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

University Hospital, Angers27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Acute Myelogenous Leukemia

Interventions

dasatinibDRUG

dasatinib 50 mg and 20 mg During one year

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital

Angers, France

Outcomes

Primary Outcomes

measure relapse-free survival

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time frame: 4 years

Data from ClinicalTrials.gov

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