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

September 20, 2016 updated by: Japan Clinical Oncology Group

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Nothing to describe.

Study Type

Interventional

Enrollment

130

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Nagasaki, Japan, 852-8523
        • Nagasaki University Graduate School of Biomedical Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival

Secondary Outcome Measures

Outcome Measure
Toxicity
Progression free survival
CR rate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Japan Clinical Oncology Group

Collaborators

Ministry of Health, Labour and Welfare, Japan

Investigators

  • Study Chair: Masao Tomonaga, MD, PhD, Nagasaki University Graduate School of Biomedical Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1998

Study Completion

December 1, 2004

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (ESTIMATE)

September 5, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 22, 2016

Last Update Submitted That Met QC Criteria

September 20, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JCOG9801
  • C000000066

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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