drugset / Trial / NCT06890585

Zanubrutinib, Chidamide, and Rituximab Induction With or Without CHOP Versus R-CHOP in Newly Diagnosed Double-Expressor DLBCL

NCT06890585 ↗

Phase 2 Not yet recruiting 128 enrolled Li Zhiming
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

EvaluationDrugModalityDoseRoute
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 —