Overview

A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation

Status:
Active, not recruiting

Trial end date:
2022-10-31

Target enrollment:

Participant gender:

Summary

The purpose of this study is to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated AML who are refractory to or have relapsed after first-line AML therapy as shown with overall survival (OS) compared to salvage chemotherapy. In addition, this study will evaluate safety as well as 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 Inc

Treatments:

Cytarabine
Etoposide
Etoposide phosphate
Fludarabine
Fludarabine phosphate
Lenograstim
Mitoxantrone
Sargramostim