RATIFY — Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia (RATIFY)

Phase 3 · 2017 · Acute Myeloid Leukemia

Design

Double-blind randomized trial adding midostaurin or placebo to standard 7+3 induction and high-dose cytarabine consolidation, then maintenance.

Population

Adults 18-59 with newly diagnosed FLT3-mutated (ITD or TKD) acute myeloid leukemia.

Primary Endpoint

overall survival (OS)

Key Result

Median OS 74.7 vs 25.6 months (HR 0.78, p=0.009) and improved event-free survival with midostaurin.

Guideline Impact

NCCN category 1 for newly diagnosed FLT3-mutated AML