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

RECRUITINGPHASE3

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 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

NCT07277231•BeOne Medicines

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

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

Locations (14)

Genesiscare North Shore

St Leonards, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Cabrini Hospital Malvern

Malvern East, Victoria, Australia

The Alfred Hospital

Melbourne, Victoria, Australia

Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

Porto Alegre, Brazil

Ciusss Nim Hscm

Montreal, Quebec, Canada

Ciusss de Lestrie Chus

Sherbrooke, Quebec, Canada

Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)

Québec, Canada

North Shore Hospital

Auckland, New Zealand

Auckland City Hospital

Auckland, New Zealand

Key Dates

Start Date

January 22, 2026

Primary Completion Date

February 1, 2031

Completion Date

November 1, 2031

Last Updated

March 18, 2026

Enrollment

500

ESTIMATED participants

Conditions

Chronic Lymphocytic Leukemia

Interventions

Sonrotoclax

DRUG

Zanubrutinib

DRUG

Acalabrutinib

DRUG

Venetoclax

DRUG

Contacts

Study Director

CONTACT

8778285568 clinicaltrials@beonemed.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

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