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)
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Impact of Imatinib on survival in elderly patients with Ph+ALL
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Impact of Imatinib on survival in elderly patients with Ph+ALL
Secondary Outcomes
- 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