UMIN ID: UMIN000002287
Registered date:03/08/2009
A phase2 study of Rituximab+THP-COP(R-THP-COP) in elderly subjects with untreated, advanced, CD20-positive, indolent B-cell Non-Hodgkin's lymphoma
Basic Information
| Recruitment status | Complete: follow-up continuing |
|---|---|
| Health condition(s) or Problem(s) studied | indolent B-cell lymphoma |
| Date of first enrollment | 2005/05/01 |
| Target sample size | 40 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Rituximab,Cyclophosphamide,Pirarubicin,Vincristine,Prednisolone |
Outcome(s)
| Primary Outcome | Complete response rate,safty |
|---|---|
| Secondary Outcome | overall response rate,progression-free survival,overall survival,safty |
Key inclusion & exclusion criteria
| Age minimum | 70years-old |
|---|---|
| Age maximum | 79years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1.Central nervous system(CNS) NHL 2.Current or chronic hepatitis B or C infection;known seropositiviry for human immunodeficiency virus(HIV). 3.Any evidence of serious active infection 4.Unstable or severe uncontrolled medical condition or any important medical illness or abnormal laboratory finding that would, in the investigator's judgment, increase the risk associated with the subject's participation in the study. |
Related Information
| Primary Sponsor | Hematological Malignancy Clinical Study Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Hematological Malignancy Clinical Study Group |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kazunori Ohnishi |
| Address | 1-20-1handayama,higashiku,hamamatsu,shizuoka Japan |
| Telephone | 053-435-2267 |
| Affiliation | Hamamatsu University school of Medicine Oncology center |
| scientific contact | |
| Name | Michinori Ogura |
| Address | 2-9 myoukencho,Showa,nagoya,aichi Japan |
| Telephone | 052-832-1121 |
| Affiliation | Nagoya daini red cross hospital hematology |