the Image

Clinical Trial Details

If you are a patient or a caregiver and would like to learn more our cancer clinical trials call toll-free 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials) or email cancerclinicaltrials@bsd.uchicago.edu .

Share this:
Brief Title A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation
Official Title A 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
Principal Investigator Larson, Richard
Brief Summary The purpose of this study is to determine the clinical benefit of ASP2215 therapy in patients 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 compared to salvage chemotherapy. This study will also determine the overall efficacy in event-free survival (EFS) and complete remission (CR) rate of ASP2215 compared to salvage chemotherapy.
Gender Both
Ages 18 Years
Enrollment 369
Accepts Healthy Volunteers No
Lead Sponsor Astellas Pharma Global Development, Inc.Industry
Collaborator
Study Design Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Phase Phase 3
Study Type Interventional
Contact Name
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Leukemia, Acute Myeloid (AML)
Detail for Health Professional (on clinicaltrials.gov)
More clinical trials by this PI