Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06846671

A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors

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

250

Participants Needed

116

Research Sites

253 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 (idelalisib plus rituximab \[for CLL only\] or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).

CONDITIONS

Official Title

A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) 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 with both a BTK inhibitor and a BCL2 inhibitor
  • Measurable disease by CT or MRI for participants with SLL
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2
  • Adequate liver function
  • Adequate blood clotting function
Not Eligible

You will not qualify if you...

  • Known prolymphocytic leukemia or suspected Richter's transformation
  • Autologous stem cell transplant or CAR-T therapy within the last 3 months
  • Known central nervous system involvement
  • Prior exposure to any BTK protein degraders
  • Active fungal, bacterial, or viral infection requiring intravenous treatment
  • Clinically significant cardiovascular disease
  • Other protocol-defined exclusion criteria may apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 116 locations

1

St Bernards Medical Center

Jonesboro, Arkansas, United States, 72401

Actively Recruiting

2

UCLA Department of Medicine Hematologyoncology

Los Angeles, California, United States, 90095-3075

Actively Recruiting

3

Pih Health Whittier Hospital

Whittier, California, United States, 90602

Actively Recruiting

4

Rocky Mountain Cancer Centers (Williams) Usor

Aurora, Colorado, United States, 80012-5405

Actively Recruiting

5

Florida Oncology and Hematology

Fort Myers, Florida, United States, 33912

Actively Recruiting

6

Baptist Md Anderson Cancer Center

Jacksonville, Florida, United States, 32207-8432

Actively Recruiting

7

Cleveland Clinic Florida

Weston, Florida, United States, 33331-3609

Actively Recruiting

8

Emory University Winship Cancer Institute

Atlanta, Georgia, United States, 30322-1013

Actively Recruiting

9

Our Lady of the Lake Hospital

Baton Rouge, Louisiana, United States, 70808-4365

Actively Recruiting

10

American Oncology Partners of Maryland Pa

Bethesda, Maryland, United States, 20817-7847

Actively Recruiting

11

Oncology Hematology Associates

Springfield, Missouri, United States, 65807-5288

Actively Recruiting

12

Oncology Hematology West, Pc Dba Nebraska Cancer Specialists

Omaha, Nebraska, United States, 68130-2042

Actively Recruiting

13

Memorial Sloan Kettering Cancer Center Mskcc

New York, New York, United States, 10065-6800

Actively Recruiting

14

Clinical Research Alliance, Inc

Westbury, New York, United States, 11590-5119

Actively Recruiting

15

University Hospitals

Cleveland, Ohio, United States, 44106-1716

Actively Recruiting

16

Dayton Physician Network

Dayton, Ohio, United States, 45415

Actively Recruiting

17

Oncology Associates of Oregon Willamette Valley Cancer Center

Eugene, Oregon, United States, 97401

Actively Recruiting

18

West Penn Hospital

Pittsburgh, Pennsylvania, United States, 15224

Actively Recruiting

19

Cancer Care Associates of York

York, Pennsylvania, United States, 17403-5049

Actively Recruiting

20

Texas Oncology Tyler

Tyler, Texas, United States, 75702-7522

Actively Recruiting

21

Hospital Aleman

CABA, Argentina, 1425

Actively Recruiting

22

FUNDALEU

Caba, Argentina, CP1114

Actively Recruiting

23

Hospital Italiano de Buenos Aires

Ciudad Autonoma Buenos Aires, Argentina, 1413

Actively Recruiting

24

Instituto Alexander Fleming (Iaf)

Ciudad Autonoma Buenos Aires, Argentina, 1426

Actively Recruiting

25

Concord Repatriation General Hospital

Concord, New South Wales, Australia, NSW 2139

Actively Recruiting

26

Gosford Hospital

Gosford, New South Wales, Australia, NSW 2250

Actively Recruiting

27

Port Macquarie Base Hospital

Port Macquarie, New South Wales, Australia, NSW 2444

Actively Recruiting

28

Toowoomba Hospital

Toowoomba, Queensland, Australia, QLD 4350

Actively Recruiting

29

The Alfred Hospital

Melbourne, Victoria, Australia, VIC 3004

Actively Recruiting

30

Perth Blood Institute

West Perth, Western Australia, Australia, WA 6005

Actively Recruiting

31

CETUS

Belo Horizonte, Brazil, 30110-022

Actively Recruiting

32

Hospital Sirio Libanes Brasilia

Brasília, Brazil, 70200-730

Actively Recruiting

33

Hospital Erasto Gaertner

Curitiba, Brazil, 81520-060

Actively Recruiting

34

Centro de Ensino E Pesquisa Em Oncologia de Santa Catarina (Cepen)

Florianópolis, Brazil, 88020-210

Actively Recruiting

35

Instituto Joinvilense de Hematologia E Oncologia

Joinville, Brazil, 89201-260

Actively Recruiting

36

Complexo Hospitalar de Niteroi

Niterói, Brazil, 24020-096

Actively Recruiting

37

Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

Porto Alegre, Brazil, 90110-270

Actively Recruiting

38

Hospital Santa Joana Recife

Recife, Brazil, 52011-906

Actively Recruiting

39

Hospital Sao Lucas Dasa Oncologia

Rio de Janeiro, Brazil, 22061-080

Actively Recruiting

40

Oncoclinicas Rio de Janeiro Sa

Rio de Janeiro, Brazil, 22250-040

Actively Recruiting

41

Hospital Sao Rafael (Rede Dor)

Salvador, Brazil, 41253-190

Actively Recruiting

42

Instituto Dor de Pesquisa E Ensino Sao Paulo

São Paulo, Brazil, 01401-004

Actively Recruiting

43

Instituto Brasileiro de Controle Do Cancer

São Paulo, Brazil, 04014-002

Actively Recruiting

44

Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

São Paulo, Brazil, 05652-900

Actively Recruiting

45

Hospital Santa Rita de Cassia Afecc

Vitória, Brazil, 29043-260

Actively Recruiting

46

London Health Sciences Centre

London, Ontario, Canada, N6A 5W9

Actively Recruiting

47

The Ottawa Hospital Cancer Centre

Ottawa, Ontario, Canada, K1H 8L6

Actively Recruiting

48

Centre Integre de Sante Et de Services Sociaux de La Monteregie Centre

Greenfield Park, Quebec, Canada, J4V 2H1

Actively Recruiting

49

Jewish General Hospital

Montreal, Quebec, Canada, QC H3t 1E2

Actively Recruiting

50

Fakultni Nemocnice Brno

Brno, Czechia, 625 00

Actively Recruiting

51

Fakultni Nemocnice Hradec Kralove

Hradec Králové, Czechia, 500 03

Actively Recruiting

52

Fakultni Nemocnice Ostrava

Ostrava, Czechia, 708 00

Actively Recruiting

53

Vseobecna Fakultni Nemocnice V Praze

Prague, Czechia, 10000

Actively Recruiting

54

Universitatsklinikum Augsburg

Augsburg, Germany, 86156

Actively Recruiting

55

Praxis Am Volkspark

Berlin, Germany, 10715

Actively Recruiting

56

Klinikum Chemnitz Ggmbh

Chemnitz, Germany, 09116

Actively Recruiting

57

Universitatsklinikum Essen (Aor)

Essen, Germany, 45122

Actively Recruiting

58

Centrum Fur Haematologie Und Onkologie Bethanien

Frankfurt am Main, Germany, 60389

Actively Recruiting

59

Universitatsklinikum Freiburg I Br Klinik Fur Innere Medizin I

Freiburg im Breisgau, Germany, 79106

Actively Recruiting

60

Universitatsklinikum Hamburg Eppendorf

Hamburg, Germany, 20251

Actively Recruiting

61

Universitatsklinikum Heidelberg

Heidelberg, Germany, 69120

Actively Recruiting

62

Saarland University Medical Center

Homburg, Germany, 66421

Actively Recruiting

63

Invo Institut Fur Versorgungsforschung in Der Onkologie

Koblenz, Germany, 56068

Actively Recruiting

64

Universitaetsklinikum Leipzig Aor

Leipzig, Germany, 04103

Actively Recruiting

65

Universitatsklinikum Munster Medizinische Klinik A

Münster, Germany, 48149

Actively Recruiting

66

Irccs Istituto Tumori Giovanni Paolo Ii

Bari, Italy, 70124

Actively Recruiting

67

Aou Careggi, Servizio Sanitario Toscana

Florence, Italy, 50134

Actively Recruiting

68

Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico

Milan, Italy, 20122

Actively Recruiting

69

Ospedale San Raffaele

Milan, Italy, 20132

Actively Recruiting

70

Azienda Ospedaliera Universitaria Federico Ii

Naples, Italy, 80131

Actively Recruiting

71

Aou Maggiore Della Carita

Novara, Italy, 28100

Actively Recruiting

72

Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi

Pavia, Italy, 27100

Actively Recruiting

73

Ospedale Santa Maria Della Misericordia

Perugia, Italy, 6129

Actively Recruiting

74

Fondazione Policlinico Universitario Agostino Gemelli

Roma, Italy, 00168

Actively Recruiting

75

Aichi Cancer Center Hospital Clinical Oncology

Nagoya, Aichi-ken, Japan, 464-8681

Actively Recruiting

76

Nho Shikoku Cancer Center

Matsuyama, Ehime, Japan, 791-0280

Actively Recruiting

77

Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital

Hiroshima, Hiroshima, Japan, 730-8619

Actively Recruiting

78

Aiiku Hospital

Sapporo, Hokkaido, Japan, 064-0804

Actively Recruiting

79

Hyogo Prefectural Amagasaki General Medical Center

AmagasakiCity, Hyōgo, Japan, 660-8550

Actively Recruiting

80

Kagoshima University Hospital

Kagoshima, Kagoshima-ken, Japan, 890-8520

Actively Recruiting

81

University Hospital, Kyoto Prefectural Univ of Medicine

KyotoShi, Kyoto, Japan, 602-8566

Actively Recruiting

82

Tohoku University Hospital

Sendai, Miyagi, Japan, 980-8574

Actively Recruiting

83

Niigata University Medical and Dental Hospital

Niigata, Niigata, Japan, 951-8520

Actively Recruiting

84

Kurashiki Central Hospital

Kurashikishi, Okayama-ken, Japan, 710-8602

Actively Recruiting

85

Kansai Medical University Hospital

Hirakata, Osaka, Japan, 573-1191

Actively Recruiting

86

Kindai University Hospital

Sakai, Osaka, Japan, 590-0197

Actively Recruiting

87

Saitama Medical Center

Kawagoeshi, Saitama, Japan, 350-8550

Actively Recruiting

88

Ntt Medical Center Tokyo

Shinagawaku, Tokyo, Japan, 141-0022

Actively Recruiting

89

Kumamoto University Hospital

Kumamoto, Japan, 860-8556

Actively Recruiting

90

National Hospital Organization Okayama Medical Center

Okayama, Japan, 701-1192

Actively Recruiting

91

Osaka Metropolitan University Hospital

Osaka, Japan, 545-8586

Actively Recruiting

92

Amsterdam Umc Vu Mc

Amsterdam, Netherlands, 1081 HV

Actively Recruiting

93

Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny

Brzozów, Poland, 36-200

Actively Recruiting

94

Pratia Onkologia Katowice

Katowice, Poland, 40-519

Actively Recruiting

95

Pratia McM Krakow

Krakow, Poland, 30-727

Actively Recruiting

96

Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

Lodz, Poland, 93-513

Actively Recruiting

97

Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie

Lublin, Poland, 20-090

Actively Recruiting

98

Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu

Wroclaw, Poland, 50-367

Actively Recruiting

99

Dong A University Hospital

Seogu, Busan Gwang'yeogsi, South Korea, 49201

Actively Recruiting

100

Kyungpook National University Hospital

Junggu, Daegu Gwang'yeogsi, South Korea, 41944

Actively Recruiting

101

National Cancer Center (Korea)

IlsandongGu GoyangSi, Gyeonggi-do, South Korea, 10408

Actively Recruiting

102

Chonnam National University Hwasun Hospital

HwasunGun, Jeollanam-do, South Korea, 58128

Actively Recruiting

103

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, South Korea, 06351

Actively Recruiting

104

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi, South Korea, 06591

Actively Recruiting

105

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea, 03080

Actively Recruiting

106

Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

Ankara, Turkey (Türkiye), 06200

Actively Recruiting

107

Gazi University

Ankara, Turkey (Türkiye), 6500

Actively Recruiting

108

Dokuz Eylul University

Balçova, Turkey (Türkiye), 35330

Actively Recruiting

109

Antalya Memorial Hospital

Dokuma, Turkey (Türkiye), 07025

Actively Recruiting

110

Sakarya Training and Research Hospital

Sakarya, Turkey (Türkiye), 54100

Actively Recruiting

111

Aberdeen Royal Infirmary

Aberdeen, United Kingdom, AB25 2ZN

Actively Recruiting

112

Birmingham Heartlands Hospital

Birmingham, United Kingdom, B9 5SS

Actively Recruiting

113

The Royal Bournemouth and Christchurch Hospitals Nhs Foundation

Bournemouth, United Kingdom, BH7 7DW

Actively Recruiting

114

University College Hospital

London, United Kingdom, NW1 2PG

Actively Recruiting

115

Royal Marsden Hospital

London, United Kingdom, SW3 6JJ

Actively Recruiting

116

Southampton General Hospital

Southampton, United Kingdom, SO16 6YD

Actively Recruiting

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Research Team

S

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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