Actively Recruiting
A Phase 3, Open-Label, Randomized Study of BGB-16673 Compared to Investigator's Choice Treatments in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Treated With BTK and BCL2 Inhibitors
Led by BeOne Medicines · Updated on 2026-05-29
250
Participants Needed
117
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial evaluates the safety and effectiveness of BGB-16673 compared to investigator's choice treatments in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who previously received both Bruton tyrosine kinase inhibitors (BTKi) and B-cell leukemia/lymphoma 2 protein inhibitors (BCL2i). The study focuses on participants with relapsed or refractory disease, aiming to prolong the time they live without disease progression or worsening symptoms. Participants will be randomly assigned to receive either BGB-16673 once daily or one of the investigator's choice treatments, which include idelalisib plus rituximab (for CLL only), bendamustine plus rituximab, or venetoclax plus rituximab retreatment. Treatments are given as oral medications or intravenous infusions depending on the drugs, and will continue until treatment discontinuation criteria are met. Approximately 250 participants worldwide will join this phase 3, open-label randomized study. During the study, participants will undergo regular assessments including scans, blood tests, and quality-of-life questionnaires over about 36 months. Researchers will monitor progression-free survival as the primary outcome, along with overall survival, response rates, treatment side effects, and changes in quality of life. Safety monitoring and evaluation by independent committees will help ensure thorough observation throughout the study period.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) requiring treatment based on 2018 iwCLL criteria
- Previous treatment with both a Bruton tyrosine kinase inhibitor (BTKi) and a BCL2 inhibitor (BCL2i)
- For SLL, measurable disease by CT or MRI
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Adequate liver function
- Adequate blood clotting function
You will not qualify if you...
- Known prolymphocytic leukemia or history/suspected Richter's transformation
- Prior autologous stem cell transplant or CAR-T cell therapy within 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 criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 36 months
Participants receive either BGB-16673 once daily or one of the investigator's choice treatments until discontinuation criteria are met.
Regular visits for treatment and monitoring as per protocol
Trial Site Locations
Total: 117 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
Northside Cancer Center
Atlanta, Georgia, United States, 30342
Actively Recruiting
10
Our Lady of the Lake Hospital
Baton Rouge, Louisiana, United States, 70808-4365
Actively Recruiting
11
American Oncology Partners of Maryland Pa
Bethesda, Maryland, United States, 20817-7847
Actively Recruiting
12
Oncology Hematology Associates
Springfield, Missouri, United States, 65807-5288
Actively Recruiting
13
Oncology Hematology West, Pc Dba Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130-2042
Actively Recruiting
14
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York, United States, 10065-6800
Actively Recruiting
15
Clinical Research Alliance, Inc
Westbury, New York, United States, 11590-5119
Actively Recruiting
16
University Hospitals
Cleveland, Ohio, United States, 44106-1716
Actively Recruiting
17
Dayton Physician Network
Dayton, Ohio, United States, 45415
Actively Recruiting
18
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon, United States, 97401
Actively Recruiting
19
West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
20
Cancer Care Associates of York
York, Pennsylvania, United States, 17403-5049
Actively Recruiting
21
Texas Oncology Tyler
Tyler, Texas, United States, 75702-7522
Actively Recruiting
22
Hospital Aleman
CABA, Argentina, 1425
Actively Recruiting
23
FUNDALEU
Caba, Argentina, CP1114
Actively Recruiting
24
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, Argentina, 1413
Actively Recruiting
25
Instituto Alexander Fleming (Iaf)
Ciudad Autonoma Buenos Aires, Argentina, 1426
Actively Recruiting
26
Concord Repatriation General Hospital
Concord, New South Wales, Australia, NSW 2139
Actively Recruiting
27
Gosford Hospital
Gosford, New South Wales, Australia, NSW 2250
Actively Recruiting
28
Port Macquarie Base Hospital
Port Macquarie, New South Wales, Australia, NSW 2444
Actively Recruiting
29
Toowoomba Hospital
Toowoomba, Queensland, Australia, QLD 4350
Actively Recruiting
30
The Alfred Hospital
Melbourne, Victoria, Australia, VIC 3004
Actively Recruiting
31
Perth Blood Institute
West Perth, Western Australia, Australia, WA 6005
Actively Recruiting
32
CETUS
Belo Horizonte, Brazil, 30110-022
Actively Recruiting
33
Hospital Sirio Libanes Brasilia
Brasília, Brazil, 70200-730
Actively Recruiting
34
Hospital Erasto Gaertner
Curitiba, Brazil, 81520-060
Actively Recruiting
35
Centro de Ensino E Pesquisa Em Oncologia de Santa Catarina (Cepen)
Florianópolis, Brazil, 88020-210
Actively Recruiting
36
Instituto Joinvilense de Hematologia E Oncologia
Joinville, Brazil, 89201-260
Actively Recruiting
37
Complexo Hospitalar de Niteroi
Niterói, Brazil, 24020-096
Actively Recruiting
38
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, Brazil, 90110-270
Actively Recruiting
39
Hospital Santa Joana Recife
Recife, Brazil, 52011-906
Actively Recruiting
40
Hospital Sao Lucas Dasa Oncologia
Rio de Janeiro, Brazil, 22061-080
Actively Recruiting
41
Oncoclinicas Rio de Janeiro Sa
Rio de Janeiro, Brazil, 22250-040
Actively Recruiting
42
Hospital Sao Rafael (Rede Dor)
Salvador, Brazil, 41253-190
Actively Recruiting
43
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, Brazil, 01401-004
Actively Recruiting
44
Instituto Brasileiro de Controle Do Cancer
São Paulo, Brazil, 04014-002
Actively Recruiting
45
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, Brazil, 05652-900
Actively Recruiting
46
Hospital Santa Rita de Cassia Afecc
Vitória, Brazil, 29043-260
Actively Recruiting
47
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Actively Recruiting
48
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
49
Centre Integre de Sante Et de Services Sociaux de La Monteregie Centre
Greenfield Park, Quebec, Canada, J4V 2H1
Actively Recruiting
50
Jewish General Hospital
Montreal, Quebec, Canada, QC H3t 1E2
Actively Recruiting
51
Fakultni Nemocnice Brno
Brno, Czechia, 625 00
Actively Recruiting
52
Fakultni Nemocnice Hradec Kralove
Hradec Králové, Czechia, 500 03
Actively Recruiting
53
Fakultni Nemocnice Ostrava
Ostrava, Czechia, 708 00
Actively Recruiting
54
Vseobecna Fakultni Nemocnice V Praze
Prague, Czechia, 10000
Actively Recruiting
55
Universitatsklinikum Augsburg
Augsburg, Germany, 86156
Actively Recruiting
56
Praxis Am Volkspark
Berlin, Germany, 10715
Actively Recruiting
57
Klinikum Chemnitz Ggmbh
Chemnitz, Germany, 09116
Actively Recruiting
58
Universitatsklinikum Essen (Aor)
Essen, Germany, 45122
Actively Recruiting
59
Centrum Fur Haematologie Und Onkologie Bethanien
Frankfurt am Main, Germany, 60389
Actively Recruiting
60
Universitatsklinikum Freiburg I Br Klinik Fur Innere Medizin I
Freiburg im Breisgau, Germany, 79106
Actively Recruiting
61
Universitatsklinikum Hamburg Eppendorf
Hamburg, Germany, 20251
Actively Recruiting
62
Universitatsklinikum Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
63
Saarland University Medical Center
Homburg, Germany, 66421
Actively Recruiting
64
Invo Institut Fur Versorgungsforschung in Der Onkologie
Koblenz, Germany, 56068
Actively Recruiting
65
Universitaetsklinikum Leipzig Aor
Leipzig, Germany, 04103
Actively Recruiting
66
Universitatsklinikum Munster Medizinische Klinik A
Münster, Germany, 48149
Actively Recruiting
67
Irccs Istituto Tumori Giovanni Paolo Ii
Bari, Italy, 70124
Actively Recruiting
68
Aou Careggi, Servizio Sanitario Toscana
Florence, Italy, 50134
Actively Recruiting
69
Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
70
Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
71
Azienda Ospedaliera Universitaria Federico Ii
Naples, Italy, 80131
Actively Recruiting
72
Aou Maggiore Della Carita
Novara, Italy, 28100
Actively Recruiting
73
Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi
Pavia, Italy, 27100
Actively Recruiting
74
Ospedale Santa Maria Della Misericordia
Perugia, Italy, 6129
Actively Recruiting
75
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Italy, 00168
Actively Recruiting
76
Aichi Cancer Center Hospital Clinical Oncology
Nagoya, Aichi-ken, Japan, 464-8681
Actively Recruiting
77
Nho Shikoku Cancer Center
Matsuyama, Ehime, Japan, 791-0280
Actively Recruiting
78
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
Hiroshima, Hiroshima, Japan, 730-8619
Actively Recruiting
79
Aiiku Hospital
Sapporo, Hokkaido, Japan, 064-0804
Actively Recruiting
80
Hyogo Prefectural Amagasaki General Medical Center
AmagasakiCity, Hyōgo, Japan, 660-8550
Actively Recruiting
81
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, Japan, 890-8520
Actively Recruiting
82
University Hospital, Kyoto Prefectural Univ of Medicine
KyotoShi, Kyoto, Japan, 602-8566
Actively Recruiting
83
Tohoku University Hospital
Sendai, Miyagi, Japan, 980-8574
Actively Recruiting
84
Niigata University Medical and Dental Hospital
Niigata, Niigata, Japan, 951-8520
Actively Recruiting
85
Kurashiki Central Hospital
Kurashikishi, Okayama-ken, Japan, 710-8602
Actively Recruiting
86
Kansai Medical University Hospital
Hirakata, Osaka, Japan, 573-1191
Actively Recruiting
87
Kindai University Hospital
Sakai, Osaka, Japan, 590-0197
Actively Recruiting
88
Saitama Medical Center
Kawagoeshi, Saitama, Japan, 350-8550
Actively Recruiting
89
Ntt Medical Center Tokyo
Shinagawaku, Tokyo, Japan, 141-0022
Actively Recruiting
90
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Actively Recruiting
91
National Hospital Organization Okayama Medical Center
Okayama, Japan, 701-1192
Actively Recruiting
92
Osaka Metropolitan University Hospital
Osaka, Japan, 545-8586
Actively Recruiting
93
Amsterdam Umc Vu Mc
Amsterdam, Netherlands, 1081 HV
Actively Recruiting
94
Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny
Brzozów, Poland, 36-200
Actively Recruiting
95
Pratia Onkologia Katowice
Katowice, Poland, 40-519
Actively Recruiting
96
Pratia McM Krakow
Krakow, Poland, 30-727
Actively Recruiting
97
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Lodz, Poland, 93-513
Actively Recruiting
98
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Lublin, Poland, 20-090
Actively Recruiting
99
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
Wroclaw, Poland, 50-367
Actively Recruiting
100
Dong A University Hospital
Seogu, Busan Gwang'yeogsi, South Korea, 49201
Actively Recruiting
101
Kyungpook National University Hospital
Junggu, Daegu Gwang'yeogsi, South Korea, 41944
Actively Recruiting
102
National Cancer Center (Korea)
IlsandongGu GoyangSi, Gyeonggi-do, South Korea, 10408
Actively Recruiting
103
Chonnam National University Hwasun Hospital
HwasunGun, Jeollanam-do, South Korea, 58128
Actively Recruiting
104
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
Actively Recruiting
105
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, South Korea, 06591
Actively Recruiting
106
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea, 03080
Actively Recruiting
107
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara, Turkey (Türkiye), 06200
Actively Recruiting
108
Gazi University
Ankara, Turkey (Türkiye), 6500
Actively Recruiting
109
Dokuz Eylul University
Balçova, Turkey (Türkiye), 35330
Actively Recruiting
110
Antalya Memorial Hospital
Dokuma, Turkey (Türkiye), 07025
Actively Recruiting
111
Sakarya Training and Research Hospital
Sakarya, Turkey (Türkiye), 54100
Actively Recruiting
112
Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
Actively Recruiting
113
Birmingham Heartlands Hospital
Birmingham, United Kingdom, B9 5SS
Actively Recruiting
114
The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
Bournemouth, United Kingdom, BH7 7DW
Actively Recruiting
115
University College Hospital
London, United Kingdom, NW1 2PG
Actively Recruiting
116
Royal Marsden Hospital
London, United Kingdom, SW3 6JJ
Actively Recruiting
117
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
S
Study Director
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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