD3z signalling domain that has been humanized.', 'armGroupLabels': ['ARI0002h']}]","Inclusion Criteria: 1. Patients between 18 and 75 years old diagnosed with newly diagnosed primary plasma cell leukemia (the presence of 5% or more circulating plasma cells in peripheral blood smears in patients otherwise diagnosed with symptomatic multiple myeloma), according to International Myeloma Working Group (IMWG). 2. Disease measurable at diagnosis by monoclonal component in serum or urine, or by free light chains in serum according to the eligibility criteria for clinical trials of the ""International Myeloma Working Group"". 3. ECOG Performance Status from 0 to 2 4. Life expectancy greater than 3 months. 5. Adequate venous access and absence of contraindications for lymphoapheresis. 6. Patients who, after being informed, give their consent by signing the Informed Consent Document. 7. Up to two cycles of previous treatment for symptomatic control will be allowed before inclusion. Exclusion Criteria: 1. No previous treatments, except for induction therapy for primary plasma cell leukemia. 2. Administration of any anti-BCMA therapy as part of induction 3. Not having achieved at least a minimal response with induction treatment (IMWG criteria) 4. Absolute lymphocyte count \<0.1x109/L 5. Active immunosuppressive therapy except for prednisone 10 mg/day (or equivalent). 6. Any other concomitant neoplasia, unless it has been in complete remission for 3 years or longer, except for non-melanoma skin cancer or completely resected in situ carcinoma. 7. Active infection requiring treatment. 8. Active HIV, HBV, or HCV infection. 9. Uncontrolled medical illness 10. Severe organ impairment that meets any of the following criteria: EF\<40%, DLCO \<40%, GFR \<30 ml/min, bilirubin \>3 times the upper limit of normality (unless due to Gilbert syndrome) 11. Previous diagnosis of symptomatic AL amyloidosis, 12. Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test at the screening phase. 13. Women of childbearing potential, including those whose last menstrual cycle was in the year prior to screening, who are unable or unwilling to use highly effective contraceptive methods\* from the beginning of the study to completion of the study. 14. Men who are unable or unwilling to use highly effective contraceptive methods\* from the beginning of the study to completion of the study. 15. Contraindication to receive lymphodepletive chemotherapy.",NA,ALL,NA,"[{'measure': 'Overall response rate (ORR)', 'description': 'Overall response rate (ORR) during the initial 3 months after the first infusion (at least presenting a partial response according to the International Myeloma Working Group criteria).', 'timeFrame': '3 months after the first infusion'}, {'measure': 'Rate of patients who develop cytokine release syndrome and/or neurological toxicity', 'description': 'Rate of patients who develop cytokine release syndrome and/or neurological toxicity in the first 30 days after CARTBCMA administration, according to the criteria and grading defined in the international consensus document', 'timeFrame': '30 days after CARTBCMA administration'}]","[{'measure': 'Duration of response', 'description': 'Duration of response calculated from the time of first disease evaluation', 'timeFrame': 'From day 28 after infusion to study completion, an average of 24 months'}, {'measure': 'Response rates', 'description': 'Response rates', 'timeFrame': 'During the first year after administration'}, {'measure': 'Complete response rate', 'description': 'Complete response rate', 'timeFrame': 'at 3, 6, and 12 months after the first infusion'}, {'measure': 'Overall response rate', 'description': 'Overall response rate', 'timeFrame': 'at 6, and 12 months after the first infusion'}, {'measure': 'Time to complete response', 'description': 'Time to complete response', 'timeFrame': 'through study completion, an average of 24 months'}, {'measure': 'Time to best response', 'description': 'Time to best response', 'timeFrame': 'through study completion, an average of 24 months'}, {'measure': 'MRD negative rate in bone marrow', 'description': 'MRD negative rate in bone marrow by flow cytometry', 'timeFrame': 'at 3, 6 12 and 24 months'}, {'measure': 'Response rate of extramedullary disease', 'description': 'Response rate of extramedullary disease by PET-CT', 'timeFrame': 'at 3, 6 and 12 months.'}, {'measure': 'Progression-free survival', 'description': 'defined as the time between administration of ARI0002h and disease progression or death. Patients who are alive and in complete remission will be censored at the time of the last follow-up.', 'timeFrame': 'through study completion, an average of 24 months'}, {'measure': 'Progression-free survival at 12 months after the first administration', 'description': 'Progression-free survival at 12 months after the first administration, defined as the time elapsed between the administration of ARI0002h and disease progression or death. Patients who are alive and in complete remission will be censored at the time of the last follow-up.', 'timeFrame': '12 months'}, {'measure': 'Overall survival', 'description': 'Overall survival, defined as the time between infusion of ARI0002h and death of the patient from any cause. Living patients will be censored at the time of last follow-up.', 'timeFrame': 'through study completion, an average of 24 months'}, {'measure': 'Presence of infusion reactions', 'description': 'Presence of infusion reactions, understood as the appearance of any of the following symptoms after the intravenous administration of CARTBCMA: cardiac events, chills, dyspnea, fatigue, sudden hypertension, hypotension, nausea, pain, fever, rash or urticaria.', 'timeFrame': 'through study completion, an average of 24 months'}, {'measure': 'Tumour lysis syndrome', 'description': 'Tumour lysis syndrome', 'timeFrame': 'through study completion, an average of 24 months'}, {'measure': 'Cytokine release syndrome', 'description': 'Cytokine release syndrome. According to the criteria and grading defined in the international consensus document', 'timeFrame': 'through study completion, an average of 24 months'}, {'measure': 'Neurological toxicity', 'description': 'Neurological toxicity according to the criteria and grading defined in the international consensus document (Lee, Santomasso et al. 2019)', 'timeFrame': 'through study completion, an average of 24 months'}, {'measure': 'Presence of prolonged cytopenias', 'description': 'Presence of prolonged cytopenias, defined as a grade 4 decrease in peripheral blood neutrophil or platelet counts for more than 4 weeks after infusion.', 'timeFrame': 'between 4 weeks after infusion and study completion'}, {'measure': 'Quality of life of patients', 'description': 'Quality of life during the first year after infusion according to the Quality of life questionnaire 2008 EuroQol Group EQ-5D', 'timeFrame': 'during the first year after infusion'}]" 336,NCT01971476,"{'fullName': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}",Open Dose Escalating Trial to Determine the Maximum Tolerated Dose in Paediatric Patients With Advanced Cancers for Whom no Therapy is Known,COMPLETED,"The present trial will be performed according to an open design to determine the maximum tolerable dose (MTD) by evaluation of dose-limiting toxicity (DLT) of volasertib in paediatric leukaemia and solid tumours in the age group 2 to less than 12 and 12 to less than 18 years. A further objective is to collect data on safety, tolerability, toxicity, efficacy (preliminary activity), pharmacokinetics and pharmacodynamics of volasertib in paediatric cancer patients","['Leukemia', 'Neoplasms']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'volasertib', 'description': 'intravenous administration on day 1of a treatment course', 'armGroupLabels': ['All patients']}]","Inclusion criteria: * paediatric patients with leukaemia or advanced solid tumours including lymphomas (age 2 - less than 18 years) for whom no further treatment is known * Lansky score \> 60 for children 2 to less than 12 years * Karnofsky score \> 60 for children aged 12 or older * life expectancy of at least 6 weeks as judged by the investigator * parents or legal guardians have given written informed consent and informed assent suitable for the respective age group obtained Exclusion criteria: * patient eligible for other anti-leukaemic therapy with curative intent or effective therapy known for solid tumour therapy * presence of cardiac disease (LVEF by echocardiography less than 25 %) * symptomatic Central Nervous System involvement of the malignant disease * primary CNS tumour * inadequate lab parameters * inadequate venous access * QTc prolongation * pregnancy, breastfeeding * other diseases or CTs that might interfere with evaluation of safety",NA,ALL,NA,"[{'measure': 'Number of Participants With Dose Limiting Toxicities (DLTs) in the First Cycle for the Determination of the Maximum Tolerated Dose (MTD)', 'description': 'This outcome measure presents number of participants with DLTs in the first cycle for the determination of MTD. DLTs were defined as drug related Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 (haematological and nonhaematological) Adverse Events (AEs) with the exception of a) Reduced blood cell count (any grade) without associated clinical complications qualifying for DLT. b) Febrile neutropenia Grade 3. c) Infection Grade 3 with neutrophil count \\<1000/mm3. d) Uric acid Grade ≥3. e) Nausea, vomiting and/or diarrhoea managed by adequate therapy (i.e. recovery to CTCAE Grade ≤2).', 'timeFrame': 'Up to 14 days.'}, {'measure': 'Maximum Tolerated Dose of Volasertib', 'description': 'This outcome measure presents MTD of Volasertib. The MTD was defined as the highest dose level at which DLTs were reported in not more than 1 in 6 evaluable patients during Cycle 1.', 'timeFrame': 'Up to 14 days.'}]","[{'measure': 'Number of Patients With Hepatic Injury Defined as Adverse Events of Special Interest (AESI)', 'description': 'This outcome measure presents number of patients with hepatic injury defined as AESI. Hepatic injury was defined by the following alterations of liver parameters: an elevation of Aspartate Transaminase (AST) and/or Alanine Transaminase (ALT) \\>3x Upper Limit of Normal (ULN) combined with an elevation of total bilirubin \\>2x ULN measured in the same blood sample.', 'timeFrame': 'Up to 879 days.'}, {'measure': 'Number of Patients With Clinically Relevant Laboratory Value Changes of Calcium (Hyper- and/or Hypocalcaemia) as Judged by the Investigator and Reported as AEs, CTCAE Grade ≥3', 'description': 'This outcome measure presents number of patients with clinically relevant laboratory value changes of calcium (hyper- and/or hypocalcaemia) as judged by the investigator and reported as AEs, CTCAE Grade ≥3. CTCAE Grade 3 (severe AE), 4 (life-threatening or disabling AE), 5 (death related to AE).', 'timeFrame': 'Up to 879 days.'}, {'measure': 'The Number of Patients With Changes in Cardiac Activity (Prolonged QTc Interval) Reported as Clinically Relevant Observations', 'description': ""This outcome measure presents the number of patients with changes in cardiac activity (prolonged QTc interval) reported as clinically relevant observations to assess cardiac activity based on Electrocardiogram (ECG) recordings (digital, triplicate) before and at the end of each Volasertib administration and at least at 2 more time points within the first 24 hours after end of the first Volasertib administration. Two methods of heart rate correction of the QT interval were used: the fixed corrections Fridericia's correction (QTcF) and Bazett's correction (QTcB).\n\nSMQ: Standardised Medical Dictionary for Regulatory Activities (MedDRA) query."", 'timeFrame': 'Up to 879 days.'}, {'measure': 'Best Overall Response [in Leukaemia Patients]: (Complete Remission (CR)), CR With Incomplete Neutrophil or Platelet Recovery (CRi), Partial Remission (PR), Stable Disease (SD), Progressive Disease (PD) and Death in Aplasia', 'description': 'This outcome measure includes, CR: Bone marrow blasts \\<5%; absence of blasts with Auer rods; absence of extramedullary (EM) disease; absolute neutrophil count ≥ 1.0 x 109/L (1000/μL); platelet count ≥80 x 109/L (80000/μL); independence of red blood cells transfusions. CRi: All CR criteria except for residual neutropenia (\\<1.0 x 109/L \\[1000/μL\\]) or thrombocytopenia (\\<800 x 109/L \\[80000/μL\\]), independence of red blood cell transfusions not required. PR: Decrease of bone marrow blast percentage to 5%-25%; decrease of pretreatment bone marrow (baseline) blast percentage by at least 50%; absence of EM disease. SD: Neither qualifies for CR, CRi, PR or PD. PD: At least one of the criteria a) 50% increase in bone marrow blast count over baseline b) 50% increase in peripheral blast count over baseline - evidence of new EM disease - clinically PD based on the judgment of the investigator. Death in aplasia: Deaths occurring ≥7 days after last administration of the trial drug while cytopenic.', 'timeFrame': 'Up to 849 days.'}, {'measure': 'Event-Free Survival (EFS) [in Leukaemia Patients]', 'description': 'EFS was defined as the time from the first infusion of Volasertib to the date of PD or relapse, occurrence of secondary malignancy, or death from any cause, whichever occurred first. EFS was censored at the date of last disease assessment for patients who were not reported with PD, relapse, occurrence of secondary malignancy or death.', 'timeFrame': 'Up to 849 days.'}, {'measure': 'Overall Survival (OS) [in Leukaemia Patients]', 'description': 'Overall survival was defined as time from first infusion of Volasertib to death from any cause. For patients who were lost to follow-up, OS were censored on the last date the patients were known to be alive.', 'timeFrame': 'Up to 849 days.'}, {'measure': 'Maximum Measured Concentration (Cmax, Norm) of Volasertib', 'description': 'This outcome measure presents dose normalized maximum measured concentration of Volasertib in plasma (Cmax, norm).', 'timeFrame': 'Cycle 1: -0:05 (hour/s: minute/s) before drug administration and 1:00, 1:30, 3:00, 24:00, 96:00, 216:00 after drug administration. Cycle >=2: -0:05 (hour/s: minute/s) before drug administration and 1:00 after drug administration.'}, {'measure': 'Trough Concentration (Cpre, 2) of Volasertib', 'description': 'This outcome measure presents pre-dose concentration of Volasertib in plasma immediately before administration of the second dose (Cpre,2).\n\nThe number of participants analysed displays the number of participants with available data at the timepoint of interest.', 'timeFrame': 'Cycle 1: -0:05 (hour/s: minute/s) before drug administration and 1:00, 1:30, 3:00, 24:00, 96:00, 216:00 after drug administration. Cycle >=2: -0:05 (hour/s: minute/s) before drug administration and 1:00 after drug administration.'}, {'measure': 'Area Under the Concentration-Time Curve (AUC0-∞, Norm) of Volasertib in Plasma', 'description': 'This outcome measure presents dose normalized area under the concentration-time curve of Volasertib in plasma over the time interval from zero extrapolated to infinity.', 'timeFrame': 'Cycle 1: -0:05 (hour/s: minute/s) before drug administration and 1:00, 1:30, 3:00, 24:00, 96:00, 216:00 after drug administration. Cycle >=2: -0:05 (hour/s: minute/s) before drug administration and 1:00 after drug administration.'}, {'measure': 'Half-Life (t1/2) of Volasertib', 'description': 'This outcome measure presents half-life of Volasertib.', 'timeFrame': 'Cycle 1: -0:05 (hour/s: minute/s) before drug administration and 1:00, 1:30, 3:00, 24:00, 96:00, 216:00 after drug administration. Cycle >=2: -0:05 (hour/s: minute/s) before drug administration and 1:00 after drug administration.'}]" 337,NCT01161550,"{'fullName': 'Washington University School of Medicine', 'class': 'OTHER'}",Cladribine Based Induction Therapy With All-Trans Retinoic Acid and Midostaurin in Relapsed/Refractory AML,COMPLETED,"This study will evaluate the investigational drug Midostaurin in various doses given with ATRA and CLAG chemotherapy. Midostaurin is a FLT3 inhibitor that is activated or overexpressed in a significant proportion of AML patients. Research has shown that midostaurin and drugs like midostaurin may work better in combination with chemotherapy, like CLAG. CLAG is a combination of cladribine, cytarabine, and G-CSF which is approved by the FDA and used to treat AML.","['Leukemia, Myeloid, Acute']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Granulocyte colony-stimulating factor (G-CSF)', 'armGroupLabels': ['Arm 1', 'Arm 2'], 'otherNames': ['Filgrastim']}, {'type': 'DRUG', 'name': 'Cladribine', 'armGroupLabels': ['Arm 1', 'Arm 2'], 'otherNames': ['Litak', 'Movectro']}, {'type': 'DRUG', 'name': 'Cytarabine', 'armGroupLabels': ['Arm 1', 'Arm 2'], 'otherNames': ['Cytosar-U', 'Depocyt']}, {'type': 'DRUG', 'name': 'All-Trans Retinoic Acid (ATRA)', 'armGroupLabels': ['Arm 1', 'Arm 2'], 'otherNames': ['Tretinoin']}, {'type': 'DRUG', 'name': 'Midostaurin', 'armGroupLabels': ['Arm 1', 'Arm 2'], 'otherNames': ['PKC412']}]","Inclusion Criteria: * Patient must be ≥18 of age. Because no dosing or adverse event data are currently available on the use of midostaurin in combination with ATRA and CLAG in patients \<18 years of age, children are excluded from this study but will be eligible for future pediatric phase 2 combination trials. * Patient must be diagnosed with refractory or relapsed AML. For the purpose of the study, refractory AML is defined as failure to achieve CR after 2 cycles of induction chemotherapy or persistent \> 40% bone marrow blasts after one cycle of chemotherapy induction. Relapsed AML is defined as any evidence of disease recurrence after achieving CR. Early relapse is defined as relapse occurring earlier than 12 months and late relapse is defined as relapse occurring later than 12 months. * Patient must have a Karnofsky Performance Status of ≥ 70% (unless poor performance status is related to the disease). * Patient must have the following laboratory values: * AST and ALT ≤ 1.5 x Upper Limit of Normal (ULN), * Serum Bilirubin ≤ 1.5 x ULN, * Serum Creatinine ≤ 1.5 x ULN. Laboratory values can be outside this range if secondary to AML disease. * Patient must able to understand and willing to sign a written informed consent document prior to registration on study. Exclusion Criteria: * Patient must not have newly diagnosed AML. * Patient must not have acute promyelocytic leukemia * Patient must not have known CNS leukemia * Patient must not have a history of allergic reactions to compounds of similar chemical or biologic composition to midostaurin or other agents used in the study. * Patient must not have any uncontrolled or intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, myocardial infarction within 6 months, poorly controlled hypertension, uncontrolled diabetes, chronic renal disease, or psychiatric illness/social situation that would limit compliance with study requirements. * Patient must not have any condition, including the presence of laboratory abnormalities, which places him/her at unacceptable risk if s/he were to participate in the study or confounds the ability to interpret data from the study. * Patient may not concurrently use other anti-cancer agents or treatments (with the exceptions of hydroxyurea, steroids, and leukopheresis). * Female patients must not be pregnant or breastfeeding. * Adults of reproductive potential must employ an effective method of birth control. Barrier contraceptives must be used throughout the study in both sexes. Women of childbearing potential must have a negative serum pregnancy test 48 hours prior to administration of midostaurin. Women considered not of childbearing potential include any of the following: no menses for at least 5 years; menses within 5 years but amenorrheic for at least 2 months and luteinizing hormone (LH) and follicular stimulating hormone (FSH) values within normal range (according to definition of postmenopausal for laboratory used); bilateral oophorectomy amenorrheic for at least 3 months. * Patient must not have impaired cardiac function including any of the following: * Screening ECG with a QTc \> 450 msec * Patients with congenital long QT syndrome * History or presence of sustained ventricular tachycardia * Any history of ventricular fibrillation or torsades de pointes * Bradycardia defined as HR \< 50 bpm * Right bundle branch block + left anterior hemiblock (bifascicular block) * Patients with myocardial infarction or unstable angina \< 6 months prior to starting study drug * CHF NY Heart Association class III or IV * Patients with an ejection fraction \< 50% assessed by MUGA or ECHO scan within 14 days of Day 1. * Patients must not have a known confirmed diagnosis of HIV infection or active viral hepatitis. * Patient may not have received any investigational agent within 30 days prior to Day 1. Patient may not be receiving any other investigational agents while on this trial. * Patients must not have had any surgical procedure, excluding central venous catheter placement or other minor procedures (e.g. skin biopsy) within 14 days of Day 1. * Patients must not have any pulmonary infiltrate, including those suspected to be of infectious origin. In particular, patients with resolution of clinical symptoms of pulmonary infection but with residual pulmonary infiltrates on chest x-ray are not eligible until pulmonary infiltrates have completely resolved.",NA,ALL,NA,"[{'measure': 'Tolerability of midostaurin + ATRA given with CLAG chemotherapy', 'timeFrame': '28 days following completion of therapy'}, {'measure': 'Dose limiting toxicity (DLT) of midostaurin + ATRA with CLAG chemotherapy', 'timeFrame': '28 days following completion of therapy'}]","[{'measure': 'Response', 'description': 'To determine the response rate 3, morphologic leukemia-free state, morphologic complete remission rate (CRm), cytogenetic CR (CRc) rate, CR with incomplete blood counts 1 rate, and partial remission 48 rate (PR) of patients treated with midostaurin + ATRA given with CLAG chemotherapy', 'timeFrame': '1 year'}, {'measure': 'Survival', 'description': 'To determine the duration of response and survival including disease-free survival (DFS), event-free survival (EFS), and overall survival (OS) in these patients', 'timeFrame': '1 year'}, {'measure': 'Toxicity profile of midostaurin + ATRA', 'timeFrame': '28 days following completion of treatment'}, {'measure': 'Pharmacokinetics of midostaurin', 'timeFrame': 'Cycle 1 Day 7, Cycle 1 Day 14, and Cycle 1 Day 20'}]" 338,NCT07172191,"{'fullName': 'Del-Pest Central Hospital - National Institute of Hematology and Infectious Diseases', 'class': 'OTHER'}",Fecal Microbiota Transplantation Among Adult Patients With Hematological Malignancies,ENROLLING_BY_INVITATION,"In Hungary - in comparison to other member states of the European Union - about 75000 new cases of cancer are diagnosed annually, from which approximately 4500-5000 patients suffer from so-called malignant hematological diseases. This disease group includes various leukemias (blood cancers) and lymphomas (lymph node cancers). Chemotherapy for patients with malignant hematological diseases is particularly difficult to bear, as it affects the entire body, including the ""good"" gut bacteria living inside, and recovery can take several years. Due to the decrease of the ""good"" gut bacteria during treatment, patients are more prone to acquiring various difficult-to-treat infections, which can lead to deterioration of quality of life, prolonged hospitalization, and in the worst cases, death. The method outlined in this research plan is called fecal microbiota transplantation, during which stool from a healthy person is introduced into the body of the sick patient. The ""good"" gut bacteria present in the stool then restore the patient's entire gut flora (the process is somewhat similar to the use of probiotics available on the market, but it is a much more effective method). This research aims to assess the success of fecal microbiota transplantation in adults with malignant hematological diseases over a long-term follow-up period, thus contributing to the restoration of their acceptable quality of life.",['Malignant Hematologic Neoplasm'],INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Eligible patients for inclusion are stratified into different interventional subgroups based on four differenc clinical indications for FMT as intervention:\n\n1. patient group: elimination of documented MDR colonization,\n2. patient group: treatment of active C. difficile infection,\n3. patient group: enteral microbiome restoration following autologous and allogeneic hematopoietic stem cell transplantation,\n4. patient group: treatment of corticosteroid-refractory acute gastrointestinal GvHD (see later).\n\nControl groups not receiving FMT as intervention are selected either: 1) from patients who possess the same clinical severity/stage and clinical indication for FMT, but do not agree to participate in the study or not eligible for technical reasons, or 2) randomly selected from patients without malignant hematological diseases and are hospitalized at our center. Patient recruitment is conducted consecutively, and a 1:2 ratio for case-control matching is followed during inclusion.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'Fecal Microbial Transplantation', 'description': 'The technical implementation of FMT procedure is consistent with the methodological letter issued by the National Public Health Center of Hungary. FMT is performed via nasogastric tube with suspended fresh stool graft or fecal filtrate, or lyophilised stool capsules, obtained and prepared from a pre-selected stool donor. Following FMT, the patient is observed for 24 hours at our center. The process is supervised and performed by the lead researcher.', 'armGroupLabels': ['FMT']}]","Inclusion criteria: 1. Adult patients (diagnosis age ≥18 years) with malignant hematological disease treated at our center, and 2. Capable of giving written informed consent after decision-making, and 3. Documented patient colonization with MDR bacterial or fungal isolates, or 4. Active C. difficile infection, or 5. Patient has undergone autologous or allogeneic hematopoietic stem cell transplantation, or 6. Ongoing corticosteroid-refractory acute gastrointestinal GvHD. Exclusion criteria (one or more must be met): 1. Active bacterial or fungal bloodstream infection requiring antimicrobial therapy, or 2. Peripheral blood absolute neutrophil count \<0.5 G/l on ≥7 consecutive days before planned FMT with maximum dose of administered G-CSF, or 3. Pressor-refractory septic shock, or 4. Major gastrointestinal bleeding within 7 consecutive days before planned FMT, or 5. Any pathological process inhibiting successful or safe nasogastric tube insertion, or 6. Lack of written informed consent.",NA,ALL,NA,"[{'measure': 'Disease activity', 'description': 'Disease activity: hematological remission vs. relapse, GvHD activity. Disease activity of the malignant hematological underlying disease (hematological remission vs. relapse) is defined according to the published methodological recommendations by the National Comprehensive Cancer Network and the European Hematology Association (or the American Society of Hematology, if neither has specific guidance), specifically for each disease. GvHD activity is defined according to the published methodological recommendations of the European Bone Marrow Transplantation Society.', 'timeFrame': 'On Day 7, Day 30, Day 60 and Day 180, since the intervention, compared to baseline and controls'}]","[{'measure': 'Reducibility of applied immunosuppressive pharmacotherapy', 'description': 'Reducibility of applied immunosuppressive pharmacotherapy. The reducibility of immunosuppressive and antimicrobial pharmacotherapy is determined based on the number of active substances and changes in dose intensity.', 'timeFrame': 'On Day 7, Day 30, Day 60 and Day 180, since the intervention, compared to baseline and controls'}, {'measure': 'Reducibility of applied antimicrobial pharmacotherapy', 'description': 'Reducibility of applied antimicrobial pharmacotherapy. The reducibility of immunosuppressive and antimicrobial pharmacotherapy is determined based on the number of active substances and changes in dose intensity.', 'timeFrame': 'On Day 7, Day 30, Day 60 and Day 180, since the intervention, compared to baseline and controls'}, {'measure': 'Survival', 'description': 'Survival: total and progression-free survival. Total survival: the patient does not die during the follow-up period. Progression-free survival: during the follow-up period, the stage of the malignant hematological underlying disease documented at enrollment does not change or improves (partial or complete hematological remission occurs), and the patient does not die. The activity of the malignant hematological underlying disease is defined according to the published methodological recommendations by the National Comprehensive Cancer Network and the European Hematology Association (or the American Society of Hematology, if neither has specific guidance), specifically for each disease.', 'timeFrame': 'On Day 7, Day 30, Day 60 and Day 180, since the intervention, compared controls'}, {'measure': 'Clinical cure of C. difficile infection', 'description': 'Clinical cure of C. difficile infection: we apply the guidelines of the European Society of Clinical Microbiology and Infectious Diseases to define clinical cure', 'timeFrame': 'On Day 7, Day 30, Day 60 and Day 180, since the intervention, compared to baseline and controls'}]" 339,NCT05136521,"{'fullName': 'Aziende Chimiche Riunite Angelini Francesco S.p.A', 'class': 'INDUSTRY'}",Bioavailability Study of 300 mg Trazodone Hydrochloride (New Polymer) vs. 300 mg Trazodone Hydrochloride (Contramid® Prolonged-release Tablets) Under Fasting Conditions,COMPLETED,"This study was designed to investigate the bioequivalence of the test and reference products when administered as single oral doses in two consecutive study periods, under fasting conditions.",['Healthy'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The study is single dose, open-label, randomised, two-period, two-sequence, cross-over, bioavailability and bioequivalence study', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Trazodone HCl - new polymer', 'description': 'A single 300 mg dose of the test (T) and of the reference (R) products will be administered to the study subjects in two consecutive periods, according to a randomised 2-sequence cross-over design. A wash-out interval of at least 10 days will elapse between the two administrations. The two investigational products will be administered with 240 mL of still mineral water on day 1 of the two study periods, at 08:00±1 h after an overnight fasting.', 'armGroupLabels': ['300 mg trazodone hydrochloride (HCl) prolonged-release tablets (new polymer)']}, {'type': 'DRUG', 'name': 'Trazodone HCl - Contramid®', 'description': 'A single 300 mg dose of the test (T) and of the reference (R) products will be administered to the study subjects in two consecutive periods, according to a randomised 2-sequence cross-over design. A wash-out interval of at least 10 days will elapse between the two administrations. The two investigational products will be administered with 240 mL of still mineral water on day 1 of the two study periods, at 08:00±1 h after an overnight fasting.', 'armGroupLabels': ['Trittico®, 300 mg trazodone HCl prolonged-release tablets (Contramid®)'], 'otherNames': ['Trittico®']}]","Inclusion Criteria: * Informed consent: signed written informed consent before inclusion in the study * Sex and Age: men and women, 18-45 years old inclusive * Body Mass Index (BMI): 18.5-30 kg/m2 inclusive * Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position * Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study * Contraception and fertility : men and women of child-bearing potential and with an active sexual life must be using at least one of the following reliable methods of contraception throughout the study: * Hormonal oral, implantable, intrauterine device \[IUD\], transdermal, or injectable contraceptives for at least 2 months before the screening visit (women only) * A non-hormonal intrauterine device or female condom with spermicide or contraceptive sponge with spermicide or diaphragm with spermicide or cervical cap with spermicide for at least 2 months before the screening visit (women only) * A male sexual partner who agrees to use a male condom with spermicide (women only) * A vasectomised partner (women only) * A male condom with spermicide (men only) * A sterile sexual partner Female participants of non-child-bearing potential or in post-menopausal status for at least 1 year will be admitted Exclusion Criteria: * Electrocardiogram (ECG): clinically significant abnormalities at 12-lead ECG in supine position * QTc: QTcF\>430 msec for men and QTcF\>450 msec for women at screening * Cardiac disorders: history of risk factors for torsade de pointes, such as heart failure, significant cardiac arrhythmias, significant cardiac conduction abnormalities, family history of long QT syndrome, cardiac hypertrophy, cardiomyopathy, chronic cardiac insufficiency * Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study * Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness * Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study * Diseases: history of significant renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study * Medications: medications, including over the counter (OTC) medications and herbal remedies and in particular concomitant intake of potentially hepatotoxic drugs or hepatic/gastric enzyme inducers (i.e. phenobarbital, phenytoin, carbamazepine, chlorzoxazone and rifampicin) for 2 weeks before the start of the study. Hormonal contraceptives for women will be allowed * Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval will be calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study * Blood donation: blood donations for 3 months before this study * Drug, alcohol, caffeine, tobacco: history of drug, alcohol \[\>1 drink/day for women and \>2 drinks/day for men, defined according to USDA Dietary Guidelines 2015-2020 (18)\], caffeine (\>5 cups coffee/tea/day) or tobacco (\> or equal 6 cigarettes/day) abuse; * Drug test: positive drug test at screening or day -1 * Alcohol breath test: positive alcohol breath test at day -1 * Diet: abnormal diets (\<1600 or \>3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians * Pregnancy: pregnant or lactating women; positive or missing pregnancy test at screening or day -1",NA,ALL,NA,"[{'measure': 'Cmax', 'description': 'Cmax of plasma trazodone (free base). The following PK parameter will be measured and/or calculated for plasma trazodone (free base) applying a Non-Compartmental Analysis, using the validated software Phoenix WinNonlin® version 6.3 (22) or higher (the actual version will be stated in the final report).', 'timeFrame': 'At pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 20, 24, 30, 36, 48, 72, 96 hours post-dose'}, {'measure': 'AUC(0-t)', 'description': 'AUC(0-t) of plasma trazodone (free base). The following PK parameter will be measured and/or calculated for plasma trazodone (free base) applying a Non-Compartmental Analysis, using the validated software Phoenix WinNonlin® version 6.3 (22) or higher (the actual version will be stated in the final report).', 'timeFrame': 'At pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 20, 24, 30, 36, 48, 72, 96 hours post-dose'}, {'measure': 'AUC(0-∞)', 'description': 'AUC(0-∞) of plasma trazodone (free base). The following PK parameter will be measured and/or calculated for plasma trazodone (free base) applying a Non-Compartmental Analysis, using the validated software Phoenix WinNonlin® version 6.3 (22) or higher (the actual version will be stated in the final report).', 'timeFrame': 'At pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 20, 24, 30, 36, 48, 72, 96 hours post-dose'}]","[{'measure': 'Treatment emergent adverse events (TEAEs)', 'description': 'All AEs occurring or worsening after the first dose of IMP. Adverse events (AEs) will be coded by System Organ Class (SOC) and Preferred Term (PT), using the Medical Dictionary for Regulatory Activities (MedDRA)', 'timeFrame': 'Trough study completion, an average of five months'}, {'measure': 'Residual area', 'description': 'Residual area of plasma trazodone (free base). Extrapolated area calculated as (AUC(0-∞) - AUC(0-t))/ AUC(0-∞)', 'timeFrame': 'At pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 20, 24, 30, 36, 48, 72, 96 hours post-dose'}, {'measure': 'tmax', 'description': 'Time to achieve Cmax of plasma trazodone (free base)', 'timeFrame': 'At pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 20, 24, 30, 36, 48, 72, 96 hours post-dose'}, {'measure': 'tlag', 'description': 'Lag-time observed from the dosing time point prior to that of the first measurable plasma concentration (≥ LLOQ) (tlag ≥ 0) of plasma trazodone (free base)', 'timeFrame': 'At pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 20, 24, 30, 36, 48, 72, 96 hours post-dose'}, {'measure': 'λz', 'description': 'λz is apparent terminal elimination rate constant, calculated, if feasible, by log-linear regression using at least 3 points of plasma trazodone (free base)', 'timeFrame': 'At pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 20, 24, 30, 36, 48, 72, 96 hours post-dose'}, {'measure': 't1/2', 'description': 'Apparent terminal elimination half-life, calculated, if feasible, as ln2/λz,', 'timeFrame': 'At pre-dose (0) and 0.5, 1, 2, 3, 4, 5, 6, 8, 9, 10, 11, 12, 14, 16, 20, 24, 30, 36, 48, 72, 96 hours post-dose'}]" 340,NCT04941716,"{'fullName': 'Fred Hutchinson Cancer Center', 'class': 'OTHER'}","Acalabrutinib in Combination With Venetoclax for the Treatment of Refractory or Recurrent Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, The AVENUE-2 Trial",RECRUITING,"This phase II trial is to evaluate the effects of acalabrutinib in combination with venetoclax in treating patients with chronic lymphocytic leukemia or small lymphocytic lymphoma that does not respond to treatment (refractory) or that has come back (recurrent). Acalabrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Given acalabrutinib and venetoclax may kill more cancer cells.","['Recurrent Chronic Lymphocytic Leukemia', 'Recurrent Small Lymphocytic Lymphoma', 'Refractory Chronic Lymphocytic Leukemia', 'Refractory Small Lymphocytic Lymphoma']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Acalabrutinib', 'description': 'Given PO', 'armGroupLabels': ['Treatment (acalabrutinib, venetoclax)'], 'otherNames': ['ACP-196', 'Bruton Tyrosine Kinase Inhibitor ACP-196', 'Calquence']}, {'type': 'DRUG', 'name': 'Venetoclax', 'description': 'Given PO', 'armGroupLabels': ['Treatment (acalabrutinib, venetoclax)'], 'otherNames': ['ABT-0199', 'ABT-199', 'ABT199', 'GDC-0199', 'RG7601', 'Venclexta', 'Venclyxto']}, {'type': 'PROCEDURE', 'name': 'Biospecimen Collection', 'description': 'Undergo blood sample collection', 'armGroupLabels': ['Treatment (acalabrutinib, venetoclax)']}, {'type': 'PROCEDURE', 'name': 'Bone Marrow Aspiration', 'description': 'Undergo bone marrow aspiration and biopsy', 'armGroupLabels': ['Treatment (acalabrutinib, venetoclax)']}, {'type': 'PROCEDURE', 'name': 'Bone Marrow Biopsy', 'description': 'Undergo bone marrow aspiration and biopsy', 'armGroupLabels': ['Treatment (acalabrutinib, venetoclax)']}, {'type': 'PROCEDURE', 'name': 'Computed Tomography', 'description': 'Undergo CT', 'armGroupLabels': ['Treatment (acalabrutinib, venetoclax)'], 'otherNames': ['CT Scan', 'CAT Scan', 'Computed Axial Tomography']}, {'type': 'PROCEDURE', 'name': 'Magnetic Resonance Imaging', 'description': 'Undergo MRI', 'armGroupLabels': ['Treatment (acalabrutinib, venetoclax)'], 'otherNames': ['MRI']}]","Inclusion Criteria: * Men and women \>= 18 years of age. * Diagnosis of CLL or small lymphocytic lymphoma (SLL) that meets the published diagnostic criteria. * Active disease per IWCLL 2018 criteria that require treatment. At least one of the following: * Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia and/or thrombocytopenia * Massive (\> 6 cm below left costal margin), progressive, or symptomatic splenomegaly * Massive nodes (\> 10 cm in longest diameter), or progressive or symptomatic lymphadenopathy * Progressive lymphocytosis with an increase of \> 50% over a 2-month period or lymphocyte-doubling time of \< 6 months. Lymphocyte-doubling time may be obtained by linear regression extrapolation of absolute lymphocyte counts obtained at intervals of 2 weeks over an observation period of 2 to 3 months. In patients with initial blood lymphocyte counts of \< 30 x 109/L lymphocyte-doubling time should not be used as a single parameter to define treatment indication. In addition, factors contributing to lymphocytosis or lymphadenopathy other than CLL/SLL (e.g., infection) should be excluded. * Constitutional symptoms, defined as any 1 or more of the following disease-related symptoms or signs * Unintentional weight loss of \> 10% within the previous 6 months * Significant fatigue * Fevers \> 100.5 degrees Fahrenheit (F) or 38 degrees Celsius (C) for 2 weeks without other evidence of infection * Night sweats for \> 1 month without evidence of infection * Relapsed or refractory to at least 1 prior systemic therapy for CLL/SLL. A line of therapy is defined as completing at least 2 cycles of treatment of standard regimen according to current National Comprehensive Cancer Network (NCCN) guidelines, or of an investigational regimen on a clinical trial. * Absolute neutrophil count (ANC) \>= 750 cells/microliter (0.75 x 10\^9/L); ANC \>= 500 cells/microliter (0.50 x 10\^9/L) in subjects with documented bone marrow involvement of CLL (independent of growth factor or transfusion support within 1 week of screening). * Hemoglobin \>= 10 g/dL (independent of growth factor or transfusion support within 1 week of screening). * Platelet count \>= 50,000 cells/microliter (50 x 10\^9/L); platelet count \>= 25,000 cells/microliter (25 x 10\^9/L) in subjects with documented bone marrow involvement of CLL (independent of growth factor or transfusion support within 1 week of screening). * Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN) * Total bilirubin =\< 2 x ULN, unless directly attributable to Gilbert's syndrome * Estimated creatinine clearance of \>= 50 mL/min * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Women of childbearing potential (WOCBP) who are sexually active must use highly effective methods of contraception during treatment and for 30 days after the last dose of acalabrutinib or venetoclax, whichever occurs later * Willing and able to participate in all required evaluations and procedures in this study protocol, including swallowing capsules or tablets without difficulty * Ability to understand the purpose and the risks of the study and provide signed and dated informed consent and authorization to use protected health information Exclusion Criteria: * Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation (biopsy based on clinical suspicion may be needed to rule out transformation) * Prior disease progression while on a BTK inhibitor * Prior disease progression while on venetoclax * Prior intolerance to acalabrutinib or venetoclax * Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, low-grade prostate carcinoma (Gleason grade =\< 6) or other cancer from which the subject has been disease free for \>= 2 years or which will not limit survival to \< 3 years * Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac diseases as defined by the New York Heart Association Functional Classification, or corrected QT interval (QTc) \> 480 msec at screening. Subjects with controlled, asymptomatic atrial fibrillation during screening can enroll on study. * Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass. Patients with history of such operations are eligible if in treating physician's opinion they have no absorption issues. * Known history of drug-specific hypersensitivity or anaphylaxis to acalabrutinib or venetoclax * Active bleeding or history of bleeding diathesis (e.g. hemophilia or von Willebrand disease), or requires/is receiving anticoagulation with warfarin or equivalent vitamin K antagonists * Prothrombin time (PT)/international normalized ratio (INR) or activated partial thromboplastic time (aPTT) (in the absence of lupus anticoagulant) \> 2 x ULN * Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP) * Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening * Requires treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor or inducers. The use of strong or moderate CYP3A inhibitors or inducers within 7 days of the first dose of study drug is prohibited. * For patients receiving capsule formulation of acalabrutinib only: Requires treatment with proton pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole) at the time of enrollment. Subjects receiving proton pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment to this study. * History of significant cerebrovascular disease/event, including stroke or intracranial hemorrhage, within 6 months before the first dose of study drug * Major surgical procedure within 7 days of first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the first dose of study drug * Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR). Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded. Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded. * Breastfeeding or pregnant * Concurrent participation in another therapeutic clinical trial * Known history of infection with human immunodeficiency virus (HIV) or any active significant infection (e.g,. bacterial, viral, or fungal) * History of or ongoing confirmed central nervous system (CNS) CLL * History of confirmed progressive multifocal leukoencephalopathy (PML)",NA,ALL,NA,"[{'measure': 'Rate of undetectable measurable residual disease (uMRD)', 'description': 'MRD will be assessed using multicolor flow cytometry (sensitivity 10\\^-4) (uMRD4) from peripheral blood (PB).', 'timeFrame': 'At the end of treatment (26 cycles, 1 cycle = 28 days)'}]","[{'measure': 'Overall response rate (ORR)', 'description': 'Evaluated as defined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018.', 'timeFrame': 'Up to 10 years'}, {'measure': 'Complete response (CR)', 'description': 'Evaluated as defined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018.', 'timeFrame': 'Up to 10 years'}, {'measure': 'Partial response (PR)', 'description': 'Evaluated as defined by International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018.', 'timeFrame': 'Up to 10 years'}, {'measure': 'Progression-free survival (PFS)', 'description': 'Kaplan-Meier curves and median time-to-event estimation with 95% confidence intervals will be presented.', 'timeFrame': 'Time from receiving the first treatment to the first observation of disease progression or death from any cause, whichever occurs first, assessed up to 10 years'}, {'measure': 'Overall survival (OS)', 'description': 'Kaplan-Meier curves and median time-to-event estimation with 95% confidence intervals will be presented.', 'timeFrame': 'Time from receiving the first treatment to death from any cause, assessed up to 10 years'}, {'measure': 'Toxicity of combination', 'description': 'Defined as grade 3-4 hematologic and non-hematologic malignancies.', 'timeFrame': 'Up to 10 years'}]" 341,NCT04271215,"{'fullName': 'Coordinación de Investigación en Salud, Mexico', 'class': 'OTHER_GOV'}",Overweight and Obesity as Prognostic Factors for Survival in Children With Acute Lymphoblastic Leukemia,UNKNOWN,"Background: Mexico City has one of the highest incidences and mortality rates of acute lymphoblastic leukemia (ALL) in the world and a high frequency of early relapses (17%) and early mortality (15%). Otherwise, childhood overweight and obesity are reaching epidemic proportions. They have been associated with poor outcomes in children with ALL. The aim of present study is to identify if overweight and obesity are prognostic factors associated with survival rates in Mexican children with ALL. Methods: Multicenter cohort study. ALL children younger than 15 years old are included and followed-up. Overweight and obesity are classified according World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) criteria. Deaths and relapses are the main outcomes.","['Leukemia, Lymphoblastic']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'OTHER'}","[{'type': 'OTHER', 'name': 'Chemotherapy protocol used', 'description': 'Chemotherapy protocol used in each participating hospital', 'armGroupLabels': ['Overweight/Obesity']}]","Inclusion Criteria: * Patients under 15 years of age * Newly diagnosed with acute lymphoblastic leukemia * Diagnosis confirmation by bone marrow aspiration and immunophenotype * Attended in the participating Hospitals. Exclusion Criteria: \- Patients with Down Syndrome (for being a population with different disease behavior and cytogenetic alterations than patients without this genetic condition)","The study variables and data will be collected from the clinical files. The information collected by the surveyors will be delivered weekly to our Research Unit, where the field work coordinators will be in charge of assigning them a folio number, reviewing the collection instrument and passing it on to the personnel in charge of capturing the information. In addition, the fieldwork coordinators will supervise the collection of information, the search for files in the archive, the capture of information and will be responsible for keeping the project's database up to date.",ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Overall survival', 'description': 'Deaths of patients occurring during the follow-up period will be collected. The cause of death and the date that this occurred will be also registered. In the case of patients alive at the end of follow-up, the date of the last visit to the hospital will be collected.', 'timeFrame': 'year 5'}, {'measure': 'Disease-free survival', 'description': 'Clinical data and by complementary examinations indicating that there is reappearance of the disease after complete remission has been achieved, presence of blasts \\> 5% in bone marrow (bone marrow relapse) or presence of blasts in cerebrospinal fluid fluid (CNS relapse), testicular infiltration by blasts in the biopsy (testicular relapse), combined (bone marrow/CNS) at any time during treatment . In case the patient has relapsed, the site of relapse will be collected (bone marrow, CNS, testicle, ovary, eye, etc.).', 'timeFrame': 'year 5'}]",NA 342,NCT04685915,"{'fullName': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}",Copanlisib Plus Ibrutinib or Acalabrutinib in R/R CLL,WITHDRAWN,"This research study is examining the effect of adding a fixed duration of copanlisib to ibrutinib or acalabrutinib in select participants who have been on ibrutinib or acalabrutinib for at least six months for relapsed/refractory chronic lymphocytic leukemia (CLL). The names of the study drugs involved in this study are: * Copanlisib * Ibrutinib * Acalabrutinib",['Chronic Lymphocytic Leukemia (CLL)'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Ibrutinib', 'description': 'Capsule, taken by mouth once daily', 'armGroupLabels': ['Addition of copanlisib to either ibrutinib or acalabrutinib'], 'otherNames': ['Imbruvica']}, {'type': 'DRUG', 'name': 'Copanlisib', 'description': 'Intravenous Infusion', 'armGroupLabels': ['Addition of copanlisib to either ibrutinib or acalabrutinib'], 'otherNames': ['Aliqopa']}, {'type': 'DRUG', 'name': 'Acalabrutinib', 'description': 'Capsule, taken by mouth twice daily', 'armGroupLabels': ['Addition of copanlisib to either ibrutinib or acalabrutinib'], 'otherNames': ['Calquence']}]","Inclusion Criteria: * Must have a confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma as per 2018 IWCLL criteria with evidence of persistent disease, defined as measurable adenopathy or splenomegaly, circulating disease, or marrow disease * On ibrutinib or acalabrutinib which was instituted due to patient previously meeting 2018 IWCLL criteria for treatment, started at least 6 months prior to study entry for any patient who have received at least one prior line of therapy prior to ibrutinib or acalabrutinib. Reduced dose of ibrutinib or acalabrutinib is allowed as long as the dose has been stable for at least 4 weeks and all toxicities are ≤ grade 1 * Must have achieved either SD, PR or PR-L on ibrutinib or acalabrutinib by 2018 IWCLL criteria * ECOG performance status \< 2 * Patients must meet the following hematologic criteria at screening, unless they have significant bone marrow involvement of CLL confirmed on biopsy: * Absolute neutrophil count ≥500 cells/mm3 (0.5 x 109/L). Growth factor is allowed in order to achieve this * Platelet count ≥50,000 cells/mm3 independent of transfusion within 7 days of screening * Adequate hepatic function defined as: Serum aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x upper limit of normal (ULN), bilirubin ≤2.0 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin including hemolysis) * Adequate renal function defined by serum creatinine ≤1.5 x ULN or creatinine clearance (by Cockroft-Gauldt ≥ 50 ml/min * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Patients receiving cancer therapy (i.e., chemotherapy, radiation therapy, immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization) other than ibrutinib or acalabrutinib within 2 weeks of Cycle 1/Day 1 with the following exceptions: * Limited palliative radiation is allowed if completed \> 1 weeks of C1D1 * Hormonal therapy given in the adjuvant setting * Corticosteroid therapy (prednisone or equivalent \<15 mg daily) is allowed as clinically warranted as long as the dose is stabilized at least for 7 days prior to initial dosing.Topical or inhaled corticosteroids are permitted * Within six months of allogeneic hematologic stem cell transplant at the time of starting study treatment or active graft vs. host disease requiring systemic treatment or prophylaxis within 6 weeks of starting study treatment * Prior treatment with copanlisib * Patients in CR on ibrutinib or acalabrutinib * History of other malignancies, except: * Malignancy treated with curative intent and with no known active disease present for ≥2 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease * Adequately treated carcinoma in situ without evidence of disease. * Low-risk prostate cancer on active surveillance * Vaccinated with live, attenuated vaccines \<4 weeks before first dose of study drug * Active autoimmune disease requiring systemic treatment * Recent infection requiring intravenous antibiotics that was completed ≤7 days before the first dose of study drug, or any uncontrolled active systemic infection * Known bleeding disorders (eg, von Willebrand's disease) or hemophilia * History of stroke or intracranial hemorrhage within 6 months prior to enrollment * Human immunodeficiency virus (HIV) or active hepatitis C virus (HCV) or hepatitis B virus (HBV) infection * CMV PCR positive at baseline * Major surgery within 4 weeks of first dose of study drug * History of or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator) * Concurrent diagnosis of pheochromocytoma * Uncontrolled arterial hypertension despite optimal medical management * Type 1 or type 2 diabetes mellitus with a HgbA1c \> 8.5% * Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety * Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization * Unable to swallow capsules or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction * Lactating or pregnant * Patients with known CNS involvement * Concurrent administration of medications or foods that are strong inhibitors or inducers of CYP3A * Known hypersensitivity to copanlisib, ibrutinib, or acalabrutinib",NA,ALL,NA,"[{'measure': 'Complete response (CR) Rate', 'description': 'Rate of complete response (CR) by 2018 IWCLL criteria following the addition of six months of copanlisib to the therapy of patients with SD or PR or PR-L on ibrutinib or acalabrutinib in the relapsed/refractory setting.', 'timeFrame': '6 months'}]","[{'measure': 'Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE ver. 5.0.', 'description': 'Adverse events will be collected and reported as percentages', 'timeFrame': '6 months'}, {'measure': 'Duration of Response (DOR)', 'description': 'Legnth of time the patients respond to therapy', 'timeFrame': '3 years'}, {'measure': 'Progression-free Survival (PFS)', 'description': 'The time from registration to progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation.', 'timeFrame': '3 years'}, {'measure': 'Overall Survival (OS)', 'description': 'The time from registration to death due to any cause or censored at date last known alive.', 'timeFrame': '3 years'}]" 343,NCT01757535,"{'fullName': 'Celgene', 'class': 'INDUSTRY'}",Efficacy of Oral Azacitidine Plus Best Supportive Care as Maintenance Therapy in Subjects With Acute Myeloid Leukemia (AML) in Complete Remission,COMPLETED,"This study enrolled 472 participants, aged 55 or older, with a diagnosis of de novo acute myeloid leukemia (AML) or AML secondary to prior myelodysplastic disease or chronic myelomonocytic leukemia (CMML), and who have achieved first complete remission (CR)/ complete remission with incomplete blood count recovery (CRi) following induction with or without consolidation chemotherapy. The study is amended to include an extension phase (EP). The EP allows participants who are currently receiving oral azacitidine and who are demonstrating clinical benefit as assessed by the investigator, to continue receiving oral azacitidine after unblinding by sponsor until the participant meets the criteria for study discontinuation or until oral azacitidine becomes commercially available and reimbursed. In addition, all participants in the placebo arm and participants who had been discontinued from the treatment phase (irrespective of randomization arm) and continuing in the follow-up phase will be followed for survival in the EP.","['Leukemia, Myeloid, Acute']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}","[{'type': 'DRUG', 'name': 'Oral Azacitidine', 'description': '300 mg oral azacitidine on days 1 to 14 of each 28-day treatment cycle.', 'armGroupLabels': ['Oral Azacitidine'], 'otherNames': ['CC-486; Onureg®']}, {'type': 'DRUG', 'name': 'Placebo', 'description': 'Identically matching placebo tablets on days 1 to 14 of each 28-day treatment cycle.', 'armGroupLabels': ['Placebo']}]","Key Inclusion Criteria: 1. Male or female participants ≥ 55 years of age 2. Newly diagnosed, histologically confirmed de novo acute myeloid leukemia (AML) or AML secondary to prior myelodysplastic disease or CMML (Chronic myelomonocytic leukemia) 3. First complete remission (CR)/ complete remission with incomplete blood count recovery (CRi) with induction therapy with intensive chemotherapy with or without consolidation therapy within 4 months (+/- 7 days of achieving CR or CRi) 4. Eastern Cooperative Oncology Group (ECOG) performance status - 0, 1, 2, 3 Key Inclusion Criteria in the Extended Phase of the study: At the Investigator's discretion and with approval of the sponsor, participants meeting all of the following eligibility criteria are eligible to enter the extension phase: 1. All participants randomized into the oral azacitidine or placebo arm and are continuing in either the treatment phase or follow-up phase of the CC-486-AML-001 study; * Participants randomized to oral azacitidine treatment arm and continuing in the treatment phase demonstrating clinical benefit as assessed by the investigator are eligible to receive oral azacitidine in the extension phase (EP); * Participants randomized into placebo arm of the study will not receive oral azacitidine in the EP, but will be followed for survival in the EP; * Participants currently in the follow-up phase will continue to be followed for survival in the EP; 2. Participants who have signed the informed consent for the EP of the study; 3. Participants who do not meet any of the criteria for study discontinuation Key Exclusion Criteria: 1. AML with inversion (inv)(16), translocation = t(8;21), t(16;16), t(15;17), or t(9;22) or molecular evidence of such translocations 2. Prior bone marrow or stem cell transplantation 3. Have achieved CR/CRi following therapy with hypomethylating agents 4. Diagnosis of malignant disease within the previous 12 months 5. Proven central nervous system (CNS) leukemia",NA,ALL,NA,"[{'measure': 'Kaplan-Meier (K-M) Estimate for Overall Survival (OS)', 'description': 'Overall survival was defined as time from randomization to death from any cause; participants surviving at the end of the follow-up period, or who withdraw consent, or who were lost to follow up were censored at the date last known alive.', 'timeFrame': 'Day 1 (randomization) up to data cut off date of 15 July 2019; median follow-up for OS estimated by the reverse K-M method was 41.2 months for all participants.'}]","[{'measure': 'Kaplan-Meier Estimate of Relapse Free Survival (RFS)', 'description': 'RFS was defined as the time from the date of randomization to the date of documented relapse or death from any cause, whichever occurred first. Participants who were still alive without documented relapse, or who were lost to follow-up or withdrew consent without documented relapse, were censored at the date of their last bone marrow assessment, prior to receiving any other therapy for AML. Documented relapse was defined as the earliest date of the following: • ≥ 5% bone marrow blasts (myeloblasts) from Central Pathology report, or • appearance of \\> 0% blasts in the peripheral blood with a later bone marrow confirmation (bone marrow blast \\[myeloblasts\\] ≥ 5%) within 100 days, or • at least 2 peripheral blasts ≥ 5% within 30 days.', 'timeFrame': 'From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months'}, {'measure': 'Kaplan-Meier Estimate of Time to Relapse', 'description': 'Time to relapse was defined as the interval (in months) from the date of randomization to the date of documented relapse. Estimates of relapse rate were based on the cumulative incidence function from a competing risk analysis with death as a competing risk for relapse from complete remission (CR)/ complete remission with incomplete blood count recovery (CRi). Documented relapse was defined as, the earliest date of the following: • ≥ 5% bone marrow blasts (myeloblasts) from Central Pathology report, or • appearance of \\> 0% blasts in the peripheral blood with a later bone marrow confirmation (bone marrow blast \\[myeloblasts\\] ≥ 5%) within 100 days, or • at least 2 peripheral blasts ≥ 5% within 30 days.', 'timeFrame': 'From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months'}, {'measure': 'Kaplan-Meier Estimates of Time to Discontinuation From Treatment', 'description': 'Time to discontinuation from treatment was assessed and defined as the interval from the date of randomization to the date of discontinuation from study drug. Participants who were receiving treatment at the time of study closure were censored at the date of last visit. Estimates of relapse rate were based on the cumulative incidence function from a competing risk analysis with death as a competing risk for relapse from CR/ CRi.', 'timeFrame': 'From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'description': 'TEAEs include AEs that started between first dose date and 28 days after the last dose of study drug. A serious adverse event (SAE) is: • Death • Life-threatening event • Inpatient hospitalization or prolongation of existing hospitalization • Persistent or significant disability or incapacity • Congenital anomaly or birth defect • Other important medical event The severity of AEs were assessed by the investigator according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0: Grade 1 (Mild): asymptomatic/mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 (Moderate): minimal, local or noninvasive intervention indicated; limiting age-appropriate activities of daily living. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care Grade 4: Life-threatening; urgent intervention indicated. Grade 5: Death due to AE.', 'timeFrame': 'From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months'}, {'measure': 'Mean Change in the Functional Assessment of Chronic Illness Therapy (FACIT-Fatigue Scale V 4.0) Score From Baseline', 'description': 'The functional assessment of chronic illness therapy (FACIT-Fatigue Scale V 4.0) is a subscale of the FACIT-F and has been validated in the oncology setting. The FACIT-Fatigue Scale is a short, 13-item, self-administered tool that measures the level of fatigue in an individual during usually daily activities over the past week. The level of fatigue is measured on a 5-point Likert scale (0 = not at all; 4 = very much. The scores range from 0 to 52, with higher scores indicating less fatigue. If there were missing items, but the participant answered at least 50% of the items, then subscores were prorated.', 'timeFrame': 'From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months'}, {'measure': 'Mean Change in the European Quality of Life-Five Dimensions-Three Levels (EQ-5D-3L) Score From Baseline', 'description': ""The EQ-5D-3L is a self-administered questionnaire consisting of 5 questions, pertaining to specific health dimensions (ie, mobility, self-care, pain, usual activities, and anxiety/depression) and a health status scale. Each question has 3 levels of severity, corresponding to no problems, moderate problems and severe problems. Canadian population sample weights were used to derive health utility scores. A higher utility score represents a better health state. A clinically meaningful improvement or worsening was defined as at least 0.08 points of improvement or 0.10 points of worsening from baseline, respectively, for the EQ-5D-3L Health Utility Index. The instrument is scored using the United Kingdom (UK) index ranges from -0.594 to 1, where 0 equates to death and 1 equates to full health; -0.594 is considered 'worse than death'."", 'timeFrame': 'From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months'}, {'measure': 'Time to Definitive Clinically Meaningful Deterioration for ≥ 2 Consecutive Visits as Measured Using the EQ-5D HRQoL Scale', 'description': ""Clinically meaningful deterioration was defined at least 0.10 point of deterioration from baseline for at least 2 consecutive visits for the EQ-5D Health Utility Index. The EQ-5D-3L is a self-administered questionnaire consisting of 5 questions, pertaining to specific health dimensions (ie, mobility, self-care, pain, usual activities, and anxiety/depression) and a health status scale. Each question has 3 levels of severity, corresponding to no problems, moderate problems and severe problems. Canadian population sample weights were used to derive health utility scores. A higher utility score represents a better health state. A clinically meaningful improvement or worsening was defined as at least 0.08 points of improvement or 0.10 points of worsening from baseline, respectively, for the EQ-5D-3L Health Utility Index. The EQ-5D-3L is scored using the UK index ranges from -0.594 to 1, where 0 equates to death and 1 equates to full health; -0.594 is considered 'worse than death'."", 'timeFrame': 'From day 1 (randomization) up to data cut off date of 15 July 2019; approximately 74 months'}, {'measure': 'Healthcare Resource Utilization (HRU): Rate of Hospital Events Per Person Year', 'description': 'HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective.', 'timeFrame': 'From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months'}, {'measure': 'Healthcare Resource Utilization (HRU): Number of Days Hospitalized Per Person-Year', 'description': 'HRU is defined as any consumption of healthcare resources directly or indirectly related to the treatment of the patient. HRU is a key component to understand treatment costs and budget impact of new treatments from a provider perspective.', 'timeFrame': 'From day 1 (randomization) up to data cut off date of 06 August 2024; approximately 135.5 months'}]" 344,NCT01885689,"{'fullName': 'City of Hope Medical Center', 'class': 'OTHER'}","Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia",ACTIVE_NOT_RECRUITING,"This phase II trial studies how well clofarabine and melphalan before a donor stem cell transplant works in treating patients with a decrease in or disappearance of signs and symptoms of myelodysplasia or acute leukemia (disease is in remission), or chronic myelomonocytic leukemia. Giving chemotherapy, such as clofarabine and melphalan, before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into a patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Giving clofarabine and melphalan before transplant may help prevent the cancer from coming back after transplant, and they may cause fewer side effects than standard treatment.","['Adult Acute Lymphoblastic Leukemia in Remission', 'Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome', 'Adult Acute Myeloid Leukemia in Remission', 'Myelodysplastic Syndrome', 'Secondary Myelodysplastic Syndrome', 'Chronic Myelomonocytic Leukemia', 'Therapy-Related Myelodysplastic Syndrome']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'clofarabine', 'description': 'Given IV', 'armGroupLabels': ['Treatment (clofarabine, melphalan, transplant)'], 'otherNames': ['CAFdA', 'Clofarex', 'Clolar']}, {'type': 'DRUG', 'name': 'melphalan', 'description': 'Given IV', 'armGroupLabels': ['Treatment (clofarabine, melphalan, transplant)'], 'otherNames': ['Alkeran', 'CB-3025', 'L-PAM', 'L-phenylalanine mustard', 'L-Sarcolysin']}, {'type': 'PROCEDURE', 'name': 'allogeneic hematopoietic stem cell transplantation', 'description': 'Undergo allogeneic hematopoietic stem cell transplant', 'armGroupLabels': ['Treatment (clofarabine, melphalan, transplant)']}, {'type': 'DRUG', 'name': 'tacrolimus', 'description': 'Given IV or PO', 'armGroupLabels': ['Treatment (clofarabine, melphalan, transplant)'], 'otherNames': ['FK 506', 'Prograf']}, {'type': 'DRUG', 'name': 'sirolimus', 'description': 'Given PO', 'armGroupLabels': ['Treatment (clofarabine, melphalan, transplant)'], 'otherNames': ['AY 22989', 'Rapamune', 'rapamycin', 'SLM']}, {'type': 'OTHER', 'name': 'Pharmacological Study', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (clofarabine, melphalan, transplant)']}]","Inclusion Criteria: * Patients in 1st or 2nd remission with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL), who are eligible for stem cell transplant. Remission defined as no circulating blasts, \< 5% blasts in the bone marrow, normalization of previously detected cytogenetic abnormalities, no extramedullary disease * High risk myelodysplastic syndrome (MDS) * Intermediate II and high risk by International Prognostic Scoring System (IPSS) * Intermediate, high, or very high by World Health Organization (WHO) classification-based Prognostic Scoring System (WPSS) * Transfusion dependent * Therapy-related MDS or MDS evolved from previous hematological disorder (excepting myelofibrosis) * Patients with chronic myelomonocytic leukemia (CMML) are allowed to be enrolled * Patients with MDS that has evolved to AML must be in remission * Patients must not be eligible for full ablative regimens by the attending physician * Patients with AML or MDS arising from myeloproliferative neoplasm can be enrolled after principal investigator (PI) approval on case to case basis, depends on the spleen size and degree of bone marrow fibrosis * Performance status of \>= 70% on the Karnofsky scale * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect she is pregnant while participating on the trial, she should inform her treating physician immediately * Bone marrow and peripheral blood studies must be available for confirmation of diagnosis; cytogenetics, flow cytometry, and molecular studies (such as Flt-3 status) will be obtained as per standard practice * Bone marrow aspirates/biopsies should be performed within 28 (+ 4 day window) days from registration to confirm disease remission status * A pretreatment measured creatinine clearance (absolute value) of \>= 60 mL/minute * Patients must have a serum bilirubin =\< 2.0 mg/dl * Patients must have serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =\< 2.5 times the institutional upper limit of normal * Ejection fraction measured by echocardiogram or multi gated acquisition scan (MUGA) \> 50% * Diffusing capacity of the lung for carbon monoxide (DLCO) or forced expiratory volume in 1 second (FEV1) \> 45% predicted * Availability of a human leukocyte antigen (HLA) matched (6/6) sibling donor or 8/8 matched unrelated donor; Donors with mismatch at HLA-A, HLA-B, HLA-C, and HLA-DR will be reviewed by matched unrelated donor (MUD) committee and allowed if their mismatch with the recipient does not require additional GVHD prophylaxis (other than tacrolimus and sirolimus), donors with mismatch at HLA-DQ or HLA-DPB are eligible; donor evaluation according to City of Hope (COH) standard operating procedure (SOP) * Donor stem cell source can be either peripheral blood or bone marrow * All patients must have a psychosocial evaluation prior to transplant as per COH SOP * All subjects must have the ability to understand and the willingness to sign a written informed consent * ALL or AML patients who received chemotherapy (induction or consolidation) can proceed to transplant once bone marrow cellularity is \> 10 % with no evidence of leukemia Exclusion Criteria: * Patients who have received a prior autologous or allogeneic transplant are excluded * Patients with significant hepatic dysfunction (not meeting liver function tests \[LFT\] eligibility criteria) * Patients with MDS evolved into AML that is not in remission * Patients with acute promyelocytic leukemia * Patients with myeloproliferative neoplasms * Patients with suspected or proven central nervous system (CNS) leukemia; (diagnostic lumbar puncture not required before enrollment) * Uncontrolled intercurrent illness including, but not limited to ongoing or active or poorly controlled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, poorly controlled pulmonary disease or psychiatric illness/social situations that would limit compliance with study requirements * Pregnant and lactating women are excluded from this study * Patients who do not agree to practice effective forms of contraception * Human immunodeficiency virus (HIV)-positive patients are excluded from this study * Patients are excluded if they are hepatitis B surface antigen (sAg), hepatitis B (Hep B) core antibody (cAb), or hepatitis C (Hep C) positive. Patients with Hepatitis B cAB positive and Hepatitis B PCR negative are eligible if they started prophylactic treatment prior to registration to trial * Patients who have received radiation therapy as part of their leukemia treatment may be ineligible and individual cases must be presented to the study principal investigator (PI) for determination of eligibility * Any psychiatric, social or compliance issues that, in the treating physician's opinion, will interfere with completion of the transplant treatment and follow up * Medical or psychiatric reasons which make the donor unlikely to tolerate or cooperate with filgrastim (G-CSF) therapy or leukapheresis or bone marrow harvest * Known allergies to clofarabine, melphalan, sirolimus or tacrolimus * Patients with other active malignancies (besides AML, ALL, MDS) requiring treatment or where there is concern of progression are ineligible for this study; however, patients with previously treated skin cancer, early stage cervical or prostate cancer may be eligible if there is no evidence of residual disease * Cord blood as a donor source is not acceptable * Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study",NA,ALL,NA,"[{'measure': 'Progression-free Survival at 2 Years', 'description': ""Progression-free survival (PFS) is defined as time from start of protocol treatment to disease relapse/progression, death or last contact, whichever occurs first. Progression-free survival was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula."", 'timeFrame': 'From start of protocol treatment to death due to any cause, disease relapse/progression, or last follow-up, whichever comes first, assessed up to 2 years.'}]","[{'measure': 'Overall Survival at 2 Years', 'description': ""Overall survival (OS) is defined as time from start of protocol treatment to death from any cause. It was estimated using the Kaplan-Meier method; the 95% confidence interval was calculated using Greenwood's formula."", 'timeFrame': 'From start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 2 years.'}]" 345,NCT06889168,"{'fullName': 'Columbia University', 'class': 'OTHER'}",Evaluating the Long-term Safety and Tolerability of Imatinib in Patients With Lymphangioleiomyomatosis (LAM),RECRUITING,"Lymphangioleiomyomatosis (LAM) is a rare cystic lung disease that appears to behave like a slowly growing cancer. Since clinical progression is very slow, new blood tests have been used to speed the time required to find safe and effective medications. A large National Institute of Health study called MILES showed that sirolimus (also known as Rapamycin) improved lung function in individuals with LAM. Since most individuals with LAM and impaired lung function are now on sirolimus, future studies may prove more difficult. Laboratory studies suggested that Imatinib mesylate (imatinib), an FDA-approved drug for leukemia, initiates LAM cell death. A pilot trial with imatinib titled ""Imatinib Mesylate for the treatment of Lymphangioleiomyomatosis"" - (LAMP-1) was funded by the Department of Defense in 2016, and documented (1) the safety of use of tyrosine kinase inhibitors in patients with LAM; (2) the safety of concurrent use of tyrosine kinase and mTOR inhibitors; and, (3) short term variability in vascular endothelial growth factor D (VEGF-D) - a LAM biomarker, as a response to therapies. Due to the short-term LAMP-1 trial, LAMP-2 will be a longer-term 6-month clinical study evaluating the safety and tolerability of imatinib in patients with LAM. Patients that participate in the trial will come in for 5 office visits and check-up phone calls every 2 weeks over the course of 6 months.","['Lymphangioleiomyomatosis (LAM)', 'Lymphangioleiomyomatosis']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'This study is double-blinded', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}","[{'type': 'DRUG', 'name': 'Imatimib Mesylate', 'description': 'Participants will take Imatinib mesylate (imatinib), an FDA approved drug for leukemia, orally 400 mg (twice daily)', 'armGroupLabels': ['Imatinib Mesylate Group'], 'otherNames': ['Gleevec®', 'imatinib']}, {'type': 'DRUG', 'name': 'Placebo', 'description': 'Placebo will be administered in the same dosage and manner as the study drug. The placebo looks like the study drug but contains no active ingredients.', 'armGroupLabels': ['Placebo Group']}]","Inclusion Criteria: * Women 18 through 64 years of age (inclusive) * Pulmonary Function Test (PFT) with following criteria: 1. DLCO \>20% predicted and FVC \<90% OR 2. Post bronchodilator FEV1 between 30% and 90% predicted. * Confirmed or possible diagnosis of LAM * Willing to avoid grapefruit juice and St. John's wort while in the study * Able and willing to comply with the study procedures Exclusion Criteria: * Women who have or will undergo a transplant * Women who will undergo surgery * Women who are currently pregnant or plan on a pregnancy * Women who are currently breast feeding or lactating * Dementia or other cognitive dysfunction that, in the opinion of the investigator, would prevent the participant from consenting to the study or completing study procedures * Currently taking any of the following medications: * Antifungal Medications: Ketoconazole; Itraconazole ; Voriconazole. * Antibiotics for bacterial infections: Clarithromycin. * Analgesics to treat headaches/migraines: Dihydroergotamine; Dihydroergotamine intranasal * Antiretroviral protease inhibitors used in human immunodeficiency virus (HIV) infections: Atazanavir ; Nelfinavir; Indinavir; Ritonavir; Saquinavir * Anti-epileptic or seizure medications: Carbamazepine, Fosphenytoin; Oxcarbamazepine; Phenobarbital ; Phenytoin; Primidone * Anti-depressant medications: Nefazodone; St. John's wort * Targeted cancer drugs: Regorafenib; Venetoclax ; Cobimetinib * Ivabradine (used to treat chronic heart failure); Telithromycin (used to treat community acquired pneumonia); Lomitapide (treatment of familial hypercholesterolemia); Lonafarnib (Hutchinson-Gilford progeria syndrome); conivaptan (treat low sodium levels); flibanserin (management of hypoactive sexual desire disorder (HSDD)); Naloxegol (opioid-induced constipation); Warfarin (prevent blood clots); Lurasidone (schizophrenia and bipolar depression); Eliglustat (treatment of Gaucher's disease). * Non English speaking, illiterate, or other vulnerable persons will not be included among study subjects. * Any condition that in the opinion of the investigator might adversely influence the study outcome.",NA,FEMALE,NA,"[{'measure': 'Incidence of Adverse Events', 'description': 'To observe and compare the occurrence of adverse events experienced by participants receiving imatinib mesylate compared to placebo throughout the duration of the study.', 'timeFrame': '1 year'}]","[{'measure': 'Change in VEGF-D between study groups', 'description': 'To compare the change in the log-transformed level of VEGF-D from baseline to 6 months between imatinib mesylate and placebo groups.', 'timeFrame': 'Baseline, 6 months'}, {'measure': 'Change in Forced Vital Capacity (FVC) between study groups', 'description': 'To compare the change in Forced Vital Capacity (FVC) from baseline to 6 months between imatinib mesylate and placebo groups.', 'timeFrame': 'Baseline, 6 months'}, {'measure': 'Change in percent Forced Expiratory Volume in One Second (FEV1) between study groups', 'description': 'To compare the change in the percent predicted FEV1 (Forced expiratory volume in one second) using ""GLI other"" standards from baseline to 6 months between imatinib mesylate and placebo groups.', 'timeFrame': 'Baseline, 6 months'}, {'measure': 'Change in St. George Respiratory Questionnaire (SGRQ) score between study groups', 'description': 'To compare the change in the total score of the St. George Respiratory Questionnaire (SGRQ) from baseline to 6 months between imatinib mesylate and placebo groups. Scores range from 0 to 100, with 0 representing no health impairment and 100 representing maximum health impairment.', 'timeFrame': 'Baseline, 6 months'}]" 346,NCT02390635,"{'fullName': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}","PET/MRI, 18F-FDG PET/CT and Whole Body MRI in Finding Extramedullary Myeloid Leukemia in Patients With Newly Diagnosed Acute Myeloid Leukemia",RECRUITING,"This pilot phase I trial studies how well positron emission tomography (PET)/magnetic resonance imaging (MRI), fludeoxyglucose F-18 (18F-FDG) PET/computed tomography (CT), and whole body MRI work in finding extramedullary myeloid leukemia in patients with newly diagnosed acute myeloid leukemia. Extramedullary myeloid leukemia is a type of cancer found outside of the bone marrow and can be hard to detect with routine bone marrow monitoring, such as bone marrow aspirations. Diagnostic procedures, such as PET/MRI, 18F-FDG PET/CT and whole body MRI, may help find and diagnose extramedullary myeloid leukemia in patients with newly diagnosed acute myeloid leukemia.","['Acute Myeloid Leukemia', 'Acute Promyelocytic Leukemia With PML-RARA']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'PROCEDURE', 'name': 'Computed Tomography', 'description': 'Undergo 18F-FDG PET/CT', 'armGroupLabels': ['Diagnostic (18F-FDG PET/CT, whole body PET/MRI)'], 'otherNames': ['CAT', 'CAT Scan', 'Computerized Axial Tomography', 'computerized tomography', 'CT', 'CT SCAN', 'tomography']}, {'type': 'PROCEDURE', 'name': 'Diffusion Weighted Imaging', 'description': 'Undergo whole body PET/MRI', 'armGroupLabels': ['Diagnostic (18F-FDG PET/CT, whole body PET/MRI)'], 'otherNames': ['Diffusion Weighted MRI', 'Diffusion-Weighted Magnetic Resonance Imaging', 'Diffusion-Weighted MR Imaging', 'Diffusion-Weighted MRI', 'DW-MRI', 'DWI', 'DWI MRI', 'DWI-MRI', 'MR Diffusion-Weighted Imaging']}, {'type': 'RADIATION', 'name': 'Fludeoxyglucose F-18', 'description': 'Undergo 18F-FDG PET/CT', 'armGroupLabels': ['Diagnostic (18F-FDG PET/CT, whole body PET/MRI)'], 'otherNames': ['18FDG', 'FDG', 'Fludeoxyglucose (18F)', 'fludeoxyglucose F 18', 'Fludeoxyglucose F18', 'Fluorine-18 2-Fluoro-2-deoxy-D-Glucose', 'Fluorodeoxyglucose F18']}, {'type': 'DRUG', 'name': 'Gadolinium', 'description': 'Given IV', 'armGroupLabels': ['Diagnostic (18F-FDG PET/CT, whole body PET/MRI)'], 'otherNames': ['Gd']}, {'type': 'PROCEDURE', 'name': 'Magnetic Resonance Imaging', 'description': 'Undergo whole body PET/MRI', 'armGroupLabels': ['Diagnostic (18F-FDG PET/CT, whole body PET/MRI)'], 'otherNames': ['Magnetic Resonance Imaging Scan', 'Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance', 'MR Imaging', 'MRI', 'MRI Scan', 'NMR Imaging', 'NMRI', 'Nuclear Magnetic Resonance Imaging']}, {'type': 'PROCEDURE', 'name': 'Positron Emission Tomography', 'description': 'Undergo 18F-FDG PET/CT and whole body PET/MRI', 'armGroupLabels': ['Diagnostic (18F-FDG PET/CT, whole body PET/MRI)'], 'otherNames': ['Medical Imaging, Positron Emission Tomography', 'PET', 'PET Scan', 'Positron Emission Tomography Scan', 'Positron-Emission Tomography', 'proton magnetic resonance spectroscopic imaging']}, {'type': 'PROCEDURE', 'name': 'Three-Dimensional Spoiled Gradient MRI', 'description': 'Undergo whole body PET/MRI', 'armGroupLabels': ['Diagnostic (18F-FDG PET/CT, whole body PET/MRI)'], 'otherNames': ['3-Dimensional Fast Spoiled Gradient', '3D Fast Spoiled Gradient Recalled MRI', '3D FSPGR', '3DFSPGR', 'FSPGR', 'FSPGR MRI', 'SPGR', 'SPGR MRI', 'Three-Dimensional Spoiled Gradient-Echo MR']}]","Inclusion Criteria: * Patients with newly diagnosed AML * Non-English speaking subjects will be included. Verbal Translation Preparative Sheet (VTPS) short form will be utilized in consenting non-English speaking subjects. Exclusion Criteria: * Patients with contraindications to MR * Patients with a known allergy to MR contrast agents * Uncontrollable claustrophobia * Recipients of more than minimal anti-leukemia treatment, with minimal treatment defined as: leukapheresis, hydroxyurea, or Cytarabine more than 1 g per square meter. * Patients with secondary or relapsed AML or APL should be excluded. * Patients with known extramedullary leukemia * Positive pregnancy test in a female of childbearing potential * Younger than 18 years * Greater than 400 pounds in weight * Patients with uncontrolled diabetes * Cognitive impaired adults or prisoners will be excluded * Estimated glomerular filtration rate (eGFR \<30) will be excluded",NA,ALL,NA,"[{'measure': 'Incidence of extramedullary myeloid leukemia (EML)', 'description': 'Defined as increased fludeoxyglucose F-18 uptake on positron emission tomography (PET)/computed tomography and increased signal on T2 weighted imaging or diffusion weighted imaging and enhancement in soft tissue on whole body PET/magnetic resonance imaging. Estimates and 95% confidence intervals for the incidence of EML will be reported for each imaging modality based on the exact Clopper-Pearson method.', 'timeFrame': 'At time of imaging'}]",NA 347,NCT01678508,"{'fullName': 'Rigshospitalet, Denmark', 'class': 'OTHER'}",Pharmacogenetically Based Dosing of Thiopurines in Childhood Acute Lymphoblastic Leukemia,COMPLETED,In a population-based study to explore the impact of TPMT-status on the risk of relapse and of second cancer among all patients treated according to the NOPHO ALL2000.,['Acute Lymphoblastic Leukemia'],OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}",NA,"Inclusion Criteria: * included in the NOPHO ALL2000 protocol * entered 6-mercaptopurine/Methotrexate maintenance therapy in first remission * available TPMT phenotype and/or genotype Exclusion Criteria: * children with Down Syndrome",The study cohort is based on patients enrolled in the NOPHO ALL2000 protocol.,ALL,PROBABILITY_SAMPLE,"[{'measure': ""Cumulative risk of relapse and risk of second cancer by Kaplan-Meier analysis with Gray's test comparisons at 10 years"", 'description': 'The risks will be reported as percentages.', 'timeFrame': 'Up to 10 years from diagnosis'}]",NA 348,NCT02415608,"{'fullName': 'Stanford University', 'class': 'OTHER'}",Ibrutinib in Treating Patients With Advanced Systemic Mastocytosis,TERMINATED,"This phase 2 trial studies ibrutinib to see how well it works in treating patients with systemic (affecting the entire body) mastocytosis that has spread to other parts of the body and usually cannot be cured or controlled with treatment (advanced). Systemic mastocytosis is a disease in which too many mast cells (a type of immune system cell) are found throughout the body. Mast cells give off chemicals such as histamine that can cause flushing (a hot, red face), itching, abdominal cramps, muscle pain, nausea, vomiting, diarrhea, low blood pressure, and shock. Ibrutinib may stop the growth of mast cells by blocking some of the enzymes needed for cell growth.","['Aggressive Systemic Mastocytosis', 'Mast Cell Leukemia', 'Systemic Mastocytosis']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Ibrutinib', 'description': 'Given orally in 28-day cycles', 'armGroupLabels': ['Ibrutinib 420 mg/day', 'Ibrutinib 560 mg/day'], 'otherNames': ['Imbruvica', 'PCI-32765', 'BTK Inhibitor PCI-32765', 'CRA-032765']}]","INCLUSION CRITERIA * Diagnosis of systemic mastocytosis per 2008 World Health Organization (WHO) criteria. Those with advanced systemic mastocytosis (ASM); mast cell leukemia (MCL); or systemic mastocytosis-associated hematological clonal non-mast cell lineage disease (SM-AHNMD) required to have at least 1 organ damage finding * Serum aspartate transaminase (AST) or alanine transaminase (ALT) ≤ 3.0 x upper limit of normal (ULN); if considered related to ASM/MCL ≤ 5 x ULN * Estimated creatinine clearance ≥ 30 mL/min (Cockcroft-Gault) * Total bilirubin ≤ 1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin); if considered related to ASM/MCL ≤ 3 x ULN * Female subjects must be of non-reproductive potential, or if of childbearing potential must have a negative serum pregnancy test upon study entry * Must agree to use highly effective methods of birth control * Written informed consent * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3 * Life expectancy \> 12 weeks EXCLUSION CRITERIA * Received any investigational agent, chemotherapy, interferon-alpha, or 2-chlorodeoxyadenosine (2-CdA, cladribine) within 30 days prior to day 1; or monoclonal antibody ≤ 6 weeks prior to first administration of study treatment (patients with an AHNMD with progressive leukocytosis who require control of their counts are permitted to receive hydroxyurea) * Diagnosis of AHNMD requiring immediate cytoreductive therapy or targeted drugs (eg, acute myeloid leukemia \[AML\]) * History of other malignancies, except: * Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before the first dose of study drug, and at low risk for recurrence * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease * Adequately treated carcinoma in situ without evidence of disease * Concurrent systemic immunosuppressant therapy (eg, cyclosporine A, tacrolimus, etc., or chronic administration \[\> 14 days\] of \> 10 mg/day of prednisone) within 28 days of the first dose of study drug * Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug * Systemic treatment for infection completed ≤ 14 days before the first dose of study drug * Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 4), grade 0 or 1, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia * Known bleeding disorders (eg, severe von Willebrand's disease) or severe hemophilia * History of stroke or intracranial hemorrhage within 6 months prior to enrollment * Known history of human immunodeficiency virus (HIV) or * Active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV) * Major surgery within 4 weeks of first dose of study drug * Any life-threatening illness, medical condition, or organ system dysfunction that could compromise the subject's safety or put the study outcomes at undue risk * Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization * Unable to swallow capsules or malabsorption syndrome * Disease significantly affecting gastrointestinal function * Resection of the stomach or small bowel * Symptomatic inflammatory bowel disease * Ulcerative colitis * Partial or complete bowel obstruction * Requires treatment with a strong cytochrome P450 (CYP) 3A4/5 inhibitor * Lactating or pregnant * Unwilling or unable to participate in all required study evaluations and procedures * Unable to understand the purpose and risks of the study and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information (in accordance with national and local subject privacy regulations) * Known hypersensitivity to any excipient contained in the drug * Received hematopoietic growth factor support within 14 days of day 1 of ibrutinib (Jehovah's witnesses may be given an erythropoiesis-stimulating agent before and during the trial in lieu of red blood cell transfusions but anemia and/or red blood cell (RBC) transfusion dependence cannot be used for response assessment in these patients) * Presence of the factor interacting with poly(A) polymerase alpha (PAPOLA) and cleavage and polyadenylation specific factor 1 (CPSF1) (FIP1L1)-platelet-derived growth factor receptor, alpha polypeptide (PDGFRalpha) fusion even with resistance to imatinib (such patients are no longer defined as systemic mastocytosis by the WHO) * Received any treatment with ibrutinib prior to study entry * The concomitant use of warfarin or other vitamin K antagonists unless felt to be of significant clinical need; low molecular weight heparin or other anticoagulants may be used instead if anticoagulation is required",NA,ALL,NA,"[{'measure': 'Overall Response Rate (ORR)', 'description': 'Overall response rate (ORR) is reported as the sum of the rates of participants achieving complete remission (CR), partial remission (PR), \\& clinical improvement (CI). A clinical response is a response with duration of ≥ 12 weeks.\n\nCR is defined as all 4 criteria:\n\n* No presence of compact neoplastic mast cell aggregates\n* Serum tryptase level \\< 20 ng/mL\n* Peripheral blood count remission defined as absolute neutrophil count (ANC) ≥1 x 10e9/L + normal differential, Hb ≥11 g/dL, \\& platelet count ≥100x10e9/L\n* Complete resolution of palpable hepatosplenomegaly \\& all biopsy-proven or suspected SM-related organ damage\n\nPR is defined as all 3 criteria with response duration ≥12 weeks, that is not CR or progressive disease:\n\n* ≥ 50% reduction in neoplastic mast cells\n* Serum tryptase level reduced ≥50%\n* Resolution of 1+ biopsy-proven or suspected systemic mastocytosis (SM)-related organ damage findings\n\nCI is defined as any improvement in any of the above measures.', 'timeFrame': 'Up to 6 months'}]","[{'measure': 'Number of Participants With Adverse Events', 'description': 'Adverse events will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, and reported as the number and percentage of participants having any adverse event; by each grade of adverse event; and by affected body systems.', 'timeFrame': '30 days'}, {'measure': 'Ibrutinib Pharmacokinetics (PK)', 'description': 'Plasma concentration-time profiles for each subject and mean plasma concentration-time profiles for each dose level will be plotted, plasma concentration data for ibrutinib at each time point will be summarized by descriptive statistics, and PK parameters such as maximum concentration (Cmax), minimum concentration, time at which the Cmax is reached, and area under the curve will be summarized with mean, geometric mean, medium, minimum, maximum, standard deviation, and coefficient of variation.', 'timeFrame': '28 days'}, {'measure': 'Change of Mast Cell Burden', 'description': 'The change in the number of neoplastic mast cells in tissues (blood and/or bone marrow), ie, a measure of mast cell burden, will be assessed by immunophenotyping and/or immunohistochemistry (depending on patient and disease specifics) using mast cell markers, eg, CD25, CD30, CD117, tryptase, reticulin, Wright-Giemsa staining, and/or hematoxylin-eosin staining, in peripheral blood smears or bone marrow samples. For each participant, the data are used to collectively determine a single assessment for the number of mast cells present at baseline and after treatment. The outcome is reported as the median change in that level of mast cells, with full range, from baseline up to 2 years.', 'timeFrame': '2 years'}, {'measure': 'Serum Tryptase Levels', 'description': 'Serum tryptase level is a surrogate marker for the desired histopathologic response, ie, reduction in mast cell burden. Serum tryptase levels are reported as the median of the percent reduction, with full range, from baseline up to 2 years.', 'timeFrame': '2 years'}, {'measure': 'Total Symptom Score (TSS)', 'description': 'The totality of systemic mastocytosis was assessed by the total symptom score as measured by a Myeloproliferative Neoplasm Symptom Assessment Form modified for mast cell disorders \\[MPN-SAF (MCD)\\], and reported as the change in median score with standard deviation at baseline and 30 days. The MPN-SAF is a single, 27-question questionnaire that scores the following general measures on a scale of 0 (best) to 10 (worst): fatigue levels, effects of fatigue, satiety, pain, activity, concentration, dizziness, sleep, mood, anxiety, sexual function, itching, flushing, fever, weight loss, respiratory functions, diarrhea, lesions, and allergic reactions (some of these general terms may describe more than 1 assessment). The score on the MPN-SAF is the sum total of all 27 scores, and the range of scores is from a minimum of 0 (best; symptoms for all assessment absent) to a maximum of 270 (worst; score of 10 on all assessments).', 'timeFrame': '30 days'}, {'measure': 'Change in Quality of Life (QoL)', 'description': 'The quality of life (QoL) component of the Myeloproliferative Neoplasm Symptom Assessment Form (MPNSAF) modified for mast cell symptoms, a scale of life quality ranking from 0 (best) to 10 (worst), was assessed at baseline and after 1 cycle of ibrutinib treatment (30 days), and reported as the median change in score with standard deviation.', 'timeFrame': '30 days'}, {'measure': 'Duration of Response (DoR)', 'description': 'Duration of response (DoR) was assessed through 2 years of treatment, and reported as the median with standard deviation, with response duration censored at last response assessment in the event of death or progression not documented.', 'timeFrame': '2 years'}, {'measure': 'Time-to-Response (TTR)', 'description': 'Time-to-response (TTR) was assessed through 2 years of treatment, and reported as the median with standard deviation, censored at last response assessment in the event of death or progression not documented.', 'timeFrame': '2 years'}, {'measure': 'Progression-free Survival (PFS)', 'description': 'Participants were assessed for progression-free survival (PFS) from the start of treatment through 2 years of treatment. The outcome is reported as the number of participants who were alive without disease progression after 2 years of treatment.', 'timeFrame': '2 years'}, {'measure': 'Overall Survival (OS)', 'description': 'Overall survival (OS) was assessed through 2 years of treatment, and recorded as the time from the start of treatment to either progression or death, with values censored at the last response assessment if the participant did not progress or die during that period. OS is reported as reported as the median with standard deviation.', 'timeFrame': '26 months'}]" 349,NCT06979076,"{'fullName': 'MingSight Pharmaceuticals, Inc', 'class': 'INDUSTRY'}",A Phase Ib Study of the Selective PKC-β Inhibitor MS-553 in Patients With Refractory or Relapsed CLL/SLL,NOT_YET_RECRUITING,A Phase Ib Study of the Selective PKC-β Inhibitor MS-553 in Patients with Refractory or Relapsed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma,"['CLL (Chronic Lymphocytic Leukemia)', 'SLL (Small Lymphocytic Lymphoma)']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'MS-553, DS1', 'description': 'Oral, Dose Schedule 1', 'armGroupLabels': ['MS-553, dose schedule 1 (DS1)']}, {'type': 'DRUG', 'name': 'MS-553, DS2', 'description': 'Oral, Dose Schedule 2', 'armGroupLabels': ['MS-553, dose schedule 2 (DS2)']}]","Inclusion Criteria: 1. Age 18 years or older. 2. Diagnosis of CLL or SLL: 1. History of histologically documented CLL or SLL that meets iwCLL diagnostic criteria according to the 2018 guidelines, and 2. Indication for treatment as defined by the 2018 iwCLL guidelines, or the need for disease reduction prior to allogeneic transplantation.- Exclusion Criteria: 1. Current transformation of CLL/SLL non-Hodgkin lymphoma or Hodgkin lymphoma. 2. Active and uncontrolled autoimmune cytopenia(s).",NA,ALL,NA,"[{'measure': 'The occurrence of AEs and SAEs, with abnormal laboratory tests results, abnormal physical examination findings, abnormal vital signs, and abnormal ECG readings', 'timeFrame': 'Through study completion, an average of 2 years'}]",NA 350,NCT01634217,"{'fullName': 'Masonic Cancer Center, University of Minnesota', 'class': 'OTHER'}",Inducible Regulatory T Cells (iTregs) in Non-Myeloablative Sibling Donor Peripheral Blood Stem Cell Transplantation,COMPLETED,"This is a phase I single center dose escalation study with an extension at the best available dose to determine the tolerability of inducible regulatory T cells (iTregs) when given to adult patients undergoing non-myeloablative HLA-identical sibling donor peripheral blood stem cell (PBSC) transplantation for the treatment of a high risk malignancy. Up to 5 dose cohorts will be tested. Once the tolerable dose is determined for iTregs, enrollment will continue with an additional 10 patients using sirolimus/Mycophenolate mofetil (MMF) graft-versus-host disease (GVHD) prophylaxis to gain further safety information and to provide pilot data in this treatment setting.","['Acute Myelogenous Leukemia', 'Acute Lymphocytic Leukemia', 'Chronic Myelogenous Leukemia', 'Non-Hodgkin Lymphoma', 'Hodgkin Lymphoma', 'Chronic Lymphocytic Leukemia', 'Multiple Myeloma', 'Myelodysplastic Syndrome']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'iTreg', 'description': 'The iTregs will be infused at the assigned dose without a filter or pump slowly by gravity over 15-60 minutes. The iTregs should be given at least 4 hours before the peripheral blood stem cell (PBSC) infusion (MT2001-10).', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4', 'Cohort 5 Extension']}]","Inclusion Criteria: * 18 - 75 years of age with an HLA-identical sibling donor * One of the following disease categories: * Acute myelogenous leukemia - high risk CR1 (as evidenced by preceding MDS, intermediate to high risk cytogenetics, ≥ 2 cycles to obtain CR, erythroblastic or megakaryocytic leukemia; CR2+. All patients must be in CR as defined by hematological recovery (ANC \> 0.5x 109/L), AND \<5% blasts by light microscopy within the bone marrow with a cellularity of ≥15%. * Acute lymphocytic leukemia - high risk CR1 \[t(9;22), t (1:19), t(4;11) or other MLL rearrangements\] or \>1cycle to obtain CR; CR2+. All patients must be in CR as defined by hematological recovery (ANC \> 0.5x 109/L), AND \<5% blasts by light microscopy within the bone marrow with a cellularity of ≥15%. * Chronic myelogenous leukemia all types except blast crisis (note treated blast crisis in chronic phase is eligible) * Non-Hodgkin lymphoma or Hodgkin lymphoma demonstrating chemosensitive disease * Myelodysplastic syndrome with severe pancytopenia, leading to either transfusion dependency or increased risk for infections * Performance status: Karnofsky ≥ 60% * Adequate organ function within 28 days of study enrollment defined as: * Liver: SGOT and SGPT \< 5.0 x ULN; total bilirubin \< 3 x ULN * Renal: serum creatinine \< 2.0 mg/dl or glomerular filtration rate (GFR) \> 40 mL/min/1.73m2. Patients with a creatinine \> 1.2 mg/dl or a history of renal dysfunction must have glomerular filtration rate (GFR) \> 40 mL/min/1.73m2 * Albumin: \> 2.5 g/dL * Cardiac: No decompensated CHF or uncontrolled arrhythmia; ejection fraction \> 35% within 6 weeks prior to study enrollment * Pulmonary: No O2 requirements; DLCO \> 30% predicted within 6 weeks prior to study enrollment * If recent mold infection (e.g. aspergillus) must have minimum of 30 days of therapy and responsive disease and be cleared by Infectious Disease * Sexually active females of child bearing potential and males must agree to use effective contraception for the duration of the transplant period * Voluntary written consent Exclusion Criteria: * Pregnancy or breast feeding - women of childbearing potential must have a negative pregnancy test within 28 days of study enrollment. * Prior myeloablative transplant within previous 3 months of study enrollment. * Evidence of HIV infection or known HIV positive serology. * Active serious infection.",NA,ALL,NA,"[{'measure': 'Incidence of grade 3-5 infusional toxicity', 'description': 'Targeted adverse events and unexpected events not explained by the PBSCT or disease will be collected \\[(1-4 hours after the iTreg infusion and before the PBSCT at day 0) and 24 hours and 48 hours after the iTreg infusion (+/- 2 hours)\\]', 'timeFrame': 'Within 48 Hours After iTregs Administration'}]","[{'measure': 'Cumulative incidence of grade II-IV acute graft-versus-host disease (GVHD)', 'description': ""Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body. Abstracted from the routine clinical data collected for the primary transplant protocol (MT2001-10)."", 'timeFrame': 'Day 100'}, {'measure': 'Incidence of chronic graft-versus-host disease (GVHD)', 'description': ""Graft-versus-host disease (GVHD) is a complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body. Abstracted from the routine clinical data collected for the primary transplant protocol (MT2001-10)."", 'timeFrame': '12 Months'}, {'measure': 'Relapse of Disease', 'description': 'The return of signs and symptoms of a disease after a remission.', 'timeFrame': '12 Months'}, {'measure': 'Survival', 'description': 'Number (count) of patients alive at 1 year after treatment.', 'timeFrame': '1 Year'}, {'measure': 'Survival', 'description': 'Number (count) of patients alive at Day 100.', 'timeFrame': 'Day 100'}]" 351,NCT06549790,"{'fullName': 'Nerviano Medical Sciences', 'class': 'INDUSTRY'}",Study of NMS-03597812 in Adult Patients With Relapsed/Refractory Acute Myeloid Leukemia,RECRUITING,"The aim of PERKA-812-003 study is to investigate the safety, pharmacokinetics and preliminary anti-tumor activity of treatment with NMS-03597812 as single agent in Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) patients who have exhausted standard treatment, including a subset of patients with TP53 mutations. It is anticipated that combination with venetoclax will be further evaluated following a future protocol amendment, once the Recommended Range Dose (RDR) as single agent has been defined.",['Relapsed/Refractory Acute Myeloid Leukemia'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'NMS-03597812', 'description': 'Route of Administration: Oral', 'armGroupLabels': ['NMS-03597812']}]","Inclusion Criteria: * Confirmed diagnosis of refractory/relapsed (R/R) AML according to 2022 ELN recommendation: Phase Ia * single agent dose escalation of NMS-03597812: R/R AML patients who have exhausted standard therapy: a) prior fit patients to intensive chemotherapy (IC): failed at least one cycle of IC in front-line therapy or b) prior unfit to IC: failed at least 2 cycles of hypomethylating agents (HMA)/venetoclax combination therapy, or at least 4 cycles of HMA monotherapy; c) patients must have failed all other approved therapies for which they are eligible, including FLT3 inhibitors, IDH1/2 inhibitors, and CD33 directed therapy Phase Ib * Cohort A: single agent in R/R AML TP53mt patients who have exhausted standard therapy: a) prior unfit to intensive chemotherapy (IC): failed at least 2 cycles of HMA/venetoclax combination therapy, or at least 4 cycles of HMA monotherapy; b) patients must have failed all other approved therapies for which they are eligible, including FLT3 inhibitors, IDH1/2 inhibitors, and CD33 directed therapy * Cohort B: single agent in R/R AML TP53wt patients who have exhausted standard therapy: a) prior fit patients to intensive chemotherapy (IC): failed at least one cycle of IC in front-line therapy or b) prior unfit to IC: failed at least 2 cycles of HMA/venetoclax combination therapy, or at least 4 cycles of HMA monotherapy; c) patients must have failed all other approved therapies for which they are eligible, including FLT3 inhibitors, IDH1/2 inhibitors, and CD33 directed therapy * Adult (age ≥ 18 years) patients * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Unless agreed with sponsor, the interval from prior antitumor treatment should be at least 2 weeks or 5 half-lives, whichever is longer, other than hydroxyurea * All acute toxic effects (excluding alopecia) of any prior therapy must have resolved to NCI CTCAE version 5.0 Grade≤ 1 * Adequate organ function * Must use highly effective contraception or true abstinence. Female patients must be surgically sterile or, if patient is of childbearing potential, must agree to use effective contraception of therapy and in the following 210 days after discontinuation of study treatment. Since NMS-03597812 has potential induction of CYP3A4, women of childbearing potential must be advised that hormonal contraceptives might lose efficacy and must use alternate form of highly effective contraception. Male patients must be surgically sterile or must agree to use highly effective contraception or true abstinence during the period of therapy and in the following 120 days for male patients who must refrain from donating sperm during this period after discontinuation of study treatment. * Capability to swallow capsules intact (without chewing, crushing, or opening) * Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study indications or procedures * Signed and dated Independent Ethics Committee (IEC) or Institutional Review Board (IRB)-approved informed consent form indicating that the patient is aware of the neoplastic nature of his/her disease and has been informed of the procedures to be followed, the investigational nature of the therapy, potential benefits, side effects, discomforts, risks, and alternative treatments. Exclusion Criteria: * Current enrollment in another interventional clinical study unless only participating in survival follow up * White blood cells (WBC) count \>20×10\^3/microliter (μL). However, patients can be treated with hydroxyurea and/or leukapheresis prior to study treatment start to reduce the WBC to ≤ 20×10\^3/μL to enable eligibility for study drug dosing. * Diagnosis of acute promyelocytic leukemia or BCR-ABL-positive leukemia * Currently active second malignancy, except for adequately treated basal or squamous cell skin cancer and/or cone biopsied in situ carcinoma of the cervix uteri and/or superficial bladder cancer. * Patients with known leukemia involvement of central nervous system (CNS). * Hematopoietic stem cell transplantation (HSCT) within 3 months of treatment start and/or persistent non- hematologic toxicities of Grade ≥2 related to the transplant * Active acute or chronic graft versus host disease (GVHD) requiring immunosuppressive treatment * Patients with QTcF interval ≥ 470 milliseconds or with risk factors for torsade de pointes (e.g., uncontrolled heart failure, uncontrolled hypokalemia, history of prolonged QTc interval or family history of long QT syndrome). For patients receiving treatment with concomitant medications known to prolong the QTc interval, replacement with another treatment needs to be considered. If replacement or discontinuation is not clinically feasible, a careful risk/benefit evaluation should be performed prior to enrollment. * Pregnancy. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the screening period prior to start of study drug. * Breast-feeding or planning to breast feed during the study or within 90 days after study treatment. * Known active gastrointestinal disease (eg, gastro-duodenal ulcer, gastrectomy, Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact on drug absorption. * Patient who are receiving concomitant medications with antacids (proton pump inhibitors are strictly prohibited; calcium carbonate antacids are only allowed 6 hours prior to a dose or 1 hour after). Note: exclusion criterion not applicable to optional backfill cohort for investigation of drug-drug interaction with antiacids. * Patient who are receiving concomitant medications that are strong inducers or inhibitors of CYP3A4 (with the exception of azole antifungals) and CYP2C9 that cannot be replaced with alternative therapy. * Patients who are receiving concomitant medications that are sensitive substrates of CYP3A4,CYP2D6, CYP1A2 and CYP2B6 with narrow therapeutic window that cannot be replaced with alternative therapy. Drugs with broad therapeutic indices may still be acceptable. * Patients who are receiving concomitant medications that are strong or moderate P-gp inhibitors that cannot be replaced with alternative therapy. * Major surgery within 4 weeks before study treatment start. * Radiotherapy within 4 weeks before study treatment start. However, if the radiation portal covered ≤5 % of the bone marrow reserve, the patient may be enrolled irrespective of the end date of radiotherapy. * History of necrotic pancreatitis or acute severe pancreatitis, requiring medical intervention and/or hospitalization, in the previous 6 months before study treatment start. NOTE: Other protocol defined inclusion/exclusion criteria may apply.",NA,ALL,NA,"[{'measure': 'Phase Ia (escalation) - Number of Participants with Adverse Events (AEs)', 'description': 'Evaluation of AE frequency and severity (graded using the National Cancer Institute Common Terminology Criteria for Adverse Events \\[NCI CTCAE\\] Version 5.0), including dose limiting toxicities (DLTs), laboratory measurements, electrocardiogram (ECG) measurements, vital sign measurements', 'timeFrame': 'Screening (Day ≤28) up to 28-day follow-up after end of treatment (Approximately 13 months)'}, {'measure': 'Phase Ib (expansion) - Complete Remission (CR) rate', 'description': 'Complete Remission (CR) rate, as defined by the Investigators based on the 2022 European LeukemiaNet (ELN) recommendations', 'timeFrame': 'From date of treatment initiation up to hematological relapse (Approximately 12 months)'}]","[{'measure': 'Phase Ia - Complete remission (CR) rate', 'description': 'Complete Remission (CR) rate, as defined by the Investigators based on the 2022 European LeukemiaNet (ELN) recommendations.', 'timeFrame': 'From date of treatment initiation up to hematological relapse (Approximately 12 months)'}, {'measure': 'Phase Ia - Maximum concentration (Cmax) of NMS-0597812', 'description': 'Plasma samples will be collected and used for pharmacokinetics assessments', 'timeFrame': 'Cycle 1 (each cycle is 28 days): Day 1 and Day 15'}, {'measure': 'Phase Ia - Related time of achievement of occurrence of Cmax (tmax) of NMS-0597812', 'description': 'Plasma samples will be collected and used for pharmacokinetics assessments', 'timeFrame': 'Cycle 1 (each cycle is 28 days): Day 1 and Day 15'}, {'measure': 'Trough concentration (Cτ) area under concentration versus time up to 24 hours (dosing interval) of NMS-0597812', 'description': 'Plasma samples will be collected and used for pharmacokinetics assessments', 'timeFrame': 'Cycle 1 (each cycle is 28 days): Day 1 and Day 15'}, {'measure': 'Phase Ia - Half-life of the terminal phase (t½,z) of NMS-0597812', 'description': 'Plasma samples will be collected and used for pharmacokinetics assessments', 'timeFrame': 'Cycle 1 (each cycle is 28 days): Day 1 and Day 15'}, {'measure': 'Phase Ia - Plasma clearance (CL) of NMS-0597812', 'description': 'Plasma samples will be collected and used for pharmacokinetics assessments', 'timeFrame': 'Cycle 1 (each cycle is 28 days): Day 1 and Day 15'}, {'measure': 'Phase Ia - Volume of distribution (Vss) of NMS-0597812', 'description': 'Plasma samples will be collected and used for pharmacokinetics assessments', 'timeFrame': 'Cycle 1 (each cycle is 28 days): Day 1 and Day 15'}, {'measure': 'Phase Ia - Accumulation ratio (Rac) of NMS-0597812', 'description': 'Plasma samples will be collected and used for pharmacokinetics assessments', 'timeFrame': 'Cycle 1 (each cycle is 28 days): Day 15'}, {'measure': 'Phase Ia - Renal clearance (CLR) of NMS-03597812 excreted in urine (data permitting)', 'description': 'Urine samples will be collected and used for pharmacokinetics assessments', 'timeFrame': 'Cycle 1 (each cycle is 28 days): Day 1 and Day 15'}, {'measure': 'Phase Ia - Cumulative amount recovered unchanged in the urine (Ae) of NMS-03597812 (data permitting)', 'description': 'Urine samples will be collected and used for pharmacokinetics assessments', 'timeFrame': 'Cycle 1 (each cycle is 28 days): Day 1 and Day 15'}, {'measure': 'Phase Ia - Cumulative amount recovered unchanged in the urine expressed as a fraction of administered dose (Ae%) of NMS-03597812 (data permitting)', 'description': 'Urine samples will be collected and used for pharmacokinetics assessments', 'timeFrame': 'Cycle 1 (each cycle is 28 days): Day 1 and Day 15'}, {'measure': 'Phase Ib - Complete remission (CR) + complete remission with partial hematologic recovery (CRh) rate', 'description': 'Number and percentage of patients who achieve CR and CRh as best response', 'timeFrame': 'From date of treatment initiation up to hematological relapse (Approximately 12 months)'}, {'measure': 'Phase Ib - Complete remission (CR) + Complete remission with incomplete hematologic recovery (CRi) rate', 'description': 'Number and percentage of patients who achieve CR and CRi as best response', 'timeFrame': 'From date of treatment initiation up to hematological relapse (Approximately 12 months)'}, {'measure': 'Phase Ib - Complete remission (CR) + Complete remission with partial hematologic recovery (CRh) + complete remission with incomplete hematologic recovery (CRi) rate', 'description': 'Number and percentage of patients who achieve CR, CRh and CRi as best response', 'timeFrame': 'From date of treatment initiation up to hematological relapse (Approximately 12 months)'}, {'measure': 'Phase Ib - Overall Response Rate (ORR: CR + CRh + CRi + MLFS + PR)', 'description': 'ORR: Complete remission (CR) + Complete remission with partial hematologic recovery (CRh) + Complete remission with incomplete hematologic recovery (CRi) + Morphological leukemia-free state (MLFS) + Partial remission (PR)\n\nDefined as the number and percentage of patients who achieve CR, CRh, CRi, MLFS and PR as best response in the analysis population', 'timeFrame': 'From date of treatment initiation up to hematological relapse/progressive disease (Approximately 12 months)'}, {'measure': 'Phase Ib - Overall Survival (OS)', 'description': 'Defined as the time from the date of start of treatment until the date of death from any cause. Patient who was not known to have died by the end of study will be censored at the date of last recorded date.', 'timeFrame': 'First dose to the date of death from any cause or start of a new anti-cancer therapy, whichever comes first (Approximately 18 months)'}, {'measure': 'Phase Ib - Duration of Response (DoR)', 'description': 'Defined as the time from the date of first response (CR, CRh, or CRi) until the date of documented hematologic relapse or death due to progression. DOR will be also calculated for overall response, including patients who achieve MLFS or PR as best response during the treatment.', 'timeFrame': 'From the date of first response (CR, CRh, or CRi) to the date of hematological relapse or death due to progression, whichever comes first. (Approximately 12 months)'}, {'measure': 'Phase Ib - Event-Free Survival (EFS)', 'description': 'Defined as the time from the date of treatment initiation to the date of hematological relapse from CR, CRh, or CRi, or death from any cause, whichever comes first.', 'timeFrame': 'From the date of treatment initiation to the date of hematological relapse from CR, CRh, or CRi, date of treatment failure, or death from any cause, whichever comes first. (Approximately 18 months)'}, {'measure': 'Phase Ib - Relapse-free Survival (RFS)', 'description': 'Measured only for patients achieving CR, CRh, or CRi, and it is defined as the time from the date of first achievement of remission until the date of hematologic relapse or death from any cause.', 'timeFrame': 'Date of first achievement of remission until the date of hematologic relapse or death from any cause, whichever comes first (Approximately 12 months).'}, {'measure': 'Phase Ib - Proportion of patients bridged to hemopoietic stem cell transplantation (HSCT)', 'timeFrame': 'From date of treatment initiation up to end of study (Approximately 18 months)'}, {'measure': 'Phase Ib - Rate of conversion from transfusion-dependence to transfusion independence', 'timeFrame': 'From date of treatment initiation up to end of study (Approximately 18 months)'}, {'measure': 'Phase Ib - AE frequency and severity', 'description': 'AE frequency and severity (graded using the National Cancer Institute Common Terminology Criteria for Adverse Events \\[NCI CTCAE\\] Version 5.0), laboratory, ECG and vital sign measurements', 'timeFrame': 'Screening (Day ≤28) up to 28-day follow-up after end of treatment (Approximately 13 months)'}]" 352,NCT07227584,"{'fullName': 'Dana-Farber Cancer Institute', 'class': 'OTHER'}",ALL Backbone in AYAs,NOT_YET_RECRUITING,"The goal of this research study is to evaluate a chemotherapy regiment for the treatment of newly diagnosed Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) in adolescents and young adults (AYAs). The names of the study drugs involved in this study are: * blinatumomab (a type of immunotherapy drug) * cyclophosphamide (a type of chemotherapy drug) * cytarabine (a type of antineoplastic agent) * dexamethasone (a type of synthetic glucocorticoid) * doxorubicin (a type of antineoplastic agent) * etoposide (a type of antineoplastic agent) * mercaptopurine (a type of antineoplastic agent) * methotrexate (a type of chemotherapy drug) * pegaspargase (a type of antineoplastic agent) * vincristine (a type of antineoplastic agent)","['Acute Lymphoblastic Leukemia', 'Philadelphia Chromosome-Negative Lymphoblastic Leukemia', 'Acute Lymphoblastic Leukemia (ALL)', 'Leukemia']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Blinatumomab', 'description': 'A bispecific T-cell engager (BiTE) antibody, single-use vial via intravenous infusion, per standard of care', 'armGroupLabels': ['ALL Backbone Regimen for B-Cell', 'ALL Backbone Regimen for T-Cell'], 'otherNames': ['Blincyto', 'NSC# 765986']}, {'type': 'DRUG', 'name': 'Oncaspar', 'description': 'A modified enzyme L-asparaginase, single-use vial via intravenous infusion, per standard of care', 'armGroupLabels': ['ALL Backbone Regimen for B-Cell', 'ALL Backbone Regimen for T-Cell'], 'otherNames': ['PEGASPARGASE', 'NSC #624239)']}, {'type': 'DRUG', 'name': 'Cyclophosphamide', 'description': 'An alkylating agent, single-use vial via intravenous infusion, per standard of care', 'armGroupLabels': ['ALL Backbone Regimen for B-Cell', 'ALL Backbone Regimen for T-Cell'], 'otherNames': ['Cytoxan', 'NSC #26271']}, {'type': 'DRUG', 'name': 'Cytarabine', 'description': 'An antineoplastic antimetabolite, multi-dose vial via intrathecal injection (through the spinal space), per standard of care', 'armGroupLabels': ['ALL Backbone Regimen for B-Cell', 'ALL Backbone Regimen for T-Cell'], 'otherNames': ['Cytosine Arabinoside', 'Ara-C', 'Cytostar', 'NSC#63878']}, {'type': 'DRUG', 'name': 'Dexamethasone', 'description': 'A synthetic glucocorticoid, tablets or single-use vials via orally or intravenous infusion (through the vein), per standard of care', 'armGroupLabels': ['ALL Backbone Regimen for B-Cell', 'ALL Backbone Regimen for T-Cell'], 'otherNames': ['Decadron', 'Hexadrol', 'Dexone', 'Dexameth', 'NSC#34521']}, {'type': 'DRUG', 'name': 'Doxorubicin Hydrochloride', 'description': 'An anthracycline antibiotic, single-use or multi-dose vials via intravenous infusion, per standard of care', 'armGroupLabels': ['ALL Backbone Regimen for B-Cell', 'ALL Backbone Regimen for T-Cell'], 'otherNames': ['Adriamycin', 'NSC#123127']}, {'type': 'DRUG', 'name': 'Etoposide', 'description': 'A derivative of podophyllotoxin, multi-dose vial via intravenous infusion, per standard of care', 'armGroupLabels': ['ALL Backbone Regimen for B-Cell', 'ALL Backbone Regimen for T-Cell'], 'otherNames': ['VePesid', 'Etopophos', 'VP-16', 'NSC#141540']}, {'type': 'DRUG', 'name': 'Mercaptopurine', 'description': 'A purine antagonist, tablet via orally, per standard of care', 'armGroupLabels': ['ALL Backbone Regimen for B-Cell', 'ALL Backbone Regimen for T-Cell'], 'otherNames': ['6-MP', 'Purinethol', '6-Mercaptopurine', 'Purixan', 'NSC#000755']}, {'type': 'DRUG', 'name': 'Methotrexate', 'description': 'A folate analogue, multi-dose and single-use vials via intrathecal injection, per standard of care', 'armGroupLabels': ['ALL Backbone Regimen for B-Cell', 'ALL Backbone Regimen for T-Cell'], 'otherNames': ['MTX', 'Amethopterin', 'Trexall', 'NSC#000740']}, {'type': 'DRUG', 'name': 'Vincristine', 'description': 'A vinca alkaloid, single-use vials via intravenous injection, per standard of care', 'armGroupLabels': ['ALL Backbone Regimen for T-Cell'], 'otherNames': ['Oncovin', 'VCR', 'LCR', 'NSC#67574']}]","Inclusion Criteria: 3.1.1Confirmed diagnosis of Philadelphia chromosome-negative acute lymphoblastic leukemia. * Diagnosis should be made by peripheral blood, bone marrow aspirate, bone marrow biopsy, or tissue biopsy demonstrating ≥25% involvement by lymphoblasts, with flow cytometry or immunohistochemistry confirming B-ALL or T-ALL. o Participants with B-cell and T-cell lymphoblastic lymphoma are eligible regardless of bone marrow involvement Participants with mixed phenotype acute leukemia (MPAL) ARE eligible, if an ALL regimen is felt to be most appropriate treatment. * Participants with CNS leukemia ARE eligible. 3.1.2 Allowed prior therapy: * Corticosteroids, hydroxyurea, all-trans retinoic acid (ATRA). * IT chemotherapy. * Emergent radiation therapy or leukapheresis for life threatening complications. * One cycle of prior chemotherapy (i.e. an induction cycle given at another institution and participant transfers care for post-induction treatment; OR a participant does not meet eligibility prior to induction but does meet eligibility after remission induction). 3.1.3 Age 18.00 - 50.99 years 3.1.4 Direct bilirubin \<1.4 mg/dL (total bilirubin \< 1.4 mg/dL is acceptable). 3.1.5 Willingness to use effective means of birth control. The effects of chemotherapy on the developing human fetus are unknown. For this reason and because therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of study. 3.1.6 Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Philadelphia chromosome-positive / BCR::ABL1 fusion 3.2.2 Participants with mature B-cell (Burkitt's) ALL. Mature B-cell ALL is defined by the presence of surface immunoglobulin AND any of the following: t(8;14)(q24;q32), t(8;22), t(2;8), or c-myc-gene rearrangement by FISH, PCR or other testing. \[FISH/PCR testing for c-myc rearrangements is not required prior to study entry, but it is suggested for participants with surface immunoglobulin expression or L3 morphology\]. 3.2.3 Participants with acute undifferentiated leukemia. 3.2.4 Participants receiving any other investigational agent for this condition. 3.2.5 Uncontrolled intercurrent illness including but not limited to ongoing infection with vital sign instability (hypotension, respiratory insufficiency), life-threatening acute tumor lysis syndrome (e.g., with renal failure), symptomatic congestive heart failure, cardiac arrhythmia, intracranial or other uncontrolled bleeding. Circumstances that may significantly interfere with a participant's ability to safely comply with study procedures, such as attend scheduled study visits, adhere to treatment protocols, or complete study assessments. These include a lack of reliable transportation, unstable housing, or psychiatric illness, but reasonable attempts should be made to overcome these circumstances, including but not limited to identifying sponsor, institutional, or thirdparty financial or social support as well as psychiatric consultation for objective assessment. 3.2.6 Sexually active participants of reproductive potential who have not agreed to use an effective contraceptive method for the duration of study participation are ineligible. 3.2.7 Pregnant women are excluded from this study because many of the agents used on this protocol have potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these chemotherapy agents, breastfeeding should be discontinued if the mother is enrolled.",NA,ALL,NA,"[{'measure': 'Treatment Completion Rate Through Time Point 3 (TP3)', 'description': 'Treatment completion rate through TP3 is defined as the proportion of Adolescents and Young Adults (AYAs) participants who receive all protocol-specified therapy through TP3, without early discontinuation.', 'timeFrame': 'Timeframe for TP3 depends on disease immunophenotype. Participants with CD19-positive B-ALL, TP3 occurs at the end of Blinatumomab Cycle 2 on Day 28 (130 days from study start). For participants with T-cell ALL or those who do not receive blinatum'}]","[{'measure': 'Rate of Treatment-Related Mortality (TRM)', 'description': 'Rate of TRM is defined as the proportion of participants who die due to treatment-related causes.', 'timeFrame': 'Up to 115 weeks'}, {'measure': 'Rate of Treatment Discontinuation due to Toxicity or Disease', 'description': 'Rate of treatment discontinuation during Induction, Consolidation, and Continuation phases, defined as the proportion of participants who stop protocol-specified therapy due to regimen-related toxicity and/or treatment failure.', 'timeFrame': 'Up to 115 weeks'}, {'measure': 'Rate of Asparaginase Non-Completion', 'description': 'Rate of asparaginase non-completion is defined as the proportion of participants who did not complete all planned doses of asparaginase per protocol.', 'timeFrame': 'This endpoint is assessed during Consolidation II, which occurs approximately from Day 270 to Day 480 of study treatment.'}, {'measure': 'Reason of Asparaginase Non-Completion', 'description': 'This outcome summarizes the reasons participants discontinue asparaginase treatment earlier than planned.', 'timeFrame': 'Up to 115 weeks'}, {'measure': 'Grade 3 Infections Toxicity Rate', 'description': 'Grade 3 infection toxicity rate is defined as the proportion of participants who experience grade 3 bacterial or fungal infections that are assessed as possibly, probably, or definitely related to the study treatment during the induction, consolidation, and continuation phases. Toxicity grades are determined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.', 'timeFrame': 'Adverse events will be followed for 30 days after completion of protocol treatment, with the overall treatment period up to 115 weeks.'}, {'measure': 'Grade 3 Asparaginase-associated Toxicities Rate', 'description': 'Grade 3 asparaginase-associated toxicity rate is defined as the proportion of participants who experience grade 3 asparaginase-associated toxicities (including thromboembolic events, pancreatitis, hypertriglyceridemia, hyperbilirubinemia, hypersensitivity, and hyperglycemia) that are assessed as possibly, probably, or definitely related to the study treatment during the induction, consolidation, or continuation phases. Toxicity grades are determined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.', 'timeFrame': 'Adverse events will be followed for 30 days after completion of protocol treatment, with the overall treatment period up to 115 weeks.'}, {'measure': 'Grade 3 Orthopedic Toxicity Rate', 'description': 'Grade 3 orthopedic toxicity rate is defined as the proportion of participants who experience grade 3 osteopenia or osteoporosis that are assessed as possibly, probably, or definitely related to the study treatment at the end of treatment, or osteonecrosis (ON) or fractures during or after treatment. Toxicity grades are assigned according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0.', 'timeFrame': 'Adverse events will be followed for 30 days after completion of protocol treatment, with the overall treatment period up to 115 weeks. Ostenonecrosis and fractures will be followed up to 10 years.'}, {'measure': 'Complete remission Rate (CRR)', 'description': 'CRR is defined as proportion of participants who achieve CR. Complete response (CR) is defined as an interpretable bone marrow with less than 5% malignant lymphoblasts, no lymphoblasts in peripheral blood, an absolute phagocyte count greater than 1000/µL and platelets above 100,000/µL (for participants with M2 marrow at Day 32 who achieve CR at TP2, APC above 500/µL and platelets above 50,000/µL are acceptable), no evidence of extramedullary leukemia or blasts in spinal fluid, at least a 70% reduction in the anterior mediastinal mass if present at diagnosis as measured by the sum of the products of the two greatest diameters on CT or chest X-ray, and for any other large radiographic masses at diagnosis, a 70% reduction in SPD if restaging imaging is obtained.', 'timeFrame': 'CR can be documented either at the end of Induction IA (32 days) or Induction IB (74 days).'}, {'measure': 'Measurable Residual Disease (MRD) Negativity Rate at the end of Induction IA (Time Point 1)', 'description': 'The proportion of who achieve measurable residual disease (MRD) negativity at the end of Induction IA (Time Point 1). MRD negativity is assessed by multiparameter flow cytometry (MPFC), next-generation sequencing (NGS), and/or KMT2A::AFF4 RT-PCR.', 'timeFrame': 'At the end of Induction IA (32 days from study start)'}, {'measure': 'Measurable Residual Disease (MRD) Negativity Rate at the end of Induction IB (Time Point 2)', 'description': 'The proportion of who achieve measurable residual disease (MRD) negativity at the end of Induction IB (Time Point 2). MRD negativity is assessed by multiparameter flow cytometry (MPFC), next-generation sequencing (NGS), and/or KMT2A::AFF4 RT-PCR.', 'timeFrame': 'At the end of Induction IB (74 days from study start)'}, {'measure': 'Measurable Residual Disease (MRD) Negativity Rate at Time Point 3 (TP3)', 'description': 'The proportion of who achieve measurable residual disease (MRD) negativity at TP3. MRD negativity is assessed by multiparameter flow cytometry (MPFC), next-generation sequencing (NGS), and/or KMT2A::AFF4 RT-PCR.', 'timeFrame': 'For CD19-positive B-ALL, TP3 is reached at the end of Blinatumomab Cycle 2 on Day 28 (Day 130 from study start). For T-cell ALL or participants not receiving blinatumomab, TP3 occurs on Day 28 of Consolidation IC (Day 102 from study start).'}, {'measure': 'Median Event-Free Survival (EFS)', 'description': 'EFS based on Kaplan-Meier method is defined as the time from registration to induction failure, relapse, second malignancy, or death due to any cause. Relapse is defined as the presence of more than 5% lymphoblasts in bone marrow confirmed by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests; the development of biopsy-proven extramedullary disease (e.g., CSF, testicle, lymph node, skin); or CNS relapse, defined as a CSF sample with more than 5 WBCs per high-power field with lymphoblasts on cytospin, or two consecutive CSF specimens meeting the CNS-2 criteria (\\<5 WBC/µL with lymphoblasts) obtained at least three weeks apart. Participants alive without disease relapse are censored at date of last disease evaluation (which can include clinical evaluation and blood counts, does not require a bone marrow examination).', 'timeFrame': 'Up to 10 years'}, {'measure': 'Median Disease-Free Survival (DFS)', 'description': 'DFS based on Kaplan-Meier method is defined as the time from confirmed complete remission (CR) to the earlier of relapse or death due to any cause. Relapse is defined as the presence of more than 5% lymphoblasts in bone marrow confirmed by flow cytometry, cytogenetics, FISH, immunohistochemistry, or other tests; the development of biopsy-proven extramedullary disease (e.g., CSF, testicle, lymph node, skin); or CNS relapse, defined as a CSF sample with more than 5 WBCs per high-power field with lymphoblasts on cytospin, or two consecutive CSF specimens meeting the CNS-2 criteria (\\<5 WBC/µL with lymphoblasts) obtained at least three weeks apart. Participants who are alive without disease relapse are censored at the date of last disease evaluation.', 'timeFrame': 'Up to 10 years'}, {'measure': 'Median Overall Survival (OS)', 'description': 'Overall Survival (OS) based on Kaplan-Meier method is defined as the time from registration to death due to any cause or censored at date last known alive.', 'timeFrame': 'Up to 10 years'}, {'measure': 'Rate of Allogeneic Transplantation', 'description': 'Rate of allogeneic transplantation is defined as the proportion of participants who undergo allogeneic transplantation while in their first complete remission (CR).', 'timeFrame': 'CR can be documented either at the end of Induction IA (32 days) or Induction IB (74 days).'}, {'measure': 'Reason of Allogeneic Transplantation', 'description': 'This outcome measures the number of participants who undergo allogeneic transplantation in their first complete remission (CR) and the reasons for transplantation.', 'timeFrame': 'CR can be documented either at the end of Induction IA (32 days) or Induction IB (74 days).'}]" 353,NCT01100658,"{'fullName': 'University of Minnesota', 'class': 'OTHER'}",Effects of Methylphenidate on Attention Deficits in Childhood Cancer Survivors,TERMINATED,"While neurocognitive impairments in attention, memory and executive functioning are commonly reported sequelae of childhood leukemia and brain tumors, studies have only recently begun to examine the treatment of attention deficits in this population. Numerous studies have examined the effectiveness of methylphenidate in the treatment of children with attention deficit hyperactivity disorder (ADHD). However, the effectiveness of this medication for improving attention and behavioral functioning in children with medical illnesses or brain injury are less clear. Patients will be randomized to receive one week of Metadate CD (a controlled release form of methylphenidate, similar to Ritalin) and one week of placebo in a double-blind fashion.","['ALL, Childhood', 'Leukemia, Lymphoblastic', 'Leukemia, Lymphoblastic, Acute', 'Leukemia, Lymphoblastic, Acute, L1', 'Leukemia, Lymphoblastic, Acute, L2', 'Leukemia, Lymphoblastic, Acute, Philadelphia-Positive', 'Leukemia, Lymphocytic, Acute', 'Leukemia, Lymphocytic, Acute, L1', 'Leukemia, Lymphocytic, Acute, L2', 'Lymphoblastic Leukemia', 'Lymphoblastic Leukemia, Acute', 'Lymphoblastic Leukemia, Acute, Childhood', 'Lymphoblastic Leukemia, Acute, L1', 'Lymphoblastic Leukemia, Acute, L2', 'Lymphoblastic Lymphoma', 'Lymphocytic Leukemia, Acute', 'Lymphocytic Leukemia, L1', 'Lymphocytic Leukemia, L2', 'Brain Tumors', 'Cancer of the Brain', 'Cancer of Brain', 'Malignant Primary Brain Tumors', 'Brain Neoplasms, Malignant']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}","[{'type': 'DRUG', 'name': 'Methylphenidate', 'description': '1 capsule each day for 1 week, .3 mg/kg dose.', 'armGroupLabels': ['Methylphenidate'], 'otherNames': ['Metadae CD (TM)', 'Methylphenidate hydrochloride']}, {'type': 'DRUG', 'name': 'Placebo', 'description': '1 capsule per day for 1 week.', 'armGroupLabels': ['Placebo'], 'otherNames': ['Inactive substance']}]","Inclusion Criteria: Initial Screening and Registration * Previous diagnosis of acute lymphoblastic leukemia or brain tumor and have been off treatment and in disease-free remission for a minimum of one year; treated at the University of Minnesota Medical Center, Fairview. * Proficient in English * Have given informed consent (assent) After Initial Screening * Have evidence of attention impairment based on parent report of attention deficit (\> and = 75% on attention deficit hyperactivity disorder \[ADHD\] Index, Hyperactivity, or Cognitive-Problems/Inattention Index of parent-completed attention deficit hyperactivity disorder (ADHD) rating scale \[Conners Parent Rating Scale\] and perform at least 1.0 standard deviations below the mean on Omissions, Commissions, or Variability indexes of the Test of Variables of Attention (TOVA) * Have an estimated Full Scale IQ score on the Wechsler Abbreviated Scale of Intelligence (WASI) \>55. Exclusion Criteria: * Have optic pathway gliomas and/or neurofibromatosis * Diagnosed with ADD/ADHD prior to their cancer diagnosis * Currently taking antidepressants or antipsychotics * Currently being treated with stimulant medication * Blind * Have glaucoma * Have a family or personal history of motor or phonic tics or Tourette syndrome * Have seizures not controlled by antiepileptic drugs * Taking an MAO-inhibitor * Have a history of cardiovascular disease, uncontrolled hypertension, or hyperthyroidism, or current hypertension requiring antihypertensives",NA,ALL,NA,"[{'measure': 'Effectiveness of Methylphenidate on Neurocognitive Components', 'description': 'Child performance on neuropsychological testing (i.e., using Test of Variables of Attention \\[TOVA\\] which is a computerized test of attention that assists in the screening, diagnosis, and treatment monitoring of attention disorders, like Attention Deficit Hyperactivity Disorder \\[ADHD\\], and working memory index of the WisSC IV. Standard scores average = 100 +/- 15. Higher scores indicate better performance. Scores \\< or = 1 SD below the mean represent area of deficit.', 'timeFrame': 'Week 1 and Week 2'}]","[{'measure': 'Changes in Parent and Teacher Ratings of Attention, Executive Functioning and Behavior', 'description': 'Parent and teacher ratings of attention, executive function and behavior (i.e., Behavior Rating Inventory of Executive Function \\[BRIEF -a parent questionnaire and a teacher questionnaire-designed to assess executive functioning in home and school environments. Conners Parent Rating Scale-3 Short Form \\[CPRS-3 research and clinical tool for obtaining parental reports of childhood behavior problems.\\] Standard scores average = 50 + or - 10. Higher scores indicate more severe difficulty. Scores \\> or = 60 represent areas of significant behavior concern.', 'timeFrame': 'Week 1 and Week 2'}]" 354,NCT01692652,"{'fullName': 'Yonsei University', 'class': 'OTHER'}",Changes of Inflammatory Cytokines in the Tears of Moderate and Severe MGD Treated With Topical Loteprednol Etabonate,COMPLETED,"Meibum lipids are modified in patients with MGD, resulting in tear instability, evaporative dry eye, and eyelid inflammation. These changes add to corneal damages and exacerbate ocular symptoms, which are all associated with the constant release of inflammatory mediators. To our knowledge, there has been no study on tear cytokine levels in MGD patients treated with topical loteprednol etabonate. The investigators, thus, evaluated both inflammatory tear cytokine levels and corresponding clinical outcomes for analyzing the efficacy of topical loteprednol etabonate in moderate and severe MGD. The aim of this research was to determine the concentration of inflammatory tear cytokines in patients with MGD and to compare the changes in tear cytokine levels between topical loteprednol etabonate and warm compress treatment group and warm compress only treatment group.",['Moderate and Severe Meibomiang Gland Dysfunction (Stage 3 or Stage 4 Meibomiang Gland Dysfunction)'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}","[{'type': 'DRUG', 'name': 'topical loteprednol etabonate (lotemax 0.5%) with warm compress & ocular massage', 'armGroupLabels': ['Lotemax with warm compress group']}, {'type': 'OTHER', 'name': 'warm compress only group', 'armGroupLabels': ['warm compress only group']}]","Inclusion Criteria: (1) stage 3 or 4 meibomian gland dysfunction Exclusion Criteria: 1. history of previous ocular or intraocular surgery 2. ocular infection, non dry eye ocular inflammation, ocular allergy, autoimmune disease, 3. history of intolerance or hypersensitivity to any component of the study medications, 4. wearing contact lenses during the study period, presence of current punctal occlusion, 5. pregnancy, lactating women, and children. 6. Additionally, patients were excluded if they were using any topical ocular or systemic medication that could be used for the treatment MGD or dry eye, including topical or oral antibiotics, topical cyclosporine A, topical or oral steroids, topical non-steroidal anti-inflammatory drugs, topical ocular allergy medications or artificial tears",NA,ALL,NA,"[{'measure': 'Changes of inflammatory cytokines in the tears of moderate and severe MGD', 'description': 'Cytokines were measured using the BD Cytometric Bead Array (CBA) (BD Bioscience, San Jose, CA). The cytokines analyzedwere IL-6, IL-7, IL-8, IL-1β, IL-17α, MCP-1, TNF-α, IL-12p70, and IFN-γ. Briefly, 20 μL tear fluid was thawed and added to a 50 μL mixture containing each capture antibody-bead reagent and 50 μL detector antibody-phycoerithrin (Ab-PE) reagent. The mixture was subsequently incubated for 3 h at room temperature, and washed to remove unbound detector Ab-PE reagent before flow cytometry. Data were acquired and analyzed using BD CBA software that calculates the cytokine concentration based on the standard curves and a four-parameter logistic curve-fitting model. Flow cytometry was performed using the BDTM LSRII system (BD Bioscience, San Jose, CA).', 'timeFrame': '1 second before using topical loteprednol etabonate, after 1 month, and after 2 months of using topical loteprednol etabonate'}]",NA 355,NCT06776952,"{'fullName': 'Evopoint Biosciences Inc.', 'class': 'INDUSTRY'}","A Randomized, Double-blind, Multicenter Phase III Study of XNW5004 Tablets in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma",RECRUITING,"This is a randomized, double-blind, multi-center, phase III clinical trial designed to evaluate the efficacy of XNW5004 tablets versus Chidamide in Relapsed/Refractory PTCL, with a target of enrolling 120 subjects.",['Relapsed/Refractory Peripheral T Cell Lymphoma'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}","[{'type': 'DRUG', 'name': 'XNW5004 ; Chidamide placebo', 'description': 'XNW5004 + Chidamide placebo', 'armGroupLabels': ['Treatment group A']}, {'type': 'DRUG', 'name': 'XNW5004 placebo; Chidamide', 'description': 'XNW5004 placebo + Chidamide', 'armGroupLabels': ['Treatment group B']}]","Inclusion Criteria: * Aged 18-70 years (inclusive)，gender not limited. * Pathologically diagnosed, relapsed or refractory peripheral T-cell lymphoma. * Disease status defined as relapsed or refractory after \>=1 prior systemic treatment lines, and have not received treatment with HDAC inhibitors, subjects with NK/T-cell lymphoma require treatment with a regimen containing asparaginase/protease, subjects with CD30 positive ALCL require prior treatment with Brentuximab vedotin. * Subjects who have received prior radiotherapy are allowed to enroll, but radiotherapy alone is not considered a systemic therapy. * Having at least one measurable lesion for evaluation. * Agree to provide archived tumor tissue samples or fresh tumor tissue samples that meet the requirements. * Life expectancy of at least 12 weeks. * Subjects must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale. * Have adequate organ function. * Females of childbearing potential must have a negative pregnancy test within 7 days prior to the first dose of study drug. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required.Non-sterile subjects must be willing to use a highly effective contraception (e.g., IUD, pill, or condom) for the duration of the study and for 6 months after the last dose of study drug unless their partner is sterilized. For male subjects whose partner is a woman of childbearing potential, surgical sterilization or agreement to use effective contraception for the duration of the study and for 6 months after the last dose of study drug is required. In addition, males must agree not to donate sperm during the study participation and for at least 6 months after the last dose of study drug. * Able to provide written informed consent form prior to the commencement of any study activity/procedure. Exclusion Criteria: * Prior exposure to EZH2 inhibitor(s) or EZH1/2 inhibitor(s). * Prior exposure to HDAC inhibitor(s). * Subjects with known hypersensitivity to the study drug or its active ingredients or excipients. * Subjects who have received anti-tumor therapy, such as chemotherapy, immunotherapy, radiotherapy, and targeted therapy, within 4 weeks or 5 half-lives (whichever is shorter) before the first dose of the study drug, received CAR-T therapy within 12 weeks prior to the first dose of the study drug, autologous hematopoietic stem cell transplantation (Auto-HSCT) within 3 months prior to the first dose of the study drug. * Subjects who have received other anti-tumor investigational drug treatment within 28 days prior to the first dose of XNW5004 in this study. * Subjects who have undergone major surgery within 4 weeks prior to the start of study treatment or who intend to undergo major surgery during this study (except for procedures such as puncture or lymph node biopsy). * Subjects who have an allogeneic hematopoietic stem cell transplantation or solid organ transplantation. * Subjects who have received systemic treatment with corticosteroids (prednisone at a dose of \> 10 mg per day or equivalent doses of other glucocorticoids) or other immunosuppressive drugs within 14 days prior to the use of the study drug. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal replacement therapy with prednisone at a dose of ≤ 10 mg per day or equivalent doses of other glucocorticoids are permitted. * Subjects taking known strong CYP3A4 inhibitors/inducers and P-glycoprotein (P-gp) inhibitors within 14 days prior to the first dose. * Subjects who have received live virus vaccines (including live attenuated vaccines) within 28 days prior to dosing. Inactivated vaccines are permitted. * Subjects with a history of psychotropic drug abuse or drug abuse. * Subjects who have received anti-tumor therapy in the early stage and have not recovered from toxicity (toxicity has not recovered to ≤ Grade 1 according to NCI-CTCAE 5.0). Except for other toxicities (such as alopecia, etc.) that do not affect the safety evaluation of subjects in the opinion of the investigator. * Subjects with history of other malignancies within 3 years prior to enrollment and not meeting clinical cure criteria. Exceptions are the following: cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, intraductal carcinoma in situ of the breast, and papillary carcinoma of the thyroid that can be treated locally. * Subjects with mycosis fungoides, Sézary syndrome, or primary cutaneous T-cell lymphoma. * Subjects with previous or current central nervous system invasion. * Subjects with previous or current testicular or breast invasion. * Subjects with previous or current hemophagocytic syndrome. * Subjects with previous or current primary or secondary hematologic diseases that may affect bone marrow function in addition to primary malignancies, such as immune thrombocytopenia, autoimmune hemolytic anemia, aplastic anemia, etc. * Subjects with previous or current acute myeloid leukemia (AML). * Subjects with previous or current T-cell lymphoblastic lymphoma (T-LBL) or T-lymphoblastic leukemia. * Subjects who have any history of myeloid malignancy, including myelodysplastic syndrome (MDS), or abnormal tests results of markers related to MDS or myeloproliferative neoplasm (MPN). * Subjects who previously hadcentral nervous system lesions, or diseases accompanies with central nervous system lesions, including but not limited to, epilepsy, paralysis, stroke, severe brain injury, Alzheimer's disease, Parkinson's disease, cerebellar disease, cerebral organic syndrome, or psychosis, etc. * Subjects with clinically significant cardiovascular disease. * Tumor invasion of important peripheral organs and blood vessels (such as heart and pericardium, trachea, esophagus, aorta, superior vena cava, etc.) posing a risk of bleeding or the risk of esophageal tracheal fistula or esophageal pleural fistula. * Subjects with clinically symptomatic thoracoabdominal effusion or pericardial effusion that are poorly controlled after repeated treatment. * Subjects with unexplained fever and body temperature\>38.0 ℃. * Subjects who have severe active systemic infection. * Subjects with a history of tuberculosis infection within one year prior to enrollment, or with a history of active tuberculosis infection more than one year ago without sufficient anti tuberculosis treatment. * A known history of HIV infection or acquired immunodeficiency syndrome (AIDS), or Anti- Treponema Pallidum test (anti-TP) positive. * Subjects who have HBV-DNA copy numbers higher than the lower normal limit of the detection value. Subjects with HCV-RNA copy number higher than the lower normal limit of the detection value. * Subjects who are unable to swallow or has a history of active gastrointestinal inflammation, chronic diarrhea, known diverticular disease, or has undergone gastrectomy or gastric banding that affects drug absorption. But gastroesophageal reflux that has been treated with proton pump inhibitors is allowed (if there is no possibility of drug interaction). * Subjects with conditions known to have bleeding tendencies, such as von Willebrand disease or hemophilia. * Subjects who are pregnant or breastfeeding, or expects to conceive within the projected duration of the study. * Subject who may not be able to complete this study for other reasons or who, in the opinion of the investigator, should not participate the study.",NA,ALL,NA,"[{'measure': 'Progression Free Survival (PFS) assessed by BICR', 'timeFrame': '24 mounths'}]","[{'measure': 'Objective response rate (ORR)', 'timeFrame': '24 mounths'}, {'measure': 'Time to Response', 'timeFrame': 'around 4 months'}, {'measure': 'Duration of response', 'timeFrame': '24 mounths'}, {'measure': 'Overall survival', 'timeFrame': 'around 5 years'}]" 356,NCT05370547,"{'fullName': 'Chinese PLA General Hospital', 'class': 'OTHER'}",Chidamide Bridging for CAR-T Therapy,UNKNOWN,"The previous research suggests that the low expression of NOXA protein may be an important biomarker for the treatment of drug resistance of chimeric antigen receptor-T (CAR-T) cells. Up regulating the expression of NOXA through histone deacetylase inhibitor (HDACi) can improve drug resistance and significantly improve the therapeutic effect of CAR-T cells. This study will enroll approximately 120 subjects with recurrent or refractory (r/r) B-cell non-Hodgkin's lymphoma (NHL). Those with high expression of NOXA will receive conventional CAR-T treatment (without chidamide bridging), and those with low expression of NOXA will be randomly assigned 1:1 to those without or containing chidamide bridging. The purpose of this study was to evaluate the clinical response and safety of chidamide bridging.","[""Non Hodgkin's Lymphoma""]",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Chidamide', 'description': '1. Chidamide monotherapy mode: Chidamide was administered for at least 6 times after leukapheresis, 10mg oral D1-4, 20mg oral D7 every 3 days to the beginning day of FC conditioning.\n2. Chidamide combination mode: The combination of one or more of the following drugs in addition to chidamide is permitted: glucocorticoids, BTK inhibitors, chemotherapy, other previously used resistance drugs, etc.', 'armGroupLabels': ['low NOXA expression and chidamide intervention'], 'otherNames': ['HDACi']}, {'type': 'DRUG', 'name': 'Fludarabine and cyclophosphamide', 'description': ""Patients should be received FC regimen conditioning 3 to 5 days prior to CAR-T cell infusion. The recommended regimen is intravenous fludarabine (25-30 mg/m\\^2) and cyclophosphamide (250-500 mg/m\\^2) daily for 3 consecutive days. The clinician may also adjust the cleansing regimen according to the patient's actual situation."", 'armGroupLabels': ['high NOXA expression', 'low NOXA expression and chidamide intervention', 'low NOXA expression and no chidamide intervention'], 'otherNames': ['FC regimen']}, {'type': 'BIOLOGICAL', 'name': 'Anti-CD19 CAR-T cells', 'description': 'A single infusion of CAR-transduced autologous T cells administered intravenously at a target dose of 100 × 10\\^6 for Relma-cel or 2 × 10\\^6/kg for Axi-cel. Other commercial CAR-T doses are determined by specific drug infusion instructions. The dose of experimental CAR-T was determined by the investigator. Infusion volume was calculated based on CAR-T cell density and recommended dose.', 'armGroupLabels': ['high NOXA expression', 'low NOXA expression and chidamide intervention', 'low NOXA expression and no chidamide intervention'], 'otherNames': ['Relma-cel', 'Axi-cel', 'Other commercial CAR-T cells', 'Experimental CAR-T cells']}]","Inclusion Criteria: 1. Age 16-75, male or female; 2. Recurrent or refractory large B-cell lymphoma (LBCL) ,grade 1-3a follicular lymphoma (FL) and mantle cell lymphoma (MCL). Recurrent or refractory disease was defined as progression after systemic treatment with second-line or more lines (including CD20 monoclonal antibody and doxorubicin) or primary resistance (disease progression during first-line treatment or within 6 months after completion of treatment). LBCL includes diffuse large B-cell lymphoma non-specific type (DLBCL-NOS), diffuse large B-cell lymphoma transformed by follicular lymphoma (TFL), grade 3b FL, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma with MYC and Bcl-2 and/or Bcl-6 rearrangement ( double strike/triple hit lymphoma, DHL/THL); 3. Eastern Cooperative Oncology Group (ECOG) physical status is 0-3; 4. Life expectancy ≥12 weeks; 5. Subjects must be willing to undergo either excised or large-needle lymph node or tissue biopsy, or provide lymph node or tissue biopsy from the most recent available archived tissue for immunohistochemical NOXA testing and pathology review in the study center laboratory; 6. There are measurable target lesions; 7. CD19 positive; 8. Are willing to use contraception according to the following criteria: A. Women of reproductive age (15-49 years) must undergo a pregnancy test with negative results within 7 days before starting treatment; B. Women of reproductive age should use effective contraception for at least 120 days after the last dose of the study drug (contraceptive success rate of at least 99%). The subject should communicate with the available contraceptive methods with at least 99% success rate and confirm the understanding of the period; C. Male subjects used effective contraception for at least 93 days after the last dose of study drug (contraceptive success rate of at least 99%). The subject should communicate with the available contraceptive methods with at least 99% success rate and confirm the understanding of the period; D. Infertile women (i.e., surgically sterilized by hysterectomy and/or bilateral oophorectomy or amenorrhea ≥12 months and age \> 45 years) are not subject to conditions A and B above 9. Adequate bone marrow and organ functions (normal values shall not be obtained with growth factors, and hemocytopenia caused by lymphoma invasion of bone marrow is not subject to conditions A, B, and C below) : A. Neutrophil count (ANC) ≥1.0×10\^9/L; B. Hemoglobin ≥8.0g/dL; C. Platelet count ≥50×10\^9/L; D. Total bilirubin ≤1.5× upper limit of normal value (ULN) (\< 3 TIMES ULN for patients with Gilbert syndrome, cholestasis caused by hilar compression adenosis, biliary obstruction caused by liver involvement or lymphoma); E. Alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤2.5×ULN or ≤5×ULN when liver invasion is present; F. Creatinine clearance ≥40ml/min using the cockcroft-gault equation or glomerular filtration rate ≥40ml/min/1.73m2 using the modified renal disease diet formula; G. Lipase ≤1.5×ULN. Exclusion Criteria: 1. Patients known to be allergic to the drug Chidamide; 2. Lymphoma involves the central nervous system; 3. Known human immunodeficiency virus (HIV) infection or immunopositive test; 4. Viral infections that cannot be controlled by antiviral drugs, such as herpetic virus infection, acute or chronic active hepatitis B, acute or chronic active hepatitis C, etc. \[Note: chronic hepatitis B virus (HBV) carriers or non-active hepatitis B surface antigen (HBsAg) positive subjects and HBV-DNA lower than the detection limit can be included in the group; hepatitis C virus (HCV) antibody negative can be enrolled, HCV antibody positive patients need to be tested for HCV-RNA, if negative can be enrolled\]; 5. Presence of active infectious disease requiring treatment; 6. Received live vaccine within 30 days prior to enrollment; 7. Active autoimmune disease requiring systemic treatment within 12 months prior to enrollment (i.e., disease-modifying drugs, corticosteroids, or immunosuppressive drugs). Note: Alternative therapies (such as thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary dysfunction) are not considered a systemic treatment; 8. History of severe allergic reactions; 9. Presence of congestive heart failure or uncontrolled arrhythmias classified by the New York Heart Association as class III-IV; 10. Patients with clinically significant electrocardiogram abnormalities and potential risk of malignant arrhythmias; 11. Clinically significant cardiac events, including unstable angina, acute myocardial infarction, and/or cardiac transmission problems, occurred within 6 months prior to enrollment; 12. A history of stroke or intracranial hemorrhage within 3 months prior to enrollment; 13. Major surgery or trauma occurred within 28 days prior to enrollment, or major side effects have not been recovered; 14. Accompanied by uncontrolled major medical conditions, including, but not limited to, kidney, liver, blood, gastrointestinal, endocrine, pulmonary, neurological, brain or psychiatric disorders; 15. Current or previous malignancy within 3 years prior to enrollment, excluding cured basal or squamous cell skin cancer, superficial bladder cancer, prostatic intraepithelial tumor and carcinoma in situ of the cervix; 16. Conditions in which a known mental or physical illness interferes with cooperation with the requirements of the study or disrupts the results or interpretation of the results and, in the opinion of the therapeutic investigator, makes the patient unfit for study participation; 17. There is the situation that the researcher's judgment will interfere with the whole study participation; Situations where there is significant risk to the subject; Or interferes with the interpretation of research data; 18. Pregnant or breast-feeding patients; 19. Inability to swallow and retain oral medications, malabsorption syndrome, diseases that significantly affect gastrointestinal function, total resection of the stomach or small intestine, ulcerative colitis, symptomatic inflammatory bowel disease, partial or complete intestinal obstruction; 20. Inability to understand or unwillingness to sign informed consent.",NA,ALL,NA,"[{'measure': 'Percentage of participants with progression-free survival (PFS) at 6 months after CAR-T infusion among all participants', 'description': 'PFS is defined as the time between the date of CAR-T infusion and disease progression or death from any cause. At the time of statistical analysis of study endpoints, there were no PFS events, and data were truncated as the date of the last objective tumor evaluation. Patients who were lost to follow-up or withdrew informed consent will be included in the end point evaluation, with data truncated as the date of the last objective tumor evaluation.', 'timeFrame': '6 months'}]","[{'measure': 'Incidence of adverse events (AE) of chidamide bridging and subsequent CAR-T infusion arm', 'description': 'AE is defined as any adverse medical event from the time between the date of randomization and the date of 12 months after CAR-T infusion. AE may be an adverse sign (including abnormal laboratory tests, etc.), symptom, or illness that is not related to the purpose of medication and is time-related to drug use, regardless of causality to the drug, such as long-term cytopenia, cytokine release syndrome, neurotoxicity, etc.', 'timeFrame': '12 months'}, {'measure': 'Participants with objective response rate (ORR) at 3 months after CAR-T infusion among all participants', 'description': 'ORR was defined as the percentage of subjects who achieved complete response or partial response assessed by investigators and based on the Lugano 2014 assessment criterion. All subjects who do not meet objective response criteria by the data analysis deadline will be considered nonresponders. The source of this endpoint will only include the assessment of response obtained after CAR-T infusion and prior to any additional antitumor therapy.', 'timeFrame': '3 months'}, {'measure': 'Participants with complete response rate (CRR) at 3 months after CAR-T infusion among all participants', 'description': 'CRR was defined as the percentage of subjects who achieved a CR assessed by investigators and based on the Lugano 2014 assessment criterion.', 'timeFrame': '3 months'}, {'measure': 'Percentage of participants with recurrence-free survival (RFS) at 6 months after CAR-T infusion among all participants', 'description': 'RFS was defined as the time between the date of CAR-T infusion and the date of first lymphoma recurrence (local, regional, distant metastasis) or death (whatever the cause) for subjects who received complete response after CAR-T infusion. For participants who remained alive and whose disease had not recurred, RFS was censored on the date of last visit/contact with disease assessments.', 'timeFrame': '6 months'}, {'measure': 'Percentage of participants with RFS at 12 months after CAR-T infusion among all participants', 'description': 'RFS was defined as above.', 'timeFrame': '12 months'}, {'measure': 'Percentage of participants with PFS at 12 months after CAR-T infusion among all participants', 'description': 'PFS was defined as above.', 'timeFrame': '12 months'}, {'measure': 'Percentage of participants with overall survival (OS) at 12 months after CAR-T infusion among all participants', 'description': 'OS was defined as the time between the date of CAR-T infusion and death from any cause.', 'timeFrame': '12 months'}]" 357,NCT06774326,"{'fullName': 'IRCCS Azienda Ospedaliero-Universitaria di Bologna', 'class': 'OTHER'}",Role of Spectral CT in the Evaluation of Cardiotoxicity in Patients With Hodgkin's Lymphoma and Diffuse Large B-cell Lymphoma Treated With Anthracyclines,RECRUITING,To evaluate the diagnostic capability of Spectral CT (performed with contrast agent as part of routine oncological follow-up) in detecting signs of acute and chronic early-onset cardiac toxicity from anthracyclines in patients with Hodgkin's lymphoma and diffuse large B-cell lymphoma undergoing treatment regimens that include a drug from this family.,"['Cardiac Imaging', 'Cardiac Imaging Techniques', 'Lymphoma', 'Hodgkin Disease']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}",NA,"Inclusion Criteria: * Patients with Hodgkin's lymphoma or diffuse large B-cell lymphoma (DLBCL) undergoing treatment regimens including anthracyclines * Age ≥18 years * Informed consent obtained Exclusion Criteria: * Absolute or relative contraindications to CT examination and/or administration of iodinated contrast agents (e.g., pregnancy, severe renal insufficiency in non-dialysis patients with GFR \<15-30 ml/min/1.73m²). * Patients with a concomitant positive history of cardiovascular disease (e.g., myocardial infarction, known coronary artery disease, heart failure, arrhythmias, prior myocarditis, cardiomyopathies). * History of mediastinal radiotherapy.",Patients diagnosed with Hodgkin's lymphoma and diffuse large B-cell lymphoma (DLBCL) undergoing treatment regimens including anthracyclines will participate in the study. They will be enrolled and undergo CT and MRI follow-ups conducted by the cardiac radiology team.,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Myocardial damage', 'description': 'Diagnosis of the presence of acute myocardial damage (hyperemia present) or chronic damage (hyperemia absent) based on the evaluation of the following parameters obtained from Spectral CT:\n\n* Increased ECV (ECV value above the upper limit of normality, set at 30%).\n* Presence of Late Iodine Enhancement (LIE) in the myocardium (areas of myocardial hyperdensity due to late-phase iodine contrast accumulation) and its relative extent.\n* Presence of Hyperemia or Hypoperfusion using the Spectral ""Iodine No Water"" parameter (visual scoring of hyper- or hypodense areas; consideration of a possible quantitative score in mgI/ml).\n* Diagnosis of myocardial damage due to chemotherapy (CHT) based on clinical practice upon hospital discharge.', 'timeFrame': '36 months after starting CHT'}]",NA 358,NCT05549284,"{'fullName': 'Affiliated Hospital to Academy of Military Medical Sciences', 'class': 'OTHER'}","Orelabrutinib,Rituximab and Methotrexate in Newly-diagnosed Primary Central Nervous System Lymphoma(PCNSL)",UNKNOWN,"This is a prospective single arm,multi-center,phase 2 study,and this study is to evaluate the efficacy and safety of Orelabrutinib,Rituximab combined with high-dose Methotrexate(RMO) as first line regimens in the treatments of newly diagnosed primary central nervous system lymphoma(PCNSL).Objective response and complete response are the primary endpoint.",['Primary Central Nervous System Lymphoma'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Orelabrutinib,Rituximab and Methotrexate', 'description': 'Orelabrutinib, Rituximab combined with high-dose Methotrexate(RMO) as first line regimens in the treatments of newly diagnosed primary central nervous system lymphoma. The response will be evaluated every 2 cycles. Patients who achieved complete remission (CR) or partial remission (PR) will receive further treatment, and there are 6 cycles of RMO regimen for the induction. The patients with stable disease (SD) or progressed disease(PD) will withdraw from the trial and receive salvage regimens. After total 6 induction cycles, the investigators evaluate the efficiency again. After 6 cycles, the patients who receive CR or PR, can tolerate Autologous Hematopoietic Stem Cell Transplantation (AHSCT) will be candidates of high-dose chemotherapy and stem rescue. The patients who achieve CR or PR, cannot tolerate AHSCT will go to whole brain radiotherapy or Orelabrutinib maintenance. The patients with SD or PD will receive salvage regimen.', 'armGroupLabels': ['Orelabrutinib,Rituximab and Methotrexate'], 'otherNames': ['RMO']}]","Inclusion Criteria: * primary central nervous system diffuse large B-cell lymphoma histologically confirmed by brain biopsy; * Aged 18-70 years * Signature of informed consent; * At least one measurable lesion; * Neutropile≥1.5X109/L,Hemoglobin≥80g/L,Platelets≥75X109/L,Billrubin\<2XULN,ALT\<4XULN,AST4XULN * The expected survival time is at least 3 months Exclusion Criteria: * Those who have contraindications to any of the components in the Orelabrutinib,Rituximab and HD-MTX * History of other malignancies that may affect the compliance of the research protocol or the analysis of the results * Severe cardiac insufficiency * Other antitumor treatments were used * Human immunodeficiency virus(HIV)antibody is positive * Pregnant or lactating women * Researchers consider if anyone not suitable for enrollment.",NA,ALL,NA,"[{'measure': 'primary endpoint', 'description': 'Objective response rate(ORR) is the primary endpoint', 'timeFrame': 'Enrollment is expected to last for two year, followed up for five years'}]","[{'measure': 'secondary endpoints', 'description': 'Complete rate(CR)、progression free survival(PFS)、overall survival(OS) are the secondary endpoints', 'timeFrame': 'Enrollment is expected to last for two year, followed up for five years'}]" 359,NCT04293900,"{'fullName': 'George Washington University', 'class': 'OTHER'}","Diet, Physical Activity and Body Composition Changes During R-CHOP",WITHDRAWN,"In this pilot study, observational data will be collected to describe the usual trajectory of changes in dietary intake, ability to be physically active, body composition, environmental exposures, and the gut microbiome over the course of R-CHOP treatment for non-Hodgkin lymphoma (NHL).","['Non-Hodgkin Lymphoma', 'DLBCL', 'Diffuse Large B Cell Lymphoma']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'OTHER', 'name': '24-hour dietary recall', 'description': 'Dietary intake assessment conducted by a Registered Dietitian Nutritionist. This assessment will occur prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.', 'armGroupLabels': ['Study cohort']}, {'type': 'OTHER', 'name': 'Hand grip strength', 'description': 'Measurement of grip strength using a hand dynamometer. This will test occur prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.', 'armGroupLabels': ['Study cohort']}, {'type': 'OTHER', 'name': 'International Physical Activity Questionnaire', 'description': 'Survey about physical activity over the previous 7 days. This survey will be administered prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.', 'armGroupLabels': ['Study cohort'], 'otherNames': ['IPAQ']}, {'type': 'OTHER', 'name': 'Patient-reported outcomes survey', 'description': 'Survey about symptoms and side effects experienced during cancer treatment. This will be administered prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.', 'armGroupLabels': ['Study cohort'], 'otherNames': ['NCI-PRO-CTCAE']}, {'type': 'OTHER', 'name': 'Pittsburgh Sleep Quality Index', 'description': 'Survey about sleep habits and quality over the past month. This will be administered prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.', 'armGroupLabels': ['Study cohort'], 'otherNames': ['PSQI']}, {'type': 'OTHER', 'name': 'Functional Assessment of Cancer Treatment - Lymphoma', 'description': 'Survey about quality of life for people with a diagnosis of lymphoma. This will be administered prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.', 'armGroupLabels': ['Study cohort'], 'otherNames': ['FACT-lym']}, {'type': 'OTHER', 'name': 'urine sample (optional)', 'description': 'Collect three urine samples either in the clinic or at home. This specimen collection will occur prior to starting R-CHOP chemotherapy, after the third round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.', 'armGroupLabels': ['Study cohort']}, {'type': 'OTHER', 'name': 'fecal sample (optional)', 'description': 'Collect a fecal sample either in the clinic or at home. This sample collection will occur prior to starting R-CHOP chemotherapy, after the third round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.', 'armGroupLabels': ['Study cohort']}]","Inclusion Criteria: * Diagnosis of one of the non-Hodgkin lymphomas * Scheduled to receive R-CHOP at the George Washington University Cancer Center Exclusion Criteria: * Diagnosis of cancer other than one of the non-Hodgkin lymphomas * Patients who are scheduled to receive their R-CHOP somewhere other than the George Washington University Cancer Center * Patients who are not competent to provide informed consent to participate",Patients being treated at the George Washington University for non-Hodgkin lymphoma who are scheduled to receive R-CHOP chemotherapy,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Change in lean body mass (LBM) from baseline to end of R-CHOP chemotherapy', 'description': 'change in kilograms of lean body mass as measured from staging CT-scans from pre- to post-R-CHOP chemotherapy.', 'timeFrame': 'baseline and post-R-CHOP chemotherapy (18 weeks)'}]","[{'measure': 'Change in adipose tissue volume from baseline to end of R-CHOP chemotherapy', 'description': 'change in adipose tissue volume (cm\\^3) as measured from staging CT-scans from pre- to post-R-CHOP chemotherapy.', 'timeFrame': 'baseline and post-R-CHOP chemotherapy (18 weeks)'}, {'measure': 'Change in dietary energy from baseline to end of R-CHOP chemotherapy', 'description': 'Change in total energy intake (kcal/day) from pre- to post-R-CHOP chemotherapy.', 'timeFrame': 'baseline, each chemotherapy visit (3, 6, 9, 12, and 15 weeks), and post-R-CHOP chemotherapy (18 weeks)'}, {'measure': 'Change in dietary protein intake from baseline to end of R-CHOP chemotherapy', 'description': 'Change in dietary protein intake (g/day) from pre- to post-R-CHOP chemotherapy measured by diet history.', 'timeFrame': 'baseline, each chemotherapy visit (3, 6, 9, 12, and 15 weeks), and post-R-CHOP chemotherapy (18 weeks)'}, {'measure': 'Change in physical activity level from baseline to end of R-CHOP chemotherapy', 'description': 'Change in daily metabolic equivalents (MET) of physical activity as measured by accelerometer from pre- to post-R-CHOP chemotherapy.', 'timeFrame': 'baseline, each chemotherapy visit (3, 6, 9, 12, and 15 weeks), and post-R-CHOP chemotherapy (18 weeks)'}, {'measure': 'Change in urinary bisphenol levels', 'description': 'percent of change in urinary bisphenol levels (ng/mL) as measured by liquid chromotography-tandem mass spectrometry from pre- to post-R-CHOP chemotherapy', 'timeFrame': 'baseline, after the third chemotherapy visit (9 weeks), and post-R-CHOP chemotherapy (18 weeks)'}, {'measure': 'Change in urinary phthalate levels', 'description': 'percent of change in urinary phthalate levels (ng/ML) as measured by liquid chromotography-tandem mass spectrometry from pre- to post-R-CHOP chemotherapy', 'timeFrame': 'baseline, after the third chemotherapy visit (9 weeks), and post-R-CHOP chemotherapy (18 weeks)'}, {'measure': 'Change in gut microbiome composition', 'description': 'Change in species and type of gut microbiota from pre- to post-R-CHOP chemotherapy', 'timeFrame': 'baseline, after the third chemotherapy visit (9 weeks), and post-R-CHOP chemotherapy (18 weeks)'}]" 360,NCT01761500,"{'fullName': 'Sun Yat-sen University', 'class': 'OTHER'}",Improve the Survival Rate of Chinese Children and Adolescents With Non-Hodgkin's Lymphoma,COMPLETED,Non-Hodgkin's lymphoma is an aggressive malignance disease in children and adolescents. This study was designed to evaluate the efficacy and toxicity of the modified NHL-BFM-90 protocol in Chinese children and adolescents with Non-Hodgkin's lymphoma.,"[""Childhood Non-Hodgkin's Lymphoma""]",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'OTHER', 'name': 'Modified BFM-90 protocol', 'description': 'Using Modified BFM-90 protocol to treat Chinese children and Adolescents with NHL', 'armGroupLabels': ['Modified BFM-90 protocol']}]","Inclusion Criteria: 1. Untreated children and adolescents with Non-Hodgkin's lymphoma 2. Age ≤ 20 years 3. The informed consent of their guardians was obtained. Exclusion Criteria: 1. Recurrence Non-Hodgkin's lymphoma 2. Age \>20 years 3. No abide by the protocol",NA,ALL,NA,"[{'measure': 'The event free survival (EFS)', 'description': 'The event free survival (EFS) was defined as the time from the start of treatment to one of the following events: death from any cause, disease progression during treatment, relapse, or to the date of the last follow up if patient did not experience any event.', 'timeFrame': 'Up to 5 years'}]","[{'measure': 'Number of Participants with Adverse Events', 'description': 'To assess the number of adverse events from the start of treatment to one of the following events: death from any cause, disease progression during treatment, relapse, severe infection, therapy related complication and second malignancy.', 'timeFrame': 'Up to 5 years'}]" 361,NCT00074087,"{'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}","Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides",COMPLETED,"RATIONALE: Drugs used in chemotherapy, such as liposomal doxorubicin, use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients who have stage IIB, stage IVA, or stage IVB recurrent or refractory mycosis fungoides.",['Lymphoma'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'pegylated liposomal doxorubicin hydrochloride', 'armGroupLabels': ['Caelyx']}]","DISEASE CHARACTERISTICS: * Histologically confirmed mycosis fungoides * Stage IIB, IVA, or IVB * Refractory or recurrent disease after at least 2 of the following prior therapies: * Local and/or systemic steroids * Retinoids * Interferon alfa * Local carmustine * Systemic chemotherapy * Psoralen and ultraviolet A (PUVA) light therapy * No CNS involvement * No erythroderma (T4) PATIENT CHARACTERISTICS: Age * Over 18 Performance status * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * Neutrophil count at least 1,500/mm\^3 * WBC at least 2,000/mm\^3 * Platelet count at least 75,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT and SGPT no greater than 2.5 times ULN Renal * Creatinine no greater than 1.5 times ULN Cardiovascular * LVEF normal by echocardiography or radionuclide angiocardiography Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 2 years after study participation * No psychological, familial, sociological, or geographical condition that would preclude study compliance or follow-up * No active infection requiring specific therapy (e.g., antibiotics or anti-HIV therapy) * No other prior or concurrent primary malignant tumor except adequately treated carcinoma in situ of the cervix or squamous cell or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * See Disease Characteristics * More than 2 weeks since prior immunotherapy Chemotherapy * See Disease Characteristics * Prior systemic chemotherapy allowed provided all of the following conditions are met: * Cumulative anthracycline dose is less than 200 mg/m\^2 * No allergy to anthracyclines * Prior methotrexate is low dose (i.e., weekly dose less than 30 mg) * More than 2 weeks since prior chemotherapy Endocrine therapy * See Disease Characteristics * No concurrent systemic steroids Radiotherapy * More than 2 weeks since prior radiotherapy Surgery * Not specified Other * Recovered from toxic effects of prior therapy, excluding alopecia * No other concurrent anticancer therapy",NA,ALL,NA,[{'measure': 'Response (complete clinical [CCR] and partial resp. [PR]) rate by Tumor Burden Index for cutaneous disease and appearance or disappearance of lesions for noncutaneous disease every 8 wks during treatment and then every 12 wks until progression'}],"[{'measure': 'Time to progression measured by Tumor Burden Index for cutaneous disease and appearance or disappearance of lesions for noncutaneous disease every 8 weeks during treatment'}, {'measure': 'Duration of response measured by Tumor Burden Index for cutaneous disease and appearance or disappearance of lesions for noncutaneous disease every 8 weeks during treatment and then every 12 weeks until progression'}, {'measure': 'Toxicity assessed by CTC v.2.0 at the end of each course'}]" 362,NCT01030900,"{'fullName': 'National Institutes of Health Clinical Center (CC)', 'class': 'NIH'}",Phase II Trial of Alemtuzumab (Campath) and Dose-Adjusted EPOCH-Rituximab (DA-EPOCH-R) in Relapsed or Refractory Diffuse Large B-Cell and Hodgkin Lymphomas,COMPLETED,"Background: * Studies conducted at the National Cancer Institute suggest that certain chemotherapy drugs may be more effective if given by continuous infusion into the vein rather than by the standard method of rapid intravenous injection. One combination of six chemotherapy drugs, known as etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (EPOCH-R), has had a high degree of effectiveness in people with certain kinds of cancer. * Recent evidence also indicates that the effects of chemotherapy may be improved by combining the treatment with monoclonal antibodies, which are purified proteins that are specially made to attach to foreign substances such as cancer cells. A monoclonal antibody called campath (alemtuzumab) has been manufactured to attach to a protein called Campath-1 antigen (CD52) that may target tumor cells or the surrounding inflammatory cells. * Researchers are interested in developing new treatments for large B-cell lymphoma or Hodgkin lymphoma that can best be treated with chemotherapy. This protocol is specifically for people with diffuse large B-cell or Hodgkin lymphomas that have not responded to standard treatments. Objectives: \- To test whether giving campath (alemtuzumab) in combination with continuous infusion EPOCH-R chemotherapy will improve the outcome of lymphoma treatment. Eligibility: \- Individuals 18 years of age and older who have large B-cell lymphoma or Hodgkin lymphoma that has not responded well to standard treatments. Design: * During the study, patients will receive standard EPOCH-R chemotherapy, which includes the following drugs: etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab. The additional drug, campath, will be given by intravenous (IV) infusion on the first day of treatment over several hours. * When the campath IV infusion and rituximab IV infusion are complete, the drugs doxorubicin, etoposide, and vincristine will each be given by continuous IV infusion over the next 4 days (that is, continuously for a total of 96 hours). Cyclophosphamide will be given by IV infusion over several hours on Day 5. Prednisone will be given by mouth twice each day for 5 days. * Patients may be given other drugs to treat the side effects of chemotherapy, to prevent possible infections, and to improve white blood cell counts. * The campath-EPOCH-R therapy will be repeated every 21 days, as a cycle of therapy, for a total of 6 cycles. Following the fourth and sixth treatment cycles (approximately weeks 12 and 18) of campath-EPOCH-R treatment, study researchers will perform blood tests and computed tomography (CT)/magnetic resonance imaging (MRI) scans on all patients to assess their response to the treatment.","['Hodgkin Lymphoma', 'Diffuse Large B-Cell Lymphoma']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'Campath', 'description': 'campath plus etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) and rituximab every 3 weeks for up to 6 cycles', 'armGroupLabels': ['Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin + Rituximab + Campath'], 'otherNames': ['Alemtuzumab']}, {'type': 'BIOLOGICAL', 'name': 'Rituximab', 'description': 'rituximab plus etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) and campath every 3 weeks for up to 6 cycles', 'armGroupLabels': ['Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin + Rituximab + Campath'], 'otherNames': ['Rituxan']}, {'type': 'DRUG', 'name': 'EPOCH', 'description': 'Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) plus rituximab and campath every 3 weeks for up to 6 cycles', 'armGroupLabels': ['Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin + Rituximab + Campath'], 'otherNames': ['Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin']}]","* INCLUSION CRITERIA: 1. Previously treated or refractory classical large B-cell lymphomas, Grey-zone lymphoma and Hodgkin lymphoma, including Lymphocyte predominant Hodgkin Lymphoma (LPHL). 2. Confirmed pathological diagnosis by the Laboratory of Pathology, National Cancer Institute (NCI). 3. Age greater than or equal to 18 years. 4. Eastern Cooperative Oncology Group (ECOG) performance 0-2 5. Laboratory tests: absolute neutrophil count (ANC) greater than or equal to 1000/mm(3), platelet greater than or equal to 75,000/mm(3). Creatinine less than or equal to 1.5 mg/dL or creatinine clearance greater than or equal to 60 ml/min; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal (ULN). Total bilirubin \< 2.0 mg/dl except \< 5mg/dL in patients with Gilbert's (as defined as \> 80% unconjugated hyperbilirubinemia without other known cause); unless impairment due to organ involvement by lymphoma. EXCLUSION CRITERIA: 1. Active symptomatic ischemic heart disease, myocardial infarction or congestive heart failure within the past year. If echocardiogram (ECHO) is obtained, the left ventricular ejection fraction (LVEF) should exceed 40%. 2. Human immunodeficiency virus (HIV) positive, because of the unknown effects of combined therapy with chemotherapy and an immunosuppressive agent on HIV progression. 3. Female subject of child-bearing potential not willing to use an acceptable method of birth control (i.e. a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study and two years beyond treatment completion. 4. Female subject pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotrophin (beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not required for women without childbearing potential. 5. Male subject unwilling to use an acceptable method for contraception for the duration of the study and one year beyond treatment completion. 6. Invasive or active malignancy in past 2 years. 7. Serious concomitant medical illnesses that would jeopardize the patient s ability to receive the regimen with reasonable safety. 8. Active central nervous system (CNS) lymphoma. These patients have a poor prognosis and because they frequently develop progressive neurological dysfunction that would confound the evaluation of neurological and other adverse events. 9. Systemic cytotoxic therapy within 3 weeks of treatment.",NA,ALL,NA,"[{'measure': 'Progression Free Survival (PFS)', 'description': ""PFS is the time interval from start of treatment to documented evidence of disease progression estimated using a Kaplan Meier curve. Progression was assessed by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphomas and is defined as ≥50% increase from nadir in the sum of the products of diameters of any previously identified abnormal node for partial response or non-responders. And an appearance of any new lesion during or at the end of therapy."", 'timeFrame': 'Time of progression or death, approximately 10 months'}, {'measure': 'Overall Survival (OS)', 'description': 'OS is from enrollment to the day of death estimated using the Kaplan-Meier curve.', 'timeFrame': 'Median overall survival from enrollment to the day of death, approximately 17.9 months'}]","[{'measure': 'Clinical Response on Study and at Relapse After Dose Adjusted - Etoposide + Prednisone + Vincristine + Cyclophosphamide + Doxorubicin + Rituximab (DA-EPOCH-RC)', 'description': ""Clinical response was assessed by the International Workshop to Standardize Response Criteria for non-Hodgkin's Lymphomas. Complete remission is complete disappearance of all detectable clinical and radiographic evidence of disease. Complete response unconfirmed is as per complete remission except that if a residual node is greater than 1.5cm, it must have decreased by greater than 75% in the sum of the products of the perpendicular diameters (SPD). Partial response is ≥50% decreased in the SPD of 6 largest dominant nodes or nodal masses. Relapsed disease is appearance of any new lesion or increase by ≥50% in the size of the previously involved sites. Stable disease is defined as less than a partial response but not progressive disease. Progression is ≥50% increase from nadir in the SPD of diameters of any previously identified abnormal node for partial response or non-responders; and an appearance of any new lesion during or at the end of therapy."", 'timeFrame': 'On study and at relapse after study treatment, approximately 10 months'}]" 363,NCT06830421,"{'fullName': 'University Hospital Freiburg', 'class': 'OTHER'}",Adjusted High-dose Chemotherapy With Autologous Stem Cell Transplant vs. Conventional Immunochemotherapy in Elderly PCNSL Patients,RECRUITING,"Most patients being diagnosed with primary diffuse large B-cell lymphoma of the central nervous system (PCNSL) are 60 years or older. Elderly patients with PCNSL have a poor prognosis and there is a great medical need to improve outcome for this vulnerable population. In Germany and many international centres, there are currently two widely used strategies to treat elderly PCNSL patients who are eligible for high-dose methotrexate (HD-MTX) treatment, which have not yet been compared head-to-head. The R-MP regimen has been established by the Cooperative PCNSL Study Group as a ""conventional"" immunochemotherapy standard treatment for elderly patients with newly diagnosed disease and consists of Rituximab, HD-MTX and Procarbazine followed by maintenance therapy with Procarbazine. In contrast, another recently established protocol also includes HD-MTX-based induction therapy, but followed by consolidating high-dose chemotherapy and autologous stem cell transplantation (HCT-ASCT). This is an overall more intensive, but substantially shorter treatment approach, feasible for elderly patients being considered eligible for a more intensive treatment. The PRIMA-CNS trial aims to compare these two treatment approaches with respect to survival, response rates and toxicity.",['Primary Central Nervous System Lymphoma'],INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized, controlled, open-label, multicenter phase III trial with 2 parallel arms investigating a more intensive, shorter treatment with 2 cycles of MARTA (rituximab, HD-MTX, AraC) followed by HCT with rituximab, busulfan and thiotepa followed by ASCT compared to standard therapy comprising 3 cycles of R-MP followed by procarbazine maintenance for 6 months.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'R-MP and Procarbazine maintenance', 'description': 'Firstline systemic treatment with conventinal immunochemotherapy (3 cycles of Rituximab-MTX-Procarbazine) followed by Procarbazine maintenance', 'armGroupLabels': ['Arm A']}, {'type': 'DRUG', 'name': 'R-MTX/AraC (MARTA) induction followed by consolidating HCT-ASCT', 'description': 'Firstline systemic treatment with age-adjusted MTX based induction (2 cycles of Rituximab-Methotrexate-Cytarabin) followed by consolidating aged-adapted high-dose chemotherapy and autologous stem cell transplantation', 'armGroupLabels': ['Arm B']}]","Inclusion Criteria: 1. Immunocompetent patients with newly-diagnosed primary DLBCL of the central nervous system. 2. Age \> 70 years or age 65-70 years if not eligible for more intensive treatment (e.g. OptiMATe trial). 3. Histologically or cytologically assessed diagnosis of B-cell lymphoma by local pathologist. 4. Diagnostic sample obtained by stereotactic or surgical biopsy, cerebrospinal fluid (CSF) cytology examination or vitrectomy. 5. Disease exclusively located in the CNS. 6. At least 1 measurable lesion. 7. Eastern Cooperative Oncology Group (ECOG)-Performance Status (PS) ≤ 2. ECOG PS \> 2 accepted if due to PCNSL symptoms. 8. Patients possibly eligible for HCT-ASCT as judged by the treating physician. 9. Written informed consent obtained according to international guidelines and local laws by patient or authorized legal representative in case patient is temporarily legally not competent due to his or her disease. Additional randomization criteria: 1. Patients eligible for HCT-ASCT defined by the EBL score (at most one of the 3 following conditions may apply: ECOG PS \> 1, Barthel Index of activities of daily living (ADL) \< 20 and Lachs geriatric screening \> 3), improvement of PS after pre-phase treatment or clinical judgement by the treating physician after discussion with the study expert team. 2. No evidence of disease progression after pre-phase treatment. Exclusion Criteria: 1. Congenital or acquired immunodeficiency including HIV infection and previous organ transplantation. 2. Systemic lymphoma manifestation (outside the CNS). 3. Primary vitreoretinal lymphoma or primary leptomeningeal lymphoma without manifestation in the brain parenchyma or spinal cord. 4. Previous or concurrent malignancies with the exception of surgically cured carcinoma in situ or other kinds of cancer without evidence of disease for at least 5 years. 5. Previous systemic Non-Hodgkin lymphoma at any time. 6. Inadequate renal function (creatinine clearance \<60 ml/min). 7. Inadequate bone marrow, cardiac, pulmonary or hepatic function according to investigator´s decision. 8. Active hepatitis B or C disease. 9. Concurrent treatment with other experimental drugs or participation in an interventional clinical trial with administration of study medication within the last thirty days before the start of this study. 10. Third space fluid accumulation \>500 ml. 11. Hypersensitivity to study treatment or any component of the formulation. 12. Taking any medications likely to cause interactions with the study medication. 13. Known or persistent abuse of medication, drugs or alcohol. 14. Active COVID-19-infection or non-compliance with the prevailing hygiene measures regarding the COVID-19 pandemic. 15. Patients without legal capacity and who are unable to understand the nature, significance and consequences of the study and without designated legal representative. 16. Previous participation in this trial. 17. Persons who are in a relationship of dependency/employment to the sponsor and/ or investigator. 18. Any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule. 19. Fertile patients refusing to use safe contraceptive methods during the study.",NA,ALL,NA,"[{'measure': 'Progression free survival (PFS) between the 2 arms', 'description': 'PFS is defined as the time from randomization to disease progression or death of any cause, with censoring at the last date the patient was seen alive and free of disease progression', 'timeFrame': 'up to 6 years'}]","[{'measure': 'Overall survival (OS) between the 2 arms', 'description': 'OS is defined as time from randomization until death from any cause, with censoring at the last date the patient was seen alive', 'timeFrame': 'up to 6 years'}, {'measure': 'Event free survival (EFS) between the 2 arms', 'description': 'EFS, defined as time from randomization to premature end of treatment (EOT) due to any reason, lymphoma progression or death, whichever occurs first, with censoring at the last date the patient was seen event-free', 'timeFrame': 'up to 6 years'}, {'measure': 'Remission status after 2 cycles of rituximab-methotrexate-procarbazine (R-MP) (arm A)/2 cycles of R-MTX/cytarabine (AraC)', 'description': 'Remission status after 2 cycles of RMP (arm A) / 2 cycles of R-MTX/AraC will be determined at response assessment (RA) I in both arms and will be divided in complete remission (CR), unconfirmed complete remission (CRu), partial remission (PR), stable disease (SD), progressive disease(PD) according to international PCNSL collaborative group (IPCG) criteria', 'timeFrame': 'at RA I: after 8 weeks (Arm A), after 6 weeks (Arm B)'}, {'measure': 'Remission status after 3 cycles of R-MP (arm A)/consolidating HCT-ASCT (arm B)', 'description': 'determined at response assessment (RA) II and will be divided in CR, CRu, PR, SD, PD according to IPCG criteria', 'timeFrame': 'at RA II: after 12 weeks'}, {'measure': 'Remission status after completion of maintenance treatment (arm A)/6 months follow-up (arm B)', 'description': 'will be determined 6 months after RA II and will be divided in CR, CRu, PR, SD, PD according to IPCG criteria', 'timeFrame': '6 months after RA II'}, {'measure': 'Quality of life (EORTC QLQ-C30)', 'description': 'EORTC quality of life questionnaire (QLQ)-C30 performed at screening, at RA II /premature EOT and thereafter every 12 months during follow-up', 'timeFrame': 'from date of informed consent form (ICF) signature up to 6 years'}, {'measure': 'Quality of Life (EORTC-QLQ BN 20)', 'description': 'EORTC-QLQ brain neoplasm (BN) 20, performed at screening, at RA II /premature EOT and thereafter every 12 months during follow-up', 'timeFrame': 'from date of informed consent form (ICF) signature up to 6 years'}]" 364,NCT04651348,"{'fullName': 'Beijing Mabworks Biotech Co., Ltd.', 'class': 'INDUSTRY'}",A Clinical Study of MIL95 in Advanced Malignancies.,RECRUITING,"This study is composed of two stages: Part A initial dose escalation and Part B maintenance dose escalation. Both parts will adopt the classical 3+3 dose escalation design. The starting dose for phase Ia part A is 0.1 mg/kg QW, followed by 3 dose cohorts (0.3mg/kg QW, 0.8mg/kg QW and 1mg/kg QW). Duration of dose limiting toxicity (DLT) observation is 14 days. Part B will have 5 dose cohorts(3mg/kg QW, 10mg/kg QW, 20mg/kg QW 30mg/kg QW and 45mg/kg QW). DLT observation period is 28 days. The subject number for each cohort in Part B will be increased to 6 if the subject number enrolled in each cohort is less than 6.",['Advanced Malignancies'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Recombinant Humanized Monoclonal Antibody MIL95', 'description': 'PART A :The patients confirming to the eligibility criteria will be assigned to the 4 dose groups (0.1mg/kg, 0.3mg/kg, 0.8mg/kg, 1.0mg/kg, respectively) based on the sequence of inclusion. Each patient will receive an intravenous infusion of MIL95 every week on Day 1 for a maximum of Twelve weeks.\n\nPART B:One recommended dose as a priming dose will be selected from 4 dose groups(0.1mg/kg、0.3mg/kg、0.8mg/kg、1.0mg/kg) based on results of PART A. Each patient will receive a priming dose of MIL95 on Day 1 Cycle 1.The patients will be assigned to the 5 maintenance dose groups (3mg/kg, 10mg/kg, 20mg/kg, 30mg/kg, 45mg/kg, respectively) based on the sequence of inclusion. The maintenance dose was given on Day 8,15,22 Cycle 1 and on Day 1,8,15,22 Cycle 2+. Each cycle was 28 days.', 'armGroupLabels': ['MIL95']}]","Inclusion Criteria: 1. Adult patients, \>=18 years of age; 2. Diagnosis of Refractory/relapsed lymphomas or solid tumor; 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 4. Life expectancy \>=3 months; 5. Sufficient organ and bone marrow function; 6. At least one measurable lesion or evaluable lesion (recist v1.1 or Lugano 2014); 7. Able and willing to provide written informed consent and to comply with the study protocol. Exclusion Criteria: 1. Prior use of any anti-cancer therapy(including chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc) within 4 weeks of study start; 2. Previous exposure to any drug targeting CD47 or SIRPα; 3. Major surgery within 4 weeks prior to the first administration or expected to undergo major surgery during the study treatment; 4. Live attenuated vaccine administrated within 4 weeks before the first administration or during the study period; 5. Central nervous system metastasis; 6. History of other primary malignant tumors in 5 years; 7. Evidence of significant, uncontrolled concomitant disease; 8. Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C(including HBsAg,HBcAb positive with abnormal HBV DNA or HCV RNA ); 9. Active or suspected autoimmune diseases; 10. Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual contact during the following time periods related to this study: 1) while participating in the study; 2) for at least 12 months after discontinuation of all study treatments; 11. Known history of hemolytic anemia; 12. Known severe allergic reaction or/and infusion reaction to monoclonal antibody.",NA,ALL,NA,"[{'measure': 'Percentage of Participants with Adverse Events', 'description': 'Percentage of Participants with AEs and SAEs assessed by NCI CTCAE v5.0.', 'timeFrame': 'up to 1year after enrollment'}]","[{'measure': 'Pharmacokinetics:AUC', 'description': 'The area under the curve (AUC) of serum concentration of the drug after the administration', 'timeFrame': 'up to 1year after enrollment'}, {'measure': 'Pharmacokinetics: Cmax', 'description': 'Maximum concentration(Cmax) of the drug after administration', 'timeFrame': 'up to 1year after enrollment'}, {'measure': 'Objective response rate (ORR)', 'description': 'To evaluate preliminary anti-tumor activity of MIL95 in subjects with advanced malignancies.ORR includes complete remission(CR) and partial remission(PR) assessed by RECIST v1.1 criteria for solid tumors and Lugano2014 criteria for lymphoma.', 'timeFrame': 'up to 1year after enrollment'}, {'measure': 'Duration of response (DoR)', 'description': 'DOR is defined as the time from the initial response (CR or PR) to the time of disease progression or death, whichever occurs first.', 'timeFrame': 'up to 1year after enrollment'}, {'measure': 'Progression free survival (PFS)', 'description': 'Defined as the time from the first day of study treatment to disease progression or death, whichever occurs first.', 'timeFrame': 'up to 1year after enrollment'}, {'measure': 'Immunogenicity', 'description': 'Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity of MIL95.', 'timeFrame': 'up to 1year after enrollment'}]" 365,NCT00909948,"{'fullName': 'Massachusetts General Hospital', 'class': 'OTHER'}",Intentional Rejection of the Donor Graft Using Recipient Leukocyte Infusion(s) Following Nonmyeloablative Allogeneic Stem Cell Transplant,TERMINATED,"The proposed study is based on our observation of paradoxical tumor regression after rejection of the donor graft in conjunction with the results of our murine experiments. We hypothesize that clinically meaningful responses can be achieved in patients with advanced malignancies with a transplant strategy using nonmyeloablative conditioning and related mismatched donor stem cell transplant where the intention will be to initially achieve mixed chimerism which will be followed by recipient lymphocyte infusion (RLI) in an attempt to deliberately reject the donor graft. This will lead to the development of novel transplant strategies for achieving antitumor effects without the risk of graft versus host disease (GVHD). This proposed protocol is a Pilot Study that will evaluate the safety of this outpatient transplant strategy, i.e., establishment of initial mixed chimerism followed by RLI for donor graft rejection, in patients with advanced lymphomas, and multiple myeloma. In addition, because RLI have been reported to reverse ongoing GVHD, this approach might potentially reverse GVHD while achieving antitumor responses if this complication unexpectedly occurs.","[""Non Hodgkin's Lymphoma"", 'Hodgkin Disease', 'Multiple Myeloma']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'OTHER', 'name': 'Fludarabine and total body irradiation', 'description': 'The patients in the second cohort will receive fludarabine 30 mg/m2/day on days -4 to -2 and 200 cGy TBI on day 0.', 'armGroupLabels': ['Fludarabine']}, {'type': 'RADIATION', 'name': 'Total body irradiation', 'description': 'Patients will receive 200 cGy TBI on day 0,4-6 hours prior to HCT.', 'armGroupLabels': ['TBI only']}]","Inclusion Criteria: 1. Patients with chemorefractory non-Hodgkin's or Hodgkin's lymphoma or multiple myeloma. Criteria for consideration of enrollment will include: 1. primary refractory or refractory relapsed disease for which autologous HCT is unlikely to be beneficial; 2. relapse after autologous HCT 3. ineligibility for standard myeloablative or nonmyeloablative allo-HCT because of either lack of a donor or patient considerations 2. Non Hodgkin's lymphoma, or Hodgkin's lymphoma: primary refractory or refractory relapse 3. Multiple myeloma; primary refractory or refractory relapse 4. Patients with the above malignancies who have had a previous autologous or allogeneic bone marrow or stem cell transplant. 5. An estimated disease-free survival of less than one year. 6. Age 18 to age \< 75 years 7. ECOG performance status of 0, 1, or 2. Exclusion Criteria: 1. Patients whose life expectancy is limited by diseases other than their malignancy 2. Patients who have a 5/6 or better matched related donor or a 4/6 or better umbilical cord blood donor and who are medically eligible for conventional myeloablative or non-myeloablative transplant will be excluded 3. Cardiac disease: symptomatic congestive heart failure or RVG or echocardiogram determined LVEF ogf\< 30%, active angina pectoris or uncontrolled hypertension 4. Pulmonary disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or corrected DLCO \< 40% of predicted 5. Renal disease: serum creatinine \> 3.0 mg/dl. 6. Hepatic disease: serum bilirubin \> 3.0 mg/dl or alkaline phosphatase, SGOT or SGPT \> 3 x ULN 7. Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation (pervious CNS malignancy presently in CR is not an exclusion) 8. Uncontrolled infection. 9. Recipient leukocyte infusion (RLI) might involve the infusion of circulating tumor cells to the patients. To minimize this risk patients who have evidence of circulating tumor cells by light microscopy and flow cytometry will be excluded 10. Patients with acute leukemia will be excluded because they will likely have much greater circulating tumor burden, which would increase the risk of infusion of clonal tumor cells",NA,ALL,NA,"[{'measure': 'To determine the safety at ≤100 days of a non myeloablative mismatched related HCT when followed by recipient leukocyte infusion to induce deliberate rejection of the donor graft.', 'timeFrame': '100 days post transplant'}]","[{'measure': 'To evaluate the incidence of acute and chronic GVHD', 'timeFrame': 'Up to 2 years post transplant'}, {'measure': 'To evaluate the incidence of loss of donor grafts', 'timeFrame': 'Up to 2 years post transplant'}, {'measure': 'To evaluate progression-free and overall survival', 'timeFrame': 'Up to 2 years post transplant'}, {'measure': 'To evaluate antitumor responses following this transplant strategy', 'timeFrame': 'Up to 2 years post transplant'}]" 366,NCT07493148,"{'fullName': 'The First Hospital of Jilin University', 'class': 'OTHER'}",Chidamide Combination With R-mini CHOP Followed by Chidamide+CD20 Maintenance in Elderly Newly Diagnosed MYC/BCL2+ DLBCL,RECRUITING,"Efficacy and safety of chidamide in combination with the R-mini CHOP regimen, followed by chidamide plus CD20 monoclonal antibody as maintenance therapy, in elderly patients with newly diagnosed MYC/BCL2 double-expressor DLBCL.",['Diffuse Large B-Cell Lymphoma (DLBCL)'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Chidamide', 'description': 'Chidamide, oral, 20 mg (4 tablets) each time, twice a week, D1-14.', 'armGroupLabels': ['Chidamide group'], 'otherNames': ['CS055', 'HBI-8000', 'Tucidinostat']}, {'type': 'DRUG', 'name': 'Rituximab', 'description': 'Rituximab, 375 mg/m² IV, Cycle 1-4, Day 1.', 'armGroupLabels': ['Chidamide group'], 'otherNames': ['MabThera']}, {'type': 'DRUG', 'name': 'Cyclophosphamide', 'description': 'Cyclophosphamide, 400 mg/m² IV, Cycle 1-4, Day 2.', 'armGroupLabels': ['Chidamide group'], 'otherNames': ['Cytoxan']}, {'type': 'DRUG', 'name': 'Doxorubicin', 'description': 'Doxorubicin, 25 mg/m² IV, Cycle 1-4, Day 2.', 'armGroupLabels': ['Chidamide group'], 'otherNames': ['Hydroxydaunorubicin']}, {'type': 'DRUG', 'name': 'Vincristine', 'description': 'Vincristine, 1 mg/m² IV, Cycle 1-4, Day 2.', 'armGroupLabels': ['Chidamide group'], 'otherNames': ['VCR']}, {'type': 'DRUG', 'name': 'Prednisone', 'description': 'Prednisone, 40 mg/m² orally, Cycle 1-4, Days 1-5.', 'armGroupLabels': ['Chidamide group']}, {'type': 'DRUG', 'name': 'Chidamide + Rituximab maintenance', 'description': 'Chidamide, oral, 20 mg (4 tablets) each time, twice a week, D1-14. Rituximab, 375 mg/m² IV, once every 12 weeks. 21 days/cycle.', 'armGroupLabels': ['Chidamide group']}]","Inclusion Criteria: 1. Age ≥ 70 years; 2. No prior treatment for DLBCL; 3. Histopathologically confirmed diagnosis (all of the following conditions must be met simultaneously): ① Diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS), and CD20-positive; ② ""MYC/BCL2 double-expressor"": Immunohistochemistry (IHC) per WHO criteria: MYC ≥ 40%, and BCL2 ≥ 50%; ③ Non-""double-hit"" or ""triple-hit"" lymphoma; 4. At least one 18F-fluorodeoxyglucose (18FDG)-avid lesion on positron emission tomography-computed tomography (PET-CT) according to the 2014 Lugano classification for Hodgkin and non-Hodgkin lymphoma; 5. International Prognostic Index (IPI) score \> 1; 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2; 7. At screening, laboratory tests must meet the following criteria, unless judged by the investigator to be due to lymphoma (no corrective or supportive treatment for the indicators below within 2 weeks prior to assessment): ① Hematology: Hemoglobin (Hb) ≥ 90 g/L, Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, Platelet count (PLT) ≥ 90 × 10⁹/L; ② Biochemistry: Serum creatinine (Cr) ≤ 1.5 × upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN (≤ 5 × ULN in cases of liver metastasis); 8. Life expectancy ≥ 6 months; 9. Understand and voluntarily sign a written informed consent form. Exclusion Criteria: 1. Central nervous system (CNS) involvement; 2. Transformed lymphoma, i.e., lymphoma transformed from other lymphoma types such as follicular lymphoma, marginal zone B-cell lymphoma, or chronic lymphocytic leukemia/small lymphocytic lymphoma; specific subtypes of DLBCL (e.g., primary CNS DLBCL, etc.); 3. Uncontrolled cardiovascular or cerebrovascular diseases, coagulation disorders, autoimmune diseases, or severe infectious diseases; 4. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergic reactions to murine products; contraindications to any component of the CHOP regimen or chidamide; 5. HIV/HCV infection; 6. If HBsAg is positive, HBV DNA testing is required; patients with negative DNA may be enrolled. If HBsAg is negative but HBcAb is positive (regardless of HBsAb status), HBV DNA testing is required; patients with negative DNA may be enrolled. 7. Uncontrolled cardiovascular or cerebrovascular diseases, coagulation disorders, autoimmune diseases, or severe infectious diseases; 8. Inability to comply with the study protocol due to psychiatric or other unknown reasons; 9. For female patients of childbearing potential or male patients with partners of childbearing potential, unwillingness or inability to use effective contraception throughout the study treatment period and for 12 weeks after the last dose of chidamide or 12 months after the last dose of rituximab, whichever is longer; pregnant or breastfeeding women; 10. Other conditions deemed unsuitable for participation in this trial.",NA,ALL,NA,"[{'measure': 'Progression-free survival (PFS)', 'description': 'The time from study enrollment to the first documented disease progression or death from any cause, whichever occurs first.', 'timeFrame': '24 months'}]","[{'measure': 'Overall Response Rate (ORR)', 'description': 'To assess the Overall Response Rate (ORR) referred to Lugano 2014.', 'timeFrame': '24 months'}, {'measure': 'Duration of Response (DOR)', 'description': 'The duration from the first documentation of response (achievement of complete response or partial response) to the first unequivocal evidence of relapse or progression.', 'timeFrame': '24 months'}, {'measure': 'Complete Response Rate (CRR)', 'description': 'To assess the Complete Response Rate (CRR) referred to Lugano 2014.', 'timeFrame': '24 months'}, {'measure': 'Percentage of patients converting from PR/SD to CR/PR', 'description': 'Percentage of patients converting from PR/SD to CR/PR', 'timeFrame': '24 months'}, {'measure': 'Overall survival（OS）', 'description': 'Overall survival（OS） is defined as the time from the date of enrollment to the date of death from any cause.', 'timeFrame': '24 months'}, {'measure': 'Adverse Events', 'description': 'An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment, assessed by NCI-CTCAE v5.0. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.', 'timeFrame': '24 months'}]" 367,NCT01800838,"{'fullName': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}",Silicon Phthalocyanine 4 and Photodynamic Therapy in Stage IA-IIA Cutaneous T-Cell Non-Hodgkin Lymphoma,COMPLETED,"This phase I trial studies the side effects and best dose of silicon phthalocyanine 4 and photodynamic therapy in treating patients with stage IA-IIA cutaneous T-cell non-Hodgkin lymphoma. Photodynamic therapy (PDT) uses a drug, silicon phthalocyanine 4, that becomes active when it is exposed to a certain kind of light. When the drug is active, cancer cells are killed. This may be effective against cutaneous T-cell non-Hodgkin lymphoma. Funding Source - FDA OOPD","['Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma', 'Recurrent Mycosis Fungoides/Sezary Syndrome', 'Stage I Cutaneous T-cell Non-Hodgkin Lymphoma', 'Stage IA Mycosis Fungoides/Sezary Syndrome', 'Stage IB Mycosis Fungoides/Sezary Syndrome', 'Stage II Cutaneous T-cell Non-Hodgkin Lymphoma', 'Stage IIA Mycosis Fungoides/Sezary Syndrome']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'silicon phthalocyanine 4', 'description': 'Given topically', 'armGroupLabels': ['Treatment (silicon phthalocyanine 4 and PDT)'], 'otherNames': ['Pc 4', 'Pc-4 (Silicone phthalocyanine)']}, {'type': 'DRUG', 'name': 'photodynamic therapy', 'description': 'Undergo PDT', 'armGroupLabels': ['Treatment (silicon phthalocyanine 4 and PDT)'], 'otherNames': ['Light Infusion Therapy™', 'PDT', 'therapy, photodynamic']}, {'type': 'OTHER', 'name': 'pharmacological study', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (silicon phthalocyanine 4 and PDT)'], 'otherNames': ['pharmacological studies']}, {'type': 'OTHER', 'name': 'laboratory biomarker analysis', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (silicon phthalocyanine 4 and PDT)']}]","Inclusion Criteria: * Diagnosed with early stage MF (CTCL stage IA-IIA) * Has at least 2 evaluable plaques * Has been off systemic therapies for at least 4 weeks * Has been off topical therapies for at least 2 weeks * Has been off phototherapies for at least 2 weeks * All skin photo-types will be included * Subjects must have the ability to understand and the willingness to sign a written informed consent form * Women of child-bearing potential must agree to utilize a birth control which results in a failure rate of less that 1% per year during the study; accepted forms of birth control for this study include: injections such as Depo-Provera and Lunelle, implants such as Norplant, and intra-uterine devices * Sexually active males must agree to use a medically acceptable form of birth control for the duration of the study and for at least 3 months after the last dose of the study medication; appropriate birth control methods are using a condom with a spermicide or surgical sterilization Exclusion Criteria: * Active history of photosensitivity (e.g. xeroderma pigmentosum, lupus erythematosus, porphyria, severe polymorphous light eruption, solar urticaria) * Any medical condition that could be aggravated or may cause extreme discomfort during the study period * Lesions only on the face, scalp or other sites that would make biopsies not cosmetically acceptable * Women of childbearing potential who are pregnant or attempting to become pregnant are excluded from this study * History of allergic reactions attributed to compounds of similar chemical or biologic composition to silicon phthalocyanine (Pc 4) or other agents used in this study * Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements",NA,ALL,NA,"[{'measure': 'MTD of Photodynamic Therapy', 'description': 'Defined as the dose immediately below the dose in which 2 or more of 6 patients experience a grade 4 toxicity assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.', 'timeFrame': 'Up to 30 days'}, {'measure': 'MTD of Silicon Phthalocyanine 4 Defined as the Dose Immediately Below the Dose in Which 2 or More of 6 Patients Experience a Grade 4 Toxicity Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0', 'timeFrame': 'Up to 30 days'}]",NA 368,NCT01557348,"{'fullName': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}",An Observational Study of MabThera/Rituxan (Rituximab) and Alternative TNF-Inhibitors in Patients With Rheumatoid Arthritis and an Inadequate Response to a Single Previous TNF-Inhibitor,COMPLETED,"This multicenter, prospective, observational study will assess the efficacy of MabThera/Rituxan (rituximab) and alternative TNF-inhibitors in patients with rheumatoid arthritis who are non-responders or intolerant to a single previous TNF-inhibitor. Data will be collected from each patient from the time of change in biologic therapy for 12 months.",['Rheumatoid Arthritis'],OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}",NA,"Inclusion Criteria: * Adult patients, \>/= 18 years of age * Patients with rheumatoid arthritis (RA) who have not responded or have been intolerant to a single TNF-inhibitor therapy * Initiated on treatment with MabThera/Rituxan or an alternative TNF-inhibitor therapy, in accordance with the relevant Summary of Product Characteristics Exclusion Criteria: * Patients whose second biologic therapy is given as part of a clinical trial studying RA treatment",Rheumatoid arthritis patients who are non-responders or intolerant to a single TNF-inhibitor,ALL,PROBABILITY_SAMPLE,"[{'measure': 'Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month 6', 'description': 'The DAS28-3 (ESR) is a measure of disease activity in rheumatoid arthritis. It is calculated from the number of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, and ESR (millimeters per hour \\[mm/hr\\]). Total score ranges from 0 to 9.4, where higher score indicated more disease activity. Decrease in score indicated improvement in disease activity.', 'timeFrame': 'Baseline (Day of change in biologic therapy [<=Day 1]) and Month 6'}]","[{'measure': 'Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month12', 'description': 'The DAS28-3 (ESR) is a measure of disease activity in rheumatoid arthritis. It is calculated from the number of swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, and ESR (millimeters per hour \\[mm/hr\\]). Total score ranges from 0 to 9.4, where higher score indicated more disease activity. Decrease in score indicated improvement in disease activity.', 'timeFrame': 'Baseline (Day of change in biologic therapy [<=Day 1]) and Month 12'}, {'measure': 'Least Squares Mean Change From Baseline in TJC at Months 6 and 12', 'description': 'The TJC is the most specific clinical method to quantify abnormalities in participants with rheumatoid arthritis (RA). A total of 28 joints were assessed for tenderness. Decrease in score indicated an improvement in disease activity.', 'timeFrame': 'Baseline, Month 6, and Month 12'}, {'measure': 'Least Squares Mean Change From Baseline in SJC at Months 6 and 12', 'description': 'The SJC is the most specific clinical method to quantify abnormalities in participants with RA. A total of 28 joints were assessed for swelling. Decrease in the score indicated improvement in disease activity.', 'timeFrame': 'Baseline, Month 6, and Month 12'}, {'measure': 'Least Squares Mean Change From Baseline in C-reactive Protein at Months 6 and 12', 'description': 'C-reactive protein (CRP) is an inflammation marker. Normal range is from 0-10 milligram/Liter. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement in disease activity.', 'timeFrame': 'Baseline, Month 6, and Month 12'}, {'measure': 'Least Squares Mean Change From Baseline in ESR at Months 6 and 12', 'description': 'The ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells sediment in a period of one hour. Normal range is 0-30 mm/hr. A reduction in the level of ESR is considered as an improvement in disease activity.', 'timeFrame': 'Baseline, Month 6, and Month 12'}, {'measure': 'Least Squares Mean Change From Baseline in Physician Global Assessment of Disease at Months 6 and 12', 'description': 'Physician global assessment of disease was measured on a 0 to 100 millimeter (mm) visual analog scale (VAS), with 0 mm = no disease activity and 100 mm = highest possible disease activity. Higher scores indicate worsening of disease.', 'timeFrame': 'Baseline, Month 6, and Month 12'}, {'measure': 'Least Squares Mean Change From Baseline in Patient Global Assessment of Disease at Months 6 and 12', 'description': 'Patient Global Assessment of Disease was measured on a 0 to 100 mm VAS, with 0 mm = no disease activity and 100 mm = highest possible disease activity. Higher scores indicate worsening of disease.', 'timeFrame': 'Baseline, Month 6, and Month 12'}, {'measure': ""Least Squares Mean Change From Baseline in Participant's VAS Pain Score at Months 6 and 12"", 'description': 'Participants were asked to assess their pain intensity (severity of pain) on a 100-millimeter (mm) VAS with the left edge (0 mm) defined as ""no pain"" and the right edge (100 mm) defined as ""severest pain"". Higher scores indicate worsening of disease.', 'timeFrame': 'Baseline, Month 6, and Month 12'}, {'measure': 'Least Squares Mean Change From Baseline in Health Assessment Questionnaire-Disability Index at Months 6 and 12', 'description': 'Health Assessment Questionnaire-Disability Index (HAQ-DI) is participant reported assessment of ability to perform tasks in 8 categories of daily living activities as dress/groom, arise, eat, walk, reach, grip, hygiene, and common activities over past week. Each item was scored on a 4-point scale from 0 to 3, where 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. Overall score was computed as the sum of domain scores divided by the number of domains answered. Total possible score range was 0-3, where 0 = least difficulty and 3 = extreme difficulty.', 'timeFrame': 'Baseline, Month 6, and Month 12'}, {'measure': 'Least Squares Mean Change From Baseline in Duration of Morning Stiffness at Months 6 and 12', 'description': 'Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes. Participants with available data at the time of assessment were included in the analysis.', 'timeFrame': 'Baseline, Month 6, and Month 12'}, {'measure': 'Percentage of Participants Who Remained on Their Second Biologic Therapy at Months 6 and 12 After Start of Second Biologic Therapy', 'description': 'Percentage of participants who remained on their second biologic therapy at 6 and 12 months after start of second biologic therapy were reported.', 'timeFrame': 'Month 6 and Month 12'}, {'measure': 'Reasons for Stopping the Second Biologic Therapy and Subsequent Therapy Choice', 'timeFrame': 'Up to 12 months'}, {'measure': 'Number of Participants With Any Adverse Events, Any Serious Adverse Event, Adverse Events Leading to Withdrawal, and Death', 'description': 'An Adverse event is defined as any unfavorable and unintended medical occurrence/sign (including an abnormal laboratory finding), symptom or disease in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. A serious adverse event is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is medically significant or requires intervention to prevent one or other of the outcomes listed above.', 'timeFrame': 'Up to 12 Months'}, {'measure': 'Number of Participants With Reasons for Discontinuation of the First TNFi Therapy', 'description': ""The reasons for discontinuation of first TNFi therapy included inefficacy, intolerance and other reasons. The other reasons included complete remission and participants' non-compliance."", 'timeFrame': 'Day 1 (Study entry visit)'}, {'measure': 'Number of Participants With Previous TNFi Therapy', 'description': 'The previous TNFi therapy included adalimumab, etanercept, infliximab, and others (certolizumab, and golimumab). Number of participants with previous TNFi therapy history was reported.', 'timeFrame': 'Day 1 (Study entry visit)'}, {'measure': 'Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy', 'description': 'The previous disease-modifying anti-rheumatic drugs therapy included auranofin, aurothioglucose, aurotioprol, azathioprine, chloroquine, ciclosporin, gold, hydroxychloroquine, infliximab, leflunomide, methotrexate, methotrexate sodium, minocycline, penicillamine, sodium aurothiomalate, sodium aurotiosulfate, sulfasalazine, and tiopronin. Number of participants with previous disease-modifying anti-rheumatic drugs therapy was reported.', 'timeFrame': 'Day 1 (Study entry visit)'}, {'measure': 'Factors Related to Selection of Second Biologic Therapy Following an Insufficient Response or Intolerance to a Single Previous TNFi', 'description': ""The factors included participant characteristics and the reasons that led to the selection of second biologic therapy following an insufficient response or intolerance to a single previous TNFi. The participant characteristics included participant's option for treatment and option for follow-up. The other reasons included RA disease (rheumatoid factor \\[RF\\] and cyclic citrullinated peptide \\[CCP\\] status), primary failure, and new treatment characteristics (rapidity of action, route of administration, frequency of administration, low infectious risk, and no lymphoma risk). Participants were included in more than one of these factors."", 'timeFrame': 'Baseline'}]" 369,NCT02371148,"{'fullName': 'Fondazione Italiana Linfomi - ETS', 'class': 'OTHER'}",Fase II Study With BRB for Non-Hodgkin Lymphoplasmacytic Lymphoma/Waldenstrom Macroglobulinemia's,COMPLETED,"This is a prospective, multicenter phase II trial designed to determine efficacy and safety of Bortezomib plus Rituximab plus Bendamustine in patients with relapsed/refractory Waldenstrom's Macroglobulinemia.","[""Waldenstrom's Macroglobulinemia""]",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Bortezomib-Rituximab-Bendamustine', 'description': 'Bortezomib-Rituximab-Bendamustine Bortezomib: 1.3 mg/mq sc days 1, 8, 15, 22\\* Rituximab: 375 mg/sqm i.v. day 1\\*\\* Bendamustine: 90 mg/sqm iv days 1-2 or days 2-3 according to institutional/physician choice Repeat cycles every 28 days for a total of 6 cycles \\*In case of toxicity is omitted\n\n\\*\\*In cycles 1, in order to avoid tumor lysis syndrome, Rituximab will be given on day 8', 'armGroupLabels': ['Bortezomib-Rituximab-Bendamustine'], 'otherNames': ['BRB']}]","Inclusion Criteria: * Histological proven diagnosis of Lymphoplasmacytic/cytoid lymphoma/Waldenstrom macroglobulinemia according to REAL/WHO Classification * Relapsed/refractory disease after receiving one line chemotherapy (rituximab). If patients received bortezomib or bendamustine and have obtained a partial response lasting at least two years. * Age \>= 18 * Presence of at least one of the following criteria for the definition of active disease: Systemic symptoms or Hemoglobin less than 10 g/dL (due to lymphoma) or Platelets less than 100 x 109/L (due to lymphoma) or symptomatic splenomegaly or Bulky disease (\>7 cm) or Hyperviscosity syndrome, peripheral neuropathy up to grade 1 (Waldenstrom's disease-related), hemolytic anemia, and immune complex vasculitis * Life expectancy \>6 months * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * left ventricular ejection fraction (LVEF) ≥45% or FS ≥37% * Creatinine up to 1.5 x upper limit of normal * Conjugated bilirubin up to 2 x upper limit of normal * Alkaline phosphatase and transaminases up to 2 x upper limit of normal * Written informed content Exclusion Criteria: * Patients who received bortezomib or bendamustine first-line therapy, that or haven't obtained at least partial response nor partial response lasting at least two years. * Patients not agreeing to take adequate contraceptive precautions during and for at least 6 months after cessation of therapy * History of other malignancies within 3 years prior to study entry except for: adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage, localized prostate cancer treated surgically with curative intent; good prognosis ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone with curative intent * Medical condition requiring long term use (\>1 months) of systemic corticosteroids * Active bacterial, viral, or fungal infection requiring systemic therapy * Peripheral neuropathy of any grade ≥ 2 \[see Appendix Section A\] * Concurrent medical condition which might exclude administration of therapy * Cardiac insufficiency (NYHA grade III/IV) * Myocardial infarction within 6 months of entry on study * Severe chronic obstructive pulmonary disease with hypoxemia * Severe diabetes mellitus difficult to control with adequate insulin therapy * Hypertension that is difficult to control * Impaired renal function with creatinine clearance \<30 ml/min * HIV positivity HBV positivity with the exception of patients HbsAg and HBV-DNA negative and Ab anti-HB core positive (these patients need to receive prophylaxis with Lamivudine) * HCV positivity with the exception of patients with HCV RNA negative * Participation at the same time in another study in with investigational drugs are used * Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins * Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent. * Women in pregnancy or breastfeeding",NA,ALL,NA,"[{'measure': 'Progression Free Survival (PFS)', 'description': ""This is a prospective, multicenter phase II trial designed to determine efficacy and safety of Bortezomib plus Rituximab plus Bendamustine in patients with relapsed/refractory Waldenstrom's Macroglobulinemia. Primary Objective is to assess whether the experimental treatment achieves an absolute increase of PFS rate from 50 to 65% at 18 months with respect to the standard treatment. PFS is measured from the beginning of therapy to the date of disease progression, relapse or death from any cause.\n\nPatients without any relapse at the end of the follow-up will be censored at their last assessment date."", 'timeFrame': '18 months'}]","[{'measure': 'Overall Response Rate (ORR)', 'description': ""Overall response rate (ORR): a patient is defined as a responder if he has a complete or very good partial or partial response, evaluated in based on Waldenstrom macroglobulinemia consensus recommendations of the 6th International Workshop on Waldestrom's macroglobulinemia."", 'timeFrame': '2 years'}, {'measure': 'Overall Survival (OS)', 'description': 'Overall survival (OS): measured from the beginning of therapy to the date of death from any cause. Patients alive at the time of the final analysis will be censored at the date of the last contact. Minimum follow up time required for all patients will be 2 years.', 'timeFrame': '2 years'}, {'measure': 'Toxicity', 'description': 'Toxicity: severe, life- threatening, fatal (grade 3, 4 and 5)', 'timeFrame': '2 years'}, {'measure': 'Number of serious adverse events', 'description': 'Number of serious adverse events are defined according to ""Common Terminology Criteria for Adverse Events"" (CTCAE), version 4.0', 'timeFrame': '2 years'}]" 370,NCT04263935,"{'fullName': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}",Correlation Between Driver Gene Abnormalities and Clinicopathological Characteristics and Disease Prognosis in Lymphoma,RECRUITING,Correlation Between Driver Gene Abnormalities and Clinicopathological Characteristics and Disease Prognosis in Lymphoma,"['Lymphoma', 'Gene Abnormality']",OBSERVATIONAL,"{'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}",NA,"Inclusion Criteria: 1. Diagnosed as lymphoma (according to WHO 2017 classification criteria) 2. Life expectancy no less than 3 months 3. Agreeing to sign the written informed consents Exclusion Criteria: 1. Other malignant tumor history or active malignant tumor need be treated 2. Researchers determine unsuited to participate in this trial",Including demographic characteristics / clinical characteristics / pathological characteristics / treatment and efficacy evaluations.,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Incidence of driver gene abnormalities', 'description': 'the incidence of driver gene abnormalities by fixed gene testing technology', 'timeFrame': 'from the day of the first patient was included to the date of the end of this trial, assessed up to 36 months'}]","[{'measure': 'objective response rate', 'description': 'the total proportion of patients with complete response (CR) and partial response (PR)', 'timeFrame': 'from the date of the first patient was included to the date of the end of this trial, assessed up to 36 months'}, {'measure': '5-year overall survival', 'description': 'from the date of first patient was included to the date of death by any cause', 'timeFrame': 'from the date of the first patient was included to the date of the end of this trial, assessed up to 5 years'}, {'measure': 'Clinicopathological Characteristics', 'description': 'study data on clinicopathological characteristics related to incidence of driver gene abnormalities', 'timeFrame': 'from the date of the first patient was included to the date of the end of this trial, assessed up to 36 months'}]" 371,NCT04889716,"{'fullName': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}",CAR-T Followed by Bispecific Antibodies,RECRUITING,"The research study is being conducted to test the safety and effectiveness of the experimental drug mosunetuzumab (Cohort 1) or obinutuzumab and glofitamab (Cohort 2) when given after CAR (genetically modified) T cells. The study is for patients who have already received a CAR T-cell infusion. Some patients who join the study will receive mosunetuzumab, other patients later in the study may receive a different experimental drug (glofitamab, in combination with obinutuzumab).","['Large B-cell Lymphoma', 'DLBCL - Diffuse Large B Cell Lymphoma']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Cohort 1 subjects will receive mosunetuzumab. Pending demonstrated safety of cohort 1, the trial will progress to cohort 2, in which subjects will receive glofitamab with obinutuzumab.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'mosunetuzumab', 'description': '1 mg IV on Cycle 1 Day 1; 2 mg IV Cycle 1 Day 8; 60 mg IV Cycle 1 Day 15; 60 mg IV on Cycle 2 Day 1 and then 30 mg IV every 21 days beginning Cycle 2 Day 1 through Cycle 17.', 'armGroupLabels': ['Cohort 1'], 'otherNames': ['RO7030816', 'BTCT4465A', 'Lunsumio']}, {'type': 'DRUG', 'name': 'glofitamab', 'description': '2.5 mg IV Cycle 1 Day 8; 10 mg IV Cycle 1 Day 15 then 30 mg every 21 days beginning Cycle 2 Day 1 through Cycle 12', 'armGroupLabels': ['Cohort 2'], 'otherNames': ['CD20 TCB', 'RO7082859']}, {'type': 'DRUG', 'name': 'obinutuzumab', 'description': '1000 mg IV on Cycle 1 Day 1.', 'armGroupLabels': ['Cohort 2'], 'otherNames': ['Gazyva', 'Gazyvaro', 'RO5072759', 'huMAb ', 'GA101']}]","Inclusion Criteria: * Life expectancy of at least 12 weeks * History of relapsed or refractory large B-cell lymphoma (including transformed follicular lymphoma, and follicular lymphoma Grade 3B) who have relapsed after or failed to respond to at least one prior standard systemic treatment regimen that contains an anthracycline and at least one containing an anti-CD20-directed therapy and for whom there is no available therapy expected to improve survival (e.g., standard chemotherapy, autologous or allogeneic stem cell transplant). * PET/CT scan (preferred), diagnostic CT scan, or MRI prior to CAR-T cell therapy, with at least one bi-dimensionally measurable lesion (≥ 1.5 cm for nodal lesion or ≥ 1cm for extra-nodal lesions in largest dimension by low-dose computerized tomography \[CT\] scan with FDG-uptake ≥ liver); this imaging must have been obtained within 56 days of receiving CAR T cell therapy. * PET/CT scan (preferred), diagnostic CT scan, or MRI with at least one bi-dimensionally measurable lesion (≥ 1.5 cm for nodal lesion or ≥ 1cm for extra-nodal lesions in largest dimension by low-dose computerized tomography \[CT\] scan with FDG-uptake ≥ liver); this imaging documenting measurable disease must be obtained at least day +28 after CAR T cell infusion and prior to cycle 1 day 1. * Be at least 30 days after CAR T-cell infusion at time of study enrollment. * Adequate laboratory studies, * Ability and willingness to take proper contraceptive precautions Exclusion Criteria: * Had \> Grade 3 cytokine release syndrome (CRS) by ASTCT criteria after CAR-T therapy or who have unresolved CRS after CAR-T therapy * Had ≥ grade 2 neurologic toxicity by ASTCT criteria after CAR-T therapy or who have active neurologic toxicity after CAR-T therapy * Inability to comply with protocol-mandated hospitalization and activities restrictions in the investigators' decision * Pregnant or lactating, or intending to become pregnant during the study or within 3 months after the last dose of bispecific antibody or 18 months of obinutuzumab, whichever comes later * Prior solid organ transplantation * Active systemic autoimmune disease or other disease requiring chronic immunosuppressive therapy * History of confirmed progressive multifocal leukoencephalopathy (PML) * History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins) * History of other malignancy that could affect compliance with the protocol or interpretation of results * Significant cardiovascular disease such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina) * Significant active pulmonary disease (e.g., bronchospasm and/or obstructive pulmonary disease) requiring oxygen or corticosteroid use. * Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major documented infection requiring treatment with IV antibiotics or hospitalization within 2 weeks prior to first mosunetuzumab or glofitamab administration. Empiric or prophylactic antibiotics administered during neutropenia or neutropenic fever without microbiologic evidence of infection do not exclude patients. * Recent major surgery within 4 weeks prior to first mosunetuzumab or glofitamab administration * Active or chronic infection(s) would have increased risks for toxicity if treated with bispecific antibody therapy, thus will be excluded. * Administration of a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study * Received systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) with the exception of corticosteroid treatment \< 20 mg/day prednisone or equivalent within 2 weeks prior to first dose of bispecific antibody * History of drug or alcohol abuse within 12 months prior to screening in the investigator's judgment * Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's and/or Medical Monitor's judgment, precludes the patient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results",NA,ALL,NA,"[{'measure': 'Assessment of the percentage of subjects who achieve a complete metabolic response at 24 weeks from date of first infusion as measured by Cheson 14 (ie Lugano) criteria', 'description': 'Complete response will be assessed using Cheson 2014 or Lugano criteria, utilizing simple 5 point score (Deauville score). For this study complete response will be a score of 1 (no uptake), 2 (uptake ≤ mediastinum), or 3 (uptake \\>mediastinum but ≤ liver, with no new lesions, and no FDG-uptake in the bone marrow, that is not expected (i.e. due to growth factors or therapy', 'timeFrame': '24 weeks from date of first infusion of investigational agent'}, {'measure': 'Assessment of the percentage of subjects who experience non-hematologic dose limiting toxicity associated with early administration of glofitimab following SOC CAR-T Cell therapy.', 'description': 'Non-hematologic DLTs include the following: unexpected ≥grade 3 non-hematologic that is at least possibly related to the study drug, any grade 3 event that does not improve to ≤ grade 2 within 72 hours, any grade 3 AST, ALT or total bilirubin that lasts more than 72 hours in the absence of other causes, ≥ grade 3 neurotoxicity or seizure of any grade.\n\nCytokine Relsease Syndrome: CRS grade 4, Grade 3 CRS that does not improve to ≤ grade 2 within 72 hours.\n\nGrade 1: Temperature ≥ 38°C, no hypotension, no hypoxia. Grade 2: Temperature ≥ 38°C, hypotension not requiring vasopressors and/or hypoxia requiring low flow nasal cannula. Grade 3: Temperature ≥ 38°C, hypotension requiring a vasopressor and/or requiring high flow oxygen. Grade 4: Temperature ≥ 38°C, hypotension requiring multiple vasopressor and/or requiring positive pressure, intubation or mechanical ventilation.', 'timeFrame': '63 days from the date of first infusion of glofitimab'}]","[{'measure': 'Determine Response Duration', 'description': 'Average length of response in months of any partial or complete metabolic responses', 'timeFrame': 'from time of first response assessment to up to five years from last dose of bispecific antibody therapy'}]" 372,NCT04760184,"{'fullName': 'Uppsala University', 'class': 'OTHER'}",Impact of COVID-19 After Autologous Hematopoietic Stem Cell Transplantation in Sweden,COMPLETED,"This retrospective observational cohort study aims to describe the impact of COVID-19 in patients treated with autologous stem cell transplantation (ASCT) for malignant disease in terms of risk factors, morbidity, need for supportive care and mortality. All patients treated with ASCT in Sweden from 1st January 2020 until 31st December 2020 are eligible for this study. Patients who also has tested positive for SARS-CoV-2 from start of conditioning or later will be identified through the national registry of the Public Health Agency of Sweden and a systematic analysis of their medical records will be performed.","['Covid19', 'Myeloma Multiple', 'Malignant Lymphoma', 'Hematologic Neoplasms', 'Stem Cell Transplant Complications']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}","[{'type': 'OTHER', 'name': 'Autologous stem cell transplantation', 'description': 'The study will describe the implications of COVID-19 infection following autologous stem cell transplantation', 'armGroupLabels': ['COVID19 positives after autologous stem cell transplantation']}]","Inclusion Criteria: * Diagnosis of hematological cancer (C81-C96 according to the International Classification of Diseases 10th revision (ICD-10). * Autologous hematopoietic stem cell transplantation performed 1 January 2020 until 31st December 2020 at a Swedish transplantation center. * Positive RT-PCR test for SARS-CoV-2 performed in Sweden Exclusion Criteria: \- Age below 18 years and 0 months at the time of transplantation",All Swedish citizens treated with ASCT for malignant disease in Sweden from 1st January 2020 until 31st December 2020 are eligible for this study. There will be a minimum follow-up time of one month for all patients.,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Overall survival', 'description': 'Overall survival after infection with COVID-19', 'timeFrame': '30 days'}, {'measure': 'Overall survival', 'description': 'Overall survival after infection with COVID-19', 'timeFrame': '90 days'}, {'measure': 'COVID-19 related mortality', 'description': 'As classified by the WHO; a death resulting from a clinically compatible illness in a confirmed COVID-19 case, unless there is a clear alternative cause of death that cannot be related to COVID disease (e.g., trauma). There should be no period of complete recovery between the illness and death', 'timeFrame': 'within 6 months after infection'}]","[{'measure': 'Time of COVID-19 infection', 'description': 'Time of SARS-CoV-2 infection in relation to autologous stem cell transplantation', 'timeFrame': 'Up to 15 months'}, {'measure': 'Hospitalization', 'description': 'Duration of hospitalization', 'timeFrame': 'Up to 15 months'}, {'measure': 'Oxygen treatment', 'description': 'Duration of oxygen treatment', 'timeFrame': 'Up to 15 months'}, {'measure': 'High-flow oxygen therapy', 'description': 'Duration of high-flow oxygen therapy', 'timeFrame': 'Up to 15 months'}, {'measure': 'Non-invasive ventilation', 'description': 'Duration of non-invasive ventilation (NIV)', 'timeFrame': 'Up to 15 months'}, {'measure': 'Intensive care', 'description': 'Duration of care in intensive care unit', 'timeFrame': 'Up to 15 months'}, {'measure': 'Invasive mechanical ventilation', 'description': 'Duration of Invasive mechanical ventilation', 'timeFrame': 'Up to 15 months'}, {'measure': 'ECMO', 'description': 'Duration of extracorporeal membrane oxygenation (ECMO)', 'timeFrame': 'Up to 15 months'}, {'measure': 'Occurence of ARDS', 'description': 'Diagnosis of Acute respiratory distress syndrome (ARDS)', 'timeFrame': 'Up to 15 months'}, {'measure': 'Occurence of arterial thrombosis', 'description': 'Event of arterial thrombosis', 'timeFrame': 'Up to 15 months'}, {'measure': 'Occurence of venous thrombosis', 'description': 'Event of venous thrombosis', 'timeFrame': 'Up to 15 months'}, {'measure': 'Occurence of arrhythmias', 'description': 'Event of recorded arrhythmias', 'timeFrame': 'Up to 15 months'}, {'measure': 'Occurence of acute cardiac injury', 'description': 'Event of acute cardiac injury', 'timeFrame': 'Up to 15 months'}, {'measure': 'Occurence of secondary infection', 'description': 'Event of any secondary infection', 'timeFrame': 'Up to 15 months'}, {'measure': 'Occurence of cytokine release syndrome', 'description': 'Event of cytokine release syndrome', 'timeFrame': 'Up to 15 months'}, {'measure': 'Comorbidities', 'description': 'Description of comorbidities prior to autologous stem cell transplantation', 'timeFrame': 'Prior to autologous stem cell transplantation'}, {'measure': 'Disease status', 'description': 'Description of disease status prior to autologous stem cell transplantation', 'timeFrame': 'Prior to autologous stem cell transplantation'}, {'measure': 'Previous disease modifying treatment', 'description': 'Description of previous disease modifying treatment prior to autologous stem cell transplantation', 'timeFrame': 'Prior to autologous stem cell transplantation'}, {'measure': 'Conditioning treatment', 'description': 'Description of conditioning treatment prior to autologous stem cell transplantation', 'timeFrame': 'At autologous stem cell transplantation'}, {'measure': 'Time of infection', 'description': 'Time of COVID-19 in relation to autologous stem cell transplantation', 'timeFrame': 'At autologous stem cell transplantation or up to 15 months'}, {'measure': 'Neutropenia', 'description': 'Event of neutropenia at diagnosis of COVID-19', 'timeFrame': 'At autologous stem cell transplantation or up to 15 months'}, {'measure': 'Elevated CRP', 'description': 'Event of elevated C-reactive protein (CRP) at diagnosis of COVID-19', 'timeFrame': 'At autologous stem cell transplantation or up to 15 months'}, {'measure': 'Elevated leukocyte count', 'description': 'Event of elevated leukocyte count at diagnosis of COVID-19', 'timeFrame': 'At autologous stem cell transplantation or up to 15 months'}, {'measure': 'Lymphocytopenia', 'description': 'Event of lymphocytopenia at diagnosis of COVID-19', 'timeFrame': 'At autologous stem cell transplantation or up to 15 months'}, {'measure': 'Elevated liver enzymes', 'description': 'Event of elevated liver enzymes at diagnosis of COVID-19', 'timeFrame': 'At autologous stem cell transplantation or up to 15 months'}, {'measure': 'Elevated lactate dehydrogenase', 'description': 'Event of elevated lactate dehydrogenase at diagnosis of COVID-19', 'timeFrame': 'At autologous stem cell transplantation or up to 15 months'}, {'measure': 'Elevated ferritin', 'description': 'Event of elevated ferritin at diagnosis of COVID-19', 'timeFrame': 'At autologous stem cell transplantation or up to 15 months'}, {'measure': 'Elevated d-dimer', 'description': 'Event of elevated d-dimer at diagnosis of COVID-19', 'timeFrame': 'At autologous stem cell transplantation or up to 15 months'}, {'measure': 'Prolonged aPTT', 'description': 'Event of prolonged activated partial thromboplastin time (aPTT) at diagnosis of COVID-19', 'timeFrame': 'At autologous stem cell transplantation or up to 15 months'}, {'measure': 'Elevated troponin', 'description': 'Event of elevated troponin at diagnosis of COVID-19', 'timeFrame': 'At autologous stem cell transplantation or up to 15 months'}, {'measure': 'Elevated creatinine', 'description': 'Event of elevated creatinine at diagnosis of COVID-19', 'timeFrame': 'At autologous stem cell transplantation or up to 15 months'}]" 373,NCT04833504,"{'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}",Clinical Follow-up Study of CD19 CAR-T Expressing IL7 and CCL19 for Relapsed or Refractory B Cell Lymphoma,COMPLETED,"This study is designed to monitor all patients exposed to CD19 CAR-T expressing IL7 and CCL19 for 5 years following infusion, to assess their long-term efficacy, including the CAR-vector persistence, the normal immunity rebuilding and the risk of delayed adverse events (AEs).","['Diffuse Large B-cell Lymphoma', 'Mantle Cell Lymphoma', 'Transformed Follicular Lymphoma', 'Primary Mediastinal Large B-cell Lymphoma']",OBSERVATIONAL,"{'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'BIOLOGICAL', 'name': 'CD19 CAR-T Expressing IL7 and CCL19', 'description': 'A fourth generation CD19 targeting CAR-T expressing IL7 and CCL19'}]","Inclusion Criteria: * All patients who have received the CD19-IL7/CCL19 CAR-T therapy in the earlier enrolled clinical trail and met including and excluding criteria criteria (NCT0325847) Patients who have provided informed consent for the long term follow up study prior to their study participation . Exclusion Criteria: * There are no specific exclusion criteria for this study.",39 patients meet including and excluding criteria criteria,ALL,PROBABILITY_SAMPLE,"[{'measure': 'Evaluate the efficacy of CD19-IL7/CCL19 CAR-T', 'description': 'Evaluate the efficacy of CD19-IL7/CCL19 CAR-T including duration of response, progression-free survival, overall surviva and objective response rate (CR + PR) .', 'timeFrame': '5 years'}]","[{'measure': 'Evaluate the persistence of CAR-T cells', 'description': 'Levels and persistence of CAR+ T cells in serum samples', 'timeFrame': '5 years'}, {'measure': 'Evaluate the incidence of adverse events', 'description': 'The incidence of CRS and CRES; Levels and persistence of cytokines in serum samples;Proportion of patients who relapse or progress among patients who had not relapsed or progressed at study entry/re-entry;Incidence of death ;B- and T- lymphocyte count;', 'timeFrame': '5 years'}]" 374,NCT05883449,"{'fullName': 'Affimed GmbH', 'class': 'INDUSTRY'}",Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL,TERMINATED,"AFM13-203 is a phase 2, open-label, multi-center, multi-cohort study with a safety run-in followed by expansion cohorts. The study is evaluating the safety and efficacy of AFM13 in combination with AB-101 in subjects with R/R classical HL and CD30-positive PTCL.","['Relapsed or Refractory Hodgkin Lymphoma', 'Peripheral T Cell Lymphoma']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'AFM13', 'description': 'anti-human CD30 × anti-human CD16A recombinant antibody therapy, intravenous infusion', 'armGroupLabels': ['Dose Level A in Hodgkin Lymphoma', 'Dose Level B in Hodgkin Lymphoma', 'Exploratory: AFM13 + AB-101 on CD30-positive PTCL', 'Safety run-in in Hodgkin Lymphoma']}, {'type': 'DRUG', 'name': 'AB-101', 'description': 'NK cell therapy, intravenous infusion', 'armGroupLabels': ['Dose Level A in Hodgkin Lymphoma', 'Dose Level B in Hodgkin Lymphoma', 'Exploratory: AFM13 + AB-101 on CD30-positive PTCL', 'Safety run-in in Hodgkin Lymphoma']}, {'type': 'DRUG', 'name': 'Cyclophosphamide', 'description': 'Lymphodepleting chemotherapy, intravenous infusion', 'armGroupLabels': ['Dose Level A in Hodgkin Lymphoma', 'Dose Level B in Hodgkin Lymphoma', 'Exploratory: AFM13 + AB-101 on CD30-positive PTCL', 'Safety run-in in Hodgkin Lymphoma']}, {'type': 'DRUG', 'name': 'Fludarabine', 'description': 'Lymphodepleting chemotherapy, intravenous infusion', 'armGroupLabels': ['Dose Level A in Hodgkin Lymphoma', 'Dose Level B in Hodgkin Lymphoma', 'Exploratory: AFM13 + AB-101 on CD30-positive PTCL', 'Safety run-in in Hodgkin Lymphoma']}, {'type': 'DRUG', 'name': 'Interleukin-2', 'description': 'Immune cytokine, subcutaneously', 'armGroupLabels': ['Dose Level A in Hodgkin Lymphoma', 'Dose Level B in Hodgkin Lymphoma', 'Exploratory: AFM13 + AB-101 on CD30-positive PTCL', 'Safety run-in in Hodgkin Lymphoma']}]","Inclusion Criteria: * Subjects with a diagnosis of FDG-avid relapsed or refractory classical HL OR select subtypes of FDG-avid CD30-positive relapsed or refractory PTCL * For subjects with R/R PTCL a pre-enrollment tumor biopsy positive for CD30 locally assessed by Ber-H2 targeted immunohistochemistry at ≥1% is mandatory (PTCL subtypes: PTCL-NOS, Angioimmunoblastic T-cell lymphoma, ALCL, anaplastic lymphoma kinase (ALK)-positive, ALCL, ALK-negative) * Subjects with R/R classical HL must have received at least two lines of therapy including one prior line of combination chemotherapy. Prior therapy must also have included brentuximab vedotin and a PD1 check point inhibitor. * Subjects with R/R PTCL must have received at least one prior line of combination chemotherapy. Subjects with ALCL subtype of PTCL must have received or been intolerant to brentuximab vedotin. * Subjects with R/R classical HL AND R/R PTCL: Prior ASCT is permitted if completed at least 3 months prior to the first dose of study treatment. Prior allogeneic stem cell transplantation will be permitted if completed at least 1 year from study enrollment and there are no signs or symptoms of GVHD. Prior CAR-T therapy is permitted if last CAR-T dose completed at least 6 months prior to the first dose of study treatment. * Ability to understand and sign the ICF Exclusion Criteria: * Active central nervous system (CNS) involvement (untreated or uncontrolled parenchymal brain metastasis or positive cytology of cerebrospinal fluid) * Previous treatment with AFM13 or CBNK cells * History of a solid organ allograft, or an inflammatory or autoimmune disease likely to be exacerbated by IL-2 (including subjects requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease that may require systemic steroids or immunosuppressive agents * Treatment with any therapeutic mAb or immunosuppressive medications * Known active Hepatitis B or C defined per protocol * Active HIV Infection * History of any other systemic malignancy, unless previously treated with curative intent and the subject has been disease free for 2 years or longer * Active acute or chronic graft vs. host disease (GVHD) or GVHD requiring immunosuppressive treatment, clinically significant central nervous system (CNS) dysfunction",NA,ALL,NA,"[{'measure': 'Objective Response Rate (ORR) by Independent Radiology Committee', 'description': 'Best ORR (complete response (CR) + partial response \\[PR\\]) by Independent Radiology Committee (IRC) based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification. A participant will be assumed as a responder if he/she achieves complete or partial response at any postbaseline visit.', 'timeFrame': 'Disease assessments were conducted on Day 43 (+- 3 days) of each cycle. All subjects were treated for a maximum of 3 cycles.'}]","[{'measure': 'Duration of Response by Independent Radiology Committee', 'description': 'Duration of response (DOR) defined as time from first assessment of PR or CR to the first assessment of progressive disease/death. Response based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification assessed by Independent Radiology Committee.', 'timeFrame': 'Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 20 months)'}, {'measure': 'Complete Response Rate (CRR) by Independent Radiology Committee', 'description': 'Complete Response Rate based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification.', 'timeFrame': 'Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 20 months)'}, {'measure': 'ORR by Investigator Based on PET-CT as Assessed by the Lugano Classification', 'description': 'ORR (CR + PR) by Investigator based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification', 'timeFrame': 'Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 20 months)'}, {'measure': 'Duration of Response by Investigator', 'description': 'Duration of response (DOR) defined as time from first assessment of PR or CR to the first assessment of progressive disease/death. Response based on positron emission tomography-computed tomography (PET-CT) as assessed by the Lugano classification assessed locally by the Investigator.', 'timeFrame': 'Tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 20 months)'}, {'measure': 'Incidence of Subjects Receiving Subsequent Transplant', 'description': 'The number of subjects receiving subsequent transplant will be assessed and summarized by percentage rates', 'timeFrame': 'Throughout study completion (up to 20 months)'}, {'measure': 'Frequency of Subjects With Study Drug Related TEAEs', 'description': 'The number of subjects with study-drug related (AFM13 or AB-101) treatment-emergent adverse events (TEAEs)', 'timeFrame': 'From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)'}, {'measure': 'Frequency of Subjects With Serious Treatment Emergent Adverse Events', 'description': 'The number of subjects who had serious treatment emergent adverse events.', 'timeFrame': 'From the time of first protocol-specific intervention until 30 days after the last administration (up to 20 months)'}, {'measure': 'Frequency of Subjects Developing Anti-drug Antibodies (ADAs) Against AFM13', 'description': 'The number of subjects developing anti-drug antibodies (ADAs) against AFM13', 'timeFrame': 'During treatment cycles (up to 6 months)'}, {'measure': 'Progression-free Survival (PFS) by Independent Radiology Committee', 'description': 'Progression-free survival (PFS) defined as time from first treatment (AFM13/AB-101) received until progressive disease (PD). Subjects who started a new anti-lymphoma therapy prior to a documented progressive disease were censored at the last disease assessment prior to initiation of new anti-lymphoma therapy. Subjects who discontinued the study before the first assessment of progressive disease or death were censored at their last disease assessment.', 'timeFrame': 'From the first treatment received until the first progression disease assessed by IRC or death.'}, {'measure': 'Overall Survival', 'description': 'Overall Survival (OS) was defined as (date of death - date of first dose)/30.4375. Patients alive at the end of study will be censored on the last date of observation.', 'timeFrame': 'From the first treatment received until the death.'}]" 375,NCT06292208,"{'fullName': 'SUNHO（China）BioPharmaceutical CO., Ltd.', 'class': 'INDUSTRY'}",A Clinical Trial to Evaluate Effect of IBD0333 in Patients With Advanced Malignant Tumors,RECRUITING,"Primary Objectives Dose escalation phase To evaluate the safety and tolerability of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma and to determine the maximum tolerated dose (MTD), extended recommended dose (DRDE), and/or dose limiting toxicity (DLT). Dose expansion phase To evaluate the safety and tolerability of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma and to determine the recommended Phase 2 dose (RP2D). Clinical exploration phase To evaluate the preliminary efficacy of IBD0333 in patients with specific tumor. Secondary objectives Dose escalation phase \& Dose expansion phase To evaluate the pharmacokinetic (PK) of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma; To evaluate the immunogenicity of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma; To evaluate the preliminary efficacy of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma. Clinical exploration Phase To evaluate the safety and tolerability of IBD0333 in patients with specific tumor; To evaluate the immunogenicity of IBD0333 in patients with specific tumor. Exploratory Objectives To explore biomarkers in blood and tissue that predict potential efficacy of IBD0333.",['MTD'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'IBD0333', 'description': 'This is a phase I/II, open, non-randomized, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetic (PK), immunogenicity, and preliminary efficacy of IBD0333 in patients with locally advanced/metastatic solid tumor or non-Hodgkin lymphoma in dose-escalation, dose-expansion, and clinical exploration phases.', 'armGroupLabels': ['IBD0333']}]","Inclusion Criteria In order to be eligible for participation in this trial, the patient must: 1. Male or female, 18 to 80 years old. 2. Patients with histologically or cytologically confirmed locally advanced/metastatic solid tumor or non-Hodgkin lymphoma who have failed or have no standard therapy, or for whom the standard therapy is intolerant. 3. There is at least one assessable tumor lesion in the dose escalation phase and at least one measurable lesion in the dose expansion phase according to RECIST 1.1 (solid tumors) or Lugano 2014 (lymphomas) (tumor lesions located in areas of prior radiotherapy or other localized regional treatment areas are generally not considered as measurable lesions unless the lesion shows definite progression or persists after 3 months of radiotherapy). 4. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status. 5. Have a life expectancy of at least 3 months. 6. Have adequate organ function as indicated by the following laboratory values. 1. Hematological (no transfusion or hematopoietic stimulating factor therapy within 14 days): absolute neutrophil count (ANC)≥1.5×109/L, platelet count (PLT)≥ 90 ×109/L, hemoglobin (HGB)≥90 g/L; 2. Hepatic: total bilirubin (TBIL)≤1.5×upper limit of normal (ULN), except for Gilbert syndrome; alanine aminotransferase (ALT) and aspartate aminotransferase (AST)≤3.0×ULN, or ALT and AST ≤ 5.0×ULN in patients with liver metastases or liver cancer; 3. Renal: creatinine clearance (Ccr)≥50mL/min (calculated according to the Cockcroft-Gault Method:); 4. Coagulation: international normalized ratio (INR) ≤ 1.5×ULN, activated partial thromboplastin time (APTT) ≤1.5×ULN. 7. Eligible patients (male and female) of childbearing potential must agree to use a reliable contraception measure (hormonal or barrier contraception or abstinence) with their partner for the duration of the trial and for at least 120 days after the discontinuation of investigational product. Female patients of childbearing potential must have a negative serum pregnancy test at within 7 days of first dose of investigational product. 8. According to the investigator's assessment, the patient could benefit from IBD0333. 9. Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment. Exclusion Criteria 1. Known hypersensitivity reaction (NCI-CTCAE 5.0 ≥ grade 3) recombinant proteins or any excipient contained in the drug or vehicle formulation for IBD0333. 2. History of 4-1BB monoclonal antibody or 4-1BB-containing dual antibody immune costimulatory molecule agonist. 3. History of anti-cancer therapies prior to the initiation of investigational product (chemotherapy within 3 weeks; radiotherapy, biologic therapy, endocrine therapy, targeted therapy, immunotherapy within 4 weeks) and the following are except: 1. Nitrosourea or mitomycin C within 6 weeks prior to the initiation of investigational product; 2. Oral fluorouracil and small molecule-targeted drugs within 2 weeks prior to the initiation of investigational product; 3. Chinese patent drugs within 2 weeks prior to the initiation of investigational product. 4. History of investigational anti-cancer drug within 4 weeks prior to the initiation of investigational product. 5. History of major surgery (except for puncture biopsy) or significant trauma within 4 weeks prior to the initiation of investigational product, or require the selective surgery during the trial. 6. History of systemic corticosteroids (prednisone \>10 mg/day or equivalent) or immunosuppressive medication \<14 days prior to the initiation of investigational product. Steroids for topical, ocular, intra-articular, intranasal and inhaled and short-term prophylactic treatment (e.g., to prevent contrast allergy) were allowed. 7. Treatment with immunomodulatory agents within 14 days prior to the initiation of investigational product, including but not limited to thymidine, interleukin-2, interferon, etc. 8. Vaccination with live attenuated vaccine within 4 weeks prior to the initiation of investigational product. 9. History of allogeneic hematopoietic stem cell or organ transplantation. 10. The adverse effects related to prior anticancer treatment (except alopecia, peripheral neurotoxicity with grade 2, and stable hypothyroidism after hormone replacement therapy or the other toxicities judged by the investigator without safety risk) that have not resolved to ≤ Grade 1 according to common terminology criteria for adverse events (NCI-CTCAE 5.0) or relevant provisions of the inclusion criteria prior to initiation of investigational product. 11. Parenchymal brain metastases or meningeal metastases unless previously received therapies and have no evidence of progression on magnetic resonance imaging (MRI) or computed tomography (CT) for at least 8 weeks after the treatment and for 4 weeks prior to the initiation of investigational product. 12. Evidence of active infection requiring intravenous systemic therapy. 13. History of immunodeficiency, including the positive for human immunodeficiency virus (HIV) antibodies. 14. Active hepatitis B infection (HBsAg positive and HBV-DNA \> 500 IU/mL or lower limit of detection \[only if lower limit is above 500 IU/mL\]). Active hepatitis C is defined by a known positive Hep C Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay. 15. Has interstitial lung disease (except for the radiographic pulmonary fibrosis without hormone therapy). 16. History of serious cardiovascular disease, including but not limited to: 1. Have severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, II-III-degree atrioventricular block, etc.; 2. The mean QT interval corrected for heart rate by Fridericia's formula (QTcF) \>470msec. 3. History of acute coronary syndromes, congestive heart failure, aortic dissection, stroke or other cardiovascular or cerebrovascular ≥ grade 3 within the 6 months prior to initiation of investigational product. 4. Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system or left ventricular ejection fraction (LVEF) \< 50%, or structural heart disease with high risk judged by investigators; 5. Uncontrollable hypertension. 17. Previous or current autoimmune disease (systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.), except for the stable autoimmune thyroid disease, type I diabetes, vitiligo, cured atopic dermatitis in children, and psoriasis (within the past 2 years and without systemic therapy). 18. History of ≥Grade 3 Immune-Related Adverse Events (irAE) or ≥Grade 2 immune-associated myocarditis (experienced immune-associated thyroid toxicity ≥grade 3 could be enrolled). 19. History of malignancy or current other malignant tumors (other than in non-melanoma skin cancer, localized prostate cancer, carcinoma in situ \[situ cervical cancer\] treated with curative intent and without evidence of disease for 2 years or longer). 20. Has uncontrollable third interstitial fluid that are unsuitable for enrollment (judged by the investigator). 21. Has alcohol or drug dependence. 22. Has a psychiatric disorder or poor compliance. 23. Pregnant or breastfeeding. Have serious systemic disease or are unsuitable for participation in the study.",NA,ALL,NA,"[{'measure': 'MTD', 'description': 'Maximum tolerated dose', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'DRDE', 'description': 'Extended recommended dose', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Dose limiting toxicity (DLT)', 'description': 'To determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D).', 'timeFrame': '28 days after first dose(dose-escalation phase)'}, {'measure': 'RP2D', 'description': 'Recommended Phase 2 dose', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'ORR', 'description': 'Objective response rate', 'timeFrame': 'through study completion, an average of 1 year'}]","[{'measure': 'pharmacokinetic parameters', 'description': 'AUC0-t', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'pharmacokinetic parameters', 'description': 'Cmax', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'pharmacokinetic parameters', 'description': 'Tmax', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'pharmacokinetic parameters', 'description': 't1/2', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'ADA', 'description': 'Anti-drug antibody', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'ORR', 'description': 'Objective response rate', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'DCR', 'description': 'Disease control rate', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'DoR', 'description': 'Duration of relief', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'PFS', 'description': 'Progression-free survival', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Frequency of adverse events (AEs) and SAEs', 'description': 'To investigate the safety characteristics.', 'timeFrame': 'through study completion, an average of 1 year'}]" 376,NCT01401504,"{'fullName': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}","Study of an Investigational Drug, ASP3026, in Patients With Solid Tumors",COMPLETED,A study to evaluate the safety and anti-tumor activity of ASP3026 in patients with advanced malignancies (solid tumors).,['Solid Tumor'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'ASP3026', 'description': 'oral', 'armGroupLabels': ['ASP3026']}]","Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status \< 2. * Histologically or cytologically confirmed diagnosis of a relapsed/refractory solid tumor * Patient meets at least 1 of the following criteria: * Disease progression despite standard therapies * No standard therapies are available or such therapies are not anticipated to result in a durable response * Standard therapies are considered unsuitable or have been refused * Life expectancy \> 12 weeks * Able to be hospitalized from 1 day prior to the initial dosing until day 15 of the dosing, and from day 27 until day 29 of the dosing Exclusion Criteria: * Patient exhibits persistent subjective and objective findings of toxicity ≥ Grade 2 (CTCAE v4.0-JCOG) from the previous cancer treatment with antitumor effect (except of alopecias) * Received previous treatment with antitumor effect within 21 days prior to the scheduled initial dosing * Patient had a major surgical procedure within 21 days prior to the scheduled initial dosing or a major surgical procedure scheduled during the course of the study * Use of an investigational drug or device within 21 days prior to the scheduled initial dosing * Use of blood transfusion or hematopoietic growth factors within 14 days prior to the scheduled initial dosing * A positive test for hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) * Known history of a positive test for human immunodeficiency virus (HIV) infection * Patient has central nervous system (CNS) or leptomeningeal involvement with clinical symptoms",NA,ALL,NA,"[{'measure': 'Safety and tolerability of ASP3026 assessed by recording of adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs) and clinical observations', 'timeFrame': 'Up to 30 days after last subject discontinues treatment'}]","[{'measure': 'Pharmacokinetics of ASP3026 by assessment of area under the curve over the time (AUC) and maximum concentration (Cmax) in plasma and urine', 'timeFrame': 'Up to Day 29'}, {'measure': 'Objective response rate (ORR)', 'description': 'Objective response rate is the proportion of subjects who experience complete response/remission (CR) or partial response/remission (PR)', 'timeFrame': '30 Days after the last subject discontinues treatment'}]" 377,NCT06021678,"{'fullName': 'Guangzhou Excelmab Inc.', 'class': 'INDUSTRY'}",Safety and Efficacy of EX103 in Subjects with Relapsed/Refractory CD20-Positive Non-Hodgkin Lymphoma,RECRUITING,"This is a multicenter, single-arm, open, dose-escalation Phase I/II clinical trial, consisting of a dose-escalation phase (accelerated titration phase, 3+3 design) and a dose expansion phase.",['CD20-positive Non-Hodgkin Lymphoma'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'EX103 injection', 'description': 'Administered as specified in the treatment arm.', 'armGroupLabels': ['EX103 injection'], 'otherNames': ['EX103', 'bispecific monoclonal antibody that recognizes both CD3 and CD20']}]","Inclusion Criteria: \- 1\. Provision of signed and dated informed consent form; stated willingness to comply with all study procedures and availability for the duration of the study; 2. Aged ≥ 18 years old, male or female; 3. Meeting the following criteria: 1. Dose-escalation phase: (1) with CD20-positive non-Hodgkin lymphoma confirmed at the first diagnosis (excluding patients whose CD20 turned negative after rituximab treatment); (2) with relapsed or refractory disease after least 2 prior lines of systemic therapy; (3) currently with no suitable therapy available for prolonging survival; 2. Dose-expansion phase: (i) Cohort 1: 1. Histopathologically and immunohistochemically confirmed CD20-positive diffuse large B-cell lymphoma (DLBCL) (excluding patients whose CD20 turned negative after rituximab treatment) : including non-specific (NOS) DLBCL, high-grade B-cell lymphoma (HGBCL), primary mediastinal (thymus) large B-cell lymphoma (PMBCL), and translational follicular lymphoma (trFL) (patients who have converted from follicular lymphoma to DLBCL can be enrolled, and pathology reports should be provided at the same time if there is a disease transformation), or follicular lymphoma (FL) with histological grade 3b; the sponsor may limit the number of patients with PMBCL and trFL enrolled; 2. Previous failure or relapse after second-line or higher systemic treatment regimens (at least one of which included anti-CD20 targeted therapy and at least one of which included anthracyclines); (ii) Cohort 2: 1. Histopathologically and immunohistochemically confirmed CD20-positive follicular lymphoma (FL) (excluding patients whose CD20 turned negative after rituximab treatment); 2. The histological grade ranged from 1 to 3a; 3. Previous failure or recurrence of second-line or higher systemic regimens (at least one of which included anti-CD20 targeted therapies and alkylating agents; The sponsor may limit the minimum number of patients who are refractory to both anti-CD20-targeted therapies and alkylating agents); 4. Must be indicative of treatment due to symptoms and/or tumor burden; (iii) Cohort 3: 1. Histopathologically and immunohistochemically confirmed CD20-positive non-Hodgkin lymphoma (excluding patients with CD20 turning negative after rituximab treatment), other than the types included in cohort 1 and cohort 2; the sponsor may limit the number of patients with certain or several specific tumor species to be enrolled; 2. Previous failure or relapse after second-line or higher standard treatment, at least one of which included a combination of anti-CD20 monoclonal antibodies and chemotherapy agents; 3. In cases of indolent lymphoma, indications for treatment must be present due to symptoms and/or tumor burden; 4\. At the dose escalation and expansion stages, the subjects must have at least one two- dimensionally measurable lesion as the basis for evaluation by CT, or MRI, if CT is not applicable: for intranodal lesions, the long diameter is ≥ 1.5 cm; for extranodal lesions, the long diameter is ≥ 1.0 cm; 5\. ECOG performance status score: 0-2; 6\. Life expectancy ≥ 12 weeks; 7\. The laboratory test results should be met before each cycle beyond cycle 1 (blood components, short-acting cell growth factors, albumin, and other drugs are not allowed to be given within the first 7 days of laboratory tests; long-acting cell growth factors are not allowed to be given within the first 14 days): 1. Absolute neutrophil count ≥ 1.0×109/L; 2. Platelet count ≥ 50×109/L; 3. Hemoglobin ≥ 80 g/L; 4. Serum total bilirubin ≤ 1.5×ULN; if there is liver invasion, serum total bilirubin ≤ 3×ULN; 5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; if there is liver invasion, ALT and AST ≤ 5×ULN; 6. Serum creatinine ≤1.5×ULN or creatinine clearance estimated by Cockcroft-Gault formula ≥ 30 mL/min; 7. International normalized ratio (INR) or plasma prothrombin time (PT) ≤ 1.5×ULN; 8\. Women of childbearing potential and men with a partner of childbearing potential who consent to use highly effective methods of birth control during treatment and for an additional 90 days after the last administration of the protocol specified treatment; women of childbearing age without surgical sterilization must have a negative result in serum HCG test within 7 days before enrollment in the study and isn't breastfeeding. Exclusion Criteria: 1. Clear history of drug allergy, foreign protein, biologics or ingredients of investigational drugs; 2. Uncontrolled active infection during the screening period; 3. Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplant; or received autologous hematopoietic stem cell transplantation (HSCT) or CAR-T cell therapy within 3 months; 4. CNS metastases, or other serious central nervous system diseases (such as epilepsy, cerebral infarction, and cerebral hemorrhage) within 6 months, History of neurodegenerative condition or CNS movement disorder. Subjects with a history seizure within 12 months prior to study enrollment are excluded; 5. At least one active person is known to have human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV). Subjects with evidence below are eligible for study entry: 1. Human immunodeficiency virus antibody (HIV-Ab) is negative; 2. Hepatitis B surface antigen (HBsAg) is negative; when HbsAg or HbcAb is positive, HBV-DNA (HBV deoxyribonucleic acid) is \< lower limit of detection; 3. Hepatitis C virus antibody is positive, and HCV RNA is negative. 6. Toxicities caused by previous anti-tumor therapy has not recovered to grade ≤ 1 (CTCAE v5.0), except alopecia and other tolerable events as determined by the investigator; 7. Develop any other malignancy within 5 years (except for completely treated cervical carcinoma in situ or basal cell or squamous cell skin cancer); 8. Use of any vaccine within 4 weeks prior to initial pretreatment with dexamethasone or methylprednisolone or during the intended study period; 9. Systemic immunosuppressive drugs, including but not limited to radiotherapy immune conjugate, antibody drug conjugations, immune/cytokines, monoclonal antibodies, etc., have been used within 4 weeks prior to initial pretreatment with dexamethasone or methylprednisolone. 10. With a history of active autoimmune diseases, including but not limited to myocarditis, pneumonia, myasthenia gravis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, Wegener's granulomatosis, multiple sclerosis, vasculitis, or glomerulonephritis; 11. Any condition that the investigator believes may not be appropriate for participating in the study.",NA,ALL,NA,"[{'measure': 'Incidence of Dose Limiting Toxicities (DLTs) [dose escalation (Cycle 0 and Cycle 1)]', 'description': 'To determine the RP2D and the MTD, if reached.', 'timeFrame': 'During the DLT evaluation period (28 days from Cycle1 Day1 at the dose escalation stage).'}, {'measure': 'Safety endpoints：incidence and severity of adverse events (AE), laboratory tests, etc.', 'description': 'Treatment-emergent AEs (TEAEs) as assessed by CTCAE v5.0. Abnormal laboratory values are reported as AEs per protocol.', 'timeFrame': 'From first dose until the end of the safety follow-up period [within 28 ± 7 days after the last study treatment or before the start of other anti-tumor treatments (whichever occurs earlier)].'}]","[{'measure': 'All parts: Time to reach Cmax (Tmax)', 'description': 'Tmax is one of the characteristics of Pharmacokinetic (PK) endpoint.', 'timeFrame': 'From first dose until treatment discontinuation, expected average of 3.5 years.'}, {'measure': 'All parts: Maximum (peak) plasma concentration (Cmax)', 'description': 'Cmax is one of the characteristics of Pharmacokinetic (PK) endpoint.', 'timeFrame': 'From first dose until treatment discontinuation, expected average of 3.5 years.'}, {'measure': 'All parts: Area under the concentration-time curve from time 0 to the last measurable concentration using linear-log trapezoidal rule (AUC0-t)', 'description': 'AUC0-t is one of the characteristics of Pharmacokinetic (PK) endpoint.', 'timeFrame': 'From first dose until treatment discontinuation, expected average of 3.5 years.'}, {'measure': 'All parts: Elimination half-life (t 1/2)', 'description': 't 1/2 is one of the characteristics of Pharmacokinetic (PK) endpoint.', 'timeFrame': 'From first dose until treatment discontinuation, expected average of 3.5 years.'}, {'measure': 'All parts: Total body clearance of drug from the plasma (CL)', 'description': 'CL is one of the characteristics of Pharmacokinetic (PK) endpoint.', 'timeFrame': 'From first dose until treatment discontinuation, expected average of 3.5 years.'}, {'measure': 'All parts: Steady-state maximum plasma concentration(Css,max)', 'description': 'Css,max is one of the characteristics of Pharmacokinetic (PK) endpoint.', 'timeFrame': 'From first dose until treatment discontinuation, expected average of 3.5 years.'}, {'measure': 'All parts: Steady-state minimum plasma concentration(Css,min)', 'description': 'Css,min is one of the characteristics of Pharmacokinetic (PK) endpoint.', 'timeFrame': 'From first dose until treatment discontinuation, expected average of 3.5 years.'}, {'measure': 'All parts: Steady-state time to maximum concentration(Tss,max)', 'description': 'Tss,max is one of the characteristics of Pharmacokinetic (PK) endpoint.', 'timeFrame': 'From first dose until treatment discontinuation, expected average of 3.5 years.'}, {'measure': 'All parts: Area under the plasma concentration versus time curve at Steady-State(AUCss)', 'description': 'AUCss is one of the characteristics of Pharmacokinetic (PK) endpoint.', 'timeFrame': 'From first dose until treatment discontinuation, expected average of 3.5 years.'}, {'measure': 'All parts: Pharmacodynamic (PD) endpoint', 'description': 'Before and after administration of EX103, changes in lymphocyte subsets and peripheral blood cytokine levels.', 'timeFrame': 'From first dose until treatment discontinuation, expected average of 3.5 years.'}, {'measure': 'All parts: Objective response rate (ORR)', 'description': 'ORR is defined as the proportion of subjects whose optimal response is CR or CRi or PR. Subjects who did not undergo tumor evaluation after baseline were considered to have no objective, as determined by the investigator using Lugano 2014 criteria.', 'timeFrame': 'From first dose until treatment discontinuation, expected average of 3.5 years.'}, {'measure': 'All parts: Disease control rate (DCR)', 'description': 'DCR is defined as the proportion of subjects whose best response is CR or CRi or PR or SD.', 'timeFrame': 'From first dose until treatment discontinuation, expected average of 3.5 years.'}, {'measure': 'All parts: Duration of response (DoR)', 'description': 'Duration of response (DoR) is defined as the time between the first onset of CR or CRi or PR and the onset of PD or death from any cause, whichever occurs first, in subjects with objective response.', 'timeFrame': 'From first dose until treatment discontinuation, expected average of 3.5 years.'}, {'measure': 'All parts: Incidence of anti-drug antibodies (ADA)', 'description': 'Percentage of positive patients of anti-drug antibody.', 'timeFrame': 'From first dose until treatment discontinuation, expected average of 3.5 years.'}, {'measure': 'All parts: Incidence of neutralizing antibody (NAb)', 'description': 'Percentage of positive patients of neutralizing antibody.', 'timeFrame': 'From first dose until treatment discontinuation, expected average of 3.5 years.'}, {'measure': 'All parts: Confirmation of anti-drug antibody and neutralizing antibodies.', 'description': 'Screening of antibodies against corresponding antigens and confirmation of positive antibodies, and determination of the titers of related antibodies (IgG, etc.) produced in the humoral and cellular immunity.', 'timeFrame': 'From first dose until treatment discontinuation, expected average of 3.5 years.'}]" 378,NCT00169143,"{'fullName': 'Lymphoma Study Association', 'class': 'OTHER'}",Study of R-ACVBP Regimen Supported by Pegfilgrastim in High-Risk Diffuse Large B-Cell Lymphoma,COMPLETED,Evaluation of the efficacy of a single injection of Pegfilgrastim (6mg) administered at day 3 of each cycle of R-ACVBP regimen during 4 cycles in patients with CD20+ diffuse large B-cell lymphoma presenting at least 2 adverse prognostic factor of the age-adjusted international prognostic index (Aa-IPI).,['Untreated CD20-positive Large B-cell Lymphoma'],INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Rituximab + ACVBP regimen plus Pegfilgrastim'}, {'type': 'PROCEDURE', 'name': 'Autologous stem cell transplant'}]","Inclusion Criteria: * Patient with histologically proven CD20+ diffuse large B cell lymphoma (WHO Classification). * Age \>18 and \< 61 years, eligible for transplant. * Patient not previously treated. * With at least two prognostic factors of the Aa-IPI. * With a minimum life expectancy of 3 months. * Creatinin level ≤ 150mmol/l, total bilirubin level 30mmol/l and transaminases 2.5 maximum normal level, unless abnormalities are related to the lymphoma. * Neutrophils \> 1.5 G/l and platelets \> 100 G/l, unless if patient has a bone marrow infiltration. * Negative HIV, HBV and HCV serologies 4 weeks (except after vaccination). * Having previously signed a written informed consent. Exclusion Criteria: * Any other histological type of lymphoma. * Any history of treated or non-treated indolent lymphoma. * Central nervous system or meningeal involvement by lymphoma. * Contra-indication to any drug contained in the chemotherapy regimens. * Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. * Any serious active disease (according to the investigator's decision). * Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study. * Pregnant or lactating women or women of childbearing potential not currently practicing an adequate method of contraception. * Adult patient under tutelage.",NA,ALL,NA,[{'measure': 'To evaluate the optimal combined dose intensity of the drug regimen'}],"[{'measure': 'Specific dose intensities, incidence of neutropenia and neutropenic fever, duration of severe neutropenia, complete response rate, event-free and overall survival'}]" 379,NCT01262235,"{'fullName': 'Arbutus Biopharma Corporation', 'class': 'INDUSTRY'}",A Dose Finding Study of TKM-080301 Infusion in Neuroendocrine Tumors (NET) and Adrenocortical Carcinoma (ACC) Patients,COMPLETED,"This study will be a Phase I/II, open-label, non-randomized, dose-finding trial conducted at multiple clinical centers. The study is designed to determine the safety, tolerability and PK of TKM-080301 in adult patients with solid tumors or lymphomas that are refractory to standard therapy or for whom there is no standard therapy. After the determination of the maximum tolerated dose this dose will be utilized in an expansion cohort or subjects with refractory neuroendocrine tumors (NET) or adrenocortical carcinoma (ACC) tumors.","['Cancer', 'Neuroendocrine Tumors', 'NET', 'Adrenocortical Carcinoma', 'ACC']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'TKM-080301', 'description': 'Repeat dose IV infusion.', 'armGroupLabels': ['TKM-080301'], 'otherNames': ['PLK1 SNALP', 'TKM-PLK1']}]","Inclusion Criteria: * Patients must have a histologically and cytologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy is known to exist, or who are not candidates for standard therapy, or non-Hodgkin's lymphoma or Hodgkin's disease that is refractory to standard therapy (i.e., patients have relapsed following at least 2 prior therapies) or for which no standard therapy is known to exist. For the Neuroendocrine (NET) and adrenocortical carcinoma (ACC) expansion cohort subjects must have histologically or cytologically confirmed, measurable (per RECIST 1.1) NET or ACC tumor that is refractory to standard therapy or for which no standard therapy is known to exist, or who are not candidates for standard therapy. * Patient has an ECOG performance status of 0 - 1, * Patient has adequate hematologic, hepatic and renal function, * Patient is seronegative for hepatitis B virus (HBV) and hepatitis C virus (HCV), * Patients must have a life expectancy of at least 12 weeks. Exclusion Criteria: * Unresolved toxicities (\> Grade 1) of previous chemotherapy, * Patients with primary tumors of the central nervous system (CNS), * Prophylactic hematologic growth factors administered \ 30 IU/L, or surgically sterile for at least 3 months, or if a woman of childbearing potential, must be non-pregnant confirmed by blood and urine pregnancy tests, and non-lactating. 9. Female patients of childbearing potential must agree to use acceptable method(s) of contraception from consent through at least 6 months after last dose of drug infusion. 10. Male patients of reproductive capacity must agree to use effective contraception from start of mobilization through at least 6 months after last dose of drug infusion. 11. Patients with chronic HBV infection with active disease who meet the criteria for anti HBV therapy (HBV DNA test is less than 2000 IU/ml) should be on a suppressive antiviral therapy prior to initiation of cancer therapy. Patients with a history of HCV infection should have completed curative antiviral treatment and HCV viral load below the limit of quantification. Patients with HCV Ab positive but HCV RNA negative due to prior treatment or natural resolution are eligible. Patients on concurrent HCV treatment should have HCV below the limit of quantification. 12. Patients must be able to follow up after the treatment. 13. Patients must understand and voluntarily sign the informed consent form. Exclusion Criteria Patients will be excluded from participation for any of the following criteria: 1. Received systemic or absorbable dosage of steroid hormone (prednisone or equivalent) of \> 10 mg/day in the 14 days prior to enrollment; 1. Prednisone \> 10 mg/day 2. Dexamethasone \> 1.5 mg/day. 2. Allergic or intolerant to salmonella sensitive antibiotics, or combined with infectious diseases and currently using antibiotics. 3. Present assessable tumors in hollow organs (Stomach, esophagus, intestine, urinary tract etc.). 4. Present with symptomatic central nervous system metastasis or brain abscess at screening. 5. Present with diverticulitis or conditions at screening that might promote the unintentional growth of anaerobic bacteria in non target lesions. 6. Existing cardiac clinical symptoms or diseases that cannot be well controlled, such as: 1. NYHA grade 2 or above heart failure; 2. Unstable angina pectoris; 3. Myocardial infarction occurred within 1 year; 4. Patients with supraventricular or ventricular arrhythmias that have clinical significance and need treatment or intervention; 5. Uncontrolled hypertension (systolic blood pressure) ≥160 mmHg and (diastolic blood pressure) ≥100 mmHg after drug treatment; 6. Patients with valvular heart disease or mitral valve prolapse, aortic valve disease or other source of turbulent cardiac blood flow. 7. Those who had received radiotherapy, chemotherapy, hormone therapy, surgery or molecular targeted therapy that ended fewer than 4 weeks before the first dose of study treatment (if nitrosourea or mitomycin chemotherapy, the interval between end of chemotherapy and first dose of study treatment must be no less than 6 weeks). 8. Patients with active or uncontrolled infection or fever, \> 38.5℃, of unknown cause during screening or before the first administration of the study drug (according to the judgment of the researcher, fever caused by tumor can be included). 9. Positive for the presence of human immunodeficiency virus-1 (HIV-1) or human immunodeficiency virus-2 (HIV-2) (positive antigen/antibody and nucleic acid tests); or follow standard of care for HIV diagnosis. 10. Patients with Anti-TP positive. 11. Patients participating in other clinical studies or participating in other clinical studies within 4 weeks (or 5 half-lives of other study drugs), whichever is longer, prior to enrollment and receiving experimental drug administration. 12. Vaccination within 28 days of the first trial treatment, except for administration of inactivated vaccines and RNA vaccines (e.g., inactivated influenza vaccines and COVID-19 RNA vaccines). 13. Received live or attenuated vaccines within 4 weeks of study drug administration, during treatment, or within 5 months of the last administration. 14. In the judgment of the investigator, there are other factors that may lead to termination: for example, adrenal cortex insufficiency, pituitary insufficiency after treatment, and other serious diseases (including 14.mental diseases) need to be treated together, there are serious abnormalities in laboratory examination, family or social factors, which may affect the safety of the patients or test data and sample collection. 15. In the researcher's judgment, patients who are not suitable for other reasons. 16. Documented salmonella infections within 6 months. 17. Abdominal standing position plain film or abdominal CT indicates the possibility of bowel obstruction within 6 months from screening, or the Investigator believes there is a risk of bowel obstruction. 18. Patients with implants such as pacemakers, prosthetic cardiac valves, or metal orthopedic prostheses (not include vascular implants for Part 3).",NA,ALL,NA,"[{'measure': 'Incidence and severity of AEs (adverse events).', 'description': 'An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality.\n\nEvents meeting the definition of an AE include:\n\n* Any abnormal laboratory test results (hematology, serum chemistry, or urinalysis) or other safety assessments (e.g., ECGs, vital signs measurements), including those that worsen from baseline, and was felt to be clinically significant in the medical and scientific judgment of the Investigator.\n* Exacerbation of a chronic or intermittent pre-existing condition including either an increase in frequency and/or intensity of the condition.\n* New conditions detected or diagnosed after study treatment administration even though it may have been present prior to the start of the study.\n* Signs, symptoms, or the clinical sequelae of a suspected interaction.', 'timeFrame': 'From receiving study drug and throughout the study, until 28 days after the last dosing.'}, {'measure': 'Incidence of SAEs.', 'description': 'An AE or suspected adverse reaction is considered ""serious"" if it results in any of the following outcomes:\n\n* Death\n* Life-threatening\n* Inpatient hospitalization or prolongation of existing hospitalization\n* A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions\n* A congenital anomaly/birth defect\n* Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.', 'timeFrame': 'From receiving study drug and throughout the study, until 28 days after the last dosing.'}, {'measure': 'Objective response rate (ORR)', 'description': 'The efficacy endpoints include ORR, DCR and PFS. The ORR is defined as the proportion of patients who achieve PR or better according to the RECIST v1.1 and Choi, mRECIST is used to assess Hepatocellular carcinoma, and LYRIC is used to assess Lymphoma. as assessed by investigator.', 'timeFrame': 'From signing the informed consent form until 28 days after the last dose.'}, {'measure': 'Disease control rate (DCR)', 'description': 'The efficacy endpoints include ORR, DCR and PFS. The DCR is defined as the proportion of patients who achieve SD or better according to the RECIST v1.1 and Choi , mRECIST is used to assess Hepatocellular carcinoma, and LYRIC is used to assess Lymphoma. as assessed by investigator.', 'timeFrame': 'From signing the informed consent form until 28 days after the last dose.'}, {'measure': 'Progress Free Survival (PFS)', 'description': 'The efficacy endpoints include ORR, DCR and PFS. PFS is defined as the time interval from date of first dose of SGN1 to the date of documented disease progression (iRECIST is used when the subject is suspected to have pseudo disease progression) or death due to any cause, whichever occurs first.', 'timeFrame': 'From signing the informed consent form until 28 days after the last dose.'}]","[{'measure': 'Incidence with any dose limiting toxicity (DLT),to determine the MTD.', 'description': 'Any of the following judged to be associated with SGN1 (i.e., possibly-, probably-, or definitely related to), may be considered a DLT:\n\n1. Any Grade 5 adverse event that is at least possibly related to investigational drug.\n2. Non-hematological toxicities:\n\n 1. Grade 4 non-hematological toxicities (excluding alopecia) lasting \\> 3 days despite optimal supportive care (OSC).\n 2. Grade 3 non-hematologic toxicities lasting \\> 7 days despite optimal supportive care (OSC).\n3. Hematological toxicities:\n\n 1. Grade 4 hematologic toxicity lasting \\> 7 days (except following b and c).\n 2. Grade 3 or 4 febrile neutropenia (body temperature ≥38.5°C) lasting \\> 7 days.\n 3. Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia.', 'timeFrame': 'Up to 28 days post first dose.'}, {'measure': 'Incidence with adverse events and preliminary efficacy data to determine the OBD.', 'description': 'OBD will be determined by adverse events, preliminary efficacy data,and the OBD determined by the SMC.', 'timeFrame': 'From receiving study drug and throughout the study, until 28 days after the last dosing.'}, {'measure': 'PK analysis of SGN1 level in blood.', 'description': ""Concentrations of SGN1 will be measured. In Part 1 and Part 3, blood sampling for pharmacokinetics analyses will be conducted. The blood collection times for PK are within 30 minutes Pre-dose and immediately end of injection of first 4 infusions (C1D1, C1D8, C1D15 and C1D22);for first and fourth infusion(C1D1 and C1D22) extra blood sample needs to be collected at the following timepoints after the end of infusion procedure: 15 minutes (± 3 minute), 30 minutes (± 3 minute), 45 minutes (± 3 minute), 1 hour (± 5 minutes), 1.5 hours (± 5 minutes), 2 hours (± 5 minutes), 4 hours (± 10 minutes) and every 30 minutes (± 3 minute) during the infusion procedure, besides, after the start time of infusion, following PK timepoints:24 hours ± 1 hour, 48 hours ± 1 hour and 72 hours ± 1 hour for C1D1 and C1D22.PK blood sampling points may be modified based on patients' PK parameters in future."", 'timeFrame': 'For the first four infusions in Part 1 and Part 3'}, {'measure': 'Bacterial shedding of SGN1 level in blood.', 'description': 'In Part 1 and Part 3 ,SGN1 blood concentrations before and after the first SGN1 infusion are measured in the PK Analysis described above. The qPCR results from PK blood samples will contribute to the analysis as the bacterial shedding of SGN1 in blood.\n\nFor subsequent SGN1 infusions (starting with Dose 2),blood samples shall be collected within 2 hours prior to the start of SGN1 infusion and 24 hours±3 hours post end of infusion.\n\nIf blood samples test positive for SGN1, collection of shedding samples should continue with weekly SGN1 administration until the samples from three consecutive infusions result below the limit of detection (LOD). If samples collected around the first three doses result at or below the limit of detection (LOD), subsequent sample collection and testing is not required.\n\nIn EOT/ET visit, blood samples for bacterial shedding will be collected.', 'timeFrame': 'Before the first administration up to 28 days after the last dosing.'}, {'measure': 'Bacterial shedding of SGN1 level in urine.', 'description': 'In Part 1 and Part 3, for the first SGN1 administration (C1D1), urine sampling for bacterial shedding will be conducted within 2 hours before administration, 3 hours ±1 hour, 6 hours ±1 hour, 24 hours ±3 hours, 48 hours ±3 hours and 72 hours ±3 hours after end of infusion.\n\nFor subsequent SGN1 infusions (starting with Dose 2), urine samples shall be collected within 2 hours prior to the start of SGN1 infusion and within 24 hours ±3 hours post end of infusion.\n\nIf urine samples test positive for SGN1, collection of shedding samples should continue with weekly SGN1 administration until the samples from three consecutive infusions result below the limit of detection (LOD). If samples collected around the first three doses result at or below the limit of detection (LOD), subsequent sample collection and testing is not required.\n\nIn EOT/ET visit, urine samples for bacterial shedding will be collected.', 'timeFrame': 'Before the first administration up to 28 days after the last dosing.'}, {'measure': 'Bacterial shedding of SGN1 level in saliva.', 'description': 'For the first SGN1 administration (C1D1), saliva sampling for bacterial shedding will be conducted within 2 hours before administration, 3 hours ±1 hour, 6 hours ±1 hour, 24 hours ±3 hours, 48 hours ±3 hours and 72 hours ±3 hours after end of infusion.\n\nFor subsequent SGN1 infusions (starting with Dose 2), saliva samples shall be collected within 2 hours prior to the start of SGN1 infusion and within 24 hours ±3 hours post end of infusion. If saliva samples test positive for SGN1, collection of shedding samples should continue with weekly SGN1 administration until the samples from three consecutive infusions result below the limit of detection (LOD). If samples collected around the first three doses result at or below the limit of detection (LOD), subsequent sample collection and testing is not required.\n\nIn EOT/ET visit, saliva samples for bacterial shedding will be collected.', 'timeFrame': 'Before the first administration up to 28 days after the last dosing.'}, {'measure': 'Bacterial shedding of SGN1 level in feces.', 'description': 'Feces samples for bacterial shedding will be collected by the patient before first administration of SGN1; this sample may be collected at any time during the screening period. Additional feces samples are to be collected after the end of the first infusion within the time frames below.\n\n0-24 hours 24-48 hours 48-72 hours For subsequent SGN1 infusions (starting with Dose 2), will be collected by the subject within 72 hours prior to infusion and within 72 hours after the end of infusion.\n\nIf feces samples test positive for SGN1, collection of shedding samples should continue with weekly SGN1 administration until the samples from three consecutive infusions result below the limit of detection (LOD).If samples collected around the first three doses result at or below the limit of detection (LOD), subsequent sample collection and testing is not required.\n\nIn EOT/ET visit, feces samples will be collected by the subject within 24 hours prior to the EOT/ET visit.', 'timeFrame': 'Before the first administration up to 28 days after the last dosing.'}, {'measure': 'Anti-Drug antibody (ADA) of SGN1.', 'description': ""Collecting of anti-drug antibodies (ADA) blood samples from all patients.\n\nBlood samples will be collected before the each administration (within 2 days) for first 2 cycles and first administration of 3rd cycle (C1D1\\~C3D1) and 24 hours (± 6 hours) post infusion for cycle 1 and cycle 2 (C1D2\\~C2D23), and at the end of treatment/withdrawal visit.\n\nThe Subsequent ADA blood samples collection timepoints will be adjusted according to the subject's ADA analysis result."", 'timeFrame': 'Before the first administration up to 28 days after the last dosing.'}, {'measure': 'Assessment of tumor colonization.', 'description': 'For appropriate superficial tumors, colonization of the tumor by SGN1 will be assessed by fine needle aspiration and/or excise biopsies every 8 weeks.', 'timeFrame': 'From receiving study drug and throughout the study, until 28 days after the last dosing.'}, {'measure': 'Proinflammatory cytokines', 'description': 'Proinflammatory cytokines including IL-1β, IFN-γ,TNF-α, IL-6, and IL-8.', 'timeFrame': 'Within 7 days prior to the first dose, and at 2, 4, 6, and 24 hours post end of first infusion.'}]" 381,NCT07334574,"{'fullName': 'Ruijin Hospital', 'class': 'OTHER'}",Clinical Study of XP-006 mRNA Vaccine for R/R B-NHL,NOT_YET_RECRUITING,"The main objective of this study is to observe and evaluate the safety and tolerability of the XP-006 personalized tumor mRNA vaccine for the treatment of relapsed or refractory B-cell non-Hodgkin's lymphoma. Secondary objectives focus on evaluating preliminary efficacy through several parameters: XP-006-induced antigen-specific CD4+/CD8+ T cell activation levels, objective remission rate (ORR), complete remission rate (CRR), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS).","[""B-cell Non-Hodgkin's Lymphoma (B-NHL)""]",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'Personalized neoantigen tumor vaccine', 'description': 'Neoantigen tumor vaccine', 'armGroupLabels': ['Neoantigen tumor vaccine monotherapy arm'], 'otherNames': ['XP-006']}]","Inclusion Criteria: 1. Subjects voluntarily signed written informed consent files, able to comply with the study protocol, in the investigator's judgment. 2. Subjects must be ≥18 years of age at time of informed consent, regardless of gender. 3. B-NHL was confirmed by histology according to world Health Organization (WHO) disease classification (excluding primary central lymphoma and HIV-associated lymphoma). 4. Prior treatment with sufficient first-line anti-lymphoma therapy, no remission within 90 days of the last administration, or disease progression after sufficient first-line anti-lymphoma therapy, and no current anti-lymphoma therapy (≥2 weeks since the last anti-lymphoma therapy). Patients were allowed to receive hormone drugs or rituximab at least 1 week after enrollment for symptom control reasons. 5. Gene mutation and the peripheral blood HLA typing both meet the requirements of the vaccine. 6. There are evaluable lesions detected by PET/CT. 7. Life expectancy of more than 3 months. 8. ECOG 0-2 points. 9. No serious organic lesions in the main organs, meeting the requirements of the following laboratory examination indicators (conducted within 7 days before treatment) : ① Absolute value of neutrophil count ≥1500/mm3; Platelet count ≥75,000/mm3 ② Total bilirubin ≤2× upper limit of normal value (ULN) ③ Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (serum glutamate pyruvate aminotransferase \[SGPT\]) ≤3× upper limit of normal value (ULN) ④ the creatinine clearance rate was ≥60ml/min ⑤ No cardiac dysfunction. Exclusion Criteria: 1. Pregnant or lactating women (lactating women must agree not to breastfeed while taking pomadomide); 2. Known hepatitis B (HBV), hepatitis C (HCV) infection (HBV infection refers to HBV-DNA \> detectable limit); And other acquired, congenital immune deficiency disorders, including but not limited to HIV-infected persons; 3. Subjects with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months; 4. Bone marrow failure, defined as ANC\<1500/mm3 or platelet \<75,000/mm3, unless hematologic changes are thought to be associated with lymphomas infiltrating the bone marrow; 5. Clinically significant heart disease, including unstable angina, acute myocardial infarction 6 months before enrollment, congestive heart failure (NYHA) heart function grade III or IV; Or left ventricular ejection fraction \<50%; 6. Lymphoma with central nervous system (CNS) involvement; 7. Those who are known to be allergic to the test drug ingredients; 8. Those who have received grade II or above surgery within three weeks before treatment; 9. Patients who have received organ transplants; 10. Has been diagnosed with or is being treated for malignancy other than lymphoma, except for: ① They have received therapeutic treatment and have not had known active disease malignancy for ≥5 years prior to enrollment; ② Basal cell carcinoma of the skin (except melanoma) without signs of disease after adequate treatment; ③ Cervical carcinoma in situ without signs of disease after adequate treatment. 11. With severe infection; 12. Substance abuse, medical, psychological, or social conditions that may interfere with the subjects' participation in the study or evaluation of the study results; The researchers deemed unsuitable for the group.",NA,ALL,NA,"[{'measure': 'Dose-limiting toxicity (DLT) & Maximum tolerated dose (MTD)', 'timeFrame': 'Day1 to Day 21'}]","[{'measure': 'Objective remission rate at the end of treatment', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Progression-Free Survival (PFS)', 'description': 'Progression-free Survival of Personalized mRNA Tumor Vaccine', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Overall Survival (OS)', 'description': 'Overall Survival of Personalized mRNA Tumor Vaccine', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Reaction of antigen-specific T cells in peripheral blood', 'description': 'personalized tumor vaccine induced neoantigen-specific CD4+ and CD8+ T lymphocyte responses', 'timeFrame': 'Up to 104 weeks'}]" 382,NCT04439318,"{'fullName': 'National Cancer Institute (NCI)', 'class': 'NIH'}",Testing Trametinib as a Potential Targeted Treatment in Cancers With NF1 Genetic Changes (MATCH-Subprotocol S1),ACTIVE_NOT_RECRUITING,"This phase II MATCH treatment trial identifies the effects of trametinib in patients whose cancer has a has a genetic change called NF1 mutation. Trametinib blocks proteins called MEK1 and MEK2, which may be needed for cancer cell growth when an NF1 mutation is present. Researchers hope to learn if trametinib will shrink this type of cancer or stop its growth.","['Advanced Lymphoma', 'Advanced Malignant Solid Neoplasm', 'Hematopoietic and Lymphoid Cell Neoplasm', 'Refractory Lymphoma', 'Refractory Malignant Solid Neoplasm', 'Refractory Multiple Myeloma']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Trametinib Dimethyl Sulfoxide', 'description': 'Given PO', 'armGroupLabels': ['Treatment (trametinib)'], 'otherNames': ['Mekinist', 'Meqsel', 'Spexotras']}]","Inclusion Criteria: * Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol * Patients must have deleterious inactivating mutations of NF-1, or another aberration, as determined via the MATCH Master Protocol * Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have NONE of the following cardiac criteria: * Clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block). * Treatment-refractory hypertension defined as a blood pressure of systolic \> 140 mmHg and/or diastolic \> 90 mmHg which cannot be controlled by anti-hypertensive therapy * Patients must have an echocardiogram (ECHO) or a nuclear study (multigated acquisition scan \[MUGA\] or First Pass) within 4 weeks prior to registration to treatment and must not have a left ventricular ejection fraction (LVEF) \< the institutional lower limit of normal (LLN). If the LLN is not defined at a site, the LVEF must be \> 50% for the patient to be eligible * Patients who previously received monoclonal antibody therapy (eg. ipilimumab, nivolumab, pembrolizumab and others) must have stopped the prior therapy for 8 or more weeks before starting on trametinib * Patients with glioblastoma must have histologically or radiographically confirmed recurrent or progressive World Health Organization (WHO) grade 4 glioma (glioblastoma) * NOTE: All baseline and post-baseline disease assessments must be performed using contrast-enhanced cranial magnetic resonance spectroscopy (MRI) or contrast-enhanced computed tomography (CT) for subjects who cannot have MRI performed Exclusion Criteria: * Patients with a history of interstitial lung disease or pneumonitis are excluded * Patients must not have known hypersensitivity to trametinib or compounds of similar chemical or biologic composition or to dimethyl sulfoxide (DMSO). * Patients must not have a history or current evidence/risk of retinal vein occlusion (RVO). An eye exam is required at baseline * Patients who previously received MEK inhibitors (including, but not limited to, trametinib, binimetinib, cobimetinib, selumetinib, RO4987655 (CH4987655), GDC-0623 and pimasertib) will be excluded",NA,ALL,NA,"[{'measure': 'Objective Response Rate (ORR)', 'description': 'Overall response rate was defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) among all eligible and treated patients. Best overall response was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for the detailed definitions of response criteria. The 90% two-sided binomial exact confidence interval was calculated for ORR.', 'timeFrame': 'Tumor assessments occurred at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration'}]","[{'measure': '6-month Progression-free Survival (PFS) Rate', 'description': 'Progression free survival is defined as time from treatment start date to date of progression or death from any cause, whichever occurs first. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression. 6 month PFS rate was estimated using the Kaplan-Meier method, which can provide a point estimate for any specific time point.', 'timeFrame': 'Assessed at baseline, then every 2 cycles for the first 26 cycles, and every 3 cycles thereafter until disease progression, up to 3 years post registration, from which 6-month PFS rate is determined'}, {'measure': 'Progression Free Survival (PFS)', 'description': 'PFS was defined as time from treatment start date to date of disease progression or death from any causes, whichever occurred first. Median PFS was estimated using the Kaplan-Meier method. Disease progression was evaluated using the Response Evaluation Criteria in Solid Tumors version 1.1, the Cheson (2014) criteria for lymphoma patients, and the Response Assessment in Neuro-Oncology criteria for glioblastoma patients. Please refer to the protocol for detailed definitions of disease progression.', 'timeFrame': 'Assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration'}]" 383,NCT04680884,"{'fullName': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}",Empirical Steroids and/or Antifungals in Immunocompromised Patients With Acute Respiratory Failure From Undetermined Etiology: a Multicenter Double-blind Randomized Controlled Trial,UNKNOWN,"Acute respiratory failure (ARF) is the leading reason of ICU admission in immunocompromised patients. Failure to identify the ARF etiology is associated with increased mechanical ventilation and mortality rates. This was confirmed in the large Efraim 1 study published in 2017, where undetermined ARF etiology affected 609/1611 (38%) patients at day 3, 402 (25%) patients at day 7 and 199 (12.3%) patients overall, and was associated with a case fatality of 55% (vs. 40% in other patients). In lung biopsy/autopsy findings from these patients, invasive fungal infection, steroid-sensitive affections (organized pneumonia, non-infectious interstitial involvement, drug-related pulmonary toxicity…), and lung infiltration by the underlying disease (lymphoma, carcinomatous lymphangitis, systemic vasculitis, connective tissue diseases, etc.) were the leading etiologies. No study has evaluated survival benefits from empirical steroids and/or antifungals in immunocompromised patients with ARF from undetermined etiology. The main objective of this study is to reduce the 90-day mortality in immunocompromised patients with ARF from undetermined etiology at day-3. The intervention would evaluate the impact of steroids ± isavuconazole for 14 days or until ICU discharge.","['Acute Respiratory Failure', 'Immunocompromised Patients']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}","[{'type': 'DRUG', 'name': 'Experimental for steroid', 'description': '2 mg/kg/day of IV methylprednisolone for three days. As of day 4, the daily dose will be tapered to 1 mg/kg/day until day 7, followed by 0,5 mg/kg/day from day 8 to day 14 + IV placebo of isavuconazole', 'armGroupLabels': ['Experimental for steroid']}, {'type': 'DRUG', 'name': 'Experimental for antifungals', 'description': 'IV placebo of methylprednisolone + IV isavuconazole (200 mg every 8 hours for 2 days followed by 200 mg per day until ICU discharge or for a total duration of 14 days)', 'armGroupLabels': ['Experimental for antifungals']}, {'type': 'DRUG', 'name': 'Experimental for steroids and antifungals', 'description': 'IV methylprednisolone 2 mg/kg/day for three days. As of day 4, the daily dose will be tapered to 1 mg/kg/day until day 7, followed by 0.5 mg/kg/day from day 8 to day 14 + IV isavuconazole 200 mg every 8 hours for 2 days followed by 200 mg per day until ICU discharge or for a total duration of 14 days)', 'armGroupLabels': ['Experimental for steroids and antifungals']}, {'type': 'OTHER', 'name': 'Standard of care', 'description': 'IV placebo of methylprednisolone + IV placebo of isavuconazole. This group receives the treatment that is currently recommended.', 'armGroupLabels': ['Best standard of care']}]","Inclusion Criteria: * Age \>18 years and \< 90 years * Known immunosuppression: 1. immunosuppressive drug 2. solid organ transplant 3. solid tumor 4. hematological malignancies 5. primary immune deficiency * ICU admission for acute respiratory failure as defined by 1. respiratory distress with tachypnea (respiratory rate\>30/min) 2. cyanosis 3. laboured breathing 4. need for more than 6L of standard oxygen to maintain SpO2\>95%, or for high flow oxygen, non-invasive or invasive mechanical ventilation * No established ARF etiology at day 3 * Informed consent signed: * by the patient, * Or informed consent signed by a family members/trustworthy person if his condition does not allow him to express his consent in written as per L1111-6, * Or in an emergency situation and in the absence of family members/trustworthy person, the patient can be enrolled. The consent to participate to the research will be requested as soon as the condition of the patient will allow). Note: Patient with Pneumocystis pneumonia can be included given that their treatment does not require the use of neither antifungal drugs nor corticosteroids Exclusion Criteria: * Patient who improved enough to be discharged from the ICU at day 3 * Documented invasive fungal infection that requires antifungal therapy. * Patient needing or receiving prophylactic or empirical antifungal treatment for clinical care * Patient needing or receiving corticoid therapy * Patient receiving palliative care with comfort measures only (Do Not Intubate (DNI) and Do Not Resuscitate (DNR) patients can be included) * Pregnant or breastfeeding patient * No social security coverage * Known hypersensitivity to isavuconazole or to any of excipients of CRESEMBA® specialty * Patient treated by ketoconazole, ritonavir, or any CYP3A4/5 inductor * Short QT syndrome and/or patient with a family history of short QT syndrome; * Liver insufficiency (any stage) * Moribund patients * Participation in another interventional research",NA,ALL,NA,"[{'measure': 'Mortality', 'description': 'Overall death', 'timeFrame': 'at day 90'}]","[{'measure': 'ICU mortality', 'description': 'Mortality at ICU discharge', 'timeFrame': 'at ICU discharge within 6 months'}, {'measure': 'Hospital mortality', 'description': 'Mortality at hospital discharge', 'timeFrame': 'at hospital discharge within 6 months'}, {'measure': 'Mortality', 'description': 'Overall death', 'timeFrame': 'at day 28'}, {'measure': 'Proportion of patients with ICU acquired microbiologically documented bacterial infections', 'timeFrame': 'at day 28'}, {'measure': 'Proportion of patients with invasive fungal infection', 'timeFrame': 'at day 28'}, {'measure': 'Proportion of patients with herpes simplex virus (HSV) reactivation', 'timeFrame': 'at day 28'}, {'measure': 'Proportion of patients with varicella-zoster virus (VZV) reactivation', 'timeFrame': 'at day 28'}, {'measure': 'Proportion of patients with cytomegalovirus (CMV) reactivation', 'timeFrame': 'at day 28'}, {'measure': 'Occurrence of severe hypokalemia', 'description': 'Severe hypokalemia will be defined as kalemia \\<2,5 meq/l', 'timeFrame': 'at day 28'}, {'measure': 'Occurence of decompensated diabetes', 'timeFrame': 'at day 28'}, {'measure': 'Occurence of severe or newly acquired hypertension', 'timeFrame': 'at day 28'}, {'measure': 'Emergence of aspergillus species', 'timeFrame': 'at day 28'}, {'measure': 'Incidence of candida infection', 'timeFrame': 'at day 28'}, {'measure': 'Incidence of post-traumatic Stress Disorder', 'description': 'Post-traumatic Stress Disorder will be evaluated using IES-R scale. Impact of Event Scale - Revised (IES-R) is a 22-item self-report measure that assesses subjective distress caused by traumatic events. The higher the score, the more severe the symptoms.', 'timeFrame': 'at 6 months'}, {'measure': 'Incidence of anxiety and depression', 'description': 'Depression and anxiety will be assessed using Hospital Anxiety and Depression Scale (HADS) questionnaire. HADS is a self-administered scale of 14 items which assessed levels of depression and anxiety, divided into 2 subscales of 7 items (Anxiety or HADS-A, Depression or HADS-D). Each item is scored on a scale of 0 to 3. A score is generated for each of the two sub-scales (sum of the 7 items, ranging from 0 to 21). Limit scores : clearly or clinically symptomatic cases (score ≥ 11).', 'timeFrame': 'at 6 months'}, {'measure': 'Quality of life', 'description': 'Quality of life will be evaluated using SF36. SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting. Items are grouped into three categories: functional status, well-being, overall health assessment. In two dimensions, the answer is binary (yes / no) and in the other 6 in ordinal quality (3 to 6 possible answers). For each dimension, the scores for the different items are coded and then summed and transformed linearly on a scale ranging from 0 to 100. A physical composite score and a mental composite score can be calculated according to an established algorithm', 'timeFrame': 'at 6 months'}]" 384,NCT01415752,"{'fullName': 'Eastern Cooperative Oncology Group', 'class': 'NETWORK'}","Rituximab, Bendamustine Hydrochloride, and Bortezomib Followed by Rituximab and Lenalidomide in Treating Older Patients With Previously Untreated Mantle Cell Lymphoma",ACTIVE_NOT_RECRUITING,"RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as bendamustine hydrochloride, also work in different ways to kill cancer cells or stop them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide may stop the growth of mantle cell lymphoma by blocking blood flow to the cancer. It is not yet known whether giving rituximab together with bendamustine and bortezomib is more effective than rituximab and bendamustine, followed by rituximab alone or with lenalidomide in treating mantle cell lymphoma. PURPOSE: This randomized phase II trial studies rituximab, bortezomib, bendamustine, and lenalidomide in treating previously untreated older patients with mantle cell lymphoma.","['Lymphoma', 'Mantle Cell Lymphoma']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'rituximab', 'description': 'Given IV', 'armGroupLabels': ['Induction: (A) Bendamustine + Rituximab then Maintenance: (E) Rituximab', 'Induction: (B) Bendamustine + Rituximab + Bortezomib then Maintenance: (F) Rituximab', 'Induction: (C) Bendamustine + Rituximab then Maintenance: (G) Lenalidomide + Rituximab', 'Induction: (D) Bendamustine + Rituximab + Bortezomib then Maintenance: (H) Lenalidomide + Rituximab'], 'otherNames': ['IDEC-C2B8', 'Chimeric anti-CD20 monoclonal antibody', 'Rituxan']}, {'type': 'DRUG', 'name': 'Bendamustine', 'description': 'Given IV', 'armGroupLabels': ['Induction: (A) Bendamustine + Rituximab then Maintenance: (E) Rituximab', 'Induction: (B) Bendamustine + Rituximab + Bortezomib then Maintenance: (F) Rituximab', 'Induction: (C) Bendamustine + Rituximab then Maintenance: (G) Lenalidomide + Rituximab', 'Induction: (D) Bendamustine + Rituximab + Bortezomib then Maintenance: (H) Lenalidomide + Rituximab'], 'otherNames': ['bendamustine hydrochloride', 'CEP-18083', 'TREANDA', 'BENDEKA']}, {'type': 'DRUG', 'name': 'bortezomib', 'description': 'Given IV or SC', 'armGroupLabels': ['Induction: (B) Bendamustine + Rituximab + Bortezomib then Maintenance: (F) Rituximab', 'Induction: (D) Bendamustine + Rituximab + Bortezomib then Maintenance: (H) Lenalidomide + Rituximab'], 'otherNames': ['MLN341', 'LDP-341', 'Velcade®']}, {'type': 'DRUG', 'name': 'lenalidomide', 'description': 'Given PO', 'armGroupLabels': ['Induction: (C) Bendamustine + Rituximab then Maintenance: (G) Lenalidomide + Rituximab', 'Induction: (D) Bendamustine + Rituximab + Bortezomib then Maintenance: (H) Lenalidomide + Rituximab'], 'otherNames': ['IMiDTM compound CC-5013', 'Revlimid®']}]","Step 1 (Induction) Inclusion Criteria: * Mantle Cell Lymphoma International Prognostic Index (MIPI) score must be calculated and entered in OPEN * Histologically confirmed untreated mantle cell lymphoma (MCL), with documented cyclin D1 by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescence in situ hybridization (FISH) * Patients must have at least one objective measurable disease parameter * Negative pregnancy test * Women of childbearing potential and sexually active males use an accepted and effective method of contraception * ECOG performance status 0-2 * Absolute neutrophil count (ANC) ≥ 1,500/mcL (1.5 x 10\^9/L) * Platelets ≥ 100,000/mcL (100 x 10\^9/L) * Aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 2 times upper limit of normal (ULN) * Bilirubin ≤ 2 times ULN * Calculated creatinine clearance by Cockroft-Gault formula ≥ 30 mL/min * Patient agrees that if randomized to Arms C or D, and proceeding onto Arms G or H, they must register into the mandatory RevAssist program, and be willing and able to comply with the requirements of RevAssist. Patients must have no medical contra-indications to, and be willing to take, DVT prophylaxis as all patients registering to the lenalidomide/rituximab Arms G and H will be required to have deep vein thrombosis (DVT) prophylaxis. Patients randomized to Arms G or H who have a history of a thrombotic vascular event will be required to have full anticoagulation, therapeutic doses of low molecular weight heparin or warfarin to maintain an INR between 2.0 - 3.0, or any other accepted full anticoagulation regimen (e.g. direct thrombin inhibitors or Factor Xa inhibitors) with appropriate monitoring for that agent. Patients on Arms G and H without a history of a thromboembolic event are required to take a daily aspirin (81 mg or 325 mg) for DVT prophylaxis. Patients who are unable to tolerate aspirin should receive low molecular weight heparin therapy or warfarin treatment or another accepted full anticoagulation regimen. Ways to minimize risk of DVT should be discussed with patients, including, but not limited to, avoiding smoking, minimizing prothrombotic hormone replacement, avoiding prolonged periods of inactivity (e.g. uninterrupted long car or plane trips). * HIV-positive patients are not excluded but, to enroll, must meet all of the below criteria: * HIV is sensitive to antiretroviral therapy * Must be willing to take effective antiretroviral therapy, if indicated * CD4 count at screening \>= 300 cells/mm³ * If on antiretroviral therapy, must not be taking zidovudine or stavudine * Must be willing to take prophylaxis for Pneumocystis jiroveci pneumonia (PCP) during therapy and until at least 2 months following the completion of therapy or until the CD4 cells recover to over 250 cells/mm³, whichever occurs later Step 1 (Induction) Exclusion Criteria: * Women (sexually mature female) must not be pregnant or breast-feeding * Evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma, low grade prostate carcinoma (Gleason grade ≤ 6) managed with observation that has been stable for at least 6 months, or any malignancy treated with curative intent continuously disease free for \>=3 years so as not to interfere with interpretation of radiographic response * Prior therapy for MCL, except: \< 2 weeks of steroid therapy for symptom control or local radiation therapy for symptom control if there is measurable disease outside the radiation portal. Patients may be on chronic steroids for non-malignant disease if on a stable dose equivalent to ≤ 20 mg prednisone per day. * CNS involvement * History of AIDS-defining conditions * Grade 2 or greater peripheral neuropathy. * NYHA Class III or IV heart failure, uncontrolled angina severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia * Hypersensitivity to bortezomib, boron or mannitol * A serious medical or psychiatric illness likely to interfere with study participation * Participating in any other therapeutic clinical trial or taking any other experimental medications within 14 days prior to registration. Step 2 (Maintenance) Inclusion Criteria: * ECOG performance status between 0-2 * Complete response, partial response or stable disease after Step 1 * ANC \>= 1000 cells/mm3 (1.0 x 10\^9/L) * Platelets \>= 75,000 cells/mm3 (75 x 10\^9/L) * AST/ALT \<= 2 x upper limit of normal (ULN) * Total bilirubin \<= 2 x upper limit of normal (ULN) or, if total elevated, direct bilirubin \<= 2 x upper limit of normal (ULN) * Calculated creatinine clearance by Cockroft-Gault formula \>= 30 ml/min * Patient agrees that if randomized to Arms C or D, and proceeding onto Arms G or H, they must register into the mandatory REMS program, and be willing and able to comply with the requirements of REMS. * Pregnancy tests must occur within 10 - 14 days and again within 24 hours prior to initiation of Cycle 1 of lenalidomide. * Females of childbearing potential (FCBP)\* with regular or no menstruation must have a pregnancy test weekly for the first 28 days and then every 28 days while on lenalidomide therapy (including breaks in therapy); at discontinuation of lenalidomide and at Day 28 post the last dose of lenalidomide. Females with irregular menstruation must have a pregnancy test weekly for the first 28 days and then every 14 days while on lenalidomide therapy (including breaks in therapy), at discontinuation of lenalidomide and at Day 14 and Day 28 post the last dose of lenalidomide (see Appendix VI: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods). * Females of childbearing potential (FCBP)\* must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days and again within 24 hours prior to starting Cycle 1 of lenalidomide and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. All patients must be counseled at a minimum of every 28 days about pregnancy precautions and risks of fetal exposure. * A female of childbearing potential is any sexually mature female, regardless of sexual orientation of whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). * Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study/lenaliomide: 1) for at least 28 days before starting lenalidomide; 2) while participating in the study including interruptions in therapy; and 3) for at least 28 days after discontinuation/stopping lenalidomide. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal \[birth control pills, injections, or implants\], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed. * Women must agree to abstain from donating blood during study participation and for at least 28 days after discontinuation from protocol treatment. * Males must agree to abstain from donating blood, semen, or sperm during study participation and for at least 28 days after discontinuation from protocol treatment. All males, regardless of whether they have undergone a successful vasectomy, must agree to use a latex condom during sexual contact with a female of childbearing potential, or to practice complete abstinence from heterosexual intercourse with any female of childbearing potential during all cycles of study treatment and for at least 28 days following discontinuation of protocol treatment * Patients must have no medical contra-indications to, and be willing to take, DVT prophylaxis as all patients registering to the lenalidomide/rituximab Arms G and H will be required to have deep vein thrombosis (DVT) prophylaxis. Patients randomized to Arms G or H who have full anticoagulation, a history of a thrombotic vascular event will be required to have therapeutic doses of low molecular weight heparin or warfarin to maintain an INR between 2.0 - 3.0, or any other accepted full anticoagulation regimen (e.g. direct thrombin inhibitors or Factor Xa inhibitors) with appropriate monitoring for that agent. Patients on Arms G and H without a history of a thromboembolic event are required to take a daily aspirin (81 mg or 325 mg) for DVT prophylaxis. Patients who are unable to tolerate aspirin should receive low molecular weight heparin therapy or warfarin treatment or another accepted full anticoagulation regimen. Ways to minimize risk of DVT should be discussed with patients, including, but not limited to, avoiding smoking, minimizing pro-thrombotic hormone replacement, avoiding prolonged periods of inactivity (e.g. uninterrupted long car or plane trips).",NA,ALL,NA,"[{'measure': 'Progression-free Survival (PFS) for Induction Phase', 'description': 'PFS is defined as time from randomization to lymphoma progression or death. Progression is defined as:\n\n* Appearance of any new lesion \\>1.5 cm in any axis during or at the end of therapy\n* \\>=50% increase from nadir in the sum of products of the diameters (SPD) of any previously involved nodes or extranodal masses, or in a single involved node or extranodal mass, or the size of other lesions.\n* \\>=50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis.\n* Lesions should be PET positive if observed in a typical FDG-avid lymphoma or the lesion was PET positive before therapy unless the lesion is too small to be detected with current PET systems', 'timeFrame': 'Assessed at baseline, every 3 months for 2.5 years, every 6 months up to 10 years from end of treatment, and then annually up to 10 years and 6 months'}, {'measure': 'Progression-free Survival (PFS) for Maintenance Phase (Step 2)', 'description': 'PFS is defined as time from Step 2 registration to lymphoma progression or death. Progression is defined as:\n\n* Appearance of any new lesion \\>1.5 cm in any axis during or at the end of therapy\n* \\>=50% increase from nadir in the sum of products of the diameters (SPD) of any previously involved nodes or extranodal masses, or in a single involved node or extranodal mass, or the size of other lesions.\n* \\>=50% increase in the longest diameter of any single previously identified node or extranodal mass more than 1 cm in its short axis.\n* Lesions should be PET positive if observed in a typical FDG-avid lymphoma or the lesion was PET positive before therapy unless the lesion is too small to be detected with current PET systems', 'timeFrame': 'Assessed at registration to step 2, cycles 6, 12, 18, treatment completion, then every 3 months for 2.5 years, every 6 months up to 10 years from end of treatment, and then annually up to 10 years and 6 months'}]","[{'measure': 'Objective Response for Induction Phase (Step 1)', 'description': 'Objective response is defined as either complete response (CR) or partial response (PR).\n\nCR is defined as disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy.\n\nPR is defined as:\n\n* ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses\n* No increase in the size of other nodes, liver or spleen.\n* Bone marrow assessment is irrelevant for determination of a PR if the sample was positive prior to treatment. However, if positive, the cell type should be specified, e.g. large-cell lymphoma or small cleaved cell lymphoma.\n* No new sites of disease.\n* Patients who achieve a CR but have persistent morphologic bone marrow involvement will be considered partial responders.\n* When the bone marrow was involved before therapy and a clinical CR was achieved, but with no bone marrow assessment after treatment, patients are considered partial responders.', 'timeFrame': 'Assessed at baseline and 24 weeks (end of cycle 6)'}, {'measure': 'PET-documented Complete Response for Induction Phase (Step 1)', 'description': 'Complete response is defined as disappearance of all detectable clinical evidence of disease.', 'timeFrame': 'Assessed at baseline and 24 weeks (end of cycle 6)'}, {'measure': 'Overall Survival (OS) Rate at 5 Years Since Maintenance (Step 2)', 'description': 'OS is defined as the time from registration of Step 2 (maintenance) until death from any cause or last know alive. The Kaplan-Meier estimate of 5-year OS rate is reported.', 'timeFrame': 'Assessed every 3 months for 2.5 years, every 6 months for years 2.5-5'}, {'measure': 'Objective Response for Maintenance (Step 2) Among Patients Without PET-documented CR at the End of Induction', 'description': 'Objective response is defined as either complete response (CR) or partial response (PR).\n\nCR is defined as disappearance of all detectable clinical evidence of disease, and disease-related symptoms if present prior to therapy.\n\nPR is defined as:\n\n* ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or extranodal masses\n* No increase in the size of other nodes, liver or spleen.\n* Bone marrow assessment is irrelevant for determination of a PR if the sample was positive prior to treatment. However, if positive, the cell type should be specified, e.g. large-cell lymphoma or small cleaved cell lymphoma.\n* No new sites of disease.\n* Patients who achieve a CR but have persistent morphologic bone marrow involvement will be considered partial responders.\n* When the bone marrow was involved before therapy and a clinical CR was achieved, but with no bone marrow assessment after treatment, patients are considered partial responders.', 'timeFrame': 'Assessed at baseline and every 4 months for 2 years'}]" 385,NCT00901615,"{'fullName': 'Lymphoma Study Association', 'class': 'OTHER'}",Lenalidomide and R-CHOP in B-cell Lymphoma,COMPLETED,"The purpose of the study is to determine the recommended dose (RD) of lenalidomide (Revlimid) when administered in association with R-CHOP (rituximab (R), cyclophosphamide, doxorubicin, vincristine and prednisone).","['Lymphoma, Large B-Cell, Diffuse', 'Follicular Lymphoma', 'Mantle Cell Lymphoma', 'Marginal Zone Lymphoma']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Lenalidomide and R-CHOP', 'description': 'Lenalidomide dose administered orally during 14 days in combination with 6 courses of fixed doses of R-CHOP 21.', 'armGroupLabels': ['Lenalidomide and R-CHOP'], 'otherNames': ['REVLIMID']}]","Inclusion Criteria: * Patients with one of the following B-cell Lymphoma, CD 20 positive: * Mantle cell, Marginal zone, follicular * Histological transformation from low grade to high grade * Diffuse large B cell * Aged from 18 to 70 years * WHO performance status 0, 1 or 2 * Signed inform consent * Life expectancy of ≥ 90 days (3 months). * Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL not more than 3 days from the start of study drug and must either commit to continued abstinence from heterosexual intercourse or begin one acceptable method of birth control, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to monthly pregnancy testing and must be counseled at a minimum of every 4 weeks about pregnancy precautions and risks of fetal exposure. * Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. Men must also be counseled at a minimum of every 4 weeks about pregnancy precautions and risks of fetal exposure. * † A female patient is considered to have childbearing potential unless she meets at least one of the following criteria 1) Age \> 50 years and naturally amenorrhoeic for \> 1 year (amenorrhoea following cancer therapy does not rule out childbearing potential); or 2) Premature ovarian failure confirmed by a specialist gynaecologist or 3) Previous bilateral salpingo-oophorectomy, or hysterectomy, or 4) XY genotype, turner syndrome, uterine agenesis. Exclusion Criteria: * Previous treatment with immunotherapy or chemotherapy except: * Chlorambucil or Cyclophosphamide per os alone during less than 6 months, if stopped more than one year before inclusion * Rituximab alone during less than three months, if stopped more than one year before inclusion * Previous radiotherapy except if localized to one lymph node area * Other type of lymphomas: Burkitt, T cell, lymphocytic, CD 20 negative * Central nervous system or meningeal involvement * Contraindication to any drug contained in the chemotherapy regimen * HIV disease, active hepatitis B or C * Any serious active disease or co-morbid medical condition (according to investigator's decision) * Any of the following laboratory abnormalities : * Absolute neutrophil count (ANC) \< 1,500 cells/mm3 (1.5 x 109/L). * Platelet count \< 100,000/mm3 (100 x 109/L). * Serum SGOT/AST or SGPT/ALT 5.0 x upper limit of normal (ULN). * Serum total bilirubin \> 2.0 mg/dL (34 µmol/L), except in case of hemolytic anemia. * Calculated creatinine clearance (Cockcroft-Gault formula) of \< 50 mL /min * Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for ≥ 3 years * Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. * Pregnant or lactating females. * Prior ≥ Grade 3 allergic reaction/hypersensitivity to thalidomide. * Prior ≥ Grade 3 rash or any desquamating (blistering) rash while taking thalidomide. * Subjects with ≥ Grade 2 neuropathy. * Prior use of lenalidomide. * Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug therapy.",NA,ALL,NA,"[{'measure': 'Incidence of Dose Limiting Toxicities', 'timeFrame': '42 days'}]","[{'measure': 'Complete response rate and Overall response rate at the end of treatment', 'timeFrame': '3 months after the end of treatment'}, {'measure': 'Complete and Overall response rates after induction', 'timeFrame': 'at the end of third cycle of treatment (between Day 56 and Day 63)'}, {'measure': 'Progression-Free Survival and Overall survival', 'timeFrame': '7 years'}, {'measure': 'Duration of response', 'timeFrame': '7 years'}, {'measure': 'Collection of adverse events', 'timeFrame': '6 months'}]" 386,NCT03287817,"{'fullName': 'Autolus Limited', 'class': 'INDUSTRY'}",Cluster of Differentiation Antigen 19/22(CD19/22) CAR T Cells (AUTO3) for the Treatment of Diffuse Large B Cell Lymphoma,TERMINATED,"The purpose of this study is to test the safety and efficacy of AUTO3, a CAR T cell treatment targeting CD19 and CD22 with consolidation or pre-conditioning with anti-PD1 antibody in patients with DLBCL",['Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A dose escalation and expansion phase (Phase I) followed by Phase II', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'AUTO3', 'description': 'Following preconditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with doses from 50 x 10⁶ to 900 x 10⁶ CD19/ CD22 Chimeric Antigen Receptor (CAR) positive T cells with limited duration of anti-PD1 antibody (pembrolizumab).', 'armGroupLabels': ['AUTO3']}]","Inclusion Criteria: 1. Male or female, aged ≥18 years. 2. Willing and able to give written, informed consent. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1. 4. Histologically confirmed DLBCL and large B cell lymphoma subsets, including: Phase I and Phase II Cohort 1: 1. DLBCL, not otherwise specified (NOS), per World Health Organisation classification and DLBCL with MYC oncogene (MYC) and B cell lymphoma 2 (BCL2) gene and/or B cell lymphoma 6 (BCL6) gene rearrangements (double/triple hit). 2. Transformed DLBCL from follicular lymphoma (FL). 3. High-grade B cell lymphoma with MYC expression (excluding Burkitt's lymphoma) Phase I and Phase II Cohort 2. 4. Transformed DLBCL from other indolent lymphomas (excluding Richter's transformation). 5. Primary mediastinal large B cell lymphoma. 5. Chemotherapy-refractory disease, defined as one or more of the following: 1. Stable disease (≤12 months) or progressive disease as best response to most recent chemotherapy containing regimen. Refractory disease after frontline chemo-immunotherapy is allowed. 2. Disease progression or recurrence in ≤12 months of prior autologous haematopoietic stem cell transplantation (ASCT). OR 6. Relapse after ≥two lines of therapy or after ASCT. At a minimum: 1. Patients must have received rituximab or another anti-cluster of differentiation antigen 20 (CD20) monoclonal antibody (unless Investigator determines that tumour is CD20-negative) and an anthracycline-containing chemotherapy regimen. 2. Patients must have either failed ASCT, or be ineligible for or not consenting to ASCT. 3. Patients with transformed DLBCL must have received at least one line of therapy after transformation to DLBCL. 7. Positron emission tomography-positive disease per Lugano classification. 8. For females of childbearing potential, a negative serum or urine pregnancy test must be documented at screening, prior to pre-conditioning and confirmed before receiving the first dose of study treatment. For females who are not postmenopausal or surgically sterile, highly effective methods of contraception must be used during the treatment period and for at least 12 months after the last dose of study treatment. 9. For males, it must be agreed that that two acceptable methods of contraception are used. 10. Adequate renal, hepatic, pulmonary, and cardiac function defined as: 1. Creatinine clearance ≥40 cc/min. 2. Serum alanine aminotransferase / aspartate aminotransferase ≤2.5 x upper limit of normal (ULN). 3. Total bilirubin ≤1.5 x ULN, except in subjects with Gilbert's syndrome. 4. Left ventricular ejection fraction (LVEF) ≥50% (by echocardiogram \[ECHO\] or Multiple gated acquisition scan \[MUGA\]) unless the institutional lower limit of normal is lower. 5. Baseline oxygen saturation \>92% on room air and ≤Grade 1 dyspnoea. 11. Patient has adequate bone marrow (BM) function without requiring ongoing blood product or granulocyte-colony stimulating factor support and meets the following criteria: 1. Absolute neutrophil count ≥1.0 × 10\^9/L. 2. Absolute lymphocyte count ≥0.3 × 10\^9/L (at enrolment and prior to leukapheresis). 3. Haemoglobin ≥80 g/L. 4. Platelets ≥75 × 10\^9/L 12. No contra-indications for leukapheresis. Exclusion Criteria: 1. Prior allogeneic haematopoietic stem cell transplant. 2. Females who are pregnant or lactating. 3. History or presence of clinically relevant CNS pathology such as epilepsy, paresis, aphasia, stroke within prior 3 months, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis. 4. Patients with active CNS involvement by malignancy. Patients with history of central nervous system (CNS) involvement with malignancy may be eligible if CNS disease has been effectively treated and provided treatment was at least 4 weeks prior to enrolment (at least 8 weeks prior to AUTO3 infusion). 5. Clinically significant, uncontrolled heart disease or a recent (within 12 months) cardiac event. 1. Uncontrolled cardiac arrhythmia (patients with rate-controlled atrial fibrillation are not excluded). 2. Evidence of pericardial effusion 6. Patients with a history (within 3 months) or evidence of deep vein thrombosis or pulmonary embolism requiring ongoing therapeutic anticoagulation at the time of pre-conditioning. 7. Patients with active gastrointestinal bleeding. 8. Patients with any major surgical intervention in the last 3 months. 9. Active bacterial, viral or fungal infection requiring systemic treatment. Active or latent hepatitis B infection or hepatitis C infection. Testing positive for human immunodeficiency virus, human T cell lymphotropic virus (HTLV1 and 2) or syphilis. 10. History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 24 months. 11. Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the CNS. 12. Evidence of active pneumonitis on chest computed tomography (CT) scan at screening or history of drug-induced pneumonitis, idiopathic pulmonary fibrosis, organising pneumonia, or idiopathic pneumonitis. 13. History of other malignant neoplasms unless disease free for at least 24 months (carcinoma in situ, non-melanoma skin cancer, breast or prostate cancer on hormonal therapy allowed). 14. Prior treatment with PD1, programmed cell death ligand 1 (PD-L1), or cytotoxic T lymphocyte-associated protein-4-targeted therapy, or tumour necrosis factor (TNF) receptor superfamily agonists within 6 weeks prior to AUTO3 infusion. 15. Prior treatment with investigational or approved gene therapy or cell therapy products until a dose level has treated at least three patients and has been declared safe. 16. Prior CD19 or CD22 targeted therapy. 17. The following medications are excluded: 1. Steroids: Therapeutic doses of corticosteroids within 7 days of leukapheresis or 72 hours prior to AUTO3 administration. However, physiological replacement, topical, and inhaled steroids are permitted. 2. Immunosuppression: Immunosuppressive medication must be stopped ≥2 weeks prior to leukapheresis or AUTO3 infusion. 3. Cytotoxic chemotherapies within 2 weeks of AUTO3 infusion and 1 week prior to leukapheresis (2 weeks for lymphodepleting chemotherapy). 4. Antibody therapy use including anti-CD20 therapy within 2 weeks prior to AUTO3 infusion, or 5 half-lives of the respective antibody, whichever is shorter. 5. Granulocyte-colony stimulating factor less than 10 days prior to leukapheresis. 6. Live vaccine ≤4 weeks prior to enrolment. 7. Prophylactic intrathecal therapy: Methotrexate within 4 weeks and other intrathecal chemotherapy (e.g. Ara-C) within 2 weeks prior to starting pre-conditioning chemotherapy. 18. Prior limited radiation therapy within 4 weeks of AUTO3 infusion or within 24 weeks for definitive radiation to chest. 19. Research participants receiving any other investigational agents, or concurrent biological, chemotherapy, or radiation therapy. 20. Known allergy to albumin, dimethyl sulphoxide (DMSO), cyclophosphamide or fludarabine, pembrolizumab or tocilizumab. 21. Any contraindications to receive anti-PD1 antibody pembrolizumab will be excluded from cohorts requiring administration of pembrolizumab. 22. Patients, who in the opinion of the Investigator, may not be able to understand or comply with the safety monitoring requirements of the study. 23. Any other condition that in the Investigator's opinion would make the patient unsuitable for the clinical trial. Phase I outpatient cohort: 24. Subjects who do not have caregiver support (in line with institutional outpatient transplant guidelines) for outpatient/ambulatory care setting. 25. Subjects who are staying greater than 60 minutes (or whatever is permissible per institutional outpatient transplant guidelines) from the clinical trial site at the time of treatment. For AUTO3 Infusion: Patients meeting any of the following exclusion criteria must not be treated with AUTO3 or have treatment delayed until they no longer meet these criteria: 1. Severe intercurrent infection. 2. Requirement for supplementary oxygen or active pulmonary infiltrates. 3. Clinical deterioration of organ function (renal and hepatic) exceeding the criteria set at study entry.",NA,ALL,NA,"[{'measure': 'Phase I Escalation - Safety (Number of Participants With Grade 3-5 Toxicities) and Identification of Recommended Phase II Dose and Schedule (RP2D).', 'description': 'Number of patients with Grade 3-5 toxicities during escalation part of Phase I (Cohorts: 50x10\\^6 CD19/22 CAR+ T Cells; 50x10\\^6 CD19/22 CAR+ T Cells+Pembrolizumab \\[Pem\\] Day 14; 150-450x10\\^6 CD19/22 CAR+ T Cells+Pem Day 14; 150-450x10\\^6 CD19/22 CAR+ T Cells+Pem Day -1 in Inpatient Setting)\n\nDose-limiting toxicity defined as:\n\n* New non-hematological AE Grade \\>=3 using NCI CTCAE (5.0), probably/definitely related to AUTO3, occurring in DLT evaluation period, which did not resolve to Grade 2 or better in 14 days, despite supportive measures.\n* Grade 4 CRS, neurotoxicity (NT), or cerebral edema, or Grade 3 NT that lasted \\>72 hrs\n* Grade \\>3 Disseminated Intravascular Coagulation\n* Grade \\>2 Infusion Reaction with AUTO3\n* Grade 4 or 5 event not managed with conventional supportive measures or necessitating dose reduction or modification to trial therapy\n* Any event that in opinion of Investigator and/or medical monitor put patient at undue risk could also have been considered DLT', 'timeFrame': 'Within 75 days of AUTO3 infusion'}, {'measure': 'Phase I Expansion - Safety (Incidence of Grade 3-5 Toxicities) in the Outpatient / Ambulatory Care Setting', 'description': 'The incidence of Grade 3-5 toxicities during the expansion part of Phase I (Dose cohort: 150 to 450 x 10\\^6 CD19/CD22 CAR-positive T Cells + Pembrolizumab at Day -1 in an Outpatient Setting)', 'timeFrame': 'Within 75 days of AUTO3 infusion'}, {'measure': 'Phase II - Overall Response Rate as Per Lugano Criteria', 'description': ""This was not analysed due to study termination prior to initiation of Phase II. End of study notification submitted to Medicines and Healthcare products Regulatory Agency (MHRA) (reference 46113/0003/001-0016) - The Last patient last visit was 19 October 2023 (at end of Phase 1) and the study is considered completed (End of study). As per protocol v10.0, end of study is defined as 36 months after the last patient has received AUTO3 infusion or earlier in the event of death or consent withdrawal. Fifty-two patients received AUTO3 in the Phase I part of the study. After reviewing the data and taking into consideration the available treatment landscape in r/r DLBCL, Autolus didn't progress AUTO3-DB1 into the Phase II part of the study. Autolus notified MHRA on 08 November 2021 about enrolment to Phase II of the study (Autolus has decided not to progress AUTO3-DB1 into the Phase II part of the study), and MHRA acknowledged it on 09 November 2021."", 'timeFrame': 'Up to 2 years'}]","[{'measure': ""Feasibility of Generating AUTO3: Number of Patients' Cells Successfully Manufactured as a Proportion of the Number of Patients Undergoing Leukapheresis."", 'description': 'Feasibility of product generation was examined by assessing the number of AUTO3 successfully manufactured as a fraction of the number of patients undergoing leukapheresis (all patients enrolled).', 'timeFrame': 'Up to 8 weeks post leukapheresis.'}, {'measure': 'Determine the Complete Response Rate Following Treatment With AUTO3, as Per Lugano Criteria.', 'description': 'Participants achieving objective response per Lugano criteria based on independent central radiology review.\n\nThe Lugano classification of response by 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) PET-CT:\n\n1. no uptake or no residual uptake (when used interim)\n2. slight uptake, but below blood pool (mediastinum)\n3. uptake above mediastinal, but below or equal to uptake in the liver\n4. uptake slightly to moderately higher than liver\n5. markedly increased uptake or any new lesion (on response evaluation) Non-progressive disease\n\n * complete metabolic response - score of 1, 2 or 3 in nodal or extranodal sites with or without a residual mass\n * partial metabolic response - score of 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size\n * stable disease or no metabolic response - score of 4 or 5 with no obvious change in FDG uptake Progressive disease score 4 or 5 in any lesion with an increase in intensity of FDG uptake from baseline (and/or', 'timeFrame': 'Up to 2 years'}, {'measure': 'Duration of Response (DOR).', 'description': 'Duration of response was defined as the time from the first observed complete response or partial response \\[from the first post-baseline response assessment\\] until the date of first progressive disease or death due to underlying cancer (primary reason for death=progressive disease), whichever occurred first.\n\nOnly responders (patients with complete response \\[CR\\] or partial response \\[PR\\]) were included in the analysis of duration of response.\n\nResponse defined by Lugano classification (see Outcome Measure 5). Patients with death not due to underling cancer (primary reason for death=adverse event \\[AE\\] or Other or Unknown) or who received new anti-cancer therapy other than SCT or discontinued from the study for other reason than progressive disease (PD) or who were lost to follow-up or reached the time point of analysis without a known record of progression or death had the duration of response censored at the date of last adequate disease assessment for response.', 'timeFrame': 'Up to 2 years'}, {'measure': 'Progression-free Survival (PFS).', 'description': 'The progression-free survival was defined as the time from first AUTO3 treatment until the first progression of disease or death from any cause, whichever occurred first.\n\nPatients who reached the time point of analysis without a known record of progression had the PFS censored at the date of last adequate disease assessment.\n\nPatients who received a new stem cell transplantation (SCT) were censored at the start date of this new SCT.\n\nPatients who received a new anti-cancer therapy or discontinued from the study for other reason than disease progression and who were lost to follow-up were censored at the date of last adequate disease assessment.\n\nResponse defined by Lugano classification (see Outcome Measure 5).', 'timeFrame': 'Up to 2 years'}, {'measure': 'Overall Survival (OS).', 'description': 'Overall survival (OS) was defined as the time from the date of first AUTO3 treatment up to the date of death, regardless of cause of death.\n\nPatients alive at the time of the analysis had the OS censored at the date of last assessment when the patient was known alive.', 'timeFrame': 'Up to 2 years'}]" 387,NCT00294840,"{'fullName': 'Rambam Health Care Campus', 'class': 'OTHER'}",Dynamic PET acquisition-a Quantitative Technique for Grading of Malignant Tumors and Prediction of Response to Treatment,COMPLETED,"To assess a quantitative kinetic model of FDG uptake measurement using PET in patients with aggressive Non-Hodgkin's lymphoma and cancer of the pancreas, malignancies with known variability in disease aggressiveness and prognosis, for optimized tailoring of the therapeutic strategy in the individual patient.",['Pancreatic Cancer'],OBSERVATIONAL,"{'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'DEVICE', 'name': 'PET-CT'}]","Inclusion Criteria: * age\>18 * newly diagnosed untreated aggressive NHL * newly diagnosed untreated cancer of pancreas Exclusion Criteria: * none",Patients with pancreatric cancer,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'The impact of the imaging modality on patient management', 'timeFrame': '5 years'}]","[{'measure': 'patient management', 'timeFrame': '10 years'}]" 388,NCT07634289,"{'fullName': 'Olivia Newton-John Cancer Research Institute', 'class': 'OTHER'}",Radiotherapy in Combination With Glofitamab in Relapsed/Refractory Diffuse Large B Cell Lymphoma,NOT_YET_RECRUITING,"The goal of this clinical trial is to see if a new combination of standard of care radiotherapy treatment prior to administering the study drugs obinutuzumab and glofitamab in relapsed/refractory Diffuse Large B Cell Lymphoma patients is effective. The main question it aims to answer is: If you are able to tolerate the study treatments, and whether your cancer responds to the study treatment, compared with other reported studies of standard care treatments. Participants will have three parts they need to complete over a 5 year period. * Screening period over a 28 day period * Treatment period - Radiotherapy followed by 12 treatment cycles every three weeks (total time approx. 37 weeks) * Follow up, up to 4 years. Additional PET imaging studies will be performed in a cohort of patients (up to 6) who are willing to undergo infusions of 89Zr-Df-Crefmirlimab and 18F-Granzyme B for evaluation of the impact of radiotherapy plus glofitamab with relapsed diffuse large B-cell lymphoma.",['Relapsed /Refractory DLBCL'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Glofitamab', 'description': 'Glofitamab is the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more prior systemic therapies.', 'armGroupLabels': ['Intervention'], 'otherNames': ['Columvi']}, {'type': 'RADIATION', 'name': 'Radiotherapy', 'description': '25 Gy in 5 fractions.', 'armGroupLabels': ['Intervention']}, {'type': 'DRUG', 'name': 'Obinutuzumab', 'description': 'Obinutuzumab as a pre-treatment to reduce the risk of CRS induced by glofitamab is approved in Australia.', 'armGroupLabels': ['Intervention'], 'otherNames': ['Gazyva']}, {'type': 'OTHER', 'name': '89Zr-Df-crefmirlimab', 'description': '89Zr-Df-crefmirlimab infusion and imaging (24hrs+/- 4 hours) - must be at least 5 days prior to the first fraction of radiotherapy of study treatment, A second infusion of 89Zr-Df-crefmirlimab and imaging will be after Cycle 2 (15 days +/- 3 days)', 'armGroupLabels': ['Intervention'], 'otherNames': ['89Zr-DF-IAB22M2C']}, {'type': 'OTHER', 'name': '18F-granzyme B', 'description': 'Eligible participants will receive an initial injection of 18F-CSB-321 followed by PET imaging up to 14 days prior to commencing therapy.\n\n370 MBq (±10%) of 18F-CSB-321 is injected, without the need of pre-medications. Participants will be monitored for adverse events up to 2 hours post-injection.', 'armGroupLabels': ['Intervention'], 'otherNames': ['[AI18F]-NODA-CSB-321', 'CSB-321']}]","Inclusion Criteria: 1. Age 18 years. 2. Histologically proven relapsed/refractory CD20+ve DLBCL or a recognised subtype, including follicular large B-cell lymphoma and high grade B-cell lymphoma. 3. Prior systemic treatment: ≥2 lines OR after 1 line AND autologous stem cell transplant/CAR-T ineligible 4. Eastern Collaborative Oncology Group (ECOG) performance status 0 to 2. 5. Measurable FDG avid disease on baseline PET/CT scan 6. At least one site of active, PET positive disease that can be safely irradiated. Patients with disease only in previously irradiated sites that cannot be safely irradiated again due to tissue tolerance will be excluded. 7. Adequate bone marrow function including: * Haemoglobin \>8.0 g/dL * White cell count (WCC) ≥2000/μL * Neutrophils \>1.0 x 109/L * Platelets \>75 x 109/L at the time of study entry, unless attributed to lymphoma. Red cell transfusion is permitted. 8. Adequate renal function with serum creatinine ≤1.5 x ULN or creatinine clearance (CrCl) ≥ 45mL/min (using Cockcroft-Gault formula, Modification of Diet in Renal Disease Study Equation, 24hr urine collection, eGFR or a formal nuclear medicine technique) unless attributed to lymphoma (e.g. ureteric obstruction). 9. Adequate hepatic function with AST/ALT ≤3x ULN and total bilirubin ≤1.5 x ULN (except subjects with Gilbert syndrome, who can have a total bilirubin ≤3 mg/dL or ≤51.3 μmol/L) unless attributed to lymphoma (e.g. liver infiltration or biliary obstruction). 10. Adequate left ventricular ejection fraction of \>40% as demonstrated on a Gated Cardiac Blood Pool Scan or echocardiogram. 11. Life expectancy \> 3 months. 12. Patients of childbearing potential willing to adhere to the following contraceptive precautions: For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs, as defined below: Women must remain abstinent or use contraceptive methods with a failure rate of \<1% per year during the treatment period and for at least 6 months after the final dose of obinutuzumab and 2 months after the final dose of glofitamab. Women must refrain from donating eggs during this same period. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements. Examples of contraceptive methods with a failure rate of \<1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. If required per local guidelines or regulations, locally recognized acceptable methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below: With a female partner of childbearing potential or pregnant female partners, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \<1% per year during the treatment period and for at least 6 months after obinutuzumab, and 2 months after the final dose of glofitamab or tocilizumab to avoid exposing the embryo. Men must refrain from donating sperm during this same period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. 13. Written, informed consent. Exclusion Criteria: 1. Patient has failed only one prior line of therapy and is a candidate for stem cell 2. Transplantation or CAR-T cell therapy 3. Excessively bulky or rapidly progressive disease that, in the opinion of the investigator, requires rapid debulking or is unsafe to be irradiated 4. Richter's transformation from CLL. Transformation from other low-grade histology (e.g. Follicular lymphoma, Marginal zone lymphoma etc) is permitted 5. Refractory to prior therapy with glofitamab or other anti-CD3/CD20 bispecific antibodies, defined as progression during or within 3 months of cessation. 6. Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 4 weeks or 5 half-lives (whichever is shorter) prior to first study treatment. 7. Current central nervous system, meningeal involvement or spinal cord compression by lymphoma. Previous involvement is permitted if there is currently no active CNS disease. 8. Patients with active, known or suspected autoimmune disease. Patients with well controlled type I diabetes mellitus, coeliac disease, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, vitiligo or psoriasis not requiring systemic treatment, or other conditions not expected to recur in the absence of an external trigger are permitted to enrol. 9. Subjects with a condition requiring systemic treatment with either corticosteroids (\>10mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration without prior discussion with the medical monitor. Inhaled or topical steroids, and adrenal replacement therapy are permitted in the absence of active autoimmune disease. 10. Prior solid organ transplantation or allogeneic bone marrow transplantation within 6 months. 11. Prior malignancy active within the previous 2 years except for those treated with curative intent and with a \<20% chance of relapse. Low-grade prostate cancer under observation or well controlled on hormone therapy is permitted. Resected or locally treated non-melanoma skin cancer is permitted. 12. Uncontrolled or severe cardiovascular disease (NYHA class III or IV heart failure; myocardial infarction within the last 6 months of study entry); unstable angina; unstable cardiac arrhythmias; clinically significant pericardial disease. 13. Any other serious active disease or infection that in the opinion of the investigator takes precedence over the DLBCL, or will impact on the ability to deliver study treatment. 14. Any positive test result for hepatitis B or hepatitis C virus during screening indicating acute or chronic infection. Latent hepatitis B with undetectable viral load by PCR is allowable provided appropriate anti-viral prophylaxis is given as per institutional guidelines. 15. Any positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) unless the viral load is fully suppressed for \>2 years with a CD4 count of \>350x106/L and compliant with antiretroviral therapy. 16. Any history of severe hypersensitivity reactions to other monoclonal antibodies. 17. A history of allergy or intolerance (unacceptable AEs) to study drug components. 18. Patients incarcerated or without Medicare 19. Medical or psychiatric conditions that compromise the patient's ability to give informed consent.",NA,ALL,NA,"[{'measure': 'Complete Response Rate After Radiotherapy and Glofitamab Treatment', 'description': 'The study will assess how many participants achieve a complete metabolic response after radiotherapy and 12 cycles of glofitamab treatment, without severe side effects that require stopping treatment early', 'timeFrame': '37 weeks'}]","[{'measure': 'Safety assessment through adverse events', 'description': 'The study will assess the safety and effectiveness of treatment, including side effects such as cytokine release syndrome (CRS) and infections. All adverse events will be graded according to CTCAE v 5.0.', 'timeFrame': '5 years total'}, {'measure': ""Assessment of impact of side effects on patient's quality of life - EORTC-QLQ-C30"", 'description': 'The EORTC QLQ-C30 is a patient-reported outcome measure that evaluates health-related quality of life across multiple domains. It includes five functional domains, physical, role, cognitive, emotional, and social functioning. As well as nine symptom domains covering fatigue, pain, nausea and vomiting, dyspnoea, appetite loss, insomnia, constipation, diarrhoea, and financial impact. In addition, it contains a global health status/quality-of-life scale. Responses are recorded using both 4-point and 7-point rating scales. Changes in global health status from baseline will be analysed. For the functional domains, higher scores indicate better levels of functioning, while higher scores on symptom domains represent greater symptom severity or burden.', 'timeFrame': '5 years'}, {'measure': 'Overall Toxicity (all grades)', 'description': 'Overall Toxicity (all grades) and adverse events of special interest of treatment will be collected and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.', 'timeFrame': '5 years'}, {'measure': 'Overall Response Rate to study treatment', 'description': 'Overall Response Rate as defined by the number of subjects with a best overall response of complete remission (CR), partial remission (PR) as assessed by CT plus PET, defined by the Lugano Response assessment for Non Hodgkin Lymphoma, at the completion of treatment or during the study.', 'timeFrame': '5 years'}, {'measure': 'Time to Treatment failure', 'description': 'Time to Treatment failure will be calculated from the date of study enrolment until a progression event occurs. Progression events are defined as clinical or radiological documented disease progression.', 'timeFrame': '5 years'}, {'measure': 'Progression-free Survival', 'description': 'Progression-free Survival will be calculated from the date of study enrolment until a progression event occurs, or death from any cause. Patients alive without progression will be censored at date last known to be alive.', 'timeFrame': '5 years'}, {'measure': 'Overall survival', 'description': 'Overall survival will be measured from study entry to date of death from any cause; surviving patients will be censored at date last known to be alive.', 'timeFrame': '5 years'}, {'measure': ""Assessment of impact of side effects on patient's quality of life - PRO-CTCAE"", 'description': 'PRO-CTCAE assessments will be analysed to evaluate data integrity, describe baseline symptom burden, monitor symptom trajectories over time, assess the emergence and evolution of patient-reported adverse events, and explore concordance between patient-reported outcomes and investigator-rated adverse events. Results will be summarized descriptively by reporting the frequency and percentage of participants selecting each response level for each PRO-CTCAE item. Comparisons between treatment arms will be undertaken at the individual question level.', 'timeFrame': '5 years'}, {'measure': ""Assessment of impact of side effects on patient's quality of life - EORTC-IL4"", 'description': 'The EORTC-IL4 is a disease-specific quality-of-life instrument developed to supplement the EORTC QLQ-C30 by capturing additional symptoms and concerns relevant to the study population. Questionnaire responses will be summarised descriptively at each assessment time point. Scores will be calculated and transformed according to EORTC scoring guidelines, where applicable. Changes from baseline will be evaluated over time to assess the impact of treatment on patient-reported symptoms and health-related quality of life. Higher scores on symptom-related items indicate a greater symptom burden or level of concern, whereas higher scores on functioning-related items indicate better functioning and quality of life.', 'timeFrame': '5 years'}]" 389,NCT04986189,"{'fullName': 'The Christie NHS Foundation Trust', 'class': 'OTHER'}",Lung Screening in People Cured of Hodgkin Lymphoma,COMPLETED,A single site non-commercial study in which people treated for Hodgkin lymphoma survivors will be invited to have a single low dose CT of thorax for lung cancer screening,"['Hodgkin Lymphoma', 'Lung Cancer']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'SCREENING', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DIAGNOSTIC_TEST', 'name': 'Low dose CT thorax', 'description': 'A low dose CT scan of the thorax to screen for lung cancer', 'armGroupLabels': ['Invitation to have a low dose CT thorax']}]","Inclusion Criteria: * Aged 18-80 * 5 year or more survivor of HL * Any of: a) treated with radiotherapy for HL with radiation dose to the lung b) an alkylating agent containing chemotherapy regimen known to increase lung cancer risk * Living within approximately 40 miles of The Christie Hospital Exclusion Criteria: * Previous diagnoses of malignant neoplasm of trachea, bronchus, lung, thymus or pleura * A current diagnosis of metastatic cancer * Residents in nursing homes or housebound * Had a CT scan of the thorax within the last 12 months * Pregnant women * Unable to provide consent",NA,ALL,NA,"[{'measure': 'Primary outcome: the lung cancer screening uptake rate among eligible individuals invited to the study', 'description': 'Feasibility outcome', 'timeFrame': 'Measured 6 months after recruitment begins when all interested participants have undergone a full eligibility check and those eligible have undergone their baseline low dose CT scan'}]","[{'measure': 'Decisional conflict scores in those who receive the decision aid measured using the validated Decisional Conflict Scale (score 0-100 with higher score representing higher levels of decisional conflict)', 'timeFrame': '14 months'}, {'measure': 'Preparedness for decision making in those who receive the decision aid using the validated Preparedness for Decision Making Scale (score 0-100 with higher score representing higher perceived levels of preparedness for decision making)', 'timeFrame': '4 months'}, {'measure': 'Lung cancer screening knowledge pre and post receipt of the decision aid measured using a novel scale (score 0-16 with higher score representing high levels of knowledge about lung cancer screening)', 'timeFrame': '4 months'}, {'measure': 'The proportion who have made an informed decision as measured by the Multidimensional Measure of Informed Choice', 'timeFrame': '6 and 12 months following CT scan'}, {'measure': 'Anxiety levels pre and post screening measured using the State Trait Anxiety Inventory -6 validated scale (score 6-24 with higher score representing higher levels of anxiety)', 'timeFrame': '2 months post CT scan'}, {'measure': 'Cancer worry severity levels pre and post screening measured using measured using 4-item Brief Worry Scale (score 4-20 with higher score representing higher cancer worry severity levels)', 'timeFrame': '12 months'}, {'measure': 'Cancer worry frequency measured using intrusive thoughts subscale from Revised impact of events scale (score 6-30 with higher score representing more frequent cancer worry)', 'timeFrame': '12 months'}, {'measure': 'Health related quality of life pre-screening then 6 and 12 months post screening measured using the validated SF-12 (short-form-12) scale (Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning)', 'timeFrame': '12 months'}, {'measure': 'The rates of smoking cessation 6 and 12 months following screening', 'timeFrame': '12 months'}, {'measure': 'The acceptability of undergoing screening measured using non-validated scale (Score 7-70 with higher score representing higher perceived acceptability of lung cancer screening)', 'timeFrame': '2 months'}, {'measure': 'Rates of normal, indeterminate and positive screening scans, reported according to definitions in the British Thoracic Society Pulmonary Nodule Management Guidelines', 'timeFrame': '12 months'}, {'measure': 'The type and prevalence of incidental findings on screening scans', 'timeFrame': '12 months'}, {'measure': 'The barriers and facilitators to undergoing lung cancer screening measured qualitatively and categorised according to the Theoretical Domains Framework', 'timeFrame': '12 months'}]" 390,NCT05348213,"{'fullName': 'Ruijin Hospital', 'class': 'OTHER'}",Novel Targeted Drugs Combined With R-ICE Regimen in Relapsed and Refractory Diffuse Large B-cell Lymphoma,RECRUITING,"A single-center, open, single-arm clinical study of the efficacy and safety of a novel targeted agent in combination with R-ICE in the treatment of relapsed and refractory diffuse Large B-cell lymphoma.",['Diffuse Large B Cell Lymphoma'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Zanubrutinib plus R-ICE', 'description': 'Zanubrutinib 160mg/bid PO D1-21 Rituximab 375mg/m2 IV D0 Ifosfamide 1500mg/m2 IV D1-3 Carboplatin AUC×\\[GFR(ml/min) + 25\\] mg/d,AUC=5 IV D2 Etoposide 100 mg/m2 IV D1-3', 'armGroupLabels': ['R-ICE+X'], 'otherNames': ['ZR-ICE']}, {'type': 'DRUG', 'name': 'Decitabine plus R-ICE', 'description': 'Decitabine 10mg/m2 IV D1-5 Rituximab 375mg/m2 IV D0 Ifosfamide 1500mg/m2 IV D1-3 Carboplatin AUC×\\[GFR(ml/min) + 25\\] mg/d,AUC=5 IV D2 Etoposide 100 mg/m2 IV D1-3', 'armGroupLabels': ['R-ICE+X'], 'otherNames': ['DR-ICE']}, {'type': 'DRUG', 'name': 'Chidamide plus R-ICE', 'description': 'Chidamide 20mg/d PO D1、4、8、11 Rituximab 375mg/m2 IV D0 Ifosfamide 1500mg/m2 IV D1-3 Carboplatin AUC×\\[GFR(ml/min) + 25\\] mg/d,AUC=5 IV D2 Etoposide 100 mg/m2 IV D1-3', 'armGroupLabels': ['R-ICE+X'], 'otherNames': ['CR-ICE']}, {'type': 'DRUG', 'name': 'Tofacitinib plus R-ICE', 'description': 'Tofacitinib 5mg/bid PO D1-10 Rituximab 375mg/m2 IV D0 Ifosfamide 1500mg/m2 IV D1-3 Carboplatin AUC×\\[GFR(ml/min) + 25\\] mg/d,AUC=5 IV D2 Etoposide 100 mg/m2 IV D1-3', 'armGroupLabels': ['R-ICE+X'], 'otherNames': ['TR-ICR']}, {'type': 'DRUG', 'name': 'Pomalidomide plus R-ICE', 'description': 'Pomalidomide 4mg/d PO D1-10 Rituximab 375mg/m2 IV D0 Ifosfamide 1500mg/m2 IV D1-3 Carboplatin AUC×\\[GFR(ml/min) + 25\\] mg/d,AUC=5 IV D2 Etoposide 100 mg/m2 IV D1-3', 'armGroupLabels': ['R-ICE+X'], 'otherNames': ['PR-ICE']}]","Inclusion Criteria: * DLBCL was confirmed by histology according to world Health Organization (WHO) disease classification (excluding primary central lymphoma and HIV-associated lymphoma); * There are evaluable lesions detected by PET/CT; * Life expectancy of more than 3 months; * Prior treatment with sufficient first-line anti-lymphoma therapy, no remission within 90 days of the last administration, or disease progression after sufficient first-line anti-lymphoma therapy, and no current anti-lymphoma therapy (≥2 weeks since the last anti-lymphoma therapy). Patients were allowed to receive hormone drugs or rituximab at least 1 week after enrollment for symptom control reasons; * 18≤ age ≤75 years old, male and female; * ECOG 0-2 points; * No serious organic lesions in the main organs, meeting the requirements of the following laboratory examination indicators (conducted within 7 days before treatment) : ① Absolute value of neutrophil count ≥1500/mm3; Platelet count ≥75,000/mm3 ② Total bilirubin ≤2× upper limit of normal value (ULN) ③ Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) (serum glutamate pyruvate aminotransferase \[SGPT\]) ≤3× upper limit of normal value (ULN) ④ the creatinine clearance rate was ≥60ml/min ⑤ No cardiac dysfunction * If the subject is of reproductive age and requires effective contraception, he/she agrees to comply with all contraceptive requirements: 1) there are fertile women have to decide, at the same time take two reliable contraceptive methods (a kind of high efficient contraceptives - tubal ligation, intrauterine contraceptive device, hormone (birth control pills, needle, patch, vaginal ring or implants) or partner vasectomy, another effective birth control method -- men or synthetic rubber condom, diaphragm or cervical cap). 2) Unless hysterectomy, effective contraception is required even if there is a history of infertility; * Fertile men must always use rubber or synthetic condoms when having sexual contact with fertile women during the use of this product and within 28 days of discontinuation of this product, even if they have successfully vasectomy; The subjects knew the characteristics of the disease, voluntarily joined the study, received treatment and follow-up, and the informed consent was signed by the subjects themselves or their guardians and impartial witnesses. Exclusion Criteria: * Pregnant or lactating women (lactating women must agree not to breastfeed while taking pomadomide); * Known hepatitis B (HBV), hepatitis C (HCV) infection (HBV infection refers to HBV-DNA \> detectable limit); And other acquired, congenital immune deficiency disorders, including but not limited to HIV-infected persons; * Subjects with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months; * Bone marrow failure, defined as ANC\<1500/mm3 or platelet \<75,000/mm3, unless hematologic changes are thought to be associated with lymphomas infiltrating the bone marrow; * Clinically significant heart disease, including unstable angina, acute myocardial infarction 6 months before enrollment, congestive heart failure (NYHA) heart function grade III or IV; Or left ventricular ejection fraction \<50%; * Lymphoma with central nervous system (CNS) involvement; * Those who are known to be allergic to the test drug ingredients; * Those who have received grade II or above surgery within three weeks before treatment; * Patients who have received organ transplants; * Has been diagnosed with or is being treated for malignancy other than lymphoma, except for: ① They have received therapeutic treatment and have not had known active disease malignancy for ≥5 years prior to enrollment; ② Basal cell carcinoma of the skin (except melanoma) without signs of disease after adequate treatment; ③ Cervical carcinoma in situ without signs of disease after adequate treatment. * With severe infection; * Substance abuse, medical, psychological, or social conditions that may interfere with the subjects' participation in the study or evaluation of the study results; The researchers deemed unsuitable for the group.",NA,ALL,NA,"[{'measure': 'Complete response rate after 3 cycle chemotherapy', 'description': 'Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.', 'timeFrame': 'At the end of cycle 3 (each cycle is 21 days)'}]","[{'measure': 'Objective remission rate after 3 cycle chemotherapy', 'description': 'Percentage of participants with complete response or partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.', 'timeFrame': 'At the end of cycle 3 (each cycle is 21 days)'}, {'measure': '2 year progression free survival', 'description': 'Progression-free survival was defined as the time from the date of randomization until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.', 'timeFrame': 'Baseline up to data cut-off (up to approximately 2 years)'}, {'measure': '2 year overall survival', 'description': 'Overall survival was defined as the time from the date of randomization to the date of death from any cause.', 'timeFrame': 'Baseline up to data cut-off (up to approximately 2 years)'}, {'measure': 'Chemotherapy-related adverse reactions', 'description': 'Any harmful reaction that occurs during the treatment of a disease according to the normal usage and dosage of a drug, which is unrelated to the purpose of treatment.', 'timeFrame': 'At the end of cycle 3 (each cycle is 21 days)'}]" 391,NCT00739206,"{'fullName': 'Sanofi', 'class': 'INDUSTRY'}",Study of SAR97276A in the Treatment of Uncomplicated and Severe Malaria in Adults and Children.,TERMINATED,"The objective of the study is to assess the efficacy and safety of SAR97276A in severe malaria in pediatric patients. Before treating pediatric patients with severe malaria, the efficacy and safety of SAR97276A will be first tested in adult patients, then in pediatric patients, with uncomplicated malaria. The safety and the concentration of SAR97276A in blood and plasma will be assessed in adult and pediatric patients.",['Malaria'],INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'SAR97276A', 'description': 'Dose based on body weight', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3']}]","Inclusion Criteria: * Adult patients with uncomplicated malaria will be enrolled in cohort 1 * Pediatric patients with uncomplicated malaria will be enrolled in cohort 2 * Pediatric patients with severe malaria will be enrolled in cohort 3 * Plasmodium falciparum malaria confirmed in blood smear * Fever within the last 24 hours. Exclusion Criteria: * Treatment with an antimalarial agent within 72h of screening * Severe concomitant disease * Pregnant or breast-feeding women * Women of child bearing potential not protected by an effective method of birth control The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",NA,ALL,NA,"[{'measure': 'Combination of fever clearance, general condition improvement at 48h parasite reduction at 72h and no need for rescue therapy at 72h', 'timeFrame': '3 initial days'}]","[{'measure': 'Parasite reduction', 'timeFrame': '3 initial days (72h)'}, {'measure': 'Safety assessment', 'timeFrame': '28 days post 1st study drug administration'}]" 392,NCT04240808,"{'fullName': 'University of Colorado, Denver', 'class': 'OTHER'}",Study of Feasibility and Safety of UCD19 Chimeric Antigen Receptor (CAR) T Cells in Adult Subjects With Relapsed/Refractory (R/R) B-Cell Non-Hodgkin's Lymphoma (B-NHL),COMPLETED,"This study will test whether immune cells modified to recognize B-cell non-Hodgkin lymphoma (NHL) can be successfully manufactured at the University of Colorado Anschutz and whether these cells can be administered with an acceptable safety profile. Adults who have been diagnosed with B-cell non-Hodgkin lymphoma (NHL) that has relapsed or no longer responds to chemotherapy (relapsed or refractory) may be eligible to participate in this study. The investigators will use participants own immune cells, called T cells, to kill the lymphoma. These T cells are involved in fighting infections and in some cases, can also kill cancer cells. The investigators will extract T cells from the participant's blood, modify the cells in a laboratory, and then return teh cells to the participant's body via intravenous (IV) injection. In the laboratory, the investigators will add a new gene into the T cells that allows the T cells to recognize and kill the lymphoma cells, and allows these modified cells to multiply and increase in numbers. To put the new gene into your T cells, the investigators will use a weakened virus. The virus is modified so that it cannot multiply or spread once the cells are infused.",['Non Hodgkin Lymphoma'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'UCD19 CAR T Cells', 'description': 'Lymphodepleting chemotherapy followed by infusion of UCD19 CAR T Cells (Lentiviral Vector \\[LV\\] Transduced Autologous Peripheral Blood Lymphocytes)', 'armGroupLabels': ['UCD19 CAR T Cells']}]","Inclusion Criteria: * Provision of signed and dated Informed Consent form. * Stated willingness to comply with all study procedures and availability for the duration of the parent study and the long-term follow-up observational study. * Male or non-pregnant, non-lactating females, aged 18 to 80 years. * Performance status according to the Eastern Cooperative Oncology Group ≤ 2. * Failed two or more lines of systemic therapy. * Unable to receive commercially available CD19 CAR T Cells. * Relapsed or primary refractory CD19 positive (i.e. CD19 expressing) B-NHL of the following types as confirmed by either flow cytometry, Immunohistochemistry (IHC), or both: * Diffuse large B-cell lymphoma (DLBCL) * Burkitt lymphoma * Intermediate lymphoma between Burkitt and DLBCL * Primary Mediastinal B-cell lymphoma (PMBL) * Follicular lymphoma * Mantle cell lymphoma (MCL) * Marginal zone lymphoma (MZL) * No available curative alternative treatment, as determined by primary treating oncologist. * No active Graft-versus-Host Disease (GvHD). * In women of childbearing potential, willingness to use effective means of birth control for 1 year after UCD19 CAR T Cell infusion. Exclusion Criteria: * Prior therapies: * Received monoclonal antibody therapy within 14 days of the apheresis; or * Received immunomodulatory drugs (lenalidomide, tyrosine kinase inhibitors) within 14 days of the apheresis; or * Received corticosteroids more than 7.5mg/day within 14 days of the apheresis (physiologic replacement allowed up until apheresis, as clinically indicated); or * Allogeneic hematopoietic stem cell transplant with 90 days (immunosuppressive therapy for at least 4 weeks) of apheresis; or * Donor lymphocyte infusion within 4 weeks of apheresis. * Cluster of differentiation 3 (CD3) count \<0.15 x 106 cells/mL * Severe psychiatric illness that could impede the patient's ability to provide informed consent and/or adhere to the parent protocol and/or the long-term follow-up protocol. * Active HIV (Acquired Immune Deficiency Syndrome) or history of HIV infection, as directed by schedule or if known. * Active Hepatitis B or Hepatitis C infection. * Diffusion capacity of the lungs for carbon monoxide \< 40% predicted prior to lymphodepletion. * Left ventricular ejection fraction \< 40% (evaluated by echocardiogram \[ECHO\] or Multigated Acquisition Scan \[MUGA\]) prior to lymphodepletion. * Transaminases \> 5x upper limit of normal prior to lymphodepletion. * Serum Bilirubin \> 4 mg/dL prior to lymphodepletion. * Serum Creatinine \> 1.6 mg/dL or measured creatinine clearance \< 50 mL/min prior to lymphodepletion. * Active infection that is unresponsive to antimicrobial therapy prior to lymphodepletion. * Females planning to become pregnant during the course of the study. * Unwillingness or inability to comply with study visits and study procedures for the entire duration of study participation. * Unsuitable for cellular therapy for any reason, in the opinion of the Investigator. * Any prior gene therapy, including prior CAR T cell therapy. * Active central nervous system (CNS) disease.",NA,ALL,NA,"[{'measure': 'Feasibility: Successful manufacture of UCD19 CAR T Cells, as determined by the number of successfully manufactured doses', 'description': ""The successful manufacture of UCD19 Chimeric Antigen Receptor (CAR) T Cells onsite meeting the IND-defined release criteria. Manufacture of UCD19 CAR T Cells will begin after enrollment and be completed within 1 month. Success will be determined by whether or not the participant's CAR T Cell count meets the target dose required for infusion at Day 0. The number of successfully manufactured doses will be reported."", 'timeFrame': 'Day 0 (infusion)'}, {'measure': 'Feasibility: Percent of Participants successfully infused with UCD19 CAR T Cells', 'description': 'The percent of participants who are able to receive an infusion of UCD19 CAR T cells.', 'timeFrame': 'Day 0 (infusion)'}, {'measure': 'Safety: Number of Participants Who Experience a Dose Limiting Toxicity (DLT) within 30 days after treatment', 'description': ""The number of subjects who receive UCD19 CAR T Cells and experience a DLT within 30 days after treatment, as defined herein using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5.0)."", 'timeFrame': 'Up to 30 Days Post-Infusion'}, {'measure': 'Safety: Percent of Participants Who Experience a Dose Limiting Toxicity (DLT) within 30 days after treatment', 'description': ""The percent of all subjects who receive UCD19 CAR T Cells and experience a DLT within 30 days after treatment, as defined herein using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE v5.0)."", 'timeFrame': 'Up to 30 Days Post-Infusion'}]","[{'measure': 'Efficacy: Overall response rate (Complete Response (CR)/Partial Response (PR)/Stable Disease (SD)) at 90 days', 'description': 'The number of participants with Complete Response (CR)/Partial Response (PR)/Stable Disease (SD) at 90 days post-treatment, as determined by the investigators.', 'timeFrame': '90 Days Post-Infusion'}, {'measure': 'Efficacy: Overall response rate (Complete Response (CR)/Partial Response (PR)/Stable Disease (SD)) at 6 Months', 'description': 'The number of participants with Complete Response (CR)/Partial Response (PR)/Stable Disease (SD) at 6 months post-treatment, as determined by the investigators.', 'timeFrame': '6 Months Post-Infusion'}, {'measure': 'Efficacy: Overall response rate (Complete Response (CR)/Partial Response (PR)/Stable Disease (SD)) at 1 Year', 'description': 'The number of participants with Complete Response (CR)/Partial Response (PR)/Stable Disease (SD) at 1 Year post-treatment, as determined by the investigators.', 'timeFrame': '1 Year Post-Infusion'}, {'measure': 'Efficacy: Rate of participants with Complete Response at 6 Months', 'timeFrame': '6 Months Post-Infusion'}, {'measure': 'Efficacy: Rate of participants with Complete Response at 1 Year', 'timeFrame': '1 Year Post-Infusion'}, {'measure': 'Efficacy: Median Duration of Remission at 1 Year', 'timeFrame': '1 Year Post-Infusion'}, {'measure': 'Efficacy: Progression Free Survival (PFS) at 1 Year', 'description': 'Number of participants with Progression Free Survival (PFS) at 1 year post-infusion.', 'timeFrame': '1 Year Post-Infusion'}, {'measure': 'Efficacy: Overall Survival (OS) at 1 Year', 'description': 'Number of participants surviving at 1 year post-infusion.', 'timeFrame': '1 Year Post-Infusion'}]" 393,NCT05797948,"{'fullName': 'The First Affiliated Hospital of Soochow University', 'class': 'OTHER'}",GZL Sequential CD19/CD22 CAR-T in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma,UNKNOWN,"This study intends to use Obinutuzumab, Zanubrutinib, and Lenalidomide sequential CD19/CD22 CAR-T in the treatment of Relapsed or Refractory B-cell Non-Hodgkin Lymphoma patients. The main purpose of this study is to explore a new treatment mode for R/R B-NHL patients and observe the efficacy and safety of this treatment regimen.",['Relapsed or Refractory B-cell Non-Hodgkin Lymphoma'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Obinutuzumab', 'description': 'Obinutuzumab Injection 1000mg ivgtt C1-C4 d1；', 'armGroupLabels': ['GZL sequential CD19/CD22 CAR-T'], 'otherNames': ['Gazyva']}, {'type': 'DRUG', 'name': 'Zanubrutinib', 'description': 'Zanubrutinib 160mg (2 capsules) oral bid；', 'armGroupLabels': ['GZL sequential CD19/CD22 CAR-T'], 'otherNames': ['Brukinsa']}, {'type': 'DRUG', 'name': 'Lenalidomide', 'description': 'Lenalidomide 25mg (1 capsule) oral C1-C4 d1-d10.', 'armGroupLabels': ['GZL sequential CD19/CD22 CAR-T'], 'otherNames': ['Anxian']}, {'type': 'DRUG', 'name': 'CD19/CD22 CAR-T', 'description': 'Targets of CAR-T cells are tandem CD19/CD22. 1 \\* 10 \\^ 7/kg dual-target CAR-T cells were reinfused with 10%, 30% and 60% of the total dose on d1, d2, d3 respectively.', 'armGroupLabels': ['GZL sequential CD19/CD22 CAR-T']}, {'type': 'DRUG', 'name': 'Azacitidine For Injection', 'description': 'Azacitidine For Injection 100mg i.h. d1-d5;', 'armGroupLabels': ['GZL sequential CD19/CD22 CAR-T'], 'otherNames': ['Anyve']}, {'type': 'DRUG', 'name': 'Fludarabine', 'description': 'Fludarabine 300mg/m2 ivgtt d3-d5;', 'armGroupLabels': ['GZL sequential CD19/CD22 CAR-T'], 'otherNames': ['Fludara']}, {'type': 'DRUG', 'name': 'Cyclophosphamide', 'description': 'Cyclophosphamide 300mg/m2 ivgtt d3-d5.', 'armGroupLabels': ['GZL sequential CD19/CD22 CAR-T'], 'otherNames': ['Endoxan']}]","Inclusion Criteria: 1. Histologically confirmed CD22 + and/or CD19 + aggressive B-cell non-Hodgkin lymphoma (NHL), including the following types as defined by World Health Organization (WHO) 2016: Diffuse large B-cell lymphoma (DLBCL); High grade B-cell lymphoma (HGBL); Primary mediastinal large B-cell lymphoma(PMBCL); T cell/histiocyte-rich large B-cell lymphoma (THRBCL); High grade follicular cell lymphoma Grade 3b (3bFL); Mantle cell lymphoma (MCL) except indolent; Other aggressive B-cell lymphomas. 2. Disease refractory to first-line therapy or early relapse within 12 months of last treatment. 3. Relapse or progressive disease (PD) ≥ 3 months after targeted CD19 therapy including CD19 CAR T cells or anti-CD19/anti-CD3. 4. Successful leukapheresis assessment and T-cell preculture. 5. Life expectancy \> 3 months. 6. Appropriate organ function: Creatinine \< 1.6 mg/dL (140 µmol/L) or creatinine clearance ≥ 60ml/min; Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) \< 3 × upper limit of normal; Bilirubin \< 2.0 mg/dL unless subject has Gilbert 's syndrome (\< 3.0 mg/dL); Pulmonary reserve ≤ Grade 1 dyspnea and SPO2 \> 91%; Cardiac ejection fraction ≥ 50% in the absence of oxygen, no evidence of pericardial effusion as determined by echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings. 7. Adequate bone marrow reserve was defined as: Absolute neutrophil count (ANC) \> 1000/mm3; Absolute lymphocyte count (ALC) ≥ 300/mm3; Platelet count ≥ 50,000/mm3. Hemoglobin \> 7.0 mg/dL. 8. Measurable or evaluable lesions according to ""IWG response criteria for malignant lymphoma"" (Cheson 2014). 9. Patients have the ability to understand and are willing to provide written informed consent. Exclusion Criteria: 1. severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine \> 3 times the upper limit of normal); 2. the presence of structural heart disease, and lead to clinical symptoms or abnormal heart function (NYHA ≥ 2); 3. uncontrolled active infection; 4. the presence of other tumors requiring treatment or intervention; 5. the current or expected need for systemic corticosteroid therapy; 6. pregnant or lactating women. 7. Other psychological conditions that prevent patients from participating in the study or signing informed consent; 8. According to the investigator 's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or fail to meet the requirements for participation in the study.",NA,ALL,NA,"[{'measure': 'Overall response rate (ORR) after GZL therapy', 'description': 'the rate of patients who achieved CR or PR after GZL therapy', 'timeFrame': 'At the end of GZL therapy (2-4 cycles, each cycle is 21days)'}, {'measure': 'Complete response rate (CRR) after CAR-T', 'description': 'the best rate of patients who achieved CR after CAR-T therapy', 'timeFrame': 'Within 3 months after CAR-T therapy'}, {'measure': 'Progression-free survival (PFS) after CAR-T', 'description': 'PFS will be assessed from the GZL combination therapy given to date of progression, relapse, death or end of follow-up.', 'timeFrame': ""up to 24 months after the end of last patient's treatment""}]","[{'measure': 'Incidence of treatment-emergent adverse events, treatment-related adverse events and serious adverse events', 'description': 'The safety and tolerability of the therapeutic regimen measured by the incidence of Treatment-Emergent Adverse Event.', 'timeFrame': 'Initiation of GZL therapy until 30 days after CAR-T therapy'}, {'measure': 'Overall response rate (ORR) after CAR-T', 'description': 'The best rate of patients who achieved CR or PR after CAR-T therapy', 'timeFrame': 'Within 3 months after CAR-T therapy'}, {'measure': 'Overall survival (OS) after CAR-T', 'description': 'OS will be assessed from the GZL combination therapy given to date of death or end of follow-up.', 'timeFrame': ""up to 24 months after the end of last patient's treatment""}, {'measure': 'Duration of Response(DOR) after CAR-T', 'description': 'DOR will be assessed from the date of CAR-T infusion to the date of progression, relapse, death or end of follow-up', 'timeFrame': ""up to 24 months after the end of last patient's treatment""}]" 394,NCT02589548,"{'fullName': 'Universidade Federal do Rio de Janeiro', 'class': 'OTHER'}",Brazilian Prospective Hodgkin Lymphoma Registry,UNKNOWN,"The study is a prospective registry of Hodgkin Lymphoma (HL) patients in Brazil. The purpose of the study is to gather clinical, epidemiologic and outcomes data on the treatment of HL, on the basis of records collected by key Brazilian institutions, through a centralized web-based registry of clinical data verified by central board of hematopathologists.","['Hodgkin Lymphoma', 'Hodgkin Disease']",OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}",NA,"Inclusion Criteria: * Previously untreated HL patients * Clinical data including baseline information on disease localization and laboratory parameters at staging, features of treatment adopted and assurance of follow-up updating for at least 5 years are requested * Written informed consent Exclusion Criteria: \-",Hodgkin Lymphoma patients,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Overall Survival', 'description': 'Overall Survival', 'timeFrame': '5 years'}]","[{'measure': 'Event Free survival', 'description': 'Event free survival', 'timeFrame': '5 years'}]" 395,NCT07126678,"{'fullName': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}","Fixed-Duration Zanubrutinib, Bendamustine, and Obinutuzumab (ZBG) in Treatment-Naïve Advanced Stage Follicular Lymphoma",RECRUITING,"This study investigates a fixed-duration regimen of zanubrutinib, bendamustine, and obinutuzumab (ZBG) in the treatment of treatment-naïve patients with advanced-stage follicular lymphoma. Patients will receive combination therapy with zanubrutinib, bendamustine, and obinutuzumab over 6 cycles, with each cycle lasting 28 days. The specific dosing schedule is as follows: Bendamustine 70 mg/m²: administered intravenously on Days 2-3 of Cycle 1, and on Days 1-2 of Cycles 2-6. Obinutuzumab 1000 mg: administered intravenously on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-6 (every 28-day cycle). Zanubrutinib 160 mg orally twice daily (bid), continuously throughout Cycles 1-6. Treatment is discontinued after 6 cycles, with no subsequent maintenance therapy. Primary endpoint is 2-year PFS. Secondary endpoints include: CR rate after 6 cycles, ORR after 3 and 6 cycles MRD-negative rate after 3 and 6 cycles, OS, safety and tolerability.","['Follicular Lymphoma', 'Treatment Naive']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'zanubrutinib, bendamustine, and obinutuzumab', 'description': 'Patients will receive combination therapy with zanubrutinib, bendamustine, and obinutuzumab over 6 cycles, with each cycle lasting 28 days. The specific dosing schedule is as follows: Bendamustine 70 mg/m²: administered intravenously on Days 2-3 of Cycle 1, and on Days 1-2 of Cycles 2-6. Obinutuzumab 1000 mg: administered intravenously on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-6 (every 28-day cycle). Zanubrutinib 160 mg orally twice daily (bid), continuously throughout Cycles 1-6.\n\nTreatment is discontinued after 6 cycles, with no subsequent maintenance therapy.', 'armGroupLabels': ['ZBG']}]","Inclusion Criteria: 1. Voluntary participation with signed informed consent; 2. Age ≥18 years and ≤75 years, regardless of gender; 3. Life expectancy ≥3 months; 4. ECOG performance status 0-2; patients with ECOG 3 may be enrolled only if their decline in performance status is disease-related and the investigator judges they may benefit from treatment; 5. Histologically confirmed diagnosis of grade I, II, or IIIa follicular lymphoma (FL), treatment-naïve, stage III-IV disease, and meeting treatment criteria (GELF criteria); 6. Measurable and/or evaluable lymphoma lesions; 7. Adequate bone marrow reserve: absolute neutrophil count (ANC) \>1.0×10⁹/L or platelets \>75×10⁹/L, unless cytopenia is deemed related to bone marrow infiltration by lymphoma and the investigator believes it may recover; 8. Liver function: AST (SGOT), ALT (SGPT) ≤2.5×ULN (without liver involvement) or ≤5×ULN (with liver involvement); total bilirubin (TBIL) ≤ULN; serum creatinine (CRE) ≤1.5×ULN; 9. Creatinine clearance ≥30 mL/min (calculated by Cockcroft-Gault formula); 10. Ability to comply with study visit schedules and other protocol requirements; 11. All patients of childbearing potential must agree to use effective contraception during the study and for 24 months after treatment cessation; women of childbearing potential must have a negative urine pregnancy test before treatment initiation. Exclusion Criteria: 1. Grade IIIb FL or transformed FL; 2. Received lymphoma-directed therapy within 2 weeks prior to enrollment; 3. Any severe medical condition, including but not limited to: * Poorly controlled hypertension (defined as failure to achieve control despite lifestyle modifications and treatment with at least 3 maximally tolerated antihypertensive drugs \[including diuretics\] for ≥4 weeks, or requiring ≥4 antihypertensive drugs for adequate control); * Uncontrolled congestive heart failure (NYHA class 3 \[moderate\] or 4 \[severe\]) within 6 months prior to screening; * Left ventricular ejection fraction (LVEF) \<50%; * Symptomatic coronary artery disease (e.g., chest pain, palpitations, fatigue) or requiring medication; * Severe bradycardia (heart rate \<40 bpm), hypotension, dizziness, or syncope; patients with arrhythmia history require cardiac evaluation; * Active bacterial, viral, fungal, or other infections (except for nail fungal infections) or major infections within 2 weeks before the first dose of study drug; * Moderate to severe liver disease (Child-Pugh B or C); * Active bleeding within 2 months before screening or clinically significant bleeding tendency per investigator judgment; * Pulmonary conditions impairing function (e.g., pulmonary fibrosis, drug-induced pneumonitis) deemed intolerable by the investigator; * Any psychiatric or cognitive impairment that may compromise understanding of informed consent, protocol compliance, or study adherence; 4. Known active hepatitis C virus (HCV) infection; other acquired/congenital immunodeficiency disorders, including HIV infection; 5. Central nervous system (CNS) involvement by lymphoma; 6. Diagnosis or treatment for malignancies other than lymphoma, except: * Malignancies treated with curative intent and no evidence of disease for ≥5 years before enrollment; * Adequately treated basal cell carcinoma (excluding melanoma) with no evidence of disease; * Adequately treated cervical carcinoma in situ with no evidence of disease; 7. Hypersensitivity to any study drug; 8. Pregnant or breastfeeding women; 9. History of stroke or intracranial hemorrhage within 6 months before enrollment; 10. Requiring anticoagulation with warfarin or equivalent vitamin K antagonists; 11. Requiring chronic use of strong CYP3A inhibitors; 12. Administration of live attenuated vaccines within 4 weeks before study entry.",NA,ALL,NA,"[{'measure': '2-year PFS', 'description': '2-year progression-free survival (PFS)', 'timeFrame': '2 year'}]","[{'measure': 'CR Rate', 'description': 'complete remission rate', 'timeFrame': 'At the end of Cycle 6 (each cycle is 28 days)'}, {'measure': 'ORR', 'description': 'objective remission rate', 'timeFrame': 'At the end of Cycle 3 and 6 (each cycle is 28 days)'}, {'measure': 'MRD', 'description': 'minimal residue rate', 'timeFrame': 'At the end of Cycle 6 (each cycle is 28 days)'}, {'measure': 'OS', 'description': 'Overall survival', 'timeFrame': 'From date of randomization until the date of death from any cause, assessed up to 100 months'}, {'measure': 'Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE', 'description': '* Adverse events and serious adverse events\n* Treatment-related adverse events leading to dose adjustments, dose interruptions, delays, and/or study drug discontinuation', 'timeFrame': '2 year'}]" 396,NCT05559008,"{'fullName': 'Ruijin Hospital', 'class': 'OTHER'}",A Umbrella Study in R/R PTCL Guided by Molecular Subtypes,UNKNOWN,"This is a multicenter, prospective, open-label, interventional umbrella study to evaluate the efficacy and safety of targeted therapies guided by molecular subtypes in patients with relasped or refractory peripheral T-cell lymphoma.",['Peripheral T Cell Lymphoma'],INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Azacitidine Injection', 'description': 'Azacitidine Injection，SC and Dasatinib PO will be administered in T1 subtypes', 'armGroupLabels': ['T1 subtypes based on next generation sequencing results', 'T2 subtypes based on next generation sequencing results']}, {'type': 'DRUG', 'name': 'Dasatinib', 'description': 'Azacitidine Injection，SC and Dasatinib PO will be administered in T1 subtypes', 'armGroupLabels': ['T1 subtypes based on next generation sequencing results']}, {'type': 'DRUG', 'name': 'Linperlisib', 'description': 'Azacitidine Injection，SC and Linperlisib PO will be administered in T2 subtypes', 'armGroupLabels': ['T2 subtypes based on next generation sequencing results']}, {'type': 'DRUG', 'name': 'Tucidinostat', 'description': 'Tucidinostat PO and SHR2554 PO will be administered in T3.1 subtypes', 'armGroupLabels': ['T3.1 subtypes based on next generation sequencing results']}, {'type': 'DRUG', 'name': 'SHR2554', 'description': 'Tucidinostat PO and SHR2554 PO will be administered in T3.1 subtypes', 'armGroupLabels': ['T3.1 subtypes based on next generation sequencing results']}, {'type': 'DRUG', 'name': 'Camrelizumab', 'description': 'Camrelizumab and Apatinib will be administered in T3.2 subtypes', 'armGroupLabels': ['T3.2 subtypes based on next generation sequencing results']}, {'type': 'DRUG', 'name': 'Apatinib', 'description': 'Camrelizumab and Apatinib will be administered in T3.2 subtypes', 'armGroupLabels': ['T3.2 subtypes based on next generation sequencing results']}]","Inclusion Criteria: 1. Histologically-confirmed Peripheral T-cell lymphoma (without central nervous system involvement) 2. Relapsed or refractory disease after first line treatment 3. Availability of archival or freshly collected tumor tissue before study enrollment 4. Evaluable lesion by PET-CT or CT scan 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 6. Life expectancy greater than or equal to (\>/=) 3 months 7. Informed consent Exclusion Criteria: 1. Patients with central nervous system (CNS) lymphoma 2. History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix 3. Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases 4. Laboratory measures meet the following criteria at screening (unless caused by lymphoma): Neutrophils\<1.0×10\^9/L Platelets\<75×10\^9/L (Platelets\<50×10\^9/L in case of bone marrow involvement) ALT or AST is 2.5 times higher than the upper limits of normal (ULN), AKP and bilirubin are 1.5 times higher than the ULN. Creatinine is 1.5 times higher than the ULN. 5. HIV-infected patients 6. Active hepatitis infection 7. Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol 8. Pregnant or lactation 9. Other medical conditions determined by the researchers that may affect the study For T3.2 should exclude patiens with active autoimmune disease",NA,ALL,NA,"[{'measure': 'Overall response rate', 'description': 'Percentage of participants with complete and partial response was determined on the basis of investigator assessments according to 2014 Lugano criteria.', 'timeFrame': 'End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6）(each cycle is 28 days)'}]","[{'measure': 'Complete response rate', 'description': 'Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.', 'timeFrame': 'End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6）(each cycle is 28 days)'}, {'measure': 'Progression-free survival', 'description': 'Progression-free survival was defined as the time from the date of enrollment until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.', 'timeFrame': 'Baseline up to data cut-off (up to approximately 2 years)'}, {'measure': 'Overall survival', 'description': 'Overall survival was defined as the time from the date of enrollment to the date of death from any cause.', 'timeFrame': 'Baseline up to data cut-off (up to approximately 2 years)'}, {'measure': 'Duration of response', 'description': 'Duration of response was defined as the time from the date of favorable response until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria', 'timeFrame': 'Baseline up to data cut-off (up to approximately 2 years)'}, {'measure': 'Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0', 'description': 'An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.', 'timeFrame': 'From enrollment to study completion, a maximum of 4 years'}]" 397,NCT06745076,"{'fullName': 'University of Washington', 'class': 'OTHER'}",Personalized Reduction of Chemotherapy Intensity Through ctDNA Evaluation for the Treatment of Patients With Advanced Hodgkin Lymphoma,RECRUITING,"This phase II trial tests how well personalized reduction of chemotherapy (nivolumab, doxorubicin, vinblastine and dacarbazine) based on circulating tumor deoxyribonucleic acid (ctDNA) evaluation works for treating patients with Hodgkin lymphoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Chemotherapy drugs, such as nivolumab, doxorubicin, vinblastine and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Many types of tumors tend to lose cells or release different types of cellular products including their DNA, which is referred to as ctDNA, into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids and, based on the result, assign patients to a reduced number of chemotherapy treatments or the standard number of chemotherapy treatments. Using ctDNA to assign a personalized reduction of chemotherapy may be effective in treating patients with advanced Hodgkin lymphoma.","['Advanced Hodgkin Lymphoma', 'Classic Hodgkin Lymphoma', 'Lugano Classification Stage III Hodgkin Lymphoma AJCC v8', 'Lugano Classification Stage IV Hodgkin Lymphoma AJCC v8']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'PROCEDURE', 'name': 'Biospecimen Collection', 'description': 'Undergo blood sample collection', 'armGroupLabels': ['Arm I (MRD negative)', 'Arm II (MRD positive)'], 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection']}, {'type': 'PROCEDURE', 'name': 'Computed Tomography', 'description': 'Undergo CT scan', 'armGroupLabels': ['Arm I (MRD negative)', 'Arm II (MRD positive)'], 'otherNames': ['CAT', 'CAT Scan', 'Computed Axial Tomography', 'Computerized Axial Tomography', 'Computerized axial tomography (procedure)', 'Computerized Tomography', 'Computerized Tomography (CT) scan', 'CT', 'CT Scan', 'tomography']}, {'type': 'DRUG', 'name': 'Dacarbazine', 'description': 'Given IV', 'armGroupLabels': ['Arm I (MRD negative)', 'Arm II (MRD positive)'], 'otherNames': ['4-(Dimethyltriazeno)imidazole-5-carboxamide', '5-(Dimethyltriazeno)imidazole-4-carboxamide', 'Asercit', 'Biocarbazine', 'Dacarbazina', 'Dacarbazina Almirall', 'Dacarbazine - DTIC', 'Dacatic', 'Dakarbazin', 'Deticene', 'Detimedac', 'DIC', 'Dimethyl (triazeno) imidazolecarboxamide', 'Dimethyl Triazeno Imidazol Carboxamide', 'Dimethyl Triazeno Imidazole Carboxamide', 'dimethyl-triazeno-imidazole carboxamide', 'Dimethyl-triazeno-imidazole-carboximide', 'DTIC', 'DTIC-Dome', 'Fauldetic', 'Imidazole Carboxamide', 'Imidazole Carboxamide Dimethyltriazeno', 'WR-139007']}, {'type': 'DRUG', 'name': 'Doxorubicin', 'description': 'Given IV', 'armGroupLabels': ['Arm I (MRD negative)', 'Arm II (MRD positive)'], 'otherNames': ['Adriablastin', 'Hydroxydaunomycin', 'Hydroxyl Daunorubicin', 'Hydroxyldaunorubicin']}, {'type': 'PROCEDURE', 'name': 'Echocardiography Test', 'description': 'Undergo echocardiography', 'armGroupLabels': ['Arm I (MRD negative)', 'Arm II (MRD positive)'], 'otherNames': ['EC', 'Echocardiography']}, {'type': 'PROCEDURE', 'name': 'Multigated Acquisition Scan', 'description': 'Undergo MUGA scan', 'armGroupLabels': ['Arm I (MRD negative)', 'Arm II (MRD positive)'], 'otherNames': ['Blood Pool Scan', 'Equilibrium Radionuclide Angiography', 'Gated Blood Pool Imaging', 'Gated Heart Pool Scan', 'MUGA', 'MUGA Scan', 'Multi-Gated Acquisition Scan', 'Radionuclide Ventriculogram Scan', 'Radionuclide Ventriculography', 'RNV Scan', 'RNVG', 'SYMA Scanning', 'Synchronized Multigated Acquisition Scanning']}, {'type': 'BIOLOGICAL', 'name': 'Nivolumab', 'description': 'Given IV', 'armGroupLabels': ['Arm I (MRD negative)', 'Arm II (MRD positive)'], 'otherNames': ['ABP 206', 'BCD-263', 'BMS 936558', 'BMS-936558', 'BMS936558', 'CMAB819', 'MDX 1106', 'MDX-1106', 'MDX1106', 'NIVO', 'Nivolumab Biosimilar ABP 206', 'Nivolumab Biosimilar BCD-263', 'Nivolumab Biosimilar CMAB819', 'ONO 4538', 'ONO-4538', 'ONO4538', 'Opdivo']}, {'type': 'PROCEDURE', 'name': 'Positron Emission Tomography', 'description': 'Undergo PET scan', 'armGroupLabels': ['Arm I (MRD negative)', 'Arm II (MRD positive)'], 'otherNames': ['Medical Imaging, Positron Emission Tomography', 'PET', 'PET Scan', 'Positron emission tomography (procedure)', 'Positron Emission Tomography Scan', 'Positron-Emission Tomography', 'PT']}, {'type': 'DRUG', 'name': 'Vinblastine', 'description': 'Given IV', 'armGroupLabels': ['Arm I (MRD negative)', 'Arm II (MRD positive)'], 'otherNames': ['Vincaleucoblastine', 'VLB']}, {'type': 'OTHER', 'name': 'Questionnaire', 'description': 'Complete questionnaire', 'armGroupLabels': ['Arm I (MRD negative)', 'Arm II (MRD positive)']}]","Inclusion Criteria: * Classical Hodgkin lymphoma without prior systemic therapy, stage 3 or 4. Corticosteroids for symptom relief are allowed * Measurable disease per Lugano criteria * Patients must be appropriate candidates for 6 cycles of combination chemotherapy including an anthracycline * No evidence of active central nervous system lymphoma * Eastern Cooperative Oncology Group (ECOG) performance status 0-2 * Absolute neutrophil count (ANC) ≥ 500/mm\^3. Growth factor and/or transfusion support is permissible to stabilize participant prior to study treatment if needed. There is no lower limit to cytopenias if related to bone marrow involvement or underlying Hodgkin lymphoma * Platelets ≥ 50,000/mm\^3 (without transfusion or growth factor support). Growth factor and/or transfusion support is permissible to stabilize participant prior to study treatment if needed. There is no lower limit to cytopenias if related to bone marrow involvement or underlying Hodgkin lymphoma * Hemoglobin ≥ 8 g/dL. Growth factor and/or transfusion support is permissible to stabilize participant prior to study treatment if needed. There is no lower limit to cytopenias if related to bone marrow involvement or underlying Hodgkin lymphoma * Serum creatinine \< 1.5 x upper limits of normal (ULN) or creatinine clearance greater than 30/ml per minute by Cockcroft Gault formula * Total bilirubin ≤ 1.5 times upper limit of normal OR direct bilirubin ≤ ULN for participants with total bilirubin levels \> 1.5 × ULN). Patients with Gilbert Syndrome and direct bilirubin \< 1.5 x ULN or confirmatory UGT1A1 testing are allowed to enroll * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal (≤ 5 × ULN for participants with liver involvement) * Patients must be age 18 or older * All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines * Patients must be anticipated to complete all planned study therapy * Male patients must agree to use an adequate method of barrier contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy * Female patients of childbearing potential must have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * Female patients of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year Exclusion Criteria: * Patients known positive for HIV or infectious hepatitis type B or C with a detectable viral load may not participate. Hepatitis B/C, and HIV testing are not required at screening unless mandated by local health authority. * Patients living with HIV, on anti-viral treatment and undetectable viral load are allowed * Patients with positive hepatitis (hep) B core antibody are allowed on study with an undetectable viral load and appropriate prophylaxis * Patients with positive hepatitis C antibody are allowed with undetectable viral load * Pregnant or nursing women. Men or women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method * Patients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, breast or cervical cancer in situ, or other cancer from which the patient has been disease-free for 2 years or greater, unless approved by the principal investigator * Patients who have other medical conditions that would contraindicate treatment with aggressive chemotherapy (including active infection, uncontrolled hypertension, congestive heart failure, unstable angina pectoris, or myocardial infarction within the past 6 months, uncontrolled arrhythmia, severe pulmonary disease or requirement of supplemental oxygen) * Active ischemic heart disease (eg. myocardial infarction within 6 months) or congestive heart failure (eg. left ventricular ejection fraction \< 50%) * Concurrent use of other anti-cancer agents or experimental treatments * Known current or prior autoimmune disease with the exception of vitiligo. Patients with a history of autoimmune thyroid disease on a stable dose of thyroid hormone are also allowed * Active or prior history of pneumonitis/interstitial lung disease that required corticosteroids * Current use of supplemental oxygen * Is known to have received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of trial treatment. Other non-live or live-attenuated vaccines (eg. COVID, Influenza) are allowed",NA,ALL,NA,"[{'measure': 'Progression free survival (PFS) in patients with undetectable minimal residual disease (MRD) after 2 cycles of treatment', 'timeFrame': 'At 1 year'}]","[{'measure': 'PFS in MRD positive patients after 2 cycles of treatment', 'timeFrame': 'At 1 year'}, {'measure': 'PFS in the overall cohort', 'timeFrame': 'At 2 years'}, {'measure': 'Best response', 'timeFrame': 'Up to 5 years'}]" 398,NCT03758989,"{'fullName': 'University of Rochester', 'class': 'OTHER'}",A Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma,RECRUITING,"The overarching goals of this study are to measure levels of circulating tumor DNA (ctDNA) in patients with early stage diffuse large B cell lymphoma (DLBCL), to assess the change in ctDNA during treatment in order to prospectively identify markers of treatment failure, and to use ctDNA as a future tool for response adapted therapy.",['DLBCL'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Rituximab Prednisone', 'description': 'A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma', 'armGroupLabels': ['Baseline PET']}, {'type': 'DRUG', 'name': 'Cyclophosphamide', 'description': 'A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma', 'armGroupLabels': ['Baseline PET']}, {'type': 'DRUG', 'name': 'Doxorubicin', 'description': 'A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma', 'armGroupLabels': ['Baseline PET']}, {'type': 'DRUG', 'name': 'Vincristine', 'description': 'A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma', 'armGroupLabels': ['Baseline PET']}, {'type': 'DRUG', 'name': 'Prednisone', 'description': 'A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma', 'armGroupLabels': ['Baseline PET']}]","Inclusion Criteria: * Previously untreated limited stage non bulky DLBCL; defined as limited stage by routine staging criteria in lymphoma involving FDG-PET and bone marrow biopsies (the Lugano criteria)\[21\] * Patients with grade 3B follicular lymphoma and transformed indolent lymphoma are included * Ages ≥ 18 * Measurable disease, assessable by radiographic examination with FDG-PET showing involvement * Access to archived or fresh/frozen tumor biopsies * No uncontrolled medical comorbidities * Adequate cardiac function (EF \> or equal to 50%), no unstable angina * Adequate renal function (GFR \> 60) * Adequate liver function (liver function tests should be no greater than 2 x upper limit of normal) including normal bilirubin levels, no greater than 2 x upper limit of normal unless patient has a history of Gilbert's disease * Adequate marrow reserves as indicated by complete blood count in the judgment of the treating investigator Exclusion Criteria: * Pregnancy, positive serum HCG within 28 days of enrollment, or breast-feeding * Bulky disease greater than 10 cm in any dimension",NA,ALL,NA,"[{'measure': 'Correlation between fluorodeoxyglucose positron emission tomography (FDG-PET) and MRD, as measured by circulating tumor plasma DNA (ctDNA) in patients with early stage diffuse large B cell lymphoma (DLBCL).', 'timeFrame': '5 years'}]","[{'measure': 'PET CR rate', 'timeFrame': '5 years'}, {'measure': 'Change in minimal residual disease (MRD) from baseline to time of re-staging PET', 'timeFrame': '5 years'}, {'measure': 'Re-staging Deauville score of 1, 2, or 3 (negative PET scan)', 'timeFrame': '5 years'}, {'measure': 'Following 3 cycles of R-CHOP, if PET scan demonstrates complete response, defined by Deauville score of 1, 2, or 3 (negative PET scan), radiation therapy will not be required moving forward', 'timeFrame': '5 years'}, {'measure': 'Toxicity rates using CTCAE v4.03', 'timeFrame': '5 years'}, {'measure': 'Changes in quality of life using PROMIS scale 10 scale will be administered to patients at the time of diagnosis, at the conclusion of all therapy, and at 12 month intervals', 'timeFrame': '5 years'}, {'measure': 'Overall survival (OS) of patients through two years of follow-up.', 'timeFrame': 'Patients will be assessed by physical exam and routine bloodwork every 3 months in the 1st year after conclusion of treatment, and every 6 months in the second year following treatment. They will be assessed yearly during years 3, 4 and 5.'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': 'From time of baseline scan through two years of follow-up'}]" 399,NCT07489989,"{'fullName': 'Chinese PLA General Hospital', 'class': 'OTHER'}",Enhancing CAR-T Cell Therapy Efficacy in B-cell Lymphoma Via Chidamide and PD-1 Inhibitor Combination.,RECRUITING,"B-cell non-Hodgkin lymphoma (B-NHL) is one of the most common malignancies in China, with approximately 100,000 new cases diagnosed annually. Although immunochemotherapy, novel small-molecule targeted agents, and hematopoietic stem cell transplantation have significantly improved outcomes for patients with B-cell malignancies, nearly half of patients still experience drug resistance and relapse. In high-risk aggressive B-cell lymphoma, the 5-year survival rate remains around 50%. Previous clinical guidelines recommended autologous hematopoietic stem cell transplantation as first-line consolidation therapy for high-risk patients; however, multiple studies have demonstrated that even after autologous transplantation, nearly half of these patients relapse and succumb to the disease. Chimeric antigen receptor T (CAR-T) cell therapy has achieved objective response rates of approximately 50% in relapsed/refractory lymphoma, particularly in B-cell subtypes. Nevertheless, limitations such as tumor immune antigen escape, immunosuppressive effects of the tumor microenvironment (TME) on CAR-T cells, and T-cell exhaustion continue to restrict the durability and efficacy of CAR-T-mediated cytotoxicity. This study evaluates the incorporation of chidamide (an HDAC inhibitor) combined with a PD-1 inhibitor as maintenance therapy following CAR-T cell immunotherapy in patients with relapsed/refractory high-risk aggressive B-cell lymphoma. By implementing an ""early intervention"" strategy-prompt administration of CAR-T cell therapy after induction treatment for relapsed/refractory high-risk aggressive B-cell lymphoma-and subsequent maintenance with chidamide plus a PD-1 inhibitor, the approach aims to reduce relapse rates and improve overall survival. These strategies are intended to address the current unmet clinical need for improved outcomes in relapsed/refractory high-risk aggressive B-cell lymphoma, where prognosis remains poor despite existing therapies.",['Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL)'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'CAR-T Cell Therapy + Chidamide and PD-1 Inhibitor Maintenance', 'description': 'Patients will receive maintenance therapy consisting of Chidamide combined with a PD-1 inhibitor following CAR-T cell infusion. This intervention is designed to upregulate target antigen expression on tumor cells and mitigate antigen escape. By synergistically enhancing the cytotoxic activity and persistence of CAR-T cells, the regimen aims to reduce the risk of relapse and improve long-term clinical outcomes', 'armGroupLabels': ['CAR-T + Chidamide/PD-1 Maintenance in R/R High-Risk DLBCL']}]","Inclusion Criteria \- The patient must meet all of the following inclusion criteria: 1. Histologically or cytologically confirmed CD19 and/or CD22-positive large B-cell lymphoma (LBCL) according to the WHO 2016 classification, including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), and related entities, with one of the following: 1. Partial response (PR) after induction therapy with a standard first-line chemotherapy regimen (e.g., R-CHOP for 4-6 cycles); or 2. Complete response (CR) after standard first-line induction therapy, but with high-risk features present at initial diagnosis. 2. Presence of high-risk features at initial diagnosis, defined as at least one of the following: 1. High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements (""double-hit"" or ""triple-hit"") confirmed by fluorescence in situ hybridization (FISH); 2. High-grade B-cell lymphoma with 11q aberration (Burkitt-like lymphoma with 11q aberration); 3. International Prognostic Index (IPI) score of 2-5; age-adjusted IPI (aa-IPI) score of 2-3; or National Comprehensive Cancer Network-IPI (NCCN-IPI) score of 4-8; 4. CD5 positivity by immunohistochemistry; 5. Dual expression of MYC and BCL2 by immunohistochemistry (recommended thresholds: MYC ≥ 40% and BCL2 ≥ 50%); 6. TP53 mutation detected by gene sequencing; 7. Molecular subtype MCD or N1 by next-generation sequencing (NGS); 8. Relapsed/refractory B-cell lymphoma, meeting one of criteria ①-④ plus criterion ⑤: * Less than 50% tumor reduction or disease progression after ≥4 cycles of standardized chemotherapy; * Relapse within 6 months after achieving CR with standard regimen; * ≥2 relapses after CR; * Relapse after hematopoietic stem cell transplantation; * Must have received adequate prior therapy, including at least an anti-CD20 monoclonal antibody and anthracycline-containing combination chemotherapy. 3. Age 18 to 85 years, male or female. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 5. Expected survival of \>3 months from the date of signing informed consent. 6. Hemoglobin (HGB) ≥60 g/L (transfusion permitted). 7. Absolute neutrophil count (ANC) ≥1,000/μL and platelet count ≥45,000/μL. 8. Adequate hepatic, renal, cardiac, and pulmonary function, meeting \*\*all\*\* of the following: 1. Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN) (except for patients with Gilbert's syndrome); 2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; 3. Serum creatinine (Cr) ≤1.5 × ULN \*\*or\*\* creatinine clearance (CCr) ≥60 mL/min (estimated by Cockcroft-Gault formula); 4. Left ventricular ejection fraction (LVEF) ≥50% by echocardiogram (ECHO), with no pericardial effusion and no clinically significant arrhythmias; 5. Baseline oxygen saturation by pulse oximetry \>92% on room air; 6. No clinically significant pleural effusion. Exclusion Criteria: * Patients eligible for CAR-T cell immunotherapy must \*\*NOT\*\* meet any of the following exclusion criteria: 1. Prior treatment with any form of chimeric antigen receptor (CAR) T-cell therapy or other genetically modified T-cell therapy. 2. History of severe immediate-type hypersensitivity reaction to aminoglycoside antibiotics or other drugs. 3. Known history of human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection, or any uncontrolled active systemic infection requiring intravenous antibiotics. (Active HBV infection is defined as meeting \*\*all\*\* of the following: a) HBV DNA ≥ 2000 IU/mL; b) ALT ≥ 2 × upper limit of normal (ULN); c) hepatitis not attributable to other causes such as the underlying disease or medications. Patients with active HBV at initial diagnosis who achieve non-active HBV status after adequate anti-HBV treatment may be eligible under continued effective anti-HBV therapy.) 4. Non-hematologic malignancy-related hepatic or renal impairment, including any of the following: ALT \> 3 × ULN, AST \> 3 × ULN, total bilirubin (TBIL) \> 2 × ULN, or creatinine clearance \< 30 mL/min. 5. History of myocardial infarction, percutaneous coronary intervention (including coronary angioplasty or stenting), unstable angina, active arrhythmia, or other clinically significant cardiovascular disease within the past 12 months. 6. Any other serious medical condition that, in the opinion of the investigator, may interfere with the study treatment or increase risk to the patient (e.g., poorly controlled diabetes, active peptic ulcer disease, severe respiratory or circulatory disease, severe autoimmune disease, congenital immunodeficiency, uncontrolled severe infection, or other conditions with high risk of clinical deterioration). 7. History of severe immediate-type hypersensitivity reaction to any medication required during the treatment process, or history of severe allergy to biologics (including antibiotics). 8. Female patients who are pregnant or breastfeeding (preconditioning chemotherapy regimen poses potential risk to the fetus or infant). 9. In the opinion of the investigator, the patient is unlikely to comply with all required study visits, procedures, or long-term follow-up; has poor willingness or ability to participate and cooperate fully; or has insufficient compliance (as judged by the patient and/or family). 10. History of other malignancy, unless the patient has been disease-free and has received no antitumor therapy for at least 3 years (exceptions: non-melanoma skin cancer, and carcinoma in situ of the cervix, bladder, or breast). 11. Receipt of a live vaccine within 6 weeks prior to initiation of the preconditioning regimen. 12. Major surgery (excluding lymph node biopsy) within the past 14 days, or anticipated need for major surgery during the treatment period. 13. Any other serious physical or psychiatric illness, or clinically significant laboratory abnormality, that may increase the risk associated with study participation, interfere with the interpretation of study results, or render the patient unsuitable for participation in the opinion of the investigator.",NA,ALL,NA,"[{'measure': '1-year progression free survival rate (1-year-PFSR)', 'timeFrame': '1 years after treatment'}]","[{'measure': 'overall survival (OS)', 'timeFrame': '2 years after treatment'}, {'measure': 'progression free survival (PFS)', 'timeFrame': '2 years after treatment'}, {'measure': 'time to progression (TTP)', 'timeFrame': '2 years after treatment'}, {'measure': 'disease free survival (DFS)', 'timeFrame': '2 years after treatment'}, {'measure': 'duration of response (DOR)', 'timeFrame': '2 years after treatment'}, {'measure': 'event free survival (EFS)', 'timeFrame': '2 years after treatment'}, {'measure': 'recurrence rate', 'timeFrame': '2 years after treatment'}, {'measure': 'safety', 'description': 'Evaluate post-CAR-T cell infusion adverse events by analyzing the number of cases, incidence rates, and severity grades of the following key immunotherapy-related toxicities as recorded:\n\nCytokine release syndrome (CRS) Immune effector cell-associated neurotoxicity syndrome (ICANS) Hematologic toxicity Organ toxicity\n\nand other immune-related adverse events associated with CAR-T cell therapy.', 'timeFrame': '2 years after treatment'}, {'measure': 'CAR-T cell kinetic parameters in peripheral blood', 'description': 'CAR gene copy number Peak CAR-T cell concentration (Cmax) Time to peak concentration (Tmax) Area under the concentration-time curve from day 0 to day 28 (AUC₀-₂₈d / AUC₂₈d)', 'timeFrame': '2 years after treatment'}]" 400,NCT06290050,"{'fullName': 'Takeda', 'class': 'INDUSTRY'}",A Study of the Interaction of Other Drugs With TAK-279 in Healthy Adults,COMPLETED,"The main aim of this study is to find out how several doses of TAK-279 affects the body of healthy adults and processes midazolam and repaglinide (pharmacokinetics or PK). Another aim is to learn about the side effects of TAK-279 and how well it is tolerated when given to healthy adults either alone or together with midazolam or repaglinide. During the study, participants will need to stay at the clinic for 19 days. Blood samples will be taken at several timepoints during the study. The study drug will be given by mouth (orally).",['Healthy Volunteers'],INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Midazolam', 'description': 'Midazolam syrup.', 'armGroupLabels': ['Treatment A: Midazolam 2 mg', 'Treatment C + Treatment A: TAK-279 Dose 1 + Midazolam 2 mg']}, {'type': 'DRUG', 'name': 'Repaglinide', 'description': 'Repaglinide tablets.', 'armGroupLabels': ['Treatment B: Repaglinide 0.5 mg', 'Treatment C + Treatment B: TAK-279 Dose 1 + Repaglinide 0.5 mg']}, {'type': 'DRUG', 'name': 'TAK-279', 'description': 'TAK-279 capsules.', 'armGroupLabels': ['Treatment C + Treatment A: TAK-279 Dose 1 + Midazolam 2 mg', 'Treatment C + Treatment B: TAK-279 Dose 1 + Repaglinide 0.5 mg']}]","Inclusion Criteria: Participants must fulfill all of the following inclusion criteria to be eligible for participation in the study: 1. Continuous non-smoker who has not used nicotine and tobacco containing products for at least 3 months prior to the first dosing based on subject self-reporting. 2. Body mass index (BMI) greater than or equal to (\>=) 18.0 and less than or equal to (\<=) 32.0 kilogram per square meter (kg/m\^2) at the screening visit. 3. Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, and electrocardiograms (ECGs), as deemed by the investigator or designee, including the following: * Seated blood pressure (BP) is \>=90/40 millimeter of mercury (mmHg) and \<=140/90 mmHg at the screening visit. * Seated pulse rate (PR) is \>=40 beats per minute (bpm) and \<=99 bpm at the screening visit. * ECG findings considered normal or not clinically significant by the investigator or designee at the screening visit. * Estimated glomerular filtration rate (eGFR) \>=80 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) at the screening visit. * Liver function tests including Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Alkaline phosphatase (ALP), and total bilirubin \<= ULN at the screening visit and at check-in. Exclusion Criteria: Participants must not be enrolled in the study if they meet any of the following criteria: 1. Fasting glucose \>125 milligram per deciliter (mg/dL) at the screening visit. 2. Has a history or presence of any of the following: * Active infection or febrile illness within 7 days prior to first dosing, as assessed by the investigator or designee. * Symptoms suggestive of systemic or invasive infection requiring hospitalization or treatment within 8 weeks prior to first dosing. * Chronic or recurrent bacterial disease, including but not limited to chronic pyelonephritis or cystitis, chronic bronchitis/pneumonitis, osteomyelitis, or chronic skin ulcerations/infections or fungal infections (except superficial nailbed mycosis). * An infected joint prosthesis unless that prosthesis has been removed or replaced greater than 60 days prior to first dosing. * Opportunistic infections (example, Pneumocystis jirovecii pneumonia, histoplasmosis, Coccidiomycosis) exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix is not exclusionary. * Cancer or lymphoproliferative disease within 5 years prior to first dosing, with the exception of successfully treated nonmetastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix is not exclusionary. * Known or suspected condition/illness that is consistent with compromised immunity, including but not limited to any identified congenital or acquired immunodeficiency; splenectomy. * Solid organ transplant. * Diabetes or prior episode(s) of hypoglycemia. 3. Has history or presence of alcoholism and/or drug abuse within the past 2 years prior to first dosing, as determined by the investigator or designee. 4. History or presence of hypersensitivity or idiosyncratic reaction to the study drugs. 5. History or presence of ventricular dysfunction or risk factors for Torsades de Pointes (example, heart failure, cardiomyopathy, family history of Long QT Syndrome). 6. Positive urine drug or alcohol results at the screening visit or check-in. 7. Unable to refrain from or anticipates the use of: * Any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements including any CYP3A4 and CYP2C8 inhibitors, beginning 14 days prior to the first dosing. * Any drugs known to be inducers of CYP3A4 and CYP2C8 enzymes and/or P-gp, including St. John's Wort, for 28 days prior to the first dosing. Appropriate sources (example, Flockhart Table™) including the product label for midazolam and repaglinide will be consulted to confirm lack of PK/pharmacodynamic interaction with the study drugs. 8. Has made a donation of blood or had significant blood loss within 56 days prior to first dosing. 9. Has made a plasma donation within 7 days prior to first dosing. 10. Participated in another clinical study within 30 days prior to first dosing. The 30 day window will be derived from the date of the last dosing in the previous study to Day 1 of Period 1 of the current study. 11. Herpes infections: * Has active herpes virus infection, including herpes zoster or herpes simplex 1 and 2 (demonstrated on physical examination and/or medical history) at the screening visit or Day 1 of Period 1. * Has history of serious herpetic infection that includes any episode of disseminated disease, multidermatomal herpes zoster virus, herpes encephalitis, ophthalmic herpes, or recurrent herpes zoster (defined as 2 episodes within 2 years). 12. Positive results for non-herpetic viral diseases at the screening visit: * Hepatitis C virus (HCV) antibody and a positive confirmatory test result for HCV Ribonucleic acid (RNA) (nucleic acid test or \[Polymerase chain reaction\] PCR); * Hepatitis B surface antigen (HBsAg+), hepatitis B virus DNA, or Hepatitis B core antibody (HBcAb+) with positive hepatitis B virus Deoxyribonucleic acid (DNA); * Human immunodeficiency virus (HIV). 13. Positive results for TB at the screening visit or has the following: * Has history of active TB infection, regardless of treatment status. * Has signs or symptoms of active TB (including but not limited to chronic fever, chronic productive cough, night sweats, or weight loss) as judged by the investigator or designee. * Has evidence of Latent tuberculosis infection (LTBI) as evidenced by a positive QuantiFERON TB Gold (QFT) result OR 2 indeterminant QFT results and does not have documentation of appropriate LTBI prophylaxis. Participants remains eligible if he or she can provide documentation of prior and complete treatment for LTBI (appropriate in duration and type per current local country guidelines). * Has had any imaging study prior to the screening visit, including x-ray, chest computed tomography, magnetic resonance imaging, or other chest imaging suggesting evidence of current active or a history of active TB.",NA,ALL,NA,"[{'measure': 'Cmax: Maximum Observed Plasma Concentration for Midazolam and Repaglinide When Administered Alone and With TAK-279', 'timeFrame': 'Period 1-Midazolam Alone: Day 1 predose up to 24 hours (h) postdose; Repaglinide Alone: Day 2 predose up to 16 h postdose; Period 2-Midazolam, With TAK-279: Day 14 predose up to 24 h postdose; Repaglinide with TAK-279:Day 15 predose up to 16 h postdose'}, {'measure': 'AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Midazolam and Repaglinide When Administered Alone and With TAK-279', 'timeFrame': 'Period 1-Midazolam Alone: Day 1 predose up to 24 hours (h) postdose; Repaglinide Alone: Day 2 predose up to 16 h postdose; Period 2-Midazolam, With TAK-279: Day 14 predose up to 24 h postdose; Repaglinide with TAK-279:Day 15 predose up to 16 h postdose'}, {'measure': 'AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for Midazolam and Repaglinide When Administered Alone and With TAK-279', 'timeFrame': 'Period 1-Midazolam Alone: Day 1 predose up to 24 hours (h) postdose; Repaglinide Alone: Day 2 predose up to 16 h postdose; Period 2-Midazolam, With TAK-279: Day 14 predose up to 24 h postdose; Repaglinide with TAK-279:Day 15 predose up to 16 h postdose'}]","[{'measure': 'Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESI)', 'description': 'An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an AE with an onset that occurs after receiving study drug. AESI (serious or nonserious) includes infections that are severe or serious; opportunistic; herpes virus; active tuberculosis (TB); or any infection requiring intravenous systemic therapy or immunomodulatory therapy, Creatine phosphokinase (CPK) elevation Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or higher (severe) greater than (\\>) 5\\* upper limit of normal (ULN), Liver injury, MACE (Major adverse cardiovascular events), Gastrointestinal perforation, Thromboembolic events, Malignancies including all malignancies, Nonmelanoma skin cancer (NMSC), and excluding NMSC and Lymphoma.', 'timeFrame': 'From Day 1 of Period 1 up to 14 days after the last dose of TAK-279 in Period 2 (up to 29 days)'}]" 401,NCT04670874,"{'fullName': 'City of Hope Medical Center', 'class': 'OTHER'}",Quality of Life in Cutaneous Lymphoma Patients Using the Skindex29,RECRUITING,"This study assesses the quality of life in patients with cutaneous lymphoma diagnosis as it relates to their personal, clinical, and therapeutic information using the Skindex29 questionnaire and also assesses patients' understanding of their diagnosis and need for resources related to their care. Cutaneous lymphomas are a rare type of blood cancers (non-Hodgkin lymphoma) that present in the skin. The information gained from this study, may help researchers improve quality of life in cutaneous lymphoma patients.",['Cutaneous Lymphoma'],OBSERVATIONAL,"{'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}","[{'type': 'OTHER', 'name': 'Quality-of-Life Assessment', 'description': 'Complete quality of life questionnaire', 'armGroupLabels': ['Observational (quality of life questionnaire)'], 'otherNames': ['Quality of Life Assessment']}, {'type': 'OTHER', 'name': 'Questionnaire Administration', 'description': 'Complete quality of life questionnaire', 'armGroupLabels': ['Observational (quality of life questionnaire)']}]","Inclusion Criteria: * Agreement to participate in the research study * Presumed or confirmed diagnosis of CL",Patients with presumed or confirmed diagnosis of CL who present to the Multidisciplinary CL Clinic at City of Hope,ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Skindex-29 domain (symptom, function, and emotion) scores', 'description': ""Skindex-29 domain (symptom, function, and emotion) scores will be summarized by diagnosis group, demographics, disease characteristics, treatment/intervention, and disease response/clinical outcome. Cross-sectional and longitudinal summary of the data will be performed. Descriptive statistics for continuous data (mean, standard deviation, median, range, etc.) will be used to summarize quality of life. Descriptive and summary statistics or continuous and categorical data (counts and percentages) will be used to summarize continuous or categorical demographics or other patient/disease characteristics respectively. Graphical representation of the data will be used when helpful. Descriptive statistics for categorical data will be used to assess patients' understanding of their cancer diagnosis and need for resources based on the survey."", 'timeFrame': 'At completion of questionnaire'}, {'measure': 'Burden of pruritus', 'description': ""Burden of pruritus as measured by pruritus scale will be summarized by diagnosis group, demographics, disease characteristics, treatment/intervention, and disease response/clinical outcome. Cross-sectional and longitudinal summary of the data will be performed. Descriptive statistics for continuous data (mean, standard deviation, median, range, etc.) will be used to summarize pruritus score. Descriptive and summary statistics or continuous and categorical data (counts and percentages) will be used to summarize continuous or categorical demographics or other patient/disease characteristics respectively. Graphical representation of the data will be used when helpful. Descriptive statistics for categorical data will be used to assess patients' understanding of their cancer diagnosis and need for resources based on the survey."", 'timeFrame': 'At completion of questionnaire'}]",NA 402,NCT01563874,"{'fullName': 'National Institutes of Health Clinical Center (CC)', 'class': 'NIH'}",Proteomic-Based Profiling of Lymphomas: Chromatin Proteomics; Composition and Modification of Histone and Non-Histone Chromosomal Proteins,COMPLETED,"BACKGROUND: Lymphomas are comprised of a diversity of tumors with different pathologic and clinical features. While distinct differences in gene expression profiles have been elucidated in different lymphomas, there has been inconsistent correlation with the few published proteomic studies. Greater insights into the biology of lymphomas may be achieved by integrating current genomic information with additional studies focused on the interrelationships in tumors of the patterns of chromatin protein expression, chromatin protein modification, and RNA expression profiling (both within bulk tumor and within specific microscopic tumor niches accessible by microdissection and cell sorting approaches). OBJECTIVES: The goals of this protocol are to identify the global levels of all histones (including variant histones) and non-histone chromosomal proteins, and to measure the relative levels of most known covalent modifications on histone and non-histone chromosomal proteins. For a limited number of cases illustrative of selected pathological entities, we propose to map the genome-wide distribution of those modifications judged to be biochemically instructive. ELIGIBILITY: This work will involve the analysis of a broad panel of lymphoma and lymphoid samples, which were previously procured under multiple protocols at the NIH, and for which there is excess tissue available for research. We also request permission to extend this analysis to surplus materials to be accrued under existing protocols, upon completion of all superseding diagnostic tests and medical/scientific studies. The criteria for inclusion in this study are subsumed under the enveloping protocols. The number of cases to be included is dependent upon the size of these protocols; because statistical significance improves with increasing numbers. We hope to include up to 300 cases. DESIGN: Lysates from surplus samples will be prepared and arrayed onto microarrays. These arrays will be probed with panels of protein and modification specific antibodies. The antibody reactivity will be quantified and samples will be subjected to statistical analysis, especially hierarchical clustering to correlate patterns of reactivity with clinical and histological features. Representative cases for which sufficient surplus tissue remains will be subjected to ChIP-Seq to map the distribution of modifications across the genome.","['Lymphoma', 'Lymphoid Hyperplasia']",OBSERVATIONAL,"{'observationalModel': 'CASE_ONLY', 'timePerspective': 'RETROSPECTIVE'}",NA,"* INCLUSION CRITERIA: We propose to analyze the histone and chromatin modifications from several classes of patients: 1) patients bearing the diagnosis of lymphoid malignancies made or confirmed at the NIH. Solid tumors of the lymphoid system would constitute the major source of these tissues, however tissue samples from patients with malignant diagnoses that involve circulating malignant cells (Mycosis fungoides, Sezary syndrome, etc.) would also be appropriate for analysis; 2) non-malignant lymphoid tissue obtained for diagnostic purposes or normal lymphoid tissue obtained incidentally during surgery (in all cases only residual and surplus tissue will be used, only with the express approval of the appropriate clinical investigator(s). Primarily included among these tissues would be hyperplastic lymphoid tissue especially tonsils. Other hyperplastic and non-malignant lymph node samples showing proliferative responses or sinus histiocytosis would also be appropriate to compare with the malignant samples. EXCLUSION CRITERIA: Only cases with sufficient frozen biopsy material from initial biopsy and/or biopsies at relapse of disease to obtain adequate tissues lysates for proteomic-based analyses and in selected cases for ChIPSeq following analysis of RNA expression as performed under superseding protocols. In some cases, for some histone modifications, it may be possible to recover appropriate tissue from paraffin embedded blocks, however no such samples will be used for this study without prior consultation and approval from the clinical investigator and hematopathologist associated with the superseding protocols. Samples from minors \<18 years old will not be used.","This study relies entirely on the retrospective analysis of previously acquired material or on the analysis of incidentally acquired materially. The archived samples to be studied were accrued under the following protocols: 93-C-0133, 97-C-0178, 00C-0050, 00-C-0133, 01-C-0038, 01-C-0129, 03-C-0096, 04-C-0055, 05-C-0031, 05-C-170, 05-C-0252 and 94-H-0010.@@@@@@",ALL,NON_PROBABILITY_SAMPLE,"[{'measure': 'Global histone protein expressioon and covalent modification profiles from lymphoid cells', 'description': 'global histone protein expression and covalent modification profiles from lymphoid cells', 'timeFrame': 'End of study'}]",NA 403,NCT07389616,"{'fullName': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}",A Clinical Trial of Cidabenamine Plus Azacitidine to Prevent Post-Transplant Progression in High-Risk Peripheral T-Cell Lymphoma,RECRUITING,"This study is a single-center, single-arm, prospective, phase II clinical trial designed to evaluate the efficacy and safety of Cidabenamine combined with Azacitidine as maintenance therapy following allogeneic peripheral blood hematopoietic stem cell transplantation in patients with high-risk peripheral T-cell lymphoma.During the screening/baseline period, informed consent will be obtained, and inclusion/exclusion criteria will be verified. The study plans to enroll 40 patients in each group. Enrolled patients will undergo demographic and medical history data collection, along with assessments including vital signs, physical examination, PET-CT, bone marrow aspiration smear, flow cytometry, lymphoid gene rearrangement, and bone marrow pathology.",['Peripheral T Cell Lymphoma'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Cidabenamine, Azacitidine', 'description': 'In the study, Cidabenamine combined with Azacitidine are used as maintenance therapy following allogeneic peripheral blood hematopoietic stem cell transplantation in patients with high-risk peripheral T-cell lymphoma.', 'armGroupLabels': ['Cidabenamine combined with Azacitidine']}]","Inclusion Criteria: 1. Aged 18 to 70 years, male or female. 2. Diagnosis of peripheral T-cell lymphoma (PTCL) according to the 2022 WHO criteria, including pathological subtypes such as PTCL not otherwise specified (PTCL-NOS), anaplastic large cell lymphoma (ALCL), and angioimmunoblastic T-cell lymphoma (AITL), but excluding hepatosplenic T-cell lymphoma; and meeting at least one of the following high-risk criteria: ① Stable Disease (SD) at the time of transplantation; ② Relapse after autologous hematopoietic stem cell transplantation (any disease status); ③ ≥ Partial Response 1 (PR1). 3. Underwent allogeneic peripheral blood hematopoietic stem cell transplantation for PTCL, with no restriction on donor type. 4. Presence of complete donor chimerism in the bone marrow (T-cell chimerism \>95%). 5. ECOG performance status of 0 or 1. 6. Hematological function meeting the following requirements: ① Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L; ② Platelet count (PLT) ≥ 50 × 10⁹/L. 7. Patients must have the ability to understand and be willing to participate in the study and must provide signed informed consent. Exclusion Criteria: 1. Known hypersensitivity to hypomethylating agents or Cidabenamine. 2. Presence of grade II or higher active acute Graft-versus-Host Disease (GVHD). 3. Presence of moderate or more severe chronic GVHD. 4. Any unstable systemic disease, including but not limited to: unstable angina, cerebrovascular accident or transient ischemic attack (within 3 months prior to screening), myocardial infarction (within 3 months prior to screening), congestive heart failure (New York Heart Association \[NYHA\] Class ≥ III), status post pacemaker implantation, severe arrhythmia requiring pharmacological treatment, hepatic, renal, or metabolic disease, or pulmonary hypertension. 5. Active, uncontrolled infection, evidenced by any of the following: infection-related hemodynamic instability, worsening or new-onset infectious symptoms/signs, radiologic evidence of a new infectious focus, or persistent fever without localizing symptoms/signs where infection cannot be ruled out. 6. Known HIV infection. 7. Active Hepatitis B (HBV) or active Hepatitis C (HCV) requiring antiviral therapy. 8. History of an autoimmune disease. 9. Pregnant or lactating women. 10. Concurrent participation in another interventional clinical trial and receiving other investigational drugs.",NA,ALL,NA,"[{'measure': 'overall survival (OS)', 'description': 'The probability of survival at years, measured from the date of transplantation to death from any cause. Patients who are still alive at the time of analysis will be censored on the last follow-up date.', 'timeFrame': 'up to 1 years for the 1y-OS and up to 2 years for the 2y-OS'}]","[{'measure': 'progression-free survival (PFS)', 'description': 'Progression-Free Survival (PFS) is defined as the time from transpalntation until the first occurrence of disease progression or death from any cause, whichever occurs earlier.', 'timeFrame': 'up to 1 years for the 1y-PFS and up to 2 years for the 2y-PFS'}, {'measure': 'non-relapse mortality (NRM)', 'description': 'Death occurring after transplantation due to causes other than disease relapse, such as infection, organ toxicity, or transplantation-related complications. Deaths from any cause in the absence of prior relapse are considered events for this endpoint.', 'timeFrame': 'up to 1 year'}, {'measure': 'cumulative relapse rates (CIR)', 'description': 'The cumulative probability of disease progression (including relapse or progression of the primary disease) within 1 years after transplantation, with non-progression-related death treated as a competing event.', 'timeFrame': 'up to 1 years for the 1y-CIR and up to 2 years for the 2y-CIR'}]" 404,NCT00323076,"{'fullName': 'AHS Cancer Control Alberta', 'class': 'OTHER'}","[18]F-FAZA PET Imaging Study in Patients With Cancer of the Head & Neck, Lung, Renal Cell, Brain, Lymphoma and Neuroendocrine Tumours",TERMINATED,"Positron Emission Tomography (PET) is a Nuclear Medicine procedure that uses positron emitting radiolabeled tracer molecules to visualize biological activity. The presence of hypoxia (low oxygen) is associated with poor prognosis in a variety of tumour types and treatment strategies targeting hypoxic cells have been developed. The PET tracer \[18\]F-FAZA can identify hypoxic areas, and changes in uptake during treatment may predict tumour response.","['Renal Cell Carcinoma', 'Neuroendocrine Tumours']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': '18F-FAZA PET Imaging', 'description': 'Phase I: 110-600 MBq per injection. A single injection of 18F-FAZA and PET scan will be permitted per patient.\n\nPhase II: 110-600 MBq per injection. Up to three separate injections of 18F-FAZA and PET scans will be permitted per patient.', 'armGroupLabels': ['1']}]","Inclusion Criteria: * Male or female greater than or equal to 16 years of age. * If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required. * Patients with known primary or suspected metastatic squamous cell carcinoma of the head and neck, non-small cell or small cell carcinoma of the lung, lymphoma, GBM (greater than or equal to 3 glioma), neuroendocrine tumours, or renal cell carcinoma with at least one lesion \>1 cm in diameter.",NA,ALL,NA,"[{'measure': 'Phase I: demonstrate the safety of 18F-FAZA manufactured at the Edmonton Radiopharmaceutical Centre/Edmonton PET Centre. Phase II: determine the general biodistribution pattern of18F-FAZA.', 'description': 'Phase I: Pre-injection and post-imaging vital signs, blood haematology and blood chemistry, adverse event collection.\n\nPhase II: The location and relative uptake of normal and abnormal 18F-FAZA biodistribution patterns will be determined.', 'timeFrame': 'Phase I: 2 years, Phase II: 5 years'}]","[{'measure': 'Determine the relative tumour uptake of 18F-FAZA', 'description': 'Measure relative uptake scores (RUS) and tumour to background ratios (T/B) and correlate this uptake to disease progression, disease-free survival, overall survival and response to treatment over 12 months of follow-up.', 'timeFrame': '5 years'}, {'measure': 'Confirm the safety of 18F-FAZA manufactured at the Edmonton Radiopharmaceutical Centre/Edmonton PET Centre', 'description': 'Adverse event collection', 'timeFrame': '5 years'}]" 405,NCT00345189,"{'fullName': 'Biogen', 'class': 'INDUSTRY'}",Study of Oral CNF2024 (BIIB021) in Advanced Solid Tumors,COMPLETED,"This is an open-label, multicenter, dose-escalation, safety, pharmacokinetics, and pharmacodynamics study.","['Tumors', 'Lymphoma']",INTERVENTIONAL,"{'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'CNF2024', 'description': 'CNF2024 capsules administered orally following 2 schedules:\n\n* starting dose of 25 mg, twice a week for 3 weeks out of a 4-week course (Schedule 1) or\n* starting dose of 600 mg twice a week for 4 weeks out of a 4-week course (without drug holidays; Schedule 2).\n\nTreatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Dose escalation proceeds according to the predetermined scheme until the stopping dose is reached due to a dose limiting toxicity (DLT) occurring during the first 4-week course of treatment.', 'armGroupLabels': ['Dosing Schedule 1', 'Dosing Schedule 2'], 'otherNames': ['Advanced Solid Tumors']}]","Inclusion Criteria: * Histologically or cytologically confirmed solid tumor which has failed standard therapies (surgery, radiotherapy, endocrine therapy, chemotherapy) or for which effective therapy is not available * At least 18 years of age * Hematology: Absolute neutrophil count (ANC) \> 1500 cells/mm3, platelet count \> 100,000 cells/mm3 and hemoglobin \>= 9 gm/L * Hepatic: Bilirubin \< 1.5 X upper limit of normal (ULN); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 2.5 X ULN. Patients with known liver metastases or liver neoplasms: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 5.0 X ULN. * Renal: Serum creatinine levels \< 2.0 mg/dL or creatinine clearance \> 60 mL/min * Coagulation: international normalized ratio (INR) \< 1.5 times normal * Adrenal: Normal plasma cortisol and adrenocorticotropic hormone (ACTH) levels * Normal electrocardiogram (ECG) with QTc \<= 450 msec for men and \<= 470 msec for women * Estimated life expectancy of at least 3 months as determined by the Investigator * Eastern Cooperative Oncology Group (ECOG) performance status \<= 2 * Male and female patients of childbearing potential must practice effective double-barrier contraception during the study and continue contraception for 3 months after their last dose of study drug. Male patients must agree to not have intercourse with pregnant or nursing women during the study and for 3 months after their last dose of study drug, unless using double-barrier contraception. The only exceptions to double-barrier contraception are: Patient or partner is surgically sterile,female patient is postmenopausal for at least 1 year before screening or patient abstains from sexual intercourse, at the discretion of the Investigator Exclusion Criteria: * Pregnant or nursing women, women of child-bearing age not using reliable means of contraception. * Radiotherapy or chemotherapy within the previous 28 days. Recovery to Grade 1 or less from chemotherapy-induced toxic effect, except alopecia, is required. * Participation in any investigational drug study within 28 days prior to CNF2024 administration * Active infection requiring intravenous antibiotic treatment * Patients with second malignancy requiring active treatment (except hormonal therapy) * Concurrent severe or uncontrolled medical disease (i.e., systemic infection, diabetes, hypertension, coronary artery disease, congestive heart failure) * Active symptomatic fungal, bacterial and/or viral infection including active HIV or viral (A, B or C) hepatitis * Problems with swallowing or malabsorption * Chronic diarrhea (excess of 2-3 stools/day above normal frequency) * Gastrointestinal diseases including gastritis, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis * Major surgery of the stomach or small intestine * Adrenal dysfunction \> Grade 2 * Patients with diabetes (your doctor will discuss if you are eligible for this study)",NA,ALL,NA,"[{'measure': 'To determine the maximum tolerated dose (MTD)', 'timeFrame': 'Dose escalation will proceed according to the predetermined scheme until the stopping dose (dose > MTD) is reached due to dose limiting toxicities (DLT) occurring during the first 4-week course of treatment.'}, {'measure': 'To determine the safety profile', 'timeFrame': 'Study duration'}, {'measure': 'pharmacokinetic profile', 'timeFrame': 'Dosing period'}, {'measure': 'effect on pharmacodynamic biomarkers', 'timeFrame': 'Dosing period'}, {'measure': 'antitumor activity', 'timeFrame': 'At screening and after every 2 courses'}]",NA 406,NCT04139304,"{'fullName': 'AIDS Malignancy Consortium', 'class': 'NETWORK'}",A Study of Daratumumab and Dose-Adjusted EPOCH in Plasmablastic Lymphoma,RECRUITING,"This feasibility trial studies how well daratumumab in combination with dose-adjusted etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (DA-EPOCH) works in treating patients with newly diagnosed stage I-IV plasmablastic lymphoma. Plasmablastic lymphoma cells have high levels of a protein called CD38. Daratumumab is a monoclonal antibody that specifically targets CD38 expressing cells, and may help the body's immune system attack the cancer and interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving daratumumab may enhance the effectiveness of a standard chemotherapy (DA-EPOCH) in patients with plasmablastic lymphoma.","['Plasmablastic Lymphoma', 'Ann Arbor Stage I Diffuse Large B-Cell Lymphoma', 'Ann Arbor Stage II Diffuse Large B-Cell Lymphoma', 'Ann Arbor Stage III Diffuse Large B-Cell Lymphoma', 'Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma']",INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Cyclophosphamide', 'description': 'Given IV', 'armGroupLabels': ['Treatment (daratumumab, DA-EPOCH)'], 'otherNames': ['(-)-Cyclophosphamide', '2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate', 'Carloxan', 'Ciclofosfamida', 'Ciclofosfamide', 'Cicloxal', 'Clafen', 'Claphene', 'CP monohydrate', 'CTX', 'CYCLO-cell', 'Cycloblastin', 'Cycloblastine', 'Cyclophospham', 'Cyclophosphamid monohydrate', 'Cyclophosphamide Monohydrate', 'Cyclophosphamidum', 'Cyclophosphan', 'Cyclophosphane', 'Cyclophosphanum', 'Cyclostin', 'Cyclostine', 'Cytophosphan', 'Cytophosphane', 'Cytoxan', 'Fosfaseron', 'Genoxal', 'Genuxal', 'Ledoxina', 'Mitoxan', 'Neosar', 'Revimmune', 'Syklofosfamid', 'WR- 138719']}, {'type': 'BIOLOGICAL', 'name': 'Daratumumab', 'description': 'Given IV', 'armGroupLabels': ['Treatment (daratumumab, DA-EPOCH)'], 'otherNames': ['Anti-CD38 Monoclonal Antibody', 'Darzalex', 'HuMax-CD38', 'JNJ-54767414']}, {'type': 'DRUG', 'name': 'Doxorubicin', 'description': 'Given IV', 'armGroupLabels': ['Treatment (daratumumab, DA-EPOCH)'], 'otherNames': ['Adriablastin', 'Hydroxydaunomycin', 'Hydroxyl Daunorubicin', 'Hydroxyldaunorubicin']}, {'type': 'DRUG', 'name': 'Doxorubicin Hydrochloride', 'description': 'Given IV', 'armGroupLabels': ['Treatment (daratumumab, DA-EPOCH)'], 'otherNames': ['5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI)', 'ADM', 'Adriacin', 'Adriamycin', 'Adriamycin Hydrochloride', 'Adriamycin PFS', 'Adriamycin RDF', 'ADRIAMYCIN, HYDROCHLORIDE', 'Adriamycine', 'Adriblastina', 'Adriblastine', 'Adrimedac', 'Chloridrato de Doxorrubicina', 'DOX', 'DOXO-CELL', 'Doxolem', 'Doxorubicin HCl', 'Doxorubicin.HCl', 'Doxorubin', 'Farmiblastina', 'FI 106', 'FI-106', 'hydroxydaunorubicin', 'Rubex']}, {'type': 'DRUG', 'name': 'Etoposide', 'description': 'Given IV', 'armGroupLabels': ['Treatment (daratumumab, DA-EPOCH)'], 'otherNames': ['Demethyl Epipodophyllotoxin Ethylidine Glucoside', 'EPEG', 'Lastet', 'Toposar', 'Vepesid', 'VP 16', 'VP 16-213', 'VP-16', 'VP-16-213', 'VP16']}, {'type': 'DRUG', 'name': 'Prednisone', 'description': 'Given PO', 'armGroupLabels': ['Treatment (daratumumab, DA-EPOCH)'], 'otherNames': ['.delta.1-Cortisone', '1, 2-Dehydrocortisone', 'Adasone', 'Cortancyl', 'Dacortin', 'DeCortin', 'Decortisyl', 'Decorton', 'Delta 1-Cortisone', 'Delta-Dome', 'Deltacortene', 'Deltacortisone', 'Deltadehydrocortisone', 'Deltasone', 'Deltison', 'Deltra', 'Econosone', 'Lisacort', 'Meprosona-F', 'Metacortandracin', 'Meticorten', 'Ofisolona', 'Orasone', 'Panafcort', 'Panasol-S', 'Paracort', 'Perrigo Prednisone', 'PRED', 'Predicor', 'Predicorten', 'Prednicen-M', 'Prednicort', 'Prednidib', 'Prednilonga', 'Predniment', 'Prednisone Intensol', 'Prednisonum', 'Prednitone', 'Promifen', 'Rayos', 'Servisone', 'SK-Prednisone']}, {'type': 'DRUG', 'name': 'Vincristine', 'description': 'Given IV', 'armGroupLabels': ['Treatment (daratumumab, DA-EPOCH)'], 'otherNames': ['LEUROCRISTINE', 'VCR', 'Vincrystine']}, {'type': 'DRUG', 'name': 'Vincristine Sulfate', 'description': 'Given IV', 'armGroupLabels': ['Treatment (daratumumab, DA-EPOCH)'], 'otherNames': ['Kyocristine', 'Leurocristine sulfate', 'Leurocristine, sulfate', 'Oncovin', 'Vincasar', 'Vincosid', 'Vincrex', 'Vincristine, sulfate']}]","Inclusion Criteria: * Participants must have histologically and immunophenotypically (via at least a core or ideally, incisional or excisional biopsy) documented plasmablastic lymphoma. * Stage II-IV disease (Ann Arbor staging criteria) or stage I disease with elevated lactate dehydrogenase (LDH) or bulky tumor (\> 7.5 cm). * Known HIV status. At most 7 HIV negative patients will be allowed on the study. Once 7 HIV negative patients have been enrolled, future enrollment will allow only HIV positive patients. Participants may be HIV positive, with documentation of HIV infection by means of any one of the following: * Documentation of HIV diagnosis in the medical record by a licensed health care provider; * Documentation of receipt of highly active antiretroviral therapy (HAART) (at least three different medications) by a licensed health care provider (documentation may be a record of an HAART prescription in the participant?s medical record, a written prescription in the name of the participant for HAART, or pill bottles for HAART with a label showing the participant?s name); * HIV-1 ribonucleic acid (RNA) detection by a licensed HIV-1 RNA assay demonstrating \>1000 RNA copies/mL; * Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay. * NOTE: A ?licensed? assay refers to a U.S. Food and Drug Administration (FDA)-approved assay, which is required for all Investigational New Drug (IND) studies. * Participants without HIV infection must have evidence of a negative result using any licensed HIV screening antibody assay and/or HIV antibody/antigen combination assay. * Participants must have measurable disease (unless marrow-only disease is present), defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter) as \>= 15 mm (\>= 1.5cm) by computed tomography (CT) or positron emission tomography (PET) scan or evaluable by bone marrow. * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 50%). * Absolute neutrophil count \>= 1,000 cells/mcL unless decreased due to bone marrow involvement. * Platelets \>= 75,000 cells/mcL unless decreased due to bone marrow involvement. * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (\< 3.0 x ULN for patients with Gilbert syndrome). If, however, the elevated bilirubin is felt to be secondary to antiretroviral therapy, the total bilirubin must be =\< 3.5 mg/dL, provided that the direct bilirubin is normal and the aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x the upper limit of normal. * AST (serum glutamic oxaloacetic transaminase \[SGOT\])/ALT (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 x institutional ULN (=\< 5 x ULN is acceptable if liver metastases are present). * Creatinine =\< 1.5 x institutional ULN OR glomerular filtration rate (GFR) \>= 45 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal, as calculated by the Cockcroft-Gault formula. * Adequate cardiac function defined as an ejection fraction on echocardiogram (ECHO) or multigated acquisition scan (MUGA) that is at or above 45%. * CD4 count \>= 100 cell/mL for HIV-positive participants. * If HIV-positive, participant must not have a history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the past year. * If HIV-positive, participant should have concurrent treatment with effective highly active antiretroviral therapy (HAART) or agree to start HAART. * The effects of daratumumab on the developing human fetus are unknown. For this reason and because another monoclonal antibody (mAb), rituximab, crosses the placenta and other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, the duration of study participation, and 90 days after completion of therapy. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men with female partners treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 90 days after completion of daratumumab administration. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: 1. Prior cytotoxic chemotherapy or radiotherapy for this lymphoma other than palliative radiation for medical emergencies (like cord compression) or the following chemotherapy: • A maximum of one cycle of combination chemotherapy, including EPOCH or CHOP-like therapy. The start of the previous chemotherapy cycle must occur at least 21 days but no more than 28 days prior to the beginning of therapy under this protocol, and such cycle will count towards the maximum of 6 cycles under this study (i.e., cycle off study will count as cycle 1 in terms of feasibility determination as per primary endpoint). OR • One prior cycle of limited therapy including cyclophosphamide and/or glucocorticoids to improve performance status or hepatic or renal function impaired due to lymphoma involvement. The start of this therapy may occur up to 28 days prior to the beginning of study treatment under this protocol. Cyclophosphamide administration must have been completed at least 14 days prior to initiation of study treatment. Such treatment will not count towards the maximum of 6 cycles under this study (i.e., participants will receive 6 cycles on study). 2. Patients who are receiving any other investigational agents. 3. Participants must not have had previous anthracycline treatment within the last two years, except for liposomal doxorubicin. Any prior exposure to liposomal doxorubicin is allowed as long as the LVEF is ≥45%. It is at the discretion of the investigator if prior exposure to doxorubicin is acceptable. 4. Participants who have previously received daratumumab for another indication. 5. Participants must not be on cobicistat, indinavir, or ritonavir, or agents that are strong CYP3A4 inhibitors. If on a strong CYP3A4 inhibitor regimen prior to study enrollment, participants must be switched to alternative drugs at least one week prior to administration of study therapy. 6. Participants with peripheral neuropathy grade ≥ 3 or neuropathic pain grade ≥ 2. 7. Expected survival \< 2 months. 8. Participants with known brain metastases from solid tumors will be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. 9. Patients with known or suspected parenchymal brain or spinal cord disease, and/or suspected or symptomatic leptomeningeal disease from lymphoma, prior to study enrolled will be excluded. Asymptomatic leptomeningeal disease only will be allowed. 10. Patients who are seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]). All participants will be required to be screened for Hepatitis B. Participants with resolved infection (i.e., participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen (anti-HBc) and/or antibodies to hepatitis B surface antigen (anti-HBs) must be screened using real-time polymerase chain reaction (PCR) measurement of HBV DNA levels. Participants who are PCR positive will be excluded. EXCEPTION: Participants with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR. 11. Patients diagnosed with Hepatitis C who are Hepatitis C antibody positive, whether Hepatitis C RNA level is measurable or not, must have no evidence of cirrhosis and have liver function tests. 12. History of allergic reactions, hypersensitivity, or intolerance attributed to compounds of similar chemical or biologic composition to daratumumab, or other agents used in the study or known sensitivity to mammalian-derived products. 13. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 14. Pregnancy or breastfeeding. A pregnancy test must be performed within 7 days prior to therapy administration in women of childbearing potential. Pregnant women are excluded from this study because the effects of daratumumab on the developing human fetus are unknown. Immunoglobulin G1 (IgG1) monoclonal antibodies are transferred across the placenta. Based on its mechanism of action, daratumumab may cause fetal myeloid or lymphoid-cell depletion and decreased bone density. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with daratumumab, breastfeeding should be discontinued if the mother is treated with daratumumab. These potential risks may also apply to other agents used in this study. Both male and female participants must use effective methods of birth control during the course of the study and for 3 months after stopping daratumumab. Participants must also agree to not donate eggs or sperm while taking daratumumab and for 3 months after stopping. 15. Unable to comply with the requirements of the protocol, or unable to provide adequate informed consent in the opinion of the Principal Investigator. 16. Serious, ongoing, non-malignant disease or infection, which in the opinion of the investigator and/or the sponsor would compromise other protocol objectives. Participants with active opportunistic infections are ineligible. 17. Major surgery, other than diagnostic surgery, occurring 4 weeks prior to study entry. Splenectomy will not be considered an exclusionary major surgery. 18. Myocardial infarction (MI) within 6 months prior to study entry, New York Heart Association (NYHA) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities. 19. Either of the following: * Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) is \<50% of predicted normal. Note that FEV1 testing also is required for subjects suspected of having COPD and subjects must be excluded if FEV1 is \<50% of predicted normal. * Known moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification. (Subjects who currently have controlled intermittent asthma or controlled mild persistent asthma are allowed to participate in the study.) 20. Participants with prior malignancies are ineligible unless: * Treatment for the prior malignancy was completed at least 2 years prior to the lymphoma treatment start date and the participant has no evidence of the concurrent malignancy OR * The concurrent malignancy is clinically stable and does not require tumor-directed treatment.",NA,ALL,NA,"[{'measure': 'Percentage of newly diagnosed plasmablastic lymphoma patients who complete at least 3 cycles of daratumumab with dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (DA-EPOCH)', 'description': 'The proportion of participants completing \\>= 3 cycles of DA-EPOCH with daratumumab will be calculated with the denominator being eligible, evaluable participants.', 'timeFrame': 'Up to the completion of 3 cycles (each cycle is 21 days)'}]","[{'measure': 'Complete response (CR) rate', 'description': 'Defined by the 2017 Response Evaluation Criteria in Lymphoma (RECIL) Criteria.', 'timeFrame': 'Up to the completion of 3 cycles (each cycle is 21 days)'}, {'measure': 'Incidence of adverse events', 'description': 'The frequency of various adverse events and proportion of participants affected will be calculated. Toxicity data will be presented by type and severity. Incidence of toxicity related dose reductions and treatment discontinuations will be summarized.', 'timeFrame': 'Up to 2 years'}, {'measure': 'Progression free survival (PFS)', 'description': 'Will be estimated by Kaplan-Meier method as well as the corresponding 95% confidence intervals.', 'timeFrame': 'Up to 1 year'}, {'measure': 'Overall survival (OS)', 'description': 'Will be estimated by Kaplan-Meier method as well as the corresponding 95% confidence intervals.', 'timeFrame': 'Up to 1 year'}]" 407,NCT02785952,"{'fullName': 'SWOG Cancer Research Network', 'class': 'NETWORK'}",Lung-MAP: Nivolumab With or Without Ipilimumab as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers,ACTIVE_NOT_RECRUITING,"This randomized phase III trial compares nivolumab with ipilimumab and nivolumab alone in treating patients with stage IV squamous cell lung cancer that has come back after previous treatment. This is a ""non-match"" sub-study that includes all screened patients not eligible for a biomarker-driven sub-study. Monoclonal antibodies, such as nivolumab and ipilimumab, may be able to shrink tumors. It is not yet known whether nivolumab works better with or without ipilimumab in treating patients with squamous cell lung cancer.","['Recurrent Squamous Cell Lung Carcinoma', 'Stage IV Squamous Cell Lung Carcinoma AJCC v7']",INTERVENTIONAL,"{'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'BIOLOGICAL', 'name': 'Ipilimumab', 'description': 'Given IV', 'armGroupLabels': ['Arm I (nivolumab, ipilimumab)'], 'otherNames': ['Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody', 'BMS-734016', 'MDX-010', 'MDX-CTLA4', 'Yervoy']}, {'type': 'OTHER', 'name': 'Laboratory Biomarker Analysis', 'description': 'Correlative studies', 'armGroupLabels': ['Arm I (nivolumab, ipilimumab)', 'Arm II (nivolumab)']}, {'type': 'BIOLOGICAL', 'name': 'Nivolumab', 'description': 'Given IV', 'armGroupLabels': ['Arm I (nivolumab, ipilimumab)', 'Arm II (nivolumab)'], 'otherNames': ['BMS-936558', 'MDX-1106', 'NIVO', 'ONO-4538', 'Opdivo']}, {'type': 'OTHER', 'name': 'Quality-of-Life Assessment', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (nivolumab, ipilimumab)', 'Arm II (nivolumab)'], 'otherNames': ['Quality of Life Assessment']}, {'type': 'OTHER', 'name': 'Questionnaire Administration', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (nivolumab, ipilimumab)', 'Arm II (nivolumab)']}]","Inclusion Criteria: * Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map) * Patients must have been assigned to S1400I * Patients must not have had prior treatment with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-cytotoxic T-lymphocyte-associated protein (CTLA)-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways * Patients must not have an active, known, or suspected autoimmune disease; patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger * Patients must not have any known allergy or reaction to any component of the nivolumab and ipilimumab formulations * Patients must not have received systemic treatment with corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days prior to sub-study registration; inhaled or topical steroids, and adrenal replacement doses =\< 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease * Patients must not have a known positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection; patients with a positive hepatitis C antibody with a negative viral load are allowed * Patients must not have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) * Patients must not have interstitial lung disease that is symptomatic or disease that may interfere with the detection or management of suspected drug-related pulmonary toxicity * Patients must also be offered participation in banking for future use of specimens * Patients must have a lipase, amylase, TSH with reflex free T3/T4 performed within 7 days prior to sub-study registration * Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia * Patients with a history of congestive heart failure (CHF) or at risk because of underlying cardiovascular disease or exposure to cardiotoxic drug should have an electrocardiogram (EKG) and echocardiogram performed to evaluate cardiac function as clinically indicated * Patients with evidence of congestive heart failure (CHF), myocardial infarction (MI), cardiomyopathy, or myositis should have a cardiac evaluation including lab tests and cardiology consultations as clinically indicated including EKG, creatine phosphokinase (CPK), troponin, and echocardiogram * Patients who can complete Patient Reported Outcomes (PRO) forms in English are required to complete a pre-study S1400I Patient Reported Outcomes (PRO) Questionnaire and a pre-study S1400I European Quality of Life Five Dimension (EQ-5D) Questionnaire within 14 days prior to registration; NOTE: Patients enrolled to S1400I prior to 9/1/2016 are not eligible for the PRO study",NA,ALL,NA,"[{'measure': 'Overall Survival', 'description': 'Duration from randomization to death due to any cause', 'timeFrame': 'From date of registration to maximum of 3 years or death'}]","[{'measure': 'Investigator-assessed Progression-free Survival (IA-PFS)', 'description': 'Duration from randomization to first occurrence of progression by RECIST 1.1, symptomatic deterioration, or death due to any cause. The IA-PFS for patients last known to be alive and free of progression or symptomatic deterioration was censored at the date of last disease assessment.\n\nProgression is defined as one or more of the following: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline as well as an absolute increase of at least 0.5 cm; Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided); Appearance of any new lesion/site; Death due to disease without prior documentation of progression and without symptomatic deterioration', 'timeFrame': 'From date of registration to maximum of 3 years or death'}, {'measure': 'Objective Response Rate', 'description': 'Response was defined as the occurrence of a complete or partial response, confirmed or unconfirmed per RECIST 1.1 criteria. Response for patients not known to have a response was coded as nonresponse.\n\nComplete response: Complete disappearance of all target and non-target lesions. No new lesions. No disease related symptoms. Any lymph nodes (whether target or non-target) must have reduction in short axis to \\< 1.0 cm. All disease must be assessed using the same technique as baseline.\n\nPartial response: Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions must be assessed using the same techniques as baseline.', 'timeFrame': 'From date of registration to maximum of 3 years or death'}, {'measure': 'Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs', 'description': 'Only adverse events that are possibly, probably or definitely related to study drug are reported. CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for reporting SAEs.', 'timeFrame': 'Duration of treatment and follow up until death or 3 years post registration'}]" 408,NCT01015248,"{'fullName': 'Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea', 'class': 'OTHER'}",Trial of Bendamustine And Rituximab for Patients With Previously Untreated Extranodal Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma,COMPLETED,"The aim of the study is to assess the therapeutic activity and safety of the combination of Bendamustine and Rituximab in MALT lymphomas. Primary endpoint: * Event-free-survival (EFS) (failure or death from any cause) for all patients. Secondary endpoints: * Complete and partial remission rates for all patients * Response duration (time to relapse or progression) for responder patients * Progression-free-survival (PFS) (disease progression or death from lymphoma: for all patients * Overall survival for all patients * Acute and long-term toxicity",['MALT LYMPHOMA'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'Rituximab and Bendamustine', 'description': 'Rituximab 375 mg/m2 iv. day 1 Bendamustine 90 mg/m2 iv. day 1 and 2', 'armGroupLabels': ['Rituximab and Bendamustine']}]","Inclusion Criteria: 1. Histologically proven diagnosis of CD20-positive marginal zone B-cell lymphoma of MALT type arisen at any extranodal site (WHO classification) 2. Any stage (Ann Arbor I-IV) 3. The novo disease en any extranodal site. For primary gastric or cutaneous lymphoma, local/specific previous treatment is accepted, just following the below criteria: 1. Cutaneous lymphoma: recurrent lymphoma after local therapy 2. Gastric lymphoma: b1. H. pylori-negative cases, either de novo (non pre-treated) or at relapse following local therapy (i.e., surgery, radiotherapy or antibiotics). b2. H. pylori-positive cases at diagnosis, who failed antibiotic therapy, including patients with: clinical (endoscopic) and histological evidence of disease progression at any time post H. pylori eradication; stable disease with persistent lymphoma at 1 year post H. pylori eradication; relapse (without H. pylori re-infection), after a remission; patients who failed either first line antibiotics or further local treatment (surgery or radiotherapy) 4. No evidence of histologic transformation to a high grade lymphoma 5. Measurable or evaluable disease 6. Age \>18 and \<85 7. ECOG performance status 0-2 8. Life expectancy of at least 1 year 9. Written informed consent given according to national/local regulations Exclusion Criteria: 1. Prior chemotherapy or prior immunotherapy with any anti-CD20 monoclonal antibody 2. Prior radiotherapy in the last 6 weeks 3. Corticosteroids during the last 28 days, unless prednisone chronically administered at a dose \<20 mg/day for indications other than lymphoma or lymphoma-related symptoms 4. Major impairment of renal function (serum creatinine \> 2,5 x upper normal) or liver function (ASAT/ALAT \<2,5 x upper normal, total bilirubin \<2,5x upper normal), unless due to lymphoma involvement. 5. Impairment of bone marrow function (WBC \<3.0x109/L, ANC \<1.5x109/L, PLT \<100x109/L), unless due to lymphoma involvement 6. Evidence of clinically significant cardiac, neurological or metabolic disease, unless due to lymphoma involvement 7. Evidence of symptomatic central nervous system (CNS) disease 8. Active HBV and/or HCV infection 9. Known HIV infection 10. Prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer 11. Any psychiatric disease potentially hampering compliance with the study protocol and follow-up schedule 12. Potential to attend regular visits to the hospital, on an outpatient regimen 13. Hypersensibility to any compound of the study medication. 14. Non appropriate contraceptive method in women of childbearing potential or men 15. Treatment with any drug under research within 30 days previous to start the study medication.",NA,ALL,NA,"[{'measure': 'The primary endpoint of assessment is the event-free-survival (EFS) according to the criteria of the International Workshop to Standardize Response Criteria for NHL and Criteria for evaluation of response in NHL', 'timeFrame': '2 years follow-up'}]","[{'measure': 'Include evaluation of the next parameters: Complete and partial remission rates for all patients Response duration for responder patients PFS for all patients Overall survival for all patients Acute and long-term toxicity', 'timeFrame': '2 years follow-up'}]" 409,NCT00854425,"{'fullName': 'Fudan University', 'class': 'OTHER'}",L-asparaginase Monotherapy as Salvage Treatment in Patients With NK/T Cell Lymphoma,COMPLETED,The purpose of this study is to evaluate the efficacy and tolerability of L-asparaginase monotherapy as salvage treatment in patients with NK/T cell lymphoma,['Lymphoma'],INTERVENTIONAL,"{'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}","[{'type': 'DRUG', 'name': 'L-asparaginase', 'description': 'L-asparaginase 600mg/m2 days 1-7 repeated every 3 weeks for a total of 6 cycles', 'armGroupLabels': ['L-asp'], 'otherNames': ['L-asp']}]","Inclusion Criteria: * Age range 18-75 years old * Histological confirmed NK/T cell lymphoma with progressive or recurrent disease * ECOG performance status 0-2 * Life expectancy of more than 3 months * Normal laboratory values: hemoglobin \> 80 g/dl, neutrophil \> 2×109/L, platelet \> 100×109/L, serum creatine \< 1.5×upper limitation of normal (ULN), serum bilirubin \< 1.5×ULN, ALT and AST \< 2.5×ULN Exclusion Criteria: * Pregnant or lactating women * Serious uncontrolled diseases and intercurrent infection * The evidence of CNS metastasis * History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix",NA,ALL,NA,"[{'measure': 'Response rate', 'timeFrame': '6 weeks'}]","[{'measure': 'Progression-free survival and overall survival', 'timeFrame': '2 years'}]"