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 Mye-loid Leukemia (AML) - AMLSG 11-08 - AMLSG 11-08
- Conditions
- ewly diagnosed core binding factor acute myeloid leukemia.
- Registration Number
- EUCTR2008-008238-35-AT
- Lead Sponsor
- niversitätsklinikum Ulm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 25
•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 consecutive months.
•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
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) yes
F.1.3.1 Number of subjects for this age range
•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
•Patients with a currently active” second malignancy other than non-melanoma skin can-cers. Patients are not considered to have a currently active” malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of re-lapse within one year.
•Severe neurological or psychiatric disorder interfering with ability of giving an informed consent
•Known positive for HIV
•Bleeding disorder independent of leukemia
•No consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician about study participation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Primary Endpoint: <br>•Feasibility as a combined endpoint is defined by:<br>•Rate of early/hypoplastic death (Rate(ED/HD))<10% <br>•Rate of pleural or pericardial effusion grade 3/4 (Rate(effuse))<10%<br>•Rate of liver toxicity grade 3 or 4 that does not improve to grade 2 or less within 14 days after discontinuing responsible medication (Rate(liver))<10%<br>•Rate of refractory disease (Rate(RD))<10%<br>;Main Objective: Primary Objective: <br>•To assess the feasibility of dasatinib 100 mg QD given after intensive induction (daunoru-bicin and cytarabine) and consolidation chemotherapy (high-dose cytarabine) and as sin-gle agent in maintenance therapy.<br>;Secondary Objective: Secondary Objective(s):<br>•To assess survival endpoints such as cumulative incidence of relapse (CIR) and death (CID), and overall survival (OS)<br>
- Secondary Outcome Measures
Name Time Method