Phase III Study of Tucidinostat in Combination With R-CHOP in Patients With Newly Diagnosed Double-Expressor DLBCL

Phase 3 Completed 423 enrolled Chipscreen Biosciences, Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Tucidinostat (formerly known as chidamide) is an oral subtype-selective histone deacetylase inhibitor. This Randomized, Double-blind, Placebo-controlled Phase 3 trail is studying the efficacy and safety of Tucidinostat, in Combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed MYC/BCL2 Double-Expressor Diffuse Large B-cell Lymphoma.

Timeline

Start: 2020-05-21
Primary completion: 2023-01-10
Completion: 2025-06-29

Outcome

Met primary endpoint

paper The tucidinostat group demonstrated a 28% lower risk of disease progression, relapse after complete response, death, or initiation of new therapy for residual disease PMID 42018318 ↗

paper stratified hazard ratio, 0.72 [95% CI, 0.54-0.96]; P = .02 PMID 42018318 ↗

Publications

Xu PP, Song YQ, Shen JZ, Cai QQ, Zhou H, Zhang LL, Xiang Y, Sun XH, Yang W, Yao ZH, Jing HM, Wen SJ, Jin J, Xue HW, Cen H, Ding KY, Jin ZM, Liu LH, Xing XJ, Li LF, Hou M, Liu L, Zhang MZ, Li WY, Bai O, Feng R, Zhu ZM, Wu HJ, Su LP, Gao L, Li F, Huang WR, Liu P, Yan XJ, Zhao Y, Su H, Zhao XL, Fu R, Liu H, Shi WY, Li HZ, Chen B, Ning ZQ, Zhu J, Zhao WL. Tucidinostat Plus R-CHOP vs R-CHOP in MYC/BCL2 Double-Expressor Diffuse Large B-Cell Lymphoma: A Randomized Clinical Trial. JAMA. 2026 May 19;335(19):1684-1693. doi: 10.1001/jama.2026.4199.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tucidinostat	Small molecule	30 mg	Oral
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
Background	Vincristine	Small molecule	1.4 mg/m2	Intravenous