Trial | NCT00145002  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    130
To test the superiority of VCAP-AMP-VECP regimen over biweekly-CHOP in aggressive ATLL in terms of survival benefit.
Nothing to describe.
Study Started
Aug 31
1998
Study Completion
Dec 31
2004
Last Update
Sep 22
2016
Estimate

Drug VCAP-AMP-VECP with G-CSF and intrathecal prophylaxis

Drug biweekly-CHOP with G-CSF and intrathecal prophylaxis

Criteria 

Inclusion Criteria:

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 Criteria:

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
No Results Posted