NIPH Clinical Trials Search

UMIN ID: UMIN000000929

Registered date:04/12/2007

Randomized phase II/III study of R-CHOP versus weekly rituximab plus CHOP for CD20 positive diffuse large B cell lymphoma (JCOG0601)

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedCD20 positive diffuse large B cell lmyphoma
Date of first enrollment2007/12/04
Target sample size422
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)A:R-CHOP B:RW+CHOP(weekly rituximab plus CHOP)


Primary OutcomephaseII : complete response rate phaseIII : progression free survival
Secondary OutcomephaseII : progression free survival, overall survival, adverse events, seriouse adverse events phaseIII : overall survival, adverse events, seriouse adverse events

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum79years-old
GenderMale and Female
Include criteria
Exclude criteria(1)anamnesis of graucoma (2)diabetes mellitus treating insulin or uncontrolled (3)uncontrollable hypertension (4)coronary artery necessary, cardiomyopathy and heart failure necessary treatment, arrhythmia treating antiarrhyshmic (5)HBs-Ag positive (6)HCV positive (7)HIV positive (8)interstitial pneumonia, plumonary fiblosis (9)severe infection (10)synchronous or metachronous malignancy (11)pregnant/lactating woman (12)psychosis (13)given systemic steroid

Related Information


public contact
Name Ken Ohmachi
Address 143 shimokasuya, Isehara, Kanagawa, 259-1193, JAPAN Japan
Telephone 0463-93-1121
Affiliation JCOG0601 Coordinating Office Tokai University, Division of Hematology Oncology
scientific contact
Name Tomohiro Kinoshita
Address 1-1 Kanokoden, Chikusa-ku Nagoya 464-8681, Japan Japan
Telephone 052-762-6111
Affiliation Aichi Cancer Center Hospital Department of Hematology and Cell Therapy