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Clinical Trial Details

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Brief Title Quizartinib With Standard of Care Chemotherapy and as Maintenance Therapy in Patients With Newly Diagnosed FLT3-ITD (+) AML
Official Title A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib (AC220) Administered in Combination With Induction and Consolidation Chemotherapy, and Administered as Maintenance Therapy in Subjects 18 to 75 Years Old With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia
Principal Investigator Larson, Richard
Brief Summary This is a phase 3, randomized, double-blind, placebo-control global study. The purpose of this study is to compare the effect of quizartinib versus placebo (administered with standard induction and consolidation chemotherapy, then administered as maintenance therapy for up to 12 cycles) on event-free survival in subjects with FLT3-ITD positive AML.
Gender Both
Ages 18 Years
Enrollment 536
Accepts Healthy Volunteers No
Lead Sponsor Daiichi Sankyo Inc.Industry
Collaborator
Study Design Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), 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 Acute Myeloid Leukemia
Detail for Health Professional (on clinicaltrials.gov)
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