Actively Recruiting
A Phase 3 Randomized Double-Blind Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma
Led by BeOne Medicines · Updated on 2026-06-03
300
Participants Needed
152
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of combining sonrotoclax with zanubrutinib compared to zanubrutinib with placebo in adults who have relapsed or refractory mantle cell lymphoma (MCL). This phase 3 randomized, double-blind study aims to determine if sonrotoclax plus zanubrutinib can improve outcomes for patients who have received prior treatments including anti-CD20 monoclonal antibodies or chemoimmunotherapy. The trial is sponsored by BeOne Medicines and includes patients with measurable disease and adequate organ function. Participants are randomly assigned to one of two groups: one receives sonrotoclax plus zanubrutinib taken orally, and the other receives a placebo plus zanubrutinib, also taken orally. Treatment continues under blinded conditions to compare the effects of the study drug combination versus placebo. The study includes multiple outcome measures such as progression-free survival, overall survival, response rates, and quality of life assessments over periods ranging from about 41 to 92 months. During the trial, participants will undergo regular assessments including tumor evaluations, laboratory tests, and quality of life questionnaires using specific tools like the EORTC-QLQ-NHL-HG29 and EORTC-QLQ-C30. Safety is closely monitored from the first dose until 30 days after the last dose. The study spans several years, allowing researchers to track long-term outcomes and treatment-emergent side effects while participants continue follow-up visits according to the study schedule.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of mantle cell lymphoma based on WHO 2022 or International Consensus Classification
- Ability to provide archival or fresh tumor tissue for confirmation of diagnosis
- Received 1 to 5 prior systemic therapy lines including anti-CD20 monoclonal antibody or chemoimmunotherapy
- Relapsed or refractory disease after last therapy
- Measurable disease with at least one nodal lesion > 1.5 cm or extranodal lesion > 1 cm
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate organ function
You will not qualify if you...
- Prior therapy with B-cell lymphoma-2 inhibitor (BCL2i)
- Prior therapy with BTK degraders
- Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitors unless intolerant to non-zanubrutinib BTKi
- Prior autologous stem cell transplant or CAR T-cell therapy within 3 months before study drug
- Prior allogeneic stem cell transplant within 6 months before study drug
- Known central nervous system involvement by lymphoma
- Clinically significant cardiovascular disease
- History of stroke or intracranial hemorrhage within 6 months before study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to approximately 58 months
Participants receive Sonrotoclax plus Zanubrutinib or Placebo plus Zanubrutinib to treat relapsed or refractory mantle cell lymphoma.
Trial Site Locations
Total: 152 locations
1
University of Alabama At Birmingham Hospital
Birmingham, Alabama, United States, 35294-0004
Actively Recruiting
2
University of Arizona Cancer Center
Tucson, Arizona, United States, 85724-0001
Actively Recruiting
3
Ucsf Fresno
Fresno, California, United States, 93701
Actively Recruiting
4
Kaiser Permanente Southern California
Irvine, California, United States, 92618-3734
Actively Recruiting
5
Yale University Yale Cancer Center
New Haven, Connecticut, United States, 06520-8028
Actively Recruiting
6
Memorial Cancer Institute, Memorial Healthcare System
Pembroke Pines, Florida, United States, 33026-4119
Actively Recruiting
7
Cleveland Clinic Florida
Weston, Florida, United States, 33331-3609
Actively Recruiting
8
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
9
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46804
Actively Recruiting
10
Mission Cancer and Blood
Waukee, Iowa, United States, 50263
Actively Recruiting
11
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201-1544
Actively Recruiting
12
Dana Farber Cancer Institute Longwood Medical Center
Boston, Massachusetts, United States, 02215-5418
Actively Recruiting
13
University of Michigan
Ann Arbor, Michigan, United States, 48109-1382
Actively Recruiting
14
The Cancer and Hematology Centers
Grand Rapids, Michigan, United States, 49503-2563
Actively Recruiting
15
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905-0001
Actively Recruiting
16
Hattiesburg Hematology and Oncology Clinic
Hattiesburg, Mississippi, United States, 39401-7233
Actively Recruiting
17
Washington University School of Medicine
St Louis, Missouri, United States, 63110-1010
Actively Recruiting
18
Nebraska Cancer Specialists St Francis Grand Island
Grand Island, Nebraska, United States, 68803
Actively Recruiting
19
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68130-2042
Actively Recruiting
20
The Valley Hospital, Inc
Paramus, New Jersey, United States, 07652
Actively Recruiting
21
Atrium Health Levine Cancer Institute (Lci)
Charlotte, North Carolina, United States, 28204-2990
Actively Recruiting
22
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
23
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
24
University Hospitals
Cleveland, Ohio, United States, 44106-1716
Actively Recruiting
25
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195-0001
Actively Recruiting
26
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210-1280
Actively Recruiting
27
Ohio Health Research Institute
Columbus, Ohio, United States, 43214-3907
Actively Recruiting
28
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
29
McGlinn Cancer Institute
West Reading, Pennsylvania, United States, 19611-2143
Actively Recruiting
30
Tennessee Oncology Nashville St Thomas Midtown Clinic
Nashville, Tennessee, United States, 37205
Actively Recruiting
31
Tennessee Oncology
Nashville, Tennessee, United States, 37205
Actively Recruiting
32
Md Anderson Cancer Center
Houston, Texas, United States, 77030-3907
Actively Recruiting
33
Texas Oncology Austin Midtown
Round Rock, Texas, United States, 78681-4019
Actively Recruiting
34
University of Virginia
Charlottesville, Virginia, United States, 22908-0817
Actively Recruiting
35
Virgina Cancer Specialists
Gainesville, Virginia, United States, 20155-3257
Actively Recruiting
36
Vcu Massey Cancer Center
Richmond, Virginia, United States, 23298-5026
Actively Recruiting
37
Northwest Cancer Specialist, Pc(Us Oncology Research)
Vancouver, Washington, United States, 98684-6930
Actively Recruiting
38
Hospital Aleman
CABA, Argentina, 1425
Actively Recruiting
39
FUNDALEU
Caba, Argentina, CP1114
Actively Recruiting
40
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, Argentina, 1413
Actively Recruiting
41
Hospital Universitario de Cordoba
Córdoba, Argentina, X5000HUA
Actively Recruiting
42
Concord Repatriation General Hospital
Concord, New South Wales, Australia, NSW 2139
Actively Recruiting
43
Genesiscare North Shore
St Leonards, New South Wales, Australia, NSW 2065
Actively Recruiting
44
Westmead Hospital
Westmead, New South Wales, Australia, NSW 2145
Actively Recruiting
45
Sunshine Coast Hospital and Health Service
Birtinya, Queensland, Australia, QLD 4575
Actively Recruiting
46
Box Hill Hospital
Box Hill, Victoria, Australia, VIC 3128
Actively Recruiting
47
Monash Health
Clayton, Victoria, Australia, VIC 3168
Actively Recruiting
48
Rockingham Hospital
Cooloongup, Western Australia, Australia, WA 6168
Actively Recruiting
49
Linear Clinical Research
Nedlands, Western Australia, Australia, WA 6009
Actively Recruiting
50
One Clinical Research
Nedlands, Western Australia, Australia, WA 6009
Actively Recruiting
51
Perth Blood Institute
West Perth, Western Australia, Australia, WA 6005
Actively Recruiting
52
Ordensklinikum Linz Gmbh Elisabethinen
Linz, Austria, 4020
Actively Recruiting
53
Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg
Salzburg, Austria, 5020
Actively Recruiting
54
Uk St Poelten
Sankt Pölten, Austria, 3100
Active, Not Recruiting
55
Medical University Vienna Oncology
Vienna, Austria, 1090
Actively Recruiting
56
Fundacao Pio Xii Hospital de Amor de Barretos
Barretos, Brazil, 14.784-400
Actively Recruiting
57
Hospital Felicio Rocho
Belo Horizonte, Brazil, 30110-068
Actively Recruiting
58
Universidade de Campinas Centro de Hematologia E Hemoterapia
Campinas, Brazil, 13083-878
Actively Recruiting
59
Hospital Erasto Gaertner
Curitiba, Brazil, 81520-060
Actively Recruiting
60
Instituto Joinvilense de Hematologia E Oncologia
Joinville, Brazil, 89201-260
Actively Recruiting
61
Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude
Petrópolis, Brazil, 95070-560
Actively Recruiting
62
Hospital de Clinicas de Porto Alegre
Porto AlegreRS, Brazil, 900350-903
Actively Recruiting
63
Hospital Do Cancer de Pernambuco
Recife, Brazil, 50040-000
Actively Recruiting
64
Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
São Paulo, Brazil, 05402-000
Actively Recruiting
65
Hospital Santa Rita de Cassia Afecc
Vitória, Brazil, 29043-260
Actively Recruiting
66
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
67
Beijing Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
68
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 630014
Actively Recruiting
69
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
Actively Recruiting
70
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
71
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
Actively Recruiting
72
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150000
Actively Recruiting
73
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Actively Recruiting
74
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Actively Recruiting
75
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430030
Actively Recruiting
76
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
77
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221000
Actively Recruiting
78
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China, 330029
Actively Recruiting
79
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China, 110042
Actively Recruiting
80
Shaanxi Provincial Peoples Hospital
Xi'an, Shaanxi, China, 710068
Actively Recruiting
81
Linyi Cancer Hospital
Linyi, Shandong, China, 276001
Actively Recruiting
82
The Affiliated Hospital of Qingdao University Branch West Coast
Qingdao, Shandong, China, 266555
Actively Recruiting
83
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
84
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, China, 610071
Actively Recruiting
85
The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
Hangzhou, Zhejiang, China, 310002
Actively Recruiting
86
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
87
Chu Montpellier Hopital Saint Eloi
Montpellier, France, 34090
Actively Recruiting
88
Centre Hospitalier Universitaire Nantes Hotel Dieu
Nantes, France, 44000
Active, Not Recruiting
89
Chu Hopital Lyon Sud
PierreBenite, France, 69495
Active, Not Recruiting
90
Chu Tours Hopital Bretonneau
Tours, France, 37000
Actively Recruiting
91
Klinikum Chemnitz Ggmbh
Chemnitz, Germany, 09116
Actively Recruiting
92
Universitatsklinikum Frankfurt
Frankfurt am Main, Germany, 60596
Actively Recruiting
93
Universitatsklinikum Halle
Halle, Germany, 06120
Actively Recruiting
94
Universitatsklinikum Hamburg Eppendorf
Hamburg, Germany, 20251
Actively Recruiting
95
Stauferklinikum Schwabisch Gmund Kliniken Ostalb
Mutlangen, Germany, 73557
Actively Recruiting
96
Dept of Medicine Iii, University Hospitallmu
München, Germany, 81377
Actively Recruiting
97
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna, Italy, 40138
Actively Recruiting
98
Ospedale Vito Fazzi, Asl Lecce
Leece, Italy, 73100
Actively Recruiting
99
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
Meldola, Italy, 47014
Actively Recruiting
100
Azienda Sanitaria Universitaria Giuliano Isontina
Trieste, Italy, 34129
Actively Recruiting
101
Centroricerche Cliniche Di Verona Srl
Verona, Italy, 37134
Actively Recruiting
102
Aichi Cancer Center Hospital Clinical Oncology
Nagoya, Aichi-ken, Japan, 464-8681
Actively Recruiting
103
Toyohashi Municipal Hospital
Toyohashishi, Aichi-ken, Japan, 441-8570
Actively Recruiting
104
Chiba Cancer Center
Chiba, Chiba, Japan, 260-8717
Actively Recruiting
105
Matsuyama Red Cross Hospital
Matsuyama, Ehime, Japan, 790 8524
Actively Recruiting
106
Ogaki Municipal Hospital
Ōgaki, Gifu, Japan, 503-8502
Actively Recruiting
107
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
Hiroshima, Hiroshima, Japan, 730-8619
Actively Recruiting
108
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
Actively Recruiting
109
Kobe City Medical Center General Hospital
KobeShi, Hyōgo, Japan, 650-0047
Actively Recruiting
110
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, Japan, 890-8520
Actively Recruiting
111
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan, 241-8515
Actively Recruiting
112
Tohoku University Hospital
Sendai, Miyagi, Japan, 980-8574
Actively Recruiting
113
Kurashiki Central Hospital
Kurashikishi, Okayama-ken, Japan, 710-8602
Actively Recruiting
114
Osaka Red Cross Hospital
Osakashi, Osaka, Japan, 543-8555
Actively Recruiting
115
Dokkyo Medical University Saitama Medical Center
Koshigaya, Saitama, Japan, 503-8502
Actively Recruiting
116
Institute of Science Tokyo Hospital
Bunkyoku, Tokyo, Japan, 113-8519
Actively Recruiting
117
National Hospital Organization Okayama Medical Center
Okayama, Japan, 701-1192
Actively Recruiting
118
Osaka Metropolitan University Hospital
Osaka, Japan, 545-8586
Actively Recruiting
119
Yokohama Municipal Citizens Hospital
Yokohama, Japan, 221-0855
Actively Recruiting
120
North Shore Hospital
Auckland, New Zealand, 0622
Actively Recruiting
121
Christchurch Hospital
Christchurch, New Zealand, 8011
Actively Recruiting
122
Dunedin Hospital
Dunedin, New Zealand, 9016
Actively Recruiting
123
Tauranga Hospital
Tauranga, New Zealand, 3112
Actively Recruiting
124
Wellington Regional Hospital (Ccdhb)
Wellington, New Zealand, 6021
Actively Recruiting
125
Pratia McM Krakow
Krakow, Poland, 30-727
Active, Not Recruiting
126
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
Lodz, Poland, 93-513
Active, Not Recruiting
127
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Lublin, Poland, 20-090
Active, Not Recruiting
128
Aidport Sp Z O O
Skorzewo, Poland, 60-185
Active, Not Recruiting
129
Dolnoslaskie Centrum Onkologii, Pulmonologii I Hematologii
Wroclaw, Poland, 53-439
Active, Not Recruiting
130
Auxilio Mutuo Cancer Center
San Juan, Puerto Rico, 00917
Actively Recruiting
131
Pusan National University Hospital
Seogu, Busan Gwang'yeogsi, South Korea, 49241
Actively Recruiting
132
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620
Actively Recruiting
133
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
Actively Recruiting
134
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, South Korea, 06591
Actively Recruiting
135
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
Actively Recruiting
136
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea, 03080
Actively Recruiting
137
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea, 05505
Actively Recruiting
138
The Catholic University of Korea, Yeouido St Marys Hospital
Yeongdeungpo-gu, Seoul Teugbyeolsi, South Korea, 07345
Actively Recruiting
139
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Active, Not Recruiting
140
Ico H Duran I Reynals
Barcelona, Spain, 08907
Active, Not Recruiting
141
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain, 28040
Active, Not Recruiting
142
H Puerta de Hierro Majadahonda
Majadahonda, Spain, 28222
Active, Not Recruiting
143
Etlik City Hospital
Ankara, Turkey (Türkiye), 06170
Active, Not Recruiting
144
Antalya Memorial Hospital
Dokuma, Turkey (Türkiye), 07025
Active, Not Recruiting
145
Kocaeli Universitesi Tip Fakultesi
Kocaeli, Turkey (Türkiye), 41380
Actively Recruiting
146
Birmingham Heartlands Hospital
Birmingham, United Kingdom, B9 5SS
Actively Recruiting
147
The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
Bournemouth, United Kingdom, BH7 7DW
Actively Recruiting
148
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YN
Actively Recruiting
149
Oxford University Hospitals Nhs Trust Churchill Hospital
Headington, United Kingdom, OX3 7LE
Actively Recruiting
150
University College Hospital
London, United Kingdom, NW1 2PG
Actively Recruiting
151
Clatterbridge Cancer Centre
Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
Actively Recruiting
152
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Actively Recruiting
Research Team
S
Study Director
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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