Status:
COMPLETED
A Study for Aggressive Adult T-cell Leukemia-lymphoma (ATLL)
Lead Sponsor:
Japan Clinical Oncology Group
Collaborating Sponsors:
Ministry of Health, Labour and Welfare, Japan
Conditions:
Adult T-cell Leukemia
Lymphoma
Eligibility:
All Genders
15-70 years
Phase:
PHASE3
Brief Summary
To test the superiority of VCAP-AMP-VECP regimen over biweekly-CHOP in aggressive ATLL in terms of survival benefit.
Detailed Description
Nothing to describe.
Eligibility Criteria
Inclusion
- Diagnosis of ATL was made based on seropositivity for HTLV-I by either enzyme-linked immunosorbent assay or particle agglutination assay, and histologically- and/or cytologically-proven peripheral T-cell malignancy
- Aggressive ATL, i.e., acute-, lymphoma- or unfavorable chronic-type ATL
- Aged 15-69 years
- No prior chemotherapy or radiotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3 or 4 as a result of hypercalcemia
- Preserved organ (bone marrow, liver, kidney, heart and lung) functions
- All patients were required to provide written informed consent
Exclusion
- Diabetes mellitus necessitating treatment with insulin
- Active systemic infection
- Cardiac disorders expected to become worse as a result of the DOX-containing regimen
- Acute hepatitis, chronic hepatitis or liver cirrhosis
- Positive for HBs Ag or anti-HCV Ab
- Active concurrent malignancy
- Other serious medical or psychiatric conditions
- Pregnancy or breast feeding
- Central nervous system involvement by ATL cells
Key Trial Info
Start Date :
August 1 1998
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00145002
Start Date
August 1 1998
End Date
December 1 2004
Last Update
September 22 2016
Active Locations (1)
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1
Nagasaki University Graduate School of Biomedical Science
Nagasaki, Nagasaki, Japan, 852-8523