[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100479084":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":35,"centralContacts":48,"locations":54,"responsibleParty":71,"collaborators":35,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":35,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":35,"studyType":86,"phases":87,"briefSummary":89,"conditions":90,"keywords":96,"overallStatus":57,"whyStopped":35,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Federal Research Institute of Pediatric Hematology, Oncology and Immunology","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"R1: stage I and II","EXPERIMENTAL","R1: resection status: complete, stage I and II",[13],"Drug: Cyclophosphamide, Cytarabine, Dexamethasone, Etoposide, Ifosfamide, Methotrexate",{"label":15,"type":10,"description":16,"interventionNames":17},"R2: incomplete, stage I and II","R2: resection status: incomplete, stage I and II",[18],"Drug: Cyclophosphamide, Cytarabine, Dexamethasone, Etoposide, Ifosfamide, Methotrexate, Vincristine",{"label":20,"type":10,"description":21,"interventionNames":22},"R3: incomplete, stage III and LDH \u003C 2 x ULN","R3: resection status: incomplete, stage III and LDH \\\u003C 2 x ULN",[23],"Drug: Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin hydrochloride, Etoposide, Ifosfamide, Methotrexate, vincristine",{"label":25,"type":10,"description":26,"interventionNames":27},"R4: stage III and LDH ≥ 2 x ULN, stage IV\u002FB-AL and CNS negative; CNS +","R4: resection status: incomplete, stage III and LDH ≥ 2 x ULN, stage IV\u002FB-AL and CNS negative; CNS +",[28],"Drug: Cyclophosphamide , Cytarabine, Dexamethasone, Doxorubicin hydrochloride, Etoposide, Ifosfamide, Methotrexate, Vincristine, Сarboplatine, CCNU\u002F BCNU, Melphalan, Idarubicin",[30,36,40,44],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","Cyclophosphamide, Cytarabine, Dexamethasone, Etoposide, Ifosfamide, Methotrexate","For patients with very limited disease (R1- stage I\u002FII СR), the addition of rituximab might allow the omission of anthracyclines and vincristine without jeopardizing survival rates but reducing acute and long term toxicities. In this treatment arm, it is tested whether the event-free survival is similar to that of the historical control",[9],null,{"type":31,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Cyclophosphamide, Cytarabine, Dexamethasone, Etoposide, Ifosfamide, Methotrexate, Vincristine","R2: Drug: Rituximab 2 doses of Rituximab (375 mg\u002Fm²) before the start of the first chemotherapy cycle, 2 doses of Rituximab before the start of the second chemotherapy cycle",[15],{"type":31,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin hydrochloride, Etoposide, Ifosfamide, Methotrexate, vincristine","2 doses of Rituximab (375 mg\u002Fm²) before the start of the first chemotherapy cycle, 2 doses of Rituximab before the start of the second",[20],{"type":31,"name":45,"description":46,"armGroupLabels":47,"otherNames":35},"Cyclophosphamide , Cytarabine, Dexamethasone, Doxorubicin hydrochloride, Etoposide, Ifosfamide, Methotrexate, Vincristine, Сarboplatine, CCNU\u002F BCNU, Melphalan, Idarubicin","Rituximab 4 doses of Rituximab (375 mg\u002Fm²) before the start of the first chemotherapy cycle, Further",[25],[49],{"name":50,"role":51,"phone":52,"phoneExt":35,"email":53},"Yulia Abugova","CONTACT","+7-916-074-74-76","Yuliya.Abugova@fccho-moscow.ru",[55],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology and Immunology","RECRUITING","Moscow","RF","117198","Russia","RU",{"type":64,"coordinates":65},"Point",[66,67],37.61781,55.75204,{"lat":67,"lon":66},[70],{"name":50,"role":51,"phone":35,"phoneExt":35,"email":35},{"type":72,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100479084","phase-4-b-cell-mature-non-hodgkins-lymphoma-treatment-protocol-in-children-and-adolescents-2021-100479084",false,"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","ALL","1 Day","18 Years",{"count":84,"type":85},300,"ESTIMATED","INTERVENTIONAL",[88],"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",[91,92,93,94,95],"Non-hodgkin Lymphoma,B Cell","Burkitt Lymphoma","Primary Mediastinal Lymphoma","Primary CNS Lymphoma","Diffuse Large B-cell Lymphoma",[97,98,99,100,101,102,103],"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":106,"type":107},"2022-08-26","ACTUAL",{"date":109,"type":107},"2022-05-25",{"date":111,"type":85},"2027-05-16",{"name":5,"class":6},1]