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
2 other identifiers
interventional
500
17 countries
91
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2026
Longer than P75 for phase_3
91 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2025
CompletedFirst Posted
Study publicly available on registry
December 11, 2025
CompletedStudy Start
First participant enrolled
January 22, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2031
July 23, 2026
July 1, 2026
5 years
December 2, 2025
July 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-Free Survival (PFS) as Determined by Independent Review Committee (IRC)
PFS is defined as the time from the date of randomization to the date of disease progression as determined by IRC or death due to any cause, whichever occurs first.
Up to approximately 70 months
Rate of Undetectable Minimal Residual Disease at < 10^-4 sensitivity (uMRD4)
Rate of uMRD4 is defined as the percentage of participants that achieved uMRD4 measured in both peripheral blood (PB) and bone marrow aspirate (BMA) at the post-treatment follow-up visit (PTFU1) based on next generation sequencing (NGS).
Up to approximately 16 months
Secondary Outcomes (11)
PFS in High-Risk Participants
Up to approximately 70 months
Overall Survival (OS)
Up to approximately 70 months
Overall Response Rate (ORR) as Determined by IRC
Up to approximately 70 months
Rate of Undetectable Minimal Residual Disease at < 10^-5 sensitivity (uMRD5)
Up to approximately 16 months
Number of Participants with Adverse Events
Up to approximately 70 months
- +6 more secondary outcomes
Study Arms (2)
Arm A: Sonrotoclax plus Zanubrutinib
EXPERIMENTALParticipants will receive sonrotoclax and zanubrutinib for a fixed duration followed by observation.
Arm B: Venetoclax plus Acalabrutinib
ACTIVE COMPARATORParticipants will receive venetoclax and acalabrutinib for a fixed duration followed by observation.
Interventions
Administered orally.
Administered orally.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Previous systemic treatment for CLL
- Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
- Known central nervous system involvement
- History of confirmed progressive multifocal leukoencephalopathy (PML)
- Uncontrolled hypertension or clinically significant cardiovascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeOne Medicineslead
Study Sites (91)
Stanford Cancer Institute
Palo Alto, California, 94304-2205, United States
Northwestern University
Chicago, Illinois, 60611, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-4433, United States
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, NSW 2148, Australia
Concord Repatriation General Hospital
Concord, New South Wales, NSW 2139, Australia
Genesiscare North Shore
St Leonards, New South Wales, NSW 2065, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, QLD 4102, Australia
Monash Health
Clayton, Victoria, VIC 3168, Australia
Austin Health
Heidelberg, Victoria, VIC 3084, Australia
Cabrini Hospital Malvern
Malvern, Victoria, VIC 3144, Australia
The Alfred Hospital
Melbourne, Victoria, VIC 3004, Australia
Instituto Dor de Pesquisa E Ensino Distrito Federal
Brasília, 70390140, Brazil
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, 90110-270, Brazil
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, 01401-004, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, 05652-900, Brazil
Bc Cancer Victoria
Victoria, British Columbia, V8R 6V5, Canada
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
Ciusss Nim Hscm
Montreal, Quebec, H4J 1C5, Canada
Jewish General Hospital
Montreal, Quebec, QC H3t 1E2, Canada
Ciusss de Lestrie Chus
Sherbrooke, Quebec, J1H 5N4, Canada
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
Québec, G1J 1Z4, Canada
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 630014, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350005, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000, China
Sun Yat Sen University Cancer Center Huangpu Branch
Guangzhou, Guangdong, 510555, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
Guizhou Provincial Peoples Hospital
Guiyang, Guizhou, 550002, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 201203, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710004, China
Shandong Provincial Hospital
Jinan, Shandong, 250000, China
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, 610071, China
Institute of Hematology and Hospital of Blood Disease
Tianjin, Tianjin Municipality, 300020, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
Hangzhou, Zhejiang, 310002, China
Fakultni Nemocnice Brno
Brno, 625 00, Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, 500 03, Czechia
Fakultni Nemocnice Olomouc
Olomouc, 77900, Czechia
Fakultni Nemocnice Ostrava
Ostrava, 708 00, Czechia
Fakultni Nemocnice Plzen
PLZE, 323 00, Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, 10000, Czechia
Centre de Lutte Contre Le Cancer Institut Bergonie
Bordeaux, 33000, France
Chu Clermont Ferrand Therapie Cellulaire and Hematolo
ClermontFerrand, 63100, France
Centre Hospitalier Le Mans
Le Mans, 72037, France
Hopital Claude Huriez Chu Lille
Lille, 59000, France
Centre Leon Berard
Lyon, 69373, France
Chu Montpellier Hopital Saint Eloi
Montpellier, 34090, France
Iuc Toulouse Oncopole
Toulouse, 31100, France
Donauisar Klinikum Deggendorf Klinik Fur Onkologie Und Hamatologie
Deggendorf, 94469, Germany
Centrum Fur Haematologie Und Onkologie Bethanien
Frankfurt am Main, 60389, Germany
Klinikum St Elisabeth Straubing Gmbh Mvz Klinikum Straubing Gmbh
Straubing, 94315, Germany
Irccs Azienda Ospedaliero Universitaria Bologna
Bologna, 40138, Italy
Aou Careggi, Servizio Sanitario Toscana
Florence, 50134, Italy
Ospedale San Raffaele
Milan, 20132, Italy
Azienda Ospedaliera Di Padova
Padova, 35128, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168, Italy
Flevoziekenhuis
Almere Stad, 1315 RA, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, 3318 AT, Netherlands
Hagaziekenhuis
Sgravenhage, 2545 AA, Netherlands
North Shore Hospital
Auckland, 0622, New Zealand
Auckland City Hospital
Auckland, 1023, New Zealand
Health New Zealand Canterbury
Christchurch, 8011, New Zealand
Dunedin Hospital
Dunedin, 9016, New Zealand
Wellington Regional Hospital (Ccdhb)
Wellington, 6021, New Zealand
Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny
Brzozów, 36-200, Poland
Pratia Onkologia Katowice
Katowice, 40-519, Poland
Pratia McM Krakow
Krakow, 30-727, Poland
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Lublin, 20-090, Poland
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
Wroclaw, 50-367, Poland
Coltea Clinical Hospital
Bucharest, 30171, Romania
Institutul Clinic Fundeni
Bucureti, 022328, Romania
Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca
ClujNapoca, 400015, Romania
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, 06591, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, 05505, South Korea
Hospital Universitario Virgen de Las Nieves
Granada, 18014, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, 28222, Spain
Hospital Clinico Universitario Virgen de La Arrixaca
Murcia, 30120, Spain
Karolinska Universitetssjukhuset Solna
Stockholm, 171 76, Sweden
University Hospitals Dorset Royal Bournemouth Hospital
Bournemouth, BH7 7DW, United Kingdom
Kings College Hospital
London, SE5 9RS, United Kingdom
Norfolk and Norwich University Hospitals Nhs Foundation Trust
Norwich, NR4 7UY, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
BeOne Medicines
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2025
First Posted
December 11, 2025
Study Start
January 22, 2026
Primary Completion (Estimated)
February 1, 2031
Study Completion (Estimated)
November 1, 2031
Last Updated
July 23, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.