A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia
NCT07277231 · Phase 3 · Duarte, California, United States
- Condition
- Leukemia
- Disease stage
- Stage I-IV
- Phase
- Phase 3
- Study type
- DRUG
- Intervention
- Sonrotoclax, Zanubrutinib, Acalabrutinib, Venetoclax
- Age
- 18 Years to
- Gender
- All
- Sponsor
- BeOne Medicines
- Research institution
- BeOne Medicines
- Facility
- City of Hope National Medical Center
- Research center
- City of Hope National Medical Center
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).
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.
Primary outcomes
Progression-Free Survival (PFS) as Determined by Independent Review Committee (IRC); Rate of Undetectable Minimal Residual Disease at < 10^-4 sensitivity (uMRD4)
Secondary outcomes
PFS in High-Risk Participants; Overall Survival (OS); Overall Response Rate (ORR) as Determined by IRC