Acute Myelogenous Leukemia
Conditions
Keywords
Core Binding Factors, Acute Myelogenous Leukemia refractory to conventional chemotherapy, molecular relapse
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.
Interventions
DRUGdasatinib
dasatinib 50 mg and 20 mg During one year
Sponsors
University Hospital, Angers
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| measure relapse-free survival | 4 years | Number of Participants with Adverse Events as a Measure of Safety and Tolerability |
Countries
France
Outcome results
None listed