Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)
18 Years and older, Male and Female
BGB-11417-301 (primary)
NCI-2023-09813
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)
Objectives
Chronic lymphocytic leukemia is a type of blood cancer that affects people around the
world. People with CLL suffer from enlarged lymph nodes, spleen, or liver, or have
symptoms like night sweats, weight loss and fever. They have shorter life expectancy
compared to healthy people. There is an urgent need for new treatment to prolong
participant life and control disease-related symptoms.
In this study, participants with CLL, without prior treatment will receive either
venetoclax plus obinutuzumab combination treatment that is considered a standard first
line treatment or receive sonrotoclax plus zanubrutinib. It is hypothesized that
sonrotoclax plus zanubrutinib may be better than venetoclax plus obinutuzumab in treating
CLL.
The main purpose of this study is to compare the duration the participants live without
the CLL getting worse between participants who received venetoclax plus obinutuzumab
versus sonrotoclax plus zanubrutinib. Approximately 640 participants will be included in
this study around the world. Participants will have equal chance to be allocated to
receive either of the treatment combinations.
Eligibility
- 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
Treatment Sites in Georgia
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