Study to Assess Dasatinib in Patients With Core Binding Factors Acute Myelogenous Leukemia
- Registration Number
- NCT02113319
- Lead Sponsor
- University Hospital, Angers
- Brief Summary
In patients with Core Binding Factors Acute Myelogenous Leukemia, the level of Minimal Residual Disease after chemotherapy is predictive of relapse. The relapse risk is also increased in case of mutations of receptors tyrosine kinase. For patients with a high Minimal Residual Disease level at the end of consolidation or in molecular relapse, maintenance by the inhibitor dasatinib is proposed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
- Patient presenting de novo or secondary Core Binding Factors Acute Myelogenous Leukemia
- Patient in first and presenting one of following criteria:
- "Resistant" Patient: decrease of less than 3 log of the Acute Myelogenous Leukemia transcript level in the bone marrow after 2 consolidations
- Patient in " molecular relapse ": increase of of more than 1 log of the Core Acute Myelogenous Leukemia transcript level on two successive marrow samples
Exclusion Criteria
- Woman of childbearing potential
- Concurrent incurable malignacy other than Acute Myelogenous Leukemia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description dasatinib dasatinib -
- Primary Outcome Measures
Name Time Method measure relapse-free survival 4 years Number of Participants with Adverse Events as a Measure of Safety and Tolerability
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital
🇫🇷Angers, France