NCT01059630

A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN)

An Open-Label, Multicenter, Randomized, Phase III Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+RO5072759 (GA101) in Patients With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 413 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open-label, multicenter, randomized Phase III study will investigate the efficacy, safety, pharmacokinetics and pharmacoeconomics of obinutuzumab (RO5072759, GA101) combined with bendamustine followed by continued obinutuzumab treatment (maintenance monotherapy) compared with bendamustine alone treatment in participants with rituximab-refractory indolent Non-Hodgkin's lymphoma (iNHL). The end of study was defined to when safety follow-up for all patients had been completed (2 years' safety follow-up from last dose).

Conditions

• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Obinutuzumab	IV infusion.
DRUG	Bendamustine	IV infusion.

Timeline

• Start date: 2010-04-30
• Primary completion: 2014-09-30
• Completion: 2018-11-30
• First posted: 2010-02-01
• Last updated: 2020-01-13
• Results posted: 2016-11-17

Locations

121 sites across 14 countries: United States, Austria, Belgium, Canada, Czechia, France, Germany, Italy, Netherlands, Russia, Spain, Sweden, Switzerland, United Kingdom