A Study for Aggressive Adult T-Cell Leukemia-Lymphoma (ATLL) - Full Text View

A Study for Aggressive Adult T-Cell Leukemia-Lymphoma (ATLL)

This study has been completed.

Sponsors and Collaborators:	Japan Clinical Oncology Group Japanese Ministry of Health, Labor and Welfare
Information provided by:	Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:	NCT00145002

Purpose

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

Condition	Intervention	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 III

MedlinePlus related topics:

Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma

Drug Information available for:

Granulocyte colony-stimulating factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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.

Further study details as provided by Japan Clinical Oncology Group:

Primary Outcome Measures:

Overall survival

Secondary Outcome Measures:

Toxicity
CR rate
Progression free survival

Estimated Enrollment:	130
Study Start Date:	August 1998
Estimated Study Completion Date:	December 2004

Detailed Description:

Nothing to describe.

Eligibility

Ages Eligible for Study:	15 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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
Aggressive ATL, i.e., acute-, lymphoma- or unfavorable chronic-type ATL
Aged 15-69 years
No prior chemotherapy or radiotherapy
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3 or 4 as a result of hypercalcemia
Preserved organ (bone marrow, liver, kidney, heart and lung) functions
All patients were required to provide written informed consent

Exclusion Criteria:

Diabetes mellitus necessitating treatment with insulin
Active systemic infection
Cardiac disorders expected to become worse as a result of the DOX-containing regimen
Acute hepatitis, chronic hepatitis or liver cirrhosis
Positive for HBs Ag or anti-HCV Ab
Active concurrent malignancy
Other serious medical or psychiatric conditions
Pregnancy or breast feeding
Central nervous system involvement by ATL cells

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145002

Locations


Japan, Nagasaki
	Nagasaki University Graduate School of Biomedical Science
	1-12-4 Sakamoto, Nagasaki, Nagasaki, Japan, 852-8523

Sponsors and Collaborators

Japan Clinical Oncology Group

Japanese Ministry of Health, Labor and Welfare

Investigators


Study Chair:	Masao Tomonaga, MD, PhD	Nagasaki University Graduate School of Biomedical Science

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	JCOG9801, C000000066
First Received:	September 1, 2005
Last Updated:	January 17, 2007
ClinicalTrials.gov Identifier:	NCT00145002
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Japan Clinical Oncology Group:

ATLL

chemotherapy

phase III study

VCAP-AMP-VECP

biweekly-CHOP

Study placed in the following topic categories:

Lymphatic Diseases

Leukemia

Leukemia, Lymphoid

Immunoproliferative Disorders

Leukemia-Lymphoma, Adult T-Cell

Leukemia, T-Cell

Lymphoproliferative Disorders

Aggression

Lymphoma

Additional relevant MeSH terms:

Neoplasms

Neoplasms by Histologic Type

Immune System Diseases

ClinicalTrials.gov processed this record on October 31, 2008