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

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

  • Chronic Lymphocytic Leukemia

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

Stanford Cancer Institute
Palo Alto, California 94304-2205

Fred Hutchinson Cancer Research Center
Seattle, Washington 98109-4433

More Details

Status
Recruiting
Sponsor
BeOne Medicines

Study Contact

Study Director
8778285568
clinicaltrials@beonemed.com