Status:
COMPLETED
High-Dose Imatinib for Relapsed/Refractory c-Kit Positive Acute Myelogenous Leukemia (AML)
Lead Sponsor:
Nantes University Hospital
Conditions:
AML
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
This is a multicenter open-label phase II trial of high dose imatinib mesylate in patients with AML in first or second relapse, or with refractory disease. Daily dosing of imatinib 600 mg/day is plann...
Detailed Description
Daily dosing of imatinib 600 mg/day is planned for one month or until progression of disease. Dose increase to 800 mg/ day imatinib is permitted for 2 additional months in the event of response failur...
Eligibility Criteria
Inclusion
- age \> 18 years,
- AML in first or second relapse,
- refractory AML
- performance status of 0-2 on the Eastern Cooperative Oncology Group scale,
- adequate hepatic and renal functions (AST or ALT \<= 5 times the upper limit of normal
- creatinine \< 2 times the upper limit of normal)
- 20% blasts in bone marrow,
- 70% of bone marrow blast population c-kit positive as assessed by immunophenotyping
- Bcr-Abl negative chromosomal analysis (assessed by fluorescence in situ hybridization; FISH), and no chromosome 5-12 translocation
Exclusion
- Previous treatment by Imatinib
- Secondary AML
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00707408
Start Date
February 1 2004
End Date
January 1 2009
Last Update
February 2 2009
Active Locations (1)
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1
Nantes University Hopspital
Nantes, France, 44093