Treatment of Philadelphia-Positive Acute Lymphocytic Leukemia (Ph+ ALL) in the Elderly With Imatinib Mesylate (STI571) and Chemotherapy.
Phase 2
- Conditions
- Acute Lymphocytic Leukemia
- Registration Number
- NCT00149136
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Ph+ ALL patients
- 55 years or older
- Signed written informed consent
Exclusion Criteria
- CML in transformation
- Concomitant malignancy
- Previous treatment by Imatinib
- Severe organ condition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Impact of Imatinib on survival in elderly patients with Ph+ALL
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Xavier THOMAS
🇫🇷Lyon, France