[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-mediastinal-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-mediastinal-lymphoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"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",false,"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.","ALL","18 Years","70 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","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.",[27],"Primary Mediastinal Lymphoma",[29,30,31],"PET-adapted Treatment","Nivolumab at the fixed dose 40 mg","R-DA-EPOCH","RECRUITING","2023-12-18",{"date":35,"type":36},"2024-01-03","ACTUAL",{"date":38,"type":36},"2022-04-01",{"date":40,"type":21},"2029-04-01",{"name":42,"class":43},"National Research Center for Hematology, Russia","NETWORK",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":17,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":63,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":44},"100479084","phase-4-b-cell-mature-non-hodgkins-lymphoma-treatment-protocol-in-children-and-adolescents-2021-100479084","NCT05518383","B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021","B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021 (B-NHL-M-2021)","Inclusion Criteria:\n\n* Age at diagnosis 0 to 18 years.\n* The diagnosis of Burkitt's lymphoma, Diffuse large B-cell lymphom, primary mediastinal lymphoma, primary CNS lymphoma, B-cell (Burkitt) AL\n* Informed consent of the patient parents (guardians) to be treated\n\nExclusion Criteria:\n\n* previous malignancy, prior organ transplant, HIV infection or AIDS or severe immunodeficiency\n* hypersensitivity to rituximab or to ingredients of other IMPs.\n* no informed consent of the patient parents (guardians) to be treated","1 Day",{"count":54,"type":21},300,[56],"PHASE4","The aim of the trial is to evaluate the molecular characteristics and MDD\u002FMRD of B-NHL in pediatric patients in order to identify on the one hand the very high risk group and to prescribe them more intensive treatment on the other hand to identify those patients who don't need very aggressive therapy. One more study question is to evaluate the role of PET\u002FCT in assessment of the completeness of remission.\n\nThe following primary study questions are going to be analyzed:\n\n* the effectiveness (event-free survival) in pediatric patients with very limited mature B-NHL (R1 - stage I and II R) of substituting anthracyclines and vincristine by the rituximab without compromising survival rates.\n* the effectiveness (event-free survival) in pediatric patients with limited mature B-NHL (R2 - stage I and II NR) of substituting anthracyclines by the rituximab without compromising survival rates.\n* the effectiveness (event-free survival) in pediatric patients with advanced VHR mature B-NHL (R4 - stages with unfavourable genetics of substituting standard chemotherapy by \"second-line\" block VICI in order to improve results\n\nSecondary study questions will address\n\n* additional parameters for immune reconstitution, lymphocyte subpopulations, immunoglobulin levels, vaccination titers and infection rates\n* kinetics of immune reconstitution after treatment",[59,60,27,61,62],"Non-hodgkin Lymphoma,B Cell","Burkitt Lymphoma","Primary CNS Lymphoma","Diffuse Large B-cell Lymphoma",[64,65,66,67,68,69,70],"B-cell mature non-Hodgkin's lymphoma","Burkitt's lymphoma","Diffuse large B-cell lymphoma","primary mediastinal lymphoma, primary CNS lymphoma","rituximab","children, adolescents","treatment","2022-08-25",{"date":73,"type":36},"2022-08-26",{"date":75,"type":36},"2022-05-25",{"date":77,"type":21},"2027-05-16",{"name":79,"class":80},"Federal Research Institute of Pediatric Hematology, Oncology and Immunology","OTHER"]