Studie ke zkoumání účinnosti a bezpečnosti přípravku Sonrotoclax plus Zanubrutinib ve srovnání s placebem plus Zanubrutinib u dospělých s relapsem/refrakterním lymfomem z plášťových buněk
Randomizovaná dvojitě slepá multicentrická studie fáze 3 Sonrotoclax Plus Zanubrutinib versus Placebo Plus Zanubrutinib u pacientů s relapsem/refrakterním lymfomem z plášťových buněk
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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 3
Kontakty a umístění
Studijní kontakt
- Jméno: Study Director
- Telefonní číslo: 1.877.828.5568
- E-mail: clinicaltrials@beonemed.com
Studijní místa
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Caba, Argentina, CP1114
- Aktivní, ne nábor
- FUNDALEU
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Caba, Argentina, 1425
- Nábor
- Hospital Aleman
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Ciudad Autonoma Buenos Aires, Argentina, 1413
- Aktivní, ne nábor
- Hospital Italiano de Buenos Aires
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Córdoba, Argentina, X5000HUA
- Aktivní, ne nábor
- Hospital Universitario de Cordoba
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Queensland
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Birtinya, Queensland, Austrálie, QLD 4575
- Aktivní, ne nábor
- Sunshine Coast Hospital and Health Service
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Victoria
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Box Hill, Victoria, Austrálie, VIC 3128
- Aktivní, ne nábor
- Box Hill Hospital
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Clayton, Victoria, Austrálie, VIC 3168
- Aktivní, ne nábor
- Monash Health
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Western Australia
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Cooloongup, Western Australia, Austrálie, WA 6168
- Aktivní, ne nábor
- Rockingham Hospital
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West Perth, Western Australia, Austrálie, WA 6005
- Aktivní, ne nábor
- Perth Blood Institute
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Barretos, Brazílie, 14.784-400
- Aktivní, ne nábor
- Fundacao Pio Xii Hospital de Amor de Barretos
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Belo Horizonte, Brazílie, 30110-068
- Aktivní, ne nábor
- Hospital Felicio Rocho
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Campinas, Brazílie, 13083-878
- Aktivní, ne nábor
- Universidade de Campinas Centro de Hematologia E Hemoterapia
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Caxias do Sul, Brazílie, 95070-560
- Aktivní, ne nábor
- Fundacao Universidade de Caxias Do Sul
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Curitiba, Brazílie, 81520-060
- Aktivní, ne nábor
- Hospital Erasto Gaertner
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Joinville, Brazílie, 89201-260
- Aktivní, ne nábor
- Instituto Joinvilense de Hematologia E Oncologia
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Porto AlegreRS, Brazílie, 900350-903
- Aktivní, ne nábor
- Hospital de Clinicas de Porto Alegre
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Recife, Brazílie, 50040-000
- Aktivní, ne nábor
- Hospital Do Cancer de Pernambuco
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São Paulo, Brazílie, 05403-010
- Aktivní, ne nábor
- Hcfmusp Pesquisa Clinica Do Servico de Hematologia E Terapia Celular
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Vitória, Brazílie, 29043-260
- Nábor
- Hospital Santa Rita de Cassia Afecc
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Montpellier, Francie, 34090
- Nábor
- Chu Montpellier Hopital Saint Eloi
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Nantes, Francie, 44000
- Aktivní, ne nábor
- Centre Hospitalier Universitaire Nantes Hotel Dieu
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PierreBenite, Francie, 69495
- Aktivní, ne nábor
- Chu Hopital Lyon Sud
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Tours, Francie, 37000
- Nábor
- Chu Tours Hopital Bretonneau
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Bologna, Itálie, 40138
- Aktivní, ne nábor
- Policlinico Sorsola Malpighi, Aou Di Bologna
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Lecce, Itálie, 73100
- Aktivní, ne nábor
- Ospedale Vito Fazzi, Asl Lecce
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Meldola, Itálie, 47014
- Aktivní, ne nábor
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
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Trieste, Itálie, 34129
- Aktivní, ne nábor
- Azienda Sanitaria Universitaria Giuliano Isontina
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Verona, Itálie, 37134
- Aktivní, ne nábor
- Centroricerche Cliniche Di Verona Srl
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Yokohama, Japonsko, 221-0855
- Nábor
- Yokohama Municipal Citizens Hospital
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Aichi-ken
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Nagoya, Aichi-ken, Japonsko, 464-8681
- Nábor
- Aichi Cancer Center Hospital Clinical Oncology
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Toyohashishi, Aichi-ken, Japonsko, 441-8570
- Nábor
- Toyohashi Municipal Hospital
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Chiba
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Chiba, Chiba, Japonsko, 260-8717
- Nábor
- Chiba Cancer Center
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Ehime
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Matsuyama, Ehime, Japonsko, 790 8524
- Nábor
- Matsuyama Red Cross Hospital
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Gifu
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Ōgaki, Gifu, Japonsko, 503-8502
- Nábor
- Ogaki Municipal Hospital
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Hiroshima
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Hiroshima, Hiroshima, Japonsko, 730-8619
- Nábor
- Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
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Hokkaido
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Sapporo, Hokkaido, Japonsko, 060-8648
- Nábor
- Hokkaido University Hospital
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Hyōgo
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KobeShi, Hyōgo, Japonsko, 650-0047
- Nábor
- Kobe City Medical Center General Hospital
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Kagoshima-ken
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Kagoshima, Kagoshima-ken, Japonsko, 890-8520
- Nábor
- Kagoshima University Hospital
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Kanagawa
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Yokohama, Kanagawa, Japonsko, 241-8515
- Nábor
- Kanagawa Cancer Center
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Miyagi
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Sendai, Miyagi, Japonsko, 980-8574
- Nábor
- Tohoku University Hospital
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Okayama-ken
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Kurashikishi, Okayama-ken, Japonsko, 710-8602
- Nábor
- Kurashiki Central Hospital
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Okayama, Okayama-ken, Japonsko, 701-1192
- Nábor
- National Hospital Organization Okayama Medical Center
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Osaka
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Osaka, Osaka, Japonsko, 545-8586
- Nábor
- Osaka Metropolitan University Hospital
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Osakashi, Osaka, Japonsko, 543-8555
- Nábor
- Osaka Red Cross Hospital
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Saitama
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Koshigaya, Saitama, Japonsko, 503-8502
- Nábor
- Dokkyo Medical University Saitama Medical Center
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Tokyo
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Bunkyoku, Tokyo, Japonsko, 113-8519
- Nábor
- Institute of Science Tokyo Hospital
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Busan Gwang'Yeogsi
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Seogu, Busan Gwang'Yeogsi, Jižní Korea, 49241
- Aktivní, ne nábor
- Pusan National University Hospital
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Seoul Teugbyeolsi
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GangnamGu, Seoul Teugbyeolsi, Jižní Korea, 06351
- Aktivní, ne nábor
- Samsung Medical Center
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SeochoGu, Seoul Teugbyeolsi, Jižní Korea, 06591
- Aktivní, ne nábor
- The Catholic University of Korea, Seoul St Marys Hospital
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Seoul, Seoul Teugbyeolsi, Jižní Korea, 03080
- Aktivní, ne nábor
- Seoul National University Hospital
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SongpaGu, Seoul Teugbyeolsi, Jižní Korea, 05505
- Aktivní, ne nábor
- Asan Medical Center
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Yeongdeungpo-gu, Seoul Teugbyeolsi, Jižní Korea, 07345
- Aktivní, ne nábor
- The Catholic University of Korea, Yeouido St Marys Hospital
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Auckland, Nový Zéland, 0622
- Aktivní, ne nábor
- North Shore Hospital
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Christchurch, Nový Zéland, 8011
- Aktivní, ne nábor
- Christchurch Hospital
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Dunedin, Nový Zéland, 9016
- Aktivní, ne nábor
- Dunedin Hospital
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Tauranga, Nový Zéland, 3112
- Aktivní, ne nábor
- Tauranga Hospital
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Wellington, Nový Zéland, 6021
- Aktivní, ne nábor
- Wellington Regional Hospital (Ccdhb)
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Chemnitz, Německo, 09116
- Nábor
- Klinikum Chemnitz Ggmbh
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Frankfurt am Main, Německo, 60596
- Nábor
- Universitatsklinikum Frankfurt
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Halle, Německo, 06120
- Nábor
- Universitatsklinikum Halle
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Mutlangen, Německo, 73557
- Nábor
- Stauferklinikum Schwabisch Gmund Kliniken Ostalb
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München, Německo, 81377
- Nábor
- Dept of Medicine Iii, University Hospitallmu
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Siegen, Německo, 57074
- Nábor
- Diakonie Klinikum Jung Stilling Krankenhaus
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Stuttgart, Německo, 70376
- Nábor
- Robert Bosch Krankenhaus, Abteilung Hamatologie, Onkologie Und Palliativmedizin
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Krakow, Polsko, 30-727
- Aktivní, ne nábor
- Pratia McM Krakow
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Lodz, Polsko, 93-510
- Aktivní, ne nábor
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
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Lublin, Polsko, 20-090
- Aktivní, ne nábor
- Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
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Skorzewo, Polsko, 60-185
- Aktivní, ne nábor
- Aidport Sp Z O O
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Wroclaw, Polsko, 53-439
- Aktivní, ne nábor
- Dolnoslaskie Centrum Onkologii, Pulmonologii I Hematologii
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San Juan, Portoriko, 00917
- Nábor
- Auxilio Mutuo Cancer Center
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Sankt Pölten, Rakousko, 3100
- Aktivní, ne nábor
- Uk St Poelten
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Birmingham, Spojené království, B9 5SS
- Nábor
- Birmingham Heartlands Hospital
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Bournemouth, Spojené království, BH7 7DW
- Nábor
- The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
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Glasgow, Spojené království, G12 0YN
- Nábor
- Beatson West of Scotland Cancer Centre
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Headington, Spojené království, OX3 7LE
- Nábor
- Oxford University Hospitals Nhs Trust Churchill Hospital
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London, Spojené království, NW1 2PG
- Nábor
- University College Hospital
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Metropolitan Borough of Wirral, Spojené království, CH63 4JY
- Nábor
- Clatterbridge Cancer Centre
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Plymouth, Spojené království, PL6 8DH
- Nábor
- Derriford Hospital
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Alabama
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Birmingham, Alabama, Spojené státy, 35294-0004
- Nábor
- University of Alabama At Birmingham Hospital
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Arizona
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Tucson, Arizona, Spojené státy, 85724-0001
- Nábor
- University of Arizona Cancer Center
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California
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Fresno, California, Spojené státy, 93701
- Nábor
- Ucsf Fresno
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Irvine, California, Spojené státy, 92618-3734
- Nábor
- Kaiser Permanente Southern California
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Connecticut
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New Haven, Connecticut, Spojené státy, 06520-8028
- Nábor
- Yale University Yale Cancer Center
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Florida
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Pembroke Pines, Florida, Spojené státy, 33026-4119
- Nábor
- Memorial Cancer Institute, Memorial Healthcare System
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Weston, Florida, Spojené státy, 33331-3609
- Nábor
- Cleveland Clinic Florida
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Illinois
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Chicago, Illinois, Spojené státy, 60607
- Nábor
- Rush University Medical Center
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Chicago, Illinois, Spojené státy, 60637-1443
- Nábor
- University of Chicago Medical Center
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Indiana
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Fort Wayne, Indiana, Spojené státy, 46804
- Nábor
- Fort Wayne Medical Oncology and Hematology
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Iowa
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Waukee, Iowa, Spojené státy, 50263
- Nábor
- Mission Cancer and Blood
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Louisiana
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Baton Rouge, Louisiana, Spojené státy, 70808-4365
- Nábor
- Our Lady of the Lake Hospital
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Maryland
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Baltimore, Maryland, Spojené státy, 21201
- Nábor
- The University of Maryland Greenebaum Comprehensive Cancer Center
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02215-5418
- Nábor
- Dana Farber Cancer Institute Longwood Medical Center
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Michigan
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Ann Arbor, Michigan, Spojené státy, 48109-1382
- Nábor
- University of Michigan
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Grand Rapids, Michigan, Spojené státy, 49503-2563
- Nábor
- The Cancer and Hematology Centers
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Minnesota
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Rochester, Minnesota, Spojené státy, 55905-0001
- Nábor
- Mayo Clinic Rochester
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Mississippi
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Hattiesburg, Mississippi, Spojené státy, 39401-7233
- Nábor
- Hattiesburg Hematology and Oncology Clinic
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Missouri
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St Louis, Missouri, Spojené státy, 63110-1010
- Nábor
- Washington University School of Medicine
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Nebraska
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Grand Island, Nebraska, Spojené státy, 68803
- Nábor
- Nebraska Cancer Specialists St Francis Grand Island
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Omaha, Nebraska, Spojené státy, 68130-2042
- Nábor
- Nebraska Cancer Specialists
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New Jersey
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Paramus, New Jersey, Spojené státy, 07652
- Nábor
- The Valley Hospital, Inc
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New York
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New York, New York, Spojené státy, 10065-6800
- Nábor
- Memorial Sloan Kettering Cancer Center Mskcc
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North Carolina
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Charlotte, North Carolina, Spojené státy, 28204-2990
- Nábor
- Atrium Health Levine Cancer Institute (Lci)
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Durham, North Carolina, Spojené státy, 27710
- Nábor
- Duke University
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Winston-Salem, North Carolina, Spojené státy, 27157
- Nábor
- Atrium Health Wake Forest Baptist
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Ohio
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Cleveland, Ohio, Spojené státy, 44195-0001
- Nábor
- Cleveland Clinic Foundation
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Cleveland, Ohio, Spojené státy, 44106-1716
- Nábor
- University Hospitals
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Columbus, Ohio, Spojené státy, 43210-1280
- Nábor
- Ohio State University Comprehensive Cancer Center
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Columbus, Ohio, Spojené státy, 43214-3907
- Nábor
- Ohio Health Research Institute
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Pennsylvania
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Hershey, Pennsylvania, Spojené státy, 17033
- Nábor
- Penn State Milton S Hershey Medical Center
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West Reading, Pennsylvania, Spojené státy, 19611-2143
- Nábor
- McGlinn Cancer Institute
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Tennessee
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Nashville, Tennessee, Spojené státy, 37205
- Nábor
- Tennessee Oncology
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Nashville, Tennessee, Spojené státy, 37205
- Nábor
- Tennessee Oncology Nashville St Thomas Midtown Clinic
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Texas
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Houston, Texas, Spojené státy, 77030-3907
- Nábor
- Md Anderson Cancer Center
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Round Rock, Texas, Spojené státy, 78681-4019
- Nábor
- Texas Oncology Austin Midtown
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Virginia
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Charlottesville, Virginia, Spojené státy, 22908-0817
- Nábor
- University of Virginia
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Gainesville, Virginia, Spojené státy, 20155-3257
- Nábor
- Virgina Cancer Specialists
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Richmond, Virginia, Spojené státy, 23298-5026
- Nábor
- Vcu Massey Cancer Center
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Washington
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Vancouver, Washington, Spojené státy, 98684-6930
- Nábor
- Northwest Cancer Specialist, Pc(Us Oncology Research)
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Wisconsin
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Madison, Wisconsin, Spojené státy, 53792-0001
- Nábor
- University of Wisconsin
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-
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Ankara, Turecko (Türkiye), 06170
- Aktivní, ne nábor
- Etlik City Hospital
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Dokuma, Turecko (Türkiye), 07025
- Aktivní, ne nábor
- Antalya Memorial Hospital
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Kocaeli, Turecko (Türkiye), 41380
- Aktivní, ne nábor
- Kocaeli Universitesi Tip Fakultesi
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Beijing Municipality
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Beijing, Beijing Municipality, Čína, 100142
- Nábor
- Beijing Cancer Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Čína, 630014
- Nábor
- The First Affiliated Hospital of Chongqing Medical University
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Guangdong
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Guangzhou, Guangdong, Čína, 510515
- Nábor
- Nanfang Hospital, Southern Medical University
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Guangzhou, Guangdong, Čína, 510060
- Nábor
- Sun Yat Sen University Cancer Center
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Heilongjiang
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Harbin, Heilongjiang, Čína, 150000
- Nábor
- Harbin Medical University Cancer Hospital
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Henan
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Zhengzhou, Henan, Čína, 450052
- Nábor
- The First Affiliated Hospital of Zhengzhou University
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Hubei
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Wuhan, Hubei, Čína, 430030
- Aktivní, ne nábor
- Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
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Wuhan, Hubei, Čína, 430022
- Aktivní, ne nábor
- Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
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Jiangsu
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Nanjing, Jiangsu, Čína, 210029
- Nábor
- Jiangsu Province Hospital
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Xuzhou, Jiangsu, Čína, 221000
- Nábor
- The Affiliated Hospital of Xuzhou Medical University
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Jiangxi
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Nanchang, Jiangxi, Čína, 330029
- Nábor
- Jiangxi Cancer Hospital
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Liaoning
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Shenyang, Liaoning, Čína, 110042
- Nábor
- Liaoning Cancer Hospital and Institute
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Shaanxi
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Xi'an, Shaanxi, Čína, 710068
- Nábor
- Shaanxi Provincial Peoples Hospital
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Shandong
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Linyi, Shandong, Čína, 276001
- Nábor
- Linyi Cancer Hospital
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Qingdao, Shandong, Čína, 266555
- Nábor
- The Affiliated Hospital of Qingdao University Branch West Coast
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Čína, 200000
- Nábor
- Fudan University Shanghai Cancer Center
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Sichuan
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Chengdu, Sichuan, Čína, 610071
- Nábor
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
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Zhejiang
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Hangzhou, Zhejiang, Čína, 310002
- Nábor
- The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
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Wenzhou, Zhejiang, Čína, 325000
- Nábor
- The First Affiliated Hospital of Wenzhou Medical University
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-
-
-
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Barcelona, Španělsko, 08036
- Aktivní, ne nábor
- Hospital Clinic de Barcelona
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Barcelona, Španělsko, 08907
- Aktivní, ne nábor
- Ico H Duran I Reynals
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Madrid, Španělsko, 28040
- Dokončeno
- Hospital Universitario Fundacion Jimenez Diaz
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Majadahonda, Španělsko, 28222
- Aktivní, ne nábor
- H Puerta de Hierro Majadahonda
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Arm A: sonrotoclax plus zanubrutinib
Sonrotoclax and zanubrutinib will be administered in combination. |
Administered orally
Ostatní jména:
Administered orally
Ostatní jména:
|
|
Komparátor placeba: Arm B: placebo plus zanubrutinib
Placebo and zanubrutinib will be administered in combination. |
Administered orally Administered orally
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC)
Časové okno: Approximately 41 months
|
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first. |
Approximately 41 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Overall Survival (OS)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Study Director, BeOne Medicines
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- BGB-11417-302
- 2024-515593-27-00 (Ctis)
- CTR20250207 (Identifikátor registru: ChinaDrugTrials)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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.
Časový rámec sdílení IPD
See plan description
Kritéria přístupu pro sdílení IPD
See plan description
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- CSR
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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