drugset / Trial / NCT06890585
Zanubrutinib, Chidamide, and Rituximab Induction With or Without CHOP Versus R-CHOP in Newly Diagnosed Double-Expressor DLBCL
RandomizedParallel-groupOpen-labelTreatment
Summary
Zanubrutinib, as a new generation of BTK inhibitors, has shown more potent antitumor activity and lower adverse reactions than ibrutinib in head-to-head clinical studies, which make it a promising regimen for B cell lymphoma. Chidamide is an oral subtype-selective histone deacetylase inhibitor. This Randomized, Multicenter, Open-Label Phase II Clinical Study is comparing the efficacy and safety of Zanubrutinib, Chidamide, and Rituximab induction therapy sequentially combined with or without CHOP versus R-CHOP in the first-line treatment of patients with newly diagnosed double-expressor DLBCL.
Timeline
- Start
- 2025-06-01
- Primary completion
- 2029-12-31
- Completion
- 2029-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Comparator | Doxorubicin | Other / unclassified | 50 mg/m2 | Intravenous |
| Comparator | Epirubicin | Small molecule | 50 mg/m2 | Intravenous |
| Comparator | Prednisone | Other / unclassified | 30 mg | Oral |
| Comparator | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Subject | Tucidinostat | Small molecule | 20 mg | Oral |
| Comparator | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |
| Subject | Zanubrutinib | Small molecule | 160 mg | — |