Clinical Trial 19456

Study Title

Phase III Randomized Study of Crenolanib versus Midostaurin Administered Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed Subjects with FLT3 Mutated Acute Myeloid Leukemia

Summary

This study is to compare the efficacy of an investigational drug called crenolanib with midostaurin (RYDAPT®) which has been approved for treatment of newly diagnosed acute myeloid leukemia patients with FLT3 mutations. Crenolanib has not yet been approved for use by the United States Food and Drug Administration (FDA).

Objective

Primary Objective To compare the efficacy of crenolanib with midostaurin administered following induction chemotherapy and consolidation therapy on event-free survival (EFS) in newly diagnosed acute myeloid leukemia subjects with FLT3 mutation. Secondary Objectives To compare the efficacy of crenolanib with midostaurin administered following induction chemotherapy and consolidation therapy on: Overall survival, Relapse free survival, Composite complete remission rate, Duration of response To assess the safety and tolerability of crenolanib compared with midostaurin administered following induction chemotherapy and consolidation therapy on: Early death (ED), Duration of hematologic recovery, Incidence and relatedness of adverse events (AE) Explorative objectives 1. To compare the baseline FLT3 allelic burden and treatment outcome of the crenolanib treatment arm with that of midostaurin administered following induction chemotherapy and consolidation therapy 2. To compare the efficacy of crenolanib with midostaurin administered following induction chemotherapy and consolidation therapy by investigating subjects molecular disease response