A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Patients With Previously Untreated Chronic Lymphocytic Leukemia
Status: Recruiting
Location: See all (99) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to investigate the efficacy and safety of fixed-duration sonrotoclax (also known as BGB-11417) plus zanubrutinib (also known as BGB-3111) (SZ) compared with fixed-duration of venetoclax plus acalabrutinib (AV) in participants with previously untreated chronic lymphocytic leukemia (CLL).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Treatment-naïve (TN) adults with confirmed diagnosis of CLL which requires treatment
• Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
• Measurable disease by Computer Tomography/Magnetic Resonance Imaging
• Adequate bone marrow and organ function
Locations
United States
California
City of Hope National Medical Center
RECRUITING
Duarte
Chao Family Comprehensive Cancer Center
RECRUITING
Orange
Stanford Cancer Institute
RECRUITING
Palo Alto
Colorado
Rocky Mountain Cancer Centers (Williams) Usor
RECRUITING
Aurora
Florida
Mount Sinai Medical Center Braman Comprehensive Cancer Center
RECRUITING
Miami
Illinois
Northwestern University
RECRUITING
Chicago
Midwestern Regional Medical Center
RECRUITING
Zion
Louisiana
Ochsner Clinic Foundation
RECRUITING
New Orleans
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
Pennsylvania
Upmc Hillman Cancer Center(Univ of Pittsburgh)
RECRUITING
Pittsburgh
Texas
Texas Oncology Tyler
RECRUITING
Tyler
Washington
Fred Hutchinson Cancer Research Center
RECRUITING
Seattle
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Other Locations
Australia
Blacktown Cancer and Haematology Centre
RECRUITING
Blacktown
Monash Health
RECRUITING
Clayton
Concord Repatriation General Hospital
RECRUITING
Concord
Austin Health
RECRUITING
Heidelberg
Cabrini Hospital Malvern
RECRUITING
Malvern
The Alfred Hospital
RECRUITING
Melbourne
Genesiscare North Shore
RECRUITING
St Leonards
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Brazil
Instituto Dor de Pesquisa E Ensino Distrito Federal
RECRUITING
Brasília
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
RECRUITING
Porto Alegre
Ensino E Terapia de Inovacao Clinica Amo Etica
RECRUITING
Salvador
Instituto Dor de Pesquisa E Ensino Sao Paulo
RECRUITING
São Paulo
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
RECRUITING
São Paulo
Canada
Juravinski Cancer Centre
RECRUITING
Hamilton
Ciusss Nim Hscm
RECRUITING
Montreal
Jewish General Hospital
RECRUITING
Montreal
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
RECRUITING
Québec
Ciusss de Lestrie Chus
RECRUITING
Sherbrooke
Bc Cancer Victoria
RECRUITING
Victoria
China
Peking Union Medical College Hospital
RECRUITING
Beijing
The Second Xiangya Hospital of Central South University
RECRUITING
Changsha
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
RECRUITING
Chengdu
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
The First Affiliated Hospital of Fujian Medical University
RECRUITING
Fuzhou
Sun Yat Sen University Cancer Center Huangpu Branch
RECRUITING
Guangzhou
Zhujiang Hospital of Southern Medical University
RECRUITING
Guangzhou
Guizhou Provincial Peoples Hospital
RECRUITING
Guiyang
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
RECRUITING
Hangzhou
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
Shandong Provincial Hospital
RECRUITING
Jinan
First Affiliated Hospital of Kunming Medical University
RECRUITING
Kunming
The Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Jiangsu Province Hospital
RECRUITING
Nanjing
The First Affiliated Hospital of Guangxi Medical University
RECRUITING
Nanning
Affiliated Hospital of Nantong University
RECRUITING
Nantong
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
Institute of Hematology and Hospital of Blood Disease
RECRUITING
Tianjin
The Second Affiliated Hospital of Xian Jiaotong University
RECRUITING
Xi'an
Henan Cancer Hospital
RECRUITING
Zhengzhou
France
Centre de Lutte Contre Le Cancer Institut Bergonie
RECRUITING
Bordeaux
Chu Clermont Ferrand Therapie Cellulaire and Hematolo
RECRUITING
Clermontferrand
Centre Hospitalier Le Mans
RECRUITING
Le Mans
Hopital Claude Huriez Chu Lille
RECRUITING
Lille
Centre Leon Berard
RECRUITING
Lyon
Chu Montpellier Hopital Saint Eloi
RECRUITING
Montpellier
Iuc Toulouse Oncopole
RECRUITING
Toulouse
Germany
Donauisar Klinikum Deggendorf Klinik Fur Onkologie Und Hamatologie
RECRUITING
Deggendorf
Centrum Fur Haematologie Und Onkologie Bethanien
RECRUITING
Frankfurt Am Main
Geho Munster
RECRUITING
Münster
Klinikum St Elisabeth Straubing Gmbh Mvz Klinikum Straubing Gmbh
RECRUITING
Straubing
Italy
Irccs Azienda Ospedaliero Universitaria Bologna
RECRUITING
Bologna
Aou Careggi, Servizio Sanitario Toscana
RECRUITING
Florence
Ospedale San Raffaele
RECRUITING
Milan
Azienda Ospedaliera Di Padova
RECRUITING
Padova
Fondazione Policlinico Universitario Agostino Gemelli
RECRUITING
Roma
Netherlands
Flevoziekenhuis
RECRUITING
Almere Stad
Albert Schweitzer Ziekenhuis
RECRUITING
Dordrecht
Hagaziekenhuis
RECRUITING
Sgravenhage
New Zealand
Auckland City Hospital
RECRUITING
Auckland
North Shore Hospital
RECRUITING
Auckland
Health New Zealand Canterbury
RECRUITING
Christchurch
Dunedin Hospital
RECRUITING
Dunedin
Wellington Regional Hospital (Ccdhb)
RECRUITING
Wellington
Poland
Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny
RECRUITING
Brzozów
Pratia Onkologia Katowice
RECRUITING
Katowice
Pratia McM Krakow
RECRUITING
Krakow
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
RECRUITING
Lublin
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
RECRUITING
Wroclaw
Republic of Korea
The Catholic University of Korea, Seoul St Marys Hospital
RECRUITING
Seochogu
Severance Hospital Yonsei University Health System
RECRUITING
Seodaemungu
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Seoul National University Hospital
RECRUITING
Seoul
Asan Medical Center
RECRUITING
Songpagu
Romania
Coltea Clinical Hospital
RECRUITING
Bucharest
Institutul Clinic Fundeni
RECRUITING
Bucureti
Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca
RECRUITING
Clujnapoca
Spain
Hospital Universitario Virgen de Las Nieves
RECRUITING
Granada
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro Majadahonda
RECRUITING
Majadahonda
Hospital Clinico Universitario Virgen de La Arrixaca
RECRUITING
Murcia
Sweden
Karolinska Universitetssjukhuset Solna
RECRUITING
Stockholm
United Kingdom
Queen Elizabeth Hospital
RECRUITING
Birmingham
University Hospitals Dorset Royal Bournemouth Hospital
RECRUITING
Bournemouth
St Jamess University Hospital
RECRUITING
Leeds
Kings College Hospital
RECRUITING
London
Norfolk and Norwich University Hospitals Nhs Foundation Trust
RECRUITING
Norwich
Contact Information
Primary
Study Director
clinicaltrials@beonemed.com
8778285568
Time Frame
Start Date: 2026-01-22
Estimated Completion Date: 2031-11
Participants
Target number of participants: 500
Treatments
Experimental: Arm A: Sonrotoclax plus Zanubrutinib
Participants will receive sonrotoclax and zanubrutinib for a fixed duration followed by observation.
Active_comparator: Arm B: Venetoclax plus Acalabrutinib
Participants will receive venetoclax and acalabrutinib for a fixed duration followed by observation.
Related Therapeutic Areas
Sponsors
Leads: BeOne Medicines