Efficacy Study of Imatinib Mesylate to Treat Philadelphia-Positive Acute Lymphocytic Leukemia

• Status: Completed
• Trial end date: 2007-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to determine the efficacy and safety of imatinib mesylate in patients diagnosed as having Philadelphia chromosome positive acute lymphocytic leukemia (ALL).

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Imatinib Mesylate

Criteria

Inclusion Criteria:

• Patients with histologically confirmed diagnosis of ALL.

• Patients confirmed to be Ph chromosome positive or bcr-abl gene positive.

• Patients in relapse

• Patients refractory to initial remission induction therapy

• Patients ineligible for initial remission induction therapy

• Patients with an ECOG Performance Status Score from 0 to 2

• Serum creatinine concentration of not more than 2 × the upper limit of the normal range (ULN)

• AST (SGOT) and ALT (SGPT) of not more than 3 × ULN. In patients with hepatic dysfunction from leukemic involvement, AST (SGOT) and ALT (SGPT) should be not more than 5 × ULN

• Serum bilirubin level not more than 3 × ULN

Exclusion Criteria:

• Patients with findings indicative of leukemic involvement of the central nervous system

• Patients with any serious concomitant medical condition (e.g., poorly controllable infection, interstitial pneumonia, pulmonary fibrosis, congestive cardiac failure, poorly controlled diabetes mellitus, mental disorder)

• Patients expected to receive any hematopoietic stem cell transplantation within 6 weeks of the planned initiation of the study drug

• Patients having received any hematopoietic stem cell transplantation who have a Grade 3 or 4 GVHD.

Other protocol-defined inclusion/exclusion criteria may apply.