En studie för att undersöka effektiviteten och säkerheten av Sonrotoclax Plus Zanubrutinib jämfört med Placebo Plus Zanubrutinib hos vuxna med återfall/refraktärt mantelcellslymfom
En fas 3 randomiserad dubbelblind multicenterstudie av Sonrotoclax Plus Zanubrutinib kontra placebo Plus Zanubrutinib hos patienter med återfall/refraktärt mantelcellslymfom
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studiekontakt
- Namn: Study Director
- Telefonnummer: 1.877.828.5568
- E-post: clinicaltrials@beonemed.com
Studieorter
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Caba, Argentina, CP1114
- Aktiv, inte rekryterande
- FUNDALEU
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Caba, Argentina, 1425
- Rekrytering
- Hospital Aleman
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Ciudad Autonoma Buenos Aires, Argentina, 1413
- Aktiv, inte rekryterande
- Hospital Italiano de Buenos Aires
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Córdoba, Argentina, X5000HUA
- Aktiv, inte rekryterande
- Hospital Universitario de Cordoba
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Queensland
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Birtinya, Queensland, Australien, QLD 4575
- Aktiv, inte rekryterande
- Sunshine Coast Hospital and Health Service
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Victoria
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Box Hill, Victoria, Australien, VIC 3128
- Aktiv, inte rekryterande
- Box Hill Hospital
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Clayton, Victoria, Australien, VIC 3168
- Aktiv, inte rekryterande
- Monash Health
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Western Australia
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Cooloongup, Western Australia, Australien, WA 6168
- Aktiv, inte rekryterande
- Rockingham Hospital
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West Perth, Western Australia, Australien, WA 6005
- Aktiv, inte rekryterande
- Perth Blood Institute
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-
-
-
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Barretos, Brasilien, 14.784-400
- Aktiv, inte rekryterande
- Fundacao Pio Xii Hospital de Amor de Barretos
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Belo Horizonte, Brasilien, 30110-068
- Aktiv, inte rekryterande
- Hospital Felicio Rocho
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Campinas, Brasilien, 13083-878
- Aktiv, inte rekryterande
- Universidade de Campinas Centro de Hematologia E Hemoterapia
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Caxias do Sul, Brasilien, 95070-560
- Aktiv, inte rekryterande
- Fundacao Universidade de Caxias Do Sul
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Curitiba, Brasilien, 81520-060
- Aktiv, inte rekryterande
- Hospital Erasto Gaertner
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Joinville, Brasilien, 89201-260
- Aktiv, inte rekryterande
- Instituto Joinvilense de Hematologia E Oncologia
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Porto AlegreRS, Brasilien, 900350-903
- Aktiv, inte rekryterande
- Hospital de Clinicas de Porto Alegre
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Recife, Brasilien, 50040-000
- Aktiv, inte rekryterande
- Hospital Do Cancer de Pernambuco
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São Paulo, Brasilien, 05403-010
- Aktiv, inte rekryterande
- Hcfmusp Pesquisa Clinica Do Servico de Hematologia E Terapia Celular
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Vitória, Brasilien, 29043-260
- Rekrytering
- Hospital Santa Rita de Cassia Afecc
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-
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Montpellier, Frankrike, 34090
- Rekrytering
- Chu Montpellier Hopital Saint Eloi
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Nantes, Frankrike, 44000
- Aktiv, inte rekryterande
- Centre Hospitalier Universitaire Nantes Hotel Dieu
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PierreBenite, Frankrike, 69495
- Aktiv, inte rekryterande
- Chu Hopital Lyon Sud
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Tours, Frankrike, 37000
- Rekrytering
- Chu Tours Hopital Bretonneau
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Alabama
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Birmingham, Alabama, Förenta staterna, 35294-0004
- Rekrytering
- University of Alabama At Birmingham Hospital
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Arizona
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Tucson, Arizona, Förenta staterna, 85724-0001
- Rekrytering
- University of Arizona Cancer Center
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California
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Fresno, California, Förenta staterna, 93701
- Rekrytering
- Ucsf Fresno
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Irvine, California, Förenta staterna, 92618-3734
- Rekrytering
- Kaiser Permanente Southern California
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Connecticut
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New Haven, Connecticut, Förenta staterna, 06520-8028
- Rekrytering
- Yale University Yale Cancer Center
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Florida
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Pembroke Pines, Florida, Förenta staterna, 33026-4119
- Rekrytering
- Memorial Cancer Institute, Memorial Healthcare System
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Weston, Florida, Förenta staterna, 33331-3609
- Rekrytering
- Cleveland Clinic Florida
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-
Illinois
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Chicago, Illinois, Förenta staterna, 60607
- Rekrytering
- Rush University Medical Center
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Chicago, Illinois, Förenta staterna, 60637-1443
- Rekrytering
- University of Chicago Medical Center
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-
Indiana
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Fort Wayne, Indiana, Förenta staterna, 46804
- Rekrytering
- Fort Wayne Medical Oncology and Hematology
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-
Iowa
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Waukee, Iowa, Förenta staterna, 50263
- Rekrytering
- Mission Cancer and Blood
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Louisiana
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Baton Rouge, Louisiana, Förenta staterna, 70808-4365
- Rekrytering
- Our Lady of the Lake Hospital
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Maryland
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Baltimore, Maryland, Förenta staterna, 21201
- Rekrytering
- The University of Maryland Greenebaum Comprehensive Cancer Center
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02215-5418
- Rekrytering
- Dana Farber Cancer Institute Longwood Medical Center
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48109-1382
- Rekrytering
- University of Michigan
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Grand Rapids, Michigan, Förenta staterna, 49503-2563
- Rekrytering
- The Cancer and Hematology Centers
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Minnesota
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Rochester, Minnesota, Förenta staterna, 55905-0001
- Rekrytering
- Mayo Clinic Rochester
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Mississippi
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Hattiesburg, Mississippi, Förenta staterna, 39401-7233
- Rekrytering
- Hattiesburg Hematology and Oncology Clinic
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-
Missouri
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St Louis, Missouri, Förenta staterna, 63110-1010
- Rekrytering
- Washington University School of Medicine
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-
Nebraska
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Grand Island, Nebraska, Förenta staterna, 68803
- Rekrytering
- Nebraska Cancer Specialists St Francis Grand Island
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Omaha, Nebraska, Förenta staterna, 68130-2042
- Rekrytering
- Nebraska Cancer Specialists
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New Jersey
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Paramus, New Jersey, Förenta staterna, 07652
- Rekrytering
- The Valley Hospital, Inc
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New York
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New York, New York, Förenta staterna, 10065-6800
- Rekrytering
- Memorial Sloan Kettering Cancer Center Mskcc
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North Carolina
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Charlotte, North Carolina, Förenta staterna, 28204-2990
- Rekrytering
- Atrium Health Levine Cancer Institute (Lci)
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Durham, North Carolina, Förenta staterna, 27710
- Rekrytering
- Duke University
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Winston-Salem, North Carolina, Förenta staterna, 27157
- Rekrytering
- Atrium Health Wake Forest Baptist
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Ohio
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Cleveland, Ohio, Förenta staterna, 44195-0001
- Rekrytering
- Cleveland Clinic Foundation
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Cleveland, Ohio, Förenta staterna, 44106-1716
- Rekrytering
- University Hospitals
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Columbus, Ohio, Förenta staterna, 43210-1280
- Rekrytering
- Ohio State University Comprehensive Cancer Center
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Columbus, Ohio, Förenta staterna, 43214-3907
- Rekrytering
- Ohio Health Research Institute
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Pennsylvania
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Hershey, Pennsylvania, Förenta staterna, 17033
- Rekrytering
- Penn State Milton S Hershey Medical Center
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West Reading, Pennsylvania, Förenta staterna, 19611-2143
- Rekrytering
- McGlinn Cancer Institute
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Tennessee
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Nashville, Tennessee, Förenta staterna, 37205
- Rekrytering
- Tennessee Oncology
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Nashville, Tennessee, Förenta staterna, 37205
- Rekrytering
- Tennessee Oncology Nashville St Thomas Midtown Clinic
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Texas
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Houston, Texas, Förenta staterna, 77030-3907
- Rekrytering
- Md Anderson Cancer Center
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Round Rock, Texas, Förenta staterna, 78681-4019
- Rekrytering
- Texas Oncology Austin Midtown
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Virginia
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Charlottesville, Virginia, Förenta staterna, 22908-0817
- Rekrytering
- University of Virginia
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Gainesville, Virginia, Förenta staterna, 20155-3257
- Rekrytering
- Virgina Cancer Specialists
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Richmond, Virginia, Förenta staterna, 23298-5026
- Rekrytering
- Vcu Massey Cancer Center
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Washington
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Vancouver, Washington, Förenta staterna, 98684-6930
- Rekrytering
- Northwest Cancer Specialist, Pc(Us Oncology Research)
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Wisconsin
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Madison, Wisconsin, Förenta staterna, 53792-0001
- Rekrytering
- University of Wisconsin
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Bologna, Italien, 40138
- Aktiv, inte rekryterande
- Policlinico Sorsola Malpighi, Aou Di Bologna
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Lecce, Italien, 73100
- Aktiv, inte rekryterande
- Ospedale Vito Fazzi, Asl Lecce
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Meldola, Italien, 47014
- Aktiv, inte rekryterande
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
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Trieste, Italien, 34129
- Aktiv, inte rekryterande
- Azienda Sanitaria Universitaria Giuliano Isontina
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Verona, Italien, 37134
- Aktiv, inte rekryterande
- Centroricerche Cliniche Di Verona Srl
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Yokohama, Japan, 221-0855
- Rekrytering
- Yokohama Municipal Citizens Hospital
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 464-8681
- Rekrytering
- Aichi Cancer Center Hospital Clinical Oncology
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Toyohashishi, Aichi-ken, Japan, 441-8570
- Rekrytering
- Toyohashi Municipal Hospital
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Chiba
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Chiba, Chiba, Japan, 260-8717
- Rekrytering
- Chiba Cancer Center
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Ehime
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Matsuyama, Ehime, Japan, 790 8524
- Rekrytering
- Matsuyama Red Cross Hospital
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Gifu
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Ōgaki, Gifu, Japan, 503-8502
- Rekrytering
- Ogaki Municipal Hospital
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Hiroshima
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Hiroshima, Hiroshima, Japan, 730-8619
- Rekrytering
- Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
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Hokkaido
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Sapporo, Hokkaido, Japan, 060-8648
- Rekrytering
- Hokkaido University Hospital
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Hyōgo
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KobeShi, Hyōgo, Japan, 650-0047
- Rekrytering
- Kobe City Medical Center General Hospital
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Kagoshima-ken
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Kagoshima, Kagoshima-ken, Japan, 890-8520
- Rekrytering
- Kagoshima University Hospital
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Kanagawa
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Yokohama, Kanagawa, Japan, 241-8515
- Rekrytering
- Kanagawa Cancer Center
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Miyagi
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Sendai, Miyagi, Japan, 980-8574
- Rekrytering
- Tohoku University Hospital
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Okayama-ken
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Kurashikishi, Okayama-ken, Japan, 710-8602
- Rekrytering
- Kurashiki Central Hospital
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Okayama, Okayama-ken, Japan, 701-1192
- Rekrytering
- National Hospital Organization Okayama Medical Center
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Osaka
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Osaka, Osaka, Japan, 545-8586
- Rekrytering
- Osaka Metropolitan University Hospital
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Osakashi, Osaka, Japan, 543-8555
- Rekrytering
- Osaka Red Cross Hospital
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Saitama
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Koshigaya, Saitama, Japan, 503-8502
- Rekrytering
- Dokkyo Medical University Saitama Medical Center
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Tokyo
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Bunkyoku, Tokyo, Japan, 113-8519
- Rekrytering
- Institute of Science Tokyo Hospital
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100142
- Rekrytering
- Beijing Cancer Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Kina, 630014
- Rekrytering
- The First Affiliated Hospital of Chongqing Medical University
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Guangdong
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Guangzhou, Guangdong, Kina, 510515
- Rekrytering
- Nanfang Hospital, Southern Medical University
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Guangzhou, Guangdong, Kina, 510060
- Rekrytering
- Sun Yat Sen University Cancer Center
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Heilongjiang
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Harbin, Heilongjiang, Kina, 150000
- Rekrytering
- Harbin Medical University Cancer Hospital
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Henan
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Zhengzhou, Henan, Kina, 450052
- Rekrytering
- The First Affiliated Hospital of Zhengzhou University
-
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Hubei
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Wuhan, Hubei, Kina, 430030
- Aktiv, inte rekryterande
- Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
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Wuhan, Hubei, Kina, 430022
- Aktiv, inte rekryterande
- Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
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Jiangsu
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Nanjing, Jiangsu, Kina, 210029
- Rekrytering
- Jiangsu Province Hospital
-
Xuzhou, Jiangsu, Kina, 221000
- Rekrytering
- The Affiliated Hospital of Xuzhou Medical University
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Jiangxi
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Nanchang, Jiangxi, Kina, 330029
- Rekrytering
- Jiangxi Cancer Hospital
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Liaoning
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Shenyang, Liaoning, Kina, 110042
- Rekrytering
- Liaoning Cancer Hospital and Institute
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Shaanxi
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Xi'an, Shaanxi, Kina, 710068
- Rekrytering
- Shaanxi Provincial Peoples Hospital
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Shandong
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Linyi, Shandong, Kina, 276001
- Rekrytering
- Linyi Cancer Hospital
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Qingdao, Shandong, Kina, 266555
- Rekrytering
- The Affiliated Hospital of Qingdao University Branch West Coast
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200000
- Rekrytering
- Fudan University Shanghai Cancer Center
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Sichuan
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Chengdu, Sichuan, Kina, 610071
- Rekrytering
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310002
- Rekrytering
- The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
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Wenzhou, Zhejiang, Kina, 325000
- Rekrytering
- The First Affiliated Hospital of Wenzhou Medical University
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Auckland, Nya Zeeland, 0622
- Aktiv, inte rekryterande
- North Shore Hospital
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Christchurch, Nya Zeeland, 8011
- Aktiv, inte rekryterande
- Christchurch Hospital
-
Dunedin, Nya Zeeland, 9016
- Aktiv, inte rekryterande
- Dunedin Hospital
-
Tauranga, Nya Zeeland, 3112
- Aktiv, inte rekryterande
- Tauranga Hospital
-
Wellington, Nya Zeeland, 6021
- Aktiv, inte rekryterande
- Wellington Regional Hospital (Ccdhb)
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-
-
-
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Krakow, Polen, 30-727
- Aktiv, inte rekryterande
- Pratia McM Krakow
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Lodz, Polen, 93-510
- Aktiv, inte rekryterande
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
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Lublin, Polen, 20-090
- Aktiv, inte rekryterande
- Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
-
Skorzewo, Polen, 60-185
- Aktiv, inte rekryterande
- Aidport Sp Z O O
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Wroclaw, Polen, 53-439
- Aktiv, inte rekryterande
- Dolnoslaskie Centrum Onkologii, Pulmonologii I Hematologii
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-
-
-
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San Juan, Puerto Rico, 00917
- Rekrytering
- Auxilio Mutuo Cancer Center
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-
-
-
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Barcelona, Spanien, 08036
- Aktiv, inte rekryterande
- Hospital Clinic de Barcelona
-
Barcelona, Spanien, 08907
- Aktiv, inte rekryterande
- Ico H Duran I Reynals
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Madrid, Spanien, 28040
- Avslutad
- Hospital Universitario Fundacion Jimenez Diaz
-
Majadahonda, Spanien, 28222
- Aktiv, inte rekryterande
- H Puerta de Hierro Majadahonda
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-
-
-
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Birmingham, Storbritannien, B9 5SS
- Rekrytering
- Birmingham Heartlands Hospital
-
Bournemouth, Storbritannien, BH7 7DW
- Rekrytering
- The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
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Glasgow, Storbritannien, G12 0YN
- Rekrytering
- Beatson West of Scotland Cancer Centre
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Headington, Storbritannien, OX3 7LE
- Rekrytering
- Oxford University Hospitals Nhs Trust Churchill Hospital
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London, Storbritannien, NW1 2PG
- Rekrytering
- University College Hospital
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Metropolitan Borough of Wirral, Storbritannien, CH63 4JY
- Rekrytering
- Clatterbridge Cancer Centre
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Plymouth, Storbritannien, PL6 8DH
- Rekrytering
- Derriford Hospital
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-
-
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Busan Gwang'Yeogsi
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Seogu, Busan Gwang'Yeogsi, Sydkorea, 49241
- Aktiv, inte rekryterande
- Pusan National University Hospital
-
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Seoul Teugbyeolsi
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GangnamGu, Seoul Teugbyeolsi, Sydkorea, 06351
- Aktiv, inte rekryterande
- Samsung Medical Center
-
SeochoGu, Seoul Teugbyeolsi, Sydkorea, 06591
- Aktiv, inte rekryterande
- The Catholic University of Korea, Seoul St Marys Hospital
-
Seoul, Seoul Teugbyeolsi, Sydkorea, 03080
- Aktiv, inte rekryterande
- Seoul National University Hospital
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SongpaGu, Seoul Teugbyeolsi, Sydkorea, 05505
- Aktiv, inte rekryterande
- Asan Medical Center
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Yeongdeungpo-gu, Seoul Teugbyeolsi, Sydkorea, 07345
- Aktiv, inte rekryterande
- The Catholic University of Korea, Yeouido St Marys Hospital
-
-
-
-
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Ankara, Turkiet (Türkiye), 06170
- Aktiv, inte rekryterande
- Etlik City Hospital
-
Dokuma, Turkiet (Türkiye), 07025
- Aktiv, inte rekryterande
- Antalya Memorial Hospital
-
Kocaeli, Turkiet (Türkiye), 41380
- Aktiv, inte rekryterande
- Kocaeli Universitesi Tip Fakultesi
-
-
-
-
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Chemnitz, Tyskland, 09116
- Rekrytering
- Klinikum Chemnitz Ggmbh
-
Frankfurt am Main, Tyskland, 60596
- Rekrytering
- Universitatsklinikum Frankfurt
-
Halle, Tyskland, 06120
- Rekrytering
- Universitatsklinikum Halle
-
Mutlangen, Tyskland, 73557
- Rekrytering
- Stauferklinikum Schwabisch Gmund Kliniken Ostalb
-
München, Tyskland, 81377
- Rekrytering
- Dept of Medicine Iii, University Hospitallmu
-
Siegen, Tyskland, 57074
- Rekrytering
- Diakonie Klinikum Jung Stilling Krankenhaus
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Stuttgart, Tyskland, 70376
- Rekrytering
- Robert Bosch Krankenhaus, Abteilung Hamatologie, Onkologie Und Palliativmedizin
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-
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Sankt Pölten, Österrike, 3100
- Aktiv, inte rekryterande
- Uk St Poelten
-
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Arm A: sonrotoclax plus zanubrutinib
Sonrotoclax and zanubrutinib will be administered in combination. |
Administered orally
Andra namn:
Administered orally
Andra namn:
|
|
Placebo-jämförare: Arm B: placebo plus zanubrutinib
Placebo and zanubrutinib will be administered in combination. |
Administered orally Administered orally
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC)
Tidsram: Approximately 41 months
|
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first. |
Approximately 41 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall Survival (OS)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: Study Director, BeOne Medicines
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
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Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- BGB-11417-302
- 2024-515593-27-00 (Ctis)
- CTR20250207 (Registeridentifierare: ChinaDrugTrials)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Tidsram för IPD-delning
See plan description
Kriterier för IPD Sharing Access
See plan description
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- CSR
Läkemedels- och apparatinformation, studiedokument
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