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Clinical Trials in China / NCT06970743
Active, not recruiting Phase 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

NCT06970743 · tracked via the Priya Life Science China tracker
Sponsor
BeOne Medicines
Phase
Phase 3
Started
2025-05-29
Last updated
2026-08-24

Condition(s) studied

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Investigational drug(s) / intervention(s)

BGB-16673BendamustineRituximabMethylprednisoloneChlorambucilObinutuzumab

BGB-16673: Administered orally

Bendamustine: Administered intravenously

Rituximab: Administered intravenously

Methylprednisolone: Administered intravenously

Chlorambucil: Administered orally

Obinutuzumab: Administered intravenously

Study 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 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Confirmed diagnosis of CLL/SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) 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: 1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation 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, rituximab, chlorambucil, or obinutuzumab) 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 NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

Trial sites (56)

FacilityCityRegionStatus
The First Affiliated Hospital of Anhui Medical University Hefei Anhui
Peking University Third Hospital Beijing Beijing Municipality
Peking University Peoples Hospital Beijing Beijing Municipality
Peking Union Medical College Hospital Beijing Beijing Municipality
Chongqing University Three Gorges Central Hospital Chongqing Chongqing Municipality
The First Affiliated Hospital of Chongqing Medical University Chongqing Chongqing Municipality
Fujian Medical University Union Hospital Fuzhou Fujian
The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian
Zhujiang Hospital of Southern Medical University Guangzhou Guangdong
Sun Yat Sen University Cancer Center Huangpu Branch Guangzhou Guangdong
Meizhou People Hospital Meizhou Guangdong
Shenzhen Nanshan Peoples Hospital Shenzhen Guangdong
The First Affiliated Hospital of Guangxi Medical University Nanning Guangxi
Red Cross Hospital of Yulin City Yulin Guangxi
Guizhou Provincial Peoples Hospital Guiyang Guizhou
Harbin Medical University Cancer Hospital Harbin Heilongjiang
The First Affiliated Hospital of Harbin Medical Universitynangang Branch Harbin Heilongjiang
The First Affiliated Hospital of Xinxiang Medical University Xinxiang Henan
Xuchang Central Hospitalluminghu Branch Xuchang Henan
Henan Cancer Hospital Zhengzhou Henan
Henan Provincial Peoples Hospital Zhengzhou Henan
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
Taihe Hospital Shiyan Hubei
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei
Yichang Central Peoples Hospital Yichang Hubei
The First Peoples Hospital of Changde City Changde Hunan
The Second Xiangya Hospital of Central South University Changsha Hunan
Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School Nanjing Jiangsu
Jiangsu Province Hospital Nanjing Jiangsu
Affiliated Hospital of Nantong University Nantong Jiangsu
The First Affiliated Hospital of Soochow University Suzhou Jiangsu
The Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu
The Second Affiliated Hospital of Nanchang University Nanchang Jiangxi
The First Hospital of Jilin University Changchun Jilin
Affiliated Zhongshan Hospital of Dalian University Dalian Liaoning
Qinghai University Affiliated Hospital Xining Qinghai
Binzhou Medical University Hospital Binzhou Shandong
Affiliated Hospital of Jining Medical University Jining Shandong
Linyi Cancer Hospital Linyi Shandong

+ 16 more sites — see the full list on the official registry below.

On this site

📄 Rituxan (rituximab) drug profile →

More BeOne Medicines trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06970743 on ClinicalTrials.gov ↗ ← All trials in China