Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)

NCT06073821 · tracked via the Priya Life Science China tracker

Sponsor

BeOne Medicines

Phase

Phase 3

Started

2023-11-11

Last updated

2026-08-07

Condition(s) studied

CLL

Investigational drug(s) / intervention(s)

Sonrotoclax →Zanubrutinib →Venetoclax →Obinutuzumab →

Sonrotoclax: Administered orally

Zanubrutinib: Administered orally

Venetoclax: Administered orally

Obinutuzumab: Administered intravenously

Study summary

The main objective of this study is to compare the efficacy of sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab in participants with 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 liver function as indicated by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x the institutional upper limits of normal (ULNs) value; serum total bilirubin \< 3.0 x ULN * Adequate renal function as defined as creatinine clearance ≥ 50 milliliters per minute 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 Note: Other protocol defined criteria may apply

Primary outcome measure(s)

Cohort 1: Progression Free Survival (PFS） — Up to approximately 9 years
PFS is defined as the time from the date of enrollment to the date of first confirmed disease progression or death due to any cause, whichever occurs first, as determined by independent review committee (IRC)
Cohort 1: Rate of Undetectable Measurable Residual Disease — Up to one and a half years
Undetectable measurable residual disease uMRD4 rate at the first Post- Treatment Follow-up (PTFU 1) Visit will be based on next-generation sequencing.

Trial sites (201)

Facility	City	Region
Alaska Oncology and Hematology, Llc	Anchorage	Alaska
City of Hope National Medical Center	Duarte	California
University of California San Diego (Ucsd) Moores Cancer Center	La Jolla	California
Valkyrie Clinical Trials	Los Angeles	California
UCLA Department of Medicine Hematologyoncology	Los Angeles	California
Chao Family Comprehensive Cancer Center	Orange	California
Stanford Medicine	Palo Alto	California
University of Colorado Cancer Center	Aurora	Colorado
Medstar Georgetown University Hospital	Washington D.C.	District of Columbia
Mount Sinai Medical Center Braman Comprehensive Cancer Center	Miami	Florida
Moffitt Cancer Center	Tampa	Florida
Southeastern Regional Medical Center	Newnan	Georgia
Northwestern University	Chicago	Illinois
Illinois Cancercare, Pc	Peoria	Illinois
Fort Wayne Medical Oncology and Hematology	Fort Wayne	Indiana
University of Iowa Hospitals and Clinics	Iowa City	Iowa
Mission Cancer and Blood	Waukee	Iowa
The University of Kansas Cancer Center	Westwood	Kansas
Norton Cancer Institute Pavilion	Louisville	Kentucky
Ochsner Clinic Foundation	New Orleans	Louisiana
University of Minnesota	Minneapolis	Minnesota
Washington University School of Medicine	St Louis	Missouri
John Theurer Cancer Center Hackensack University Medical Center	Hackensack	New Jersey
Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
Columbia University Medical Center	New York	New York
Optum Medical Care, Pc	Westbury	New York
University of North Carolina At Chapel Hill	Chapel Hill	North Carolina
Atrium Health Levine Cancer Institute (Lci)	Charlotte	North Carolina
Duke University Medical Center	Durham	North Carolina
Cleveland Clinic Foundation	Cleveland	Ohio
The James Cancer Hospital and Solove Research Institute At Ohio State University	Columbus	Ohio
Oncology Associates of Oregon Willamette Valley Cancer Center	Eugene	Oregon
Fox Chase Cancer Center	Philadelphia	Pennsylvania
Scri Tennessee Oncology Chattanooga	Chattanooga	Tennessee
Huntsman Cancer Institute	Salt Lake City	Utah
Virginia Cancer Institute	Richmond	Virginia
Vcu Health System Massey Comprehensive Cancer Center	Richmond	Virginia
Fred Hutchinson Cancer Research Center	Seattle	Washington
Gunderson Health System	La Crosse	Wisconsin
Medical College of Wisconsin	Milwaukee	Wisconsin

+ 161 more sites — see the full list on the official registry below.

On this site

📄 Brukinsa (zanubrutinib) drug profile → 📄 Venclexta (venetoclax) drug profile →

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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 NCT06073821 on ClinicalTrials.gov ↗ ← All trials in China