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

BeOne Medicines

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 range: 18+ years
Sex: All
Healthy volunteers: No

Detailed 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 signi…

Interventions

Drug
Sonrotoclax
Administered orally.
Drug
Zanubrutinib
Administered orally.
Drug
Acalabrutinib
Administered orally.
Drug
Venetoclax
Administered orally.

Locations (115)

City of Hope National Medical Center
Duarte, California
Chao Family Comprehensive Cancer Center
Orange, California
Stanford Cancer Institute
Palo Alto, California
Rocky Mountain Cancer Centers (Williams) Usor
Aurora, Colorado
Mayo Clinic Jacksonville
Jacksonville, Florida
Mount Sinai Medical Center Braman Comprehensive Cancer Center
Miami, Florida