drugset / Trial / NCT06806033
A Study to Evaluate the Optimization of the Cytokine Release Syndrome Profile for Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed/Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma
NaSingle-groupOpen-labelTreatment
Summary
This Phase II trial evaluates the optimization of the cytokine release syndrome (CRS) profile for glofitamab in combination with gemcitabine and oxaliplatin (Glofit-GemOx) in participants with relapsed or refractory aggressive B-cell Non-Hodgkin's lymphoma. The study utilizes an optimized steroid premedication regimen and monitoring schedule specifically designed to enable the administration of the treatment regimen in an outpatient setting.
Timeline
- Start
- 2025-03-05
- Primary completion
- 2027-01-31
- Completion
- 2029-03-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gemcitabine | Small molecule | — | Intravenous |
| Subject | Glofitamab | Monoclonal antibody | — | Intravenous |
| Subject | Obinutuzumab | Monoclonal antibody | — | Intravenous |
| Subject | Oxaliplatin | Small molecule | — | Intravenous |