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
Status: Recruiting
Location: See all (64) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Confirmed diagnosis of CLL/SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
• Previously received treatment for CLL/SLL with a covalent BTKi.
• Measurable disease by computer tomography/magnetic resonance imaging for patients with SLL.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Adequate bone marrow function
• Adequate kidney and liver function
• Adequate blood clotting function
Locations
Other Locations
China
Peking Union Medical College Hospital
NOT_YET_RECRUITING
Beijing
Peking University Peoples Hospital
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
Binzhou Medical University Hospital
RECRUITING
Binzhou
The First Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
The First Peoples Hospital of Changde City
RECRUITING
Changde
The Second Xiangya Hospital of Central South University
RECRUITING
Changsha
The First Peoples Hospital of Changzhou
RECRUITING
Changzhou
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
RECRUITING
Chengdu
Sichuan Cancer Hospital and Institute
RECRUITING
Chengdu
Chongqing University Three Gorges Central Hospital
RECRUITING
Chongqing
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Affiliated Zhongshan Hospital of Dalian University
RECRUITING
Dalian
Deyangs People Hospital
RECRUITING
Deyang
Fujian Medical University Union Hospital
RECRUITING
Fuzhou
The First Affiliated Hospital of Fujian Medical University
RECRUITING
Fuzhou
Sun Yat Sen University Cancer Center(Huangpu Campus)
RECRUITING
Guangzhou
Zhujiang Hospital of Southern Medical University
RECRUITING
Guangzhou
Guizhou Provincial Peoples Hospital
RECRUITING
Guiyang
Sir Run Run Shaw Hospital, Zhejiang University School of Medicineqiantang Branch
RECRUITING
Hangzhou
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
NOT_YET_RECRUITING
Harbin
The First Affiliated Hospital of Harbin Medical Universitynangang Branch
RECRUITING
Harbin
The First Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
Affiliated Hospital of Jining Medical University
RECRUITING
Jining
The First Peoples Hospital of Kashgar
RECRUITING
Kashgar
The First Peoples Hospital of Yunnan Province
RECRUITING
Kunming
Linyi Cancer Hospital
RECRUITING
Linyi
Lishui Central Hospital
RECRUITING
Lishui
The First Affiliated Hospital of Henan University of Science and Technologykaiyuan Branch
RECRUITING
Luoyang
Meizhou People Hospital
RECRUITING
Meizhou
The Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Jiangsu Province Hospital
RECRUITING
Nanjing
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
RECRUITING
Nanjing
The First Affiliated Hospital of Guangxi Medical University
RECRUITING
Nanning
Affiliated Hospital of Nantong University
RECRUITING
Nantong
Nanyang Central Hospital
RECRUITING
Nanyang
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Shenzhen Nanshan Peoples Hospital
RECRUITING
Shenzhen
Taihe Hospital
RECRUITING
Shiyan
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Taian City Central Hospital
RECRUITING
Taian
Shanxi Bethune Hospital
RECRUITING
Taiyuan
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
RECRUITING
Tianjin
The Xinjiang Uygur Autonomous Region Peoples Hospital
RECRUITING
Ürümqi
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
The Second Affiliated Hospital of Xian Jiaotong University
NOT_YET_RECRUITING
Xi'an
Qinghai University Affiliated Hospital
RECRUITING
Xining
The First Affiliated Hospital of Xinxiang Medical University
RECRUITING
Xinxiang
Xuchang Central Hospitalluminghu Branch
RECRUITING
Xuchang
The Affiliated Hospital of Xuzhou Medical University
RECRUITING
Xuzhou
The Second Peoples Hospital of Yibin
RECRUITING
Yibin
Yichang Central Peoples Hospital
RECRUITING
Yichang
Red Cross Hospital of Yulin City
RECRUITING
Yulin
Henan Cancer Hospital
RECRUITING
Zhengzhou
Henan Provincial Peoples Hospital
NOT_YET_RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Taiwan
Chang Bing Show Chwan Memorial Hospital
RECRUITING
Changhua
China Medical University Hospital
RECRUITING
North Dist
National Cheng Kung University Hospital
RECRUITING
North Dist
Koo Foundation Sun Yat Sen Cancer Center
RECRUITING
Taipei
National Taiwan University Hospital
RECRUITING
Zhongzheng Dist
Contact Information
Primary
Study Director Study Director
clinicaltrials@beigene.com
1.877.828.5568
Time Frame
Start Date: 2025-05-29
Estimated Completion Date: 2029-11-30
Participants
Target number of participants: 150
Treatments
Experimental: Arm A: BGB-16673 Monotherapy
Participants will receive BGB-16673 once daily until any of the treatment discontinuation criteria are met
Active_comparator: Arm B: Investigator's Choice
Participants will receive investigator's choice of bendamustine plus rituximab or high-dose methylprednisolone plus rituximab for up to six 28-day cycles.~Participants with unequivocal disease progression confirmed by Independent Review Committee (IRC) may cross over to receive treatment with BGB-16673 at the Investigator's discretion
Related Therapeutic Areas
Sponsors
Leads: BeiGene