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A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia
RECRUITINGPhase 3Sponsored by BeOne Medicines
Actively Recruiting
PhasePhase 3
SponsorBeOne Medicines
Started2026-01-22
Est. completion2031-02
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations21 sites
View on ClinicalTrials.gov →
NCT07277231
Summary
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
Age: 18 Years+Healthy volunteers accepted
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.
Conditions2
CancerChronic Lymphocytic Leukemia
Interventions4
Locations21 sites
City of Hope National Medical Center
Chao Family Comprehensive Cancer Center
Stanford Cancer Institute
Rocky Mountain Cancer Centers (Williams) Usor
Mayo Clinic Jacksonville
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Actively Recruiting
PhasePhase 3
SponsorBeOne Medicines
Started2026-01-22
Est. completion2031-02
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations21 sites
View on ClinicalTrials.gov →
NCT07277231