Last updated on January 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Acute myeloid leukemia
  • Age: Between 18 - 70 Years
  • Gender: Male or Female

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 non active lung infection are eligible)
  • Known impairment of gastrointestinal (GI) function or GI disease that might alter significantly the absorption of midostaurin
  • Cardiac or cardiac repolarization abnormality
  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 4 months after stopping medication Other protocol-defined Inclusion/Exclusion criteria may apply.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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