{"entity":{"id":"aall0434","kind":"trial","name":"COG AALL0434","aka":["AALL0434"],"tldr":"AALL0434 was the largest trial ever run in childhood T-cell leukaemia; it showed that adding the drug nelarabine to standard chemotherapy cut relapses, and that most children could be cured without radiation to the brain.","summary":"The Children's Oncology Group trial AALL0434 enrolled 1895 patients aged 1 to 30 with newly diagnosed T-cell acute lymphoblastic leukaemia or T-lymphoblastic lymphoma. Intermediate- and high-risk patients were randomised in a two-by-two design to augmented Berlin-Frankfurt-Munster chemotherapy with or without six courses of nelarabine, and to Capizzi escalating-dose methotrexate with pegaspargase or to high-dose methotrexate.\n\nNelarabine improved disease-free survival in T-cell leukaemia, with fewer central nervous system relapses, and the Capizzi methotrexate arm outperformed high-dose methotrexate. Cranial irradiation was omitted for all but the highest-risk group without excess central nervous system relapse. Overall survival across the trial was the best yet reported for T-cell leukaemia, and nelarabine became part of front-line therapy for higher-risk disease.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00408005","url":"https://clinicaltrials.gov/study/NCT00408005"}],"tags":["subtype-trials"],"related":[],"cancers":["all-paediatric-high-risk","all-leukemia"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["nelarabine","methotrexate"],"companies":["childrens-oncology-group"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["kimberly-dunsmore"],"bottlenecks":[],"keyPapers":["paper-aall0434-nelarabine-t-all-dunsmore-jco-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00408005","phase":"3","setting":"Newly diagnosed T-cell acute lymphoblastic leukaemia and lymphoblastic lymphoma in children and young adults: augmented BFM chemotherapy with or without nelarabine, and Capizzi-style escalating methotrexate against high-dose methotrexate","sponsor":"Children's Oncology Group (National Cancer Institute)","result":"Nelarabine improved disease-free survival in T-cell acute lymphoblastic leukaemia, and Capizzi methotrexate outperformed high-dose methotrexate.","started":"2007-01-30","startedType":"actual","yearReported":2020,"enrolled":1895,"enrolledBasis":"registry","outcomes":[{"endpoint":"Disease-free survival at 5 years (nelarabine randomisation)","unit":"%","arms":[{"name":"Nelarabine","n":323,"value":88.2},{"name":"No nelarabine","n":336,"value":82.1}],"p":"0.029","source":"https://doi.org/10.1200/JCO.20.00256"},{"endpoint":"Isolated or combined CNS relapse","unit":"%","arms":[{"name":"Nelarabine","value":1.3},{"name":"No nelarabine","value":6.9}],"p":"0.0001","source":"https://doi.org/10.1200/JCO.20.00256"},{"endpoint":"Event-free survival at 5 years, all patients","unit":"%","arms":[{"name":"All patients","n":1562,"value":83.7}],"source":"https://doi.org/10.1200/JCO.20.00256"},{"endpoint":"Overall survival at 5 years, all patients","unit":"%","arms":[{"name":"All patients","n":1562,"value":89.5}],"source":"https://doi.org/10.1200/JCO.20.00256"}]},"route":"/trials/aall0434/","neighbours":{"cancer":[{"id":"all-leukemia","kind":"cancer","name":"Acute lymphoblastic leukaemia","route":"/cancers/all-leukemia/"},{"id":"all-paediatric-high-risk","kind":"cancer","name":"High-risk acute lymphoblastic leukaemia in children (high-risk B-ALL and T-ALL)","route":"/cancers/all-paediatric-high-risk/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"methotrexate","kind":"drug","name":"Methotrexate","route":"/drugs/methotrexate/"},{"id":"nelarabine","kind":"drug","name":"Nelarabine","route":"/drugs/nelarabine/"}],"company":[{"id":"childrens-oncology-group","kind":"company","name":"Children's Oncology Group (COG)","route":"/companies/childrens-oncology-group/"}],"person":[{"id":"kimberly-dunsmore","kind":"person","name":"Kimberly P. Dunsmore","route":"/people/kimberly-dunsmore/"}],"paper":[{"id":"paper-aall0434-nelarabine-t-all-dunsmore-jco-2020","kind":"paper","name":"AALL0434: nelarabine in newly diagnosed T-cell acute lymphoblastic leukaemia in children and young adults","route":"/key-papers/paper-aall0434-nelarabine-t-all-dunsmore-jco-2020/"}]}}