NCT07277231From ClinicalTrials.govRecruiting

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

Chronic Lymphocytic Leukemia

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: BeOne Medicines
Enrolment target: 500
Started: 22 January 2026
Main results due: February 2031
Study sites: 115
Registry updated: 28 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(115)

City of Hope National Medical Center
Duarte, California, United States
Recruiting
Chao Family Comprehensive Cancer Center
Orange, California, United States
Recruiting
Stanford Cancer Institute
Palo Alto, California, United States
Recruiting
Rocky Mountain Cancer Centers (Williams) Usor
Aurora, Colorado, United States
Recruiting
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Recruiting
Mount Sinai Medical Center Braman Comprehensive Cancer Center
Miami, Florida, United States
Recruiting
Moffitt Cancer Center
Tampa, Florida, United States
Recruiting
Northwestern University
Chicago, Illinois, United States
Recruiting
Midwestern Regional Medical Center
Zion, Illinois, United States
Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Recruiting
Mayo Clinic Rochester
Rochester, Minnesota, United States
Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, United States
Recruiting
Columbia University Medical Center
New York, New York, United States
Recruiting
Atrium Health Levine Cancer Institute (Lci)
Charlotte, North Carolina, United States
Recruiting
Duke University Medical Center
Durham, North Carolina, United States
Recruiting
Oncology Associates of Oregon Willamette Valley Cancer Center
Eugene, Oregon, United States
Recruiting
Upmc Hillman Cancer Center(Univ of Pittsburgh)
Pittsburgh, Pennsylvania, United States
Recruiting
Texas Oncology Tyler
Tyler, Texas, United States
Recruiting
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Recruiting
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Recruiting
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, Australia
Recruiting
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Recruiting
Genesiscare North Shore
St Leonards, New South Wales, Australia
Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Recruiting
Monash Health
Clayton, Victoria, Australia
Recruiting
Austin Health
Heidelberg, Victoria, Australia
Recruiting
Cabrini Hospital Malvern
Malvern, Victoria, Australia
Recruiting
The Alfred Hospital
Melbourne, Victoria, Australia
Recruiting
Instituto Dor de Pesquisa E Ensino Distrito Federal
Brasília, Brazil
Recruiting
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, Brazil
Recruiting
Ensino E Terapia de Inovacao Clinica Amo Etica
Salvador, Brazil
Recruiting
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, Brazil
Recruiting
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, Brazil
Recruiting
Bc Cancer Victoria
Victoria, British Columbia, Canada
Recruiting
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Recruiting
Ciusss Nim Hscm
Montreal, Quebec, Canada
Recruiting
Jewish General Hospital
Montreal, Quebec, Canada
Recruiting
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
Québec, Quebec, Canada
Recruiting
Ciusss de Lestrie Chus
Sherbrooke, Quebec, Canada
Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Active, not recruiting
Sun Yat Sen University Cancer Center Huangpu Branch
Guangzhou, Guangdong, China
Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Recruiting
Guizhou Provincial Peoples Hospital
Guiyang, Guizhou, China
Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, China
Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Recruiting
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China
Recruiting
Shandong Provincial Hospital
Jinan, Shandong, China
Recruiting
Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Recruiting
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, China
Recruiting
Institute of Hematology and Hospital of Blood Disease
Tianjin, Tianjin Municipality, China
Recruiting
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Recruiting

Showing 60 of 115 sites — filter to narrow it down. 114 of the 115 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07277231. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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