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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
Sponsor: BeOne Medicines
Summary
The purpose of this study is to evaluate the efficacy and safety of BGB-16673 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).
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2025-09-04
Completion Date
2028-04-17
Last Updated
2026-03-18
Healthy Volunteers
No
Interventions
BGB-16673
BGB-16673 will be administered orally
Pirtobrutinib
Pirtobrutinib will be administered orally
Locations (129)
Mayo Clinic Phoenix
Phoenix, Arizona, United States
University of California San Diego (Ucsd) Moores Cancer Center
La Jolla, California, United States
UCLA Department of Medicine Hematologyoncology
Los Angeles, California, United States
Stanford Cancer Institute
Palo Alto, California, United States
Christiana Care
Newark, Delaware, United States
Cancer Specialists of North Florida
Jacksonville, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 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
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
Dayton Physician Network
Dayton, Ohio, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Tennessee Oncology, Pllc Nashville
Nashville, Tennessee, United States
Blue Ridge Cancer Care (Oncology and Hematology Associates of Southwest Virginia)
Roanoke, 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
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Sunshine Coast Hospital and Health Service
Birtinya, 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 East, Victoria, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Medizinische Universitatsklinik Innsbruck
Innsbruck, Austria
UZ GENT
Ghent, Belgium
Az Groeninge Campus Loofstraat
Kortrijk, Belgium
Chc Montlegia
Liège, Belgium
Chu de Liege
Liège, Belgium
Chu Ucl Namur
Yvoir, Belgium
Centro de Pesquisa Clinica Dom Bosco Ltda
Araçatuba, Brazil
Ictr Instituto Do Cancer E Transplante de Curitiba
Curitiba, Brazil
Hospital de Clinicas de Goiania Ufg
Goiânia, 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
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
Gemeinschaftspraxis Fur Hamatologie Und Onkologie Dortmund
Dortmund, Germany
Luebecker Onkologische Schwerpunktpraxis Dres Med Uthgenanntkisroweber
Lübeck, Germany
Universitaetsklinikum Ulm
Ulm, 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
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
Japanese Red Cross Kyoto Daini Hospital
Kyotoshi, Kyoto, Japan
Okayama University Hospital
Okayama, Okayama-ken, Japan
Kindai University Hospital
Sakai, Osaka, 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
Osaka Metropolitan University Hospital
Osaka, Japan
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
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Lodz, Poland
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie Uniwersytet Medyczny W Lublinie
Lublin, Poland
Szpital Kliniczny Mswia Z Warmisko Mazurskim Centrum Onkologii
Olsztyn, Poland
Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie Hematology Unit
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
Hull Royal Infirmary
Hull, United Kingdom
Salisbury Foundation Trust
Salisbury, United Kingdom