{"entity":{"id":"alfa-0701","kind":"trial","name":"ALFA-0701","aka":[],"tldr":"ALFA-0701 was the trial that rescued the first ADC: giving gemtuzumab in three small doses with chemotherapy improved event-free survival without the toxicity that got it withdrawn.","summary":"Gemtuzumab 3 mg/m² on days 1, 4, 7. Median EFS 17.3 vs 9.5 months (HR 0.56, 95% CI 0.42-0.76); relapse-free survival improved; OS not significantly different in the final analysis (27.5 vs 21.8 months). Lancet 2012; basis of the 2017 US re-approval. Meta-analysis of five trials confirmed OS benefit in favourable- and intermediate-risk cytogenetics.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00927498","url":"https://clinicaltrials.gov/study/NCT00927498"}],"tags":[],"related":[],"cancers":["aml"],"sections":[],"technologies":["adc"],"targets":["cd33"],"drugs":["gemtuzumab-ozogamicin","cytarabine-7-3"],"companies":["alfa"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00927498","phase":"3","setting":"Newly diagnosed de novo AML, age 50-70: fractionated gemtuzumab ozogamicin added to 7+3 vs 7+3 alone","sponsor":"ALFA group (France)","result":"EFS 17.3 vs 9.5 months; HR 0.56.","started":"2007-12","yearReported":2012,"enrolled":280,"enrolledBasis":"registry","outcomes":[{"endpoint":"Event-free survival (median)","primary":true,"unit":"months","arms":[{"name":"GO + 7+3","n":135,"value":17.3},{"name":"7+3","n":136,"value":9.5}],"hr":0.56,"ci":[0.42,0.76],"source":"https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)60485-1/fulltext"},{"endpoint":"Overall survival (median)","unit":"months","arms":[{"name":"GO + 7+3","value":27.5,"note":"Not significant vs control"},{"name":"7+3","value":21.8}],"source":"https://doi.org/10.1016/S0140-6736(12)60485-1"}],"replication":"Hills et al. meta-analysis (Lancet Oncology 2014, 3,325 patients) confirmed reduced relapse and improved OS in favourable/intermediate cytogenetics, none in adverse risk."},"route":"/trials/alfa-0701/","neighbours":{"cancer":[{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"}],"target":[{"id":"cd33","kind":"target","name":"CD33","route":"/targets/cd33/"}],"drug":[{"id":"cytarabine-7-3","kind":"drug","name":"Cytarabine + anthracycline ('7+3')","route":"/drugs/cytarabine-7-3/"},{"id":"gemtuzumab-ozogamicin","kind":"drug","name":"Gemtuzumab ozogamicin","route":"/drugs/gemtuzumab-ozogamicin/"}],"company":[{"id":"alfa","kind":"company","name":"ALFA (Acute Leukemia French Association)","route":"/companies/alfa/"}],"trial":[{"id":"aaml0531","kind":"trial","name":"COG AAML0531","route":"/trials/aaml0531/"}]}}