Randomized phase II/III study of R-CHOP versus weekly rituximab plus CHOP for CD20 positive diffuse large B cell lymphoma (JCOG0601)
Phase 2
- Conditions
- CD20 positive diffuse large B cell lmyphoma
- Registration Number
- JPRN-UMIN000000929
- Lead Sponsor
- Japan Clinical Oncology Group(JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 422
Inclusion Criteria
Not provided
Exclusion 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method phaseII : complete response rate phaseIII : progression free survival
- Secondary Outcome Measures
Name Time Method phaseII : progression free survival, overall survival, adverse events, seriouse adverse events phaseIII : overall survival, adverse events, seriouse adverse events