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Orelabrutinib Plus ICP 248 vs Orelabrutinib for Relapsed/Refractory Marginal Zone Lymphoma
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Summary
To evaluate the efficacy of olubrutinib combined with ICP-248 compared with the olubrutinib in the treatment of r/r MZL
Official title: A Randomized, Multicenter, Open Label Phase 3 Study to Evaluate Orelabrutinib Combined With ICP 248 Versus Orelabrutinib Monotherapy for Relapsed/Refractory Marginal Zone Lymphoma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
292
Start Date
2026-10
Completion Date
2032-01
Last Updated
2026-10-27
Healthy Volunteers
No
Interventions
Orelabrutinib
Participants receive orelabrutinib 150 mg oral once daily continuous dosing; each cycle is 28 days.
ICP-248
Eligible patients will receive ICP-248 orally as per the protocol
Locations (46)
Bozhou People's Hospital
Bozhou, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Xinqiao Hospital Army Medical University
Chongqing, Chongqing Municipality, China
Southwest Hospital, Army Medical University
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Liuzhou People's Hospital
Liuzhou, Guangxi, China
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Harbin Medical University cancer hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University)
Zhengzhou, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
The Second Xiangya Hospital, Central South University
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University
Nanjing, Jiangsu, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
QiLu Hospital of Shandong University
Jinan, Shandong, China
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, China
Xijing Hospital, Air Force Medical University
Xian, Shanxi, China
The first Affiliated Hospital Of Xi'an Jiaotong University
Xi’an, Shanxi, China
The Second Affiliated Hospital of Xi'an Jiaotong University（Xibei Hospital）
Xi’an, Shanxi, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, Xinjiang, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
Shandong Cancer Hospital and Institute
Jinan, China
Tianjin First Central Hospital
Tianjin, China