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	Intervention	Phase
Acute Lymphocytic Leukemia	Drug: imatinib	Phase II

Further Study Details: 

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
Expected Total Enrollment:  30

Ages Eligible for Study:  55 Years   -   90 Years,  Genders Eligible for Study:  Both

Criteria

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

France
      Xavier THOMAS, Lyon,  69437,  France

Study chairs or principal investigators

Xavier THOMAS, MD,  Principal Investigator,  Hospices Civils de Lyon   

Study ID Numbers:  2002.280
Last Updated:  September 7, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00149136
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-13