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A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia
Sponsor: BeOne Medicines
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).
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2026-01-22
Completion Date
2031-11
Last Updated
2026-05-27
Healthy Volunteers
No
Conditions
Interventions
Sonrotoclax
Administered orally.
Zanubrutinib
Administered orally.
Acalabrutinib
Administered orally.
Venetoclax
Administered orally.
Locations (46)
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Genesiscare North Shore
St Leonards, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Monash Health
Clayton, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Cabrini Hospital Malvern
Malvern, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Instituto Dor de Pesquisa E Ensino Distrito Federal
Brasília, Brazil
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, Brazil
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, Brazil
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Ciusss Nim Hscm
Montreal, Quebec, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Ciusss de Lestrie Chus
Sherbrooke, Quebec, Canada
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
Québec, Canada
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, China
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, France
Hopital Claude Huriez Chu Lille
Lille, France
Chu Montpellier Hopital Saint Eloi
Montpellier, France
Donauisar Klinikum Deggendorf Klinik Fur Onkologie Und Hamatologie
Deggendorf, Germany
Aou Careggi, Servizio Sanitario Toscana
Florence, Italy
Azienda Ospedaliera Di Padova
Padova, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Italy
North Shore Hospital
Auckland, New Zealand
Auckland City Hospital
Auckland, New Zealand
Health New Zealand Canterbury
Christchurch, New Zealand
Wellington Regional Hospital (Ccdhb)
Wellington, New Zealand
Pratia Onkologia Katowice
Katowice, Poland
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Lublin, Poland
Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca
ClujNapoca, Romania
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-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
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea
Hospital Universitario Virgen de Las Nieves
Granada, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Spain
University Hospitals Dorset Royal Bournemouth Hospital
Bournemouth, United Kingdom
Kings College Hospital
London, United Kingdom