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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: BeOne Medicines • ClinicalTrials.gov ID: NCT06973187

Registry updated: 2026-09-28
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Description

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

Interventions

  • Tacabrutideg (Drug)
    Tacabrutideg will be administered orally
  • Pirtobrutinib (Drug)
    Pirtobrutinib will be administered orally

Eligibility criteria

Inclusion Criteria: * Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 iwCLL criteria * Previously received treatment for CLL/SLL with a covalent Bruton tyrosine kinase inhibitor (cBTKi). Patients should have disease relapsed after or refractory to at least 1 line of therapy including a cBTKi. * Participants with SLL must have measurable disease by computed tomography/magnetic resonance imaging, defined as ≥ 1 lymph node \> 1.5 cm in longest diameter and measurable in 2 perpendicular diameters. Exclusion Criteria: * Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation. * History of known bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention * History of ischemic stroke or intracranial hemorrhage within 6 months before first dose of study drug * Prior exposure to any Bruton tyrosine kinase (BTK) protein degraders or noncovalent Bruton tyrosine kinase inhibitor (ncBTKi). * Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by CLL/SLL NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Conditions

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma

Locations

  • University of Alabama At Birmingham Hospital — Birmingham, Alabama, United States
  • Mayo Clinic Phoenix — Phoenix, Arizona, United States
  • Kaiser Permanente Southern California — Irvine, California, United States
  • University of California San Diego (Ucsd) Moores Cancer Center — La Jolla, California, United States
  • Cancer and Blood Specialty Clinic — Los Alamitos, California, United States
  • UCLA Department of Medicine Hematologyoncology — Los Angeles, California, United States
  • Kaiser Permanente Oakland Medical Center — Oakland, California, United States
  • Stanford Cancer Institute — Palo Alto, California, United States
  • Kaiser Permanente Roseville Medical Center — Roseville, California, United States
  • Kaiser Permanente San Francisco Medical Center Oncology — San Francisco, California, United States
  • Kaiser Permanente Santa Clara Medical Center Oncologyhematology — Santa Clara, California, United States
  • Kaiser Permanente Northern California — Vallejo, California, United States
  • Kaiser Permanente Walnut Creek Medical Center — Walnut Creek, California, United States
  • Christiana Care — Newark, Delaware, United States
  • Medstar Georgetown University Hospital — Washington D.C., District of Columbia, United States
  • Mayo Clinic Jacksonville — Jacksonville, Florida, United States
  • Cancer Specialists of North Florida — Jacksonville, Florida, United States
  • Mount Sinai Medical Center Braman Comprehensive Cancer Center — Miami, Florida, United States
  • University of Chicago Medical Center — Chicago, Illinois, United States
  • Mission Cancer and Blood — Waukee, Iowa, United States
  • The University of Kansas Cancer Center — Westwood, Kansas, United States
  • Our Lady of the Lake Hospital — Baton Rouge, Louisiana, United States
  • Mary Bird Perkins Cancer Center — Baton Rouge, Louisiana, United States
  • Ochsner Clinic Foundation — New Orleans, Louisiana, United States
  • Dana Farber Cancer Institute — Boston, Massachusetts, United States
  • Karmanos Cancer Institute — Detroit, Michigan, United States
  • Mayo Clinic Rochester — Rochester, Minnesota, United States
  • Washington University School of Medicine — St Louis, Missouri, United States
  • Titan Health Partners Llc Dba Astera Cancer Care — East Brunswick, New Jersey, United States
  • John Theurer Cancer Center Hackensack University Medical Center — Hackensack, New Jersey, United States
  • Columbia University Medical Center — New York, New York, United States
  • Weill Cornell Medical College Newyork Presbyterian Hospital — New York, New York, United States
  • Memorial Sloan Kettering Cancer Center Mskcc — New York, New York, United States
  • University of Rochester — Rochester, New York, United States
  • University of North Carolina At Chapel Hill — Chapel Hill, North Carolina, United States
  • Atrium Health Levine Cancer Institute (Lci) — Charlotte, North Carolina, United States
  • Duke University Medical Center — Durham, North Carolina, United States
  • Atrium Health Wake Forest Baptist — Winston-Salem, North Carolina, United States
  • Dayton Physician Network — Dayton, Ohio, United States
  • Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
  • Medical University of South Carolina — Charleston, South Carolina, United States
  • Tennessee Oncology, Pllc Nashville — Nashville, Tennessee, United States
  • Md Anderson Cancer Center — Houston, Texas, United States
  • Texas Oncology Palestine Cancer Center — Palestine, Texas, United States
  • Blue Ridge Cancer Care (Oncology and Hematology Associates of Southwest Virginia) — Roanake, Virginia, United States
  • Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
  • Summit Cancer Centers — Spokane, Washington, United States
  • Northwest Medical Specialties — Tacoma, Washington, United States
  • Gunderson Health System — La Crosse, Wisconsin, United States
  • FUNDALEU — Caba, Argentina
  • Sanatorio Allende — Córdoba, Argentina
  • Centro Oncologico de Integracion Regional (Coir) — Mendoza, Argentina
  • Hospital Privado de Rosario — Rosario, Argentina
  • Concord Repatriation General Hospital — Concord, New South Wales, Australia
  • St George Private Hospital — Kogarah, New South Wales, Australia
  • Westmead Private Hospital — Westmead, New South Wales, Australia
  • Pindara Private Hospital — Benowa, Queensland, Australia
  • Sunshine Coast Hospital and Health Service — Birtinya, Queensland, Australia
  • John Flynn Private Hospital — Tugun, Queensland, Australia
  • Flinders Medical Centre — Bedford PK, South Australia, Australia
  • St Vincents Hospital Melbourne — Fitzroy, Victoria, Australia
  • Peninsula Private Hospital — Frankston, Victoria, Australia
  • Austin Health — Heidelberg, Victoria, Australia
  • Cabrini Hospital Malvern — Malvern, Victoria, Australia
  • Peter Maccallum Cancer Centre — Melbourne, Victoria, Australia
  • The Alfred Hospital — Melbourne, Victoria, Australia
  • Linear Clinical Research — Nedlands, Western Australia, Australia
  • Medical University Graz — Graz, Austria
  • Medizinische Universitatsklinik Innsbruck — Innsbruck, Austria
  • Ordensklinikum Linz Gmbh Elisabethinen — Linz, Austria
  • Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg — Salzburg, Austria
  • Uk St Poelten — Sankt Pölten, Austria
  • Institut Jules Bordet — Anderlecht, Belgium
  • UZ GENT — Ghent, Belgium
  • Az Groeninge Campus Loofstraat — Kortrijk, Belgium
  • Chc Montlegia — Liège, Belgium
  • Chu de Liege — Liège, Belgium
  • Az Sint Maarten — Mechelen, Belgium
  • Chu Ucl Namur — Yvoir, Belgium
  • Centro de Pesquisa Clinica Dom Bosco Ltda — Araçatuba, Brazil
  • Hospital Felicio Rocho — Belo Horizonte, Brazil
  • Ictr Instituto Do Cancer E Transplante de Curitiba — Curitiba, Brazil
  • Hospital de Clinicas de Goiania Ufg — Goiânia, Brazil
  • Inca Instituto Nacional de Cancer — Rio de Janeiro, Brazil
  • Ensino E Terapia de Inovacao Clinica Amo Etica — Salvador, Brazil
  • Hospital Nove de Julho Dasa — São Paulo, Brazil
  • Hcfmusp Hospital Das Clinicas Da Faculdade de Medicina Da Universidade de Sao Paulo — São Paulo, Brazil
  • Peking Union Medical College Hospital — Beijing, Beijing Municipality, China
  • Fujian Medical University Union Hospital — Fuzhou, Fujian, China
  • The First Hospital of Lanzhou University — Lanzhou, Gansu, China
  • Sun Yat Sen University Cancer Center — Guangzhou, Guangdong, China
  • Jiangmen Central Hospital — Jiangmen, Guangdong, China
  • The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China
  • Guizhou Provincial Peoples Hospital — Guiyang, Guizhou, China
  • The Fourth Hospital of Hebei Medical University East Branch — Shijiazhuang, Hebei, China
  • The First Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China
  • Xuchang Central Hospitalluminghu Branch — Xuchang, Henan, China
  • Henan Cancer Hospital — Zhengzhou, Henan, China
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technologychegu Branch — Wuhan, Hubei, China
  • Hunan Cancer Hospital — Changsha, Hunan, China
  • Affiliated Hospital of Nantong University — Nantong, Jiangsu, China
  • The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China
  • Wuxi Peoples Hospital — Wuxi, Jiangsu, China
  • The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China
  • The Second Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China
  • The First Hospital of Jilin University — Changchun, Jilin, China
  • The Second Hospital of Dalian Medical University — Dalian, Liaoning, China
  • Shengjing Hospital of China Medical University — Shenyang, Liaoning, China
  • Qinghai University Affiliated Hospital — Xining, Qinghai, China
  • The Second Affiliated Hospital of Xian Jiaotong University — Xi'an, Shaanxi, China
  • Binzhou Medical University Hospital — Binzhou, Shandong, China
  • Taian City Central Hospital — Taian, Shandong, China
  • Renji Hospital Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China
  • Shanxi Bethune Hospital — Taiyuan, Shanxi, China
  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital — Chengdu, Sichuan, China
  • Dazhou Central Hospital — Dazhou, Sichuan, China
  • The Affiliated Hospital of Southwest Medical University — Luzhou, Sichuan, China
  • Institute of Hematology and Hospital of Blood Disease — Tianjin, Tianjin Municipality, China
  • First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China
  • The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China
  • The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China
  • Centre de Lutte Contre Le Cancer Institut Bergonie — Bordeaux, France
  • Hopital Estaing — ClermontFerrand, France
  • Centre Hospitalier Universitaire Nantes Hotel Dieu — Nantes, France
  • Hopital Saint Louis — Paris, France
  • Centre Henri Becquerel — Rouen, France
  • Iuc Toulouse Oncopole — Toulouse, France
  • Chu Tours Hopital Bretonneau — Tours, France
  • Chu Nancy Hopital Brabois — VandoeuvrelesNancy, France
  • St Josef Hospital Klinikum Der Ruhr Universitat Bochum — Bochum, Germany
  • Universitatsklinikum Bonn — Bonn, Germany
  • Uniklinik Koeln (Aoer) — Cologne, Germany
  • Gemeinschaftspraxis Fur Hamatologie Und Onkologie Dortmund — Dortmund, Germany
  • Stadtisches Klinikum Karlsruhe — Karlsruhe, Germany
  • Mvz Fur Hamatologie Und Onkologie Lubeckgmbh — Lübeck, Germany
  • Robert Bosch Krankenhaus, Abteilung Hamatologie, Onkologie Und Palliativmedizin — Stuttgart, Germany
  • Universitaetsklinikum Ulm — Ulm, Germany
  • Gemeinschaftspraxis Fuer Haematologie Und Onkologie Westerstede — Westerstede, Germany
  • Bnai Zion Medical Center — Haifa, Israel
  • Shaare Zedek Medical Center — Jerusalem, Israel
  • Hadassah University Hospital Ein Kerem — Jerusalem, Israel
  • Meir Medical Center — KfarSava, Israel
  • Rabin Medical Center — Petah Tikva, Israel
  • Sheba Medical Center — Ramat Gan, Israel
  • Sourasky Tel Aviv Medical Center — Tel Aviv, Israel
  • Policlinico Sorsola Malpighi, Aou Di Bologna — Bologna, Italy
  • Ospedale San Raffaele — Milan, Italy
  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda — Milan, Italy
  • Azienda Ospedaliera Di Padova — Padova, Italy
  • Aichi Cancer Center Hospital Clinical Oncology — Nagoya, Aichi-ken, Japan
  • Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital — Nakamuraku, Aichi-ken, Japan
  • Matsuyama Red Cross Hospital — Matsuyama, Ehime, Japan
  • Fukushima Medical University Hospital — Fukushima, Fukushima, Japan
  • Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital — Hiroshima, Hiroshima, Japan
  • Aiiku Hospital — Sapporo, Hokkaido, Japan
  • Kochi Medical School Hospital — Nankoku, Kochi, Japan
  • Kumamoto University Hospital — Kumamoto, Kumamoto, Japan
  • Japanese Red Cross Kyoto Daini Hospital — Kyotoshi, Kyoto, Japan
  • Oita Prefectural Hospital — Ōita, Oita Prefecture, Japan
  • Okayama University Hospital — Okayama, Okayama-ken, Japan
  • Osaka Metropolitan University Hospital — Osaka, Osaka, Japan
  • Kindai University Hospital — Sakai, Osaka, Japan
  • Dokkyo Medical University Saitama Medical Center — Koshigaya, Saitama, Japan
  • Tokyo Metropolitan Komagome Hospital — Bunkyoku, Tokyo, Japan
  • Cancer Institute Hospital of Jfcr — Kotoku, Tokyo, Japan
  • National Hospital Organization (Nho) Disaster Medical Center — Tachikawashi, Tokyo, Japan
  • Yamagata University Hospital — Yamagata, Yamagata, Japan
  • Centro de Investigacion Clinica Gramel — México, Mexico
  • Christus Latam Hub Center of Excellence and Innovation Sc — Monterrey, Mexico
  • Centro de Investigacion Clinica de Oaxaca — Oaxaca City, Mexico
  • Centro Hemato Oncologico Privado de Toluca — Toluca, Mexico
  • Albert Schweitzer Ziekenhuis — Dordrecht, Netherlands
  • Catharina Hospital — EJ Eindhoven, Netherlands
  • Groene Hart Hospital — Gouda, Netherlands
  • University of Medical Center Groningen (Umcg) — Groningen, Netherlands
  • Canisius Wilhelmina Ziekenhuis — Nijmegen, Netherlands
  • Universitair Medisch Centrum Utrecht — Utrecht, Netherlands
  • North Shore Hospital — Auckland, New Zealand
  • Tauranga Hospital — Tauranga, New Zealand
  • Wellington Regional Hospital (Ccdhb) — Wellington, New Zealand
  • Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii — Gdansk, Poland
  • Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach — Kielce, Poland
  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi — Lodz, Poland
  • Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie — Lublin, Poland
  • Szpital Kliniczny Mswia Z Warmisko Mazurskim Centrum Onkologii — Olsztyn, Poland
  • Wojewodzki Szpital Zespolony Im L Rydygiera W Toruniu — Torun, Poland
  • Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie — Warsaw, Poland
  • Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu — Wroclaw, Poland
  • Auxilio Mutuo Cancer Center — San Juan, Puerto Rico
  • Coltea Clinical Hospital — Bucharest, Romania
  • Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca — ClujNapoca, Romania
  • Institutul Regional de Oncologie Iasi — Iași, Romania
  • Singapore General Hospital — Singapore, Singapore
  • Tan Tock Seng Hospital Haematology — Singapore, Singapore
  • Pusan National University Hospital — Seogu, Busan Gwang'Yeogsi, South Korea
  • Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do, South Korea
  • Gyeongsang National University Hospital — Jinju, Gyeongsangnam-do, South Korea
  • The Catholic University of Korea, Seoul St Marys Hospital — SeochoGu, Seoul Teugbyeolsi, South Korea
  • Severance Hospital Yonsei University Health System — SeodaemunGu, Seoul Teugbyeolsi, South Korea
  • Seoul National University Hospital — Seoul, Seoul Teugbyeolsi, South Korea
  • Ico Badalona — Badalona, Spain
  • Hospital Universitario de Burgos — Burgos, Spain
  • Hospital Universitario de Gran Canaria Dr Negrin — Las Palmas de Gran Canaria, Spain
  • Hospital Universitario Fundacion Jimenez Diaz — Madrid, Spain
  • Hospital Universitario Puerta de Hierro Majadahonda — Majadahonda, Spain
  • Hospital Universitari Son Espases — Palma de Mallorca, Spain
  • Hospital Universitario Virgen Del Rocio — Seville, Spain
  • Sahlgrenska Universitetssjukhuset — Gothenburg, Sweden
  • Karolinska Universitetssjukhuset Solna — Stockholm, Sweden
  • Inselspital Bern (Inselspital, Universitatsspital Bern) — Bern, Switzerland
  • Universitatsspital Zurich — Zurich, Switzerland
  • University Hospitals Sussex Nhs Foundation Trust — Brighton, United Kingdom
  • Kent and Canterbury Hospital — Canterbury, United Kingdom
  • Norfolk and Norwich University Hospitals Nhs Foundation Trust — Norwich, United Kingdom
  • Oxford University Hospitals Nhs Foundation Trust — Oxford, United Kingdom
  • Spire Leeds Healthcare Spire Leeds Hospital — Roundhay, United Kingdom
  • Salisbury Foundation Trust — Salisbury, United Kingdom
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Official Source

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

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