Phase II Study of Imatinib Mesylate for Philadelphia-Positive Acute Lymphocytic Leukemia
- 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
- 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
- Patients with findings indicative of leukemic involvement of the central nervous
- 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.