{"entity":{"id":"admiral","kind":"trial","name":"ADMIRAL","aka":[],"tldr":"Showed a pill beats intensive salvage chemotherapy in relapsed FLT3-mutated AML, with fewer days in hospital.","summary":"ADMIRAL, trial NCT02421939 sponsored by Astellas and published in the New England Journal of Medicine in 2019, showed that the FLT3 inhibitor gilteritinib as a single tablet beats intensive salvage chemotherapy in relapsed or refractory FLT3-mutated acute myeloid leukaemia, with fewer days in hospital. It randomised 371 patients, met its primary endpoints of overall survival and complete remission with partial haematological recovery, converted gilteritinib's accelerated approval to full approval and made FLT3 inhibitor monotherapy the standard bridge to transplant at relapse. OnCo links it to acute myeloid leukaemia, FLT3 as a target, gilteritinib, Alexander E. Perl and the ADMIRAL paper. Whether gilteritinib should be combined with venetoclax or chemotherapy at relapse is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02421939","url":"https://clinicaltrials.gov/study/NCT02421939"},{"label":"NEJM 2019","url":"https://www.nejm.org/doi/full/10.1056/NEJMoa1902688"}],"tags":[],"related":[],"cancers":["aml","aml-flt3"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["flt3"],"drugs":["gilteritinib"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["alexander-perl"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02421939","phase":"3","setting":"Relapsed or refractory FLT3-mutated AML: gilteritinib monotherapy vs salvage chemotherapy","sponsor":"Astellas","result":"OS 9.3 vs 5.6 months; HR 0.64.","started":"2015-10-20","startedType":"actual","yearReported":2019,"enrolled":371,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall survival (median)","primary":true,"unit":"months","arms":[{"name":"Gilteritinib","n":247,"value":9.3},{"name":"Salvage chemotherapy","n":124,"value":5.6}],"hr":0.64,"ci":[0.49,0.83],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1902688"},{"endpoint":"CR/CRh","primary":true,"unit":"%","arms":[{"name":"Gilteritinib","value":34},{"name":"Salvage chemotherapy","value":15.3}],"source":"https://doi.org/10.1056/NEJMoa1902688"}],"replication":"Real-world cohorts reproduce ~30% CR/CRh; the LACEWING trial (gilteritinib + azacitidine in unfit frontline) did not improve OS, showing the setting matters."},"route":"/trials/admiral/","neighbours":{"cancer":[{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"},{"id":"aml-flt3","kind":"cancer","name":"FLT3-mutated acute myeloid leukaemia","route":"/cancers/aml-flt3/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"flt3","kind":"target","name":"FLT3","route":"/targets/flt3/"}],"drug":[{"id":"gilteritinib","kind":"drug","name":"Gilteritinib","route":"/drugs/gilteritinib/"}],"company":[{"id":"astellas","kind":"company","name":"Astellas","route":"/companies/astellas/"}],"person":[{"id":"alexander-perl","kind":"person","name":"Alexander E. Perl","route":"/people/alexander-perl/"}],"paper":[{"id":"paper-admiral-gilteritinib-flt3-nejm-2019","kind":"paper","name":"ADMIRAL: gilteritinib pills versus chemotherapy for relapsed FLT3-mutated acute myeloid leukaemia","route":"/key-papers/paper-admiral-gilteritinib-flt3-nejm-2019/"}]}}