Uno studio per indagare l'efficacia e la sicurezza di Sonrotoclax più Zanubrutinib rispetto a Placebo più Zanubrutinib negli adulti affetti da linfoma mantellare recidivante/refrattario
Uno studio multicentrico randomizzato in doppio cieco di fase 3 su Sonrotoclax più Zanubrutinib rispetto a Placebo più Zanubrutinib in pazienti con linfoma mantellare recidivante/refrattario
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.
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
Mantle cell lymphoma (MCL) is a rare, aggressive type of B-cell lymphoma. B-cells are white blood cells that help fight infections. Lymphoma is a cancer in the lymphatic system. Sometimes this type of cancer can come back after treatment (relapse), or it does not respond to treatment or stops responding to treatment (refractory).
Sonrotoclax is a drug which blocks a protein called B-cell lymphoma-2 (Bcl-2). Zanubrutinib works by blocking a protein called Bruton tyrosine kinase (BTK). Bcl-2 and BTK help certain blood cancer cells live and grow. By blocking Bcl-2 and BTK, sonrotoclax and zanubrutinib may slow or stop cancer cell growth and help them die.
The purpose of this study is to test if sonrotoclax plus zanubrutinib is safe and if it works better in adults with R/R MCL compared to zanubrutinib plus placebo. The main goal is to compare how long participants live without their disease getting worse. The study will also evaluate side effects and overall safety.
This study has two treatment groups. Participants will be randomly assigned (by chance) to receive sonrotoclax plus zanubrutinib or zanubrutinib plus placebo. All study treatments will be taken by mouth. Placebo is a pill that looks like the study drug but has no active ingredient. Participants and the study doctor will not know what treatment group the participant is assigned to during the study, unless there is an urgent medical need.
The study will enroll approximately 300 adults with R/R MCL at multiple centers worldwide.
The overall time to participate in this study is up to approximately 7 years. Participants will make regular visits to the clinic for treatment, health checks, blood tests, and tumor imaging tests.
Note: Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 3
Contatti e Sedi
Contatto studio
- Nome: Study Director
- Numero di telefono: 1.877.828.5568
- Email: clinicaltrials@beonemed.com
Luoghi di studio
-
-
-
Caba, Argentina, CP1114
- Attivo, non reclutante
- FUNDALEU
-
Caba, Argentina, 1425
- Reclutamento
- Hospital Aleman
-
Ciudad Autonoma Buenos Aires, Argentina, 1413
- Attivo, non reclutante
- Hospital Italiano de Buenos Aires
-
Córdoba, Argentina, X5000HUA
- Attivo, non reclutante
- Hospital Universitario de Cordoba
-
-
-
-
Queensland
-
Birtinya, Queensland, Australia, QLD 4575
- Attivo, non reclutante
- Sunshine Coast Hospital and Health Service
-
-
Victoria
-
Box Hill, Victoria, Australia, VIC 3128
- Attivo, non reclutante
- Box Hill Hospital
-
Clayton, Victoria, Australia, VIC 3168
- Attivo, non reclutante
- Monash Health
-
-
Western Australia
-
Cooloongup, Western Australia, Australia, WA 6168
- Attivo, non reclutante
- Rockingham Hospital
-
West Perth, Western Australia, Australia, WA 6005
- Attivo, non reclutante
- Perth Blood Institute
-
-
-
-
-
Sankt Pölten, Austria, 3100
- Attivo, non reclutante
- Uk St Poelten
-
-
-
-
-
Barretos, Brasile, 14.784-400
- Attivo, non reclutante
- Fundacao Pio Xii Hospital de Amor de Barretos
-
Belo Horizonte, Brasile, 30110-068
- Attivo, non reclutante
- Hospital Felicio Rocho
-
Campinas, Brasile, 13083-878
- Attivo, non reclutante
- Universidade de Campinas Centro de Hematologia E Hemoterapia
-
Caxias do Sul, Brasile, 95070-560
- Attivo, non reclutante
- Fundacao Universidade de Caxias Do Sul
-
Curitiba, Brasile, 81520-060
- Attivo, non reclutante
- Hospital Erasto Gaertner
-
Joinville, Brasile, 89201-260
- Attivo, non reclutante
- Instituto Joinvilense de Hematologia E Oncologia
-
Porto AlegreRS, Brasile, 900350-903
- Attivo, non reclutante
- Hospital de Clinicas de Porto Alegre
-
Recife, Brasile, 50040-000
- Attivo, non reclutante
- Hospital Do Cancer de Pernambuco
-
São Paulo, Brasile, 05403-010
- Attivo, non reclutante
- Hcfmusp Pesquisa Clinica Do Servico de Hematologia E Terapia Celular
-
Vitória, Brasile, 29043-260
- Reclutamento
- Hospital Santa Rita de Cassia Afecc
-
-
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Cina, 100142
- Reclutamento
- Beijing Cancer Hospital
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, Cina, 630014
- Reclutamento
- The First Affiliated Hospital of Chongqing Medical University
-
-
Guangdong
-
Guangzhou, Guangdong, Cina, 510515
- Reclutamento
- Nanfang Hospital, Southern Medical University
-
Guangzhou, Guangdong, Cina, 510060
- Reclutamento
- Sun Yat Sen University Cancer Center
-
-
Heilongjiang
-
Harbin, Heilongjiang, Cina, 150000
- Reclutamento
- Harbin Medical University Cancer Hospital
-
-
Henan
-
Zhengzhou, Henan, Cina, 450052
- Reclutamento
- The First Affiliated Hospital of Zhengzhou University
-
-
Hubei
-
Wuhan, Hubei, Cina, 430030
- Attivo, non reclutante
- Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
-
Wuhan, Hubei, Cina, 430022
- Attivo, non reclutante
- Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
-
-
Jiangsu
-
Nanjing, Jiangsu, Cina, 210029
- Reclutamento
- Jiangsu Province Hospital
-
Xuzhou, Jiangsu, Cina, 221000
- Reclutamento
- The Affiliated Hospital of Xuzhou Medical University
-
-
Jiangxi
-
Nanchang, Jiangxi, Cina, 330029
- Reclutamento
- Jiangxi Cancer Hospital
-
-
Liaoning
-
Shenyang, Liaoning, Cina, 110042
- Reclutamento
- Liaoning Cancer Hospital and Institute
-
-
Shaanxi
-
Xi'an, Shaanxi, Cina, 710068
- Reclutamento
- Shaanxi Provincial Peoples Hospital
-
-
Shandong
-
Linyi, Shandong, Cina, 276001
- Reclutamento
- Linyi Cancer Hospital
-
Qingdao, Shandong, Cina, 266555
- Reclutamento
- The Affiliated Hospital of Qingdao University Branch West Coast
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Cina, 200000
- Reclutamento
- Fudan University Shanghai Cancer Center
-
-
Sichuan
-
Chengdu, Sichuan, Cina, 610071
- Reclutamento
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
-
-
Zhejiang
-
Hangzhou, Zhejiang, Cina, 310002
- Reclutamento
- The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
-
Wenzhou, Zhejiang, Cina, 325000
- Reclutamento
- The First Affiliated Hospital of Wenzhou Medical University
-
-
-
-
Busan Gwang'Yeogsi
-
Seogu, Busan Gwang'Yeogsi, Corea del Sud, 49241
- Attivo, non reclutante
- Pusan National University Hospital
-
-
Seoul Teugbyeolsi
-
GangnamGu, Seoul Teugbyeolsi, Corea del Sud, 06351
- Attivo, non reclutante
- Samsung Medical Center
-
SeochoGu, Seoul Teugbyeolsi, Corea del Sud, 06591
- Attivo, non reclutante
- The Catholic University of Korea, Seoul St Marys Hospital
-
Seoul, Seoul Teugbyeolsi, Corea del Sud, 03080
- Attivo, non reclutante
- Seoul National University Hospital
-
SongpaGu, Seoul Teugbyeolsi, Corea del Sud, 05505
- Attivo, non reclutante
- Asan Medical Center
-
Yeongdeungpo-gu, Seoul Teugbyeolsi, Corea del Sud, 07345
- Attivo, non reclutante
- The Catholic University of Korea, Yeouido St Marys Hospital
-
-
-
-
-
Montpellier, Francia, 34090
- Reclutamento
- Chu Montpellier Hopital Saint Eloi
-
Nantes, Francia, 44000
- Attivo, non reclutante
- Centre Hospitalier Universitaire Nantes Hotel Dieu
-
PierreBenite, Francia, 69495
- Attivo, non reclutante
- Chu Hopital Lyon Sud
-
Tours, Francia, 37000
- Reclutamento
- Chu Tours Hopital Bretonneau
-
-
-
-
-
Chemnitz, Germania, 09116
- Reclutamento
- Klinikum Chemnitz Ggmbh
-
Frankfurt am Main, Germania, 60596
- Reclutamento
- Universitatsklinikum Frankfurt
-
Halle, Germania, 06120
- Reclutamento
- Universitatsklinikum Halle
-
Mutlangen, Germania, 73557
- Reclutamento
- Stauferklinikum Schwabisch Gmund Kliniken Ostalb
-
München, Germania, 81377
- Reclutamento
- Dept of Medicine Iii, University Hospitallmu
-
Siegen, Germania, 57074
- Reclutamento
- Diakonie Klinikum Jung Stilling Krankenhaus
-
Stuttgart, Germania, 70376
- Reclutamento
- Robert Bosch Krankenhaus, Abteilung Hamatologie, Onkologie Und Palliativmedizin
-
-
-
-
-
Yokohama, Giappone, 221-0855
- Reclutamento
- Yokohama Municipal Citizens Hospital
-
-
Aichi-ken
-
Nagoya, Aichi-ken, Giappone, 464-8681
- Reclutamento
- Aichi Cancer Center Hospital Clinical Oncology
-
Toyohashishi, Aichi-ken, Giappone, 441-8570
- Reclutamento
- Toyohashi Municipal Hospital
-
-
Chiba
-
Chiba, Chiba, Giappone, 260-8717
- Reclutamento
- Chiba Cancer Center
-
-
Ehime
-
Matsuyama, Ehime, Giappone, 790 8524
- Reclutamento
- Matsuyama Red Cross Hospital
-
-
Gifu
-
Ōgaki, Gifu, Giappone, 503-8502
- Reclutamento
- Ogaki Municipal Hospital
-
-
Hiroshima
-
Hiroshima, Hiroshima, Giappone, 730-8619
- Reclutamento
- Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
-
-
Hokkaido
-
Sapporo, Hokkaido, Giappone, 060-8648
- Reclutamento
- Hokkaido University Hospital
-
-
Hyōgo
-
KobeShi, Hyōgo, Giappone, 650-0047
- Reclutamento
- Kobe City Medical Center General Hospital
-
-
Kagoshima-ken
-
Kagoshima, Kagoshima-ken, Giappone, 890-8520
- Reclutamento
- Kagoshima University Hospital
-
-
Kanagawa
-
Yokohama, Kanagawa, Giappone, 241-8515
- Reclutamento
- Kanagawa Cancer Center
-
-
Miyagi
-
Sendai, Miyagi, Giappone, 980-8574
- Reclutamento
- Tohoku University Hospital
-
-
Okayama-ken
-
Kurashikishi, Okayama-ken, Giappone, 710-8602
- Reclutamento
- Kurashiki Central Hospital
-
Okayama, Okayama-ken, Giappone, 701-1192
- Reclutamento
- National Hospital Organization Okayama Medical Center
-
-
Osaka
-
Osaka, Osaka, Giappone, 545-8586
- Reclutamento
- Osaka Metropolitan University Hospital
-
Osakashi, Osaka, Giappone, 543-8555
- Reclutamento
- Osaka Red Cross Hospital
-
-
Saitama
-
Koshigaya, Saitama, Giappone, 503-8502
- Reclutamento
- Dokkyo Medical University Saitama Medical Center
-
-
Tokyo
-
Bunkyoku, Tokyo, Giappone, 113-8519
- Reclutamento
- Institute of Science Tokyo Hospital
-
-
-
-
-
Bologna, Italia, 40138
- Attivo, non reclutante
- Policlinico Sorsola Malpighi, Aou Di Bologna
-
Lecce, Italia, 73100
- Attivo, non reclutante
- Ospedale Vito Fazzi, Asl Lecce
-
Meldola, Italia, 47014
- Attivo, non reclutante
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
-
Trieste, Italia, 34129
- Attivo, non reclutante
- Azienda Sanitaria Universitaria Giuliano Isontina
-
Verona, Italia, 37134
- Attivo, non reclutante
- Centroricerche Cliniche Di Verona Srl
-
-
-
-
-
Auckland, Nuova Zelanda, 0622
- Attivo, non reclutante
- North Shore Hospital
-
Christchurch, Nuova Zelanda, 8011
- Attivo, non reclutante
- Christchurch Hospital
-
Dunedin, Nuova Zelanda, 9016
- Attivo, non reclutante
- Dunedin Hospital
-
Tauranga, Nuova Zelanda, 3112
- Attivo, non reclutante
- Tauranga Hospital
-
Wellington, Nuova Zelanda, 6021
- Attivo, non reclutante
- Wellington Regional Hospital (Ccdhb)
-
-
-
-
-
Krakow, Polonia, 30-727
- Attivo, non reclutante
- Pratia McM Krakow
-
Lodz, Polonia, 93-510
- Attivo, non reclutante
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
-
Lublin, Polonia, 20-090
- Attivo, non reclutante
- Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
-
Skorzewo, Polonia, 60-185
- Attivo, non reclutante
- Aidport Sp Z O O
-
Wroclaw, Polonia, 53-439
- Attivo, non reclutante
- Dolnoslaskie Centrum Onkologii, Pulmonologii I Hematologii
-
-
-
-
-
San Juan, Porto Rico, 00917
- Reclutamento
- Auxilio Mutuo Cancer Center
-
-
-
-
-
Birmingham, Regno Unito, B9 5SS
- Reclutamento
- Birmingham Heartlands Hospital
-
Bournemouth, Regno Unito, BH7 7DW
- Reclutamento
- The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
-
Glasgow, Regno Unito, G12 0YN
- Reclutamento
- Beatson West of Scotland Cancer Centre
-
Headington, Regno Unito, OX3 7LE
- Reclutamento
- Oxford University Hospitals Nhs Trust Churchill Hospital
-
London, Regno Unito, NW1 2PG
- Reclutamento
- University College Hospital
-
Metropolitan Borough of Wirral, Regno Unito, CH63 4JY
- Reclutamento
- Clatterbridge Cancer Centre
-
Plymouth, Regno Unito, PL6 8DH
- Reclutamento
- Derriford Hospital
-
-
-
-
-
Barcelona, Spagna, 08036
- Attivo, non reclutante
- Hospital Clinic de Barcelona
-
Barcelona, Spagna, 08907
- Attivo, non reclutante
- Ico H Duran I Reynals
-
Madrid, Spagna, 28040
- Completato
- Hospital Universitario Fundacion Jimenez Diaz
-
Majadahonda, Spagna, 28222
- Attivo, non reclutante
- H Puerta de Hierro Majadahonda
-
-
-
-
Alabama
-
Birmingham, Alabama, Stati Uniti, 35294-0004
- Reclutamento
- University of Alabama At Birmingham Hospital
-
-
Arizona
-
Tucson, Arizona, Stati Uniti, 85724-0001
- Reclutamento
- University of Arizona Cancer Center
-
-
California
-
Fresno, California, Stati Uniti, 93701
- Reclutamento
- Ucsf Fresno
-
Irvine, California, Stati Uniti, 92618-3734
- Reclutamento
- Kaiser Permanente Southern California
-
-
Connecticut
-
New Haven, Connecticut, Stati Uniti, 06520-8028
- Reclutamento
- Yale University Yale Cancer Center
-
-
Florida
-
Pembroke Pines, Florida, Stati Uniti, 33026-4119
- Reclutamento
- Memorial Cancer Institute, Memorial Healthcare System
-
Weston, Florida, Stati Uniti, 33331-3609
- Reclutamento
- Cleveland Clinic Florida
-
-
Illinois
-
Chicago, Illinois, Stati Uniti, 60607
- Reclutamento
- Rush University Medical Center
-
Chicago, Illinois, Stati Uniti, 60637-1443
- Reclutamento
- University of Chicago Medical Center
-
-
Indiana
-
Fort Wayne, Indiana, Stati Uniti, 46804
- Reclutamento
- Fort Wayne Medical Oncology and Hematology
-
-
Iowa
-
Waukee, Iowa, Stati Uniti, 50263
- Reclutamento
- Mission Cancer and Blood
-
-
Louisiana
-
Baton Rouge, Louisiana, Stati Uniti, 70808-4365
- Reclutamento
- Our Lady of the Lake Hospital
-
-
Maryland
-
Baltimore, Maryland, Stati Uniti, 21201
- Reclutamento
- The University of Maryland Greenebaum Comprehensive Cancer Center
-
-
Massachusetts
-
Boston, Massachusetts, Stati Uniti, 02215-5418
- Reclutamento
- Dana Farber Cancer Institute Longwood Medical Center
-
-
Michigan
-
Ann Arbor, Michigan, Stati Uniti, 48109-1382
- Reclutamento
- University of Michigan
-
Grand Rapids, Michigan, Stati Uniti, 49503-2563
- Reclutamento
- The Cancer and Hematology Centers
-
-
Minnesota
-
Rochester, Minnesota, Stati Uniti, 55905-0001
- Reclutamento
- Mayo Clinic Rochester
-
-
Mississippi
-
Hattiesburg, Mississippi, Stati Uniti, 39401-7233
- Reclutamento
- Hattiesburg Hematology and Oncology Clinic
-
-
Missouri
-
St Louis, Missouri, Stati Uniti, 63110-1010
- Reclutamento
- Washington University School of Medicine
-
-
Nebraska
-
Grand Island, Nebraska, Stati Uniti, 68803
- Reclutamento
- Nebraska Cancer Specialists St Francis Grand Island
-
Omaha, Nebraska, Stati Uniti, 68130-2042
- Reclutamento
- Nebraska Cancer Specialists
-
-
New Jersey
-
Paramus, New Jersey, Stati Uniti, 07652
- Reclutamento
- The Valley Hospital, Inc
-
-
New York
-
New York, New York, Stati Uniti, 10065-6800
- Reclutamento
- Memorial Sloan Kettering Cancer Center Mskcc
-
-
North Carolina
-
Charlotte, North Carolina, Stati Uniti, 28204-2990
- Reclutamento
- Atrium Health Levine Cancer Institute (Lci)
-
Durham, North Carolina, Stati Uniti, 27710
- Reclutamento
- Duke University
-
Winston-Salem, North Carolina, Stati Uniti, 27157
- Reclutamento
- Atrium Health Wake Forest Baptist
-
-
Ohio
-
Cleveland, Ohio, Stati Uniti, 44195-0001
- Reclutamento
- Cleveland Clinic Foundation
-
Cleveland, Ohio, Stati Uniti, 44106-1716
- Reclutamento
- University Hospitals
-
Columbus, Ohio, Stati Uniti, 43210-1280
- Reclutamento
- Ohio State University Comprehensive Cancer Center
-
Columbus, Ohio, Stati Uniti, 43214-3907
- Reclutamento
- Ohio Health Research Institute
-
-
Pennsylvania
-
Hershey, Pennsylvania, Stati Uniti, 17033
- Reclutamento
- Penn State Milton S Hershey Medical Center
-
West Reading, Pennsylvania, Stati Uniti, 19611-2143
- Reclutamento
- McGlinn Cancer Institute
-
-
Tennessee
-
Nashville, Tennessee, Stati Uniti, 37205
- Reclutamento
- Tennessee Oncology
-
Nashville, Tennessee, Stati Uniti, 37205
- Reclutamento
- Tennessee Oncology Nashville St Thomas Midtown Clinic
-
-
Texas
-
Houston, Texas, Stati Uniti, 77030-3907
- Reclutamento
- Md Anderson Cancer Center
-
Round Rock, Texas, Stati Uniti, 78681-4019
- Reclutamento
- Texas Oncology Austin Midtown
-
-
Virginia
-
Charlottesville, Virginia, Stati Uniti, 22908-0817
- Reclutamento
- University of Virginia
-
Gainesville, Virginia, Stati Uniti, 20155-3257
- Reclutamento
- Virgina Cancer Specialists
-
Richmond, Virginia, Stati Uniti, 23298-5026
- Reclutamento
- Vcu Massey Cancer Center
-
-
Washington
-
Vancouver, Washington, Stati Uniti, 98684-6930
- Reclutamento
- Northwest Cancer Specialist, Pc(Us Oncology Research)
-
-
Wisconsin
-
Madison, Wisconsin, Stati Uniti, 53792-0001
- Reclutamento
- University of Wisconsin
-
-
-
-
-
Ankara, Turchia (Türkiye), 06170
- Attivo, non reclutante
- Etlik City Hospital
-
Dokuma, Turchia (Türkiye), 07025
- Attivo, non reclutante
- Antalya Memorial Hospital
-
Kocaeli, Turchia (Türkiye), 41380
- Attivo, non reclutante
- Kocaeli Universitesi Tip Fakultesi
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Arm A: sonrotoclax plus zanubrutinib
Sonrotoclax and zanubrutinib will be administered in combination. |
Administered orally
Altri nomi:
Administered orally
Altri nomi:
|
|
Comparatore placebo: Arm B: placebo plus zanubrutinib
Placebo and zanubrutinib will be administered in combination. |
Administered orally Administered orally
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC)
Lasso di tempo: Approximately 41 months
|
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first. |
Approximately 41 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Overall Survival (OS)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Study Director, BeOne Medicines
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- BGB-11417-302
- 2024-515593-27-00 (Ctis)
- CTR20250207 (Identificatore di registro: ChinaDrugTrials)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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.
Periodo di condivisione IPD
See plan description
Criteri di accesso alla condivisione IPD
See plan description
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .