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).
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
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)
Parallel
Sonrotoclax
DrugAdministered orally.
Zanubrutinib
DrugAdministered orally.
Acalabrutinib
DrugAdministered orally.
Venetoclax
DrugAdministered orally.
Progression-Free Survival (PFS) as Determined by Independent Review Committee (IRC)
PFS is defined as the time from the date of randomization to the date of disease progression as determined by IRC or death due to any cause, whichever occurs first.
Rate of Undetectable Minimal Residual Disease at < 10^-4 sensitivity (uMRD4)
Rate of uMRD4 is defined as the percentage of participants that achieved uMRD4 measured in both peripheral blood (PB) and bone marrow aspirate (BMA) at the post-treatment follow-up visit (PTFU1) based on next generation sequencing (NGS).
PFS in High-Risk Participants
PFS is defined as the time from the date of randomization to the date of disease progression as determined by IRC or death due to any cause, whichever occurs first.
Overall Survival (OS)
OS is defined as the time from the date of randomization to the date of death due to any cause.
Overall Response Rate (ORR) as Determined by IRC
ORR is defined as the percentage of participants with a complete response (CR), complete response with incomplete hematopoietic recovery (CRi), nodal partial response (nPR), or partial response (PR), before disease progression, death, or the start of new anti-CLL treatment (whichever is earlier), as assessed by IRC.
Rate of Undetectable Minimal Residual Disease at < 10^-5 sensitivity (uMRD5)
Rate of uMRD5 is defined as the percentage of participants who achieved uMRD5 measured in both PB and BMA at the PTFU1 Visit based on NGS, before disease progression, death, or the start of new anti-CLL treatment (whichever is earlier).
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