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

Phase II Study of Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia

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).

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.