A Global Study of the Efficacy and Safety of Midostaurin + Chemotherapy in Newly Diagnosed Patients With FLT3 Mutation Negative (FLT3-MN) Acute Myeloid Leukemia (AML)

Inclusion Criteria:

1. Diagnosis of AML (≥20% blasts in the bone marrow based on WHO 2016 classification).
Patients with APL with PML-RARA are not eligible.

2. Suitability for intensive induction chemotherapy in the judgment of the investigator

3. Documented absence of an ITD and TKD activating mutation at codons D835 and I836 in
the FLT3 gene, as determined by analysis in a Novartis designated laboratory using a
validated clinical trial assay with clinical cutoff of 0.05 mutant to wild type signal
ratio

4. Age ≥18 years

5. Laboratory values that indicate adequate organ function assessed locally at the
screening visit

Exclusion Criteria:

1. Central nervous system (CNS) leukemia

2. Therapy-related secondary AML

3. Isolated extramedullary leukemia

4. Prior therapy for leukemia or myelodysplasia

5. AML after antecedent myelodysplasia (MDS) with prior cytotoxic treatment (e.g.,
azacytidine or decitabine)

6. Prior treatment with a FLT3 inhibitor (e.g., midostaurin, quizartinib, sorafenib)