Sonrotoclax plus zanubrutinib versus venetoclax plus acalabrutinib in untreated chronic lymphocytic leukemia
Compares two drug pairs in adults with chronic lymphocytic leukemia not yet treated.
Plain-language title generated from the registry record
Registry title: A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia
Key facts
- Where
- Bologna, Florence, Milan, Padova, and Rome, ItalySee the 6 sites
- Phase
- Phase 3
Where in Italy
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyTaking people
- Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyTaking people
- ASST Grande Ospedale Metropolitano NiguardaMilan, ItalyTaking people
- Ospedale San Raffaele S.r.l.Milan, ItalyTaking people
- Azienda Ospedaliera di PadovaPadova, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- BeOne Medicines
- Trial code
- NCT07277231EU 2025-524366-21-00
- Record updated
- 28 September 2026
- Original description
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).Read full original descriptionShow less
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
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).
Inclusion: 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: Previous systemic treatment for CLL; 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; Known central nervous system involvement.