{"entity":{"id":"nct03182244","kind":"trial","name":"A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation","aka":[],"tldr":"A phase 3 trial of Gilteritinib, Cytarabine, Mitoxantrone, Etoposide and Fludarabine in acute myeloid leukaemia, run by Astellas Pharma Inc, now completed.","summary":"A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation is a phase 3 interventional study registered as NCT03182244 by Astellas Pharma Inc, with 276 participants enrolled, started 2017-10-25 and reached its primary completion in 2023-12-25. Interventions recorded: Gilteritinib, Cytarabine, Mitoxantrone, Etoposide, G-CSF and Fludarabine. Results have been posted on the registry.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT03182244","url":"https://clinicaltrials.gov/study/NCT03182244"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["aml","aml-flt3"],"sections":[],"technologies":[],"targets":[],"drugs":["gilteritinib","cytarabine","mitoxantrone","etoposide","fludarabine"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Registry status on 22 September 2026: Completed (registry record last updated 22 September 2026; primary completion reached 25 December 2023)."],"nct":"NCT03182244","phase":"3","setting":"Phase 3 Open-label, Multicenter, Randomized Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation","sponsor":"Astellas Pharma Inc","started":"2017-10-25","startedType":"actual","yearReported":2025,"enrolled":276,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival (OS)","primary":true,"unit":"months","arms":[{"name":"Gilteritinib","n":137,"value":10.3,"note":"95% CI 8.8 to 12.7; Figures from the ClinicalTrials.gov results section (first posted 2025-01-14), not from a publication"},{"name":"Salvage Chemotherapy","n":139,"value":5.4,"note":"95% CI 4.1 to 8.1"}],"hr":0.612,"ci":[0.451,0.832],"p":"0.00152","source":"https://clinicaltrials.gov/study/NCT03182244?tab=results"}]},"route":"/trials/nct03182244/","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/"}],"drug":[{"id":"cytarabine","kind":"drug","name":"Cytarabine","route":"/drugs/cytarabine/"},{"id":"etoposide","kind":"drug","name":"Etoposide","route":"/drugs/etoposide/"},{"id":"fludarabine","kind":"drug","name":"Fludarabine","route":"/drugs/fludarabine/"},{"id":"gilteritinib","kind":"drug","name":"Gilteritinib","route":"/drugs/gilteritinib/"},{"id":"mitoxantrone","kind":"drug","name":"Mitoxantrone","route":"/drugs/mitoxantrone/"}],"company":[{"id":"astellas","kind":"company","name":"Astellas","route":"/companies/astellas/"}]}}