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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
Summary
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).
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
2026-09-28
Healthy Volunteers
No
Interventions
Tacabrutideg
Tacabrutideg will be administered orally
Pirtobrutinib
Pirtobrutinib will be administered orally
Locations (217)
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