High-Dose Imatinib for Relapsed/Refractory c-Kit Positive Acute Myelogenous Leukemia (AML)
- Conditions
- AML
- Registration Number
- NCT00707408
- Lead Sponsor
- Nantes University Hospital
- 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 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 failure. Response is assessed after 1, 2 and 3 months of treatment by bone marrow aspirate.
- 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 failure. Novartis provided supplies of imatinib for all patients included in the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
-
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
- Previous treatment by Imatinib
- Secondary AML
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Nantes University Hopspital
🇫🇷Nantes, France