A phase III, randomized, double-blind study of chemotherapy with daunorubicin or idarubicin and cytarabine for induction and intermediate dose cytarabine for consolidation plus midostaurin (PKC412) or chemotherapy plus placebo in newly diagnosed patients with FLT-3 mutation negative acute myeloid leukemia (AML)
Phase 2
Completed
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 502
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>exploratory<br>pharmacokinetics