Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06973187

A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

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

500

Participants Needed

149

Research Sites

136 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to evaluate the efficacy and safety of BGB-16673 alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).

CONDITIONS

Official Title

A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) needing treatment based on 2018 iwCLL criteria
  • Previously treated for CLL or SLL with at least one line of therapy including a covalent Bruton tyrosine kinase inhibitor (cBTKi) with disease relapsed or refractory
  • For participants with SLL, measurable disease by CT or MRI with at least one lymph node larger than 1.5 cm in longest diameter and measurable in two perpendicular diameters
Not Eligible

You will not qualify if you...

  • Known prolymphocytic leukemia or history or suspicion of Richter's transformation
  • History of bleeding disorders such as hemophilia A, hemophilia B, von Willebrand disease, or spontaneous bleeding requiring transfusion or other medical intervention
  • History of ischemic stroke or intracranial hemorrhage within 6 months before starting study drug
  • Previous exposure to any Bruton tyrosine kinase (BTK) protein degraders or noncovalent BTK inhibitors (ncBTKi)
  • Current or past central nervous system involvement by CLL or SLL including brain, spinal cord, leptomeninges, or cerebrospinal fluid as shown by imaging, cytology, or biopsy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 149 locations

1

Mayo Clinic Phoenix

Phoenix, Arizona, United States, 85054-4502

Actively Recruiting

2

Kaiser Permanente Southern California

Irvine, California, United States, 92618-3734

Actively Recruiting

3

University of California San Diego (Ucsd) Moores Cancer Center

La Jolla, California, United States, 92093-1503

Actively Recruiting

4

Cancer and Blood Specialty Clinic

Los Alamitos, California, United States, 90720-3302

Actively Recruiting

5

UCLA Department of Medicine Hematologyoncology

Los Angeles, California, United States, 90095-3075

Actively Recruiting

6

Stanford Cancer Institute

Palo Alto, California, United States, 94304-2205

Actively Recruiting

7

Christiana Care

Newark, Delaware, United States, 19713-2055

Actively Recruiting

8

Cancer Specialists of North Florida

Jacksonville, Florida, United States, 001625

Actively Recruiting

9

Mayo Clinic Jacksonville

Jacksonville, Florida, United States, 32224-1865

Actively Recruiting

10

Mount Sinai Comprehensive Cancer Center

Miami, Florida, United States, 33140-2840

Actively Recruiting

11

University of Chicago Medical Center

Chicago, Illinois, United States, 60637-1443

Actively Recruiting

12

The University of Kansas Cancer Center

Westwood, Kansas, United States, 66205-2003

Actively Recruiting

13

Our Lady of the Lake Hospital

Baton Rouge, Louisiana, United States, 70808-4365

Actively Recruiting

14

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States, 70809-3738

Actively Recruiting

15

Ochsner Clinic Foundation

New Orleans, Louisiana, United States, 70121-2429

Actively Recruiting

16

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215-5418

Actively Recruiting

17

Karmanos Cancer Institute

Detroit, Michigan, United States, 48201-2013

Actively Recruiting

18

Mayo Clinic Rochester

Rochester, Minnesota, United States, 55905-0001

Actively Recruiting

19

Washington University School of Medicine

St Louis, Missouri, United States, 63110-1010

Actively Recruiting

20

Titan Health Partners Llc Dba Astera Cancer Care

East Brunswick, New Jersey, United States, 08816-4096

Actively Recruiting

21

John Theurer Cancer Center Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601-2191

Actively Recruiting

22

Columbia University Medical Center

New York, New York, United States, 10032

Actively Recruiting

23

Memorial Sloan Kettering Cancer Center Mskcc

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

Actively Recruiting

24

University of Rochester

Rochester, New York, United States, 14642-0001

Actively Recruiting

25

University of North Carolina At Chapel Hill

Chapel Hill, North Carolina, United States, 27514-4220

Actively Recruiting

26

Atrium Health Levine Cancer Institute (Lci)

Charlotte, North Carolina, United States, 28204-2990

Actively Recruiting

27

Duke University Medical Center

Durham, North Carolina, United States, 27705-3976

Actively Recruiting

28

Dayton Physician Network

Dayton, Ohio, United States, 45415

Actively Recruiting

29

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111-2434

Actively Recruiting

30

Tennessee Oncology, Pllc Nashville

Nashville, Tennessee, United States, 37203

Actively Recruiting

31

Md Anderson Cancer Center

Houston, Texas, United States, 77030-3907

Actively Recruiting

32

Blue Ridge Cancer Care (Oncology and Hematology Associates of Southwest Virginia)

Roanoke, Virginia, United States, 24014

Actively Recruiting

33

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States, 98109-4433

Actively Recruiting

34

Summit Cancer Centers

Spokane, Washington, United States, 99208-1129

Actively Recruiting

35

Northwest Medical Specialties

Tacoma, Washington, United States, 98405

Actively Recruiting

36

Gunderson Health System

La Crosse, Wisconsin, United States, 54601-5467

Actively Recruiting

37

Concord Repatriation General Hospital

Concord, New South Wales, Australia, NSW 2139

Actively Recruiting

38

Sunshine Coast Hospital and Health Service

Birtinya, Queensland, Australia, QLD 4575

Actively Recruiting

39

Flinders Medical Centre

Bedford PK, South Australia, Australia, SA 5042

Actively Recruiting

40

St Vincents Hospital Melbourne

Fitzroy, Victoria, Australia, VIC 3065

Actively Recruiting

41

Peninsula Private Hospital

Frankston, Victoria, Australia, VIC 3199

Actively Recruiting

42

Austin Health

Heidelberg, Victoria, Australia, VIC 3084

Actively Recruiting

43

Cabrini Hospital Malvern

Malvern East, Victoria, Australia, VIC 3144

Actively Recruiting

44

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia, VIC 3000

Actively Recruiting

45

The Alfred Hospital

Melbourne, Victoria, Australia, VIC 3004

Actively Recruiting

46

Linear Clinical Research

Nedlands, Western Australia, Australia, WA 6009

Actively Recruiting

47

Medizinische Universitatsklinik Innsbruck

Innsbruck, Austria, 6020

Actively Recruiting

48

Ordensklinikum Linz Gmbh Elisabethinen

Linz, Austria, 4020

Actively Recruiting

49

Uk St Poelten

Sankt Pölten, Austria, 3100

Actively Recruiting

50

Institut Jules Bordet

Anderlecht, Belgium, 1070

Actively Recruiting

51

UZ GENT

Ghent, Belgium, 9000

Actively Recruiting

52

Az Groeninge Campus Loofstraat

Kortrijk, Belgium, 8500

Actively Recruiting

53

Chc Montlegia

Liège, Belgium, 4000

Actively Recruiting

54

Chu de Liege

Liège, Belgium, 4000

Actively Recruiting

55

Az Sint Maarten

Mechelen, Belgium, 2800

Actively Recruiting

56

Chu Ucl Namur

Yvoir, Belgium, 5530

Actively Recruiting

57

Centro de Pesquisa Clinica Dom Bosco Ltda

Araçatuba, Brazil, 16015-150

Actively Recruiting

58

Ictr Instituto Do Cancer E Transplante de Curitiba

Curitiba, Brazil, 80510-130

Actively Recruiting

59

Hospital de Clinicas de Goiania Ufg

Goiânia, Brazil, 74605-020

Actively Recruiting

60

Inca Instituto Nacional de Cancer

Rio de Janeiro, Brazil, 20231-050

Actively Recruiting

61

Ensino E Terapia de Inovacao Clinica Amo Etica

Salvador, Brazil, 41950-640

Actively Recruiting

62

Hospital Nove de Julho Dasa

São Paulo, Brazil, 01409-001

Actively Recruiting

63

Hcfmusp Hospital Das Clinicas Da Faculdade de Medicina Da Universidade de Sao Paulo

São Paulo, Brazil, 05403-010

Actively Recruiting

64

Centre de Lutte Contre Le Cancer Institut Bergonie

Bordeaux, France, 33000

Actively Recruiting

65

Hopital Estaing

Clermontferrand, France, 63100

Actively Recruiting

66

Centre Hospitalier Universitaire Nantes Hotel Dieu

Nantes, France, 44000

Actively Recruiting

67

Hopital Saint Louis

Paris, France, 75010

Actively Recruiting

68

Centre Henri Becquerel

Rouen, France, 76038

Actively Recruiting

69

Iuc Toulouse Oncopole

Toulouse, France, 31100

Actively Recruiting

70

Chu Tours Hopital Bretonneau

Tours, France, 37000

Actively Recruiting

71

Chu Nancy Hopital Brabois

VandoeuvrelesNancy, France, 54511

Actively Recruiting

72

Gemeinschaftspraxis Fur Hamatologie Und Onkologie Dortmund

Dortmund, Germany, 44309

Actively Recruiting

73

Luebecker Onkologische Schwerpunktpraxis Dres Med Kisroweber

Lübeck, Germany, 23562

Actively Recruiting

74

Universitaetsklinikum Ulm

Ulm, Germany, 89081

Actively Recruiting

75

Gemeinschaftspraxis Fuer Haematologie Und Onkologie Westerstede

Westerstede, Germany, 26655

Actively Recruiting

76

Bnai Zion Medical Center

Haifa, Israel, 31048

Actively Recruiting

77

Shaare Zedek Medical Center

Jerusalem, Israel, 9103102

Actively Recruiting

78

Hadassah University Hospital Ein Kerem

Jerusalem, Israel, 91120

Actively Recruiting

79

Meir Medical Center

KfarSava, Israel, 4428164

Actively Recruiting

80

Rabin Medical Center

Petah Tikva, Israel, 49100

Actively Recruiting

81

Sheba Medical Center

Ramat Gan, Israel, 5262100

Actively Recruiting

82

Sourasky Tel Aviv Medical Center

Tel Aviv, Israel, 6423906

Actively Recruiting

83

Policlinico Sorsola Malpighi, Aou Di Bologna

Bologna, Italy, 40138

Actively Recruiting

84

Ospedale San Raffaele

Milan, Italy, 20132

Actively Recruiting

85

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

Milan, Italy, 20162

Actively Recruiting

86

Azienda Ospedaliera Di Padova

Padova, Italy, 35128

Actively Recruiting

87

Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital

Nakamuraku, Aichi-ken, Japan, 453-8511

Actively Recruiting

88

Matsuyama Red Cross Hospital

Matsuyama, Ehime, Japan, 790 8524

Actively Recruiting

89

Fukushima Medical University Hospital

Fukushima, Fukushima, Japan, 960-1295

Actively Recruiting

90

Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital

Hiroshima, Hiroshima, Japan, 730-8619

Actively Recruiting

91

Aiiku Hospital

Sapporo, Hokkaido, Japan, 064-0804

Actively Recruiting

92

Kochi Medical School Hospital

Nankoku, Kochi, Japan, 783-8505

Actively Recruiting

93

Japanese Red Cross Kyoto Daini Hospital

Kyotoshi, Kyoto, Japan, 602-8026

Actively Recruiting

94

Okayama University Hospital

Okayama, Okayama-ken, Japan, 700-8558

Actively Recruiting

95

Kindai University Hospital

Sakai, Osaka, Japan, 590-0197

Actively Recruiting

96

Dokkyo Medical University Saitama Medical Center

Koshigaya, Saitama, Japan, 503-8502

Actively Recruiting

97

Tokyo Metropolitan Komagome Hospital

Bunkyoku, Tokyo, Japan, 113-8677

Actively Recruiting

98

Cancer Institute Hospital of Jfcr

Kotoku, Tokyo, Japan, 135-8550

Actively Recruiting

99

National Hospital Organization (Nho) Disaster Medical Center

Tachikawashi, Tokyo, Japan, 190-0014

Actively Recruiting

100

Yamagata University Hospital

Yamagata, Yamagata, Japan, 990-9585

Actively Recruiting

101

Kumamoto University Hospital

Kumamoto, Japan, 860-8556

Actively Recruiting

102

Osaka Metropolitan University Hospital

Osaka, Japan, 545-8586

Actively Recruiting

103

Oita Prefectural Hospital

Ōita, Japan, 870-8511

Actively Recruiting

104

Albert Schweitzer Ziekenhuis

Dordrecht, Netherlands, 3318 AT

Actively Recruiting

105

Catharina Hospital

EJ Eindhoven, Netherlands, 5623

Actively Recruiting

106

Groene Hart Hospital

Gouda, Netherlands, 2803

Actively Recruiting

107

University of Medical Center Groningen (Umcg)

Groningen, Netherlands, 9713 GZ

Actively Recruiting

108

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands, 6532 SZ

Actively Recruiting

109

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands, 3584 CX

Actively Recruiting

110

North Shore Hospital

Auckland, New Zealand, 0622

Actively Recruiting

111

Tauranga Hospital

Tauranga, New Zealand, 3112

Actively Recruiting

112

Wellington Regional Hospital (Ccdhb)

Wellington, New Zealand, 6021

Actively Recruiting

113

Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii

Gdansk, Poland, 80-219

Actively Recruiting

114

Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach

Kielce, Poland, 25-734

Actively Recruiting

115

Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

Lodz, Poland, 93-513

Actively Recruiting

116

Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie Uniwersytet Medyczny W Lublinie

Lublin, Poland, 20-400

Actively Recruiting

117

Szpital Kliniczny Mswia Z Warmisko Mazurskim Centrum Onkologii

Olsztyn, Poland, 10-228

Actively Recruiting

118

Wojewodzki Szpital Zespolony Im L Rydygiera W Toruniu

Torun, Poland, 87-100

Actively Recruiting

119

Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie Hematology Unit

Warsaw, Poland, 02-781

Actively Recruiting

120

Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu

Wroclaw, Poland, 50-367

Actively Recruiting

121

Auxilio Mutuo Cancer Center

San Juan, Puerto Rico, 00917

Actively Recruiting

122

Coltea Clinical Hospital

Bucharest, Romania, 30171

Actively Recruiting

123

Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca

ClujNapoca, Romania, 400015

Actively Recruiting

124

Institutul Regional de Oncologie Iasi

Iași, Romania, 700483

Actively Recruiting

125

Singapore General Hospital

Singapore, Singapore, 168582

Actively Recruiting

126

Tan Tock Seng Hospital Haematology

Singapore, Singapore, 308433

Actively Recruiting

127

Pusan National University Hospital

Seogu, Busan Gwang'yeogsi, South Korea, 49241

Actively Recruiting

128

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea, 13620

Actively Recruiting

129

Gyeongsang National University Hospital

Jinju, Gyeongsangnam-do, South Korea, 52727

Actively Recruiting

130

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi, South Korea, 06591

Actively Recruiting

131

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722

Actively Recruiting

132

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea, 03080

Actively Recruiting

133

Ico Badalona

Badalona, Spain, 08916

Actively Recruiting

134

Hospital Universitario de Burgos

Burgos, Spain, 09006

Actively Recruiting

135

Hospital Universitario de Gran Canaria Dr Negrin

Las Palmas de Gran Canaria, Spain, 35010

Actively Recruiting

136

Hospital Universitario Fundacion Jimenez Diaz

Madrid, Spain, 28040

Actively Recruiting

137

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Spain, 28222

Actively Recruiting

138

Hospital Universitari Son Espases

Palma de Mallorca, Spain, 07120

Actively Recruiting

139

Hospital Universitario Virgen Del Rocio

Seville, Spain, 41013

Actively Recruiting

140

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden, 413 46

Actively Recruiting

141

Karolinska Universitetssjukhuset Solna

Stockholm, Sweden, 171 76

Actively Recruiting

142

Inselspital Bern (Inselspital, Universitatsspital Bern)

Bern, Switzerland, 3010

Actively Recruiting

143

Universitatsspital Zurich

Zurich, Switzerland, 8091

Actively Recruiting

144

University Hospitals Sussex Nhs Foundation Trust

Brighton, United Kingdom, BN2 5BE

Actively Recruiting

145

Kent and Canterbury Hospital

Canterbury, United Kingdom, CT1 3NG

Actively Recruiting

146

Hull Royal Infirmary

Hull, United Kingdom, HU3 2JZ

Actively Recruiting

147

Norfolk and Norwich University Hospitals Nhs Foundation Trust

Norwich, United Kingdom, NR4 7UY

Actively Recruiting

148

Spire Leeds Healthcare Spire Leeds Hospital

Roundhay, United Kingdom, LS8 1NT

Actively Recruiting

149

Salisbury Foundation Trust

Salisbury, United Kingdom, SP2 8BJ

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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