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

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ClinicalTrials.gov Identifier: NCT00145002
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : September 22, 2016
Sponsor:
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group

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

Condition or disease Intervention/treatment 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

Detailed Description:
Nothing to describe.

Study Type : Interventional  (Clinical Trial)
Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : August 1998
Study Completion Date : December 2004





Primary Outcome Measures :
  1. Overall survival

Secondary Outcome Measures :
  1. Toxicity
  2. CR rate
  3. Progression free survival


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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00145002


Locations
Japan
Nagasaki University Graduate School of Biomedical Science
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

Additional Information:
ClinicalTrials.gov Identifier: NCT00145002     History of Changes
Other Study ID Numbers: JCOG9801
C000000066
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: September 22, 2016
Last Verified: September 2016

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

Additional relevant MeSH terms:
Lymphoma
Leukemia
Leukemia, T-Cell
Leukemia-Lymphoma, Adult T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs