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

September 1, 2005
January 17, 2007
August 1998
Not Provided
Overall survival
Same as current
Complete list of historical versions of study NCT00145002 on ClinicalTrials.gov Archive Site
  • Toxicity
  • CR rate
  • Progression free survival
Same as current
Not Provided
Not Provided
 
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.

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

Nothing to describe.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Adult T-Cell Leukemia
  • Lymphoma
  • Drug: VCAP-AMP-VECP with G-CSF and intrathecal prophylaxis
  • Drug: biweekly-CHOP with G-CSF and intrathecal prophylaxis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
December 2004
Not Provided

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
Both
15 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00145002
JCOG9801, C000000066
Not Provided
Not Provided
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Study Chair: Masao Tomonaga, MD, PhD Nagasaki University Graduate School of Biomedical Science
Japan Clinical Oncology Group
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP