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

StatusRecruiting
PhasePhase 3
Started2026-01-22
View on ClinicalTrials.gov ↗

Amendment history

2026-09-09
minor
Study Status, Contacts/Locations v14
Trial sites expanded: 105 → 114 locations
2026-08-18
minor
Study Status, Contacts/Locations v13
Trial sites expanded: 96 → 105 locations
2026-08-05
minor
Study Status, Contacts/Locations v12
Trial sites expanded: 91 → 96 locations
2026-07-22
minor
Study Status, Contacts/Locations v11
Trial sites expanded: 88 → 91 locations
2026-07-09
minor
Study Status, Contacts/Locations v10
Trial sites expanded: 77 → 88 locations
2026-06-17
minor
Study Status, Contacts/Locations v9
Trial sites expanded: 66 → 77 locations
2026-06-01
minor
Study Status, Contacts/Locations v8
Trial sites expanded: 46 → 66 locations
2026-05-26
minor
Study Status, Contacts/Locations v7
Trial sites expanded: 29 → 46 locations
2026-05-08
minor
Study Status, Contacts/Locations v6
Trial sites expanded: 24 → 29 locations
2026-04-20
minor
Study Status, Contacts/Locations v5
Trial sites expanded: 20 → 24 locations
2026-04-14
minor
Study Status, Contacts/Locations v4
Trial sites expanded: 14 → 20 locations
2026-03-17
minor
Study Status, Contacts/Locations v3
Study sites9→14
2026-03-04
minor
Study Status, Contacts/Locations v2
Study sites8→9
2026-02-20
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2026-01-31→confirmed 2026-01-22
Study sites0→8
2025-12-02
minor
Original filing
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).
Trial Details
NCT Number NCT07277231
Lead Sponsor BeOne Medicines
Conditions Chronic Lymphocytic Leukemia
Enrollment 500 participants
Start Date 2026-01-22
Primary Completion 2031-02 (estimated)
Study Completion 2031-11 (estimated)
Updated on ClinicalTrials.gov 2026-09-28