drugset / Trial / NCT00991211

Bendamustine Plus Rituximab Versus CHOP Plus Rituximab

NCT00991211 ↗

Phase 3 Completed 549 enrolled University of Giessen
RandomizedParallel-groupOpen-labelTreatment

Summary

The study addresses the question if the first line therapy of low malignant and mantle cell lymphomas with bendamustine plus rituximab is comparable (non inferior) with CHOP plus rituximab with regard to progression free survival (PFS).

Timeline

Start
2004-01
Primary completion
2009-08
Completion
2009-08

Outcome

Met primary endpoint

paper median progression-free survival was significantly longer in the bendamustine plus rituximab group than in the R-CHOP group PMID 23433739 ↗

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Bendamustine Small molecule 90 mg/m2 Intravenous
Comparator Cyclophosphamide Other / unclassified 750 mg/m2 —
Comparator Doxorubicin Other / unclassified 50 mg/m2 —
Comparator Prednisone Other / unclassified 100 mg Oral
Comparator Vincristine Small molecule 1.4 mg/m2 —
Comparator Rituximab Monoclonal antibody 375 mg/m2 —