Phase III Study of VCAP-AMP-VECP vs. Biweekly CHOP in Aggressive Adult T-Cell Leukemia-Lymphoma (ATLL): Japan Clinical Oncology Group Study, JCOG9801.

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