Open-Label, Multicenter Phase Ib/IIa Study For the Evaluation of Dasatinib (Sprycel™) Following Induction and Consolida-tion Therapy as Well as in Maintenance Therapy in Patients With Newly Diagnosed Core Binding Factor (CBF) Acute Myeloid Leukemia (AML)
- Core binding factor (CBF) AML with molecular diagnosis of RUNX1-RUNX1T1 fusion
transcript resulting from t(8;21)(q22;q22) (or a variant form) or of CBFB-MYH11
fusion transcript resulting from inv(16)(p13.1q22)/t(16;16)(p13.1;q22) as assessed in
one of the central AMLSG reference laboratories.
- Age ≥ 18; there is no upper age limit.
- No prior chemotherapy for leukemia except hydroxyurea for up to 5 days during the
diag-nostic screening phase.
- Non-pregnant and non-nursing. Due to the unknown teratogenic potential of dasatinib
in humans, pregnant or nursing patients may not be enrolled. Women of childbearing
poten-tial (WOCBP) must have a negative serum or urine pregnancy test within a
sensitivity of at least 25 mIU/mL within 72 hours prior to registration. Women of
child-bearing potential must either commit to continued abstinence from heterosexual
intercourse or begin TWO acceptable methods of birth control - one highly effective
method (e.g., IUD, hormonal, tubal ligation, or partner's vasectomy), and one
additional effective method (e.g., latex condom, diaphragm, or cervical cap) - AT THE
SAME TIME, at least four weeks before she begins dasatinib therapy. "Women of
childbearing potential" is defined as a sexually active mature woman who has not
undergone a hysterectomy or who has had menses at any time in the preceding 24
- Men must agree not to father a child and must use a latex condom during any sexual
con-tact with women of childbearing potential while taking dasatinib and for 4 weeks
after therapy is stopped, even if they have undergone a successful vasectomy.
- Signed written informed consent
- Performance status WHO >2
- Pulmonary edema and/or pleural/pericardial effusion within 14 days of Day 1. If
edema/effusion resolves to CTC Grade ≤ 1, patients can be treated with dasatinib.
- Patients with ejection fraction < 50% by echocardiography within 14 days of day 1
- Organ insufficiency (creatinine >1.5x upper normal serum level; bilirubin, AST or AP
>2.5x upper normal serum level; heart failure NYHA III/IV; severe obstructive or
restrictive ventilation disorder)
- Uncontrolled infection
- Severe neurological or psychiatric disorder interfering with ability of giving an
- Known positive for HIV
- Bleeding disorder independent of leukemia
- No consent for registration, storage and processing of the individual
disease-characteristics and course