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

NCT07277231 · tracked via the Priya Life Science UK tracker

Sponsor

BeOne Medicines

Phase

Phase 3

Started

2026-01-22

Last updated

2026-09-11

Condition(s) studied

Chronic Lymphocytic Leukemia

Investigational drug(s) / intervention(s)

SonrotoclaxZanubrutinibAcalabrutinibVenetoclax

Sonrotoclax: Administered orally.

Zanubrutinib: Administered orally.

Acalabrutinib: Administered orally.

Venetoclax: Administered orally.

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 bone marrow and organ function 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 or clinically significant cardiovascular disease Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

Progression-Free Survival (PFS) as Determined by Independent Review Committee (IRC) — Up to approximately 70 months
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) — Up to approximately 16 months
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).

Trial sites (114)

Facility	City	Region	Status
City of Hope National Medical Center	Duarte	California	Recruiting
Chao Family Comprehensive Cancer Center	Orange	California	Recruiting
Stanford Cancer Institute	Palo Alto	California	Recruiting
Rocky Mountain Cancer Centers (Williams) Usor	Aurora	Colorado	Recruiting
Mayo Clinic Jacksonville	Jacksonville	Florida	Recruiting
Mount Sinai Medical Center Braman Comprehensive Cancer Center	Miami	Florida	Recruiting
Moffitt Cancer Center	Tampa	Florida	Recruiting
Northwestern University	Chicago	Illinois	Recruiting
Midwestern Regional Medical Center	Zion	Illinois	Recruiting
Ochsner Clinic Foundation	New Orleans	Louisiana	Recruiting
Dana Farber Cancer Institute	Boston	Massachusetts	Recruiting
Mayo Clinic Rochester	Rochester	Minnesota	Recruiting
University of Nebraska Medical Center	Omaha	Nebraska	Recruiting
Columbia University Medical Center	New York	New York	Recruiting
Atrium Health Levine Cancer Institute (Lci)	Charlotte	North Carolina	Recruiting
Oncology Associates of Oregon Willamette Valley Cancer Center	Eugene	Oregon	Recruiting
Upmc Hillman Cancer Center(Univ of Pittsburgh)	Pittsburgh	Pennsylvania	Recruiting
Texas Oncology Tyler	Tyler	Texas	Recruiting
Huntsman Cancer Institute	Salt Lake City	Utah	Recruiting
Fred Hutchinson Cancer Research Center	Seattle	Washington	Recruiting
Medical College of Wisconsin	Milwaukee	Wisconsin	Recruiting
Blacktown Cancer and Haematology Centre	Blacktown	New South Wales	Recruiting
Concord Repatriation General Hospital	Concord	New South Wales	Recruiting
Genesiscare North Shore	St Leonards	New South Wales	Recruiting
Princess Alexandra Hospital	Woolloongabba	Queensland	Recruiting
Monash Health	Clayton	Victoria	Recruiting
Austin Health	Heidelberg	Victoria	Recruiting
Cabrini Hospital Malvern	Malvern	Victoria	Recruiting
The Alfred Hospital	Melbourne	Victoria	Recruiting
Instituto Dor de Pesquisa E Ensino Distrito Federal	Brasília	Brazil	Recruiting
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus	Porto Alegre	Brazil	Recruiting
Ensino E Terapia de Inovacao Clinica Amo Etica	Salvador	Brazil	Recruiting
Instituto Dor de Pesquisa E Ensino Sao Paulo	São Paulo	Brazil	Recruiting
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein	São Paulo	Brazil	Recruiting
Bc Cancer Victoria	Victoria	British Columbia	Recruiting
Juravinski Cancer Centre	Hamilton	Ontario	Recruiting
Ciusss Nim Hscm	Montreal	Quebec	Recruiting
Jewish General Hospital	Montreal	Quebec	Recruiting
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)	Québec	Quebec	Recruiting
Ciusss de Lestrie Chus	Sherbrooke	Quebec	Recruiting

+ 74 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07277231 on ClinicalTrials.gov ↗ ← All trials in the UK