A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia
NCT ID: NCT07277231
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
500 participants
INTERVENTIONAL
2026-01-31
2031-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: Sonrotoclax plus Zanubrutinib
Participants will receive sonrotoclax and zanubrutinib for a fixed duration followed by observation.
Sonrotoclax
Administered orally.
Zanubrutinib
Administered orally.
Arm B: Venetoclax plus Acalabrutinib
Participants will receive venetoclax and acalabrutinib for a fixed duration followed by observation.
Acalabrutinib
Administered orally.
Venetoclax
Administered orally.
Interventions
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Sonrotoclax
Administered orally.
Zanubrutinib
Administered orally.
Acalabrutinib
Administered orally.
Venetoclax
Administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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BeOne Medicines
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeOne Medicines
Central Contacts
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Other Identifiers
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2025-524366-21-00
Identifier Type: CTIS
Identifier Source: secondary_id
BGB-11417-304
Identifier Type: -
Identifier Source: org_study_id
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