Treatment of Philadelphia-Positive Acute Lymphocytic Leukemia (Ph+ ALL) in the Elderly With Imatinib Mesylate (STI571) and Chemotherapy.
This trial is active, not recruiting.
|Condition||acute lymphocytic leukemia|
|Sponsor||Hospices Civils de Lyon|
|Start date||August 2002|
|Trial size||30 participants|
|Trial identifier||NCT00149136, 2002.280|
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.
|Intervention model||single group assignment|
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
Male or female participants from 55 years up to 90 years old.
- Ph+ ALL patients
- 55 years or older
- Signed written informed consent
- CML in transformation
- Concomitant malignancy
- Previous treatment by Imatinib
- Severe organ condition
|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)|
|Principal investigator||Xavier THOMAS, MD|
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