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Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Participants With Chronic Lymphocytic Leukemia (CLL)

StatusActive, Not Recruiting
PhasePhase 3
Started2023-11-11
View on ClinicalTrials.gov ↗

Amendment history

2026-08-06
Study Status, Contacts/Locations v41
Study sitesdetails revised at 1 of 201 sites
2026-07-21
Study Status, Contacts/Locations v40
Study sites201 entries, revised
OPTUMOptum Medical Care, Pc
2026-07-08
Study Status, Contacts/Locations v39
Study sitesdetails revised at 1 of 201 sites
2026-07-01
Study Status, Contacts/Locations v38
Study sites201 entries, revised
Clinical Research Alliance, IncOPTUM Nanfang Hospital of, Southern Medical University
2026-05-28
Study Status, Outcome Measures, Contacts/Locations v37
Secondary endpoints16 entries, reordered
Study sites201 entries, revised
Mount Sinai Medical Center Braman Comprehensive Cancer Center Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Show 36 earlier versions
2026-05-08
Study Status, Contacts/Locations v36
Study sites201 entries, revised
Vcu Health SystemmasseySystem Massey Comprehensive Cancer Center
2026-04-21
Study Status, Contacts/Locations v35
Study sitesdetails revised at 1 of 201 sites
2026-04-15
Study Status, Contacts/Locations v34
Study sites201 entries, revised
Instytut Hematologii I Transfuzjologii W Warszawie
2026-03-18
Study Status, Study Description, Contacts/Locations v33
Study sites202→201
Study description+210 characters
[...] e allocated to receive either of the treatment combinations. Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
2026-03-03
Study Status v32
Re-verified, no change to tracked fields
2026-02-19
Study Status, Contacts/Locations v31
Study sites202 entries, revised
Churchill Hospital Oxford University HospitalHospitals Nhs Trust Churchill Hospital
2026-01-21
Study Status, Contacts/Locations v30
Study sites203→202
2026-01-05
Study Status, Contacts/Locations v29
Study sites203 entries, revised
HealthChristchurch New Zealand CanterburyHospital
2025-12-15
Study Status, Contacts/Locations v28
Study sites203 entries, revised
MaasstadChu HospitalHopital Lyon Sud
2025-11-20
Study Status, Contacts/Locations v27
Study sitesdetails revised at 1 of 203 sites
2025-11-11
Recruiting→Active, Not Recruiting Study Status, Sponsor/Collaborators, Contacts/Locations, IPDSharing v26
Trial statusRecruiting→Active, Not Recruiting
Study sites205→203
Lead sponsorBeiGene→BeOne Medicines
2025-10-23
Study Identification, Study Status, Contacts/Locations v25
Study sites205 entries, revised
Uniwersytecki Szpital Kliniczny W Poznaniu
2025-09-23
Study Status, Contacts/Locations v24
Study sites207→205
2025-08-19
Study Status, Contacts/Locations v23
Study sitesdetails revised at 13 of 207 sites
2025-08-05
Study Status, Contacts/Locations v22
Study sites209→207
2025-06-20
Study Status, Contacts/Locations v21
Study sites211→209
2025-06-05
Study Status, Contacts/Locations v20
Study sites210→211
2025-05-13
Study Status, Study Description, Study Design, Outcome Measures, Contacts/Locations, IPDSharing v19
Enrollment target640→652
Study sites212→210
Secondary endpoints12 to 16 entries
Cohort 1: Complete Response Rate (CRR ) by IRC Cohort 1: Overall Survival (OS) RatesCohort 1: PFS by Investigator Assessment Cohort 1: CRR by Investigator Assessment Cohort 1: Rate of Undetectable Measurable Residual Disease OverallCohort Survival1: (OS) PFS by Investigator Assessment CRR by Investigator Assessment Rates of uMRD4 Based on Flow-Cytometry Overall Response Rate (ORR) Determined by IRC and Investigator Assessment Cohort 1: Duration of Response (DOR) by IRC and Investigator Assessment Pooled Cohorts: PFS by IRC and Investigator Assessment Pooled Cohorts: ORR by IRC and Investigator [...] [...]
Primary endpoints1 to 2 entries
Cohort 1: Progression Free Survival (PFS)） Cohort 1: Rate of Undetectable Measurable Residual Disease
Study description-13 characters
[...] eople. There is an urgent need for new treatment to prolong participant life and control disease-related symptoms. In this study, participants with CLL, without prior treatment will receive either venetoclax plus [...] out the CLL getting worse between participants who received sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab versus sonrotoclax plus zanubrutinib. Approximately 640652 participants will be included in this study around the worl [...]
2025-03-31
Study Status, Contacts/Locations v18
Study sites217→212
2025-03-18
Study Status, Contacts/Locations v17
Study sites214→217
2025-02-18
Study Status, Contacts/Locations v16
Study sites218→214
2025-01-30
Study Status, Contacts/Locations v15
Study sites218 entries, revised
KanagawaWestmead Cancer CenterHospital
2025-01-10
Study Status, Contacts/Locations v14
Study sites231→218
2024-12-12
Study Identification, Study Status, Contacts/Locations v13
Study sites110→231
2024-10-23
Study Status, Contacts/Locations v12
Study sites194→110
2024-10-16
Study Status, Contacts/Locations v11
Study sites176→194
2024-09-27
Study Status, Contacts/Locations v10
Study sites141→176
2024-08-16
Study Status, Contacts/Locations v9
Study sites117→141
2024-07-30
Study Status, Contacts/Locations v8
Study sites103→117
2024-07-22
Study Status, Contacts/Locations v7
Study sites82→103
2024-06-05
Study Status, Contacts/Locations v6
Study sites47→82
2024-05-29
Study Status, Contacts/Locations v5
Study sites39→47
2024-04-24
Study Status, Contacts/Locations v4
Study sites18→39
2024-02-02
Study Status, Contacts/Locations v3
Study sites15→18
2024-01-17
Study Status, Contacts/Locations v2
Study sites11→15
2024-01-08
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2023-12-01→confirmed 2023-11-11
Study sites0→11
2023-10-03
Original filing
The main objective of this study is to compare the efficacy of sonrotoclax plus zanubrutinib versus venetoclax plus obinutuzumab in participants with chronic lymphocytic leukemia (CLL)
Trial Details
NCT Number NCT06073821
Lead Sponsor BeOne Medicines
Conditions CLL
Enrollment 652 participants
Start Date 2023-11-11
Primary Completion 2032-02 (estimated)
Study Completion 2032-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-28