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
CaDAnCe-303
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
1 other identifier
interventional
150
2 countries
64
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2025
Longer than P75 for phase_3
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2025
CompletedFirst Posted
Study publicly available on registry
May 14, 2025
CompletedStudy Start
First participant enrolled
May 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2029
April 22, 2026
April 1, 2026
4.5 years
May 6, 2025
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) by IRC
PFS is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with R/R CLL and the Lugano Classification for patients with R/R SLL.
Approximately 23 Months
Secondary Outcomes (10)
PFS as Assessed by the Investigator
Approximately 12 Months
Overall Survival (OS)
Approximately 21 Months
Overall Response Rate (ORR) by IRC and Investigator Assessment
Approximately 23 Months
Rate of Partial Response with Lymphocytosis (PR-L) or Higher Determined by Investigator Assessment
Approximately 23 Months
Duration of Response (DOR) by IRC and Investigator Assessment
Approximately 9 Months
- +5 more secondary outcomes
Study Arms (2)
Arm A: BGB-16673 Monotherapy
EXPERIMENTALParticipants will receive BGB-16673 once daily until any of the treatment discontinuation criteria are met
Arm B: Investigator's Choice
ACTIVE COMPARATORParticipants 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
- \. Prior autologous stem cell transplant (unless ≥ 3 months after transplant) or chimeric antigen receptor-T cell (unless ≥ 6 months after cell infusion)
- History of severe allergic reactions or hypersensitivity to the active ingredient and excipients of study treatment (BGB-16673, bendamustine, or rituximab)
- Current or history of central nervous system involvement
- History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug
- History of confirmed progressive multifocal leukoencephalopathy.
- Active fungal, bacterial, and/or viral infection requiring parenteral systemic therapy
- Clinically significant cardiovascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeOne Medicineslead
Study Sites (64)
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230000, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100000, China
Peking University Peoples Hospital
Beijing, Beijing Municipality, 100044, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Chongqing University Three Gorges Central Hospital
Chongqing, Chongqing Municipality, 404000, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 630014, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000, China
Sun Yat Sen University Cancer Centerhuangpu Branch
Guangzhou, Guangdong, 510555, China
Meizhou People Hospital
Meizhou, Guangdong, 514031, China
Shenzhen Nanshan Peoples Hospital
Shenzhen, Guangdong, 518052, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
Red Cross Hospital of Yulin City
Yulin, Guangxi, 537000, China
Guizhou Provincial Peoples Hospital
Guiyang, Guizhou, 550002, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
The First Affiliated Hospital of Harbin Medical Universitynangang Branch
Harbin, Heilongjiang, 150001, China
The First Affiliated Hospital of Henan University of Science and Technologykaiyuan Branch
Luoyang, Henan, 471023, China
Nanyang Central Hospital
Nanyang, Henan, 473000, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453100, China
Xuchang Central Hospitalluminghu Branch
Xuchang, Henan, 461000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Henan Provincial Peoples Hospital
Zhengzhou, Henan, 450003, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Taihe Hospital
Shiyan, Hubei, 442000, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Yichang Central Peoples Hospital
Yichang, Hubei, 443003, China
The First Peoples Hospital of Changde City
Changde, Hunan, 415000, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
The First Peoples Hospital of Changzhou
Changzhou, Jiangsu, 213000, China
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 201203, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Affiliated Zhongshan Hospital of Dalian University
Dalian, Liaoning, 116001, China
Qinghai University Affiliated Hospital
Xining, Qinghai, 810001, China
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710004, China
Binzhou Medical University Hospital
Binzhou, Shandong, 256603, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272000, China
Linyi Cancer Hospital
Linyi, Shandong, 276001, China
Taian City Central Hospital
Taian, Shandong, 271099, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032, China
Sichuan Cancer Hospital and Institute
Chengdu, Sichuan, 610041, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, 610071, China
Deyangs People Hospital
Deyang, Sichuan, 618000, China
The Second Peoples Hospital of Yibin
Yibin, Sichuan, 644000, China
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
Tianjin, Tianjin Municipality, 301617, China
The First Peoples Hospital of Kashgar
Kashgar, Xinjiang, 844099, China
Peoples Hospital of Xinjiang Uygur Autonomous Region
Ürümqi, Xinjiang, 830001, China
The First Peoples Hospital of Yunnan Province
Kunming, Yunnan, 650034, China
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
Hangzhou, Zhejiang, 310002, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicineqiantang Branch
Hangzhou, Zhejiang, 310018, China
Lishui Central Hospital
Lishui, Zhejiang, 323000, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Chang Bing Show Chwan Memorial Hospital
Changhua, 505029, Taiwan
National Cheng Kung University Hospital
North Dist, 704, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Koo Foundation Sun Yat Sen Cancer Center
Taipei, 11259, Taiwan
National Taiwan University Hospital
Zhongzheng Dist, 100225, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director Study Director
BeOne Medicines
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2025
First Posted
May 14, 2025
Study Start
May 29, 2025
Primary Completion (Estimated)
November 30, 2029
Study Completion (Estimated)
November 30, 2029
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.