CI

At a glance

ClinicalIndex Comparison Record
Phase 3Active· 270 target
Drug / intervention
Obinutuzumab +5 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/NCT04408638
NCT04408638Phase 3ActiveOn TrackUpdated 2mo ago
CompareCT.gov

A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Hoffmann-La Roche·interventional·Posted May 29, 2020·Updated Apr 7, 2026

In Brief

A Phase 3 clinical trial evaluating Obinutuzumab, Glofitamab, and 4 other interventions for Diffuse Large B-cell Lymphoma. Active but no longer recruiting, targeting 270 participants across 63 sites in 13 countries.

Detailed Summary

This study will evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (Glofit-GemOx) compared with rituximab in combination with gemcitabine plus oxaliplatin (R-GemOx) in patients with R/R DLBCL.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiffuse Large B-cell Lymphoma
CountriesAustralia, Belgium, China, Denmark, France, Germany, Poland, South Korea, Spain, Switzerland, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3Active
20212022202320242025202620272028
First PostedMay 29, 2020
Enrollment StartFeb 23, 2021
Primary CompletionMar 31, 2028
TodayJul 2, 2026
Enrollment to primary: 7.1 yearsPosted 6.1 years agoPrimary completion in 1.7 years

Interventions

Obinutuzumabdrug

Participants will receive a single dose of intravenous (IV) obinutuzumab pre-treatment 7 days prior to the first dose of glofitamab.

Glofitamabdrug

Participants will receive IV glofitamab for up to 12 cycles.

Rituxumabdrug

Participants will receive IV rituxumab on Day 1 of each cycle for up to 8 cycles.

Tocilizumabdrug

Participants will receive IV tocilizumab as needed for treatment of cytokine-release syndrome (CRS).

Gemcitabinedrug

Participants will receive IV gemcitabine prior to oxaliplatin administration for up to 8 cycles.

Oxaliplatindrug

Participants will receive IV oxaliplatin after gemcitabine administration for up to 8 cycles.