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) studied | CD20 positive diffuse large B cell lmyphoma |
| Date of first enrollment | 2007/12/04 |
| Target sample size | 422 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | A:R-CHOP B:RW+CHOP(weekly rituximab plus CHOP) |
Outcome(s)
| Primary Outcome | phaseII : complete response rate phaseIII : progression free survival |
|---|---|
| Secondary Outcome | phaseII : progression free survival, overall survival, adverse events, seriouse adverse events phaseIII : overall survival, adverse events, seriouse adverse events |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 79years-old |
| Gender | Male 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
| Primary Sponsor | Japan Clinical Oncology Group(JCOG) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Ken Ohmachi |
| Address | 143 shimokasuya, Isehara, Kanagawa, 259-1193, JAPAN Japan |
| Telephone | 0463-93-1121 |
| JCOG_sir@ml.jcog.jp | |
| 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 |
| kinosita@aichi-cc.jp | |
| Affiliation | Aichi Cancer Center Hospital Department of Hematology and Cell Therapy |