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Brief Title A Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation in Patients Not Eligible for Intensive Induction Chemotherapy
Official Title A Phase 2/3 Multicenter, Open-label, 3-arm, 2-Stage Randomized Study of ASP2215 (Gilteritinib), Combination of ASP2215 Plus Azacitidine and Azacitidine Alone in the Treatment of Newly Diagnosed Acute Myeloid Leukemia With FLT3 Mutation in Patients Not Eligible for Intensive Induction Chemotherapy
Principal Investigator Larson, Richard
Brief Summary The purpose of this study is to determine the efficacy superiority of ASP2215 and/or ASP2215 plus azacitidine versus azacitidine as measured by overall survival (OS) and event-free survival.
Gender Both
Ages 18 Years
Enrollment 540
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 2/Phase 3
Study Type Interventional
Contact Name
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Acute Myeloid Leukemia (AML)
Detail for Health Professional (on clinicaltrials.gov)
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