Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia

For this trial, patients will be treated with CPX-351 100 (daunorubicin 44 mg/m2 and cytarabine 100 mg/m2) for 3 doses on days 1, 3 and 5 of one and on days 1 + 3 of a second cycle of induction therapy, depending on response obtained following the first induction. Thereafter, up to 2 cycles of consolidation therapy of 2 doses on days 1 and 3 of daunorubicin 29 mg/m2 and cytarabine 65 mg/m2 will be administered to the patients.

The FLT3 directed inhibitor, midostaurin, will be given at a dose of 50mg twice daily, starting on day 8 through day 21 of each cycle of CPX-351 until admission for allogeneic stem cell transplant.

0.8 mg/kg/dose every six hours x 12 doses administered intravenously

70 mg/m2/day x 2 doses administered intravenously

25 mg/m2/day x 5 doses administered intravenously

Allogeneic stem cell transplant infused intravenously