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A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)

StatusRecruiting
PhasePhase 3
Started2025-03-05
View on ClinicalTrials.gov ↗

Amendment history

2026-09-10
Study Status, Contacts/Locations v32
Trial sites reduced: 155 → 150 locations
Study sites155 entries, revised
BeijingDiakonie HospitalKlinikum Jung Stilling Krankenhaus
2026-08-17
Study Status, Contacts/Locations v31
Study sitesdetails revised at 2 of 155 sites
2026-07-21
Study Status, Contacts/Locations v30
Study sitesdetails revised at 28 of 155 sites
2026-07-10
Study Status, Contacts/Locations v29
Trial sites expanded: 152 → 155 locations
2026-06-18
Study Status, Contacts/Locations v28
Study sites152 entries, revised
Fujian Medical University Unionof HospitalWisconsin
Show 27 earlier versions
2026-06-01
Study Status, Contacts/Locations v27
Study sites151→152
2026-05-21
Study Status, Contacts/Locations v26
Study sites149→151
2026-05-07
Study Status, Contacts/Locations v25
Study sites148→149
2026-04-21
Study Status, Contacts/Locations v24
Study sites149→148
2026-03-17
Study Status, Contacts/Locations v23
Study sites149 entries, revised
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
2026-02-19
Study Status, Contacts/Locations v22
Study sites149 entries, revised
Churchill Hospital Oxford University HospitalHospitals Nhs Trust Churchill Hospital
2026-02-05
Study Status, Contacts/Locations v21
Study sites148→149
2026-01-22
Study Status, Contacts/Locations v20
Study sitesdetails revised at 1 of 148 sites
2025-12-18
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v19
Primary completion date2029-03-31→2028-08-31
Completion date2032-10-30→2032-03-30
Study sites141→148
Lead sponsorBeiGene→BeOne Medicines
Eligibility criteria+274 characters
Inclusion Criteria: Histologically locally confirmed diagnosis of MCL based on the World Health Organi [...] ), or based on International Consensus Classification (ICC) Ability to provide archival or fresh tumor tissue for retrospective central confirmation of MCL diagnosis Received 1 to 5 prior lines of systemic therapy including an [...] ion Criteria: Prior therapy with B-cell lymphoma-2 inhibitor (BCL2i) Prior therapy with BTK degraders Prior therapy with covalent or non-covalent Bruton tyrosine [...] intolerant of non-zanubrutinib covalent or non-covalent BTKi. Participants with refractory disease to BTKi ther [...] [...]
Secondary endpointsdetails revised at 9 of 10 entries
Study description+209 characters
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 title+18 characters
[...] inib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)
2025-11-18
Study Status, Contacts/Locations v18
Study sites138→141
2025-11-06
Study Status, Contacts/Locations v17
Study sites133→138
2025-10-22
Study Identification, Study Status, Contacts/Locations v16
Study sites148→133
2025-09-19
Study Status, Contacts/Locations v15
Study sites148 entries, revised
Tennesse Oncology Chattanooga Downtown LowerDolnoslaskie SilesianCentrum Center of OncologyOnkologii, PulmonologyPulmonologii andI HematologyHematologii
2025-09-11
Study Status, Contacts/Locations v14
Study sitesdetails revised at 6 of 148 sites
2025-08-28
Study Status, Oversight, Contacts/Locations v13
Study sitesdetails revised at 21 of 148 sites
2025-08-13
Study Status, Oversight, Contacts/Locations v12
Study sitesdetails revised at 8 of 148 sites
2025-07-22
Study Status, Contacts/Locations v11
Study sites148 entries, revised
The Catholic University of Korea, Seoul SaintSt Marys Hospital (Pharmacy)
2025-07-15
Study Status, Contacts/Locations v10
Study sites148 entries, revised
Klinikum Der Johann Wolfgang Goethe Universitat Medizinische Klinik I
2025-06-20
Study Status, Contacts/Locations v9
Study sites148 entries, revised
TrTennesse TrakyaOncology University Health Research and Application Center (Hospital)Chattanooga
2025-06-04
Study Status, Contacts/Locations v8
Study sitesdetails revised at 5 of 148 sites
2025-06-03
Study Status, Contacts/Locations v7
Start date2025-02-25→2025-03-05
Study sites146→148
2025-05-07
Study Status, Contacts/Locations v6
Study sites146 entries, revised
AziendaCentroricerche Ospedaliera Universitaria IntegrataCliniche Di Verona Srl
2025-04-30
Study Status, Contacts/Locations v5
Study sites145→146
2025-04-17
Study Status, Contacts/Locations v4
Study sites140→145
2025-03-20
Study Status, Contacts/Locations v3
Study sites138→140
2025-03-07
Study Status, Contacts/Locations v2
Study sites1→138
2025-02-27
Not Yet Recruiting→Recruiting Study Identification, Study Status, Contacts/Locations, IPDSharing v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-01-28→confirmed 2025-02-25
Study sites0→1
2024-12-16
Original filing
The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed/refractory (R/R) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.
Trial Details
NCT Number NCT06742996
Lead Sponsor BeOne Medicines
Conditions Mantle Cell Lymphoma, B Cell Lymphoma
Enrollment 300 participants
Start Date 2025-03-05
Primary Completion 2028-08-31 (estimated)
Study Completion 2032-03-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-28