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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
NCT06973187 · BeOne Medicines
In plain English
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Official title
A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
About this study
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.
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.
Study design
Enrollment target: 500 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-09-04
Estimated completion: 2028-04-17
Last updated: 2026-04-15
Interventions
Drug: BGB-16673Drug: Pirtobrutinib
Primary outcomes
- • Progression-Free Survival (PFS) per Independent Review Committee (IRC) (Up to approximately 3 years)
Sponsor
BeOne Medicines · industry
Contacts & investigators
ContactStudy Director · contact · clinicaltrials@beonemed.com · 1-877-828-5568
InvestigatorStudy Director · study_director, BeOne Medicines
All locations (143)
Mayo Clinic PhoenixRecruiting
Phoenix, Arizona, United States
Kaiser Permanente Southern CaliforniaRecruiting
Irvine, California, United States
University of California San Diego (Ucsd) Moores Cancer CenterRecruiting
La Jolla, California, United States
UCLA Department of Medicine HematologyoncologyRecruiting
Los Angeles, California, United States
Stanford Cancer InstituteRecruiting
Palo Alto, California, United States
Christiana CareRecruiting
Newark, Delaware, United States
Cancer Specialists of North FloridaRecruiting
Jacksonville, Florida, United States
Mayo Clinic JacksonvilleRecruiting
Jacksonville, Florida, United States
Mount Sinai Comprehensive Cancer CenterRecruiting
Miami Beach, Florida, United States
University of Chicago Medical CenterRecruiting
Chicago, Illinois, United States
The University of Kansas Cancer CenterRecruiting
Westwood, Kansas, United States
Our Lady of the Lake HospitalRecruiting
Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer CenterRecruiting
Baton Rouge, Louisiana, United States
Ochsner Clinic FoundationRecruiting
New Orleans, Louisiana, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Karmanos Cancer InstituteRecruiting
Detroit, Michigan, United States
Mayo Clinic RochesterRecruiting
Rochester, Minnesota, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Titan Health Partners Llc Dba Astera Cancer CareRecruiting
East Brunswick, New Jersey, United States
John Theurer Cancer Center Hackensack University Medical CenterRecruiting
Hackensack, New Jersey, United States
Columbia University Medical CenterRecruiting
New York, New York, United States
Memorial Sloan Kettering Cancer Center MskccRecruiting
New York, New York, United States
University of RochesterRecruiting
Rochester, New York, United States
University of North Carolina At Chapel HillRecruiting
Chapel Hill, North Carolina, United States
Atrium Health Levine Cancer Institute (Lci)Recruiting
Charlotte, North Carolina, United States
Duke University Medical CenterRecruiting
Durham, North Carolina, United States
Dayton Physician NetworkRecruiting
Dayton, Ohio, United States
Fox Chase Cancer CenterRecruiting
Philadelphia, Pennsylvania, United States
Tennessee Oncology, Pllc NashvilleRecruiting
Nashville, Tennessee, United States
Blue Ridge Cancer Care (Oncology and Hematology Associates of Southwest Virginia)Recruiting
Roanoke, Virginia, United States
Fred Hutchinson Cancer Research CenterRecruiting
Seattle, Washington, United States
Summit Cancer CentersRecruiting
Spokane, Washington, United States
Northwest Medical SpecialtiesRecruiting
Tacoma, Washington, United States
Gunderson Health SystemRecruiting
La Crosse, Wisconsin, United States
Concord Repatriation General HospitalRecruiting
Concord, New South Wales, Australia
Sunshine Coast Hospital and Health ServiceRecruiting
Birtinya, Queensland, Australia
Flinders Medical CentreRecruiting
Bedford PK, South Australia, Australia
St Vincents Hospital MelbourneRecruiting
Fitzroy, Victoria, Australia
Peninsula Private HospitalRecruiting
Frankston, Victoria, Australia
Austin HealthRecruiting
Heidelberg, Victoria, Australia
Cabrini Hospital MalvernRecruiting
Malvern East, Victoria, Australia
Peter Maccallum Cancer CentreRecruiting
Melbourne, Victoria, Australia
The Alfred HospitalRecruiting
Melbourne, Victoria, Australia
Linear Clinical ResearchRecruiting
Nedlands, Western Australia, Australia
Medizinische Universitatsklinik InnsbruckRecruiting
Innsbruck, Austria
Ordensklinikum Linz Gmbh ElisabethinenRecruiting
Linz, Austria
Uk St PoeltenRecruiting
Sankt Pölten, Austria
Institut Jules BordetRecruiting
Anderlecht, Belgium
UZ GENTRecruiting
Ghent, Belgium
Az Groeninge Campus LoofstraatRecruiting
Kortrijk, Belgium
Chc MontlegiaRecruiting
Liège, Belgium
Chu de LiegeRecruiting
Liège, Belgium
Chu Ucl NamurRecruiting
Yvoir, Belgium
Centro de Pesquisa Clinica Dom Bosco LtdaRecruiting
Araçatuba, Brazil
Ictr Instituto Do Cancer E Transplante de CuritibaRecruiting
Curitiba, Brazil
Hospital de Clinicas de Goiania UfgRecruiting
Goiânia, Brazil
Inca Instituto Nacional de CancerRecruiting
Rio de Janeiro, Brazil
Ensino E Terapia de Inovacao Clinica Amo EticaRecruiting
Salvador, Brazil
Hospital Nove de Julho DasaRecruiting
São Paulo, Brazil
Hcfmusp Hospital Das Clinicas Da Faculdade de Medicina Da Universidade de Sao PauloRecruiting
São Paulo, Brazil
Centre de Lutte Contre Le Cancer Institut BergonieRecruiting
Bordeaux, France
Hopital EstaingRecruiting
Clermontferrand, France
Centre Hospitalier Universitaire Nantes Hotel DieuRecruiting
Nantes, France
Hopital Saint LouisRecruiting
Paris, France
Centre Henri BecquerelRecruiting
Rouen, France
Iuc Toulouse OncopoleRecruiting
Toulouse, France
Chu Tours Hopital BretonneauRecruiting
Tours, France
Chu Nancy Hopital BraboisRecruiting
VandoeuvrelesNancy, France
Gemeinschaftspraxis Fur Hamatologie Und Onkologie DortmundRecruiting
Dortmund, Germany
Luebecker Onkologische Schwerpunktpraxis Dres Med KisroweberRecruiting
Lübeck, Germany
Universitaetsklinikum UlmRecruiting
Ulm, Germany
Gemeinschaftspraxis Fuer Haematologie Und Onkologie WesterstedeRecruiting
Westerstede, Germany
Bnai Zion Medical CenterRecruiting
Haifa, Israel
Shaare Zedek Medical CenterRecruiting
Jerusalem, Israel
Hadassah University Hospital Ein KeremRecruiting
Jerusalem, Israel
Meir Medical CenterRecruiting
KfarSava, Israel
Rabin Medical CenterRecruiting
Petah Tikva, Israel
Sheba Medical CenterRecruiting
Ramat Gan, Israel
Sourasky Tel Aviv Medical CenterRecruiting
Tel Aviv, Israel
Policlinico Sorsola Malpighi, Aou Di BolognaRecruiting
Bologna, Italy
Ospedale San RaffaeleRecruiting
Milan, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano NiguardaRecruiting
Milan, Italy
Azienda Ospedaliera Di PadovaRecruiting
Padova, Italy
Japanese Red Cross Aichi Medical Center Nagoya Daiichi HospitalRecruiting
Nakamuraku, Aichi-ken, Japan
Matsuyama Red Cross HospitalRecruiting
Matsuyama, Ehime, Japan
Fukushima Medical University HospitalRecruiting
Fukushima, Fukushima, Japan
Hiroshima Red Cross Hospital and Atomic Bomb Survivors HospitalRecruiting
Hiroshima, Hiroshima, Japan
Aiiku HospitalRecruiting
Sapporo, Hokkaido, Japan
Kochi Medical School HospitalRecruiting
Nankoku, Kochi, Japan
Japanese Red Cross Kyoto Daini HospitalRecruiting
Kyotoshi, Kyoto, Japan
Okayama University HospitalRecruiting
Okayama, Okayama-ken, Japan
Kindai University HospitalRecruiting
Sakai, Osaka, Japan
Dokkyo Medical University Saitama Medical CenterRecruiting
Koshigaya, Saitama, Japan
Tokyo Metropolitan Komagome HospitalRecruiting
Bunkyoku, Tokyo, Japan
Cancer Institute Hospital of JfcrRecruiting
Kotoku, Tokyo, Japan
National Hospital Organization (Nho) Disaster Medical CenterRecruiting
Tachikawashi, Tokyo, Japan
Yamagata University HospitalRecruiting
Yamagata, Yamagata, Japan
Kumamoto University HospitalRecruiting
Kumamoto, Japan
Osaka Metropolitan University HospitalRecruiting
Osaka, Japan
Oita Prefectural HospitalRecruiting
Ōita, Japan
Albert Schweitzer ZiekenhuisRecruiting
Dordrecht, Netherlands
Catharina HospitalRecruiting
EJ Eindhoven, Netherlands
Groene Hart HospitalRecruiting
Gouda, Netherlands
University of Medical Center Groningen (Umcg)Recruiting
Groningen, Netherlands
Canisius Wilhelmina ZiekenhuisRecruiting
Nijmegen, Netherlands
Universitair Medisch Centrum UtrechtRecruiting
Utrecht, Netherlands
North Shore HospitalRecruiting
Auckland, New Zealand
Tauranga HospitalRecruiting
Tauranga, New Zealand
Wellington Regional Hospital (Ccdhb)Recruiting
Wellington, New Zealand
Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum OnkologiiRecruiting
Gdansk, Poland
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W KielcachRecruiting
Kielce, Poland
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W LodziRecruiting
Lodz, Poland
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie Uniwersytet Medyczny W LublinieRecruiting
Lublin, Poland
Szpital Kliniczny Mswia Z Warmisko Mazurskim Centrum OnkologiiRecruiting
Olsztyn, Poland
Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie Hematology UnitRecruiting
Warsaw, Poland
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We WroclawiuRecruiting
Wroclaw, Poland
Auxilio Mutuo Cancer CenterRecruiting
San Juan, Puerto Rico
Coltea Clinical HospitalRecruiting
Bucharest, Romania
Institutul Oncologic Prof Dr Ion Chiricuta Cluj NapocaRecruiting
ClujNapoca, Romania
Institutul Regional de Oncologie IasiRecruiting
Iași, Romania
Singapore General HospitalRecruiting
Singapore, Singapore
Tan Tock Seng Hospital HaematologyRecruiting
Singapore, Singapore
Pusan National University HospitalRecruiting
Seogu, Busan Gwang'yeogsi, South Korea
Seoul National University Bundang HospitalRecruiting
Seongnam-si, Gyeonggi-do, South Korea
Gyeongsang National University HospitalRecruiting
Jinju, Gyeongsangnam-do, South Korea
The Catholic University of Korea, Seoul St Marys HospitalRecruiting
SeochoGu, Seoul Teugbyeolsi, South Korea
Severance Hospital Yonsei University Health SystemRecruiting
SeodaemunGu, Seoul Teugbyeolsi, South Korea
Seoul National University HospitalRecruiting
Seoul, Seoul Teugbyeolsi, South Korea
Ico BadalonaRecruiting
Badalona, Spain
Hospital Universitario de BurgosRecruiting
Burgos, Spain
Hospital Universitario de Gran Canaria Dr NegrinRecruiting
Las Palmas de Gran Canaria, Spain
Hospital Universitario Fundacion Jimenez DiazRecruiting
Madrid, Spain
Hospital Universitario Puerta de Hierro MajadahondaRecruiting
Majadahonda, Spain
Hospital Universitari Son EspasesRecruiting
Palma de Mallorca, Spain
Hospital Universitario Virgen Del RocioRecruiting
Seville, Spain
Sahlgrenska UniversitetssjukhusetRecruiting
Gothenburg, Sweden
Karolinska Universitetssjukhuset SolnaRecruiting
Stockholm, Sweden
Inselspital Bern (Inselspital, Universitatsspital Bern)Recruiting
Bern, Switzerland
Universitatsspital ZurichRecruiting
Zurich, Switzerland
University Hospitals Sussex Nhs Foundation TrustRecruiting
Brighton, United Kingdom
Kent and Canterbury HospitalRecruiting
Canterbury, United Kingdom
Hull Royal InfirmaryRecruiting
Hull, United Kingdom
Salisbury Foundation TrustRecruiting
Salisbury, United Kingdom