Alzenau

Researchers are investigating the effects of quizartinib compared to a placebo, both combined with chemotherapy, in adults newly diagnosed with FLT3-internal tandem duplication (ITD) negative acute myeloid leukemia (AML). This phase 3 clinical trial focuses on overall survival as the primary outcome and involves testing participants for FLT3-ITD mutation status at a central laboratory using a validated assay. Participants will receive either quizartinib or placebo at a dose of 60 mg taken orally once daily. Both groups will also receive standard induction and consolidation chemotherapy using cytarabine and an anthracycline (daunorubicin or idarubicin). After chemotherapy, quizartinib or placebo will be administered as maintenance therapy for up to 36 cycles. During the study, participants will be monitored for overall survival up to approximately 42 months from when the first patient is randomized to reach the target number of deaths. The study involves regular assessments including treatment monitoring and safety evaluations throughout the induction, consolidation, and maintenance phases to evaluate the effect of quizartinib in this patient population.