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
- Diseases
- Chronic lymphocytic leukaemia
- 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
Sites (56)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University Peoples Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Binzhou Medical University Hospital Coordinator of this site? Confirm its status | Binzhou | China | Unknown status |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| The First Peoples Hospital of Changde City Coordinator of this site? Confirm its status | Changde | China | Unknown status |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Chongqing University Three Gorges Central Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| The First Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Affiliated Zhongshan Hospital of Dalian University Coordinator of this site? Confirm its status | Dalian | China | Unknown status |
| Deyangs People Hospital Coordinator of this site? Confirm its status | Deyang | China | Unknown status |
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| The First Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Zhujiang Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Sun Yat Sen University Cancer Center Huangpu Branch Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Guizhou Provincial Peoples Hospital Coordinator of this site? Confirm its status | Guiyang | China | Unknown status |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicineqiantang Branch Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| The First Affiliated Hospital of Harbin Medical Universitynangang Branch Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| The First Affiliated Hospital of Anhui Medical University Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Affiliated Hospital of Jining Medical University Coordinator of this site? Confirm its status | Jining | China | Unknown status |
| The First Peoples Hospital of Yunnan Province Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| LinYi Cancer Hospital Coordinator of this site? Confirm its status | Linyi | China | Unknown status |
| Lishui Central Hospital Coordinator of this site? Confirm its status | Lishui | China | Unknown status |
| Meizhou People Hospital Coordinator of this site? Confirm its status | Meizhou | China | Unknown status |
| The Second Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| The First Affiliated Hospital of Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| Affiliated Hospital of Nantong University Coordinator of this site? Confirm its status | Nantong | China | Unknown status |
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shenzhen Nanshan Peoples Hospital Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| Taihe Hospital Coordinator of this site? Confirm its status | Shiyan | China | Unknown status |
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Taian City Central Hospital Coordinator of this site? Confirm its status | Taian | China | Unknown status |
| Shanxi Bethune Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Peoples Hospital of Xinjiang Uygur Autonomous Region Coordinator of this site? Confirm its status | Ürümqi | China | Unknown status |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Union Hospital of Tongji Medical College Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| Qinghai university affiliated hospital Coordinator of this site? Confirm its status | Xining | China | Unknown status |
| The First Affiliated Hospital of Xinxiang Medical University Coordinator of this site? Confirm its status | Xinxiang | China | Unknown status |
| Xuchang Central Hospitalluminghu Branch Coordinator of this site? Confirm its status | Xuchang | China | Unknown status |
| The affiliated hospital of xuzhou medical university Coordinator of this site? Confirm its status | Xuzhou | China | Unknown status |
| The Second Peoples Hospital of Yibin Coordinator of this site? Confirm its status | Yibin | China | Unknown status |
| Yichang Central Peoples Hospital Coordinator of this site? Confirm its status | Yichang | China | Unknown status |
| Red Cross Hospital of Yulin City Coordinator of this site? Confirm its status | Yulin | China | Unknown status |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Henan Provincial Peoples Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
| Chang Bing Show Chwan Memorial Hospital Coordinator of this site? Confirm its status | Changhua | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.