drugset / Trial / NCT06516978
A Study Comparing the Efficacy and Safety of Pola-RCHP-X Versus RCHOP-X and Pola-RCHP in Previously Untreated Patients With DLBCL
Phase 2
Not yet recruiting
528 enrolled
The First Affiliated Hospital with Nanjing Medical University
RandomizedParallel-groupOpen-labelTreatment
Summary
This study aims to compare the efficacy and safety of Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone combined with Orelabrutinib/Chidamide/Venetoclax/Lenalidomide/PD1 (Pola-RCHP-X) versus RCHOP-X and Pola-RCHP in previously untreated patients with DLBCL.
Timeline
- Start
- 2024-10-01
- Primary completion
- 2028-10-01
- Completion
- 2029-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lenalidomide | Other / unclassified | 25 mg | Oral |
| Subject | Orelabrutinib | Small molecule | 150 mg | Oral |
| Subject | Penpulimab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Polatuzumab Vedotin | Other / unclassified | 1.8 mg/kg | Intravenous |
| Subject | Tucidinostat | Small molecule | 20 mg | Oral |
| Subject | Venetoclax | Small molecule | 800 mg | Oral |
| Comparator | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Background | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Background | Prednisone | Other / unclassified | 100 mg | Oral |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |