Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

1. Documentation of Disease:

* Unequivocal diagnosis of AML ( \> 20% blasts in the bone marrow based on the WHO classification), excluding M3 (acute promyelocytic leukemia). Patients with neurologic symptoms suggestive of CNS leukemia are recommended to have a lumbar puncture. Patients whose CSF is positive for AML blasts are not eligible.
* Documented FLT3 mutation (ITD or point mutation), determined by analysis in a protocol- designated FLT3 screening laboratory.
2. Age Requirement:

* Age ≥ 18 and \< 60 years
3. Prior Therapy:

* No prior chemotherapy for leukemia or myelodysplasia with the following exceptions:

* emergency leukapheresis
* emergency treatment for hyperleukocytosis with hydroxyurea for ≤ 5 days
* cranial RT for CNS leukostasis (one dose only)
* growth factor/cytokine support
* AML patients with a history of antecedent myelodysplasia (MDS) remain eligible for treatment on this trial, but must not have had prior cytotoxic therapy (e.g., azacitidine or decitabine)
* Patients who have developed therapy related AML after prior RT or chemotherapy for another cancer or disorder are not eligible.
4. Cardiac Function: Patients with symptomatic congestive heart failure are not eligible.
5. Initial Laboratory Value: Total bilirubin \< 2.5 x ULN (Upper Limit of Normal)
6. Pregnancy and Nursing Status:

* Non-pregnant and non-nursing due to the unknown teratogenic potential of midostaurin in humans, pregnant or nursing patients may not be enrolled.
* Women of childbearing potential must have a negative serum or urine pregnancy test within a sensitivity of at least 50 mIU/mL within 16 days prior to registration.
* Women of child-bearing potential must either commit to continued abstinence from heterosexual intercourse or commit to TWO acceptable methods of birth control:

* one highly effective method (eg, IUD, hormonal (non-oral contraceptive), tubal ligation, or partner's vasectomy) and
* one additional effective method (e.g., latex condom, diaphragm or cervical cap)
* The two acceptable methods of birth control must be used AT THE SAME TIME, before beginning midostaurin/placebo therapy and continuing for 12 weeks after completion of all therapy.
* Note that oral contraceptives are not considered a high effective method because of the possibility of a drug interaction with midostaurin.
* Women of childbearing potential is defined as a sexually active mature woman who has not undergone a hysterectomy or who has not had menses at any time in the preceding 24 consecutive months.
* Men must agree not to father a child and must use a latex condom during any sexual contact with women of childbearing potential while taking midostaurin/placebo and for 12 weeks after therapy is stopped, even if they have undergone a successful vasectomy.