Study to Assess Dasatinib in Patients With Core Binding Factors Acute Myelogenous Leukemia (DasaCBF)

University Hospital, Angers

Status and phase: Completed; Phase 2

Conditions: Acute Myelogenous Leukemia

Treatments: Drug: dasatinib

Study type: Interventional

Funder types: Other

Identifiers

NCT02113319

CHUpromoteur2006-08

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

dasatinib

Experimental group

Treatment:

Drug: dasatinib