Tucidinostat Plus R-CHOP vs R-CHOP in MYC/BCL2 Double-Expressor Diffuse Large B-Cell Lymphoma

作者：Peng-Peng Xu, Yu-Qin Song, Jian-Zhen Shen, Qing-Qing Cai, Hui Zhou, Li-Ling Zhang, Ying Xiang, Xiu-Hua Sun, Wei Yang, Zhi-Hua Yao, Hongmei Jing, Shujuan Wen, Jie Jin, Hong‐Wei Xue, Hong Cen, Kaiyang Ding, Zhengming Jin, Lu Liu, Xiaojing Xing, Lan-Fang Li, Ming Hou, Lu Liu, M Zhang, Wen‐Yu Li, Ou Bai, Ru Feng, Zun-Min Zhu, Hui-Jing Wu, Li-Ping Su, L Gao, F Li, W R Huang, Peng Liu, Yan X, Ying Zhao, Hang Su, Xielan Zhao, Rong Fu, Hong Liu, Wen-Yu Shi, Hui-Zhi Li, Bo Chen, Zhiqiang Ning, Jun Zhu, Wei-Li Zhao · 发表于：JAMA · 年份：2026 · DOI：10.1001/jama.2026.4199 · 被引用次数：2 · 研究领域：Lymphoma Diagnosis and Treatment、Chronic Lymphocytic Leukemia Research、Acute Lymphoblastic Leukemia research

Importance: Epigenetic dysregulation is associated with the pathogenesis and progression of diffuse large B-cell lymphoma (DLBCL). MYC/BCL2 double-expressor lymphoma (DEL), a distinct population of DLBCL defined by MYC and BCL2 coexpression, refers to poor prognosis after standard rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) immunochemotherapy. Tucidinostat (or chidamide), an oral, selective histone deacetylase inhibitor, has shown promising activity in DEL. Objective: To evaluate efficacy and safety of tucidinostat plus R-CHOP vs R-CHOP alone as first-line treatment for patients with DEL. Design, Setting, and Participants: This randomized, double-blind, placebo-controlled phase 3 trial enrolled patients from May 21, 2020, through July 25, 2022, with follow-up to June 26, 2025. The trial was conducted at 40 study centers in China; a total of 423 eligible patients were enrolled. Interventions: Patients were randomly assigned in a 1:1 ratio to receive oral tucidinostat (20 mg on days 1, 4, 8, and 11 of each 21-day cycle) or matching placebo, plus 6 cycles of R-CHOP. Patients with a complete response after combination therapy received either tucidinostat or placebo maintenance up to 24 weeks. Main Outcomes and Measures: The primary end point was event-free survival. Secondary end points included complete response rate, progression-free survival, disease-free survival, overall survival, and tolerability. Results: Among 423 patients randomized...