[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530584":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":66,"centralContacts":71,"locations":80,"responsibleParty":96,"collaborators":33,"id":100,"slug":101,"hasResults":102,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":33,"eligibilityCriteria":106,"healthyVolunteers":102,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":33,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":83,"whyStopped":33,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"National Research Center for Hematology, Russia","NETWORK",[8,21],{"label":9,"type":10,"description":11,"interventionNames":12},"A","ACTIVE_COMPARATOR","Active Comparator: Arm A (DA-EPOCH-R) Patients receive prednisone or prednisolone on days 1-5 and rituximab IV or rituximab and hyaluronidase human SC over 5 minutes on day 1 or 5. Patients also receive etoposide phosphate, doxorubicin hydrochloride, and vincristine sulfate IV over 96 hours on days 1-4 and cyclophosphamide IV over 30-60 minutes on day 5. Beginning 24-72 hours after completing cyclophosphamide, patients receive filgrastim or pegylated filgrastim SC daily until ANC is \\>= 500\u002FuL after the expected nadir. Treatment repeats every 21 days for up to 6 cycles (5 if the patient had 1 prior cycle of treatment) in the absence of disease progression or unacceptable toxicity. Patients also undergo FDG-PET\u002FCT on study. When СR is achieved according to PET \u002F CT after 4 cycles of chemotherapy, 2 randomization is performed, a total of 4 or 6 chemotherapy courses",[13,14,15,16,17,18,19,20],"Drug: Cyclophosphamide","Drug: Doxorubicin Hydrochloride","Drug: Etoposide Phosphate","Drug: Prednisolone","Drug: Rituximab","Drug: Vincristine Sulfate","Drug: Filgrastim","Drug: Pegfilgrastim",{"label":22,"type":23,"description":24,"interventionNames":25},"B","EXPERIMENTAL","(DA-EPOCH-R, nivolumab) Patients receive treatment as in Arm A. Patients also receive nivolumab 40 mg IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (5 if the patient had 1 prior cycle of treatment) in the absence of disease progression or unacceptable toxicity. Patients also undergo FDG-PET\u002FCT on study. When СR is achieved according to PET \u002F CT after 4 cycles of chemotherapy, 2 randomization is performed, a total of 4 or 6 chemotherapy courses.",[13,14,15,16,17,18,19,20,26],"Drug: Nivolumab 40 mg in 4 ml Injection",[28,34,38,42,46,50,54,58,62],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"DRUG","Cyclophosphamide","Ciclofosfamida",[9,22],null,{"type":29,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"Doxorubicin Hydrochloride","Adriamycin",[9,22],{"type":29,"name":39,"description":40,"armGroupLabels":41,"otherNames":33},"Etoposide Phosphate","Etopophos",[9,22],{"type":29,"name":43,"description":44,"armGroupLabels":45,"otherNames":33},"Prednisolone","Prednisolonum",[9,22],{"type":29,"name":47,"description":48,"armGroupLabels":49,"otherNames":33},"Rituximab","Chimeric Anti-CD20 Antibody",[9,22],{"type":29,"name":51,"description":52,"armGroupLabels":53,"otherNames":33},"Vincristine Sulfate","Oncovin",[9,22],{"type":29,"name":55,"description":56,"armGroupLabels":57,"otherNames":33},"Filgrastim","G-CSF",[9,22],{"type":29,"name":59,"description":60,"armGroupLabels":61,"otherNames":33},"Pegfilgrastim","PEG-filgrastim",[9,22],{"type":29,"name":63,"description":64,"armGroupLabels":65,"otherNames":33},"Nivolumab 40 mg in 4 ml Injection","Opdivo",[22],[67],{"name":68,"affiliation":69,"role":70},"Elena Parovichnikova, MD,PhD","Nathional Medical Research Center for Hematology Moscow Russia 125167","STUDY_DIRECTOR",[72,77],{"name":73,"role":74,"phone":75,"phoneExt":33,"email":76},"Yana Mangasarova, MD","CONTACT","+74956122361","v.k.jana@mail.ru",{"name":78,"role":74,"phone":75,"phoneExt":33,"email":79},"Euvgena Zvonkov, MD,PhD","dr.zvonkov@mail.ru",[81],{"facility":82,"status":83,"city":84,"state":33,"zip":85,"country":86,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"National Research Center for Hematology","RECRUITING","Moscow","125167","Russia","RU",{"type":89,"coordinates":90},"Point",[91,92],37.61781,55.75204,{"lat":92,"lon":91},[95],{"name":73,"role":74,"phone":75,"phoneExt":33,"email":76},{"type":97,"investigatorFullName":98,"investigatorTitle":99,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Elena N.Parovichnikova","Vice-director Nathional Medical Research Center for Hematology Moscow Russia","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":111,"type":112},100,"ESTIMATED","INTERVENTIONAL",[115],"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.",[118],"Primary Mediastinal Lymphoma",[120,121,122],"PET-adapted Treatment","Nivolumab at the fixed dose 40 mg","R-DA-EPOCH","2023-12-18",{"date":125,"type":126},"2024-01-03","ACTUAL",{"date":128,"type":126},"2022-04-01",{"date":130,"type":112},"2029-04-01",{"name":5,"class":6},1]