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 (91) 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
Stanford Cancer Institute
RECRUITING
Palo Alto
Florida
Cancer Specialists of North Florida
RECRUITING
Jacksonville
Mayo Clinic Jacksonville
RECRUITING
Jacksonville
Mount Sinai Comprehensive Cancer Center
RECRUITING
Miami Beach
Louisiana
Mary Bird Perkins Cancer Center
RECRUITING
Baton Rouge
Ochsner Clinic Foundation
RECRUITING
New Orleans
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
New York
Memorial Sloan Kettering Cancer Center Mskcc
RECRUITING
New York
University of Rochester
RECRUITING
Rochester
Ohio
Dayton Physician Network
RECRUITING
Dayton
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
Belgium
UZ GENT
RECRUITING
Ghent
Az Groeninge Campus Loofstraat
RECRUITING
Kortrijk
Chu Ucl Namur
RECRUITING
Yvoir
Brazil
Hcfmusp Hospital Das Clinicas Da Faculdade de Medicina Da Universidade de Sao Paulo
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
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
Italy
Ospedale San Raffaele
RECRUITING
Milan
Azienda Ospedaliera Di Padova
RECRUITING
Padua
Japan
Fukushima Medical University Hospital
RECRUITING
Fukushima
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
RECRUITING
Hiroshima
Cancer Institute Hospital of Jfcr
RECRUITING
Kotoku
Matsuyama Red Cross Hospital
RECRUITING
Matsuyama
Kochi Medical School Hospital
RECRUITING
Nankoku
Osaka Metropolitan University Hospital
RECRUITING
Osaka
Kindai University Hospital
RECRUITING
Sakai
National Hospital Organization (Nho) Disaster Medical Center
RECRUITING
Tachikawashi
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
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
Seoul National University Bundang Hospital
RECRUITING
Bundanggu Seongnamsi
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 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
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