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

• Sponsor: Japan Clinical Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT00145002
• Collaborator: Ministry of Health, Labour and Welfare, Japan (Other)
• Enrollment: 130
• Location: 1
• Duration (Months): 76
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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 Design

• Study Type: Interventional
• 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: Aug 1, 1998
• Study Completion Date: Dec 1, 2004

Outcome Measures

Primary Outcome Measures

1. Overall survival []

Secondary Outcome Measures

1. Toxicity []

2. CR rate []

3. Progression free survival []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00145002
• Other Study ID Numbers: JCOG9801; C000000066
• First Posted: Sep 5, 2005
• Last Update Posted: Sep 22, 2016
• Last Verified: Sep 1, 2016

• Keywords provided by , ,: ATLL; chemotherapy; phase III study; VCAP-AMP-VECP; biweekly-CHOP
• Additional relevant MeSH terms: Lymphoma; Leukemia; Leukemia, T-Cell; Leukemia-Lymphoma, Adult T-Cell; Lenograstim

Study Results

No Results Posted as of Sep 22, 2016