Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06970743

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

Led by BeOne Medicines · Updated on 2026-05-11

150

Participants Needed

64

Research Sites

235 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of CLL or SLL requiring treatment based on 2018 iwCLL criteria
  • Previously treated for CLL or SLL with a covalent Bruton tyrosine kinase inhibitor
  • Measurable disease by CT or MRI for participants with SLL
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Adequate bone marrow function
  • Adequate kidney and liver function
  • Adequate blood clotting function
Not Eligible

You will not qualify if you...

  • Known prolymphocytic leukemia or history/suspicion of Richter's transformation
  • Prior autologous stem cell transplant within 3 months or CAR-T cell therapy within 6 months
  • History of severe allergic reactions to BGB-16673, bendamustine, or rituximab
  • Current or past central nervous system involvement
  • History of ischemic stroke or brain hemorrhage within 6 months before first study dose
  • History of confirmed progressive multifocal leukoencephalopathy
  • Active fungal, bacterial, or viral infection requiring intravenous treatment
  • Clinically significant cardiovascular disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 64 locations

1

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China, 230000

Actively Recruiting

2

Peking University Third Hospital

Beijing, Beijing Municipality, China, 100000

Actively Recruiting

3

Peking University Peoples Hospital

Beijing, Beijing Municipality, China, 100044

Actively Recruiting

4

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China, 100730

Actively Recruiting

5

Chongqing University Three Gorges Central Hospital

Chongqing, Chongqing Municipality, China, 404000

Actively Recruiting

6

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China, 630014

Actively Recruiting

7

Fujian Medical University Union Hospital

Fuzhou, Fujian, China, 350001

Actively Recruiting

8

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China, 350005

Actively Recruiting

9

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China, 510000

Actively Recruiting

10

Sun Yat Sen University Cancer Center Huangpu Branch

Guangzhou, Guangdong, China, 510555

Actively Recruiting

11

Meizhou People Hospital

Meizhou, Guangdong, China, 514031

Actively Recruiting

12

Shenzhen Nanshan Peoples Hospital

Shenzhen, Guangdong, China, 518052

Actively Recruiting

13

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China, 530021

Actively Recruiting

14

Red Cross Hospital of Yulin City

Yulin, Guangxi, China, 537000

Actively Recruiting

15

Guizhou Provincial Peoples Hospital

Guiyang, Guizhou, China, 550002

Actively Recruiting

16

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China, 150000

Actively Recruiting

17

The First Affiliated Hospital of Harbin Medical Universitynangang Branch

Harbin, Heilongjiang, China, 150001

Actively Recruiting

18

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

Luoyang, Henan, China, 471023

Actively Recruiting

19

Nanyang Central Hospital

Nanyang, Henan, China, 473000

Actively Recruiting

20

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China, 453100

Actively Recruiting

21

Xuchang Central Hospitalluminghu Branch

Xuchang, Henan, China, 461000

Actively Recruiting

22

Henan Cancer Hospital

Zhengzhou, Henan, China, 450000

Actively Recruiting

23

Henan Provincial Peoples Hospital

Zhengzhou, Henan, China, 450003

Actively Recruiting

24

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China, 450052

Actively Recruiting

25

Taihe Hospital

Shiyan, Hubei, China, 442000

Actively Recruiting

26

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

Wuhan, Hubei, China, 430022

Actively Recruiting

27

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

Wuhan, Hubei, China, 430030

Actively Recruiting

28

Yichang Central Peoples Hospital

Yichang, Hubei, China, 443003

Actively Recruiting

29

The First Peoples Hospital of Changde City

Changde, Hunan, China, 415000

Actively Recruiting

30

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China, 410011

Actively Recruiting

31

The First Peoples Hospital of Changzhou

Changzhou, Jiangsu, China, 213000

Actively Recruiting

32

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

Nanjing, Jiangsu, China, 210008

Actively Recruiting

33

Jiangsu Province Hospital

Nanjing, Jiangsu, China, 210029

Actively Recruiting

34

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China, 201203

Actively Recruiting

35

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215006

Actively Recruiting

36

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China, 221000

Actively Recruiting

37

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China, 330006

Actively Recruiting

38

The First Hospital of Jilin University

Changchun, Jilin, China, 130021

Actively Recruiting

39

Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, China, 116001

Actively Recruiting

40

Qinghai University Affiliated Hospital

Xining, Qinghai, China, 810001

Actively Recruiting

41

The Second Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China, 710004

Actively Recruiting

42

Binzhou Medical University Hospital

Binzhou, Shandong, China, 256603

Actively Recruiting

43

Affiliated Hospital of Jining Medical University

Jining, Shandong, China, 272000

Actively Recruiting

44

Linyi Cancer Hospital

Linyi, Shandong, China, 276001

Actively Recruiting

45

Taian City Central Hospital

Taian, Shandong, China, 271099

Actively Recruiting

46

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200000

Actively Recruiting

47

Shanxi Bethune Hospital

Taiyuan, Shanxi, China, 030032

Actively Recruiting

48

Sichuan Cancer Hospital and Institute

Chengdu, Sichuan, China, 610041

Actively Recruiting

49

Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

Chengdu, Sichuan, China, 610071

Actively Recruiting

50

Deyangs People Hospital

Deyang, Sichuan, China, 618000

Actively Recruiting

51

The Second Peoples Hospital of Yibin

Yibin, Sichuan, China, 644000

Actively Recruiting

52

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

Tianjin, Tianjin Municipality, China, 301617

Actively Recruiting

53

The First Peoples Hospital of Kashgar

Kashgar, Xinjiang, China, 844099

Actively Recruiting

54

Peoples Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, China, 830001

Actively Recruiting

55

The First Peoples Hospital of Yunnan Province

Kunming, Yunnan, China, 650034

Actively Recruiting

56

The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan

Hangzhou, Zhejiang, China, 310002

Actively Recruiting

57

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

Hangzhou, Zhejiang, China, 310018

Actively Recruiting

58

Lishui Central Hospital

Lishui, Zhejiang, China, 323000

Actively Recruiting

59

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China, 325000

Actively Recruiting

60

Chang Bing Show Chwan Memorial Hospital

Changhua, Taiwan, 505029

Actively Recruiting

61

National Cheng Kung University Hospital

North Dist, Taiwan, 704

Actively Recruiting

62

China Medical University Hospital

Taichung, Taiwan, 40447

Actively Recruiting

63

Koo Foundation Sun Yat Sen Cancer Center

Taipei, Taiwan, 11259

Actively Recruiting

64

National Taiwan University Hospital

Zhongzheng Dist, Taiwan, 100225

Actively Recruiting

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Research Team

S

Study Director Study Director

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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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 | DecenTrialz