A phase III randomized, double-blind study of induction (daunorubicin/cytarabine) and consolidation (high-dose cytarabine) chemotherapy + midostaurin (PKC 412) (IND # 101261) or placebo in newly diagnosed patients < 60 years of age with FLT3 mutated acute myeloid leukemia (AML) - PKC412A2301
- Conditions
- FLT3 mutated Acute Myeloid Leukemia (AML)MedDRA version: 20.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000012984
- Registration Number
- EUCTR2006-006852-37-CZ
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 500
Unequivocal diagnosis of AML (>20% blasts in the bone marrow based on the WHO classification), excluding M3 (acute promyelocytic leukemia).
Documented FLT3 mutation (ITD or point mutation), determined by analysis in a protocol-designed FLT3 screening laboratory.
Age greater than or equal to 18 years.
Age less than 60 years.
AML patients with a history of antecedent myelodyspasia (MDS) remain eligible for treatment on this trial, but must not have had prior cytotoxic therapy (e.g. azacitidine or decitabine).
Bilirubin < 2.5 times upper limit of normal.
Women of childbearing potential must have a negative serum or urine pregnancy test within a sensitivity of at least 50 mIU/ml within 16 days prior to registration and must either commit to continued abstinence from heterosexual intercourse or commit to two acceptable methods of birth control (one highly effective and one additional effective method) at the same time. This should be commenced before receiving midostaurin/placebo therapy and continue for 12 weeks after completion of all midostaurin therapy.
Men must agree not to father a child and must use a latex condom during any sexual contact with women of childbearing potential while taking midostaurin/placebo and for 12 weeks after therapy is stopped, even if they have undergone a successful vasectomy.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
No prior chemotherapy for leukemia or myelodysplasia with the following exceptions:
- emergency leukapheresis
- emergency treatment for hyperleukocytosis with hydroxyurea for less than or equal to 5 days
- cranial RT for CNS leukostasis (one dose only)
- growth factor/cytokine support
Patients who have developed therapy related AML after prior RT or chemotherapy for another cancer or disorder are not eligible.
Patients with symptomatic congestive heart failure are not eligible.
Pregnant or nursing patients may not be enrolled.
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