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

Japan Clinical Oncology Group

Status and phase: Completed; Phase 3

Conditions: Lymphoma; Adult T-cell Leukemia

Treatments: Drug: VCAP-AMP-VECP with G-CSF and intrathecal prophylaxis; Drug: biweekly-CHOP with G-CSF and intrathecal prophylaxis

Study type: Interventional

Funder types: Other

Identifiers

NCT00145002

C000000066

JCOG9801

Details and patient eligibility

About

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

Full description

Nothing to describe.

Sex: All

Ages: 15 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)