Status:
COMPLETED
Study of Imatinib-Combined Chemotherapy for BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL)
Lead Sponsor:
Japan Adult Leukemia Study Group
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
15-64 years
Phase:
PHASE2
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 leukem...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00130195
Start Date
September 1 2002
End Date
May 1 2008
Last Update
November 14 2008
Active Locations (1)
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1
Department of Hematology, Nagoya University Graduate School of Medicine
Nagoya, Japan, 466-8550