A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation

• Status: Active, not recruiting
• Trial end date: 2021-12-31

Summary

The purpose of this study is to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated acute myeloid leukemia (AML) who are refractory to or have relapsed after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy, and to determine the efficacy of ASP2215 therapy as assessed by the rate of complete remission and complete remission with partial hematological recovery (CR/CRh) in these participants.

This study will also determine the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.

• Phase: Phase 3

Details

• Lead Sponsor: Astellas Pharma Global Development, Inc.
• Treatments: Azacitidine; Cytarabine; Etoposide; Fludarabine; Fludarabine phosphate; Idarubicin; Lenograstim; Mitoxantrone; Sargramostim