NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: C000000066

Registered date:17/08/2005

Phase III study of VCAP-AMP-VECP vs. biweekly CHOP in aggressive adult T-cell leukemia-lymphoma (ATLL): Japan Clinical Oncology Group Study, JCOG9801.

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedadult T-cell leukemia / lymphoma
Date of first enrollment1998/08/01
Target sample size130
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)VCAP-AMP-VECP with G-CSF and intrathecal prophylaxis. biweekly-CHOP with G-CSF and intrathecal prophylaxis.

Outcome(s)

Primary OutcomeOverall survival
Secondary OutcomeToxicity, CR rate, Progression free survival

Key inclusion & exclusion criteria

Age minimum15years-old
Age maximum70years-old
GenderMale and Female
Include criteria
Exclude criteria1) 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 rrhosis. 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.

Related Information

Contact

public contact
Name Kunihiro Tsukasaki, MD, PhD
Address 1-12-4 Sakamoto, Nagasaki 852-8523, Japan Japan
Telephone
E-mail JCOG_sir@ml.jcog.jp
Affiliation JCOG9801 Coordinating Office Department of Hematology, Nagasaki University Graduate School of Biomedical Science
scientific contact
Name Masao Tomonaga, MD, PhD
Address 1-12-4 Sakamoto, Nagasaki 852-8523, Japan Japan
Telephone
E-mail
Affiliation Nagasaki University Graduate School of Biomedical Science Department of Hematology