Recruiting
Phase 3

Sonrotoclax & Zanubrutinib, Venetoclax & Acalabrutinib

Sponsor:

BeOne Medicines

Code:

NCT07277231

Conditions

Chronic Lymphocytic Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sonrotoclax

Zanubrutinib

Acalabrutinib

Venetoclax

Study Details

Brief 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).

Conditions

Chronic Lymphocytic Leukemia

Study ID

NCT07277231

Start date

Jan 22, 2026

Status verified date

Aug, 2026

Completion date

Nov, 2031

Anticipated

Primary completion date

Feb, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: Sonrotoclax plus Zanubrutinib

Participants will receive sonrotoclax and zanubrutinib for a fixed duration followed by observation.

active comparator: Arm B: Venetoclax plus Acalabrutinib

Participants will receive venetoclax and acalabrutinib for a fixed duration followed by observation.

Interventions

Sonrotoclax

Administered orally.

Zanubrutinib

Administered orally.

Acalabrutinib

Administered orally.

Venetoclax

Administered orally.

Primary outcome measure

  • Progression-Free Survival (PFS) as Determined by Independent Review Committee (IRC) [ Time Frame: Up to approximately 70 months ]
  • Rate of Undetectable Minimal Residual Disease at < 10^-4 sensitivity (uMRD4) [ Time Frame: Up to approximately 16 months ]

Central Contacts and Locations

Central contacts

Study Director

8778285568clinicaltrials@beonemed.com

Locations

City of Hope National Medical Center

Recruiting

Duarte, California, United States, 91010-3012

Chao Family Comprehensive Cancer Center

Recruiting

Orange, California, United States, 92868-3201

Stanford Cancer Institute

Recruiting

Palo Alto, California, United States, 94304-2205

Rocky Mountain Cancer Centers (Williams) Usor

Recruiting

Aurora, Colorado, United States, 80012-5405

Mount Sinai Medical Center Braman Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33140

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Midwestern Regional Medical Center

Recruiting

Zion, Illinois, United States, 60099-2676

Ochsner Clinic Foundation

Recruiting

New Orleans, Louisiana, United States, 70121-2429

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Upmc Hillman Cancer Center(Univ of Pittsburgh)

Recruiting

Pittsburgh, Pennsylvania, United States, 15232-1309

Texas Oncology Tyler

Recruiting

Tyler, Texas, United States, 75702-7522

Fred Hutchinson Cancer Research Center

Recruiting

Seattle, Washington, United States, 98109-4433

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226-3522

Bc Cancer Victoria

Recruiting

Victoria, British Columbia, Canada, V8R 6V5

Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

Ciusss Nim Hscm

Recruiting

Montreal, Quebec, Canada, H4J 1C5

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, QC H3t 1E2

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

Recruiting

Québec, Quebec, Canada, G1J 1Z4

Ciusss de Lestrie Chus

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

More Information

Sponsor

BeOne Medicines

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

  • B-cell Lymphoma-2 Inhibitor
  • Bruton Tyrosine Kinase Inhibitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by BeOne Medicines on 2026-08-19.