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

Part of paid clinical trials in Duarte, California.

Sponsor
BeOne Medicines
Study ID
NCT07277231
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sonrotoclax — DRUG
    Administered orally.
  • Zanubrutinib — DRUG
    Administered orally.
  • Acalabrutinib — DRUG
    Administered orally.
  • Venetoclax — DRUG
    Administered orally.

Study Details

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).

Key Dates

First listed
Dec 11, 2025
Start date
Jan 22, 2026
Status verified
Aug 2026
Primary completion
Feb 28, 2031
Completion
Nov 30, 2031

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Progression-Free Survival (PFS) as Determined by Independent Review Committee (IRC) [ Time Frame: Up to approximately 70 months ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010-3012-
Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-3201-
Stanford Cancer InstitutePalo AltoCalifornia94304-2205-
Rocky Mountain Cancer Centers (Williams) UsorAuroraColorado80012-5405-
Mount Sinai Medical Center Braman Comprehensive Cancer CenterMiamiFlorida33140-
Northwestern UniversityChicagoIllinois60611-
Midwestern Regional Medical CenterZionIllinois60099-2676-
Ochsner Clinic FoundationNew OrleansLouisiana70121-2429-
University of Nebraska Medical CenterOmahaNebraska68198-
Upmc Hillman Cancer Center(Univ of Pittsburgh)PittsburghPennsylvania15232-1309-
Texas Oncology TylerTylerTexas75702-7522-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-4433-
Medical College of WisconsinMilwaukeeWisconsin53226-3522-

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By research site
City of Hope National Medical Center· Duarte, CAChao Family Comprehensive Cancer Center· Orange, CAStanford Cancer Institute· Palo Alto, CARocky Mountain Cancer Centers (Williams) Usor· Aurora, COMount Sinai Medical Center Braman Comprehensive Cancer Center· Miami, FLNorthwestern University· Chicago, IL

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