Chidamide plus prednisone, cyclophosphamide, and thalidomide for relapsed or refractory peripheral T-cell lymphoma: A multicenter phase II trial

• Published in: 中华医学杂志英文版 Vol. 137; no. 13; pp. 1576 - 1582
• Main Authors: Liang Jinhua, Wang Li, Wang Xiaodong, Cui Guohui, Zhou Jianfeng, Xing Tongyao, Du Kaixin, Xu Jingyan, Wang Luqun, Liang Rong, Chen Biyun, Cheng Jian, Shen Haorui, Li Jianyong, Xu Wei
• Format: Journal Article
• Language: Chinese
• Published: Department of Hematology, The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital, Nanjing, Jiangsu 210029, China%Key Laboratory of Hematology of Nanjing Medical University, Nanjing, Jiangsu 210029, China%Collaborative Innovation Center for Cancer Personalized Medicine, Nanjing, Jiangsu 210029, China%Department of Hematology, Sichuan Academy of Medical Sciences & Sichuan Provincial People’s Hospital, School of Medicine of University of Electronic Science and Technology of China, Chengdu, Sichuan 610000, China%Department of Hematology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430022, China%Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China%Department of Hematology, Nanjing Drum Tower Hospital, Nanjing University Medical School, Nanjing, Jiangsu 210008, China%Department of Hematology, Qilu Hospital of Shandong University, Jinan, Shandong 250000, China%Department of Hematology, Xijing Hospital, The Fourth Military Medical University, Xi’an, Shaanxi 710032, China%Department of Hematology, Fujian Provincial Hospital, Fuzhou, Fujian 350001, China%Department of Hematology, Zhongda Hospital, Medical School of Southeast University, Nanjing, Jiangsu 210009, China 2024
• Subjects: Cyclophosphamide; Peripheral T-cell lymphoma; Prednisone; Thalidomide; All-oral regimen; Chidamide
• ISSN: 0366-6999
• DOI: 10.1097/CM9.0000000000002836

Background::Although the treatment of peripheral T-cell lymphoma (PTCL) has undergone advancements during the past several years, the response rate and long-term effects with respect to patients with PTCL remain unsatisfactory—particularly for relapsed or refractory (R/R) patients. This phase II trial was designed to explore the efficacy and safety of an all-oral regimen of chidamide plus prednisone, cyclophosphamide, and thalidomide (CPCT) for R/R PTCL patients who could not tolerate the standard chemotherapy for a variety of reasons.Methods::We conducted a multicenter phase II clinical trial in which we combined chidamide (30 mg twice weekly) with prednisone (20 mg daily after breakfast), cyclophosphamide (50 mg daily after lunch), and thalidomide (100 mg daily at bedtime) (the CPCT regimen) for a total of fewer than 12 cycles as an induction-combined treatment period, and then applied chidamide as single-drug maintenance. Forty-five patients were ultimately enrolled from August 2016 to April 2021 with resp