[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"National Research Center for Hematology, Russia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":162},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,57,85,113,136],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100609015","phase-2-pet-adapted-first-line-therapy-with-nivolumab-for-advanced-hodgkin-lymphoma-100609015",false,"NCT07209059","PET-Adapted First-Line Therapy With Nivolumab for Advanced Hodgkin Lymphoma","A Single-Center Pilot Study Evaluating the Efficacy and Safety of First-Line Immunochemotherapy With Nivolumab Guided by Interim PET for Stratification and Hazard Minimization in Patients With Advanced Classical Hodgkin Lymphoma (FINISH-HL)","FINISH-HL","Inclusion Criteria:\n\n* Signed written informed consent prior to any study-specific procedures\n* Histologically confirmed classical Hodgkin lymphoma (cHL)\n* Newly diagnosed disease, Ann Arbor stage IIB (bulky), III, or IV\n* At least one measurable lesion ≥15 mm in the longest diameter (by CT)\n* Age between 18 and 60 years (inclusive)\n* ECOG performance status 0-2\n* PET-CT performed at baseline\n* No prior chemotherapy, radiotherapy, or immunotherapy for lymphoma\n* Adequate organ function, including:\n* Serum creatinine ≤ 0.2 mmol\u002FL\n* Absence of severe cardiac, pulmonary, hepatic, or renal dysfunction\n* Ability to comply with the study protocol and scheduled visits\n\nExclusion Criteria:\n\n* Active hepatitis B or C infection\n* Positive test for HIV\n* Pregnancy or breastfeeding\n* Prior or active autoimmune disease requiring systemic therapy\n* Vaccination with a live vaccine within 30 days prior to first nivolumab dose\n* History of non-infectious pneumonitis requiring corticosteroids\n* Prior malignancy (except for adequately treated basal cell carcinoma or cervical carcinoma in situ)\n* Congestive heart failure, unstable angina, recent myocardial infarction, or severe cardiac arrhythmias\n* Severe renal impairment (serum creatinine \\> 0.2 mmol\u002FL), unless lymphoma-related\n* Severe hepatic dysfunction, unless directly related to lymphoma\n* Severe pneumonia with respiratory failure or hypoxemia not corrected within 2-3 days\n* Sepsis or hemodynamic instability\n* Life-threatening bleeding events (e.g., gastrointestinal or cerebral hemorrhage)\n* Cachexia (total serum protein \\\u003C 35 g\u002FL), unless due to lymphoma-related liver damage\n* Decompensated diabetes mellitus\n* Any somatic or psychiatric condition that, in the investigator's judgment, precludes informed consent or study participation","ALL","18 Years","60 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a single-center, open-label, phase 2 pilot study evaluating the efficacy and safety of a response-adapted first-line treatment strategy for patients with classical Hodgkin lymphoma (cHL) and unfavorable prognostic factors. The FINISH protocol (First-line Immuno-chemotherapy Navigated by Interim PET for Stratification and Hazard minimization In Hodgkin lymphoma) integrates nivolumab into induction therapy and tailors subsequent treatment based on interim PET-CT response. The study also includes exploratory monitoring of circulating tumor DNA (ctDNA) to investigate its role in early response assessment and residual disease detection.",[28,29,30],"Hodgkin Lymphoma","Hodgkin Disease","Advanced Hodgkin Lymphoma",[32,29,33,34,35,36,37,38,39,40,41,42,43],"Classical Hodgkin Lymphoma","Nivolumab","Immunotherapy","First-line treatment","PET-adapted therapy","Checkpoint inhibitors","ctDNA","Response-adapted treatment","EACOPD","AVD","PD-1 blockade","Circulating tumor DNA","RECRUITING","2025-09-29",{"date":47,"type":48},"2025-10-06","ACTUAL",{"date":50,"type":48},"2025-07-29",{"date":52,"type":22},"2028-12",{"name":54,"class":55},"National Research Center for Hematology, Russia","NETWORK",1,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":67,"phases":4,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":56},"100571541","an-extension-study-to-evaluate-the-safety-and-efficacy-of-an-anti-cd19-car-t-product-in-patients-with-b-cell-lymphoproliferative-disorders-100571541","NCT06721598","An Extension Study to Evaluate the Safety and Efficacy of an Anti-CD19 CAR-T Product in Patients with B-cell Lymphoproliferative Disorders","An Open-label, Non-interventional, Single-group Follow-up Study to Evaluate the Safety and Efficacy of an Anti-CD19 CAR-T Product in Adult Patients with Relapsed or Refractory Forms of B-cell Lymphoproliferative Disorders","Inclusion Criteria:\n\n1. Successful completion of the HemC101-01-01 study procedures.\n2. Negative pregnancy test for women of reproductive potential.\n\nExclusion Criteria:\n\n1. Uncontrolled life-threatening infection. A urinary tract infection is acceptable. Patients who received intravenous antibiotics before IMP administration or in whom intravenous antibiotics have not been discontinued 7 days before inclusion in the study. Prophylactic use of antibiotics, antiviral, or antifungal drugs is allowed.\n2. The use of therapeutic interventions prohibited by the protocol (glucocorticosteroids, allogeneic cell therapy, GVHD therapy, chemotherapy, alemtuzumab, clofarabine, cladribine, and biologics derived from mouse materials).\n3. Non-adherence to HemC101-01-01 study procedures that, in the investigator's opinion, put the patient at risk if they participate in the study and may significantly bias the assessment of study results.\n4. Any clinically relevant data that, in the investigator's opinion, affects the patient's ability to enter the study and puts the patient at risk.","71 Years",{"count":66,"type":22},60,"OBSERVATIONAL","This follow-up study is designed to evaluate the long-term safety and effectiveness of a treatment called anti-CD19 CAR-T cell therapy in adults with certain B-cell blood cancers. These cancers include types that have returned after treatment or have not responded to other therapies. CAR-T cell therapy involves using a patient's own immune cells, which are modified in a lab to specifically target and destroy cancer cells with a marker called CD19. The study will look at how well patients tolerate this treatment over time, as well as its ability to keep cancer in remission or reduce its severity.\n\nPatients who have previously received CAR-T therapy in an earlier clinical trial and meet specific criteria can participate in this study. The research will include regular follow-up visits over approximately 11 months to monitor for side effects, assess cancer response, and track the activity of CAR-T cells in the body. This study does not involve additional treatments but focuses on understanding the long-term outcomes of CAR-T therapy to provide better care for patients in the future.",[70,71],"Non-Hodgkin Lymphoma, B-cell","Acute Lymphoblastic Leukemia ALL",[73,74,75],"CAR-T","B-cell lymphoma","non-Hodgkin lymphoma","NOT_YET_RECRUITING","2024-12-03",{"date":79,"type":48},"2024-12-06",{"date":81,"type":22},"2025-01-09",{"date":83,"type":22},"2026-09-30",{"name":54,"class":55},{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":23,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":56},"100548267","phase-3-impact-aml-randomized-pragmatic-clinical-trial-for-relapsed-or-refractory-aml-100548267","NCT06418776","IMPACT-AML: Randomized Pragmatic Clinical Trial for Relapsed or Refractory AML","A Prospective Multicenter Randomized Clinical Trial on the Treatment of Patients With Refractory or Early Relapses of Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Primary refractory AML;\n* Early relapsed AML;\n* A signed informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Late relapsed AML;\n* Isolated extramedullary relapse;\n* MRD relapse without development of bone marrow relapse of AML;\n* Acute promyelocytic leukemia;\n* Previous refractoriness or loss of response during ongoing venetoclax therapy;\n* Previous alloHSCT;\n* Pregnancy and\u002For lactation period;\n* Refusal of patients with preserved reproductive potential to use highly effective methods of contraception during the period of participation in the study;\n* Lack of signed informed consent to participate in the study;\n* Failure of the subject to follow the study protocol;\n* Participation in any other clinical trial;\n* Uncontrolled infectious complications;\n* ECOG ≥ 3;\n* History of other malignancies within the past 3 years, excluding squamous cell and basal cell skin cancers, carcinoma in situ of the cervix, breast, or other non-invasive malignancies, which, in the opinion of the investigator, are considered adequately treated and have a minimal risk of recurrence within 3 years;\n* Chronic kidney disease with GFR ≤ 30 ml\u002Fmin\u002F1.73 m2 (according to the CKD-EPI Creatinine Equation);\n* Severe cardiac pathology:\n\n  1. uncontrolled arterial hypertension;\n  2. stable angina III-IV functional classes;\n  3. unstable angina and\u002For myocardial infarction less than 6 months before inclusion in the study;\n  4. heart failure stages IIb-III, NYHA functional classes III-IV\n  5. uncontrolled cardiac rhythm disturbances (≥ 2 grade CTCAE 5.0) or clinically significant ECG abnormalities.\n* Cirrhosis classes B-C according to the Child-Pugh classification\n* Increased liver function tests above the following values:\n\n  1. Total bilirubin \\> 1,5 above the normal range;\n  2. AST, ALT \\> 10 above the normal range.\n* Major surgical interventions underwent less than 14 days before inclusion in the study.",{"count":93,"type":22},198,[95],"PHASE3","The primary objective is to evaluate the efficacy and toxicity of high versus low intensity therapy options in patients with refractory forms and early relapses of acute myeloid leukemia (R\u002FR AML) who are scheduled for allogeneic hematopoietic stem cell transplantation (alloHSCT).",[98,99],"Refractory Acute Myeloid Leukemia","Early Relapses of Acute Myeloid Leukemia",[101,102,103,104],"Acute myeloid leukemia","Relapse of AML","Refractory AML","Allogeneic Stem Cell Transplantation","2024-05-13",{"date":107,"type":48},"2024-05-17",{"date":109,"type":48},"2024-04-01",{"date":111,"type":22},"2029-05",{"name":54,"class":55},{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":23,"phases":123,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":56},"100534312","mrd-associated-non-intensive-but-non-interruptive-treatment-of-ph-negative-acute-lymphoblastic-leukemia-adult-patients-100534312","NCT06237192","MRD-associated Non-intensive But Non-interruptive Treatment of Ph-negative Acute Lymphoblastic Leukemia Adult Patients","Multicenter Prospective Study of Safety and Efficacy MRD-associated Non-intensive But Non-interruptive Treatment of Ph-negative Acute Lymphoblastic Leukemia Adult Patients","Inclusion Criteria:\n\n• age 18-55 years old of patient,\n\n\\- Clinical diagnosis of non-treated Ph-negative ALL\n\nExclusion Criteria:\n\n• age more than 55 years old,\n\n* Clinical diagnosis of Ph-positive ALL\n* Clinical diagnosis of relapsed\u002Frefractory ALL,","55 Years",{"count":122,"type":22},200,[124],"NA","Non-intensive But Non-interruptive Treatment based on previously study RALL-2016 of Adult Ph-negative Acute Lymphoblastic Leukemia: No high-dose methotrexate (MTX) and high-dose cytarabine (ARA-C) consolidation blocks, L-asparaginaseis scheduled for 1 year of treatment, 21 intrathecal injections through the whole treament, T-ALL patients in complete remission (CR) with MRD-positive status after 2nd induction receive consolidation 1-3 with venetoclax (56 days), and B-ALL patients in complete remission (CR) with MRD-positive status after 2nd induction receive 1 consolidation with blinatumomab. After that consolidation bone samples are collected and tested for MRD and patients will continue therapy by protocol without HSCT if MRD-negative (by flow cytometry by aberrant immunophenotype in a centralized lab) status was achieved.",[127],"Precursor Cell Lymphoblastic Leukemia-Lymphoma","2024-01-31",{"date":130,"type":48},"2024-02-01",{"date":132,"type":48},"2023-04-01",{"date":134,"type":22},"2027-09-01",{"name":54,"class":55},{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":143,"enrollmentInfo":144,"targetDuration":4,"studyType":23,"phases":146,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":56},"100530584","phase-3-multicenter-study-of-safety-and-efficacy-nivolumab-at-the-fixed-dose-40-mg-nivo40-in-combination-with-chemo-immunotherapy-for-the-treatment-of-newly-diagnosed-pmbl-100530584","NCT06188676","Multicenter Study of Safety and Efficacy Nivolumab at the Fixed Dose 40 mg (Nivo40) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed PMBL","Nivolumab at the Fixed Dose 40 mg (Nivo40) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma","Inclusion Criteria:\n\n\\- Patient must have histologically confirmed primary mediastinal B-cell lymphoma (PMBCL) as defined by World Health Organization (WHO) criteria Age 18-70 years old Ejection fraction greater than 50% ECOG 0-2 status Signed informed consent No severe concurrent illness measurable disease (at least one lesion that can be accurately measured in at least two dimensions on a CT scan, at least \\>15 mm in largest diameter\n\nExclusion Criteria:\n\n* Uncontrolled bacterial or fungal infection at the time of enrollment\n* Requirement for vasopressor support at the time of enrollment\n* Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 norms\n* Karnofsky index \\\u003C30%\n* Pregnancy\n* Somatic or psychiatric disorder making the patient unable to sign an informed consent\n* Active or prior documented autoimmune disease requiring systemic treatment.","70 Years",{"count":145,"type":22},100,[95],"This compares the effects of nivolumab at a fixed dose of 40 mg with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs 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. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.",[149],"Primary Mediastinal Lymphoma",[151,152,153],"PET-adapted Treatment","Nivolumab at the fixed dose 40 mg","R-DA-EPOCH","2023-12-18",{"date":156,"type":48},"2024-01-03",{"date":158,"type":48},"2022-04-01",{"date":160,"type":22},"2029-04-01",{"name":54,"class":55},""]