Back to resultsStudy to Assess Dasatinib in Patients With Core Binding Factors Acute Myelogenous Leukemia (DasaCBF)
Primary Purpose
Acute Myelogenous Leukemia
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
dasatinib
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Myelogenous Leukemia focused on measuring Core Binding Factors, Acute Myelogenous Leukemia refractory to conventional chemotherapy, molecular relapse
Eligibility Criteria
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
Sites / Locations
- University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
dasatinib
Arm Description
Outcomes
Primary Outcome Measures
measure relapse-free survival
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Secondary Outcome Measures
Full Information
NCT ID
NCT02113319
First Posted
March 5, 2014
Last Updated
April 11, 2014
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT02113319
Brief Title
Study to Assess Dasatinib in Patients With Core Binding Factors Acute Myelogenous Leukemia
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myelogenous Leukemia
Keywords
Core Binding Factors, Acute Myelogenous Leukemia refractory to conventional chemotherapy, molecular relapse
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dasatinib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
dasatinib
Intervention Description
dasatinib 50 mg and 20 mg During one year
Primary Outcome Measure Information:
Title
measure relapse-free survival
Description
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Hospital
City
Angers
ZIP/Postal Code
49 933
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study to Assess Dasatinib in Patients With Core Binding Factors Acute Myelogenous Leukemia
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