Status:
UNKNOWN
High-Dose Methotrexate (MTX) for Adult Acute Lymphoblastic Leukemia (ALL)
Lead Sponsor:
Japan Adult Leukemia Study Group
Conditions:
Lymphoblastic Leukemia, Acute
Eligibility:
All Genders
25-64 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate the clinical efficacy of high-dose methotrexate consolidation therapy for adult patients with BCR-ABL-negative ALL.
Detailed Description
Although the multi-agent chemotherapies in current use produce complete remission for a majority of patients with acute lymphoblastic leukemia (ALL), the prognosis for adult ALL remains discouraging d...
Eligibility Criteria
Inclusion
- Previously untreated BCR-ABL-negative ALL
- Age between 25 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 :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00131027
Start Date
September 1 2002
End Date
September 1 2011
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