Actively Recruiting
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
Led by BeOne Medicines · Updated on 2026-05-11
150
Participants Needed
64
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of BGB-16673 compared with an investigator's choice of bendamustine plus rituximab or high-dose methylprednisolone plus rituximab in adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously been treated with covalent Bruton tyrosine kinase inhibitors (cBTKi). These blood cancers cause symptoms like enlarged lymph nodes, spleen, or liver, night sweats, weight loss, and fever, and they reduce life expectancy. New treatment options are needed to help manage symptoms and extend life. Participants will be randomly assigned to one of two groups: one receiving BGB-16673 taken orally once daily until treatment must be stopped, and the other receiving the investigator's choice of bendamustine plus rituximab or high-dose methylprednisolone plus rituximab administered intravenously for up to six 28-day cycles. If the disease worsens clearly, some participants in the investigator's choice group may switch to BGB-16673 treatment under medical guidance. This study is a Phase 3, open-label trial conducted in Mainland China and Taiwan involving about 150 participants. During the study, participants will be monitored regularly for disease progression and response using imaging and clinical assessments. Researchers will measure how long participants live without the disease worsening, overall survival, response rates, duration and time to response, and time until next treatment is needed. Quality of life and symptom burden will also be evaluated using questionnaires. Safety will be closely followed by recording treatment-related side effects. The main study period for progression-free survival assessment is about 23 months, with additional follow-up for other outcomes and safety up to nearly two years.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma requiring treatment based on 2018 iwCLL criteria
- Previous treatment with a covalent Bruton tyrosine kinase inhibitor
- Measurable disease by CT or MRI if diagnosed with small lymphocytic lymphoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate bone marrow function
- Adequate kidney and liver function
- Adequate blood clotting function
You will not qualify if you...
- Known prolymphocytic leukemia or history/suspicion of Richter's transformation
- Prior autologous stem cell transplant less than 3 months ago or CAR-T cell therapy less than 6 months ago
- History of severe allergic reactions or hypersensitivity to BGB-16673, bendamustine, or rituximab
- Current or past central nervous system involvement
- History of ischemic stroke or brain hemorrhage within 6 months before first study drug dose
- History of confirmed progressive multifocal leukoencephalopathy
- Active fungal, bacterial, or viral infection requiring intravenous systemic treatment
- Clinically significant cardiovascular disease
- Other protocol-defined inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 cycles of 28 days each or until treatment discontinuation criteria are met
Participants receive either BGB-16673 daily or investigator's choice of bendamustine plus rituximab or high-dose methylprednisolone plus rituximab for up to six 28-day cycles.
Regular visits as per treatment cycles
Duration - Up to approximately 23 months
Participants are monitored for disease progression, survival, response to treatment, and quality of life after treatment ends.
Periodic visits during follow-up
Trial Site Locations
Total: 64 locations
1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230000
Actively Recruiting
2
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
3
Peking University Peoples Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
4
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
5
Chongqing University Three Gorges Central Hospital
Chongqing, Chongqing Municipality, China, 404000
Actively Recruiting
6
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 630014
Actively Recruiting
7
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
8
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
Actively Recruiting
9
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
10
Sun Yat Sen University Cancer Center Huangpu Branch
Guangzhou, Guangdong, China, 510555
Actively Recruiting
11
Meizhou People Hospital
Meizhou, Guangdong, China, 514031
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12
Shenzhen Nanshan Peoples Hospital
Shenzhen, Guangdong, China, 518052
Actively Recruiting
13
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Actively Recruiting
14
Red Cross Hospital of Yulin City
Yulin, Guangxi, China, 537000
Actively Recruiting
15
Guizhou Provincial Peoples Hospital
Guiyang, Guizhou, China, 550002
Actively Recruiting
16
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150000
Actively Recruiting
17
The First Affiliated Hospital of Harbin Medical Universitynangang Branch
Harbin, Heilongjiang, China, 150001
Actively Recruiting
18
The First Affiliated Hospital of Henan University of Science and Technologykaiyuan Branch
Luoyang, Henan, China, 471023
Actively Recruiting
19
Nanyang Central Hospital
Nanyang, Henan, China, 473000
Actively Recruiting
20
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China, 453100
Actively Recruiting
21
Xuchang Central Hospitalluminghu Branch
Xuchang, Henan, China, 461000
Actively Recruiting
22
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
23
Henan Provincial Peoples Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
24
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
25
Taihe Hospital
Shiyan, Hubei, China, 442000
Actively Recruiting
26
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
27
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
28
Yichang Central Peoples Hospital
Yichang, Hubei, China, 443003
Actively Recruiting
29
The First Peoples Hospital of Changde City
Changde, Hunan, China, 415000
Actively Recruiting
30
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011
Actively Recruiting
31
The First Peoples Hospital of Changzhou
Changzhou, Jiangsu, China, 213000
Actively Recruiting
32
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210008
Actively Recruiting
33
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
34
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 201203
Actively Recruiting
35
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
36
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221000
Actively Recruiting
37
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Actively Recruiting
38
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
Actively Recruiting
39
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, China, 116001
Actively Recruiting
40
Qinghai University Affiliated Hospital
Xining, Qinghai, China, 810001
Actively Recruiting
41
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China, 710004
Actively Recruiting
42
Binzhou Medical University Hospital
Binzhou, Shandong, China, 256603
Actively Recruiting
43
Affiliated Hospital of Jining Medical University
Jining, Shandong, China, 272000
Actively Recruiting
44
Linyi Cancer Hospital
Linyi, Shandong, China, 276001
Actively Recruiting
45
Taian City Central Hospital
Taian, Shandong, China, 271099
Actively Recruiting
46
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
47
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030032
Actively Recruiting
48
Sichuan Cancer Hospital and Institute
Chengdu, Sichuan, China, 610041
Actively Recruiting
49
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, China, 610071
Actively Recruiting
50
Deyangs People Hospital
Deyang, Sichuan, China, 618000
Actively Recruiting
51
The Second Peoples Hospital of Yibin
Yibin, Sichuan, China, 644000
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52
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
Tianjin, Tianjin Municipality, China, 301617
Actively Recruiting
53
The First Peoples Hospital of Kashgar
Kashgar, Xinjiang, China, 844099
Actively Recruiting
54
Peoples Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, China, 830001
Actively Recruiting
55
The First Peoples Hospital of Yunnan Province
Kunming, Yunnan, China, 650034
Actively Recruiting
56
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
Hangzhou, Zhejiang, China, 310002
Actively Recruiting
57
Sir Run Run Shaw Hospital, Zhejiang University School of Medicineqiantang Branch
Hangzhou, Zhejiang, China, 310018
Actively Recruiting
58
Lishui Central Hospital
Lishui, Zhejiang, China, 323000
Actively Recruiting
59
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
60
Chang Bing Show Chwan Memorial Hospital
Changhua, Taiwan, 505029
Actively Recruiting
61
National Cheng Kung University Hospital
North Dist, Taiwan, 704
Actively Recruiting
62
China Medical University Hospital
Taichung, Taiwan, 40447
Actively Recruiting
63
Koo Foundation Sun Yat Sen Cancer Center
Taipei, Taiwan, 11259
Actively Recruiting
64
National Taiwan University Hospital
Zhongzheng Dist, Taiwan, 100225
Actively Recruiting
Research Team
S
Study Director Study Director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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