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


Phase 3
15 Years
70 Years
Not Enrolling
Both
Adult T-Cell Leukemia, Lymphoma

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Trial Information

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


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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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Principal Investigator

Masao Tomonaga, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Nagasaki University Graduate School of Biomedical Science

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

JCOG9801

NCT ID:

NCT00145002

Start Date:

August 1998

Completion Date:

December 2004

Related Keywords:

  • Adult T-Cell Leukemia
  • Lymphoma
  • ATLL
  • chemotherapy
  • phase III study
  • VCAP-AMP-VECP
  • biweekly-CHOP
  • Leukemia
  • Leukemia, T-Cell
  • Leukemia-Lymphoma, Adult T-Cell
  • Lymphoma

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