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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
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

Full criteria on ClinicalTrials.gov

Sites (117)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Blacktown Cancer and Haematology Centre
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BlacktownAustraliaRecruiting
Monash Health
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ClaytonAustraliaRecruiting
Concord Repatriation General Hospital
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ConcordAustraliaRecruiting
Austin Health
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HeidelbergAustraliaRecruiting
Cabrini Hospital - Malvern
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MalvernAustraliaRecruiting
The Alfred Hospital
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MelbourneAustraliaRecruiting
GenesisCare - North Shore
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St LeonardsAustraliaRecruiting
Princess Alexandra Hospital
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WoolloongabbaAustraliaRecruiting
Instituto Dor de Pesquisa E Ensino Distrito Federal
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BrasíliaBrazilRecruiting
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
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Porto AlegreBrazilRecruiting
Ensino e Terapia de Inovação Clínica AMO - ETICA
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SalvadorBrazilRecruiting
Instituto Dor de Pesquisa E Ensino Sao Paulo
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São PauloBrazilRecruiting
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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São PauloBrazilRecruiting
Juravinski Cancer Centre
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HamiltonCanadaRecruiting
Jewish General Hospital
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MontrealCanadaRecruiting
Ciusss Nim Hscm
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MontrealCanadaRecruiting
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
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QuébecCanadaRecruiting
Ciusss de Lestrie Chus
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SherbrookeCanadaRecruiting
BC Cancer - Victoria
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VictoriaCanadaRecruiting
Peking Union Medical College Hospital
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BeijingChinaRecruiting
The Second Xiangya Hospital of Central South University
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ChangshaChinaRecruiting
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
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ChengduChinaRecruiting
The First Affiliated Hospital of Chongqing Medical University
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ChongqingChinaRecruiting
The First Affiliated Hospital of Fujian Medical University
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FuzhouChinaRecruiting
Sun Yat Sen University Cancer Center Huangpu Branch
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GuangzhouChinaRecruiting
Zhujiang Hospital of Southern Medical University
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GuangzhouChinaActive, not recruiting
Guizhou Provincial Peoples Hospital
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GuiyangChinaRecruiting
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
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HangzhouChinaRecruiting
Harbin Medical University Cancer Hospital
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HarbinChinaRecruiting
Shandong Provincial Hospital
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JinanChinaRecruiting
First Affiliated Hospital of Kunming Medical University
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KunmingChinaRecruiting
The Second Affiliated Hospital of Nanchang University
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NanchangChinaRecruiting
Jiangsu Province Hospital
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NanjingChinaRecruiting
The First Affiliated Hospital of Guangxi Medical University
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NanningChinaRecruiting
Affiliated Hospital of Nantong University
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NantongChinaRecruiting
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
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ShanghaiChinaRecruiting
Institute of Hematology and Hospital of Blood Disease
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TianjinChinaRecruiting
The Second Affiliated Hospital of XiAn Jiaotong University
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Xi'anChinaRecruiting
Henan Cancer Hospital
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ZhengzhouChinaRecruiting
Fakultni nemocnice Brno
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BrnoCzechiaRecruiting
Fakultni nemocnice Hradec Kralove
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Hradec KrálovéCzechiaRecruiting
University Hospital Olomouc
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OlomoucCzechiaRecruiting
Fakultni nemocnice Ostrava
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OstravaCzechiaRecruiting
Fakultni Nemocnice Plzen
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Plzen 23CzechiaRecruiting
Vseobecna fakultni nemocnice v Praze
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PragueCzechiaRecruiting
DONAUISAR Klinikum Deggendorf-Dingolfing-Landau gKU
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DeggendorfGermanyRecruiting
Centrum für Hämatologie und Onkologie Bethanien
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Frankfurt am MainGermanyRecruiting
Institut fuer Versorgungsforschung in der Onkologie GbR
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KoblenzGermanyRecruiting
Gesellschaft Zur Forderung Des Wissenschaftlich Medizinischen Erkenntnisgewinns In Der Hamatologie Und Oncologie
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MuensterGermanyRecruiting
Klinikum Osnabrueck GmbH
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OsnabrueckGermanyRecruiting
Barmherzige Brueder gemeinnuetzige Traeger GmbH
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StraubingGermanyRecruiting
Hospital Universitario Virgen de las Nieves
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GranadaSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainRecruiting
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainRecruiting
Institut Bergonie
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BordeauxFranceRecruiting
University Hospital Of Clermont-Ferrand
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Clermont-FerrandFranceRecruiting
Centre Hospitalier Le Mans
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Le Mans Cedex 9FranceRecruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceRecruiting
Centre Leon Berard
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LyonFranceRecruiting
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceRecruiting
Centre Hospitalier Universitaire De Toulouse
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Toulouse Cedex 9FranceRecruiting
Queen Elizabeth Hospital
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BirminghamUnited KingdomRecruiting
University Hospitals Dorset Royal Bournemouth Hospital
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BournemouthUnited KingdomRecruiting
St Jamess University Hospital
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LeedsUnited KingdomRecruiting
Kings College Hospital
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LondonUnited KingdomRecruiting
Norfolk and Norwich University Hospitals NHS Foundation Trust
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NorwichUnited KingdomRecruiting
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
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BolognaItalyRecruiting
Azienda Ospedaliero-Universitaria Careggi
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FlorenceItalyRecruiting
ASST Grande Ospedale Metropolitano Niguarda
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MilanItalyRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
Azienda Ospedaliera di Padova
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PadovaItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
The Catholic University of Korea, Seoul St Marys Hospital
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SeochoGuSouth KoreaRecruiting
Severance Hospital Yonsei University Health System
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SeodaemunGuSouth KoreaRecruiting
Seoul National University Bundang Hospital
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Seongnam-siSouth KoreaRecruiting
Seoul National University Hospital
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SeoulSouth KoreaRecruiting
Asan Medical Center
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SongpaGuSouth KoreaRecruiting
Flevoziekenhuis Stichting
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AlmereNetherlandsRecruiting
Albert Schweitzer Ziekenhuis
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DordrechtNetherlandsRecruiting
Haga Hospital
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's-GravenhageNetherlandsRecruiting
Auckland City Hospital
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AucklandNew ZealandRecruiting
North Shore Hospital
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AucklandNew ZealandRecruiting
Health New Zealand Canterbury
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ChristchurchNew ZealandRecruiting
Dunedin Hospital
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DunedinNew ZealandRecruiting
Wellington Regional Hospital (Ccdhb)
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WellingtonNew ZealandRecruiting
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
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BrzozówPolandRecruiting
Pratia S.A.
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CracowPolandRecruiting
Pratia Hematologia Sp. Z o. o
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KatowicePolandRecruiting
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
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LublinPolandRecruiting
Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
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WroclawPolandRecruiting
Spitalul Clinic Colțea
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BucharestRomaniaRecruiting
Institutul Clinic Fundeni
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BucharestRomaniaRecruiting
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
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Cluj-NapocaRomaniaRecruiting
Karolinska University Hospital
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SolnaSwedenRecruiting
Rocky Mountain Cancer Centers (Williams) - USOR
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AuroraUnited StatesRecruiting
Dana-Farber Cancer Institute
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BostonUnited StatesRecruiting
Atrium Health Levine Cancer Institute (Lci)
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CharlotteUnited StatesRecruiting
Northwestern University
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ChicagoUnited StatesRecruiting
City of Hope National Medical Center
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DuarteUnited StatesRecruiting
Duke University Medical Center
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DurhamUnited StatesRecruiting
Oncology Associates of Oregon Willamette Valley Cancer Center
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EugeneUnited StatesRecruiting
Mayo Clinic- Jacksonville
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JacksonvilleUnited StatesRecruiting
Mount Sinai Medical Center Braman Comprehensive Cancer Center
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MiamiUnited StatesRecruiting
Medical College of Wisconsin
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MilwaukeeUnited StatesRecruiting
Ochsner Clinic Foundation
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New OrleansUnited StatesRecruiting
Columbia University Medical Center
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New YorkUnited StatesRecruiting
University of Nebraska Medical Center
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OmahaUnited StatesRecruiting
Chao Family Comprehensive Cancer Center
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OrangeUnited StatesRecruiting
Stanford Cancer Institute
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Palo AltoUnited StatesRecruiting
Upmc Hillman Cancer Center(Univ of Pittsburgh)
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PittsburghUnited StatesRecruiting
Mayo Clinic - Rochester
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RochesterUnited StatesRecruiting
Huntsman Cancer Institute
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Salt Lake CityUnited StatesRecruiting
Fred Hutchinson Cancer Research Center
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SeattleUnited StatesRecruiting
Moffitt Cancer Center
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TampaUnited StatesRecruiting
Texas Oncology - Tyler
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TylerUnited StatesRecruiting
Midwestern Regional Medical Center
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ZionUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.