[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605934":3},{"organization":4,"outcomesModule":7,"designInfo":16,"detailedDescription":23,"studyPopulation":11,"armGroups":24,"interventions":48,"overallOfficials":85,"centralContacts":90,"locations":95,"responsibleParty":109,"collaborators":111,"id":127,"slug":11,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":128,"sex":134,"minAge":11,"maxAge":135,"enrollmentInfo":136,"targetDuration":11,"studyType":139,"phases":140,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":97,"whyStopped":11,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"Children's Cancer Group, China","NETWORK",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Event free survival",null,"3 years",[14],{"measure":15,"description":11,"timeFrame":12},"Overall survival",{"allocation":17,"interventionModel":18,"interventionModelDescription":19,"primaryPurpose":20,"observationalModel":11,"timePerspective":11,"maskingInfo":21},"NON_RANDOMIZED","SEQUENTIAL","Arms and Interventions","TREATMENT",{"masking":22,"maskingDescription":11,"whoMasked":11},"NONE","In our previous study (CCCG-BNHL-2015), four-year EFS was 88.3%, mostly owing to the use of Rituximab. However, four-year EFS was only 73% for group R4. And three-year EFS was even lower, 61% for stage IV and B-AL with LDH≥4ULN. To improve survival for pediatric patients with high risk B-NHL, the investigators launched a new study in China. In this study (CCCG-BNHL-2025), patients with stage III and LDH≥2ULN, any stage IV, and B-AL will be stratified into group R4. Six injections of Rituximab will be used for patients in R4, compared with four injections in CCCG-BNHL-2015. And two injections of Rituximab will be used in the first and second cycles of chemotherapies. The first cycle of chemotherapy will be changed into AA, instead of A. For patients with stage IV (including B-AL) with LDH≥ 4ULN, two cycles of chemotherapies(AA and BB) will be added. Our aim is to test whether intensive chemotherapies with early, adequate, and intensive use of Rituximab will improve the EFS and OS of children and adolescents with highly aggressive B-NHL.",[25,32,37,44],{"label":26,"type":27,"description":28,"interventionNames":29},"Risk group 1","OTHER","Complete resection of stage I or II disease: 3 courses (A-B-A) and 3 intrathecal injections(Cytarabine\u002FMethotrexate\u002FDexamethasone, age adjusted);",[30,31],"Drug: Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone","Drug: Drug: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone",{"label":33,"type":27,"description":34,"interventionNames":35},"Risk group 2","Not or incompletely resected stage I\u002FII disease and LDH \\\u003C2ULN: 5 courses (A--B--A--B--A) and 8 intrathecal injections;",[30,36],"Drug: Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone",{"label":38,"type":27,"description":39,"interventionNames":40},"Risk group 3","Stage III with LDH \\\u003C 2 ULN, or Stage I,II with LDH in 2 to 4 ULN : Preface followed by 6 courses (P(Cyclophosphamide\u002FVincristine\u002FPrednisone)-AA-BB-AA-BB-AA-BB) and 13 intrathecal injections(16 intrathecal injections with CNS2-3)",[41,42,43],"Drug: Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone","Drug: Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone","Drug: Prednisone,Vincristine, Cyclophosphamide",{"label":45,"type":27,"description":46,"interventionNames":47},"Risk group 4","Stage III with LDH≥2ULN, or Stage IV, or B-AL: Preface followed by 6 dose of rituximab (375mg\u002Fm2) combined 6 courses of chemotherapy, together with 13 intrathecal injections((16 intrathecal injections with CNS2-3): P-(Rituximab-Rituximab)AA-(Rituximab-Rituximab)BB-(Rituximab)AA-(Rituximab)BB-AA-BB; stage IV or B-AL with LDH≥5ULN:P-(Rituximab-Rituximab)AA-(Rituximab-Rituximab)BB-(Rituximab)AA-(Rituximab)BB-AA-BB-AA-BB, together with 17 intrathecal injections((21 intrathecal injections with CNS2-3)",[41,42,43],[49,56,59,63,69,75,81],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"DRUG","Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone","Cyclophosphamide 800mg\u002Fm2, D1, then 200mg\u002Fm2, D2\\~4;Vincristine 1.5mg\u002Fm2 (MAX 2mg), D1; Cytarabine 1g\u002Fm2\u002Fdose, (2 doses, 12-hour interval), D4; Doxorubincin 20mg\u002Fm2, D2,3; Prednisone 60mg\u002Fm2, D1\\~7;Intrathecal injection, D1;",[26],[55],"Protocol A",{"type":50,"name":36,"description":57,"armGroupLabels":58,"otherNames":11},"Ifosphamide 1.2g\u002Fm2, D1\\~5; Etoposide, 60mg\u002Fm2, D3\\~5; Methotrexate, 0.5g\u002Fm2, D1;Vincristine 1.5mg\u002Fm2 (MAX 2mg), D1; Prednisone 60mg\u002Fm2, D1\\~7;Intrathecal injection, D1;",[26],{"type":50,"name":51,"description":60,"armGroupLabels":61,"otherNames":62},"Cyclophosphamide 800mg\u002Fm2, D1, then 200mg\u002Fm2, D2\\~4;Vincristine 1.5mg\u002Fm2 (MAX 2mg), D1; Cytarabine 1g\u002Fm2\u002Fdose, (2 doses, 12-hour interval), D4;Doxorubincin 20mg\u002Fm2, D2,3; Prednisone 60mg\u002Fm2, D1\\~7;Intrathecal injection, D1,8;",[33],[55],{"type":50,"name":64,"description":65,"armGroupLabels":66,"otherNames":67},"Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone","Ifosphamide 1.2g\u002Fm2, D1\\~5; Etoposide, 60mg\u002Fm2, D3\\~5; Methotrexate, 0.5g\u002Fm2, D1;Vincristine 1.5mg\u002Fm2 (MAX 2mg), D1; Prednisone 60mg\u002Fm2, D1\\~7;Intrathecal injection, D1",[33],[68],"Protocol B",{"type":50,"name":70,"description":71,"armGroupLabels":72,"otherNames":73},"Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone","Cyclophosphamide 800mg\u002Fm2, D1, then 200mg\u002Fm2, D2\\~4; Vindelsine 3mg\u002Fm2 (MAX 5mg), D1; Cytarabine 2g\u002Fm2\u002Fdose, (2 doses, 12-hour interval), D4; Doxorubincin 20mg\u002Fm2, D2,3; Prednisone 60mg\u002Fm2, D1\\~7;Intrathecal injection, D1,4(CNS2-3),8",[38,45],[74],"Protocol AA",{"type":50,"name":76,"description":77,"armGroupLabels":78,"otherNames":79},"Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone","Ifosphamide 1.2g\u002Fm2, D1\\~5; Etoposide, 100mg\u002Fm2, D3\\~5; Methotrexate, 5g\u002Fm2, D1;Vindelsine 3mg\u002Fm2 (MAX 5mg), D1; Prednisone 60mg\u002Fm2, D1\\~7;Intrathecal injection, D1,8",[38,45],[80],"Protocol BB",{"type":50,"name":82,"description":83,"armGroupLabels":84,"otherNames":11},"Prednisone,Vincristine, Cyclophosphamide","Prednisone 45mg\u002Fm2, D1\\~7; Vincristine 1.5mg\u002Fm2(MAX 2mg), D1; Cyclophosphamide 300mg\u002Fm2, D1; Intrathecal injection, D1",[38,45],[86],{"name":87,"affiliation":88,"role":89},"Yi-jin Gao","Shanghai Children's Medical Center","PRINCIPAL_INVESTIGATOR",[91],{"name":87,"role":92,"phone":93,"phoneExt":11,"email":94},"CONTACT","+82064 86-21-38626161","gaoyijin@scmc.com.cn",[96],{"facility":88,"status":97,"city":98,"state":99,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":11},"RECRUITING","Shanghai","Shanghai Municipality","201315","China","CN",{"type":104,"coordinates":105},"Point",[106,107],121.45806,31.22222,{"lat":107,"lon":106},{"type":110,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[112,113,115,117,119,121,123,125],{"name":88,"class":27},{"name":114,"class":27},"Nanjing Children's Hospital",{"name":116,"class":27},"Children's Hospital of Soochow University",{"name":118,"class":27},"West China Second University Hospital",{"name":120,"class":27},"Qilu Hospital of Shandong University",{"name":122,"class":27},"Tianjin Medical University Cancer Institute and Hospital",{"name":124,"class":27},"Xiangya Hospital of Central South University",{"name":126,"class":27},"Wuhan TongJi Hospital","100605934",false,"NCT07168980","Chemotherapy With Rituximab for Aggressive B-NHL in Children and Adolescents","Intensive Chemotherapy Combined With Early, Adequate, and Intensive Use of Rituximab for Aggressive B-NHL in Children and Adolescents","B-NHL","Inclusion Criteria:\n\n* Histology or cytologically confirmed mature B-cell NHL\u002FAL(Burkitt, DLBCL, PMLBL,or aggressive mature B-cell NHL non other specified or specifiable)\n* Able to comply with scheduled follow-up and with management of toxicity\n* Signed informed consent\n\nExclusion Criteria:\n\n* Follicular lymphoma, MALT and nodular marginal zone are not included into this therapeutic study\n* Patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive HIV serology.\n* Evidence of pregnancy or lactation period. Past or current anti-cancer treatment except corticosteroids during less than one week.\n\nExclusion Criteria related to Rituximab :\n\n* Tumor cell negative for CD20\n* Prior exposure to rituximab\n* Hepatitis B carrier status history of HBV or positive serology.","ALL","18 Years",{"count":137,"type":138},87,"ESTIMATED","INTERVENTIONAL",[141,142],"PHASE2","PHASE3","The purpose of this study is to test whether intensive chemotherapy combined with early, adequate, and intensive use of Rituximab for aggressive B-NHL in children and adolescents can improve the EFS and OS compared with the historical study CCCG-BNHL-2015.",[145],"Mature B-cell Non-Hodgkin Lymphoma",[147,148,149,150],"mature B-cell non-Hodgkin lymphoma","children","adolescent","rituximab","2026-06-03",{"date":153,"type":154},"2026-06-04","ACTUAL",{"date":156,"type":154},"2025-07-01",{"date":158,"type":138},"2030-06-30",{"name":5,"class":6},1]