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

April 11, 2014 updated by: University Hospital, Angers

An Open-Label, Multicenter, Phase II Study to Assess Dasatinib in Patients With Core Binding Factors Acute Myelogenous Leukemia Refractory to Conventional Chemotherapy or in Molecular Relapse. Intergroupe Français Des leucémie aiguë myéloblastique

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49 933
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dasatinib
Drug: dasatinib
dasatinib 50 mg and 20 mg During one year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measure relapse-free survival
Time Frame: 4 years
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

March 5, 2014

First Submitted That Met QC Criteria

April 11, 2014

First Posted (Estimate)

April 14, 2014

Study Record Updates

Last Update Posted (Estimate)

April 14, 2014

Last Update Submitted That Met QC Criteria

April 11, 2014

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUpromoteur2006-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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