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

Last updated: March 18, 2026
Sponsor: BeOne Medicines
Overall Status: Active - Recruiting

Phase

3

Condition

Leukemia

Chronic Lymphocytic Leukemia

Platelet Disorders

Treatment

BGB-16673

Rituximab

Idelalisib

Clinical Study ID

NCT06846671
BGB-16673-302
2024-518893-15-00
  • 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 (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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 internationalworkshop on chronic lymphocytic leukemia (iwCLL) criteria.

  2. Previously received treatment for CLL/SLL with both a BTKi and a BCL2i.

  3. Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI)

  4. Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2

  5. Adequate liver function

  6. Adequate blood clotting function

Exclusion

Exclusion Criteria:

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

  2. Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy inthe last 3 months

  3. Known central nervous system involvement

  4. Prior exposure to any BTK protein degraders

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

  6. Clinically significant cardiovascular disease

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

Study Design

Total Participants: 250
Treatment Group(s): 5
Primary Treatment: BGB-16673
Phase: 3
Study Start date:
April 10, 2025
Estimated Completion Date:
February 14, 2030

Study Description

Chronic lymphocytic leukemia is a type of blood cancer that affects people around the world. People with CLL 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 relapsed/refractory (R/R) CLL who were previously exposed to a BTKi and a BCL2i will receive BGB-16673 or the investigator's choice of idelalisib plus rituximab (for CLL only) or bendamustine plus rituximab or venetoclax plus rituximab retreatment. 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 (idelalisib plus rituximab or bendamustine plus rituximab, or venetoclax plus rituximab).

Approximately 250 participants will be included in this study around the world. Participants will be randomly allocated to receive either BGB-16673 or the investigator's choice of treatment.

"Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website."

Connect with a study center

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    Port Macquarie, New South Wales NSW 2444
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    Port Macquarie 2152659, New South Wales 2155400 NSW 2444
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    Toowoomba, Queensland QLD 4350
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    Freiburg im Breisgau 2925177, 79104
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    Hamburg, 20251
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    Heidelberg, 69120
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    Heidelberg 2907911, 69120
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    Homburg, 66421
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    Homburg 2899449, 66421
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    Koblenz, 56068
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    Koblenz 2886946, 56068
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    Leipzig, 04103
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    Leipzig 2879139, 04103
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    Munster, 48149
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    Münster, 48149
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  • Universitatsklinikum Munster Medizinische Klinik A

    Münster 2867543, 48149
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  • Krankenhaus Der Barmherzigen Bruder

    Regensburg, 93049
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  • Krankenhaus Der Barmherzigen Bruder

    Regensburg 2849483, 93049
    Germany

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  • Irccs Istituto Tumori Giovanni Paolo Ii

    Bari, 70124
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  • Irccs Istituto Tumori Giovanni Paolo Ii

    Bari 3182351, 70124
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  • Aou Careggi, Servizio Sanitario Toscana

    Firenze, 50134
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    Florence, 50134
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    Florence 3176959, 50134
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    Milan, 20122
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    Milan 6951411, 20122
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    Milano, 20122
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    Novara, 28100
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    Nagoya 1856057, Aichi-ken 1865694 464-8681
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    Kashiwa, Chiba 277-8577
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    Chiba 2113015, Chiba 2113014 260-8717
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    Kashiwa 1859924, Chiba 2113014 277-8577
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    Matsuyamashi, Ehime 791-0280
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    Kagoshima, Kagoshima-ken 890-8520
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    KyotoShi, Kyoto 602-8566
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    Kumamoto, 860-8556
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    Kyoto, 602-8566
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    Okayama, 701-1192
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    Okayama 1854383, 701-1192
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    IlsandongGu GoyangSi, Gyeonggi-do 10408
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    GangnamGu, Seoul Teugbyeolsi 06351
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    SeochoGu, Seoul Teugbyeolsi 06591
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    Seoul, Seoul Teugbyeolsi 06351
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    Seoul, Seoul Teugbyeolsi 03080
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    Seoul, Seoul Teugbyeolsi 06591
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    Monterrey, 64000
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    Oaxaca, 68020
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    Amsterdam 2759794, 1081 HV
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    Site Not Available

  • Radboud Universitair Medisch Centrum

    Nijmegen, 6525 GA
    Netherlands

    Site Not Available

  • Radboud Universitair Medisch Centrum

    Nijmegen 2750053, 6525 GA
    Netherlands

    Site Not Available

  • North Shore Hospital

    Auckland, 0622
    New Zealand

    Site Not Available

  • North Shore Hospital

    Auckland 2193733, 0622
    New Zealand

    Site Not Available

  • North Shore Hospital

    Takapuna, 0622
    New Zealand

    Site Not Available

  • Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny

    Brzozow, 36-200
    Poland

    Site Not Available

  • Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny

    Brzozów, 36-200
    Poland

    Active - Recruiting

  • Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny

    Brzozów 775086, 36-200
    Poland

    Site Not Available

  • Pratia Onkologia Katowice

    Katowice, 40-519
    Poland

    Active - Recruiting

  • Pratia Onkologia Katowice

    Katowice 3096472, 40-519
    Poland

    Site Not Available

  • Pratia McM Krakow

    Krakow, 30-727
    Poland

    Active - Recruiting

  • Pratia McM Krakow

    Krakow 3094802, 30-727
    Poland

    Site Not Available

  • Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

    Lodz, 93-513
    Poland

    Active - Recruiting

  • Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

    Lodz 3093133, 93-513
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie

    Lublin, 20-090
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny Nr W Lublinie

    Lublin, 20-090
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny Nr W Lublinie

    Lublin 765876, 20-090
    Poland

    Site Not Available

  • Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

    OD, 93-513
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu

    Wrocaw, 50-556
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu

    Wroclaw, 50-367
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu

    Wroclaw 3081368, 50-367
    Poland

    Site Not Available

  • Dong A University Hospital

    Seogu, Busan Gwang'yeogsi 49201
    South Korea

    Active - Recruiting

  • Dong A University Hospital

    Seogu 10354426, Busan Gwang'yeogsi 49201
    South Korea

    Site Not Available

  • Kyungpook National University Hospital

    Junggu, Daegu Gwang'yeogsi 41944
    South Korea

    Active - Recruiting

  • Kyungpook National University Hospital

    Junggu 8606540, Daegu Gwang'yeogsi 41944
    South Korea

    Site Not Available

  • National Cancer Center (Korea)

    IlsandongGu GoyangSi, Gyeonggi-do 10408
    South Korea

    Active - Recruiting

  • Chonnam National University Hwasun Hospital

    HwasunGun, Jeollanam-do 58128
    South Korea

    Active - Recruiting

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi 06351
    South Korea

    Active - Recruiting

  • The Catholic University of Korea, Seoul St Marys Hospital

    SeochoGu, Seoul Teugbyeolsi 06591
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi 03080
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul 1835848, Seoul Teugbyeolsi 03080
    South Korea

    Site Not Available

  • Sahlgrenska Universitetssjukhuset

    Goteborg, 416 85
    Sweden

    Site Not Available

  • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    Ankara, 06200
    Turkey

    Site Not Available

  • Gazi University

    Ankara, 6500
    Turkey

    Site Not Available

  • Antalya Memorial Hospital

    Antalya Memorial Hospital, 07025
    Turkey

    Site Not Available

  • Dokuz Eylul University

    Balcova, 35330
    Turkey

    Site Not Available

  • Antalya Memorial Hospital

    Dokuma, 07025
    Turkey

    Active - Recruiting

  • Dokuz Eylul University

    Izmir, 35340
    Turkey

    Site Not Available

  • Sakarya Training and Research Hospital

    Sakarya, 54100
    Turkey

    Site Not Available

  • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    Ankara, 06200
    Turkey (Türkiye)

    Active - Recruiting

  • Gazi University

    Ankara, 6500
    Turkey (Türkiye)

    Active - Recruiting

  • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    Ankara 323786, 06200
    Turkey (Türkiye)

    Site Not Available

  • Gazi University

    Ankara 323786, 6500
    Turkey (Türkiye)

    Active - Recruiting

  • Dokuz Eylul University

    Balçova, 35330
    Turkey (Türkiye)

    Active - Recruiting

  • Dokuz Eylul University

    Balçova 322185, 35330
    Turkey (Türkiye)

    Site Not Available

  • Antalya Memorial Hospital

    Dokuma, 07025
    Turkey (Türkiye)

    Active - Recruiting

  • Sakarya Training and Research Hospital

    Sakarya, 54100
    Turkey (Türkiye)

    Active - Recruiting

  • Sakarya Training and Research Hospital

    Sakarya 302114, 54100
    Turkey (Türkiye)

    Site Not Available

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN
    United Kingdom

    Active - Recruiting

  • Aberdeen Royal Infirmary

    Aberdeen 2657832, AB25 2ZN
    United Kingdom

    Site Not Available

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS
    United Kingdom

    Active - Recruiting

  • Birmingham Heartlands Hospital

    Birmingham 2655603, B9 5SS
    United Kingdom

    Site Not Available

  • The Royal Bournemouth and Christchurch Hospitals Nhs Foundation

    Bournemouth, BH7 7DW
    United Kingdom

    Active - Recruiting

  • The Royal Bournemouth and Christchurch Hospitals Nhs Foundation

    Bournemouth 2655095, BH7 7DW
    United Kingdom

    Site Not Available

  • Churchill Hospital Oxford University Hospital Nhs Trust

    Headington, OX3 7LE
    United Kingdom

    Site Not Available

  • Churchill Hospital Oxford University Hospital Nhs Trust

    Headington 2647239, OX3 7LE
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital

    London, SW3 6JJ
    United Kingdom

    Active - Recruiting

  • University College Hospital

    London, NW1 2PG
    United Kingdom

    Active - Recruiting

  • Royal Marsden Hospital

    London 2643743, SW3 6JJ
    United Kingdom

    Site Not Available

  • University College Hospital

    London 2643743, NW1 2PG
    United Kingdom

    Active - Recruiting

  • Nottingham University Hospitals Nhs Trust

    Nottingham, NG5 1PB
    United Kingdom

    Site Not Available

  • Nottingham University Hospitals Nhs Trust

    Nottingham 2641170, NG5 1PB
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton, SO16 6YD
    United Kingdom

    Active - Recruiting

  • Southampton General Hospital

    Southampton 2637487, SO16 6YD
    United Kingdom

    Site Not Available

  • St Bernards Medical Center

    Jonesboro, Arkansas 72401
    United States

    Active - Recruiting

  • St Bernards Medical Center

    Jonesboro 4116834, Arkansas 4099753 72401
    United States

    Site Not Available

  • UCLA Department of Medicine Hematologyoncology

    Los Angeles, California 90095-3075
    United States

    Active - Recruiting

  • Pih Health Whittier Hospital

    Whittier, California 90602
    United States

    Active - Recruiting

  • UCLA Department of Medicine Hematologyoncology

    Los Angeles 5368361, California 5332921 90095-3075
    United States

    Site Not Available

  • Pih Health Whittier Hospital

    Whittier 5409059, California 5332921 90602
    United States

    Site Not Available

  • Rocky Mountain Cancer Centers (Williams) Usor

    Aurora, Colorado 80012-5405
    United States

    Active - Recruiting

  • Rocky Mountain Cancer Centers (Williams) Usor

    Aurora 5412347, Colorado 5417618 80012-5405
    United States

    Site Not Available

  • Florida Oncology and Hematology

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

  • Baptist Md Anderson Cancer Center

    Jacksonville, Florida 32207-8432
    United States

    Active - Recruiting

  • Cleveland Clinic Florida

    Weston, Florida 33331-3609
    United States

    Active - Recruiting

  • Florida Oncology and Hematology

    Fort Myers 4155995, Florida 4155751 33912
    United States

    Site Not Available

  • Cleveland Clinic Florida

    Weston 4178003, Florida 4155751 33331-3609
    United States

    Site Not Available

  • Emory University Winship Cancer Institute

    Atlanta, Georgia 30322-1013
    United States

    Active - Recruiting

  • Emory University Winship Cancer Institute

    Atlanta 4180439, Georgia 4197000 30322-1013
    United States

    Site Not Available

  • Our Lady of the Lake Hospital

    Baton Rouge, Louisiana 70808-4365
    United States

    Active - Recruiting

  • Our Lady of the Lake Hospital

    Baton Rouge 4315588, Louisiana 4331987 70808-4365
    United States

    Site Not Available

  • American Oncology Partners of Maryland Pa

    Bethesda, Maryland 20817-7847
    United States

    Active - Recruiting

  • American Oncology Partners of Maryland Pa

    Bethesda 4348599, Maryland 4361885 20817-7847
    United States

    Site Not Available

  • Corewell Health the Michigan Cancer Consortium

    Grand Rapids, Michigan 49503-2560
    United States

    Site Not Available

  • Corewell Health the Michigan Cancer Consortium

    Grand Rapids 4994358, Michigan 5001836 49503-2560
    United States

    Site Not Available

  • Oncology Hematology Associates

    Springfield, Missouri 65807-5288
    United States

    Active - Recruiting

  • Oncology Hematology Associates

    Springfield 4409896, Missouri 4398678 65807-5288
    United States

    Site Not Available

  • Oncology Hematology West, Pc Dba Nebraska Cancer Specialists

    Omaha, Nebraska 68130-2042
    United States

    Active - Recruiting

  • Oncology Hematology West, Pc Dba Nebraska Cancer Specialists

    Omaha 5074472, Nebraska 5073708 68130-2042
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center Mskcc

    New York, New York 10065-6800
    United States

    Active - Recruiting

  • Clinical Research Alliance, Inc

    Westbury, New York 11590-5119
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center Mskcc

    New York 5128581, New York 5128638 10065-6800
    United States

    Site Not Available

  • Clinical Research Alliance, Inc

    Westbury 5144040, New York 5128638 11590-5119
    United States

    Site Not Available

  • University Hospitals

    Cleveland, Ohio 44106-1716
    United States

    Active - Recruiting

  • Dayton Physician Network

    Dayton, Ohio 45415
    United States

    Active - Recruiting

  • University Hospitals

    Cleveland 5150529, Ohio 5165418 44106-1716
    United States

    Site Not Available

  • Dayton Physician Network

    Dayton 4509884, Ohio 5165418 45415
    United States

    Site Not Available

  • Oncology Associates of Oregon Willamette Valley Cancer Center

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • Oncology Associates of Oregon Willamette Valley Cancer Center

    Eugene 5725846, Oregon 5744337 97401
    United States

    Site Not Available

  • West Penn Hospital

    Pittsburgh, Pennsylvania 15224
    United States

    Active - Recruiting

  • Cancer Care Associates of York

    York, Pennsylvania 17403-5049
    United States

    Active - Recruiting

  • West Penn Hospital

    Pittsburgh 5206379, Pennsylvania 6254927 15224
    United States

    Site Not Available

  • Cancer Care Associates of York

    York 4562407, Pennsylvania 6254927 17403-5049
    United States

    Site Not Available

  • Texas Oncology Tyler

    Tyler, Texas 75702-7522
    United States

    Active - Recruiting

  • Texas Oncology Tyler

    Tyler 4738214, Texas 4736286 75702-7522
    United States

    Site Not Available

  • Wvu Medicine, Wheeling Hospital

    Wheeling, West Virginia 26003-6379
    United States

    Site Not Available

  • Wvu Medicine, Wheeling Hospital

    Wheeling 5280854, West Virginia 4826850 26003-6379
    United States

    Site Not Available

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