Phase 2 Study of Imatinib-Combined Chemotherapy for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia
Overview
- Phase
- Phase 2
- Intervention
- imatinib
- Conditions
- Acute Lymphoblastic Leukemia
- Sponsor
- Japan Adult Leukemia Study Group
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The rate of complete remission
- Status
- Completed
- Last Updated
- 17 years ago
Overview
Brief 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.
Detailed Description
Philadelphia chromosome (Ph) is a translocation abnormality leading to the formation of the BCR-ABL gene rearrangement. This genetic abnormality occurs in up to 30% of adult acute lymphoblastic leukemia (ALL), and its presence is known to be the most adverse prognostic factor for ALL. Because long-term survival cannot be achieved by conventional chemotherapy alone, there is a clear medical need for alternative treatment approaches. Imatinib is a potent selective inhibitor of the BCR-ABL protein kinase, and it has been reported that single-agent imatinib induced response in a substantial proportion of Ph-positive ALL (Ph+ALL) patients, but that the response was not durable. The Japan Adult Leukemia Study Group (JALSG) has therefore started a phase 2 study designed to evaluate the clinical effect of imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL.
Investigators
Eligibility 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
Arms & Interventions
A
Intervention: imatinib
A
Intervention: cyclophosphamide
A
Intervention: daunorubicin
A
Intervention: vincristine
A
Intervention: prednisolone
A
Intervention: methotrexate
A
Intervention: cytarabine
A
Intervention: dexamethasone
Outcomes
Primary Outcomes
The rate of complete remission
Time Frame: 63 days
Secondary Outcomes
- Overall survival(1 year)
- Toxicity caused by combination of imatinib and chemotherapy(2 years)
- The duration of remission(1 year)