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A Study to Investigate Sonrotoclax Combined With Zanubrutinib Versus Zanubrutinib Alone in Participants With Previously Untreated Chronic Lymphocytic Leukemia

StatusActive, Not Recruiting
PhasePhase 2
Started2024-11-14
View on ClinicalTrials.gov ↗

Amendment history

2026-07-08
Study Status, Contacts/Locations v25
Study sites32 entries, revised
The University of Maryland Greenebaum Comprehensive Cancer Center Uniwersytecki Szpital Kliniczny HematologyIm Jana Mikulicza Radeckiego We Wroclawiu
2026-05-28
Study Status v24
Re-verified, no change to tracked fields
2026-04-21
Study Status, Contacts/Locations v23
Study sites33→32
2026-04-15
Study Status, Contacts/Locations v22
Study sites33 entries, revised
Utah Cancer Specialists Cancer Center
2026-03-18
Study Status, Study Description, Contacts/Locations v21
Study description+210 characters
[...] time to participate in this study is approximately 5 years. 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.
Study sites33 entries, revised
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Show 20 earlier versions
2026-02-20
Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v20
Primary completion date2027-10→2026-11
Completion date2030-06→2029-09
Eligibility criteria+81 characters
[...] erformance Status score of 0,1, or 2. Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI). Adequate marrow function. Adequate liver function as indic [...] and/or viral infection requiring systemic therapy Positive human immunodeficiency virus (HIV) serology (HIVAb) status or serologic status reflecting acti [...]
Secondary endpoints10 to 9 entries
Landmark Duration of Response Event-free Rate at 12 Months
Study sitesdetails revised at 1 of 33 sites
2026-01-21
Study Status, Contacts/Locations v19
Study sites36→33
2026-01-05
Study Status, Contacts/Locations v18
Study sitesdetails revised at 1 of 36 sites
2025-11-20
Study Status, Contacts/Locations v17
Study sites37→36
2025-11-11
Study Status, Contacts/Locations v16
Study sites38→37
2025-10-23
Study Status, Contacts/Locations v15
Study sitesdetails revised at 1 of 38 sites
2025-10-21
Recruiting→Active, Not Recruiting Study Identification, Study Status, Sponsor/Collaborators, Study Description, Study Design, Contacts/Locations, IPDSharing v14
Trial statusRecruiting→Active, Not Recruiting
Enrollment target87→94
Lead sponsorBeiGene→BeOne Medicines
Study descriptionrevised
This study will test how effective and safe sonrotoclaxSonrotoclax plus zanubrutinibZanubrutinib treatment compared with zanubrutinibZanubrutinib alone in participants with previously untreated chronic lym [...] ertain types of blood tumor cells to survive and grow. When sonrotoclaxSonrotoclax blocks Bcl-2 it slows down or stops the growth of tumor cel [...]
Study sitesdetails revised at 38 of 38 sites
2025-08-19
Study Status, Contacts/Locations v13
Study sitesdetails revised at 1 of 38 sites
2025-08-05
Study Status, Contacts/Locations v12
Study sitesdetails revised at 1 of 38 sites
2025-07-11
Study Status, Contacts/Locations v11
Study sitesdetails revised at 1 of 38 sites
2025-06-05
Study Status, Contacts/Locations v10
Study sitesdetails revised at 7 of 38 sites
2025-05-12
Study Status, Contacts/Locations v9
Study sitesdetails revised at 5 of 38 sites
2025-04-30
Study Status, Contacts/Locations v8
Study sitesdetails revised at 4 of 38 sites
2025-04-10
Study Status, Contacts/Locations v7
Study sitesdetails revised at 21 of 38 sites
2025-03-24
Study Status, Contacts/Locations v6
Study sitesdetails revised at 8 of 38 sites
2025-02-17
Study Status, Contacts/Locations, IPDSharing v5
Study sites37→38
2025-01-31
Study Status v4
Re-verified, no change to tracked fields
2025-01-13
Study Status, Contacts/Locations v3
Study sites32→37
2024-12-12
Study Status, Contacts/Locations v2
Study sites27→32
2024-11-27
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-12-01→confirmed 2024-11-14
Study sites0→27
2024-10-09
Original filing
The purpose of this study is to support the registration plan of sonrotoclax plus zanubrutinib treatment in participants with previously untreated chronic lymphocytic leukemia (CLL). This study is designed to assess the contribution of sonrotoclax to the efficacy outcome of the combination of zanubrutinib and sonrotoclax.
Trial Details
NCT Number NCT06637501
Lead Sponsor BeOne Medicines
Conditions Chronic Lymphocytic Leukemia
Enrollment 94 participants
Start Date 2024-11-14
Primary Completion 2026-11 (estimated)
Study Completion 2029-09 (estimated)
Updated on ClinicalTrials.gov 2026-07-09