En undersøgelse af Sonrotoclax (BGB-11417) plus Zanubrutinib (BGB-3111) sammenlignet med Venetoclax plus Acalabrutinib hos voksne med tidligere ubehandlet kronisk lymfatisk leukæmi
24. september 2026 opdateret af: BeOne Medicines
En fase 3, åben-label, randomiseret undersøgelse af Sonrotoclax (BGB-11417) plus Zanubrutinib (BGB-3111) sammenlignet med Venetoclax plus Acalabrutinib hos patienter med tidligere ubehandlet kronisk lymfatisk leukæmi
The purpose of this study is to investigate the efficacy and safety of fixed-duration sonrotoclax (also known as BGB-11417) plus zanubrutinib (also known as BGB-3111) (SZ) compared with fixed-duration of venetoclax plus acalabrutinib (AV) in participants with previously untreated chronic lymphocytic leukemia (CLL).
Studieoversigt
Status
Status
Rekruttering
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
Tilmelding
500
Fase
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
Studiekontakt
- Navn: Study Director
- Telefonnummer: 8778285568
- E-mail: clinicaltrials@beonemed.com
Studiesteder
-
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New South Wales
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Blacktown, New South Wales, Australien, NSW 2148
- Rekruttering
- Blacktown Cancer and Haematology Centre
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Concord, New South Wales, Australien, NSW 2139
- Rekruttering
- Concord Repatriation General Hospital
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St Leonards, New South Wales, Australien, NSW 2065
- Rekruttering
- Genesiscare North Shore
-
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Queensland
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Woolloongabba, Queensland, Australien, QLD 4102
- Rekruttering
- Princess Alexandra Hospital
-
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Victoria
-
Clayton, Victoria, Australien, VIC 3168
- Rekruttering
- Monash Health
-
Heidelberg, Victoria, Australien, VIC 3084
- Rekruttering
- Austin Health
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Malvern, Victoria, Australien, VIC 3144
- Rekruttering
- Cabrini Hospital Malvern
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Melbourne, Victoria, Australien, VIC 3004
- Rekruttering
- The Alfred Hospital
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-
-
-
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Brasília, Brasilien, 70390140
- Rekruttering
- Instituto Dor de Pesquisa E Ensino Distrito Federal
-
Porto Alegre, Brasilien, 90110-270
- Rekruttering
- Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
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Salvador, Brasilien, 41950-640
- Rekruttering
- Ensino E Terapia de Inovacao Clinica Amo Etica
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São Paulo, Brasilien, 05652-900
- Rekruttering
- Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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São Paulo, Brasilien, 01401-004
- Rekruttering
- Instituto Dor de Pesquisa E Ensino Sao Paulo
-
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-
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British Columbia
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Victoria, British Columbia, Canada, V8R 6V5
- Rekruttering
- Bc Cancer Victoria
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Ontario
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Hamilton, Ontario, Canada, L8V 5C2
- Rekruttering
- Juravinski Cancer Centre
-
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Quebec
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Montreal, Quebec, Canada, QC H3t 1E2
- Rekruttering
- Jewish General Hospital
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Montreal, Quebec, Canada, H4J 1C5
- Rekruttering
- Ciusss Nim Hscm
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Québec, Quebec, Canada, G1J 1Z4
- Rekruttering
- Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
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Sherbrooke, Quebec, Canada, J1H 5N4
- Rekruttering
- Ciusss de Lestrie Chus
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Birmingham, Det Forenede Kongerige, B15 2TH
- Rekruttering
- Queen Elizabeth Hospital
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Bournemouth, Det Forenede Kongerige, BH7 7DW
- Rekruttering
- University Hospitals Dorset Royal Bournemouth Hospital
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Leeds, Det Forenede Kongerige, LS9 7TF
- Rekruttering
- St Jamess University Hospital
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London, Det Forenede Kongerige, SE5 9RS
- Rekruttering
- Kings College Hospital
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Norwich, Det Forenede Kongerige, NR4 7UY
- Rekruttering
- Norfolk and Norwich University Hospitals Nhs Foundation Trust
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-
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California
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Duarte, California, Forenede Stater, 91010-3012
- Rekruttering
- City of Hope National Medical Center
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Orange, California, Forenede Stater, 92868-3201
- Rekruttering
- Chao Family Comprehensive Cancer Center
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Palo Alto, California, Forenede Stater, 94304-2205
- Rekruttering
- Stanford Cancer Institute
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Colorado
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Aurora, Colorado, Forenede Stater, 80012-5405
- Rekruttering
- Rocky Mountain Cancer Centers (Williams) Usor
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Florida
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Jacksonville, Florida, Forenede Stater, 32224-1865
- Rekruttering
- Mayo Clinic Jacksonville
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Miami, Florida, Forenede Stater, 33140
- Rekruttering
- Mount Sinai Medical Center Braman Comprehensive Cancer Center
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Tampa, Florida, Forenede Stater, 33612-9496
- Rekruttering
- Moffitt Cancer Center
-
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Rekruttering
- Northwestern University
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Zion, Illinois, Forenede Stater, 60099-2676
- Rekruttering
- Midwestern Regional Medical Center
-
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Louisiana
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New Orleans, Louisiana, Forenede Stater, 70121-2429
- Rekruttering
- Ochsner Clinic Foundation
-
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02215-5418
- Rekruttering
- Dana Farber Cancer Institute
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905-0001
- Rekruttering
- Mayo Clinic Rochester
-
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Nebraska
-
Omaha, Nebraska, Forenede Stater, 68198
- Rekruttering
- University of Nebraska Medical Center
-
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New York
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New York, New York, Forenede Stater, 10032
- Rekruttering
- Columbia University Medical Center
-
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28204-2990
- Rekruttering
- Atrium Health Levine Cancer Institute (Lci)
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Durham, North Carolina, Forenede Stater, 27705-3976
- Rekruttering
- Duke University Medical Center
-
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Oregon
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Eugene, Oregon, Forenede Stater, 97401
- Rekruttering
- Oncology Associates of Oregon Willamette Valley Cancer Center
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Pennsylvania
-
Pittsburgh, Pennsylvania, Forenede Stater, 15232-1309
- Rekruttering
- Upmc Hillman Cancer Center(Univ of Pittsburgh)
-
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Texas
-
Tyler, Texas, Forenede Stater, 75702-7522
- Rekruttering
- Texas Oncology Tyler
-
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Utah
-
Salt Lake City, Utah, Forenede Stater, 84112-5550
- Rekruttering
- Huntsman Cancer Institute
-
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Washington
-
Seattle, Washington, Forenede Stater, 98109-4433
- Rekruttering
- Fred Hutchinson Cancer Research Center
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Wisconsin
-
Milwaukee, Wisconsin, Forenede Stater, 53226-3522
- Rekruttering
- Medical College of Wisconsin
-
-
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-
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Bordeaux, Frankrig, 33076
- Rekruttering
- Centre de Lutte Contre Le Cancer Institut Bergonie
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ClermontFerrand, Frankrig, 63100
- Rekruttering
- Chu Clermont Ferrand Therapie Cellulaire and Hematolo
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Le Mans, Frankrig, 72037
- Rekruttering
- Centre Hospitalier Le Mans
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Lille, Frankrig, 59000
- Rekruttering
- Hopital Claude Huriez Chu Lille
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Lyon, Frankrig, 69373
- Rekruttering
- Centre Leon Berard
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Montpellier, Frankrig, 34090
- Rekruttering
- Chu Montpellier Hopital Saint Eloi
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Toulouse, Frankrig, 31100
- Rekruttering
- Iuc Toulouse Oncopole
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-
-
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Almere Stad, Holland, 1315 RA
- Rekruttering
- Flevoziekenhuis
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Dordrecht, Holland, 3318 AT
- Rekruttering
- Albert Schweitzer Ziekenhuis
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Sgravenhage, Holland, 2545 AA
- Rekruttering
- Hagaziekenhuis
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-
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Bologna, Italien, 40138
- Rekruttering
- Irccs Azienda Ospedaliero Universitaria Bologna
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Florence, Italien, 50134
- Rekruttering
- Aou Careggi, Servizio Sanitario Toscana
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Milan, Italien, 20132
- Rekruttering
- Ospedale San Raffaele
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Milan, Italien, 20162
- Rekruttering
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
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Padova, Italien, 35128
- Rekruttering
- Azienda Ospedaliera Di Padova
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Roma, Italien, 00168
- Rekruttering
- Fondazione Policlinico Universitario Agostino Gemelli
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100730
- Rekruttering
- Peking Union Medical College Hospital
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Chongqing Municipality
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Chongqing, Chongqing Municipality, Kina, 630014
- Rekruttering
- The First Affiliated Hospital of Chongqing Medical University
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Fujian
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Fuzhou, Fujian, Kina, 350005
- Rekruttering
- The First Affiliated Hospital of Fujian Medical University
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Guangdong
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Guangzhou, Guangdong, Kina, 510555
- Rekruttering
- Sun Yat Sen University Cancer Center Huangpu Branch
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Guangzhou, Guangdong, Kina, 510000
- Aktiv, ikke rekrutterende
- Zhujiang Hospital of Southern Medical University
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Guangxi
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Nanning, Guangxi, Kina, 530021
- Rekruttering
- The First Affiliated Hospital of Guangxi Medical University
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Guizhou
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Guiyang, Guizhou, Kina, 550002
- Rekruttering
- Guizhou Provincial Peoples Hospital
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Heilongjiang
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Harbin, Heilongjiang, Kina, 150000
- Rekruttering
- Harbin Medical University Cancer Hospital
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Henan
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Zhengzhou, Henan, Kina, 450000
- Rekruttering
- Henan Cancer Hospital
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Hunan
-
Changsha, Hunan, Kina, 410011
- Rekruttering
- The Second Xiangya Hospital of Central South University
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Jiangsu
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Nanjing, Jiangsu, Kina, 210029
- Rekruttering
- Jiangsu Province Hospital
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Nantong, Jiangsu, Kina, 201203
- Rekruttering
- Affiliated Hospital of Nantong University
-
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Jiangxi
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Nanchang, Jiangxi, Kina, 330006
- Rekruttering
- The Second Affiliated Hospital of Nanchang University
-
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Shaanxi
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Xi'an, Shaanxi, Kina, 710004
- Rekruttering
- The Second Affiliated Hospital of Xian Jiaotong University
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Shandong
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Jinan, Shandong, Kina, 250000
- Rekruttering
- Shandong Provincial Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 200025
- Rekruttering
- Rui Jin Hospital Shanghai Jiao Tong University School of Medicine
-
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Sichuan
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Chengdu, Sichuan, Kina, 610071
- Rekruttering
- Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
-
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina, 300020
- Rekruttering
- Institute of Hematology and Hospital of Blood Disease
-
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Yunnan
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Kunming, Yunnan, Kina, 650032
- Rekruttering
- First Affiliated Hospital of Kunming Medical University
-
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310002
- Rekruttering
- The First Affiliated Hospital, Zhejiang University School of Medicinechengzhan
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-
-
-
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Auckland, New Zealand, 1023
- Rekruttering
- Auckland City Hospital
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Auckland, New Zealand, 0622
- Rekruttering
- North Shore Hospital
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Christchurch, New Zealand, 8011
- Rekruttering
- Health New Zealand Canterbury
-
Dunedin, New Zealand, 9016
- Rekruttering
- Dunedin Hospital
-
Wellington, New Zealand, 6021
- Rekruttering
- Wellington Regional Hospital (Ccdhb)
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-
-
-
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Brzozów, Polen, 36-200
- Rekruttering
- Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny
-
Katowice, Polen, 40-519
- Rekruttering
- Pratia Onkologia Katowice
-
Krakow, Polen, 30-727
- Rekruttering
- Pratia McM Krakow
-
Lublin, Polen, 20-090
- Rekruttering
- Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
-
Wroclaw, Polen, 50-367
- Rekruttering
- Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
-
-
-
-
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Bucharest, Rumænien, 30171
- Rekruttering
- Coltea Clinical Hospital
-
Bucureti, Rumænien, 022328
- Rekruttering
- Institutul Clinic Fundeni
-
ClujNapoca, Rumænien, 400015
- Rekruttering
- Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca
-
-
-
-
-
Granada, Spanien, 18014
- Rekruttering
- Hospital Universitario Virgen de Las Nieves
-
Madrid, Spanien, 28041
- Rekruttering
- Hospital Universitario 12 de Octubre
-
Majadahonda, Spanien, 28222
- Rekruttering
- Hospital Universitario Puerta de Hierro Majadahonda
-
Murcia, Spanien, 30120
- Rekruttering
- Hospital Clinico Universitario Virgen de La Arrixaca
-
-
-
-
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Stockholm, Sverige, 171 76
- Rekruttering
- Karolinska Universitetssjukhuset Solna
-
-
-
-
Gyeonggi-do
-
Seongnam-si, Gyeonggi-do, Sydkorea, 13620
- Rekruttering
- Seoul National University Bundang Hospital
-
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Seoul Teugbyeolsi
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SeochoGu, Seoul Teugbyeolsi, Sydkorea, 06591
- Rekruttering
- The Catholic University of Korea, Seoul St Marys Hospital
-
SeodaemunGu, Seoul Teugbyeolsi, Sydkorea, 03722
- Rekruttering
- Severance Hospital Yonsei University Health System
-
Seoul, Seoul Teugbyeolsi, Sydkorea, 03080
- Rekruttering
- Seoul National University Hospital
-
SongpaGu, Seoul Teugbyeolsi, Sydkorea, 05505
- Rekruttering
- Asan Medical Center
-
-
-
-
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Brno, Tjekkiet, 625 00
- Rekruttering
- Fakultni Nemocnice Brno
-
Hradec Králové, Tjekkiet, 500 03
- Rekruttering
- Fakultni Nemocnice Hradec Kralove
-
Olomouc, Tjekkiet, 77900
- Rekruttering
- Fakultni Nemocnice Olomouc
-
Ostrava, Tjekkiet, 708 00
- Rekruttering
- Fakultni Nemocnice Ostrava
-
PLZE, Tjekkiet, 323 00
- Rekruttering
- Fakultni Nemocnice Plzen
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Prague, Tjekkiet, 10000
- Rekruttering
- Vseobecna Fakultni Nemocnice V Praze
-
-
-
-
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Deggendorf, Tyskland, 94469
- Rekruttering
- Donauisar Klinikum Deggendorf Klinik Fur Onkologie Und Hamatologie
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Frankfurt am Main, Tyskland, 60389
- Rekruttering
- Centrum Fur Haematologie Und Onkologie Bethanien
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Münster, Tyskland, 48153
- Rekruttering
- Geho Munster
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Straubing, Tyskland, 94315
- Rekruttering
- Klinikum St Elisabeth Straubing Gmbh Mvz Klinikum Straubing Gmbh
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Treatment-naïve (TN) adults with confirmed diagnosis of CLL which requires treatment
- Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2
- Measurable disease by Computer Tomography/Magnetic Resonance Imaging
- Adequate bone marrow and organ function
Exclusion Criteria:
- Previous systemic treatment for CLL
- Known prolymphocytic leukemia or history of, or currently suspected, Richter's transformation
- Known central nervous system involvement
- History of confirmed progressive multifocal leukoencephalopathy (PML)
- Uncontrolled hypertension or clinically significant cardiovascular disease
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Antal våben
2
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Arm A: Sonrotoclax plus Zanubrutinib
Participants will receive sonrotoclax and zanubrutinib for a fixed duration followed by observation. |
Administered orally.
Andre navne:
Administered orally.
Andre navne:
|
|
Aktiv komparator: Arm B: Venetoclax plus Acalabrutinib
Participants will receive venetoclax and acalabrutinib for a fixed duration followed by observation. |
Administered orally.
Andre navne:
Administered orally.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression-Free Survival (PFS) as Determined by Independent Review Committee (IRC)
Tidsramme: Up to approximately 70 months
|
PFS is defined as the time from the date of randomization to the date of disease progression as determined by IRC or death due to any cause, whichever occurs first. |
Up to approximately 70 months
|
|
Rate of Undetectable Minimal Residual Disease at < 10^-4 sensitivity (uMRD4)
Tidsramme: Up to approximately 16 months
|
Rate of uMRD4 is defined as the percentage of participants that achieved uMRD4 measured in both peripheral blood (PB) and bone marrow aspirate (BMA) at the post-treatment follow-up visit (PTFU1) based on next generation sequencing (NGS). |
Up to approximately 16 months
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
PFS in High-Risk Participants
Tidsramme: Up to approximately 70 months
|
PFS is defined as the time from the date of randomization to the date of disease progression as determined by IRC or death due to any cause, whichever occurs first. |
Up to approximately 70 months
|
|
Overall Survival (OS)
Tidsramme: Up to approximately 70 months
|
OS is defined as the time from the date of randomization to the date of death due to any cause. |
Up to approximately 70 months
|
|
Overall Response Rate (ORR) as Determined by IRC
Tidsramme: Up to approximately 70 months
|
ORR is defined as the percentage of participants with a complete response (CR), complete response with incomplete hematopoietic recovery (CRi), nodal partial response (nPR), or partial response (PR), before disease progression, death, or the start of new anti-CLL treatment (whichever is earlier), as assessed by IRC. |
Up to approximately 70 months
|
|
Rate of Undetectable Minimal Residual Disease at < 10^-5 sensitivity (uMRD5)
Tidsramme: Up to approximately 16 months
|
Rate of uMRD5 is defined as the percentage of participants who achieved uMRD5 measured in both PB and BMA at the PTFU1 Visit based on NGS, before disease progression, death, or the start of new anti-CLL treatment (whichever is earlier). |
Up to approximately 16 months
|
|
Number of Participants with Adverse Events
Tidsramme: Up to approximately 70 months
|
Number of participants with treatment-emergent adverse events (TEAEs), adverse events of clinical interest, and serious adverse events (SAEs), including laboratory values, vital signs, and physical examination findings. |
Up to approximately 70 months
|
|
PFS Determined by Investigator Assessment
Tidsramme: Up to approximately 70 months
|
PFS is defined as the time from the date of randomization to the date of disease progression as determined by investigator or death due to any cause, whichever occurs first. |
Up to approximately 70 months
|
|
Complete Response Rate (CRR) by IRC and Investigator Assessment
Tidsramme: Up to approximately 70 months
|
CRR is defined as the percentage of participants with a CR or CRi before disease progression, death, or the start of new anti-CLL treatment (whichever is earlier). |
Up to approximately 70 months
|
|
ORR Determined by Investigator Assessment
Tidsramme: Up to approximately 70 months
|
ORR is defined as the percentage of participants with a complete response or partial response, before disease progression, death, or the start of new anti-CLL treatment (whichever is earlier), as assessed by investigator. |
Up to approximately 70 months
|
|
Duration of Response (DOR)
Tidsramme: Up to approximately 70 months
|
Duration of response (determined by both IRC and investigator assessment) is defined as the time from the first qualifying response (CR, CRi, nPR, or PR) until CLL progression or death. DOR analysis will only include responders. |
Up to approximately 70 months
|
|
Time to Next Treatment (TTNT)
Tidsramme: Up to approximately 70 months
|
TTNT is defined as the time from randomization to the start of the next treatment for CLL. |
Up to approximately 70 months
|
|
Change from Baseline in Score on European Organization for Research and Treatment of Cancer (EORTC) Item Library (IL)-409 Questionnaire
Tidsramme: At baseline and up to approximately 70 months
|
Patient-reported symptoms of global health status (GHS), role functioning, and physical functioning, symptom burden and physical condition/fatigue will be measured using the European Organization for Research and Treatment of Cancer quality of life questionnaire EORTC IL-409 (an itemized version of [EORTC] quality of life questionnaire core 30 [QLQ-C30] and its CLL module CLL17). The EORTC-IL-409 consists of 17 questions answered on a 4-point scale where 1 = Not at all (best) to 4 = Very Much (worst) and 2 global health questions answered on a 7-point scale where 1 = Very poor (worst) to 7 = Excellent (best). Higher scores in GHS and functional scales and lower scores in symptom scales indicate better quality of life. |
At baseline and up to approximately 70 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Study Director, BeOne Medicines
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
Studiestart
22. januar 2026
Primær færdiggørelse (Anslået)
Primær færdiggørelse
1. februar 2031
Studieafslutning (Anslået)
Studieafslutning
1. november 2031
Datoer for studieregistrering
Først indsendt
Først indsendt
2. december 2025
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
2. december 2025
Først opslået (Faktiske)
Først opslået
11. december 2025
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
28. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. september 2026
Sidst verificeret
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Neoplasmer
- Kronisk sygdom
- Sygdomsegenskaber
- Sygdomme i immunsystemet
- Neoplasmer efter histologisk type
- Hæmatologiske sygdomme
- Lymfesygdomme
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Leukæmi, B-celle
- Leukæmi, lymfoid
- Leukæmi
- Patologiske tilstande, tegn og symptomer
- Hemiske og lymfatiske sygdomme
- Leukæmi, lymfatisk, kronisk, B-celle
- Zannubrutinib
- Venetoclax
- acalabrutinib
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- BGB-11417-304
- 2025-524366-21-00 (Ctis)
- 2025 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
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
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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 .