A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia
Sponsor: BeOne Medicines
ClinicalTrials ID:NCT07277231
This clinical trial evaluates the efficacy and safety of sonrotoclax plus zanubrutinib versus venetoclax plus acalabrutinib in treatment-naïve adults with CLL. Eligible participants must have an ECOG score of 0-2, measurable disease, and adequate bone marrow and organ function. All drugs are administered orally.
Patient Parameters
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Program Overview
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 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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Fred Hutchinson Cancer Research Center | 98109-4433 | Seattle | Washington |
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