Treatment of Philadelphia-Positive Acute Lymphocytic Leukemia (Ph+ ALL) in the Elderly With Imatinib Mesylate (STI571) and Chemotherapy.
Recruitment status was: Active, not recruiting
ALL patients aged 55 years or older were treated with steroids during one week and Ph+ve cases were then offered a specific therapy including an induction treatment with steroids, cyclophosphamide, daunorubicin and vincristine, followed, irrespective of response to induction chemotherapy, by imatinib, 600 mg daily, combined with intermittent steroids during 2 months. Patients in complete response (CR) were then given 10 blocks of alternating chemotherapy, including 2 additional two-month blocks of imatinib, for a total treatment duration of 2 years. Therapy of occult central nervous system leukemia included 5 intrathecal injections of methotrexate and cranial irradiation.
Duration of therapy : 2 years.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
|Official Title:||Evaluation of Imatinib (GLIVEC) After Induction Therapy in Patients Aged More Than 55 Years With Philadelphia Positive Acute Lymphoblastic Leukaemia (Ph+ ALL) : a Non Randomised, Controlled, Open, Multicentric, International Phase II Clinical Study (CSTI 571 AFR09 Trial)|
- Impact of Imatinib on survival in elderly patients with Ph+ALL
- Tolerance of Imatinib
- Complete remission rate
- Minimal Residual Disease after Imatinib treatment
- Leukemia free survival
- Impact of steroids given before starting chemotherapy
- Study of potential resistance mechanisums to Imatinib
|Study Start Date:||August 2002|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00149136
|Lyon, France, 69437|
|Principal Investigator:||Xavier THOMAS, MD||Hospices Civils de Lyon|