{"entity":{"id":"inter-b-nhl-ritux-2010","kind":"trial","name":"Inter-B-NHL Ritux 2010","aka":[],"tldr":"Adding the antibody rituximab to intensive chemotherapy in children with high-risk Burkitt and related lymphomas cut treatment failures by about two-thirds, making an already curable disease more so. It is the model of a joint European-North American children's cancer trial.","summary":"Open-label international randomised phase 3 (Minard-Colin et al., NEJM 2020). Among 328 randomised patients (164 per arm; 85.7% Burkitt lymphoma), events occurred in 10 with rituximab-chemotherapy versus 28 with chemotherapy alone. Three-year event-free survival was 93.9% (95% CI 89.1 to 96.7) versus 82.3% (95% CI 75.7 to 87.5), HR 0.32 (95% CI 0.15 to 0.66), and overall survival also improved. Randomisation was stopped early for efficacy and all subsequent patients received rituximab. Rituximab roughly doubled the rate of hypogammaglobulinaemia and increased infections, so immune monitoring is part of follow-up. Rituximab plus LMB is now the standard for high-risk paediatric mature B-cell lymphoma on both sides of the Atlantic and formed the basis of the 2021 FDA paediatric label extension for rituximab.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT01516580","url":"https://clinicaltrials.gov/study/NCT01516580"},{"label":"Minard-Colin et al., NEJM 2020","url":"https://doi.org/10.1056/NEJMoa1915315"}],"tags":["nci-coverage","paediatric","haematologic"],"related":[],"cancers":["burkitt-lymphoma","dlbcl"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["cd20"],"drugs":["rituximab","methotrexate","cyclophosphamide","doxorubicin","vincristine","cytarabine-7-3","etoposide"],"companies":["childrens-oncology-group"],"institutions":["gustave-roussy","siop-europe"],"pathways":[],"terms":["hypogammaglobulinaemia"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-minard-colin-n-engl-j-med"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01516580","phase":"3","setting":"High-risk mature B-cell non-Hodgkin lymphoma or B-acute leukaemia in patients under 18 (mostly Burkitt lymphoma): LMB chemotherapy with or without six doses of rituximab","sponsor":"Gustave Roussy (European Intergroup for Childhood NHL) and Children's Oncology Group","result":"3-year EFS 93.9% vs 82.3%, HR 0.32; OS also improved.","started":"2011-12","startedType":"actual","yearReported":2020,"enrolled":482,"enrolledBasis":"registry","outcomes":[{"endpoint":"3-year event-free survival","primary":true,"unit":"%","arms":[{"name":"Rituximab + LMB chemotherapy","n":164,"value":93.9},{"name":"LMB chemotherapy","n":164,"value":82.3}],"hr":0.32,"ci":[0.15,0.66],"p":"0.00096 (one-sided)","source":"https://doi.org/10.1056/NEJMoa1915315"}],"replication":"Consistent with the adult experience of rituximab in aggressive B-cell lymphoma (CODOX-M/IVAC-R, DA-EPOCH-R) and with the earlier COG ANHL01P1 pilot; no contradicting paediatric data."},"route":"/trials/inter-b-nhl-ritux-2010/","neighbours":{"cancer":[{"id":"burkitt-lymphoma","kind":"cancer","name":"Burkitt lymphoma","route":"/cancers/burkitt-lymphoma/"},{"id":"dlbcl","kind":"cancer","name":"Diffuse large B-cell lymphoma","route":"/cancers/dlbcl/"}],"technology":[{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"target":[{"id":"cd20","kind":"target","name":"CD20","route":"/targets/cd20/"}],"drug":[{"id":"cyclophosphamide","kind":"drug","name":"Cyclophosphamide","route":"/drugs/cyclophosphamide/"},{"id":"cytarabine-7-3","kind":"drug","name":"Cytarabine + anthracycline ('7+3')","route":"/drugs/cytarabine-7-3/"},{"id":"doxorubicin","kind":"drug","name":"Doxorubicin","route":"/drugs/doxorubicin/"},{"id":"etoposide","kind":"drug","name":"Etoposide","route":"/drugs/etoposide/"},{"id":"methotrexate","kind":"drug","name":"Methotrexate","route":"/drugs/methotrexate/"},{"id":"rituximab","kind":"drug","name":"Rituximab","route":"/drugs/rituximab/"},{"id":"vincristine","kind":"drug","name":"Vincristine","route":"/drugs/vincristine/"}],"company":[{"id":"childrens-oncology-group","kind":"company","name":"Children's Oncology Group (COG)","route":"/companies/childrens-oncology-group/"}],"institution":[{"id":"gustave-roussy","kind":"institution","name":"Gustave Roussy","route":"/institutions/gustave-roussy/"},{"id":"siop-europe","kind":"institution","name":"SIOP Europe (European Society for Paediatric Oncology)","route":"/institutions/siop-europe/"}],"term":[{"id":"hypogammaglobulinaemia","kind":"term","name":"Hypogammaglobulinaemia and infection risk after B-cell therapies","route":"/terms/hypogammaglobulinaemia/"}],"paper":[{"id":"paper-minard-colin-n-engl-j-med","kind":"paper","name":"Rituximab for High-Risk, Mature B-Cell Non-Hodgkin's Lymphoma in Children","route":"/key-papers/paper-minard-colin-n-engl-j-med/"}],"roadmap":[{"id":"paediatric-oncology-roadmap","kind":"roadmap","name":"Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first","route":"/roadmaps/paediatric-oncology-roadmap/"}]}}