NCT07277231RecruitingPhase 3
A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia
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
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 2 Dec 2025
- Start date
- 22 Jan 2026
- Primary completion date
- 28 Feb 2031
- Lead sponsor
- BeOne Medicines
- Diseases
- Chronic lymphocytic leukaemia
- NCT number
- NCT07277231
- EU CT number
- 2025-524366-21-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 500
- From 22 Jan 2026 to the primary completion date, 28 Feb 2031
- 117 sites in 17 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous systemic treatment for CLL
Other illness
- Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
- History of confirmed progressive multifocal leukoencephalopathy (PML)
- Uncontrolled hypertension or clinically significant cardiovascular disease
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Other
- Known central nervous system involvement
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (117)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Blacktown Cancer and Haematology Centre Coordinator of this site? Confirm its status | Blacktown | Australia | Recruiting |
| Monash Health Coordinator of this site? Confirm its status | Clayton | Australia | Recruiting |
| Concord Repatriation General Hospital Coordinator of this site? Confirm its status | Concord | Australia | Recruiting |
| Austin Health Coordinator of this site? Confirm its status | Heidelberg | Australia | Recruiting |
| Cabrini Hospital - Malvern Coordinator of this site? Confirm its status | Malvern | Australia | Recruiting |
| The Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| GenesisCare - North Shore Coordinator of this site? Confirm its status | St Leonards | Australia | Recruiting |
| Princess Alexandra Hospital Coordinator of this site? Confirm its status | Woolloongabba | Australia | Recruiting |
| Instituto Dor de Pesquisa E Ensino Distrito Federal Coordinator of this site? Confirm its status | Brasília | Brazil | Recruiting |
| Centro Gaucho Integrado de Oncologia Hospital Mae de Deus Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Recruiting |
| Ensino e Terapia de Inovação Clínica AMO - ETICA Coordinator of this site? Confirm its status | Salvador | Brazil | Recruiting |
| Instituto Dor de Pesquisa E Ensino Sao Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Juravinski Cancer Centre Coordinator of this site? Confirm its status | Hamilton | Canada | Recruiting |
| Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Ciusss Nim Hscm Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic) Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
| Ciusss de Lestrie Chus Coordinator of this site? Confirm its status | Sherbrooke | Canada | Recruiting |
| BC Cancer - Victoria Coordinator of this site? Confirm its status | Victoria | Canada | Recruiting |
| Peking Union Medical College Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The Second Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| The First Affiliated Hospital of Chongqing Medical University Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| The First Affiliated Hospital of Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
| Sun Yat Sen University Cancer Center Huangpu Branch Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Zhujiang Hospital of Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Active, not recruiting |
| Guizhou Provincial Peoples Hospital Coordinator of this site? Confirm its status | Guiyang | China | Recruiting |
| The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Recruiting |
| Shandong Provincial Hospital Coordinator of this site? Confirm its status | Jinan | China | Recruiting |
| First Affiliated Hospital of Kunming Medical University Coordinator of this site? Confirm its status | Kunming | China | Recruiting |
| The Second Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Recruiting |
| Jiangsu Province Hospital Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
| The First Affiliated Hospital of Guangxi Medical University Coordinator of this site? Confirm its status | Nanning | China | Recruiting |
| Affiliated Hospital of Nantong University Coordinator of this site? Confirm its status | Nantong | China | Recruiting |
| Rui Jin Hospital Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Institute of Hematology and Hospital of Blood Disease Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| The Second Affiliated Hospital of XiAn Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Recruiting |
| Fakultni nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Hradec Králové | Czechia | Recruiting |
| University Hospital Olomouc Coordinator of this site? Confirm its status | Olomouc | Czechia | Recruiting |
| Fakultni nemocnice Ostrava Coordinator of this site? Confirm its status | Ostrava | Czechia | Recruiting |
| Fakultni Nemocnice Plzen Coordinator of this site? Confirm its status | Plzen 23 | Czechia | Recruiting |
| Vseobecna fakultni nemocnice v Praze Coordinator of this site? Confirm its status | Prague | Czechia | Recruiting |
| DONAUISAR Klinikum Deggendorf-Dingolfing-Landau gKU Coordinator of this site? Confirm its status | Deggendorf | Germany | Recruiting |
| Centrum für Hämatologie und Onkologie Bethanien Coordinator of this site? Confirm its status | Frankfurt am Main | Germany | Recruiting |
| Institut fuer Versorgungsforschung in der Onkologie GbR Coordinator of this site? Confirm its status | Koblenz | Germany | Recruiting |
| Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie Coordinator of this site? Confirm its status | Muenster | Germany | Recruiting |
| Klinikum Osnabrueck GmbH Coordinator of this site? Confirm its status | Osnabrueck | Germany | Recruiting |
| Barmherzige Brueder gemeinnuetzige Traeger GmbH Coordinator of this site? Confirm its status | Straubing | Germany | Recruiting |
| Hospital Universitario Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro de Majadahonda Coordinator of this site? Confirm its status | Majadahonda | Spain | Recruiting |
| University Clinical Hospital Virgen De La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Recruiting |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Recruiting |
| Centre Hospitalier Le Mans Coordinator of this site? Confirm its status | Le Mans Cedex 9 | France | Recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Recruiting |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Recruiting |
| Centre Hospitalier Universitaire De Toulouse Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Recruiting |
| Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Recruiting |
| University Hospitals Dorset Royal Bournemouth Hospital Coordinator of this site? Confirm its status | Bournemouth | United Kingdom | Recruiting |
| St Jamess University Hospital Coordinator of this site? Confirm its status | Leeds | United Kingdom | Recruiting |
| Kings College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Norfolk and Norwich University Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Norwich | United Kingdom | Recruiting |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliera di Padova Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
| The Catholic University of Korea, Seoul St Marys Hospital Coordinator of this site? Confirm its status | SeochoGu | South Korea | Recruiting |
| Severance Hospital Yonsei University Health System Coordinator of this site? Confirm its status | SeodaemunGu | South Korea | Recruiting |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | SongpaGu | South Korea | Recruiting |
| Flevoziekenhuis Stichting Coordinator of this site? Confirm its status | Almere | Netherlands | Recruiting |
| Albert Schweitzer Ziekenhuis Coordinator of this site? Confirm its status | Dordrecht | Netherlands | Recruiting |
| Haga Hospital Coordinator of this site? Confirm its status | 's-Gravenhage | Netherlands | Recruiting |
| Auckland City Hospital Coordinator of this site? Confirm its status | Auckland | New Zealand | Recruiting |
| North Shore Hospital Coordinator of this site? Confirm its status | Auckland | New Zealand | Recruiting |
| Health New Zealand Canterbury Coordinator of this site? Confirm its status | Christchurch | New Zealand | Recruiting |
| Dunedin Hospital Coordinator of this site? Confirm its status | Dunedin | New Zealand | Recruiting |
| Wellington Regional Hospital (Ccdhb) Coordinator of this site? Confirm its status | Wellington | New Zealand | Recruiting |
| Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza Coordinator of this site? Confirm its status | Brzozów | Poland | Recruiting |
| Pratia S.A. Coordinator of this site? Confirm its status | Cracow | Poland | Recruiting |
| Pratia Hematologia Sp. Z o. o Coordinator of this site? Confirm its status | Katowice | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny nr 4 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu Coordinator of this site? Confirm its status | Wroclaw | Poland | Recruiting |
| Spitalul Clinic Colțea Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Institutul Clinic Fundeni Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Recruiting |
| Karolinska University Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Recruiting |
| Rocky Mountain Cancer Centers (Williams) - USOR Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
| Dana-Farber Cancer Institute Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| Atrium Health Levine Cancer Institute (Lci) Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| City of Hope National Medical Center Coordinator of this site? Confirm its status | Duarte | United States | Recruiting |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Oncology Associates of Oregon Willamette Valley Cancer Center Coordinator of this site? Confirm its status | Eugene | United States | Recruiting |
| Mayo Clinic- Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Recruiting |
| Mount Sinai Medical Center Braman Comprehensive Cancer Center Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Recruiting |
| Ochsner Clinic Foundation Coordinator of this site? Confirm its status | New Orleans | United States | Recruiting |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| University of Nebraska Medical Center Coordinator of this site? Confirm its status | Omaha | United States | Recruiting |
| Chao Family Comprehensive Cancer Center Coordinator of this site? Confirm its status | Orange | United States | Recruiting |
| Stanford Cancer Institute Coordinator of this site? Confirm its status | Palo Alto | United States | Recruiting |
| Upmc Hillman Cancer Center(Univ of Pittsburgh) Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| Huntsman Cancer Institute Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| Fred Hutchinson Cancer Research Center Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
| Moffitt Cancer Center Coordinator of this site? Confirm its status | Tampa | United States | Recruiting |
| Texas Oncology - Tyler Coordinator of this site? Confirm its status | Tyler | United States | Recruiting |
| Midwestern Regional Medical Center Coordinator of this site? Confirm its status | Zion | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.