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)
A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma
3 other identifiers
interventional
300
16 countries
138
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2025
Longer than P75 for phase_3
138 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2024
CompletedFirst Posted
Study publicly available on registry
December 19, 2024
CompletedStudy Start
First participant enrolled
March 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 30, 2032
April 23, 2026
April 1, 2026
3.5 years
December 16, 2024
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC)
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.
Approximately 41 months
Secondary Outcomes (10)
Overall Survival (OS)
Approximately 92 months
PFS as assessed by investigator (INV)
Approximately 58 months
Overall Response Rate (ORR) as assessed by BIRC and by INV
Approximately 58 months
Duration of Response (DOR) as assessed by BIRC and by INV
Approximately 58 months
Complete Response Rate (CRR) as assessed by BIRC and by INV
Approximately 58 months
- +5 more secondary outcomes
Study Arms (2)
Arm A: sonrotoclax plus zanubrutinib
EXPERIMENTALSonrotoclax and zanubrutinib will be administered in combination.
Arm B: placebo plus zanubrutinib
PLACEBO COMPARATORPlacebo and zanubrutinib will be administered in combination.
Interventions
Administered orally
Eligibility Criteria
You may qualify if:
- Histologically locally confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), 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 anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator
- Relapsed or refractory disease after the last line of therapy
- Measurable disease defined as ≥ 1 nodal lesion that is \> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is \> 1 cm in longest diameter
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
- Adequate organ function
You may not qualify if:
- Prior therapy with B-cell lymphoma-2 inhibitor (BCL2i)
- Prior therapy with BTK degraders
- Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi. Participants with refractory disease to BTKi therapy or relapse attributed to failure of BTKi therapy are ineligible.
- Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug
- Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug
- Known central nervous system involvement by lymphoma
- Clinically significant cardiovascular disease
- History of stroke or intracranial hemorrhage within 6 months before first dose of study drug
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeOne Medicineslead
Study Sites (148)
University of Alabama At Birmingham Hospital
Birmingham, Alabama, 35294-0004, United States
Yale University, Yale Cancer Center
New Haven, Connecticut, 06520-8028, United States
Memorial Cancer Institute, Memorial Healthcare System
Pembroke Pines, Florida, 33026-4119, United States
Cleveland Clinic Florida
Weston, Florida, 33331-3609, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804, United States
Mission Cancer and Blood
Waukee, Iowa, 50263, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201-1544, United States
Dana Farber Cancer Institute Longwood Medical Center
Boston, Massachusetts, 02215-5418, United States
University of Michigan
Ann Arbor, Michigan, 48109-1382, United States
The Cancer and Hematology Centers
Grand Rapids, Michigan, 49503-2563, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905-0001, United States
Hattiesburg Hematology and Oncology Clinic
Hattiesburg, Mississippi, 39401-7233, United States
Washington University School of Medicine
St Louis, Missouri, 63110-1010, United States
Nebraska Cancer Specialists St Francis Grand Island
Grand Island, Nebraska, 68803, United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68130-2042, United States
The Valley Hospital, Inc
Paramus, New Jersey, 07652, United States
Atrium Health Levine Cancer Institute (Lci)
Charlotte, North Carolina, 28204-2990, United States
Duke University
Durham, North Carolina, 27710, United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157, United States
University Hospitals
Cleveland, Ohio, 44106-1716, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195-0001, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210-1280, United States
Ohio Health Research Institute
Columbus, Ohio, 43214-3907, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
McGlinn Cancer Institute
West Reading, Pennsylvania, 19611-2143, United States
Tennesse Oncology Chattanooga Downtown
Chattanooga, Tennessee, 37404, United States
Tennessee Oncology
Nashville, Tennessee, 37205, United States
Md Anderson Cancer Center
Houston, Texas, 77030-3907, United States
Texas Oncology Austin Midtown
Round Rock, Texas, 78681-4019, United States
University of Virginia
Charlottesville, Virginia, 22908-0817, United States
Virgina Cancer Specialists
Gainesville, Virginia, 20155-3257, United States
Vcu Massey Cancer Center
Richmond, Virginia, 23298-5026, United States
Northwest Cancer Specialist, Pc(Us Oncology Research)
Vancouver, Washington, 98684-6930, United States
Hospital Aleman
CABA, 1425, Argentina
FUNDALEU
Caba, CP1114, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, 1413, Argentina
Hospital Universitario de Cordoba
Córdoba, X5000HUA, Argentina
Concord Repatriation General Hospital
Concord, New South Wales, NSW 2139, Australia
Genesiscare North Shore
St Leonards, New South Wales, NSW 2065, Australia
Westmead Hospital
Westmead, New South Wales, NSW 2145, Australia
Sunshine Coast Hospital and Health Service
Birtinya, Queensland, QLD 4575, Australia
Box Hill Hospital
Box Hill, Victoria, VIC 3128, Australia
Monash Health
Clayton, Victoria, VIC 3168, Australia
Rockingham Hospital
Cooloongup, Western Australia, WA 6168, Australia
Linear Clinical Research
Nedlands, Western Australia, WA 6009, Australia
One Clinical Research
Nedlands, Western Australia, WA 6009, Australia
Perth Blood Institute
West Perth, Western Australia, WA 6005, Australia
Ordensklinikum Linz Gmbh Elisabethinen
Linz, 4020, Austria
Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg
Salzburg, 5020, Austria
Uk St Poelten
Sankt Pölten, 3100, Austria
Medical University Vienna Oncology
Vienna, 1090, Austria
Fundacao Pio Xii Hospital de Amor de Barretos
Barretos, 14.784-400, Brazil
Hospital Felicio Rocho
Belo Horizonte, 30110-068, Brazil
Universidade de Campinas Centro de Hematologia E Hemoterapia
Campinas, 13083-878, Brazil
Hospital Erasto Gaertner
Curitiba, 81520-060, Brazil
Instituto Joinvilense de Hematologia E Oncologia
Joinville, 89201-260, Brazil
Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude
Petrópolis, 95070-560, Brazil
Hospital de Clinicas de Porto Alegre
Porto AlegreRS, 900350-903, Brazil
Hospital Do Cancer de Pernambuco
Recife, 50040-000, Brazil
Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
São Paulo, 05402-000, Brazil
Hospital Santa Rita de Cassia Afecc
Vitória, 29043-260, Brazil
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 630014, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042, China
Shaanxi Provincial Peoples Hospital
Xi'an, Shaanxi, 710068, China
Linyi Cancer Hospital
Linyi, Shandong, 276001, China
The Affiliated Hospital of Qingdao University Branch West Coast
Qingdao, Shandong, 266555, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, 610071, China
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
Hangzhou, Zhejiang, 310002, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Chu Montpellier Hopital Saint Eloi
Montpellier, 34090, France
Centre Hospitalier Universitaire Nantes Hotel Dieu
Nantes, 44000, France
Chu Hopital Lyon Sud
PierreBenite, 69495, France
Chu Tours Hopital Bretonneau
Tours, 37000, France
Klinikum Chemnitz Ggmbh
Chemnitz, 09116, Germany
Klinikum Der Johann Wolfgang Goethe Universitat
Frankfurt am Main, 60596, Germany
Universitatsklinikum Halle
Halle, 06120, Germany
Universitatsklinikum Hamburg Eppendorf
Hamburg, 20251, Germany
Stauferklinikum Schwabisch Gmund Kliniken Ostalb
Mutlangen, 73557, Germany
Dept of Medicine Iii, University Hospitallmu
München, 81377, Germany
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna, 40138, Italy
Ospedale Vito Fazzi, Asl Lecce
Leece, 73100, Italy
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
Meldola, 47014, Italy
Azienda Sanitaria Universitaria Giuliano Isontina
Trieste, 34129, Italy
Centroricerche Cliniche Di Verona Srl
Verona, 37134, Italy
Aichi Cancer Center Hospital Clinical Oncology
Nagoya, Aichi-ken, 464-8681, Japan
Toyohashi Municipal Hospital
Toyohashishi, Aichi-ken, 441-8570, Japan
Chiba Cancer Center
Chiba, Chiba, 260-8717, Japan
Matsuyama Red Cross Hospital
Matsuyama, Ehime, 790 8524, Japan
Ogaki Municipal Hospital
Ōgaki, Gifu, 503-8502, Japan
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
Hiroshima, Hiroshima, 730-8619, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Kobe City Medical Center General Hospital
KobeShi, Hyōgo, 650-0047, Japan
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, 890-8520, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515, Japan
Tohoku University Hospital
Sendai, Miyagi, 980-8574, Japan
Kurashiki Central Hospital
Kurashikishi, Okayama-ken, 710-8602, Japan
Osaka Red Cross Hospital
Osakashi, Osaka, 543-8555, Japan
Dokkyo Medical University Saitama Medical Center
Koshigaya, Saitama, 503-8502, Japan
Institute of Science Tokyo Hospital
Bunkyoku, Tokyo, 113-8519, Japan
National Hospital Organization Okayama Medical Center
Okayama, 701-1192, Japan
Osaka Metropolitan University Hospital
Osaka, 545-8586, Japan
Yokohama Municipal Citizens Hospital
Yokohama, 221-0855, Japan
North Shore Hospital
Auckland, 0622, New Zealand
Christchurch Hospital
Christchurch, 8011, New Zealand
Dunedin Hospital
Dunedin, 9016, New Zealand
Tauranga Hospital
Tauranga, 3112, New Zealand
Wellington Regional Hospital (Ccdhb)
Wellington, 6021, New Zealand
Pratia McM Krakow
Krakow, 30-727, Poland
Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Lodz, 93-513, Poland
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Lublin, 20-090, Poland
Aidport Sp Z O O
Skorzewo, 60-185, Poland
Dolnoslaskie Centrum Onkologii, Pulmonologii I Hematologii
Wroclaw, 53-439, Poland
Auxilio Mutuo Cancer Center
San Juan, 00917, Puerto Rico
Pusan National University Hospital
Seogu, Busan Gwang'yeogsi, 49241, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, 06351, South Korea
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, 06591, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, 05505, South Korea
The Catholic University of Korea, Yeouido St Marys Hospital
Yeongdeungpo-gu, Seoul Teugbyeolsi, 07345, South Korea
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
Ico H Duran I Reynals
Barcelona, 08907, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
H Puerta de Hierro Majadahonda
Majadahonda, 28222, Spain
Etlik City Hospital
Ankara, 06170, Turkey (Türkiye)
Antalya Memorial Hospital
Dokuma, 07025, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, 41380, Turkey (Türkiye)
The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
Bournemouth, BH7 7DW, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
Oxford University Hospitals Nhs Trust Churchill Hospital
Headington, OX3 7LE, United Kingdom
University College Hospital
London, NW1 2PG, United Kingdom
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
BeOne Medicines
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2024
First Posted
December 19, 2024
Study Start
March 5, 2025
Primary Completion (Estimated)
August 31, 2028
Study Completion (Estimated)
March 30, 2032
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.