Trials / Completed
CompletedNCT04313608
A Study Evaluating the Safety and Efficacy of Glofitamab or Mosunetuzumab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and High-Grade Large B-Cell Lymphoma
A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Glofitamab or Mosunetuzumab in Combination With Gemcitabine Plus Oxaliplatin in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and High-Grade Large B-Cell Lymphoma
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to evaluate the safety and efficacy of glofitamab or mosunetuzumab in combination with gemcitabine and oxaliplatin (Glofit-GemOx or Mosun-GemOx) in participants with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Glofitamab | Participants will receive intravenous (IV) glofitamab in combination with gemcitabine and oxaliplatin for up to 8 cycles, followed by up to 4 cycles of glofitamab monotherapy. |
| 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. |
| DRUG | Mosunetuzumab | Participants will receive IV mosunetuzumab in combination with gemcitabine and oxaliplatin for up to 8 cycles. |
| DRUG | Obinutuzumab | Participants will receive a single dose of IV obinutuzumab 7 days prior to the first administration of glofitamab. |
| DRUG | Tocilizumab | Participants will receive IV tocilizumab as needed to treat cytokine release syndrome (CRS). |
Timeline
- Start date
- 2020-06-04
- Primary completion
- 2021-10-26
- Completion
- 2021-10-26
- First posted
- 2020-03-18
- Last updated
- 2024-03-25
- Results posted
- 2024-03-25
Locations
3 sites across 1 country: Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04313608. Inclusion in this directory is not an endorsement.