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Patients with acute myeloid leukemia (AML) and FMS-like tyrosine kinase 3 (FLT3) internal tandem duplication (ITD) mutations have a poor prognosis with standard induction chemotherapy but improved outcomes with the use of a FLT3 inhibitor and allogeneic stem-cell transplantation (alloSCT). Investigators now report the results of a phase 3, industry-sponsored, multinational, double-blind trial in patients with newly diagnosed AML and FLT3-ITD mutations. A total of 539 patients (median age, 56) were randomized to the once-daily oral FLT3 inhibitor quizartinib or placebo, each given in combination with induction and consolidation chemotherapy followed by up to 3 years of maintenance quizartinib or placebo. Patients with a suitable donor also u…