Treatment of Philadelphia-Positive Acute Lymphocytic Leukemia (Ph+ ALL) in the Elderly With Imatinib Mesylate (STI571) and Chemotherapy.
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|ClinicalTrials.gov Identifier: NCT00149136|
Recruitment Status : Unknown
Verified April 2007 by Hospices Civils de Lyon.
Recruitment status was: Active, not recruiting
First Posted : September 8, 2005
Last Update Posted : April 27, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Lymphocytic Leukemia||Drug: imatinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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)|
|Study Start Date :||August 2002|
U.S. FDA Resources
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00149136
|Lyon, France, 69437|
|Principal Investigator:||Xavier THOMAS, MD||Hospices Civils de Lyon|