En undersøgelse for at undersøge effektiviteten og sikkerheden af Sonrotoclax Plus Zanubrutinib sammenlignet med Placebo Plus Zanubrutinib hos voksne med recidiverende/refraktær mantelcellelymfom
En fase 3 randomiseret dobbeltblind multicenterundersøgelse af Sonrotoclax Plus Zanubrutinib versus Placebo Plus Zanubrutinib hos patienter med recidiverende/refraktær mantelcellelymfom
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: Study Director
- Telefonnummer: 1.877.828.5568
- E-mail: clinicaltrials@beonemed.com
Studiesteder
-
-
-
Caba, Argentina, CP1114
- Aktiv, ikke rekrutterende
- FUNDALEU
-
Caba, Argentina, 1425
- Rekruttering
- Hospital Aleman
-
Ciudad Autonoma Buenos Aires, Argentina, 1413
- Aktiv, ikke rekrutterende
- Hospital Italiano de Buenos Aires
-
Córdoba, Argentina, X5000HUA
- Aktiv, ikke rekrutterende
- Hospital Universitario de Cordoba
-
-
-
-
Queensland
-
Birtinya, Queensland, Australien, QLD 4575
- Aktiv, ikke rekrutterende
- Sunshine Coast Hospital and Health Service
-
-
Victoria
-
Box Hill, Victoria, Australien, VIC 3128
- Aktiv, ikke rekrutterende
- Box Hill Hospital
-
Clayton, Victoria, Australien, VIC 3168
- Aktiv, ikke rekrutterende
- Monash Health
-
-
Western Australia
-
Cooloongup, Western Australia, Australien, WA 6168
- Aktiv, ikke rekrutterende
- Rockingham Hospital
-
West Perth, Western Australia, Australien, WA 6005
- Aktiv, ikke rekrutterende
- Perth Blood Institute
-
-
-
-
-
Barretos, Brasilien, 14.784-400
- Aktiv, ikke rekrutterende
- Fundacao Pio Xii Hospital de Amor de Barretos
-
Belo Horizonte, Brasilien, 30110-068
- Aktiv, ikke rekrutterende
- Hospital Felicio Rocho
-
Campinas, Brasilien, 13083-878
- Aktiv, ikke rekrutterende
- Universidade de Campinas Centro de Hematologia E Hemoterapia
-
Caxias do Sul, Brasilien, 95070-560
- Aktiv, ikke rekrutterende
- Fundacao Universidade de Caxias Do Sul
-
Curitiba, Brasilien, 81520-060
- Aktiv, ikke rekrutterende
- Hospital Erasto Gaertner
-
Joinville, Brasilien, 89201-260
- Aktiv, ikke rekrutterende
- Instituto Joinvilense de Hematologia E Oncologia
-
Porto AlegreRS, Brasilien, 900350-903
- Aktiv, ikke rekrutterende
- Hospital de Clinicas de Porto Alegre
-
Recife, Brasilien, 50040-000
- Aktiv, ikke rekrutterende
- Hospital Do Cancer de Pernambuco
-
São Paulo, Brasilien, 05403-010
- Aktiv, ikke rekrutterende
- Hcfmusp Pesquisa Clinica Do Servico de Hematologia E Terapia Celular
-
Vitória, Brasilien, 29043-260
- Rekruttering
- Hospital Santa Rita de Cassia Afecc
-
-
-
-
-
Birmingham, Det Forenede Kongerige, B9 5SS
- Rekruttering
- Birmingham Heartlands Hospital
-
Bournemouth, Det Forenede Kongerige, BH7 7DW
- Rekruttering
- The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
-
Glasgow, Det Forenede Kongerige, G12 0YN
- Rekruttering
- Beatson West of Scotland Cancer Centre
-
Headington, Det Forenede Kongerige, OX3 7LE
- Rekruttering
- Oxford University Hospitals Nhs Trust Churchill Hospital
-
London, Det Forenede Kongerige, NW1 2PG
- Rekruttering
- University College Hospital
-
Metropolitan Borough of Wirral, Det Forenede Kongerige, CH63 4JY
- Rekruttering
- Clatterbridge Cancer Centre
-
Plymouth, Det Forenede Kongerige, PL6 8DH
- Rekruttering
- Derriford Hospital
-
-
-
-
Alabama
-
Birmingham, Alabama, Forenede Stater, 35294-0004
- Rekruttering
- University of Alabama At Birmingham Hospital
-
-
Arizona
-
Tucson, Arizona, Forenede Stater, 85724-0001
- Rekruttering
- University of Arizona Cancer Center
-
-
California
-
Fresno, California, Forenede Stater, 93701
- Rekruttering
- Ucsf Fresno
-
Irvine, California, Forenede Stater, 92618-3734
- Rekruttering
- Kaiser Permanente Southern California
-
-
Connecticut
-
New Haven, Connecticut, Forenede Stater, 06520-8028
- Rekruttering
- Yale University Yale Cancer Center
-
-
Florida
-
Pembroke Pines, Florida, Forenede Stater, 33026-4119
- Rekruttering
- Memorial Cancer Institute, Memorial Healthcare System
-
Weston, Florida, Forenede Stater, 33331-3609
- Rekruttering
- Cleveland Clinic Florida
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60607
- Rekruttering
- Rush University Medical Center
-
Chicago, Illinois, Forenede Stater, 60637-1443
- Rekruttering
- University of Chicago Medical Center
-
-
Indiana
-
Fort Wayne, Indiana, Forenede Stater, 46804
- Rekruttering
- Fort Wayne Medical Oncology and Hematology
-
-
Iowa
-
Waukee, Iowa, Forenede Stater, 50263
- Rekruttering
- Mission Cancer and Blood
-
-
Louisiana
-
Baton Rouge, Louisiana, Forenede Stater, 70808-4365
- Rekruttering
- Our Lady of the Lake Hospital
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21201
- Rekruttering
- The University of Maryland Greenebaum Comprehensive Cancer Center
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02215-5418
- Rekruttering
- Dana Farber Cancer Institute Longwood Medical Center
-
-
Michigan
-
Ann Arbor, Michigan, Forenede Stater, 48109-1382
- Rekruttering
- University of Michigan
-
Grand Rapids, Michigan, Forenede Stater, 49503-2563
- Rekruttering
- The Cancer and Hematology Centers
-
-
Minnesota
-
Rochester, Minnesota, Forenede Stater, 55905-0001
- Rekruttering
- Mayo Clinic Rochester
-
-
Mississippi
-
Hattiesburg, Mississippi, Forenede Stater, 39401-7233
- Rekruttering
- Hattiesburg Hematology and Oncology Clinic
-
-
Missouri
-
St Louis, Missouri, Forenede Stater, 63110-1010
- Rekruttering
- Washington University School of Medicine
-
-
Nebraska
-
Grand Island, Nebraska, Forenede Stater, 68803
- Rekruttering
- Nebraska Cancer Specialists St Francis Grand Island
-
Omaha, Nebraska, Forenede Stater, 68130-2042
- Rekruttering
- Nebraska Cancer Specialists
-
-
New Jersey
-
Paramus, New Jersey, Forenede Stater, 07652
- Rekruttering
- The Valley Hospital, Inc
-
-
New York
-
New York, New York, Forenede Stater, 10065-6800
- Rekruttering
- Memorial Sloan Kettering Cancer Center Mskcc
-
-
North Carolina
-
Charlotte, North Carolina, Forenede Stater, 28204-2990
- Rekruttering
- Atrium Health Levine Cancer Institute (Lci)
-
Durham, North Carolina, Forenede Stater, 27710
- Rekruttering
- Duke University
-
Winston-Salem, North Carolina, Forenede Stater, 27157
- Rekruttering
- Atrium Health Wake Forest Baptist
-
-
Ohio
-
Cleveland, Ohio, Forenede Stater, 44195-0001
- Rekruttering
- Cleveland Clinic Foundation
-
Cleveland, Ohio, Forenede Stater, 44106-1716
- Rekruttering
- University Hospitals
-
Columbus, Ohio, Forenede Stater, 43210-1280
- Rekruttering
- Ohio State University Comprehensive Cancer Center
-
Columbus, Ohio, Forenede Stater, 43214-3907
- Rekruttering
- Ohio Health Research Institute
-
-
Pennsylvania
-
Hershey, Pennsylvania, Forenede Stater, 17033
- Rekruttering
- Penn State Milton S Hershey Medical Center
-
West Reading, Pennsylvania, Forenede Stater, 19611-2143
- Rekruttering
- McGlinn Cancer Institute
-
-
Tennessee
-
Nashville, Tennessee, Forenede Stater, 37205
- Rekruttering
- Tennessee Oncology
-
Nashville, Tennessee, Forenede Stater, 37205
- Rekruttering
- Tennessee Oncology Nashville St Thomas Midtown Clinic
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030-3907
- Rekruttering
- Md Anderson Cancer Center
-
Round Rock, Texas, Forenede Stater, 78681-4019
- Rekruttering
- Texas Oncology Austin Midtown
-
-
Virginia
-
Charlottesville, Virginia, Forenede Stater, 22908-0817
- Rekruttering
- University of Virginia
-
Gainesville, Virginia, Forenede Stater, 20155-3257
- Rekruttering
- Virgina Cancer Specialists
-
Richmond, Virginia, Forenede Stater, 23298-5026
- Rekruttering
- Vcu Massey Cancer Center
-
-
Washington
-
Vancouver, Washington, Forenede Stater, 98684-6930
- Rekruttering
- Northwest Cancer Specialist, Pc(Us Oncology Research)
-
-
Wisconsin
-
Madison, Wisconsin, Forenede Stater, 53792-0001
- Rekruttering
- University of Wisconsin
-
-
-
-
-
Montpellier, Frankrig, 34090
- Rekruttering
- Chu Montpellier Hopital Saint Eloi
-
Nantes, Frankrig, 44000
- Aktiv, ikke rekrutterende
- Centre Hospitalier Universitaire Nantes Hotel Dieu
-
PierreBenite, Frankrig, 69495
- Aktiv, ikke rekrutterende
- Chu Hopital Lyon Sud
-
Tours, Frankrig, 37000
- Rekruttering
- Chu Tours Hopital Bretonneau
-
-
-
-
-
Bologna, Italien, 40138
- Aktiv, ikke rekrutterende
- Policlinico Sorsola Malpighi, Aou Di Bologna
-
Lecce, Italien, 73100
- Aktiv, ikke rekrutterende
- Ospedale Vito Fazzi, Asl Lecce
-
Meldola, Italien, 47014
- Aktiv, ikke rekrutterende
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
-
Trieste, Italien, 34129
- Aktiv, ikke rekrutterende
- Azienda Sanitaria Universitaria Giuliano Isontina
-
Verona, Italien, 37134
- Aktiv, ikke rekrutterende
- Centroricerche Cliniche Di Verona Srl
-
-
-
-
-
Yokohama, Japan, 221-0855
- Rekruttering
- Yokohama Municipal Citizens Hospital
-
-
Aichi-ken
-
Nagoya, Aichi-ken, Japan, 464-8681
- Rekruttering
- Aichi Cancer Center Hospital Clinical Oncology
-
Toyohashishi, Aichi-ken, Japan, 441-8570
- Rekruttering
- Toyohashi Municipal Hospital
-
-
Chiba
-
Chiba, Chiba, Japan, 260-8717
- Rekruttering
- Chiba Cancer Center
-
-
Ehime
-
Matsuyama, Ehime, Japan, 790 8524
- Rekruttering
- Matsuyama Red Cross Hospital
-
-
Gifu
-
Ōgaki, Gifu, Japan, 503-8502
- Rekruttering
- Ogaki Municipal Hospital
-
-
Hiroshima
-
Hiroshima, Hiroshima, Japan, 730-8619
- Rekruttering
- Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
-
-
Hokkaido
-
Sapporo, Hokkaido, Japan, 060-8648
- Rekruttering
- Hokkaido University Hospital
-
-
Hyōgo
-
KobeShi, Hyōgo, Japan, 650-0047
- Rekruttering
- Kobe City Medical Center General Hospital
-
-
Kagoshima-ken
-
Kagoshima, Kagoshima-ken, Japan, 890-8520
- Rekruttering
- Kagoshima University Hospital
-
-
Kanagawa
-
Yokohama, Kanagawa, Japan, 241-8515
- Rekruttering
- Kanagawa Cancer Center
-
-
Miyagi
-
Sendai, Miyagi, Japan, 980-8574
- Rekruttering
- Tohoku University Hospital
-
-
Okayama-ken
-
Kurashikishi, Okayama-ken, Japan, 710-8602
- Rekruttering
- Kurashiki Central Hospital
-
Okayama, Okayama-ken, Japan, 701-1192
- Rekruttering
- National Hospital Organization Okayama Medical Center
-
-
Osaka
-
Osaka, Osaka, Japan, 545-8586
- Rekruttering
- Osaka Metropolitan University Hospital
-
Osakashi, Osaka, Japan, 543-8555
- Rekruttering
- Osaka Red Cross Hospital
-
-
Saitama
-
Koshigaya, Saitama, Japan, 503-8502
- Rekruttering
- Dokkyo Medical University Saitama Medical Center
-
-
Tokyo
-
Bunkyoku, Tokyo, Japan, 113-8519
- Rekruttering
- Institute of Science Tokyo Hospital
-
-
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina, 100142
- Rekruttering
- Beijing Cancer Hospital
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, Kina, 630014
- Rekruttering
- The First Affiliated Hospital of Chongqing Medical University
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510515
- Rekruttering
- Nanfang Hospital, Southern Medical University
-
Guangzhou, Guangdong, Kina, 510060
- Rekruttering
- Sun Yat Sen University Cancer Center
-
-
Heilongjiang
-
Harbin, Heilongjiang, Kina, 150000
- Rekruttering
- Harbin Medical University Cancer Hospital
-
-
Henan
-
Zhengzhou, Henan, Kina, 450052
- Rekruttering
- The First Affiliated Hospital of Zhengzhou University
-
-
Hubei
-
Wuhan, Hubei, Kina, 430030
- Aktiv, ikke rekrutterende
- Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
-
Wuhan, Hubei, Kina, 430022
- Aktiv, ikke rekrutterende
- Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210029
- Rekruttering
- Jiangsu Province Hospital
-
Xuzhou, Jiangsu, Kina, 221000
- Rekruttering
- The Affiliated Hospital of Xuzhou Medical University
-
-
Jiangxi
-
Nanchang, Jiangxi, Kina, 330029
- Rekruttering
- Jiangxi Cancer Hospital
-
-
Liaoning
-
Shenyang, Liaoning, Kina, 110042
- Rekruttering
- Liaoning Cancer Hospital and Institute
-
-
Shaanxi
-
Xi'an, Shaanxi, Kina, 710068
- Rekruttering
- Shaanxi Provincial Peoples Hospital
-
-
Shandong
-
Linyi, Shandong, Kina, 276001
- Rekruttering
- Linyi Cancer Hospital
-
Qingdao, Shandong, Kina, 266555
- Rekruttering
- The Affiliated Hospital of Qingdao University Branch West Coast
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200000
- Rekruttering
- Fudan University Shanghai Cancer Center
-
-
Sichuan
-
Chengdu, Sichuan, Kina, 610071
- Rekruttering
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina, 310002
- Rekruttering
- The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
-
Wenzhou, Zhejiang, Kina, 325000
- Rekruttering
- The First Affiliated Hospital of Wenzhou Medical University
-
-
-
-
-
Auckland, New Zealand, 0622
- Aktiv, ikke rekrutterende
- North Shore Hospital
-
Christchurch, New Zealand, 8011
- Aktiv, ikke rekrutterende
- Christchurch Hospital
-
Dunedin, New Zealand, 9016
- Aktiv, ikke rekrutterende
- Dunedin Hospital
-
Tauranga, New Zealand, 3112
- Aktiv, ikke rekrutterende
- Tauranga Hospital
-
Wellington, New Zealand, 6021
- Aktiv, ikke rekrutterende
- Wellington Regional Hospital (Ccdhb)
-
-
-
-
-
Krakow, Polen, 30-727
- Aktiv, ikke rekrutterende
- Pratia McM Krakow
-
Lodz, Polen, 93-510
- Aktiv, ikke rekrutterende
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
-
Lublin, Polen, 20-090
- Aktiv, ikke rekrutterende
- Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
-
Skorzewo, Polen, 60-185
- Aktiv, ikke rekrutterende
- Aidport Sp Z O O
-
Wroclaw, Polen, 53-439
- Aktiv, ikke rekrutterende
- Dolnoslaskie Centrum Onkologii, Pulmonologii I Hematologii
-
-
-
-
-
San Juan, Puerto Rico, 00917
- Rekruttering
- Auxilio Mutuo Cancer Center
-
-
-
-
-
Barcelona, Spanien, 08036
- Aktiv, ikke rekrutterende
- Hospital Clinic de Barcelona
-
Barcelona, Spanien, 08907
- Aktiv, ikke rekrutterende
- Ico H Duran I Reynals
-
Madrid, Spanien, 28040
- Afsluttet
- Hospital Universitario Fundacion Jimenez Diaz
-
Majadahonda, Spanien, 28222
- Aktiv, ikke rekrutterende
- H Puerta de Hierro Majadahonda
-
-
-
-
Busan Gwang'Yeogsi
-
Seogu, Busan Gwang'Yeogsi, Sydkorea, 49241
- Aktiv, ikke rekrutterende
- Pusan National University Hospital
-
-
Seoul Teugbyeolsi
-
GangnamGu, Seoul Teugbyeolsi, Sydkorea, 06351
- Aktiv, ikke rekrutterende
- Samsung Medical Center
-
SeochoGu, Seoul Teugbyeolsi, Sydkorea, 06591
- Aktiv, ikke rekrutterende
- The Catholic University of Korea, Seoul St Marys Hospital
-
Seoul, Seoul Teugbyeolsi, Sydkorea, 03080
- Aktiv, ikke rekrutterende
- Seoul National University Hospital
-
SongpaGu, Seoul Teugbyeolsi, Sydkorea, 05505
- Aktiv, ikke rekrutterende
- Asan Medical Center
-
Yeongdeungpo-gu, Seoul Teugbyeolsi, Sydkorea, 07345
- Aktiv, ikke rekrutterende
- The Catholic University of Korea, Yeouido St Marys Hospital
-
-
-
-
-
Ankara, Tyrkiet (Türkiye), 06170
- Aktiv, ikke rekrutterende
- Etlik City Hospital
-
Dokuma, Tyrkiet (Türkiye), 07025
- Aktiv, ikke rekrutterende
- Antalya Memorial Hospital
-
Kocaeli, Tyrkiet (Türkiye), 41380
- Aktiv, ikke rekrutterende
- Kocaeli Universitesi Tip Fakultesi
-
-
-
-
-
Chemnitz, Tyskland, 09116
- Rekruttering
- Klinikum Chemnitz Ggmbh
-
Frankfurt am Main, Tyskland, 60596
- Rekruttering
- Universitatsklinikum Frankfurt
-
Halle, Tyskland, 06120
- Rekruttering
- Universitatsklinikum Halle
-
Mutlangen, Tyskland, 73557
- Rekruttering
- Stauferklinikum Schwabisch Gmund Kliniken Ostalb
-
München, Tyskland, 81377
- Rekruttering
- Dept of Medicine Iii, University Hospitallmu
-
Siegen, Tyskland, 57074
- Rekruttering
- Diakonie Klinikum Jung Stilling Krankenhaus
-
Stuttgart, Tyskland, 70376
- Rekruttering
- Robert Bosch Krankenhaus, Abteilung Hamatologie, Onkologie Und Palliativmedizin
-
-
-
-
-
Sankt Pölten, Østrig, 3100
- Aktiv, ikke rekrutterende
- Uk St Poelten
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Arm A: sonrotoclax plus zanubrutinib
Sonrotoclax and zanubrutinib will be administered in combination. |
Administered orally
Andre navne:
Administered orally
Andre navne:
|
|
Placebo komparator: Arm B: placebo plus zanubrutinib
Placebo and zanubrutinib will be administered in combination. |
Administered orally Administered orally
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-Free Survival (PFS) as assessed by Blinded Independent Review Committee (BIRC)
Tidsramme: Approximately 41 months
|
PFS is defined as the time from randomization to the date of progression or death, whichever occurs first. |
Approximately 41 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival (OS)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: Study Director, BeOne Medicines
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BGB-11417-302
- 2024-515593-27-00 (Ctis)
- CTR20250207 (Registry Identifier: ChinaDrugTrials)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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.
IPD-delingstidsramme
See plan description
IPD-delingsadgangskriterier
See plan description
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .