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Completed

NCT Number: NCT00145002

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

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

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Key information

Conditions

Adult T-cell Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, T-Cell Leukemia-Lymphoma, Adult T-Cell Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

15 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nagasaki University Graduate School of Biomedical Science

Nagasaki, 852-8523, Japan

About this study

Nothing to describe.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

biweekly-CHOP with G-CSF and intrathecal prophylaxis

Drug

Primary outcomes

  1. Overall survival

Secondary outcomes

  1. Toxicity

  2. CR rate

  3. Progression free survival

Sponsors and collaborators

Lead sponsor

Japan Clinical Oncology Group

Other

Collaborators

  • Ministry of Health, Labour and Welfare, Japan

Registry information

Official study title

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

Important dates

Study start
1998
Study completion
2004
First posted
Sep 5, 2005
Registry last updated
Sep 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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