Overview
Study of Imatinib-Combined Chemotherapy for BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL)
Status:
Completed
Completed
Trial end date:
2008-05-01
2008-05-01
Target enrollment:
0
0
Participant gender:
All
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 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Japan Adult Leukemia Study GroupTreatments:
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