AML
Conditions
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.
Interventions
DRUGImatinib
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.
Sponsors
Nantes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* Previous treatment by Imatinib * Secondary AML
Countries
France
Outcome results
None listed