A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeOne Medicines

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Sonrotoclax
  • Zanubrutinib
  • Acalabrutinib
  • Venetoclax

Treatment groups

500 Participants
are divided into 2 treatment groups

Locations

77
Australia
Blacktown Cancer and Haematology CentreNSW 2148, BlacktownNew South Wales, Australia
Concord Repatriation General HospitalNSW 2139, ConcordNew South Wales, Australia
Genesiscare North ShoreNSW 2065, St LeonardsNew South Wales, Australia
Princess Alexandra HospitalQLD 4102, WoolloongabbaQueensland, Australia

Sponsors and collaborators

BeOne Medicines

Lead sponsor