This trial is active, not recruiting.

Condition acute lymphocytic leukemia
Treatment imatinib
Phase phase 2
Target BCR-ABL
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label

Primary Outcomes

Impact of Imatinib on survival in elderly patients with Ph+ALL
time frame:

Secondary Outcomes

Tolerance of Imatinib
time frame:
Complete remission rate
time frame:
Minimal Residual Disease after Imatinib treatment
time frame:
Leukemia free survival
time frame:
Impact of steroids given before starting chemotherapy
time frame:
Study of potential resistance mechanisums to Imatinib
time frame:

Eligibility Criteria

Male or female participants from 55 years up to 90 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in April 2007.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.