Overview

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