Study of Imatinib-Combined Chemotherapy for BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL)

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the clinical efficacy and safety of imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL.

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

Details

• Lead Sponsor: Japan Adult Leukemia Study Group
• Treatments: Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Imatinib Mesylate; Methotrexate; Prednisolone; Vincristine

Criteria

Inclusion Criteria:

• Previously untreated BCR-ABL-positive ALL

• Age between 15 and 64 years

• Performance status between 0 and 3 (ECOG criteria)

• Adequate functioning of the liver (serum bilirubin level < 2.0 mg/dL), kidneys (serum creatinine level < 2.0 mg/dL), and heart (left ventricular ejection fraction greater than 50% and no severe abnormalities detected on electrocardiograms and echocardiographs)

• Written informed consent to participate in the trial

Exclusion Criteria:

• Uncontrolled active infection

• Another severe and/or life-threatening disease

• Positive for HIV antibody and/or hepatitis B surface (HBs) antigen tests

• Another primary malignancy which is clinically active and/or requires medical interventions

• Pregnant and/or lactating women

• Past history of renal failure