drugset / Trial / NCT03650933
A Study Comparing the Efficacy and Safety of G-CHOP Versus R-CHOP in Untreated Diffuse Large B-cell Lymphoma Patients
RandomizedParallel-groupQuadruple-blindTreatment
Summary
A Multi-center, Randomized, Double-blind, Controlled, and Parallel Phase III Study to Compare the Efficacy and Safety of GB241 (Recombinant Anti-CD20 Human-Mouse Chimeric Monoclonal Antibody Injection, Experimental Drug) Plus CHOP Versus Rituximab Plus CHOP in Untreated Diffuse Large B-cell Lymphoma (DLBCL) Patients
Timeline
- Start
- 2018-12-28
- Primary completion
- 2022-08-17
- Completion
- 2025-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GB241 | Unknown | 375 mg/m2 | Intravenous |
| Comparator | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Comparator | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Comparator | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Comparator | Prednisone | Other / unclassified | 100 mg | Oral |
| Comparator | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |