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

Lymphoma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00145002
• Other study ID #: JCOG9801
• Secondary ID: C000000066
• Status: Completed
• Phase: Phase 3
• First received: September 1, 2005
• Last updated: September 20, 2016
• Start date: August 1998
• Est. completion date: December 2004

Study information

• Verified date: September 2016
• Source: Japan Clinical Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Description:

Nothing to describe.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 70 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Adult T-cell Leukemia
• Leukemia
• Leukemia, T-Cell
• Leukemia-Lymphoma, Adult T-Cell
• Lymphoma

Intervention

Drug:
• VCAP-AMP-VECP with G-CSF and intrathecal prophylaxis

• biweekly-CHOP with G-CSF and intrathecal prophylaxis

Locations

Country	Name	City	State
Japan	Nagasaki University Graduate School of Biomedical Science	Nagasaki

Sponsors (2)

Lead Sponsor	Collaborator
Japan Clinical Oncology Group	Ministry of Health, Labour and Welfare, Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival
Secondary	Toxicity
Secondary	CR rate
Secondary	Progression free survival

External Links

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