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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Myelogenous Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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dasatinib

Group Type EXPERIMENTAL

dasatinib

Intervention Type DRUG

dasatinib 50 mg and 20 mg During one year

Interventions

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dasatinib

dasatinib 50 mg and 20 mg During one year

Intervention Type DRUG

Eligibility Criteria

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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