Um estudo para investigar a eficácia e segurança de Sonrotoclax Plus Zanubrutinibe em comparação com Placebo Plus Zanubrutinibe em adultos com linfoma de células do manto recidivante/refratário
Um estudo multicêntrico duplo-cego randomizado de fase 3 de Sonrotoclax Plus Zanubrutinibe versus Placebo Plus Zanubrutinibe em pacientes com linfoma de células do manto recidivante/refratário
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.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Mantle cell lymphoma (MCL) is a rare, aggressive type of B-cell lymphoma. B-cells are white blood cells that help fight infections. Lymphoma is a cancer in the lymphatic system. Sometimes this type of cancer can come back after treatment (relapse), or it does not respond to treatment or stops responding to treatment (refractory).
Sonrotoclax is a drug which blocks a protein called B-cell lymphoma-2 (Bcl-2). Zanubrutinib works by blocking a protein called Bruton tyrosine kinase (BTK). Bcl-2 and BTK help certain blood cancer cells live and grow. By blocking Bcl-2 and BTK, sonrotoclax and zanubrutinib may slow or stop cancer cell growth and help them die.
The purpose of this study is to test if sonrotoclax plus zanubrutinib is safe and if it works better in adults with R/R MCL compared to zanubrutinib plus placebo. The main goal is to compare how long participants live without their disease getting worse. The study will also evaluate side effects and overall safety.
This study has two treatment groups. Participants will be randomly assigned (by chance) to receive sonrotoclax plus zanubrutinib or zanubrutinib plus placebo. All study treatments will be taken by mouth. Placebo is a pill that looks like the study drug but has no active ingredient. Participants and the study doctor will not know what treatment group the participant is assigned to during the study, unless there is an urgent medical need.
The study will enroll approximately 300 adults with R/R MCL at multiple centers worldwide.
The overall time to participate in this study is up to approximately 7 years. Participants will make regular visits to the clinic for treatment, health checks, blood tests, and tumor imaging tests.
Note: 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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 3
Contactos e Locais
Contato de estudo
- Nome: Study Director
- Número de telefone: 1.877.828.5568
- E-mail: clinicaltrials@beonemed.com
Locais de estudo
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Chemnitz, Alemanha, 09116
- Recrutamento
- Klinikum Chemnitz Ggmbh
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Frankfurt am Main, Alemanha, 60596
- Recrutamento
- Universitatsklinikum Frankfurt
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Halle, Alemanha, 06120
- Recrutamento
- Universitatsklinikum Halle
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Mutlangen, Alemanha, 73557
- Recrutamento
- Stauferklinikum Schwabisch Gmund Kliniken Ostalb
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München, Alemanha, 81377
- Recrutamento
- Dept of Medicine Iii, University Hospitallmu
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Siegen, Alemanha, 57074
- Recrutamento
- Diakonie Klinikum Jung Stilling Krankenhaus
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Stuttgart, Alemanha, 70376
- Recrutamento
- Robert Bosch Krankenhaus, Abteilung Hamatologie, Onkologie Und Palliativmedizin
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Caba, Argentina, CP1114
- Ativo, não recrutando
- FUNDALEU
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Caba, Argentina, 1425
- Recrutamento
- Hospital Aleman
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Ciudad Autonoma Buenos Aires, Argentina, 1413
- Ativo, não recrutando
- Hospital Italiano de Buenos Aires
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Córdoba, Argentina, X5000HUA
- Ativo, não recrutando
- Hospital Universitario de Cordoba
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Queensland
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Birtinya, Queensland, Austrália, QLD 4575
- Ativo, não recrutando
- Sunshine Coast Hospital and Health Service
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Victoria
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Box Hill, Victoria, Austrália, VIC 3128
- Ativo, não recrutando
- Box Hill Hospital
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Clayton, Victoria, Austrália, VIC 3168
- Ativo, não recrutando
- Monash Health
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Western Australia
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Cooloongup, Western Australia, Austrália, WA 6168
- Ativo, não recrutando
- Rockingham Hospital
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West Perth, Western Australia, Austrália, WA 6005
- Ativo, não recrutando
- Perth Blood Institute
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Barretos, Brasil, 14.784-400
- Ativo, não recrutando
- Fundacao Pio Xii Hospital de Amor de Barretos
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Belo Horizonte, Brasil, 30110-068
- Ativo, não recrutando
- Hospital Felicio Rocho
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Campinas, Brasil, 13083-878
- Ativo, não recrutando
- Universidade de Campinas Centro de Hematologia E Hemoterapia
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Caxias do Sul, Brasil, 95070-560
- Ativo, não recrutando
- Fundacao Universidade de Caxias Do Sul
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Curitiba, Brasil, 81520-060
- Ativo, não recrutando
- Hospital Erasto Gaertner
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Joinville, Brasil, 89201-260
- Ativo, não recrutando
- Instituto Joinvilense de Hematologia E Oncologia
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Porto AlegreRS, Brasil, 900350-903
- Ativo, não recrutando
- Hospital de Clinicas de Porto Alegre
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Recife, Brasil, 50040-000
- Ativo, não recrutando
- Hospital Do Cancer de Pernambuco
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São Paulo, Brasil, 05403-010
- Ativo, não recrutando
- Hcfmusp Pesquisa Clinica Do Servico de Hematologia E Terapia Celular
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Vitória, Brasil, 29043-260
- Recrutamento
- Hospital Santa Rita de Cassia Afecc
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Beijing Municipality
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Beijing, Beijing Municipality, China, 100142
- Recrutamento
- Beijing Cancer Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, China, 630014
- Recrutamento
- The First Affiliated Hospital of Chongqing Medical University
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Guangdong
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Guangzhou, Guangdong, China, 510515
- Recrutamento
- Nanfang Hospital, Southern Medical University
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Guangzhou, Guangdong, China, 510060
- Recrutamento
- Sun Yat Sen University Cancer Center
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Heilongjiang
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Harbin, Heilongjiang, China, 150000
- Recrutamento
- Harbin Medical University Cancer Hospital
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Henan
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Zhengzhou, Henan, China, 450052
- Recrutamento
- The First Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan, Hubei, China, 430030
- Ativo, não recrutando
- Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
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Wuhan, Hubei, China, 430022
- Ativo, não recrutando
- Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
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Jiangsu
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Nanjing, Jiangsu, China, 210029
- Recrutamento
- Jiangsu Province Hospital
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Xuzhou, Jiangsu, China, 221000
- Recrutamento
- The Affiliated Hospital of Xuzhou Medical University
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Jiangxi
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Nanchang, Jiangxi, China, 330029
- Recrutamento
- Jiangxi Cancer Hospital
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Liaoning
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Shenyang, Liaoning, China, 110042
- Recrutamento
- Liaoning Cancer Hospital and Institute
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Shaanxi
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Xi'an, Shaanxi, China, 710068
- Recrutamento
- Shaanxi Provincial Peoples Hospital
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Shandong
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Linyi, Shandong, China, 276001
- Recrutamento
- Linyi Cancer Hospital
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Qingdao, Shandong, China, 266555
- Recrutamento
- The Affiliated Hospital of Qingdao University Branch West Coast
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200000
- Recrutamento
- Fudan University Shanghai Cancer Center
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Sichuan
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Chengdu, Sichuan, China, 610071
- Recrutamento
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
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Zhejiang
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Hangzhou, Zhejiang, China, 310002
- Recrutamento
- The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
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Wenzhou, Zhejiang, China, 325000
- Recrutamento
- The First Affiliated Hospital of Wenzhou Medical University
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Busan Gwang'Yeogsi
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Seogu, Busan Gwang'Yeogsi, Coréia do Sul, 49241
- Ativo, não recrutando
- Pusan National University Hospital
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Seoul Teugbyeolsi
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GangnamGu, Seoul Teugbyeolsi, Coréia do Sul, 06351
- Ativo, não recrutando
- Samsung Medical Center
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SeochoGu, Seoul Teugbyeolsi, Coréia do Sul, 06591
- Ativo, não recrutando
- The Catholic University of Korea, Seoul St Marys Hospital
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Seoul, Seoul Teugbyeolsi, Coréia do Sul, 03080
- Ativo, não recrutando
- Seoul National University Hospital
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SongpaGu, Seoul Teugbyeolsi, Coréia do Sul, 05505
- Ativo, não recrutando
- Asan Medical Center
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Yeongdeungpo-gu, Seoul Teugbyeolsi, Coréia do Sul, 07345
- Ativo, não recrutando
- The Catholic University of Korea, Yeouido St Marys Hospital
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Barcelona, Espanha, 08036
- Ativo, não recrutando
- Hospital Clinic de Barcelona
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Barcelona, Espanha, 08907
- Ativo, não recrutando
- Ico H Duran I Reynals
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Madrid, Espanha, 28040
- Concluído
- Hospital Universitario Fundacion Jimenez Diaz
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Majadahonda, Espanha, 28222
- Ativo, não recrutando
- H Puerta de Hierro Majadahonda
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Alabama
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Birmingham, Alabama, Estados Unidos, 35294-0004
- Recrutamento
- University of Alabama At Birmingham Hospital
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Arizona
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Tucson, Arizona, Estados Unidos, 85724-0001
- Recrutamento
- University of Arizona Cancer Center
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California
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Fresno, California, Estados Unidos, 93701
- Recrutamento
- Ucsf Fresno
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Irvine, California, Estados Unidos, 92618-3734
- Recrutamento
- Kaiser Permanente Southern California
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06520-8028
- Recrutamento
- Yale University Yale Cancer Center
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Florida
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Pembroke Pines, Florida, Estados Unidos, 33026-4119
- Recrutamento
- Memorial Cancer Institute, Memorial Healthcare System
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Weston, Florida, Estados Unidos, 33331-3609
- Recrutamento
- Cleveland Clinic Florida
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Illinois
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Chicago, Illinois, Estados Unidos, 60607
- Recrutamento
- Rush University Medical Center
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Chicago, Illinois, Estados Unidos, 60637-1443
- Recrutamento
- University of Chicago Medical Center
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Indiana
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Fort Wayne, Indiana, Estados Unidos, 46804
- Recrutamento
- Fort Wayne Medical Oncology and Hematology
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Iowa
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Waukee, Iowa, Estados Unidos, 50263
- Recrutamento
- Mission Cancer and Blood
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70808-4365
- Recrutamento
- Our Lady of the Lake Hospital
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- Recrutamento
- The University of Maryland Greenebaum Comprehensive Cancer Center
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215-5418
- Recrutamento
- Dana Farber Cancer Institute Longwood Medical Center
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109-1382
- Recrutamento
- University of Michigan
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Grand Rapids, Michigan, Estados Unidos, 49503-2563
- Recrutamento
- The Cancer and Hematology Centers
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905-0001
- Recrutamento
- Mayo Clinic Rochester
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Mississippi
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Hattiesburg, Mississippi, Estados Unidos, 39401-7233
- Recrutamento
- Hattiesburg Hematology and Oncology Clinic
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Missouri
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St Louis, Missouri, Estados Unidos, 63110-1010
- Recrutamento
- Washington University School of Medicine
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Nebraska
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Grand Island, Nebraska, Estados Unidos, 68803
- Recrutamento
- Nebraska Cancer Specialists St Francis Grand Island
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Omaha, Nebraska, Estados Unidos, 68130-2042
- Recrutamento
- Nebraska Cancer Specialists
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New Jersey
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Paramus, New Jersey, Estados Unidos, 07652
- Recrutamento
- The Valley Hospital, Inc
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New York
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New York, New York, Estados Unidos, 10065-6800
- Recrutamento
- Memorial Sloan Kettering Cancer Center Mskcc
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North Carolina
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Charlotte, North Carolina, Estados Unidos, 28204-2990
- Recrutamento
- Atrium Health Levine Cancer Institute (Lci)
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Durham, North Carolina, Estados Unidos, 27710
- Recrutamento
- Duke University
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Winston-Salem, North Carolina, Estados Unidos, 27157
- Recrutamento
- Atrium Health Wake Forest Baptist
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195-0001
- Recrutamento
- Cleveland Clinic Foundation
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Cleveland, Ohio, Estados Unidos, 44106-1716
- Recrutamento
- University Hospitals
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Columbus, Ohio, Estados Unidos, 43210-1280
- Recrutamento
- Ohio State University Comprehensive Cancer Center
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Columbus, Ohio, Estados Unidos, 43214-3907
- Recrutamento
- Ohio Health Research Institute
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Pennsylvania
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Hershey, Pennsylvania, Estados Unidos, 17033
- Recrutamento
- Penn State Milton S Hershey Medical Center
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West Reading, Pennsylvania, Estados Unidos, 19611-2143
- Recrutamento
- McGlinn Cancer Institute
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37205
- Recrutamento
- Tennessee Oncology
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Nashville, Tennessee, Estados Unidos, 37205
- Recrutamento
- Tennessee Oncology Nashville St Thomas Midtown Clinic
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Texas
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Houston, Texas, Estados Unidos, 77030-3907
- Recrutamento
- Md Anderson Cancer Center
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Round Rock, Texas, Estados Unidos, 78681-4019
- Recrutamento
- Texas Oncology Austin Midtown
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Virginia
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Charlottesville, Virginia, Estados Unidos, 22908-0817
- Recrutamento
- University of Virginia
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Gainesville, Virginia, Estados Unidos, 20155-3257
- Recrutamento
- Virgina Cancer Specialists
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Richmond, Virginia, Estados Unidos, 23298-5026
- Recrutamento
- Vcu Massey Cancer Center
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Washington
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Vancouver, Washington, Estados Unidos, 98684-6930
- Recrutamento
- Northwest Cancer Specialist, Pc(Us Oncology Research)
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792-0001
- Recrutamento
- University of Wisconsin
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-
-
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Montpellier, França, 34090
- Recrutamento
- Chu Montpellier Hopital Saint Eloi
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Nantes, França, 44000
- Ativo, não recrutando
- Centre Hospitalier Universitaire Nantes Hotel Dieu
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PierreBenite, França, 69495
- Ativo, não recrutando
- Chu Hopital Lyon Sud
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Tours, França, 37000
- Recrutamento
- Chu Tours Hopital Bretonneau
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Bologna, Itália, 40138
- Ativo, não recrutando
- Policlinico Sorsola Malpighi, Aou Di Bologna
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Lecce, Itália, 73100
- Ativo, não recrutando
- Ospedale Vito Fazzi, Asl Lecce
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Meldola, Itália, 47014
- Ativo, não recrutando
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
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Trieste, Itália, 34129
- Ativo, não recrutando
- Azienda Sanitaria Universitaria Giuliano Isontina
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Verona, Itália, 37134
- Ativo, não recrutando
- Centroricerche Cliniche Di Verona Srl
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Yokohama, Japão, 221-0855
- Recrutamento
- Yokohama Municipal Citizens Hospital
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Aichi-ken
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Nagoya, Aichi-ken, Japão, 464-8681
- Recrutamento
- Aichi Cancer Center Hospital Clinical Oncology
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Toyohashishi, Aichi-ken, Japão, 441-8570
- Recrutamento
- Toyohashi Municipal Hospital
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Chiba
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Chiba, Chiba, Japão, 260-8717
- Recrutamento
- Chiba Cancer Center
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Ehime
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Matsuyama, Ehime, Japão, 790 8524
- Recrutamento
- Matsuyama Red Cross Hospital
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Gifu
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Ōgaki, Gifu, Japão, 503-8502
- Recrutamento
- Ogaki Municipal Hospital
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Hiroshima
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Hiroshima, Hiroshima, Japão, 730-8619
- Recrutamento
- Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
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Hokkaido
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Sapporo, Hokkaido, Japão, 060-8648
- Recrutamento
- Hokkaido University Hospital
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Hyōgo
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KobeShi, Hyōgo, Japão, 650-0047
- Recrutamento
- Kobe City Medical Center General Hospital
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Kagoshima-ken
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Kagoshima, Kagoshima-ken, Japão, 890-8520
- Recrutamento
- Kagoshima University Hospital
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Kanagawa
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Yokohama, Kanagawa, Japão, 241-8515
- Recrutamento
- Kanagawa Cancer Center
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Miyagi
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Sendai, Miyagi, Japão, 980-8574
- Recrutamento
- Tohoku University Hospital
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Okayama-ken
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Kurashikishi, Okayama-ken, Japão, 710-8602
- Recrutamento
- Kurashiki Central Hospital
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Okayama, Okayama-ken, Japão, 701-1192
- Recrutamento
- National Hospital Organization Okayama Medical Center
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Osaka
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Osaka, Osaka, Japão, 545-8586
- Recrutamento
- Osaka Metropolitan University Hospital
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Osakashi, Osaka, Japão, 543-8555
- Recrutamento
- Osaka Red Cross Hospital
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Saitama
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Koshigaya, Saitama, Japão, 503-8502
- Recrutamento
- Dokkyo Medical University Saitama Medical Center
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Tokyo
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Bunkyoku, Tokyo, Japão, 113-8519
- Recrutamento
- Institute of Science Tokyo Hospital
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Auckland, Nova Zelândia, 0622
- Ativo, não recrutando
- North Shore Hospital
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Christchurch, Nova Zelândia, 8011
- Ativo, não recrutando
- Christchurch Hospital
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Dunedin, Nova Zelândia, 9016
- Ativo, não recrutando
- Dunedin Hospital
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Tauranga, Nova Zelândia, 3112
- Ativo, não recrutando
- Tauranga Hospital
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Wellington, Nova Zelândia, 6021
- Ativo, não recrutando
- Wellington Regional Hospital (Ccdhb)
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Krakow, Polônia, 30-727
- Ativo, não recrutando
- Pratia McM Krakow
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Lodz, Polônia, 93-510
- Ativo, não recrutando
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
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Lublin, Polônia, 20-090
- Ativo, não recrutando
- Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
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Skorzewo, Polônia, 60-185
- Ativo, não recrutando
- Aidport Sp Z O O
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Wroclaw, Polônia, 53-439
- Ativo, não recrutando
- Dolnoslaskie Centrum Onkologii, Pulmonologii I Hematologii
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San Juan, Porto Rico, 00917
- Recrutamento
- Auxilio Mutuo Cancer Center
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Birmingham, Reino Unido, B9 5SS
- Recrutamento
- Birmingham Heartlands Hospital
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Bournemouth, Reino Unido, BH7 7DW
- Recrutamento
- The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
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Glasgow, Reino Unido, G12 0YN
- Recrutamento
- Beatson West of Scotland Cancer Centre
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Headington, Reino Unido, OX3 7LE
- Recrutamento
- Oxford University Hospitals Nhs Trust Churchill Hospital
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London, Reino Unido, NW1 2PG
- Recrutamento
- University College Hospital
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Metropolitan Borough of Wirral, Reino Unido, CH63 4JY
- Recrutamento
- Clatterbridge Cancer Centre
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Plymouth, Reino Unido, PL6 8DH
- Recrutamento
- Derriford Hospital
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-
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Ankara, Turquia (Türkiye), 06170
- Ativo, não recrutando
- Etlik City Hospital
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Dokuma, Turquia (Türkiye), 07025
- Ativo, não recrutando
- Antalya Memorial Hospital
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Kocaeli, Turquia (Türkiye), 41380
- Ativo, não recrutando
- Kocaeli Universitesi Tip Fakultesi
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Sankt Pölten, Áustria, 3100
- Ativo, não recrutando
- Uk St Poelten
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Arm A: sonrotoclax plus zanubrutinib
Sonrotoclax and zanubrutinib will be administered in combination. |
Administered orally
Outros nomes:
Administered orally
Outros nomes:
|
|
Comparador de Placebo: Arm B: placebo plus zanubrutinib
Placebo and zanubrutinib will be administered in combination. |
Administered orally Administered orally
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC)
Prazo: Approximately 41 months
|
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first. |
Approximately 41 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Overall Survival (OS)
Prazo: Approximately 92 months
|
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)
Prazo: Approximately 58 months
|
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
Prazo: Approximately 58 months
|
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
Prazo: Approximately 58 months
|
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
Prazo: Approximately 58 months
|
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
Prazo: Approximately 58 months
|
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
Prazo: Approximately 58 months
|
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
|
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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)
Prazo: Approximately 58 months
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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
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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)
Prazo: Approximately 58 months
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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
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Number of participants with treatment-emergent adverse events (TEAEs)
Prazo: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 58 months
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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
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Study Director, BeOne Medicines
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- BGB-11417-302
- 2024-515593-27-00 (Ctis)
- CTR20250207 (Identificador de registro: ChinaDrugTrials)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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.
Prazo de Compartilhamento de IPD
See plan description
Critérios de acesso de compartilhamento IPD
See plan description
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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