{"entity":{"id":"paper-aaml0531-gemtuzumab-gamis-jco-2014","kind":"paper","name":"AAML0531: gemtuzumab ozogamicin added to chemotherapy for children and adolescents with acute myeloid leukaemia","aka":[],"tldr":"Adding the CD33-targeted antibody-drug conjugate gemtuzumab ozogamicin to two courses of chemotherapy reduced relapses in childhood acute myeloid leukaemia, most clearly in the high-risk group, and it was later restored to the paediatric label.","summary":"Phase 3 trial of 1,022 children, adolescents and young adults with newly diagnosed AML randomised to standard chemotherapy with or without gemtuzumab ozogamicin in induction and intensification.\n\nEvent-free survival at three years was 53.1 versus 46.9 percent (hazard ratio 0.83) with relapse risk reduced from 41 to 33 percent; overall survival was not significantly different (69.4 versus 65.4 percent), and benefit was greatest in high-risk patients and those with high CD33 expression.","asOf":"2026-09-17","links":[{"label":"J Clin Oncol 2014","url":"https://doi.org/10.1200/JCO.2014.55.3628"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/25092781/"}],"tags":[],"related":[],"cancers":["aml-paediatric"],"sections":[],"technologies":[],"targets":[],"drugs":["gemtuzumab-ozogamicin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["aaml0531"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":["jco"],"dependsOn":[],"notes":[],"journal":"Journal of Clinical Oncology","year":2014,"doi":"10.1200/JCO.2014.55.3628","pmid":"25092781","authors":"Gamis AS, Alonzo TA, Meshinchi S, et al.","paperType":"rct","findings":["Three-year event-free survival 53.1 percent vs 46.9 percent; relapse risk 32.8 percent vs 41.3 percent.","Overall survival 69.4 percent vs 65.4 percent (not significant)."],"whatItMeans":"Gemtuzumab ozogamicin is part of standard induction for CD33-positive childhood AML in Children's Oncology Group protocols.","caveats":["Higher treatment-related mortality offset part of the relapse reduction.","Benefit depends on CD33 expression and splicing genotype."],"changedPractice":true,"participants":1022},"route":"/key-papers/paper-aaml0531-gemtuzumab-gamis-jco-2014/","neighbours":{"cancer":[{"id":"aml-paediatric","kind":"cancer","name":"Acute myeloid leukaemia in children","route":"/cancers/aml-paediatric/"}],"drug":[{"id":"gemtuzumab-ozogamicin","kind":"drug","name":"Gemtuzumab ozogamicin","route":"/drugs/gemtuzumab-ozogamicin/"}],"trial":[{"id":"aaml0531","kind":"trial","name":"COG AAML0531","route":"/trials/aaml0531/"}],"journal":[{"id":"jco","kind":"journal","name":"Journal of Clinical Oncology","route":"/journals/jco/"}]}}