Trials / Active Not Recruiting
Active Not RecruitingNCT04408638
A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
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
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 270 (estimated)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Obinutuzumab | Participants will receive a single dose of intravenous (IV) obinutuzumab pre-treatment 7 days prior to the first dose of glofitamab. |
| DRUG | Glofitamab | Participants will receive IV glofitamab for up to 12 cycles. |
| DRUG | Rituxumab | Participants will receive IV rituxumab on Day 1 of each cycle for up to 8 cycles. |
| DRUG | Tocilizumab | Participants will receive IV tocilizumab as needed for treatment of cytokine-release syndrome (CRS). |
| DRUG | Gemcitabine | Participants will receive IV gemcitabine prior to oxaliplatin administration for up to 8 cycles. |
| DRUG | Oxaliplatin | Participants will receive IV oxaliplatin after gemcitabine administration for up to 8 cycles. |
Timeline
- Start date
- 2021-02-23
- Primary completion
- 2028-03-31
- Completion
- 2028-03-31
- First posted
- 2020-05-29
- Last updated
- 2026-04-07
Locations
63 sites across 13 countries: United States, Australia, Belgium, China, Denmark, France, Germany, Poland, South Korea, Spain, Switzerland, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04408638. Inclusion in this directory is not an endorsement.