drugset / Trial / NCT06792253
Study Comparing BEBT-908 Combined With R to SOC for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multicenter, randomized, controlled, open-label Phase III clinical trial, aimed at evaluating the efficacy and safety of BEBT-908 combined with rituximab (R) compared to investigator-selected standard chemotherapy regimens \[Standard of Care (SOC)\] \[i.e., rituximab-gemcitabine-oxaliplatin (R-GemOx) or rituximab-ifosfamide-carboplatin-etoposide (R-ICE)\] for the treatment of relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL).
Timeline
- Start
- 2025-01-06
- Primary completion
- 2028-12-31
- Completion
- 2029-06-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | 800 mg | — |
| Comparator | Etoposide | Small molecule | 100 mg/m2 | — |
| Comparator | Gemcitabine | Small molecule | 1 g | — |
| Comparator | Ifosfamide | Small molecule | 5000 mg/m2 | — |
| Subject | Ifupinostat | Unknown | 18.5 mg/m2 | — |
| Comparator | Oxaliplatin | Small molecule | 100 mg/m2 | — |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | — |