UMIN ID: UMIN000001341
Registered date:01/09/2008
Prospective clinical study of R-CMD therapy for indolent B-cell lymphoma and mantle cell lymphoma
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | indolent B-cell lymphoma, mantle cell lymphoma |
| Date of first enrollment | 2007/11/01 |
| Target sample size | 30 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | 4 courses of R-CMD therapy (rituximab 375mg/m2, div on day1, Cladribine(2-CDA)0.10 mg/kg,2h div on day1-3, Mitoxantrone(MIT)8mg/m2,div on day1 and Dexamethasone8mg/body on day1-3) , 4 courses of rituximab 375mg/m2, div |
Outcome(s)
| Primary Outcome | CR rate |
|---|---|
| Secondary Outcome | Adverse events, Overall survival, Overall response rate |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1, low or negative expression CD20 2, severe infectious disease 3, Pre-treatment history for lymphoma 4, HIV+, HTLV1+, HBs-Ag+, HBc-Ab high titer 5, Pt who will be treat by allogenic or autologous stem cell transplantation 6, physician's decision of inappropriateness |
Related Information
| Primary Sponsor | Hematology and Immunology, Kanazawa Medical University |
|---|---|
| Secondary Sponsor | Hokuliku Hematological tumor research group |
| Source(s) of Monetary Support | Hematology and Immunology, Kanazawa Medical University |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yasufumi Masaki |
| Address | 1-1 Daigaku, Uchinada-machi, Kahoku-gun, Ishikawa Japan |
| Telephone | 076-286-3511 |
| yasum@kanazawa-med.ac.jp | |
| Affiliation | Kanazawa Medical University Hematology and Immunology |
| scientific contact | |
| Name | Yasufumi Masaki |
| Address | 1-1 Daigaku, Uchinada-machi, Kahoku-gun, Ishikawa Japan |
| Telephone | 076-286-3511 |
| Affiliation | Kanazawa Medical University Hematology and Immunology |