CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 175 enrolled
Drug / intervention
obinutuzumab (RO5072759) +1 moredrug
Likely dose
obinutuzumab (RO5072759) 1000 mgfrom 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/NCT00576758
NCT00576758Phase 2Completed
CompareCT.gov

An Open-label, Multi-center, Randomized Study to Evaluate the Efficacy on Tumor Response of GA101 (RO5072759) Monotherapy Versus Rituximab Monotherapy in Patients With Relapsed CD20+ Indolent Non-Hodgkin's Lymphoma

Hoffmann-La Roche·interventional·Posted Dec 19, 2007·Updated Aug 19, 2014

In Brief

A Phase 2 clinical trial evaluating obinutuzumab (RO5072759) and rituximab for Non-Hodgkin's Lymphoma. Completed, enrolled 175 participants across 71 sites in 17 countries.

Detailed Summary

This study will investigate the efficacy of weekly intravenous obinutuzumab \[GA101 (RO5072759)\] monotherapy, in patients with relapsed CD20+ indolent Non-Hodgkin's Lymphoma. Patients will be randomized to receive either GA101 or rituximab, given as four weekly infusions. At the conclusion of the initial trial patients may be eligible to continue therapy up to 24 months. The anticipated time on study treatment is 3- 24 months, and the target sample size is 100-500 individuals.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Hodgkin's Lymphoma
CountriesArgentina, Austria, Belgium, Brazil, Canada, Croatia, Denmark, Greece, Italy, Netherlands, Poland, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 19, 2007
Enrollment StartJan 1, 2008
Primary CompletionSep 1, 2011
Study CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 18.5 years ago

Interventions

obinutuzumab (RO5072759)drug

1000 mg obinutuzumab intravenous (IV) infusion once a week for 4 weeks.

rituximabdrug

375 mg/m\^2 rituximab IV infusion once a week for 4 weeks.