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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm A: Sonrotoclax plus Zanubrutinib 		Participants will receive sonrotoclax and zanubrutinib for a fixed duration followed by observation.
  • Drug: Sonrotoclax
    Administered orally.
    Other names:
    • BGB-11417
  • Drug: Zanubrutinib
    Administered orally.
    Other names:
    • BGB-3111
    • Brukinsa
Active Comparator
Arm B: Venetoclax plus Acalabrutinib 		Participants will receive venetoclax and acalabrutinib for a fixed duration followed by observation.
  • Drug: Acalabrutinib
    Administered orally.
    Other names:
    • Calquence
  • Drug: Venetoclax
    Administered orally.
    Other names:
    • Venclexta
    • Venclyxto

Recruiting Locations

City of Hope National Medical Center
Duarte, California 91010-3012

Chao Family Comprehensive Cancer Center
Orange, California 92868-3201

Stanford Cancer Institute
Palo Alto, California 94304-2205

Rocky Mountain Cancer Centers (Williams) Usor
Aurora, Colorado 80012-5405

Mount Sinai Medical Center Braman Comprehensive Cancer Center
Miami, Florida 33140

Northwestern University
Chicago, Illinois 60611

Midwestern Regional Medical Center
Zion, Illinois 60099-2676

Ochsner Clinic Foundation
New Orleans, Louisiana 70121-2429

University of Nebraska Medical Center
Omaha, Nebraska 68198

Upmc Hillman Cancer Center(Univ of Pittsburgh)
Pittsburgh, Pennsylvania 15232-1309

Texas Oncology Tyler
Tyler, Texas 75702-7522

Fred Hutchinson Cancer Research Center
Seattle, Washington 98109-4433

Medical College of Wisconsin
Milwaukee, Wisconsin 53226-3522

More Details

Status
Recruiting
Sponsor
BeOne Medicines

Study Contact

Study Director
8778285568
clinicaltrials@beonemed.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.