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
Status: Recruiting
Location: See all (143) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arizona
Mayo Clinic Phoenix
RECRUITING
Phoenix
California
Kaiser Permanente Southern California
RECRUITING
Irvine
University of California San Diego (Ucsd) Moores Cancer Center
RECRUITING
La Jolla
UCLA Department of Medicine Hematologyoncology
RECRUITING
Los Angeles
Stanford Cancer Institute
RECRUITING
Palo Alto
Delaware
Christiana Care
RECRUITING
Newark
Florida
Cancer Specialists of North Florida
RECRUITING
Jacksonville
Mayo Clinic Jacksonville
RECRUITING
Jacksonville
Mount Sinai Comprehensive Cancer Center
RECRUITING
Miami Beach
Illinois
University of Chicago Medical Center
RECRUITING
Chicago
Kansas
The University of Kansas Cancer Center
RECRUITING
Westwood
Louisiana
Mary Bird Perkins Cancer Center
RECRUITING
Baton Rouge
Our Lady of the Lake Hospital
RECRUITING
Baton Rouge
Ochsner Clinic Foundation
RECRUITING
New Orleans
Massachusetts
Dana Farber Cancer Institute
RECRUITING
Boston
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
Missouri
Washington University School of Medicine
RECRUITING
St Louis
North Carolina
University of North Carolina At Chapel Hill
RECRUITING
Chapel Hill
Atrium Health Levine Cancer Institute (Lci)
RECRUITING
Charlotte
Duke University Medical Center
RECRUITING
Durham
New Jersey
Titan Health Partners Llc Dba Astera Cancer Care
RECRUITING
East Brunswick
John Theurer Cancer Center Hackensack University Medical Center
RECRUITING
Hackensack
New York
Columbia University Medical Center
RECRUITING
New York
Memorial Sloan Kettering Cancer Center Mskcc
RECRUITING
New York
University of Rochester
RECRUITING
Rochester
Ohio
Dayton Physician Network
RECRUITING
Dayton
Pennsylvania
Fox Chase Cancer Center
RECRUITING
Philadelphia
Tennessee
Tennessee Oncology, Pllc Nashville
RECRUITING
Nashville
Virginia
Blue Ridge Cancer Care (Oncology and Hematology Associates of Southwest Virginia)
RECRUITING
Roanoke
Washington
Fred Hutchinson Cancer Research Center
RECRUITING
Seattle
Summit Cancer Centers
RECRUITING
Spokane
Northwest Medical Specialties
RECRUITING
Tacoma
Wisconsin
Gunderson Health System
RECRUITING
La Crosse
Other Locations
Australia
Flinders Medical Centre
RECRUITING
Bedford Pk
Sunshine Coast Hospital and Health Service
RECRUITING
Birtinya
Concord Repatriation General Hospital
RECRUITING
Concord
St Vincents Hospital Melbourne
RECRUITING
Fitzroy
Peninsula Private Hospital
RECRUITING
Frankston
Austin Health
RECRUITING
Heidelberg
Cabrini Hospital Malvern
RECRUITING
Malvern East
Peter Maccallum Cancer Centre
RECRUITING
Melbourne
The Alfred Hospital
RECRUITING
Melbourne
Linear Clinical Research
RECRUITING
Nedlands
Austria
Medizinische Universitatsklinik Innsbruck
RECRUITING
Innsbruck
Ordensklinikum Linz Gmbh Elisabethinen
RECRUITING
Linz
Uk St Poelten
RECRUITING
Sankt Pölten
Belgium
Institut Jules Bordet
RECRUITING
Anderlecht
UZ GENT
RECRUITING
Ghent
Az Groeninge Campus Loofstraat
RECRUITING
Kortrijk
Chc Montlegia
RECRUITING
Liège
Chu de Liege
RECRUITING
Liège
Chu Ucl Namur
RECRUITING
Yvoir
Brazil
Centro de Pesquisa Clinica Dom Bosco Ltda
RECRUITING
Araçatuba
Ictr Instituto Do Cancer E Transplante de Curitiba
RECRUITING
Curitiba
Hospital de Clinicas de Goiania Ufg
RECRUITING
Goiânia
Inca Instituto Nacional de Cancer
RECRUITING
Rio De Janeiro
Ensino E Terapia de Inovacao Clinica Amo Etica
RECRUITING
Salvador
Hcfmusp Hospital Das Clinicas Da Faculdade de Medicina Da Universidade de Sao Paulo
RECRUITING
São Paulo
Hospital Nove de Julho Dasa
RECRUITING
São Paulo
France
Centre de Lutte Contre Le Cancer Institut Bergonie
RECRUITING
Bordeaux
Hopital Estaing
RECRUITING
Clermontferrand
Centre Hospitalier Universitaire Nantes Hotel Dieu
RECRUITING
Nantes
Hopital Saint Louis
RECRUITING
Paris
Centre Henri Becquerel
RECRUITING
Rouen
Iuc Toulouse Oncopole
RECRUITING
Toulouse
Chu Tours Hopital Bretonneau
RECRUITING
Tours
Chu Nancy Hopital Brabois
RECRUITING
Vandoeuvrelesnancy
Germany
Gemeinschaftspraxis Fur Hamatologie Und Onkologie Dortmund
RECRUITING
Dortmund
Luebecker Onkologische Schwerpunktpraxis Dres Med Kisroweber
RECRUITING
Lübeck
Universitaetsklinikum Ulm
RECRUITING
Ulm
Gemeinschaftspraxis Fuer Haematologie Und Onkologie Westerstede
RECRUITING
Westerstede
Israel
Bnai Zion Medical Center
RECRUITING
Haifa
Hadassah University Hospital Ein Kerem
RECRUITING
Jerusalem
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Meir Medical Center
RECRUITING
Kfarsava
Rabin Medical Center
RECRUITING
Petah Tikva
Sheba Medical Center
RECRUITING
Ramat Gan
Sourasky Tel Aviv Medical Center
RECRUITING
Tel Aviv
Italy
Policlinico Sorsola Malpighi, Aou Di Bologna
RECRUITING
Bologna
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
Ospedale San Raffaele
RECRUITING
Milan
Azienda Ospedaliera Di Padova
RECRUITING
Padova
Japan
Tokyo Metropolitan Komagome Hospital
RECRUITING
Bunkyoku
Fukushima Medical University Hospital
RECRUITING
Fukushima
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
RECRUITING
Hiroshima
Dokkyo Medical University Saitama Medical Center
RECRUITING
Koshigaya
Cancer Institute Hospital of Jfcr
RECRUITING
Kotoku
Kumamoto University Hospital
RECRUITING
Kumamoto
Japanese Red Cross Kyoto Daini Hospital
RECRUITING
Kyotoshi
Matsuyama Red Cross Hospital
RECRUITING
Matsuyama
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital
RECRUITING
Nakamuraku
Kochi Medical School Hospital
RECRUITING
Nankoku
Oita Prefectural Hospital
RECRUITING
Ōita
Okayama University Hospital
RECRUITING
Okayama
Osaka Metropolitan University Hospital
RECRUITING
Osaka
Kindai University Hospital
RECRUITING
Sakai
Aiiku Hospital
RECRUITING
Sapporo
National Hospital Organization (Nho) Disaster Medical Center
RECRUITING
Tachikawashi
Yamagata University Hospital
RECRUITING
Yamagata
Netherlands
Albert Schweitzer Ziekenhuis
RECRUITING
Dordrecht
Catharina Hospital
RECRUITING
Ej Eindhoven
Groene Hart Hospital
RECRUITING
Gouda
University of Medical Center Groningen (Umcg)
RECRUITING
Groningen
Canisius Wilhelmina Ziekenhuis
RECRUITING
Nijmegen
Universitair Medisch Centrum Utrecht
RECRUITING
Utrecht
New Zealand
North Shore Hospital
RECRUITING
Auckland
Tauranga Hospital
RECRUITING
Tauranga
Wellington Regional Hospital (Ccdhb)
RECRUITING
Wellington
Poland
Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii
RECRUITING
Gdansk
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
RECRUITING
Kielce
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
RECRUITING
Lodz
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie Uniwersytet Medyczny W Lublinie
RECRUITING
Lublin
Szpital Kliniczny Mswia Z Warmisko Mazurskim Centrum Onkologii
RECRUITING
Olsztyn
Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie Hematology Unit
RECRUITING
Warsaw
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
RECRUITING
Wroclaw
Puerto Rico
Auxilio Mutuo Cancer Center
RECRUITING
San Juan
Republic of Korea
Gyeongsang National University Hospital
RECRUITING
Jinju
The Catholic University of Korea, Seoul St Marys Hospital
RECRUITING
Seochogu
Severance Hospital Yonsei University Health System
RECRUITING
Seodaemungu
Pusan National University Hospital
RECRUITING
Seogu
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Seoul National University Hospital
RECRUITING
Seoul
Romania
Coltea Clinical Hospital
RECRUITING
Bucharest
Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca
RECRUITING
Clujnapoca
Institutul Regional de Oncologie Iasi
RECRUITING
Iași
Singapore
Singapore General Hospital
RECRUITING
Singapore
Tan Tock Seng Hospital Haematology
RECRUITING
Singapore
Spain
Ico Badalona
RECRUITING
Badalona
Hospital Universitario de Burgos
RECRUITING
Burgos
Hospital Universitario de Gran Canaria Dr Negrin
RECRUITING
Las Palmas De Gran Canaria
Hospital Universitario Fundacion Jimenez Diaz
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
RECRUITING
Majadahonda
Hospital Universitari Son Espases
RECRUITING
Palma De Mallorca
Hospital Universitario Virgen Del Rocio
RECRUITING
Seville
Sweden
Sahlgrenska Universitetssjukhuset
RECRUITING
Gothenburg
Karolinska Universitetssjukhuset Solna
RECRUITING
Stockholm
Switzerland
Inselspital Bern (Inselspital, Universitatsspital Bern)
RECRUITING
Bern
Universitatsspital Zurich
RECRUITING
Zurich
United Kingdom
University Hospitals Sussex Nhs Foundation Trust
RECRUITING
Brighton
Kent and Canterbury Hospital
RECRUITING
Canterbury
Hull Royal Infirmary
RECRUITING
Hull
Salisbury Foundation Trust
RECRUITING
Salisbury
Contact Information
Primary
Study Director
clinicaltrials@beonemed.com
1-877-828-5568
Time Frame
Start Date: 2025-09-04
Estimated Completion Date: 2028-04-17
Participants
Target number of participants: 500
Treatments
Experimental: Arm A: BGB-16673
Participants will receive BGB-16673 orally.
Active_comparator: Arm B: Pirtobrutinib
Participants will receive pirtobrutinib orally.
Related Therapeutic Areas
Sponsors
Leads: BeOne Medicines