A Study for Aggressive Adult T-cell Leukemia-lymphoma (ATLL)

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To test the superiority of VCAP-AMP-VECP regimen over biweekly-CHOP in aggressive ATLL in terms of survival benefit.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Japan Clinical Oncology Group
• Collaborator: Ministry of Health, Labour and Welfare, Japan
• Treatments: Lenograstim

Criteria

Inclusion Criteria:

1. 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

2. Aggressive ATL, i.e., acute-, lymphoma- or unfavorable chronic-type ATL

3. Aged 15-69 years

4. No prior chemotherapy or radiotherapy

5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3 or 4 as a result of hypercalcemia

6. Preserved organ (bone marrow, liver, kidney, heart and lung) functions

7. All patients were required to provide written informed consent

Exclusion Criteria:

1. Diabetes mellitus necessitating treatment with insulin

2. Active systemic infection

3. Cardiac disorders expected to become worse as a result of the DOX-containing regimen

4. Acute hepatitis, chronic hepatitis or liver cirrhosis

5. Positive for HBs Ag or anti-HCV Ab

6. Active concurrent malignancy

7. Other serious medical or psychiatric conditions

8. Pregnancy or breast feeding

9. Central nervous system involvement by ATL cells