Adult T-cell Leukemia, Lymphoma
Conditions
Keywords
ATLL, chemotherapy, phase III study, VCAP-AMP-VECP, biweekly-CHOP
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.
Interventions
DRUGVCAP-AMP-VECP with G-CSF and intrathecal prophylaxis
DRUGbiweekly-CHOP with G-CSF and intrathecal prophylaxis
Sponsors
Ministry of Health, Labour and Welfare, Japan
Japan Clinical Oncology Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity | — |
| CR rate | — |
| Progression free survival | — |
Countries
Japan
Outcome results
None listed