Summary
You may be eligible for this study if you have newly diagnosed FMS-like tyrosine 3 (FLT3)-internal tandem duplication (ITD) negative acute myeloid leukaemia.
The trial is comparing the effect of a targeted drug called quizartinib versus placebo which will be given with standard induction and consolidation chemotherapy (cytarabine and daunorubicin or idarubicin), then administered as maintenance therapy for up to 36 cycles. Treatment cycles are 28-days.
Eligible participants will be randomly allocated to one of three treatment arms.
In Arm A (Experimental), participants will receive quizartinib + chemotherapy. Quizartinib will be given orally once daily for 14 days starting after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenance Phase, participants will receive quizartinib orally once daily for up to 36 cycles.
In Arm B (Placebo Comparator), participants will receive a placebo + chemotherapy. Placebo will be given orally once daily for 14 days starting after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenance Phase, participants will receive placebo orally once daily for up to 36 cycles.
In Arm C (Experimental), participants will receive quizartinib + chemotherapy then placebo maintence. Quizartinib will be given orally once daily for 14 days after the completion of chemotherapy in Induction and Consolidation Phase. In the Maintenence Phase, participants will receive placebo orally once daily for up to 36 cycles.