A Study of Midostaurin Efficacy and Safety in Newly Diagnosed Patients With FLT3-mutated AML

Inclusion Criteria: * Diagnosis of AML (≥ 20% blasts in the bone marrow based on WHO 2016 classification). Patients with APL (acute promyelocytic leukemia) with PML-RARA are not eligible * Documented presence of an ITD and/or TKD activating mutation in the FLT3 gene, as determined by analysis in a Novartis designated laboratory An exception will be patients who are enrolled into the part 1 in Japan, who may be treated with midostaurin irrespective of AML FLT3 genotype. * Patients must meet the following laboratory value criteria that indicate adequate organ function at the screening visit: * Estimated creatinine clearance ≥ 30 ml/min * Total bilirubin ≤ 1.5 x ULN, except in the setting of isolated Gilbert syndrome * Aspartate transaminase (AST) ≤ 3.0 x ULN * Alanine transaminase (ALT) ≤ 3.0 x ULN * Suitability for intensive chemotherapy in the judgment of the investigator Exclusion Criteria: * Neurologic symptoms suggestive of CNS leukemia unless CNS leukemia has been excluded by a lumbar puncture. Patients with CSF fluid positive for AML blasts are not eligible * Developed therapy-related AML after prior radiotherapy (RT) or chemotherapy for another cancer or disorder * Known hypersensitivity to midostaurin, cytarabine or daunorubicin or to any of the excipients of midostaurin/placebo, cytarabine or daunorubicin * Abnormal chest X-ray unless the abnormality represents a non-active, or non-clinically significant finding, such as scarring (subjects with controlled …