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
Conditions studied: Chronic Lymphocytic Leukemia
In brief
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).
Key facts
- Study ID
- NCT07277231
- Run by
- BeOne Medicines
- People needed
- 500
- Starts
- 2026-01-22
- Expected to finish
- 2031-11-01
- Last updated by the study team
- 2026-08-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Where it is running
- Stanford Cancer Institute — Palo Alto, California, United States (enrolling)
- Northwestern University — Chicago, Illinois, United States (enrolling)
- Midwestern Regional Medical Center — Zion, Illinois, United States (enrolling)
- Ochsner Clinic Foundation — New Orleans, Louisiana, United States (enrolling)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (enrolling)
- Fred Hutchinson Cancer Research Center — Seattle, Washington, United States (enrolling)
- Blacktown Cancer and Haematology Centre — Blacktown, New South Wales, Australia (enrolling)
- Concord Repatriation General Hospital — Concord, New South Wales, Australia (enrolling)
- Genesiscare North Shore — St Leonards, New South Wales, Australia (enrolling)
- Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (enrolling)
- Monash Health — Clayton, Victoria, Australia (enrolling)
- Austin Health — Heidelberg, Victoria, Australia (enrolling)
- Cabrini Hospital Malvern — Malvern, Victoria, Australia (enrolling)
- The Alfred Hospital — Melbourne, Victoria, Australia (enrolling)
- Instituto Dor de Pesquisa E Ensino Distrito Federal — Brasília, Brazil (enrolling)
- Centro Gaucho Integrado de Oncologia Hospital Mae de Deus — Porto Alegre, Brazil (enrolling)
- Instituto Dor de Pesquisa E Ensino Sao Paulo — São Paulo, Brazil (enrolling)
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein — São Paulo, Brazil (enrolling)
- Bc Cancer Victoria — Victoria, British Columbia, Canada (enrolling)
- Juravinski Cancer Centre — Hamilton, Ontario, Canada (enrolling)
- Ciusss Nim Hscm — Montreal, Quebec, Canada (enrolling)
- Jewish General Hospital — Montreal, Quebec, Canada (enrolling)
- Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic) — Québec, Quebec, Canada (enrolling)
- Ciusss de Lestrie Chus — Sherbrooke, Quebec, Canada (enrolling)
- City of Hope National Medical Center — Duarte, California, United States (enrolling)
Full record on ClinicalTrials.gov
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