A randomized phase III trial studying giving daunorubicin and cytarabine with or without midostaurin followed by high-dose cytarabine and midostaurin to see how well it works in treating patients with newly diagnosed acute myeloid leukemia.
- Conditions
- newly diagnosed FLT3 mutated acute myeloid leukemiaMedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2006-006852-37-AT
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 714
- Unequivocal diagnosis of AML (> 20% blasts in the bone marrow based on the WHO classification, excluding M3 (acute promyelocytic leukemia)
- Documented FLT3 mutation
- Age =18 and < 60 years
- No prior chemotherapy for leukemia or myelodysplasia with few exception listed (see protocol section 4)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 714
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Patients who have developed therapy related AML after prior RT or chemotherapy for another disorder or cancer
- Patients with symptomatic congestive heart failure
- Total bilirubin >= 2.5x upper limit of normal
- Pregnant or nursing patients
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method