drugset / Trial / NCT00269113

A Study of MabThera (Rituximab) in Patients With Advanced Non-Hodgkin's Lymphoma

NCT00269113 ↗

Phase 3 Completed 360 enrolled Hoffmann-La Roche
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

EvaluationDrugModalityDoseRoute
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous

Indications