A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia
Recruiting now Phase 3 NCT07277231
Run by BeOne Medicines · for 18 and older · All sexes
What this study is about
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).
Who can join (things the study team will check)
✅ You may be able to join 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 be able to join 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 Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Where this trial is running
- Stanford Cancer Institute, Palo Alto, California, United States
- Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
- Blacktown Cancer and Haematology Centre, Blacktown, New South Wales, Australia
- Concord Repatriation General Hospital, Concord, New South Wales, Australia
- Genesiscare North Shore, St Leonards, New South Wales, Australia
- Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
- Monash Health, Clayton, Victoria, Australia
- Austin Health, Heidelberg, Victoria, Australia
- Cabrini Hospital Malvern, Malvern, Victoria, Australia
- The Alfred Hospital, Melbourne, Victoria, Australia
- Instituto Dor de Pesquisa E Ensino Distrito Federal, Brasília, Brazil
- Centro Gaucho Integrado de Oncologia Hospital Mae de Deus, Porto Alegre, Brazil
+ 65 more sites.
Who to contact
Study Director · 8778285568 · clinicaltrials@beonemed.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07277231.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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