A Study for Aggressive Adult T-Cell Leukemia-Lymphoma (ATLL)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00145002
First received: September 1, 2005
Last updated: January 17, 2007
Last verified: September 2005
  Purpose

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


Condition Intervention Phase
Adult T-Cell Leukemia
Lymphoma
Drug: VCAP-AMP-VECP with G-CSF and intrathecal prophylaxis
Drug: biweekly-CHOP with G-CSF and intrathecal prophylaxis
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:


Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:
  • Overall survival

Secondary Outcome Measures:
  • Toxicity
  • CR rate
  • Progression free survival

Estimated Enrollment: 130
Study Start Date: August 1998
Estimated Study Completion Date: December 2004
Detailed Description:

Nothing to describe.

  Eligibility

Ages Eligible for Study:   15 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145002

Locations
Japan
Nagasaki University Graduate School of Biomedical Science
1-12-4 Sakamoto, Nagasaki, Nagasaki, Japan, 852-8523
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Investigators
Study Chair: Masao Tomonaga, MD, PhD Nagasaki University Graduate School of Biomedical Science
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00145002     History of Changes
Other Study ID Numbers: JCOG9801, C000000066
Study First Received: September 1, 2005
Last Updated: January 17, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:
ATLL
chemotherapy
phase III study
VCAP-AMP-VECP
biweekly-CHOP

Additional relevant MeSH terms:
Leukemia
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 28, 2014