Une étude visant à étudier l'efficacité et l'innocuité de Sonrotoclax Plus Zanubrutinib par rapport au Placebo Plus Zanubrutinib chez les adultes atteints de lymphome à cellules du manteau récidivant/réfractaire
Une étude multicentrique randomisée en double aveugle de phase 3 sur Sonrotoclax plus Zanubrutinib versus Placebo plus Zanubrutinib chez des patients atteints de lymphome à cellules du manteau en rechute/réfractaire
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- Phase 3
Contacts et emplacements
Coordonnées de l'étude
- Nom: Study Director
- Numéro de téléphone: 1.877.828.5568
- E-mail: clinicaltrials@beonemed.com
Lieux d'étude
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Chemnitz, Allemagne, 09116
- Recrutement
- Klinikum Chemnitz Ggmbh
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Frankfurt am Main, Allemagne, 60596
- Recrutement
- Universitatsklinikum Frankfurt
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Halle, Allemagne, 06120
- Recrutement
- Universitatsklinikum Halle
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Mutlangen, Allemagne, 73557
- Recrutement
- Stauferklinikum Schwabisch Gmund Kliniken Ostalb
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München, Allemagne, 81377
- Recrutement
- Dept of Medicine Iii, University Hospitallmu
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Siegen, Allemagne, 57074
- Recrutement
- Diakonie Klinikum Jung Stilling Krankenhaus
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Stuttgart, Allemagne, 70376
- Recrutement
- Robert Bosch Krankenhaus, Abteilung Hamatologie, Onkologie Und Palliativmedizin
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Caba, Argentine, CP1114
- Actif, ne recrute pas
- FUNDALEU
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Caba, Argentine, 1425
- Recrutement
- Hospital Aleman
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Ciudad Autonoma Buenos Aires, Argentine, 1413
- Actif, ne recrute pas
- Hospital Italiano de Buenos Aires
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Córdoba, Argentine, X5000HUA
- Actif, ne recrute pas
- Hospital Universitario de Cordoba
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Queensland
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Birtinya, Queensland, Australie, QLD 4575
- Actif, ne recrute pas
- Sunshine Coast Hospital and Health Service
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Victoria
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Box Hill, Victoria, Australie, VIC 3128
- Actif, ne recrute pas
- Box Hill Hospital
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Clayton, Victoria, Australie, VIC 3168
- Actif, ne recrute pas
- Monash Health
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Western Australia
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Cooloongup, Western Australia, Australie, WA 6168
- Actif, ne recrute pas
- Rockingham Hospital
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West Perth, Western Australia, Australie, WA 6005
- Actif, ne recrute pas
- Perth Blood Institute
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Barretos, Brésil, 14.784-400
- Actif, ne recrute pas
- Fundacao Pio Xii Hospital de Amor de Barretos
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Belo Horizonte, Brésil, 30110-068
- Actif, ne recrute pas
- Hospital Felicio Rocho
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Campinas, Brésil, 13083-878
- Actif, ne recrute pas
- Universidade de Campinas Centro de Hematologia E Hemoterapia
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Caxias do Sul, Brésil, 95070-560
- Actif, ne recrute pas
- Fundacao Universidade de Caxias Do Sul
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Curitiba, Brésil, 81520-060
- Actif, ne recrute pas
- Hospital Erasto Gaertner
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Joinville, Brésil, 89201-260
- Actif, ne recrute pas
- Instituto Joinvilense de Hematologia E Oncologia
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Porto AlegreRS, Brésil, 900350-903
- Actif, ne recrute pas
- Hospital de Clinicas de Porto Alegre
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Recife, Brésil, 50040-000
- Actif, ne recrute pas
- Hospital Do Cancer de Pernambuco
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São Paulo, Brésil, 05403-010
- Actif, ne recrute pas
- Hcfmusp Pesquisa Clinica Do Servico de Hematologia E Terapia Celular
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Vitória, Brésil, 29043-260
- Recrutement
- Hospital Santa Rita de Cassia Afecc
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Beijing Municipality
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Beijing, Beijing Municipality, Chine, 100142
- Recrutement
- Beijing Cancer Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Chine, 630014
- Recrutement
- The First Affiliated Hospital of Chongqing Medical University
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Guangdong
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Guangzhou, Guangdong, Chine, 510515
- Recrutement
- Nanfang Hospital, Southern Medical University
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Guangzhou, Guangdong, Chine, 510060
- Recrutement
- Sun Yat Sen University Cancer Center
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Heilongjiang
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Harbin, Heilongjiang, Chine, 150000
- Recrutement
- Harbin Medical University Cancer Hospital
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Henan
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Zhengzhou, Henan, Chine, 450052
- Recrutement
- The First Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan, Hubei, Chine, 430030
- Actif, ne recrute pas
- Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
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Wuhan, Hubei, Chine, 430022
- Actif, ne recrute pas
- Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
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Jiangsu
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Nanjing, Jiangsu, Chine, 210029
- Recrutement
- Jiangsu Province Hospital
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Xuzhou, Jiangsu, Chine, 221000
- Recrutement
- The Affiliated Hospital of Xuzhou Medical University
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Jiangxi
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Nanchang, Jiangxi, Chine, 330029
- Recrutement
- Jiangxi Cancer Hospital
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Liaoning
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Shenyang, Liaoning, Chine, 110042
- Recrutement
- Liaoning Cancer Hospital and Institute
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Shaanxi
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Xi'an, Shaanxi, Chine, 710068
- Recrutement
- Shaanxi Provincial Peoples Hospital
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Shandong
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Linyi, Shandong, Chine, 276001
- Recrutement
- Linyi Cancer Hospital
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Qingdao, Shandong, Chine, 266555
- Recrutement
- The Affiliated Hospital of Qingdao University Branch West Coast
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chine, 200000
- Recrutement
- Fudan University Shanghai Cancer Center
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Sichuan
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Chengdu, Sichuan, Chine, 610071
- Recrutement
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
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Zhejiang
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Hangzhou, Zhejiang, Chine, 310002
- Recrutement
- The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
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Wenzhou, Zhejiang, Chine, 325000
- Recrutement
- The First Affiliated Hospital of Wenzhou Medical University
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Busan Gwang'Yeogsi
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Seogu, Busan Gwang'Yeogsi, Corée du Sud, 49241
- Actif, ne recrute pas
- Pusan National University Hospital
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Seoul Teugbyeolsi
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GangnamGu, Seoul Teugbyeolsi, Corée du Sud, 06351
- Actif, ne recrute pas
- Samsung Medical Center
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SeochoGu, Seoul Teugbyeolsi, Corée du Sud, 06591
- Actif, ne recrute pas
- The Catholic University of Korea, Seoul St Marys Hospital
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Seoul, Seoul Teugbyeolsi, Corée du Sud, 03080
- Actif, ne recrute pas
- Seoul National University Hospital
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SongpaGu, Seoul Teugbyeolsi, Corée du Sud, 05505
- Actif, ne recrute pas
- Asan Medical Center
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Yeongdeungpo-gu, Seoul Teugbyeolsi, Corée du Sud, 07345
- Actif, ne recrute pas
- The Catholic University of Korea, Yeouido St Marys Hospital
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Barcelona, Espagne, 08036
- Actif, ne recrute pas
- Hospital Clinic de Barcelona
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Barcelona, Espagne, 08907
- Actif, ne recrute pas
- Ico H Duran I Reynals
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Madrid, Espagne, 28040
- Complété
- Hospital Universitario Fundacion Jimenez Diaz
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Majadahonda, Espagne, 28222
- Actif, ne recrute pas
- H Puerta de Hierro Majadahonda
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Montpellier, France, 34090
- Recrutement
- Chu Montpellier Hopital Saint Eloi
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Nantes, France, 44000
- Actif, ne recrute pas
- Centre Hospitalier Universitaire Nantes Hotel Dieu
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PierreBenite, France, 69495
- Actif, ne recrute pas
- Chu Hopital Lyon Sud
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Tours, France, 37000
- Recrutement
- Chu Tours Hopital Bretonneau
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Bologna, Italie, 40138
- Actif, ne recrute pas
- Policlinico Sorsola Malpighi, Aou Di Bologna
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Lecce, Italie, 73100
- Actif, ne recrute pas
- Ospedale Vito Fazzi, Asl Lecce
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Meldola, Italie, 47014
- Actif, ne recrute pas
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
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Trieste, Italie, 34129
- Actif, ne recrute pas
- Azienda Sanitaria Universitaria Giuliano Isontina
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Verona, Italie, 37134
- Actif, ne recrute pas
- Centroricerche Cliniche Di Verona Srl
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Yokohama, Japon, 221-0855
- Recrutement
- Yokohama Municipal Citizens Hospital
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Aichi-ken
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Nagoya, Aichi-ken, Japon, 464-8681
- Recrutement
- Aichi Cancer Center Hospital Clinical Oncology
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Toyohashishi, Aichi-ken, Japon, 441-8570
- Recrutement
- Toyohashi Municipal Hospital
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Chiba
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Chiba, Chiba, Japon, 260-8717
- Recrutement
- Chiba Cancer Center
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Ehime
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Matsuyama, Ehime, Japon, 790 8524
- Recrutement
- Matsuyama Red Cross Hospital
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Gifu
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Ōgaki, Gifu, Japon, 503-8502
- Recrutement
- Ogaki Municipal Hospital
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Hiroshima
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Hiroshima, Hiroshima, Japon, 730-8619
- Recrutement
- Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
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Hokkaido
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Sapporo, Hokkaido, Japon, 060-8648
- Recrutement
- Hokkaido University Hospital
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Hyōgo
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KobeShi, Hyōgo, Japon, 650-0047
- Recrutement
- Kobe City Medical Center General Hospital
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Kagoshima-ken
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Kagoshima, Kagoshima-ken, Japon, 890-8520
- Recrutement
- Kagoshima University Hospital
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Kanagawa
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Yokohama, Kanagawa, Japon, 241-8515
- Recrutement
- Kanagawa Cancer Center
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Miyagi
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Sendai, Miyagi, Japon, 980-8574
- Recrutement
- Tohoku University Hospital
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Okayama-ken
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Kurashikishi, Okayama-ken, Japon, 710-8602
- Recrutement
- Kurashiki Central Hospital
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Okayama, Okayama-ken, Japon, 701-1192
- Recrutement
- National Hospital Organization Okayama Medical Center
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Osaka
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Osaka, Osaka, Japon, 545-8586
- Recrutement
- Osaka Metropolitan University Hospital
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Osakashi, Osaka, Japon, 543-8555
- Recrutement
- Osaka Red Cross Hospital
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Saitama
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Koshigaya, Saitama, Japon, 503-8502
- Recrutement
- Dokkyo Medical University Saitama Medical Center
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Tokyo
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Bunkyoku, Tokyo, Japon, 113-8519
- Recrutement
- Institute of Science Tokyo Hospital
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Sankt Pölten, L'Autriche, 3100
- Actif, ne recrute pas
- Uk St Poelten
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Auckland, Nouvelle-Zélande, 0622
- Actif, ne recrute pas
- North Shore Hospital
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Christchurch, Nouvelle-Zélande, 8011
- Actif, ne recrute pas
- Christchurch Hospital
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Dunedin, Nouvelle-Zélande, 9016
- Actif, ne recrute pas
- Dunedin Hospital
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Tauranga, Nouvelle-Zélande, 3112
- Actif, ne recrute pas
- Tauranga Hospital
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Wellington, Nouvelle-Zélande, 6021
- Actif, ne recrute pas
- Wellington Regional Hospital (Ccdhb)
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Krakow, Pologne, 30-727
- Actif, ne recrute pas
- Pratia McM Krakow
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Lodz, Pologne, 93-510
- Actif, ne recrute pas
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
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Lublin, Pologne, 20-090
- Actif, ne recrute pas
- Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
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Skorzewo, Pologne, 60-185
- Actif, ne recrute pas
- Aidport Sp Z O O
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Wroclaw, Pologne, 53-439
- Actif, ne recrute pas
- Dolnoslaskie Centrum Onkologii, Pulmonologii I Hematologii
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San Juan, Porto Rico, 00917
- Recrutement
- Auxilio Mutuo Cancer Center
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Birmingham, Royaume-Uni, B9 5SS
- Recrutement
- Birmingham Heartlands Hospital
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Bournemouth, Royaume-Uni, BH7 7DW
- Recrutement
- The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
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Glasgow, Royaume-Uni, G12 0YN
- Recrutement
- Beatson West of Scotland Cancer Centre
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Headington, Royaume-Uni, OX3 7LE
- Recrutement
- Oxford University Hospitals Nhs Trust Churchill Hospital
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London, Royaume-Uni, NW1 2PG
- Recrutement
- University College Hospital
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Metropolitan Borough of Wirral, Royaume-Uni, CH63 4JY
- Recrutement
- Clatterbridge Cancer Centre
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Plymouth, Royaume-Uni, PL6 8DH
- Recrutement
- Derriford Hospital
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Ankara, Turquie (Türkiye), 06170
- Actif, ne recrute pas
- Etlik City Hospital
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Dokuma, Turquie (Türkiye), 07025
- Actif, ne recrute pas
- Antalya Memorial Hospital
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Kocaeli, Turquie (Türkiye), 41380
- Actif, ne recrute pas
- Kocaeli Universitesi Tip Fakultesi
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Alabama
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Birmingham, Alabama, États-Unis, 35294-0004
- Recrutement
- University of Alabama At Birmingham Hospital
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Arizona
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Tucson, Arizona, États-Unis, 85724-0001
- Recrutement
- University of Arizona Cancer Center
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California
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Fresno, California, États-Unis, 93701
- Recrutement
- Ucsf Fresno
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Irvine, California, États-Unis, 92618-3734
- Recrutement
- Kaiser Permanente Southern California
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Connecticut
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New Haven, Connecticut, États-Unis, 06520-8028
- Recrutement
- Yale University Yale Cancer Center
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Florida
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Pembroke Pines, Florida, États-Unis, 33026-4119
- Recrutement
- Memorial Cancer Institute, Memorial Healthcare System
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Weston, Florida, États-Unis, 33331-3609
- Recrutement
- Cleveland Clinic Florida
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Illinois
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Chicago, Illinois, États-Unis, 60607
- Recrutement
- Rush University Medical Center
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Chicago, Illinois, États-Unis, 60637-1443
- Recrutement
- University of Chicago Medical Center
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Indiana
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Fort Wayne, Indiana, États-Unis, 46804
- Recrutement
- Fort Wayne Medical Oncology and Hematology
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Iowa
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Waukee, Iowa, États-Unis, 50263
- Recrutement
- Mission Cancer and Blood
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Louisiana
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Baton Rouge, Louisiana, États-Unis, 70808-4365
- Recrutement
- Our Lady of the Lake Hospital
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Maryland
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Baltimore, Maryland, États-Unis, 21201
- Recrutement
- The University of Maryland Greenebaum Comprehensive Cancer Center
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Massachusetts
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Boston, Massachusetts, États-Unis, 02215-5418
- Recrutement
- Dana Farber Cancer Institute Longwood Medical Center
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109-1382
- Recrutement
- University of Michigan
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Grand Rapids, Michigan, États-Unis, 49503-2563
- Recrutement
- The Cancer and Hematology Centers
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Minnesota
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Rochester, Minnesota, États-Unis, 55905-0001
- Recrutement
- Mayo Clinic Rochester
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Mississippi
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Hattiesburg, Mississippi, États-Unis, 39401-7233
- Recrutement
- Hattiesburg Hematology and Oncology Clinic
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Missouri
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St Louis, Missouri, États-Unis, 63110-1010
- Recrutement
- Washington University School of Medicine
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Nebraska
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Grand Island, Nebraska, États-Unis, 68803
- Recrutement
- Nebraska Cancer Specialists St Francis Grand Island
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Omaha, Nebraska, États-Unis, 68130-2042
- Recrutement
- Nebraska Cancer Specialists
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New Jersey
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Paramus, New Jersey, États-Unis, 07652
- Recrutement
- The Valley Hospital, Inc
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New York
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New York, New York, États-Unis, 10065-6800
- Recrutement
- Memorial Sloan Kettering Cancer Center Mskcc
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North Carolina
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Charlotte, North Carolina, États-Unis, 28204-2990
- Recrutement
- Atrium Health Levine Cancer Institute (Lci)
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Durham, North Carolina, États-Unis, 27710
- Recrutement
- Duke University
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Winston-Salem, North Carolina, États-Unis, 27157
- Recrutement
- Atrium Health Wake Forest Baptist
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Ohio
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Cleveland, Ohio, États-Unis, 44195-0001
- Recrutement
- Cleveland Clinic Foundation
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Cleveland, Ohio, États-Unis, 44106-1716
- Recrutement
- University Hospitals
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Columbus, Ohio, États-Unis, 43210-1280
- Recrutement
- Ohio State University Comprehensive Cancer Center
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Columbus, Ohio, États-Unis, 43214-3907
- Recrutement
- Ohio Health Research Institute
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Pennsylvania
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Hershey, Pennsylvania, États-Unis, 17033
- Recrutement
- Penn State Milton S Hershey Medical Center
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West Reading, Pennsylvania, États-Unis, 19611-2143
- Recrutement
- McGlinn Cancer Institute
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Tennessee
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Nashville, Tennessee, États-Unis, 37205
- Recrutement
- Tennessee Oncology
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Nashville, Tennessee, États-Unis, 37205
- Recrutement
- Tennessee Oncology Nashville St Thomas Midtown Clinic
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Texas
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Houston, Texas, États-Unis, 77030-3907
- Recrutement
- Md Anderson Cancer Center
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Round Rock, Texas, États-Unis, 78681-4019
- Recrutement
- Texas Oncology Austin Midtown
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Virginia
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Charlottesville, Virginia, États-Unis, 22908-0817
- Recrutement
- University of Virginia
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Gainesville, Virginia, États-Unis, 20155-3257
- Recrutement
- Virgina Cancer Specialists
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Richmond, Virginia, États-Unis, 23298-5026
- Recrutement
- Vcu Massey Cancer Center
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Washington
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Vancouver, Washington, États-Unis, 98684-6930
- Recrutement
- Northwest Cancer Specialist, Pc(Us Oncology Research)
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Wisconsin
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Madison, Wisconsin, États-Unis, 53792-0001
- Recrutement
- University of Wisconsin
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Arm A: sonrotoclax plus zanubrutinib
Sonrotoclax and zanubrutinib will be administered in combination. |
Administered orally
Autres noms:
Administered orally
Autres noms:
|
|
Comparateur placebo: Arm B: placebo plus zanubrutinib
Placebo and zanubrutinib will be administered in combination. |
Administered orally Administered orally
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC)
Délai: Approximately 41 months
|
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first. |
Approximately 41 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Overall Survival (OS)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
|
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)
Délai: Approximately 58 months
|
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)
Délai: Approximately 58 months
|
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)
Délai: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 58 months
|
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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Study Director, BeOne Medicines
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- BGB-11417-302
- 2024-515593-27-00 (Ctis)
- CTR20250207 (Identificateur de registre: ChinaDrugTrials)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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.
Délai de partage IPD
See plan description
Critères d'accès au partage IPD
See plan description
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
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