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

About

Brief 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)

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 3

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

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

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