Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)

• Status: Recruiting
• Trial end date: 2032-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of this study is to compare the efficacy of sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab in participants with chronic lymphocytic leukemia (CLL)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BeiGene
• Treatments: Obinutuzumab; Venetoclax; Zanubrutinib

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 liver function as indicated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x the institutional upper limits of normal (ULNs) value; serum total bilirubin < 3.0 x ULN

• Adequate renal function as defined as creatinine clearance ≥ 50 milliliters per minute

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

Note: Other protocol defined criteria may apply