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

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.

Study Overview

• Status: Recruiting
• Conditions: B Cell Lymphoma; Mantle Cell Lymphoma
• Intervention / Treatment: Drug: Placebo; Drug: Sonrotoclax; Drug: Zanubrutinib

Detailed Description

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 Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Study Director; Phone Number: 1.877.828.5568; Email: clinicaltrials@beonemed.com

Study Locations

• Argentina
  • CABA, Argentina, 1425
    • Recruiting
    • Hospital Aleman
  • Caba, Argentina, CP1114
    • Recruiting
    • Fundaleu
  • Ciudad Autonoma Buenos Aires, Argentina, 1413
    • Recruiting
    • Hospital Italiano de Buenos Aires
  • Córdoba, Argentina, X5000HUA
    • Recruiting
    • Hospital Universitario de Cordoba
• Australia
  • New South Wales
    • Concord, New South Wales, Australia, NSW 2139
      • Recruiting
      • Concord Repatriation General Hospital
    • St Leonards, New South Wales, Australia, NSW 2065
      • Recruiting
      • Genesiscare North Shore
    • Westmead, New South Wales, Australia, NSW 2145
      • Recruiting
      • Westmead Hospital
  • Queensland
    • Birtinya, Queensland, Australia, QLD 4575
      • Recruiting
      • Sunshine Coast Hospital and Health Service
  • Victoria
    • Box Hill, Victoria, Australia, VIC 3128
      • Recruiting
      • Box Hill Hospital
    • Clayton, Victoria, Australia, VIC 3168
      • Recruiting
      • Monash Health
  • Western Australia
    • Cooloongup, Western Australia, Australia, WA 6168
      • Recruiting
      • Rockingham Hospital
    • Nedlands, Western Australia, Australia, WA 6009
      • Recruiting
      • Linear Clinical Research
    • Nedlands, Western Australia, Australia, WA 6009
      • Recruiting
      • One Clinical Research
    • West Perth, Western Australia, Australia, WA 6005
      • Recruiting
      • Perth Blood Institute
• Austria
  • Linz, Austria, 4020
    • Recruiting
    • Ordensklinikum Linz GmbH Elisabethinen
  • Salzburg, Austria, 5020
    • Recruiting
    • Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg
  • Sankt Pölten, Austria, 3100
    • Active, not recruiting
    • Uk St Poelten
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University Vienna Oncology
• Brazil
  • Barretos, Brazil, 14.784-400
    • Recruiting
    • Fundacao Pio Xii Hospital de Amor de Barretos
  • Belo Horizonte, Brazil, 30110-068
    • Recruiting
    • Hospital Felício Rocho
  • Campinas, Brazil, 13083-878
    • Recruiting
    • Universidade de Campinas Centro de Hematologia E Hemoterapia
  • Curitiba, Brazil, 81520-060
    • Recruiting
    • Hospital Erasto Gaertner
  • Joinville, Brazil, 89201-260
    • Recruiting
    • Instituto Joinvilense de Hematologia e Oncologia
  • Petrópolis, Brazil, 95070-560
    • Recruiting
    • Fundacao Universidade de Caxias Do Sul Instituto de Pesquisas Em Saude
  • Porto AlegreRS, Brazil, 900350-903
    • Recruiting
    • Hospital de Clínicas de Porto Alegre
  • Recife, Brazil, 50040-000
    • Recruiting
    • Hospital Do Cancer de Pernambuco
  • São Paulo, Brazil, 05402-000
    • Recruiting
    • Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
  • Vitória, Brazil, 29043-260
    • Recruiting
    • Hospital Santa Rita de Cassia Afecc
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
    • Beijing, Beijing Municipality, China, 100730
      • Recruiting
      • Beijing Hospital
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 630014
      • Recruiting
      • The First Affiliated Hospital of Chongqing Medical University
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Medical University Union Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Nanfang Hospital, Southern Medical University
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat Sen University Cancer Center
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Recruiting
      • Harbin Medical University Cancer Hospital
  • Henan
    • Zhengzhou, Henan, China, 450052
      • Recruiting
      • The first affiliated hospital of Zhengzhou university
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Recruiting
      • Jiangsu Province Hospital
    • Xuzhou, Jiangsu, China, 221000
      • Recruiting
      • The Affiliated Hospital of Xuzhou Medical University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330029
      • Recruiting
      • Jiangxi Cancer Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110042
      • Recruiting
      • Liaoning Cancer Hospital and Institute
  • Shaanxi
    • Xi'an, Shaanxi, China, 710068
      • Recruiting
      • Shaanxi Provincial Peoples Hospital
  • Shandong
    • Linyi, Shandong, China, 276001
      • Recruiting
      • Linyi Cancer Hospital
    • Qingdao, Shandong, China, 266555
      • Recruiting
      • The Affiliated Hospital of Qingdao University Branch West Coast
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200000
      • Recruiting
      • Fudan University Shanghai Cancer Center
  • Sichuan
    • Chengdu, Sichuan, China, 610071
      • Recruiting
      • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310002
      • Recruiting
      • The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
    • Wenzhou, Zhejiang, China, 325000
      • Recruiting
      • The First Affiliated Hospital of Wenzhou Medical University
• France
  • Montpellier, France, 34090
    • Recruiting
    • Chu Montpellier Hopital Saint Eloi
  • Nantes, France, 44000
    • Active, not recruiting
    • Centre Hospitalier Universitaire Nantes Hotel Dieu
  • PierreBenite, France, 69495
    • Active, not recruiting
    • Chu Hopital Lyon Sud
  • Tours, France, 37000
    • Recruiting
    • Chu Tours Hopital Bretonneau
• Germany
  • Chemnitz, Germany, 09116
    • Recruiting
    • Klinikum Chemnitz gGmbH
  • Frankfurt am Main, Germany, 60596
    • Recruiting
    • Universitätsklinikum Frankfurt
  • Halle, Germany, 06120
    • Recruiting
    • Universitatsklinikum Halle
  • Hamburg, Germany, 20251
    • Recruiting
    • Universitatsklinikum Hamburg Eppendorf
  • Mutlangen, Germany, 73557
    • Recruiting
    • Stauferklinikum Schwabisch Gmund Kliniken Ostalb
  • München, Germany, 81377
    • Recruiting
    • Dept of Medicine Iii, University Hospitallmu
• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • Policlinico Sorsola Malpighi, Aou Di Bologna
  • Leece, Italy, 73100
    • Recruiting
    • Ospedale Vito Fazzi, Asl Lecce
  • Meldola, Italy, 47014
    • Recruiting
    • Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
  • Trieste, Italy, 34129
    • Recruiting
    • Azienda sanitaria universitaria Giuliano Isontina
  • Verona, Italy, 37134
    • Recruiting
    • Centroricerche Cliniche Di Verona Srl
• Japan
  • Okayama, Japan, 701-1192
    • Recruiting
    • National Hospital Organization Okayama Medical Center
  • Osaka, Japan, 545-8586
    • Recruiting
    • Osaka Metropolitan University Hospital
  • Yokohama, Japan, 221-0855
    • Recruiting
    • Yokohama Municipal Citizens Hospital
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 464-8681
      • Recruiting
      • Aichi Cancer Center Hospital Clinical Oncology
    • Toyohashishi, Aichi-ken, Japan, 441-8570
      • Recruiting
      • Toyohashi Municipal Hospital
  • Chiba
    • Chiba, Chiba, Japan, 260-8717
      • Recruiting
      • Chiba Cancer Center
  • Ehime
    • Matsuyama, Ehime, Japan, 790 8524
      • Recruiting
      • Matsuyama Red Cross Hospital
  • Gifu
    • Ōgaki, Gifu, Japan, 503-8502
      • Recruiting
      • Ogaki Municipal Hospital
  • Hiroshima
    • Hiroshima, Hiroshima, Japan, 730-8619
      • Recruiting
      • Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
      • Recruiting
      • Hokkaido University Hospital
  • Hyōgo
    • KobeShi, Hyōgo, Japan, 650-0047
      • Recruiting
      • Kobe City Medical Center General Hospital
  • Kagoshima-ken
    • Kagoshima, Kagoshima-ken, Japan, 890-8520
      • Recruiting
      • Kagoshima University Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 241-8515
      • Recruiting
      • Kanagawa Cancer Center
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Recruiting
      • Tohoku University Hospital
  • Okayama-ken
    • Kurashikishi, Okayama-ken, Japan, 710-8602
      • Recruiting
      • Kurashiki Central Hospital
  • Osaka
    • Osakashi, Osaka, Japan, 543-8555
      • Recruiting
      • Osaka Red Cross Hospital
  • Saitama
    • Koshigaya, Saitama, Japan, 503-8502
      • Recruiting
      • Dokkyo Medical University Saitama Medical Center
  • Tokyo
    • Bunkyoku, Tokyo, Japan, 113-8519
      • Recruiting
      • Institute of Science Tokyo Hospital
• New Zealand
  • Auckland, New Zealand, 0622
    • Recruiting
    • North Shore Hospital
  • Christchurch, New Zealand, 8011
    • Recruiting
    • Christchurch Hospital
  • Dunedin, New Zealand, 9016
    • Recruiting
    • Dunedin Hospital
  • Tauranga, New Zealand, 3112
    • Recruiting
    • Tauranga Hospital
  • Wellington, New Zealand, 6021
    • Recruiting
    • Wellington Regional Hospital (Ccdhb)
• Poland
  • Krakow, Poland, 30-727
    • Active, not recruiting
    • Pratia MCM Krakow
  • Lodz, Poland, 93-513
    • Active, not recruiting
    • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi
  • Lublin, Poland, 20-090
    • Active, not recruiting
    • Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
  • Skorzewo, Poland, 60-185
    • Active, not recruiting
    • Aidport Sp z o o
  • Wroclaw, Poland, 53-439
    • Active, not recruiting
    • Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii
• Puerto Rico
  • San Juan, Puerto Rico, 00917
    • Recruiting
    • Auxilio Mutuo Cancer Center
• South Korea
  • Busan Gwang'yeogsi
    • Seogu, Busan Gwang'yeogsi, South Korea, 49241
      • Recruiting
      • Pusan National University Hospital
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Recruiting
      • Seoul National University Bundang Hospital
  • Seoul Teugbyeolsi
    • GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
      • Recruiting
      • Samsung Medical Center
    • SeochoGu, Seoul Teugbyeolsi, South Korea, 06591
      • Recruiting
      • The Catholic University of Korea, Seoul St Marys Hospital
    • SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
      • Recruiting
      • Severance Hospital Yonsei University Health System
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Recruiting
      • Seoul National University Hospital
    • SongpaGu, Seoul Teugbyeolsi, South Korea, 05505
      • Recruiting
      • Asan Medical Center
    • Yeongdeungpo-gu, Seoul Teugbyeolsi, South Korea, 07345
      • Recruiting
      • The Catholic University of Korea, Yeouido St Marys Hospital
• Spain
  • Barcelona, Spain, 08036
    • Active, not recruiting
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08907
    • Active, not recruiting
    • Ico H Duran I Reynals
  • Madrid, Spain, 28040
    • Active, not recruiting
    • Hospital Universitario Fundacion Jimenez Díaz
  • Majadahonda, Spain, 28222
    • Active, not recruiting
    • H Puerta de Hierro Majadahonda
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06170
    • Active, not recruiting
    • Etlik City Hospital
  • Dokuma, Turkey (Türkiye), 07025
    • Active, not recruiting
    • Antalya Memorial Hospital
  • Kocaeli, Turkey (Türkiye), 41380
    • Recruiting
    • Kocaeli Universitesi Tip Fakultesi
• United Kingdom
  • Birmingham, United Kingdom, B9 5SS
    • Recruiting
    • Birmingham Heartlands Hospital
  • Bournemouth, United Kingdom, BH7 7DW
    • Recruiting
    • The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
  • Glasgow, United Kingdom, G12 0YN
    • Recruiting
    • Beatson West Of Scotland Cancer Centre
  • Headington, United Kingdom, OX3 7LE
    • Recruiting
    • Oxford University Hospitals Nhs Trust Churchill Hospital
  • London, United Kingdom, NW1 2PG
    • Recruiting
    • University College Hospital
  • Metropolitan Borough of Wirral, United Kingdom, CH63 4JY
    • Recruiting
    • Clatterbridge Cancer Centre
  • Plymouth, United Kingdom, PL6 8DH
    • Recruiting
    • Derriford Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294-0004
      • Recruiting
      • University of Alabama At Birmingham Hospital
  • Arizona
    • Tucson, Arizona, United States, 85724-0001
      • Recruiting
      • University of Arizona Cancer Center
  • California
    • Fresno, California, United States, 93701
      • Recruiting
      • UCSF Fresno
    • Irvine, California, United States, 92618-3734
      • Recruiting
      • Kaiser Permanente Southern California
  • Connecticut
    • New Haven, Connecticut, United States, 06520-8028
      • Recruiting
      • Yale University Yale Cancer Center
  • Florida
    • Pembroke Pines, Florida, United States, 33026-4119
      • Recruiting
      • Memorial Cancer Institute, Memorial Healthcare System
    • Weston, Florida, United States, 33331-3609
      • Recruiting
      • Cleveland Clinic Florida
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Recruiting
      • Fort Wayne Medical Oncology and Hematology
  • Iowa
    • Waukee, Iowa, United States, 50263
      • Recruiting
      • Mission Cancer and Blood
  • Maryland
    • Baltimore, Maryland, United States, 21201-1544
      • Recruiting
      • University of Maryland Greenebaum Comprehensive Cancer Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215-5418
      • Recruiting
      • Dana Farber Cancer Institute Longwood Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-1382
      • Recruiting
      • University of Michigan
    • Grand Rapids, Michigan, United States, 49503-2563
      • Recruiting
      • The Cancer and Hematology Centers
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Recruiting
      • Mayo Clinic Rochester
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401-7233
      • Recruiting
      • Hattiesburg Hematology and Oncology Clinic
  • Missouri
    • St Louis, Missouri, United States, 63110-1010
      • Recruiting
      • Washington University School of Medicine
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Recruiting
      • Nebraska Cancer Specialists St Francis Grand Island
    • Omaha, Nebraska, United States, 68130-2042
      • Recruiting
      • Nebraska Cancer Specialists
  • New Jersey
    • Paramus, New Jersey, United States, 07652
      • Recruiting
      • The Valley Hospital, Inc
  • North Carolina
    • Charlotte, North Carolina, United States, 28204-2990
      • Recruiting
      • Atrium Health Levine Cancer Institute (Lci)
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Atrium Health Wake Forest Baptist
  • Ohio
    • Cleveland, Ohio, United States, 44195-0001
      • Recruiting
      • Cleveland Clinic Foundation
    • Cleveland, Ohio, United States, 44106-1716
      • Recruiting
      • University Hospitals
    • Columbus, Ohio, United States, 43210-1280
      • Recruiting
      • Ohio State University Comprehensive Cancer Center
    • Columbus, Ohio, United States, 43214-3907
      • Recruiting
      • Ohio Health Research Institute
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Recruiting
      • Penn State Milton S Hershey Medical Center
    • West Reading, Pennsylvania, United States, 19611-2143
      • Recruiting
      • McGlinn Cancer Institute
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • Recruiting
      • Tennessee Oncology
    • Nashville, Tennessee, United States, 37205
      • Recruiting
      • Tennessee Oncology Nashville St Thomas Midtown Clinic
  • Texas
    • Houston, Texas, United States, 77030-3907
      • Recruiting
      • MD Anderson Cancer Center
    • Round Rock, Texas, United States, 78681-4019
      • Recruiting
      • Texas Oncology Austin Midtown
  • Virginia
    • Charlottesville, Virginia, United States, 22908-0817
      • Recruiting
      • University of Virginia
    • Gainesville, Virginia, United States, 20155-3257
      • Recruiting
      • Virgina Cancer Specialists
    • Richmond, Virginia, United States, 23298-5026
      • Recruiting
      • Vcu Massey Cancer Center
  • Washington
    • Vancouver, Washington, United States, 98684-6930
      • Recruiting
      • Northwest Cancer Specialist, Pc(Us Oncology Research)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: sonrotoclax plus zanubrutinib; Sonrotoclax and zanubrutinib will be administered in combination.	Drug: Sonrotoclax; Administered orally; Other Names: BGB-11417; Drug: Zanubrutinib; Administered orally; Other Names: Brukinsa; BGB-3111
Placebo Comparator: Arm B: placebo plus zanubrutinib; Placebo and zanubrutinib will be administered in combination.	Drug: Placebo; Administered orally; Drug: Zanubrutinib; Administered orally; Other Names: Brukinsa; BGB-3111

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	OS is defined as the time from randomization to the date of death from any cause.	Approximately 92 months
PFS as assessed by investigator (INV)	PFS is defined as the time from randomization to the date of progression or death, whichever occurs first.	Approximately 58 months
Overall Response Rate (ORR) as assessed by BIRC and by INV	ORR is defined as the percentage of participants who achieved a best overall response of partial response (PR) or complete response (CR), per Lugano 2014 criteria.	Approximately 58 months
Duration of Response (DOR) as assessed by BIRC and by INV	DOR is defined as the time from the first qualifying response to the date of progression or death, whichever occurs first.	Approximately 58 months
Complete Response Rate (CRR) as assessed by BIRC and by INV	CRR is defined as the percentage of participants who achieved a best overall response of CR.	Approximately 58 months
Time to first response as assessed by BIRC and by INV	Time to first response is defined as time from the date of randomization to first response.	Approximately 58 months
Time to initiation of new anticancer therapy	Time to initiation of new anticancer therapy is defined as time from the date of randomization to the date of initiation of new anticancer therapy.	Approximately 58 months
Health-Related Quality of Life (HRQoL) as Assessed by the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Non-Hodgkin Lymphoma High Grade Module 29 (EORTC-QLQ-NHL-HG29)	Patient-reported symptom burden, neuropathy, and physical condition/fatigue as measured by the EORTC-QLQ-NHL-HG29 questionnaire. The EORTC-QLQ-NHL-HG29 is the NHL-aggressive module of QLQ-C30; and it consists of 5 scales: Symptom burden due to disease and/or treatment (7 items), Neuropathy (2 items), Physical condition/Fatigue (5 items), Emotional impacts (4 items), and Worries/Fears health and functioning (11 items). Items are rated using a 4-point response scale ("not at all," "a little," "quite a bit," and "very much"). A higher score for all the multi-item scales and items represents a higher level of symptomatology or problems.	Approximately 58 months
Health-Related Quality of Life (HRQoL) as Assessed by the European Organisation of Research and Treatment of Cancer-Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)	Patient-reported global health status (GHS), role, and physical function as measured by the EORTC-QLQ-C30 questionnaire. The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 =Not at all (best) to 4 =Very Much (worst) and 2 questions answered on a 7-point scale where 1 =Very poor (worst) to 7 =Excellent (best).	Approximately 58 months
Number of participants with treatment-emergent adverse events (TEAEs)	Number of participants with TEAEs, including laboratory values, vital signs, electrocardiogram results, and physical examination findings, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.	From the first dose of study drug(s) to 30 days after the last dose; up to approximately 58 months

Collaborators and Investigators

• Sponsor: BeOne Medicines
• Investigators: Study Director: Study Director, BeOne Medicines

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): March 30, 2032

Study Registration Dates

• First Submitted: December 16, 2024
• First Submitted That Met QC Criteria: December 16, 2024
• First Posted (Actual): December 19, 2024

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: MCL; mantle cell lymphoma; BGB-11417; relapsed/refractory mantle cell lymphoma; sonrotoclax
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, B-Cell; Lymphoma, Mantle-Cell; Substandard Drugs; Pharmaceutical Preparations; zanubrutinib
• Other Study ID Numbers: BGB-11417-302; 2024-515593-27-00 (Ctis); CTR20250207 (Registry Identifier: ChinaDrugTrials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD 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.

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No