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NCT00149136 Clinical Trial

Treatment of Philadelphia-Positive Acute Lymphocytic Leukemia (Ph+ ALL) in the Elderly With Imatinib Mesylate (STI571) and Chemotherapy.

Acute Lymphocytic Leukemia Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00149136
Other study ID # 2002.280
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received September 6, 2005
Last updated April 26, 2007
Start date August 2002

Study information
Verified date April 2007
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 30
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 55 Years to 90 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• imatinib

Locations
Country Name City State
France Xavier THOMAS Lyon

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Impact of Imatinib on survival in elderly patients with Ph+ALL
Secondary Tolerance of Imatinib
Secondary Complete remission rate
Secondary Minimal Residual Disease after Imatinib treatment
Secondary Leukemia free survival
Secondary Impact of steroids given before starting chemotherapy
Secondary Study of potential resistance mechanisums to Imatinib
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