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

Acute Myelogenous Leukemia Clinical Trial

— DasaCBF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02113319
• Other study ID #: CHUpromoteur2006-08
• Status: Completed
• Phase: Phase 2
• First received: March 5, 2014
• Last updated: April 11, 2014
• Start date: April 2007

Study information

• Verified date: January 2009
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Myelogenous Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• dasatinib
dasatinib 50 mg and 20 mg During one year

Locations

Country	Name	City	State
France	University Hospital	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measure relapse-free survival	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	4 years	No