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

a study on Chronic Lymphocytic Leukemia Leukemia

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
study ends around
Principal Investigator
by Catherine Coombs (uci)

Description

Summary

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).

Official Title

A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Patients With Previously Untreated Chronic Lymphocytic Leukemia

Keywords

Chronic Lymphocytic Leukemia, B-cell Lymphoma-2 Inhibitor, Bruton Tyrosine Kinase Inhibitor, Leukemia, Lymphocytic, Chronic, B-Cell, zanubrutinib, acalabrutinib, venetoclax, Sonrotoclax, Sonrotoclax plus Zanubrutinib, Venetoclax plus Acalabrutinib

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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 or clinically significant cardiovascular disease

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations

  • Chao Family Comprehensive Cancer Center accepting new patients
    Orange California 92868-3201 United States
  • Stanford Cancer Institute accepting new patients
    Palo Alto California 94304-2205 United States
  • City of Hope National Medical Center accepting new patients
    Duarte California 91010-3012 United States

Lead Scientist at University of California Health

  • Catherine Coombs (uci)
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 89 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
BeOne Medicines
ID
NCT07277231
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 500 study participants
Last Updated
Contact us about this trial