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
NCT ID: NCT06970743
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
150 participants
INTERVENTIONAL
2025-05-29
2029-11-30
Brief Summary
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Detailed Description
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In this study, participants with R/R CLL or SLL who were previously exposed to a covalent BTKi will receive BGB-16673 or the investigator's choice of bendamustine plus rituximab or high-dose methylprednisolone plus rituximab. The main purpose of this study is to compare the length of time that participants live without their CLL or SLL worsening between those participants who receive BGB-16673 versus the investigator's choice of treatment. Approximately 150 participants will be included in this study in Mainland China and Taiwan. Participants will be randomly allocated to receive either BGB-16673 or the investigator's choice of treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: BGB-16673 Monotherapy
Participants will receive BGB-16673 once daily until any of the treatment discontinuation criteria are met
BGB-16673
Administered orally
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
BGB-16673
Administered orally
Bendamustine
Administered intravenously
Rituximab
Administered intravenously
Methylprednisolone
Administered intravenously
Interventions
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BGB-16673
Administered orally
Bendamustine
Administered intravenously
Rituximab
Administered intravenously
Methylprednisolone
Administered intravenously
Eligibility Criteria
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Inclusion Criteria
2. Previously received treatment for CLL/SLL with a covalent BTKi.
3. Measurable disease by computer tomography/magnetic resonance imaging for patients with SLL.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
5. Adequate bone marrow function
6. Adequate kidney and liver function
7. Adequate blood clotting function
Exclusion Criteria
2. 2\. Prior autologous stem cell transplant (unless ≥ 3 months after transplant) or chimeric antigen receptor-T cell (unless ≥ 6 months after cell infusion)
3. History of severe allergic reactions or hypersensitivity to the active ingredient and excipients of study treatment (BGB-16673, bendamustine, or rituximab)
4. Current or history of central nervous system involvement
5. History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug
6. History of confirmed progressive multifocal leukoencephalopathy.
7. Active fungal, bacterial, and/or viral infection requiring parenteral systemic therapy
8. Clinically significant cardiovascular disease
18 Years
ALL
No
Sponsors
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BeOne Medicines
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director Study Director
Role: STUDY_DIRECTOR
BeOne Medicines
Locations
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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
Countries
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Central Contacts
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Other Identifiers
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BGB-16673-303
Identifier Type: -
Identifier Source: org_study_id
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