drugset / Trial / NCT01077518

Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy

NCT01077518

Phase 3 Terminated 346 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study was to evaluate the safety and efficacy of ofatumumab and bendamustine combination therapy in patients with indolent B-cell NHL that did not respond to rituximab or a rituximab-containing regimen during or within 6 months of the last rituximab treatment.

Timeline

Start
2010-08-26
Primary completion
2018-01-03
Completion
2018-12-26

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bendamustine Small molecule 90 mg/m2
Comparator Bendamustine Small molecule 120 mg/m2
Subject Ofatumumab Monoclonal antibody 1000 mg

Indications