Status:
UNKNOWN
Applying Pediatric Regimens to Younger Adult Patients With Acute Lymphoblastic Leukemia (ALL)
Lead Sponsor:
Japan Adult Leukemia Study Group
Conditions:
Lymphoblastic Leukemia, Acute
Eligibility:
All Genders
15-24 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate the efficacy and safety for treating adult ALL patients with the pediatric protocol.
Detailed Description
The prognosis for adult acute lymphoblastic leukemia (ALL) remains poor, which contrasts with that for pediatric ALL. It is regarded that the prognostic diversity is attributable to several difference...
Eligibility Criteria
Inclusion
- Previously untreated BCR-ABL-negative ALL
- Age between 15 and 24 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 :
120 Patients enrolled
Trial Details
Trial ID
NCT00131053
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