CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 413 enrolled
Drug / intervention
Obinutuzumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01059630
NCT01059630Phase 3Completed
CompareCT.gov

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

Genentech, Inc.·interventional·Posted Feb 1, 2010·Updated Jan 13, 2020

In Brief

A Phase 3 clinical trial evaluating Obinutuzumab and Bendamustine for Non-Hodgkin's Lymphoma. Completed, enrolled 413 participants across 121 sites in 14 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Hodgkin's Lymphoma
CountriesAustria, Belgium, Canada, Czechia, France, Germany, Italy, Netherlands, Russia, Spain, Sweden, Switzerland, United Kingdom, United States
CollaboratorsRoche Pharma AG

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 1, 2010
Enrollment StartApr 30, 2010
Primary CompletionSep 30, 2014
Study CompletionNov 30, 2018
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 16.4 years ago

Interventions

Obinutuzumabdrug

IV infusion.

Bendamustinedrug

IV infusion.