A Randomized, Open-label, Multi-center, Phase III Study of Orelabrutinib in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) vs. R-CHOP Alone in Patients With Treatment-naїve Mantle Cell Lymphoma
研究单位:[1]Beijing InnoCare Pharma Tech Co., Ltd.[2]Beijing Cancer Hospital Beijing, Beijing, China, 100143[3]Tumor in Hunan Province Hunan, Changsha, China, 410013[4]The First Affiliated Hospital of Xiamen University Xiamen, Fujian, China, 361003[5]Sun Yat-sen University Cancer Center Guangzhou, Guangdong, China, 510060[6]Guangzhou First People's Hospital Guangzhou, Guangdong, China, 510180[7]The Fourth Hospital of Hebei Medical University Shijiazhuang, Hebei, China, 50011河北医科大学第四医院[8]Henan Tumor Hospital Zhengzhou, Henan, China, 450008[9]The First Affiliated Hospital of Zhengzhou University Zhengzhou, Henan, China, 450052[10]Wuhan Union Hospital Wuhan, Hubei, China, 430022[11]Jiangsu Province Hospital Nanjing, Jiangsu, China, 210029[12]The First Affiliated Hospital of Soochow University Suzhou, Jiangsu, China, 215006[13]The First Affiliated Hospital of Nanchang University Nanchang, Jiangxi, China, 3300008[14]The First Hospital of Jilin University Changchun, Jilin, China, 130021[15]The First Hospital of China Medical University Shenyang, Liaojing, China, 110001[16]The First Affiliated Hospital of Guangxi Medical University Guangxi, Nanning, China, 530021[17]Shandong Provincial Hospital Jinan, Shandong, China, 250021[18]West China Hospital,Sichuan University Chengdu, Sichuan, China, 610041[19]Hospital of Hematology, Chinese Academy of Medical Sciences Tianjin, Tianjin, China, 300052[20]Tianjin Cancer Hospital Tianjin, Tianjin, China, 300060[21]he First Affiliated Hospital of Zhengjiang University Hangzhou, Zhejiang, China, 310003[22]Zhejiang Cancer Hospital Hangzhou, Zhejiang, China, 310022[23]Anhui Province Cancer Hospital Hefei, Anhui, China, 230009
研究目的:
To evaluate the efficacy of orelabrutinib combined with R-CHOP vs. R-CHOP alone in the treatment of treatment-naїve mantle cell lymphoma.