drugset / Trial / NCT00204659
Phase II Study With Rituximab and Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) in Patients With Gastric Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The optimal treatment of primary gastric diffuse large B-cell lymphoma (PG-DLBCL) has not yet been defined. In most circumstances, a stomach-conserving approach is favored, but the role of radiotherapy is still a matter of debate. Recently, Rituximab along with full-dose CHOP chemotherapy has been shown to improve the outcome in elderly patients with nodal DLBCL. However, no data are available with such a therapy in patients with PG-DLBCL. Therefore, in March 2003, we initiated an ongoing, prospective, multicenter phase II study in patients with PG-DLBCL with 6 to 8 cycles of Rituximab (R; 375 mg/m2) plus CHOP-21 in order to evaluate the safety and efficacy of this approach.
Timeline
- Start
- 2003-03
- Primary completion
- 2008-09
- Completion
- 2008-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | — | — |
| Subject | Doxorubicin | Other / unclassified | — | — |
| Subject | Prednisone | Other / unclassified | — | — |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | — |
| Subject | Vincristine | Small molecule | — | — |