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RECRUITING Phase 3 ClinicalTrials.gov

A Study of Tacabrutideg (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

Sponsor: BeOne Medicines • ClinicalTrials.gov ID: NCT06846671

Registry updated: 2026-09-28
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Description

The purpose of this study is to investigate the efficacy and safety of tacabrutideg 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).

Interventions

  • Tacabrutideg (Drug)
    Administered orally
  • Bendamustine (Drug)
    Administered intravenously
  • Idelalisib (Drug)
    Administered orally
  • Rituximab (Drug)
    Administered intravenously
  • Venetoclax (Drug)
    Administered orally

Eligibility criteria

Inclusion Criteria: 1. Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop 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 Criteria: 1. Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation 2. Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the 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 systemic therapy 6. Clinically significant cardiovascular disease NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Conditions

CLL Chronic Lymphocytic Leukemia

Locations

  • St Bernards Medical Center — Jonesboro, Arkansas, United States
  • UCLA Department of Medicine Hematologyoncology — Los Angeles, California, United States
  • Scripps Prebys Cancer Center — San Diego, California, United States
  • Pih Health Whittier Hospital — Whittier, California, United States
  • Rocky Mountain Cancer Centers (Williams) Usor — Aurora, Colorado, United States
  • Intermountain Health Lutheran Hospital Cancer Center of Colorado — Golden, Colorado, United States
  • Florida Oncology and Hematology — Fort Myers, Florida, United States
  • Baptist Md Anderson Cancer Center — Jacksonville, Florida, United States
  • Cleveland Clinic Florida — Weston, Florida, United States
  • Emory University Winship Cancer Institute — Atlanta, Georgia, United States
  • Northside Cancer Center — Atlanta, Georgia, United States
  • Our Lady of the Lake Hospital — Baton Rouge, Louisiana, United States
  • American Oncology Partners of Maryland Pa — Bethesda, Maryland, United States
  • Corewell Health the Michigan Cancer Consortium — Grand Rapids, Michigan, United States
  • University of Minnesota — Minneapolis, Minnesota, United States
  • St Lukes Center For Cancer Care — Chesterfield, Missouri, United States
  • Oncology Hematology Associates — Springfield, Missouri, United States
  • St Vincent Frontier Cancer Center — Billings, Montana, United States
  • Oncology Hematology West, Pc Dba Nebraska Cancer Specialists — Omaha, Nebraska, United States
  • Memorial Sloan Kettering Cancer Center Mskcc — New York, New York, United States
  • New York Cancer and Blood Specialists — Shirley, New York, United States
  • Optum Medical Care, Pc — Westbury, New York, United States
  • University Hospitals — Cleveland, Ohio, United States
  • Dayton Physician Network — Dayton, Ohio, United States
  • Oncology Associates of Oregon Willamette Valley Cancer Center — Eugene, Oregon, United States
  • West Penn Hospital — Pittsburgh, Pennsylvania, United States
  • Cancer Care Associates of York — York, Pennsylvania, United States
  • Baylor Scott and White Health — Temple, Texas, United States
  • Texas Oncology Tyler — Tyler, Texas, United States
  • Hospital Aleman — Caba, Argentina
  • CEMIC — Caba, Argentina
  • FUNDALEU — Caba, Argentina
  • Hospital Italiano de Buenos Aires — Ciudad Autonoma Buenos Aires, Argentina
  • Instituto Alexander Fleming (Iaf) — Ciudad Autonoma Buenos Aires, Argentina
  • Cice 9 de Julio Sanatorio 9 de Julio — San Miguel de Tucumán, Argentina
  • Concord Repatriation General Hospital — Concord, New South Wales, Australia
  • Gosford Hospital — Gosford, New South Wales, Australia
  • Port Macquarie Base Hospital — Port Macquarie, New South Wales, Australia
  • Prince of Wales Hospital — Randwick, New South Wales, Australia
  • Toowoomba Hospital — Toowoomba, Queensland, Australia
  • Flinders Medical Centre — Bedford PK, South Australia, Australia
  • The Alfred Hospital — Melbourne, Victoria, Australia
  • Perth Blood Institute — West Perth, Western Australia, Australia
  • CETUS — Belo Horizonte, Brazil
  • Hospital Sirio Libanes Brasilia — Brasília, Brazil
  • Hospital Erasto Gaertner — Curitiba, Brazil
  • Centro de Ensino E Pesquisa Em Oncologia de Santa Catarina (Cepen) — Florianópolis, Brazil
  • Instituto Joinvilense de Hematologia E Oncologia — Joinville, Brazil
  • Complexo Hospitalar de Niteroi — Niterói, Brazil
  • Centro Gaucho Integrado de Oncologia Hospital Mae de Deus — Porto Alegre, Brazil
  • Hospital Sao Lucas Dasa Oncologia — Rio de Janeiro, Brazil
  • Oncoclinicas Rio de Janeiro Sa — Rio de Janeiro, Brazil
  • Hospital Sao Rafael (Rede Dor) — Salvador, Brazil
  • Instituto Dor de Pesquisa E Ensino Sao Paulo — São Paulo, Brazil
  • Instituto Brasileiro de Controle Do Cancer — São Paulo, Brazil
  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein — São Paulo, Brazil
  • Hospital Santa Rita de Cassia Afecc — Vitória, Brazil
  • Juravinski Cancer Centre — Hamilton, Ontario, Canada
  • London Health Sciences Centre — London, Ontario, Canada
  • The Ottawa Hospital Cancer Centre — Ottawa, Ontario, Canada
  • Centre Integre de Sante Et de Services Sociaux de La Monteregie Centre — Greenfield Park, Quebec, Canada
  • Jewish General Hospital — Montreal, Quebec, Canada
  • Unite de Recherche Clinique Du Cisss Des Laurentides — SaintJerome, Quebec, Canada
  • Fakultni Nemocnice Brno — Brno, Czechia
  • Fakultni Nemocnice Hradec Kralove — Hradec Králové, Czechia
  • Fakultni Nemocnice Ostrava — Ostrava, Czechia
  • Vseobecna Fakultni Nemocnice V Praze — Prague, Czechia
  • Universitatsklinikum Augsburg — Augsburg, Germany
  • Praxis Am Volkspark — Berlin, Germany
  • Klinikum Chemnitz Ggmbh — Chemnitz, Germany
  • Universitatsklinikum Essen (Aor) — Essen, Germany
  • Centrum Fur Haematologie Und Onkologie Bethanien — Frankfurt am Main, Germany
  • Universitatsklinikum Freiburg I Br Klinik Fur Innere Medizin I — Freiburg im Breisgau, Germany
  • Universitatsklinikum Hamburg Eppendorf — Hamburg, Germany
  • Universitatsklinikum Heidelberg — Heidelberg, Germany
  • Universitatsklinikum Des Saarlandes — Homburg, Germany
  • Invo Institut Fur Versorgungsforschung in Der Onkologie — Koblenz, Germany
  • Universitaetsklinikum Leipzig Aor — Leipzig, Germany
  • Universitatsklinikum Munster Medizinische Klinik A — Münster, Germany
  • Irccs Istituto Tumori Giovanni Paolo Ii — Bari, Italy
  • Aou Careggi, Servizio Sanitario Toscana — Florence, Italy
  • Fondazione Irccs Ca Granda Ospedale Maggiore Policlinico — Milan, Italy
  • Ospedale San Raffaele — Milan, Italy
  • Azienda Ospedaliera Universitaria Federico Ii — Naples, Italy
  • Aou Maggiore Della Carita — Novara, Italy
  • Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi — Pavia, Italy
  • Ospedale Santa Maria Della Misericordia — Perugia, Italy
  • Fondazione Policlinico Universitario Agostino Gemelli — Roma, Italy
  • Aichi Cancer Center Hospital Clinical Oncology — Nagoya, Aichi-ken, Japan
  • Chiba Cancer Center — Chiba, Chiba, Japan
  • Nho Shikoku Cancer Center — Matsuyama, Ehime, Japan
  • Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital — Hiroshima, Hiroshima, Japan
  • Aiiku Hospital — Sapporo, Hokkaido, Japan
  • Hyogo Prefectural Amagasaki General Medical Center — AmagasakiCity, Hyōgo, Japan
  • Kagoshima University Hospital — Kagoshima, Kagoshima-ken, Japan
  • University Hospital, Kyoto Prefectural Univ of Medicine — KyotoShi, Kyoto, Japan
  • Tohoku University Hospital — Sendai, Miyagi, Japan
  • Niigata University Medical and Dental Hospital — Niigata, Niigata, Japan
  • Kurashiki Central Hospital — Kurashikishi, Okayama-ken, Japan
  • Kansai Medical University Hospital — Hirakata, Osaka, Japan
  • Kindai University Hospital — Sakai, Osaka, Japan
  • Saitama Medical Center — Kawagoeshi, Saitama, Japan
  • Tokyo Metropolitan Komagome Hospital — Bunkyoku, Tokyo, Japan
  • Ntt Medical Center Tokyo — Shinagawaku, Tokyo, Japan
  • Kumamoto University Hospital — Kumamoto, Japan
  • National Hospital Organization Okayama Medical Center — Okayama, Japan
  • Osaka Metropolitan University Hospital — Osaka, Japan
  • Amsterdam Umc Vu Mc — Amsterdam, Netherlands
  • Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny — Brzozów, Poland
  • Pratia Onkologia Katowice — Katowice, Poland
  • Pratia McM Krakow — Krakow, Poland
  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi — Lodz, Poland
  • Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie — Lublin, Poland
  • Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu — Wroclaw, Poland
  • Dong A University Hospital — Seogu, Busan Gwang'yeogsi, South Korea
  • Kyungpook National University Hospital — Junggu, Daegu Gwang'yeogsi, South Korea
  • National Cancer Center (Korea) — IlsandongGu GoyangSi, Gyeonggi-do, South Korea
  • Chonnam National University Hwasun Hospital — HwasunGun, Jeonnam-Gwangju S.M. City, South Korea
  • Samsung Medical Center — GangnamGu, Seoul Teugbyeolsi, South Korea
  • The Catholic University of Korea, Seoul St Marys Hospital — SeochoGu, Seoul Teugbyeolsi, South Korea
  • Seoul National University Hospital — Seoul, Seoul Teugbyeolsi, South Korea
  • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital — Ankara, Turkey (Türkiye)
  • Gazi University — Ankara, Turkey (Türkiye)
  • Dokuz Eylul University — Balçova, Turkey (Türkiye)
  • Antalya Memorial Hospital — Dokuma, Turkey (Türkiye)
  • Sakarya Training and Research Hospital — Sakarya, Turkey (Türkiye)
  • Aberdeen Royal Infirmary — Aberdeen, United Kingdom
  • Birmingham Heartlands Hospital — Birmingham, United Kingdom
  • The Royal Bournemouth and Christchurch Hospitals Nhs Foundation — Bournemouth, United Kingdom
  • University College Hospital — London, United Kingdom
  • Royal Marsden Hospital — London, United Kingdom
  • Southampton General Hospital — Southampton, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record