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NCT06970743Active, not recruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 24 Aug 2026

Brief summary (registry, in English)

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 or chlorambucil plus obinutuzumab) 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).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
153 (actual)
First submitted
6 May 2025
Start date
29 May 2025
Primary completion date
30 Nov 2029
Lead sponsor
BeOne Medicines
NCT number
NCT06970743

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 153
  • From 29 May 2025 to the primary completion date, 30 Nov 2029
  • 56 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 2\. Prior autologous stem cell transplant (unless ≥ 3 months after transplant) or chimeric antigen receptor-T cell (unless ≥ 6 months after cell infusion)
  • History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug

Other illness

  • Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
  • History of severe allergic reactions or hypersensitivity to the active ingredient and excipients of study treatment (BGB-16673, bendamustine, rituximab, chlorambucil, or obinutuzumab)
  • Current or history of central nervous system involvement
  • History of confirmed progressive multifocal leukoencephalopathy.
  • Active fungal, bacterial, and/or viral infection requiring parenteral systemic therapy
  • Clinically significant cardiovascular disease
    • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (56)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Peking Union Medical College Hospital
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BeijingChinaUnknown status
Peking University Peoples Hospital
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BeijingChinaUnknown status
Peking University Third Hospital
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BeijingChinaUnknown status
Binzhou Medical University Hospital
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BinzhouChinaUnknown status
The First Hospital of Jilin University
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ChangchunChinaUnknown status
The First Peoples Hospital of Changde City
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ChangdeChinaUnknown status
The Second Xiangya Hospital of Central South University
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ChangshaChinaUnknown status
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
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ChengduChinaUnknown status
Chongqing University Three Gorges Central Hospital
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ChongqingChinaUnknown status
The First Affiliated Hospital of Chongqing Medical University
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ChongqingChinaUnknown status
Affiliated Zhongshan Hospital of Dalian University
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DalianChinaUnknown status
Deyangs People Hospital
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DeyangChinaUnknown status
Fujian Medical University Union Hospital
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FuzhouChinaUnknown status
The First Affiliated Hospital of Fujian Medical University
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FuzhouChinaUnknown status
Zhujiang Hospital of Southern Medical University
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GuangzhouChinaUnknown status
Sun Yat Sen University Cancer Center Huangpu Branch
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GuangzhouChinaUnknown status
Guizhou Provincial Peoples Hospital
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GuiyangChinaUnknown status
Sir Run Run Shaw Hospital, Zhejiang University School of Medicineqiantang Branch
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HangzhouChinaUnknown status
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
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HangzhouChinaUnknown status
Harbin Medical University Cancer Hospital
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HarbinChinaUnknown status
The First Affiliated Hospital of Harbin Medical Universitynangang Branch
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HarbinChinaUnknown status
The First Affiliated Hospital of Anhui Medical University
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HefeiChinaUnknown status
Affiliated Hospital of Jining Medical University
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JiningChinaUnknown status
The First Peoples Hospital of Yunnan Province
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KunmingChinaUnknown status
LinYi Cancer Hospital
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LinyiChinaUnknown status
Lishui Central Hospital
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LishuiChinaUnknown status
Meizhou People Hospital
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MeizhouChinaUnknown status
The Second Affiliated Hospital of Nanchang University
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NanchangChinaUnknown status
Jiangsu Province Hospital
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NanjingChinaUnknown status
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
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NanjingChinaUnknown status
The First Affiliated Hospital of Guangxi Medical University
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NanningChinaUnknown status
Affiliated Hospital of Nantong University
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NantongChinaUnknown status
Fudan University Shanghai Cancer Center
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ShanghaiChinaUnknown status
Shenzhen Nanshan Peoples Hospital
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ShenzhenChinaUnknown status
Taihe Hospital
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ShiyanChinaUnknown status
The First Affiliated Hospital of Soochow University
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SuzhouChinaUnknown status
Taian City Central Hospital
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TaianChinaUnknown status
Shanxi Bethune Hospital
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TaiyuanChinaUnknown status
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch
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TianjinChinaUnknown status
Peoples Hospital of Xinjiang Uygur Autonomous Region
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ÜrümqiChinaUnknown status
The First Affiliated Hospital of Wenzhou Medical University
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WenzhouChinaUnknown status
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
Union Hospital of Tongji Medical College Huazhong University of Science and Technology
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WuhanChinaUnknown status
Qinghai university affiliated hospital
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XiningChinaUnknown status
The First Affiliated Hospital of Xinxiang Medical University
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XinxiangChinaUnknown status
Xuchang Central Hospitalluminghu Branch
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XuchangChinaUnknown status
The affiliated hospital of xuzhou medical university
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XuzhouChinaUnknown status
The Second Peoples Hospital of Yibin
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YibinChinaUnknown status
Yichang Central Peoples Hospital
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YichangChinaUnknown status
Red Cross Hospital of Yulin City
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YulinChinaUnknown status
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaUnknown status
Henan Provincial Peoples Hospital
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ZhengzhouChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
Chang Bing Show Chwan Memorial Hospital
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ChanghuaTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.