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A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) Inhibitors
Sponsor: BeOne Medicines
Summary
The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared with investigator's choice (bendamustine plus rituximab or high-dose methylprednisolone plus rituximab) in participants with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to covalent Bruton tyrosine kinase inhibitor(s) (cBTKi).
Official title: A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent BTK Inhibitors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2025-05-29
Completion Date
2029-11-30
Last Updated
2026-01-07
Healthy Volunteers
No
Interventions
BGB-16673
Administered orally
Bendamustine
Administered intravenously
Rituximab
Administered intravenously
Methylprednisolone
Administered intravenously
Locations (64)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Peking University Peoples Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Chongqing University Three Gorges Central Hospital
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Sun Yat Sen University Cancer Centerhuangpu Branch
Guangzhou, Guangdong, China
Meizhou People Hospital
Meizhou, Guangdong, China
Shenzhen Nanshan Peoples Hospital
Shenzhen, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Red Cross Hospital of Yulin City
Yulin, Guangxi, China
Guizhou Provincial Peoples Hospital
Guiyang, Guizhou, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Harbin Medical Universitynangang Branch
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science and Technologykaiyuan Branch
Luoyang, Henan, China
Nanyang Central Hospital
Nanyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Xuchang Central Hospitalluminghu Branch
Xuchang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Henan Provincial Peoples Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Taihe Hospital
Shiyan, Hubei, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
Yichang Central Peoples Hospital
Yichang, Hubei, China
The First Peoples Hospital of Changde City
Changde, Hunan, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Peoples Hospital of Changzhou
Changzhou, Jiangsu, China
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, China
Qinghai University Affiliated Hospital
Xining, Qinghai, China
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China
Binzhou Medical University Hospital
Binzhou, Shandong, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, China
Linyi Cancer Hospital
Linyi, Shandong, China
Taian City Central Hospital
Taian, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, China
Sichuan Cancer Hospital and Institute
Chengdu, Sichuan, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, China
Deyangs People Hospital
Deyang, Sichuan, China
The Second Peoples Hospital of Yibin
Yibin, Sichuan, China
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
Tianjin, Tianjin Municipality, China
The First Peoples Hospital of Kashgar
Kashgar, Xinjiang, China
Peoples Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China
The First Peoples Hospital of Yunnan Province
Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicineqiantang Branch
Hangzhou, Zhejiang, China
Lishui Central Hospital
Lishui, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Chang Bing Show Chwan Memorial Hospital
Changhua, Taiwan
China Medical University Hospital
North Dist, Taiwan
National Cheng Kung University Hospital
North Dist, Taiwan
Koo Foundation Sun Yat Sen Cancer Center
Taipei, Taiwan
National Taiwan University Hospital
Zhongzheng Dist, Taiwan