STI 571 (GLIVEC) in the Treatment of Adult Acute Lymphoblastic Leukemia

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This proposal, developed in the framework of the GIMEMA, will permit:

• to evaluate the activity and toxicity of imatinib in the treatment of Ph+ acute lymphoblastic leukemia;

• to evaluate the molecular response to the treatment, and to monitor the molecular status of remission in all cases achieving or not a molecular response.

The GIMEMA has activated a network to centralize all biological samples (bone marrow and peripheral blood) at diagnosis from all new ALL patients. This will permit to identify, in particular, Ph + and/or BCR/ABL + cases within 5 days from diagnosis, thus permitting to treat these patients according to different programs on the basis of the presence of Ph chromosome.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Treatments: Imatinib Mesylate

Criteria

Inclusion Criteria:

• Patients with Ph +ve and/or BCR/ABL +ve ALL, either in 1st CHR (independently from the molecular status) for study A, or at diagnosis and untreated for study B;

• Age >18 years and <60 for study A, >60 for study B;

• Written voluntary informed consent.

Exclusion Criteria:

• Patients of childbearing potential without a negative pregnancy test prior to the initiation of study. Barrier contraceptive precautions are to be used throughout the trial in both sexes;

• Pretreatment with steroids for more than 10 days in study B;

• Serum bilirubin and creatinine values >3 the upper limit of normal range;

• SGOT and SGPT values >3 the upper limit of the normal range;

• Patients who had received any other investigational agent within 4 weeks before the enrollment;

• Patients with cardiovascular diseases grade >3 according to the New York Heart Association (see Appendix 1);

• Patients with a history of non compliance to medical regimen or who are considered potentially unreliable;

• Patients with moderate/severe mood or psychiatric disorders;

• Concomitant neoplasia.