drugset / Trial / NCT00376467

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

NCT00376467 ↗

Phase 2 Completed 105 enrolled GIMEMA Foundation
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2001-12
Primary completion
2010-06
Completion
2011-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Imatinib Small molecule 400 mg Oral