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

Last updated: January 5, 2026
Sponsor: BeOne Medicines
Overall Status: Active - Recruiting

Phase

3

Condition

Lymphocytic Leukemia, Chronic

Leukemia (Pediatric)

Lymphoproliferative Disorders

Treatment

Rituximab

Methylprednisolone

BGB-16673

Clinical Study ID

NCT06970743
BGB-16673-303
  • Ages > 18
  • All Genders

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) 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 Criteria

Inclusion

Inclusion Criteria:

  1. Confirmed diagnosis of CLL/SLL, requiring treatment, based on 2018 internationalworkshop 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 patientswith 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

Exclusion Criteria:

  1. Known prolymphocytic leukemia or history of, or currently suspected, Richter'stransformation

    1. Prior autologous stem cell transplant (unless ≥ 3 months after transplant) orchimeric antigen receptor-T cell (unless ≥ 6 months after cell infusion)
  2. History of severe allergic reactions or hypersensitivity to the active ingredientand excipients of study treatment (BGB-16673, bendamustine, or rituximab)

  3. Current or history of central nervous system involvement

  4. History of ischemic stroke or intracranial hemorrhage within 6 months before firstdose of study drug

  5. History of confirmed progressive multifocal leukoencephalopathy.

  6. Active fungal, bacterial, and/or viral infection requiring parenteral systemictherapy

  7. Clinically significant cardiovascular disease

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 150
Treatment Group(s): 4
Primary Treatment: Rituximab
Phase: 3
Study Start date:
May 29, 2025
Estimated Completion Date:
November 30, 2029

Study Description

Chronic lymphocytic leukemia and small lymphocytic lymphoma are types of blood cancer that affects people around the world. People with CLL and SLL suffer from enlarged lymph nodes, spleen, or liver, or have symptoms like night sweats, weight loss and fever. They have shorter life expectancy compared to healthy people. There is an urgent need for new treatment to prolong life and control disease-related symptoms.

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.

Connect with a study center

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui 230000
    China

    Site Not Available

  • The First Affiliated Hospital of Anhui Medical University

    Hefei 1808722, Anhui 1818058 230000
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Site Not Available

  • Peking University Peoples Hospital

    Beijing, Beijing 100044
    China

    Active - Recruiting

  • Peking University Third Hospital

    Beijing, Beijing 100000
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing 1816670, Beijing Municipality 2038349 100730
    China

    Active - Recruiting

  • Peking University Peoples Hospital

    Beijing 1816670, Beijing Municipality 2038349 100044
    China

    Active - Recruiting

  • Peking University Third Hospital

    Beijing 1816670, Beijing Municipality 2038349 100000
    China

    Active - Recruiting

  • Chongqing University Three Gorges Central Hospital

    Chongqing, Chongqing 404000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing 630014
    China

    Site Not Available

  • Chongqing University Three Gorges Central Hospital

    Chongqing 1814906, Chongqing Municipality 1814905 404000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing 1814906, Chongqing Municipality 1814905 630014
    China

    Active - Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Active - Recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian 350005
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou 1810821, Fujian 1811017 350001
    China

    Active - Recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou 1810821, Fujian 1811017 350005
    China

    Active - Recruiting

  • Sun Yat Sen University Cancer Center(Huangpu Campus)

    Guangzhou, Guangdong 510700
    China

    Site Not Available

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

  • Meizhou People Hospital

    Meizhou, Guangdong 514031
    China

    Site Not Available

  • Shenzhen Nanshan Peoples Hospital

    Shenzhen, Guangdong 518052
    China

    Site Not Available

  • Sun Yat Sen University Cancer Center(Huangpu Campus)

    Guangzhou 1809858, Guangdong 1809935 510700
    China

    Active - Recruiting

  • Sun Yat Sen University Cancer Centerhuangpu Branch

    Guangzhou 1809858, Guangdong 1809935 510555
    China

    Active - Recruiting

  • Zhujiang Hospital of Southern Medical University

    Guangzhou 1809858, Guangdong 1809935 510000
    China

    Active - Recruiting

  • Meizhou People Hospital

    Meizhou 1800779, Guangdong 1809935 514031
    China

    Active - Recruiting

  • Shenzhen Nanshan Peoples Hospital

    Shenzhen 1795565, Guangdong 1809935 518052
    China

    Active - Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi 530021
    China

    Site Not Available

  • Red Cross Hospital of Yulin City

    Yulin, Guangxi 537000
    China

    Site Not Available

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning 1799869, Guangxi 1809867 530021
    China

    Active - Recruiting

  • Red Cross Hospital of Yulin City

    Yulin 1785781, Guangxi 1809867 537000
    China

    Active - Recruiting

  • Guizhou Provincial Peoples Hospital

    Guiyang, Guizhou 550002
    China

    Site Not Available

  • Guizhou Provincial Peoples Hospital

    Guiyang 1809461, Guizhou 1809445 550002
    China

    Active - Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150000
    China

    Site Not Available

  • The First Affiliated Hospital of Harbin Medical Universitynangang Branch

    Harbin, Heilongjiang 150001
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin 2037013, Heilongjiang 2036965 150000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Harbin Medical Universitynangang Branch

    Harbin 2037013, Heilongjiang 2036965 150001
    China

    Active - Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technologykaiyuan Branch

    Luoyang, Henan 471023
    China

    Site Not Available

  • Nanyang Central Hospital

    Nanyang, Henan 473000
    China

    Site Not Available

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan 453100
    China

    Site Not Available

  • Xuchang Central Hospitalluminghu Branch

    Xuchang, Henan 461000
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan 450000
    China

    Active - Recruiting

  • Henan Provincial Peoples Hospital

    Zhengzhou, Henan 450003
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Active - Recruiting

  • The First Affiliated Hospital of Henan University of Science and Technologykaiyuan Branch

    Luoyang 1801792, Henan 1808520 471023
    China

    Active - Recruiting

  • Nanyang Central Hospital

    Nanyang 1799629, Henan 1808520 473000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang 1788572, Henan 1808520 453100
    China

    Active - Recruiting

  • Xuchang Central Hospitalluminghu Branch

    Xuchang 1788046, Henan 1808520 461000
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou 1784658, Henan 1808520 450000
    China

    Active - Recruiting

  • Henan Provincial Peoples Hospital

    Zhengzhou 1784658, Henan 1808520 450003
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou 1784658, Henan 1808520 450052
    China

    Active - Recruiting

  • Taihe Hospital

    Shiyan, Hubei 442000
    China

    Site Not Available

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei 430030
    China

    Active - Recruiting

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei 430022
    China

    Site Not Available

  • Yichang Central Peoples Hospital

    Yichang, Hubei 443003
    China

    Site Not Available

  • Taihe Hospital

    Shiyan 1794903, Hubei 1806949 442000
    China

    Active - Recruiting

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan 1791247, Hubei 1806949 430030
    China

    Active - Recruiting

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan 1791247, Hubei 1806949 430022
    China

    Active - Recruiting

  • Yichang Central Peoples Hospital

    Yichang 1786764, Hubei 1806949 443003
    China

    Active - Recruiting

  • The First Peoples Hospital of Changde City

    Changde, Hunan 415000
    China

    Site Not Available

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan 410011
    China

    Site Not Available

  • The First Peoples Hospital of Changde City

    Changde 1791121, Hunan 1806691 415000
    China

    Active - Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha 1815577, Hunan 1806691 410011
    China

    Active - Recruiting

  • The First Peoples Hospital of Changzhou

    Changzhou, Jiangsu 213000
    China

    Site Not Available

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu 210008
    China

    Active - Recruiting

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu 201203
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Site Not Available

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu 221000
    China

    Site Not Available

  • The First Peoples Hospital of Changzhou

    Changzhou 1815456, Jiangsu 1806260 213000
    China

    Active - Recruiting

  • Jiangsu Province Hospital

    Nanjing 1799962, Jiangsu 1806260 210029
    China

    Active - Recruiting

  • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

    Nanjing 1799962, Jiangsu 1806260 210008
    China

    Active - Recruiting

  • Affiliated Hospital of Nantong University

    Nantong 1799722, Jiangsu 1806260 201203
    China

    Active - Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou 1886760, Jiangsu 1806260 215006
    China

    Active - Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou 10630003, Jiangsu 1806260 221000
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • The Second Affiliated Hospital of Nanchang University

    Nanchang 1800163, Jiangxi 1806222 330006
    China

    Active - Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun 2038180, Jilin 2036500 130021
    China

    Active - Recruiting

  • Affiliated Zhongshan Hospital of Dalian University

    Dalian, Liaoning 116001
    China

    Site Not Available

  • Affiliated Zhongshan Hospital of Dalian University

    Dalian 1814087, Liaoning 2036115 116001
    China

    Active - Recruiting

  • Qinghai University Affiliated Hospital

    Xining, Qinghai 810001
    China

    Site Not Available

  • Qinghai University Affiliated Hospital

    Xining 1788852, Qinghai 1280239 810001
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Xian Jiaotong University

    Xian, Shaanxi 710004
    China

    Site Not Available

  • The Second Affiliated Hospital of Xian Jiaotong University

    Xi'an 1790630, Shaanxi 1796480 710004
    China

    Active - Recruiting

  • Binzhou Medical University Hospital

    Binzhou, Shandong 256603
    China

    Site Not Available

  • Affiliated Hospital of Jining Medical University

    Jining, Shandong 272000
    China

    Site Not Available

  • Linyi Cancer Hospital

    Linyi, Shandong 276001
    China

    Site Not Available

  • Binzhou Medical University Hospital

    Binzhou 1816336, Shandong 1796328 256603
    China

    Active - Recruiting

  • Affiliated Hospital of Jining Medical University

    Jining 1805518, Shandong 1796328 272000
    China

    Active - Recruiting

  • Linyi Cancer Hospital

    Linyi 1803318, Shandong 1796328 276001
    China

    Active - Recruiting

  • Taian City Central Hospital

    Taian, Shandong 1796328 271099
    China

    Active - Recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai 200000
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai 1796236, Shanghai Municipality 1796231 200000
    China

    Active - Recruiting

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi 030032
    China

    Site Not Available

  • Shanxi Bethune Hospital

    Taiyuan 1793511, Shanxi 1795912 030032
    China

    Active - Recruiting

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, Sichuan 610071
    China

    Site Not Available

  • Sichuan Cancer Hospital and Institute

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • Deyangs People Hospital

    Deyang, Sichuan 618000
    China

    Site Not Available

  • The Second Peoples Hospital of Yibin

    Yibin, Sichuan 644000
    China

    Site Not Available

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu 1815286, Sichuan 1794299 610071
    China

    Active - Recruiting

  • Sichuan Cancer Hospital and Institute

    Chengdu 1815286, Sichuan 1794299 610041
    China

    Active - Recruiting

  • Deyangs People Hospital

    Deyang 1812961, Sichuan 1794299 618000
    China

    Active - Recruiting

  • The Second Peoples Hospital of Yibin

    Yibin 1786770, Sichuan 1794299 644000
    China

    Active - Recruiting

  • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch

    Tianjin, Tianjin 301617
    China

    Site Not Available

  • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciencestuanbo Branch

    Tianjin 1792947, Tianjin Municipality 1792943 301617
    China

    Active - Recruiting

  • The First Peoples Hospital of Kashgar

    Kashgar, Xinjiang 844099
    China

    Site Not Available

  • The Xinjiang Uygur Autonomous Region Peoples Hospital

    Urumqi, Xinjiang 830001
    China

    Site Not Available

  • The First Peoples Hospital of Kashgar

    Kashgar 1280849, Xinjiang 1529047 844099
    China

    Active - Recruiting

  • Peoples Hospital of Xinjiang Uygur Autonomous Region

    Ürümqi 1529102, Xinjiang 1529047 830001
    China

    Active - Recruiting

  • The Xinjiang Uygur Autonomous Region Peoples Hospital

    Ürümqi 1529102, Xinjiang 1529047 830001
    China

    Active - Recruiting

  • The First Peoples Hospital of Yunnan Province

    Kunming, Yunnan 650034
    China

    Site Not Available

  • The First Peoples Hospital of Yunnan Province

    Kunming 1804651, Yunnan 1785694 650034
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicineqiantang Branch

    Hangzhou, Zhejiang 310018
    China

    Site Not Available

  • The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan

    Hangzhou, Zhejiang 310002
    China

    Active - Recruiting

  • Lishui Central Hospital

    Lishui, Zhejiang 323000
    China

    Site Not Available

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Site Not Available

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicineqiantang Branch

    Hangzhou 1808926, Zhejiang 1784764 310018
    China

    Active - Recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan

    Hangzhou 1808926, Zhejiang 1784764 310002
    China

    Active - Recruiting

  • Lishui Central Hospital

    Lishui 1803245, Zhejiang 1784764 323000
    China

    Active - Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou 1791388, Zhejiang 1784764 325000
    China

    Active - Recruiting

  • Chang Bing Show Chwan Memorial Hospital

    Changhua, 505029
    Taiwan

    Site Not Available

  • Chang Bing Show Chwan Memorial Hospital

    Changhua 1993459, 505029
    Taiwan

    Active - Recruiting

  • China Medical University Hospital

    North Dist, 404327
    Taiwan

    Active - Recruiting

  • National Cheng Kung University Hospital

    North Dist, 704
    Taiwan

    Active - Recruiting

  • Koo Foundation Sun Yat Sen Cancer Center

    Taipei, 11259
    Taiwan

    Site Not Available

  • Koo Foundation Sun Yat Sen Cancer Center

    Taipei 1668341, 11259
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Zhongzheng Dist, 100225
    Taiwan

    Active - Recruiting

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