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Trial ID: NCT00651261
A Phase III Randomized, Double-Blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy + Midostaurin (PKC412) (IND #101261) or Placebo in Newly Diagnosed Patients < 60 Years of Age With FLT3 Mutated Acute Myeloid Leukemia (AML)
Professor of Medicine (Hematology)
Clinical Associate Professor, Medicine - Hematology
1. Documentation of Disease:
- Unequivocal diagnosis of AML ( > 20% blasts in the bone marrow based on the WHO
classification), excluding M3 (acute promyelocytic leukemia). Patients with
neurologic symptoms suggestive of CNS leukemia are recommended to have a lumbar
puncture. Patients whose CSF is positive for AML blasts are not eligible.
- Documented FLT3 mutation (ITD or point mutation), determined by analysis in a
protocol- designated FLT3 screening laboratory.
2. Age Requirement:
- Age ≥ 18 and < 60 years
3. Prior Therapy:
- No prior chemotherapy for leukemia or myelodysplasia with the following
- emergency leukapheresis
- emergency treatment for hyperleukocytosis with hydroxyurea for ≤ 5 days
- cranial RT for CNS leukostasis (one dose only)
- growth factor/cytokine support
- AML patients with a history of antecedent myelodysplasia (MDS) remain eligible
for treatment on this trial, but must not have had prior cytotoxic therapy (e.g.,
azacitidine or decitabine)
- Patients who have developed therapy related AML after prior RT or chemotherapy
for another cancer or disorder are not eligible.
4. Cardiac Function: Patients with symptomatic congestive heart failure are not eligible.
5. Initial Laboratory Value: Total bilirubin < 2.5 x ULN (Upper Limit of Normal)
6. Pregnancy and Nursing Status:
- Non-pregnant and non-nursing due to the unknown teratogenic potential of
midostaurin in humans, pregnant or nursing patients may not be enrolled.
- 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
- Women of child-bearing potential must either commit to continued abstinence from
heterosexual intercourse or commit to TWO acceptable methods of birth control:
- one highly effective method (eg, IUD, hormonal (non-oral contraceptive),
tubal ligation, or partner's vasectomy) and
- one additional effective method (e.g., latex condom, diaphragm or cervical
- The two acceptable methods of birth control must be used AT THE SAME TIME, before
beginning midostaurin/placebo therapy and continuing for 12 weeks after
completion of all therapy.
- Note that oral contraceptives are not considered a high effective method because
of the possibility of a drug interaction with midostaurin.
- Women of childbearing potential is defined as a sexually active mature woman who
has not undergone a hysterectomy or who has not had menses at any time in the
preceding 24 consecutive months.
- 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.
drug: dexamethasone acetate
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Cancer Clinical Trials Office