RecruitingRecruiting
A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia
NCT07277231 · BeOne Medicines
In plain English
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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
About this study
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 criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study design
Enrollment target: 500 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-01-22
Estimated completion: 2031-11
Last updated: 2026-09-11
Interventions
Drug: SonrotoclaxDrug: ZanubrutinibDrug: AcalabrutinibDrug: Venetoclax
Primary outcomes
- • Progression-Free Survival (PFS) as Determined by Independent Review Committee (IRC) (Up to approximately 70 months)
- • Rate of Undetectable Minimal Residual Disease at < 10^-4 sensitivity (uMRD4) (Up to approximately 16 months)
Sponsor
BeOne Medicines · industry
Contacts & investigators
ContactStudy Director · contact · clinicaltrials@beonemed.com · 8778285568
InvestigatorStudy Director · study_director, BeOne Medicines
All locations (114)
City of Hope National Medical CenterRecruiting
Duarte, California, United States
Chao Family Comprehensive Cancer CenterRecruiting
Orange, California, United States
Stanford Cancer InstituteRecruiting
Palo Alto, California, United States
Rocky Mountain Cancer Centers (Williams) UsorRecruiting
Aurora, Colorado, United States
Mayo Clinic JacksonvilleRecruiting
Jacksonville, Florida, United States
Mount Sinai Medical Center Braman Comprehensive Cancer CenterRecruiting
Miami, Florida, United States
Moffitt Cancer CenterRecruiting
Tampa, Florida, United States
Northwestern UniversityRecruiting
Chicago, Illinois, United States
Midwestern Regional Medical CenterRecruiting
Zion, Illinois, United States
Ochsner Clinic FoundationRecruiting
New Orleans, Louisiana, United States
Dana Farber Cancer InstituteRecruiting
Boston, Massachusetts, United States
Mayo Clinic RochesterRecruiting
Rochester, Minnesota, United States
University of Nebraska Medical CenterRecruiting
Omaha, Nebraska, United States
Columbia University Medical CenterRecruiting
New York, New York, United States
Atrium Health Levine Cancer Institute (Lci)Recruiting
Charlotte, North Carolina, United States
Oncology Associates of Oregon Willamette Valley Cancer CenterRecruiting
Eugene, Oregon, United States
Upmc Hillman Cancer Center(Univ of Pittsburgh)Recruiting
Pittsburgh, Pennsylvania, United States
Texas Oncology TylerRecruiting
Tyler, Texas, United States
Huntsman Cancer InstituteRecruiting
Salt Lake City, Utah, United States
Fred Hutchinson Cancer Research CenterRecruiting
Seattle, Washington, United States
Medical College of WisconsinRecruiting
Milwaukee, Wisconsin, United States
Blacktown Cancer and Haematology CentreRecruiting
Blacktown, New South Wales, Australia
Concord Repatriation General HospitalRecruiting
Concord, New South Wales, Australia
Genesiscare North ShoreRecruiting
St Leonards, New South Wales, Australia
Princess Alexandra HospitalRecruiting
Woolloongabba, Queensland, Australia
Monash HealthRecruiting
Clayton, Victoria, Australia
Austin HealthRecruiting
Heidelberg, Victoria, Australia
Cabrini Hospital MalvernRecruiting
Malvern, Victoria, Australia
The Alfred HospitalRecruiting
Melbourne, Victoria, Australia
Instituto Dor de Pesquisa E Ensino Distrito FederalRecruiting
Brasília, Brazil
Centro Gaucho Integrado de Oncologia Hospital Mae de DeusRecruiting
Porto Alegre, Brazil
Ensino E Terapia de Inovacao Clinica Amo EticaRecruiting
Salvador, Brazil
Instituto Dor de Pesquisa E Ensino Sao PauloRecruiting
São Paulo, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert EinsteinRecruiting
São Paulo, Brazil
Bc Cancer VictoriaRecruiting
Victoria, British Columbia, Canada
Juravinski Cancer CentreRecruiting
Hamilton, Ontario, Canada
Ciusss Nim HscmRecruiting
Montreal, Quebec, Canada
Jewish General HospitalRecruiting
Montreal, Quebec, Canada
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)Recruiting
Québec, Quebec, Canada
Ciusss de Lestrie ChusRecruiting
Sherbrooke, Quebec, Canada
Peking Union Medical College HospitalRecruiting
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical UniversityRecruiting
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Fujian Medical UniversityRecruiting
Fuzhou, Fujian, China
Zhujiang Hospital of Southern Medical UniversityRecruiting
Guangzhou, Guangdong, China
Sun Yat Sen University Cancer Center Huangpu BranchRecruiting
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical UniversityRecruiting
Nanning, Guangxi, China
Guizhou Provincial Peoples HospitalRecruiting
Guiyang, Guizhou, China
Harbin Medical University Cancer HospitalRecruiting
Harbin, Heilongjiang, China
Henan Cancer HospitalRecruiting
Zhengzhou, Henan, China
The Second Xiangya Hospital of Central South UniversityRecruiting
Changsha, Hunan, China
Jiangsu Province HospitalRecruiting
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong UniversityRecruiting
Nantong, Jiangsu, China
The Second Affiliated Hospital of Nanchang UniversityRecruiting
Nanchang, Jiangxi, China
The Second Affiliated Hospital of Xian Jiaotong UniversityRecruiting
Xi'an, Shaanxi, China
Shandong Provincial HospitalRecruiting
Jinan, Shandong, China
Rui Jin Hospital Shanghai Jiao Tong University School of MedicineRecruiting
Shanghai, Shanghai Municipality, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples HospitalRecruiting
Chengdu, Sichuan, China
Institute of Hematology and Hospital of Blood DiseaseRecruiting
Tianjin, Tianjin Municipality, China
First Affiliated Hospital of Kunming Medical UniversityRecruiting
Kunming, Yunnan, China
The First Affiliated Hospital, Zhejiang University School of MedicinechengzhanRecruiting
Hangzhou, Zhejiang, China
Fakultni Nemocnice BrnoRecruiting
Brno, Czechia
Fakultni Nemocnice Hradec KraloveRecruiting
Hradec Králové, Czechia
Fakultni Nemocnice OlomoucRecruiting
Olomouc, Czechia
Fakultni Nemocnice OstravaRecruiting
Ostrava, Czechia
Fakultni Nemocnice PlzenRecruiting
PLZE, Czechia
Vseobecna Fakultni Nemocnice V PrazeRecruiting
Prague, Czechia
Centre de Lutte Contre Le Cancer Institut BergonieRecruiting
Bordeaux, France
Chu Clermont Ferrand Therapie Cellulaire and HematoloRecruiting
ClermontFerrand, France
Centre Hospitalier Le MansRecruiting
Le Mans, France
Hopital Claude Huriez Chu LilleRecruiting
Lille, France
Centre Leon BerardRecruiting
Lyon, France
Chu Montpellier Hopital Saint EloiRecruiting
Montpellier, France
Iuc Toulouse OncopoleRecruiting
Toulouse, France
Donauisar Klinikum Deggendorf Klinik Fur Onkologie Und HamatologieRecruiting
Deggendorf, Germany
Centrum Fur Haematologie Und Onkologie BethanienRecruiting
Frankfurt am Main, Germany
Geho MunsterRecruiting
Münster, Germany
Klinikum St Elisabeth Straubing Gmbh Mvz Klinikum Straubing GmbhRecruiting
Straubing, Germany
Irccs Azienda Ospedaliero Universitaria BolognaRecruiting
Bologna, Italy
Aou Careggi, Servizio Sanitario ToscanaRecruiting
Florence, Italy
Ospedale San RaffaeleRecruiting
Milan, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano NiguardaRecruiting
Milan, Italy
Azienda Ospedaliera Di PadovaRecruiting
Padova, Italy
Fondazione Policlinico Universitario Agostino GemelliRecruiting
Roma, Italy
FlevoziekenhuisRecruiting
Almere Stad, Netherlands
Albert Schweitzer ZiekenhuisRecruiting
Dordrecht, Netherlands
HagaziekenhuisRecruiting
Sgravenhage, Netherlands
North Shore HospitalRecruiting
Auckland, New Zealand
Auckland City HospitalRecruiting
Auckland, New Zealand
Health New Zealand CanterburyRecruiting
Christchurch, New Zealand
Dunedin HospitalRecruiting
Dunedin, New Zealand
Wellington Regional Hospital (Ccdhb)Recruiting
Wellington, New Zealand
Szpital Specjalist W Brzozowie,Podkarpacki Osrodek OnkologicznyRecruiting
Brzozów, Poland
Pratia Onkologia KatowiceRecruiting
Katowice, Poland
Pratia McM KrakowRecruiting
Krakow, Poland
Uniwersytecki Szpital Kliniczny Nr 4 W LublinieRecruiting
Lublin, Poland
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We WroclawiuRecruiting
Wroclaw, Poland
Coltea Clinical HospitalRecruiting
Bucharest, Romania
Institutul Clinic FundeniRecruiting
Bucureti, Romania
Institutul Oncologic Prof Dr Ion Chiricuta Cluj NapocaRecruiting
ClujNapoca, Romania
Seoul National University Bundang HospitalRecruiting
Seongnam-si, Gyeonggi-do, South Korea
The Catholic University of Korea, Seoul St Marys HospitalRecruiting
SeochoGu, Seoul Teugbyeolsi, South Korea
Severance Hospital Yonsei University Health SystemRecruiting
SeodaemunGu, Seoul Teugbyeolsi, South Korea
Seoul National University HospitalRecruiting
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical CenterRecruiting
SongpaGu, Seoul Teugbyeolsi, South Korea
Hospital Universitario Virgen de Las NievesRecruiting
Granada, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
Hospital Universitario Puerta de Hierro MajadahondaRecruiting
Majadahonda, Spain
Hospital Clinico Universitario Virgen de La ArrixacaRecruiting
Murcia, Spain
Karolinska Universitetssjukhuset SolnaRecruiting
Stockholm, Sweden
Queen Elizabeth HospitalRecruiting
Birmingham, United Kingdom
University Hospitals Dorset Royal Bournemouth HospitalRecruiting
Bournemouth, United Kingdom
St Jamess University HospitalRecruiting
Leeds, United Kingdom
Kings College HospitalRecruiting
London, United Kingdom
Norfolk and Norwich University Hospitals Nhs Foundation TrustRecruiting
Norwich, United Kingdom