drugset / Trial / NCT00269113
A Study of MabThera (Rituximab) in Patients With Advanced Non-Hodgkin's Lymphoma
RandomizedParallel-groupOpen-labelTreatment
Summary
This 2 arm study will compare the efficacy and safety of the standard chemotherapy of the East German Study Group for Hematology and Oncology versus standard chemotherapy plus MabThera (375mg/m2 iv, once monthly for 8 cycles) in patients with indolent non-Hodgkin's and mantle cell lymphoma. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Timeline
- Start
- 1998-09
- Primary completion
- 2009-04
- Completion
- 2009-04
Outcome
Met primary endpoint
registry Mitoxantrone, Chlorambucil, Prednisolone (MCP) vs Rituximab + MCP; p = 0.0009; Difference in percentage of participants 17.4 NCT00269113 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |