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Efficacy Study of Imatinib Mesylate to Treat Philadelphia-Positive Acute Lymphocytic Leukemia
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
15 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.