Clinical Trial

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

Active, Not Recruiting Phase 3
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Summary
The purpose of this study was to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated AML who were refractory to or had relapse after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy. In addition, this study evaluated safety as well as determined the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.
Protocol Amendment History 1 change
minor Completion pushed: 2026-03-31 -> 2027-03-31 2026-05-06
Trial Details
NCT Number NCT03182244
Lead Sponsor Astellas Pharma Inc
Conditions AML With FLT3 Mutation
Enrollment 276 participants
Start Date 2017-10-25
Primary Completion 2023-12-25 (estimated)
Study Completion 2027-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-16