A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
MAHOGANY
A Phase 3 Randomized, Open-Label Multicenter Study of Zanubrutinib (BGB-3111) Plus Anti-CD20 Antibodies Versus Lenalidomide Plus Rituximab in Patients With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
3 other identifiers
interventional
799
27 countries
252
Brief Summary
The purpose of the study is to compare the efficacy of zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab (R\^2) in participants with relapsed/refractory (R/R) follicular lymphoma (FL), as measured by progression-free survival as determined by an independent review committee in accordance with the 2014 modification of the International Working Group on non-Hodgkin lymphoma (NHL) Criteria based on n positron emission tomography and computed tomography (PET/CT), and to compare the efficacy of zanubrutinib plus rituximab versus R\^2 in participants with R/R marginal zone lymphoma (MZL), as measured by progression free survival (PFS) assessed by IRC in accordance with CT-based Lugano 2014 Criteria.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2022
Longer than P75 for phase_3
252 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2021
CompletedFirst Posted
Study publicly available on registry
October 29, 2021
CompletedStudy Start
First participant enrolled
March 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
July 23, 2026
July 1, 2026
6.3 years
September 27, 2021
July 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival As Determined By A Blinded Independent Review Committee (BIRC)
Approximately 78 months
Secondary Outcomes (11)
Progression-free Survival As Determined By Investigator Assessment
Approximately 87 months
Duration Of Response As Determined By BIRC And By Investigator Assessment
Approximately 87 months
Overall Response Rate As Determined By BIRC And By Investigator Assessment
Approximately 87 months
Complete Response Rate As Determined By BIRC And By Investigator Assessment
Approximately 87 months
Time To Response As Determined By BIRC And By Investigator Assessment
Approximately 87 months
- +6 more secondary outcomes
Study Arms (4)
Follicular Lymphoma Arm A: Zanubrutinib plus Obinutuzumab
EXPERIMENTALParticipants will receive zanubrutinib and Obinutuzumab. Following the completion of the combination treatment, participants will continue receiving zanubrutinib monotherapy until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination, whichever occurs first.
Follicular Lymphoma Arm B: Lenalidomide plus Rituximab
ACTIVE COMPARATORParticipants will receive lenalidomide and rituximab.
Marginal Zone Lymphoma Arm C: Zanubrutinib plus Rituximab
EXPERIMENTALParticipants will receive zanubrutinib and rituximab. Following the completion of the combination treatment, participants will continue receiving zanubrutinib monotherapy until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination, whichever occurs first.
Marginal Zone Lymphoma Arm D: Lenalidomide plus Rituximab
ACTIVE COMPARATORParticipants will receive lenalidomide and rituximab.
Interventions
Zanubrutinib will be administered orally as two 80-milligram (mg) capsules twice a day (160 mg twice a day) or four 80-mg capsules once a day (320 mg once a day) continuously in repeated 28-day cycles.
Rituximab will be administered intravenously at a dose of 375 mg/meter squared on Days 1, 8, 15, and 22 of Cycle 1 and on Day 1 of Cycles 2 to 5. Each cycle is 28 days in length.
Lenalidomide will be administered orally as 20-mg capsules (10 mg if creatinine clearance ≥ 30 mL/min but \< 60 mL/min) once a day on Days 1 to 21 of each 28-day cycle for a total of 12 cycles.
Obinutuzumab will be administered at a dose of 1000 mg on Cycle 1 Days 1, 8, 15 and then on Cycles 2 to 6 Day 1.
Eligibility Criteria
You may qualify if:
- Histologically confirmed grade 1-3a FL or MZL
- Previously treated with ≥ 1 line of systemic therapy including anti-CD20 agent. Must have a documented failure to achieve at least partial response during the most recent systemic therapy or documented progressive disease after the most recent systemic therapy
- Need for systemic therapy for FL or MZL
- Measurable disease by computed tomography or magnetic resonance imaging
- Adequate bone marrow, liver and renal function
You may not qualify if:
- Transformation to aggressive lymphoma
- Requiring ongoing need for corticosteroid treatment
- Clinically significant cardiovascular disease
- Prior malignancy within the past 2 years
- Active fungal, bacterial, and/or viral infection that requires systemic therapy
- Prior treatment with lenalidomide or drug from same class, if without response (partial or complete) or short remission duration (\< 24 months)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BeOne Medicineslead
Study Sites (270)
Ucsf Fresno University of California San Francisco Fresno
Fresno, California, 93730-3595, United States
Kaiser Permanente Southern California
Irvine, California, 92618-3734, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720-3302, United States
Los Angeles Cancer Network
Los Angeles, California, 90017-4803, United States
Valkyrie Clinical Trials
Los Angeles, California, 90067-2011, United States
UCLA Hematologyoncology
Los Angeles, California, 90095-3075, United States
Scripps Health
San Diego, California, 92103-2106, United States
Sharp Healthcare Sharp Memorial Hospital
San Diego, California, 92123-2701, United States
Baptist Md Anderson Cancer Center
Jacksonville, Florida, 32207-8432, United States
Ascension Sacred Heart
Pensacola, Florida, 32504-8615, United States
Northwest Georgia Oncology Centers Marietta
Marietta, Georgia, 30060-1152, United States
Cancer Care Specialists of Illinois
Decatur, Illinois, 62526-5858, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804, United States
Mission Cancer and Blood
Waukee, Iowa, 50263, United States
Cotton Oneil Cancer Center
Topeka, Kansas, 66606-1535, United States
Cancer Center of Kansas
Wichita, Kansas, 67214-3728, United States
Baptist Health Lexington
Lexington, Kentucky, 40503-1466, United States
Christus Highland Cancer Treatment Center
Shreveport, Louisiana, 71105-6800, United States
Luminis Health Anne Arundel Medical Center
Annapolis, Maryland, 21401, United States
The University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, 21201, United States
Ascension St Agnes Hospital
Baltimore, Maryland, 21229-5201, United States
American Oncology Partners of Maryland Pa
Bethesda, Maryland, 20817-7847, United States
Henry Ford Hospital
Detroit, Michigan, 48202-2608, United States
Corewell Health the Michigan Cancer Consortium
Grand Rapids, Michigan, 49503-2560, United States
Hattiesburg Hematology and Oncology Clinic
Hattiesburg, Mississippi, 39401-7233, United States
University of Missouri Hospital, Ellis Fischel Cancer Center
Columbia, Missouri, 65212-1000, United States
Oncology Hematology Associates
Springfield, Missouri, 65807-5288, United States
St Vincent Frontier Cancer Center
Billings, Montana, 59102-6746, United States
Nebraska Cancer Specialists
Omaha, Nebraska, 68130-2042, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169-3321, United States
Iyengar Hematology Oncology Medical Center Pa
Bayonne, New Jersey, 07002-4654, United States
Summit Medical Group
Florham Park, New Jersey, 07932-1049, United States
New York Cancer and Blood Specialists
Shirley, New York, 11967, United States
Suny Upstate Medical University
Syracuse, New York, 13210-2306, United States
North Shore Hematology Oncology Associates Eccc Bronx
The Bronx, New York, 10469-5930, United States
Optum Medical Care, Pc
Westbury, New York, 11590-5119, United States
Levine Cancer Institute Wake Forest
Charlotte, North Carolina, 28204-2990, United States
Oncology Hematology Care Clinical Trials, Llc
Cincinnati, Ohio, 45245-1995, United States
Va Northeast Ohio Healthcare System
Cleveland, Ohio, 44106-1702, United States
Toledo Clinic Cancer Center
Toledo, Ohio, 43623-3536, United States
Mainline Health Lankenau Institute For Medical Research
Wynnewood, Pennsylvania, 19096, United States
Cancer Care Associates of York
York, Pennsylvania, 17403-5049, United States
Prairie Lakes Healthcare System
Watertown, South Dakota, 57201-1548, United States
Texas Oncology Baylorcharles A Sammons Cancer Center
Dallas, Texas, 75246-2003, United States
Md Anderson Cancer Center
Houston, Texas, 77030-3907, United States
Northeast Texas Cancer and Research Institute
Tyler, Texas, 75702-7522, United States
University of Washington
Seattle, Washington, 98195, United States
Medical Oncology Associates
Spokane, Washington, 99208-1129, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
Hospital Aleman
CABA, 1425, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, 1413, Argentina
Concord Repatriation General Hospital
Concord, New South Wales, NSW 2139, Australia
Gosford Hospital
Gosford, New South Wales, NSW 2250, Australia
St George Hospital
Kogarah, New South Wales, NSW 2217, Australia
Orange Health Hospital
Orange, New South Wales, NSW 2800, Australia
Port Macquarie Base Hospital
Port Macquarie, New South Wales, NSW 2444, Australia
Westmead Hospital
Westmead, New South Wales, NSW 2145, Australia
Sunshine Coast Hospital and Health Service
Birtinya, Queensland, QLD 4575, Australia
Townsville University Hospital
Douglas, Queensland, QLD 4814, Australia
Genesiscare North Adelaide
North Adelaide, South Australia, SA 5006, Australia
Monash Health
Clayton, Victoria, VIC 3168, Australia
Epworth Freemasons
East Melbourne, Victoria, VIC 3002, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, VIC 3065, Australia
Austin Health
Heidelberg, Victoria, VIC 3084, Australia
Cabrini Hospital Malvern
Malvern, Victoria, VIC 3144, Australia
The Alfred Hospital
Melbourne, Victoria, VIC 3004, Australia
La Trobe Regional Hospital
Melbourne, Victoria, VIC 3844, Australia
Royal Perth Hospital
Perth, Western Australia, WA 6000, Australia
Perth Blood Institute
West Perth, Western Australia, WA 6005, Australia
Medizinische Universitatsklinik Innsbruck
Innsbruck, 6020, Austria
Uk St Poelten
Sankt Pölten, 3100, Austria
Medical Univeristy Vienna
Vienna, 1090, Austria
Hanusch Krankenhaus
Vienna, 1140, Austria
Wiener Gesundheitsverbund Klinik Ottakring
Vienna, 1160, Austria
Institut Jules Bordet
Anderlecht, 1070, Belgium
Az Sint Jan Brugge
Bruges, 8000, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
University Hospitals Leuven
Leuven, 3000, Belgium
Hospital de Amor Barretos
Barretos, 14784-400, Brazil
Clinica de Oncologia Reichow
Blumenau, 89010-340, Brazil
Unesp Faculdade de Medicina Da Universidade Estadual Paulista Campus Botucatu
Botucatu, 18618687, Brazil
Instituto Dor de Pesquisa E Ensino Distrito Federal
Brasília, 70390140, Brazil
Universidade de Campinas Centro de Hematologia E Hemoterapia
Campinas, 13083-878, Brazil
Fundacao Universidade de Caxias Do Sul
Caxias do Sul, 95070-560, Brazil
Centro Integrado de Oncologia de Curitiba Ss Cionc
Curitiba, 80810-050, Brazil
Hospital Erasto Gaertner
Curitiba, 81520-060, Brazil
Centro de Ensino E Pesquisa Em Oncologia de Santa Catarina (Cepen)
Florianópolis, 88020-210, Brazil
Complexo Hospitalar de Niteroi
Niterói, 24020-096, Brazil
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, 90110-270, Brazil
Instituto Dor de Pesquisa E Ensino Pernambuco
Recife, 50070-170, Brazil
Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp
Ribeirão Preto, 14051-140, Brazil
Instituto Dor de Pesquisa E Ensino Rio de Janeiro
Rio de Janeiro, 22281-100, Brazil
Instituto Americas Ensino, Pesquisa E Inovacao
Rio de Janeiro, 22775-001, Brazil
Hospital Sao Rafael Instituto Dor de Pesquisa E Ensino
Salvador, 41253-190, Brazil
Ensino E Terapia de Inovacao Clinica Amo Etica
Salvador, 41950-640, Brazil
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, 01401-004, Brazil
Hospital Nove de Julho Dasa
São Paulo, 01409-001, Brazil
Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
São Paulo, 05402-000, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, 05652-900, Brazil
Hospital Santa Rita de Cassia Afecc
Vitória, 29043-260, Brazil
Umhat Svgeorgi Ead
Plovdiv, 4002, Bulgaria
Acibadem City Clinic Tokuda Umhat Ead, Department of Medical Oncology
Sofia, 1407, Bulgaria
University Multiprofile Hospital For Active Treatment Saint Ivan Rilski
Sofia, 1407, Bulgaria
NHATHD
Sofia, 1756, Bulgaria
British Columbia Cancer Agency the Vancouver Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Newfoundland and Labrador Health Services
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Queen Elizabeth Ii Health Sciences Centre
Halifax, Nova Scotia, B3H 2Y9, Canada
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
Ciusss Du Saguenay Lac St Jean
Chicoutimi, Quebec, G7H 5H6, Canada
Centre Integre de Sante Et de Services Sociaux de Chaudiere Appalaches
Lévis, Quebec, G6V 3Z1, Canada
Ciusss de Lest de Lile de Montreal Hopital Maisonneuve Rosemont
Montreal, Quebec, H1T 2M4, Canada
Unite de Recherche Clinique Du Cisss Des Laurentides
SaintJerome, Quebec, J7Z 5T3, Canada
Ciusss de Lestrie Chus
Sherbrooke, Quebec, J1H 5N4, Canada
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
Québec, G1J 1Z4, Canada
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, 241001, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Beijing Friendship Hospital, Capital Medical University(Tongzhou)
Beijing, Beijing Municipality, 101100, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003, China
The First Peoples Hospital of Foshan
Foshan, Guangdong, 528000, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Huizhou Central Peoples Hospital
Huizhou, Guangdong, 516001, China
Meizhou People Hospital
Meizhou, Guangdong, 514031, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524000, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
Anyang Tumor Hospital
Anyang, Henan, 455001, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
The First Peoples Hospital of Changde City
Changde, Hunan, 415000, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 201203, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Wuxi Peoples Hospital
Wuxi, Jiangsu, 214023, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, 330006, China
Jiangxi Province Cancer Hospital
Nanchang, Jiangxi, 330029, China
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang, Jiangxi, 332000, China
The First Hospital of Jilin University
Changchun, Jilin, 130021, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, 110042, China
Peoples Hospital of Rizhao
Rizhao, Shandong, 276827, China
The Second Affiliated Hospital of Shandong First Medical University
Taian, Shandong, 271099, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030013, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
Dongyang Peoples Hospital
Dongyang, Zhejiang, 322103, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, 314001, China
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, 321000, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Fakultni Nemocnice Hradec Kralove
Hradec Králové, 500 03, Czechia
Fakultni Nemocnice Olomouc
Olomouc, 77900, Czechia
Hopital Prive Dantony, Departement Dhemathologie
Antony, 92160, France
Centre Hospitalier Le Mans
Le Mans, 72037, France
Chu Montpellier Hopital Saint Eloi
Montpellier, 34090, France
Hopital Larchet 2 Chu Nice
Nice, 06200, France
Institut Curie
Paris, 75005, France
Necker University Hospital
Paris, 75015, France
Hopitaux Universitaires de Strasbourg Hopital de Hautepierre (Ancien Icans)
Strasbourg, 67200, France
Chu Nancy Hopital Brabois
VandoeuvrelesNancy, 54511, France
JSC VIAN
Kutaisi, 4600, Georgia
Universitaetsklinikum Essen
Essen, 45147, Germany
Universitaetsklinikum Ulm
Ulm, 89081, Germany
University Hospital of Alexandroupolis
Alexandroupoli, 68100, Greece
Evaggelismos
Athens, 106 76, Greece
General Hospital of Athens Alexandra
Athens, 115 28, Greece
University Hospital of Patra
Pátrai, 26504, Greece
St Jamess Hospital
Dublin, D08 NHY1, Ireland
University Hospital Waterford
Waterford, X91 ER8E, Ireland
Assuta Ashdod Medical Center
Ashdod, 7747629, Israel
Shaare Zedek Medical Center
Jerusalem, 9103102, Israel
Hadassah En Karem Medical Center
Jerusalem, 9112001, Israel
Rabin Medical Center
Petah Tikva, 49100, Israel
Chaim Sheba Medical Center
Ramat Gan, 5265601, Israel
Assuta Medical Center
Tel Aviv, 60000, Israel
Sourasky Tel Aviv Medical Center
Tel Aviv, 6423906, Israel
Cro Irccs Aviano
Aviano, 33081, Italy
Irccs Azienda Ospedaliero Universitaria Bologna
Bologna, 40138, Italy
Aou Careggi, Servizio Sanitario Toscana
Florence, 50134, Italy
Istituto Europeo Di Oncologia
Milan, 20141, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
Aou Maggiore Della Carita
Novara, 28100, Italy
Azienda Ospedaliera Di Padova
Padova, 35128, Italy
Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi
Pavia, 27100, Italy
Arcispedale S Maria Nuova Ausl Reggio Emilia Hematology Unit
Reggio Emilia, 42123, Italy
Aou Santa Maria Della Misericordia Di Udine
Udine, 33100, Italy
Matsuyama Red Cross Hospital
Matsuyama, Ehime, 790 8524, Japan
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
Hiroshima, Hiroshima, 730-8619, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, 003-0804, Japan
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, 890-8520, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, 241-8515, Japan
University Hospital, Kyoto Prefectural Univ of Medicine
KyotoShi, Kyoto, 602-8566, Japan
Kansai Medical University Hospital
Hirakata, Osaka, 573-1191, Japan
Kindai University Hospital
Sakai, Osaka, 590-0197, Japan
Tokyo Metropolitan Komagome Hospital
Bunkyoku, Tokyo, 113-8677, Japan
National Cancer Center Hospital
ChuoKu, Tokyo, 104-0045, Japan
Cancer Institute Hospital of Jfcr
Kotoku, Tokyo, 135-8550, Japan
Yamagata University Hospital
Yamagata, Yamagata, 990-9585, Japan
National Hospital Organization Okayama Medical Center
Okayama, 701-1192, Japan
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela
Bydgoszcz, 85-168, Poland
Uniwersyteckie Centrum Kliniczne Klinika Hematologii I Transplantologii
Gdansk, 80-214, Poland
Pratia Onkologia Katowice
Katowice, 40-519, Poland
Pratia McM Krakow
Krakow, 30-727, Poland
Uniwersytecki Szpital Kliniczny W Poznaniu
Poznan, 61-131, Poland
Wojewodzki Szpital Zespolony Im L Rydygiera W Toruniu
Torun, 87-100, Poland
Centralny Szpital Kliniczny Uck Wum
Warsaw, 02-097, Poland
Instytut Hematologii I Transfuzjologii W Warszawie
Warsaw, 02-776, Poland
Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie Hematology Unit
Warsaw, 02-781, Poland
Hospital de Braga
Braga, 4710-243, Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil, Epe
Porto, 4200-072, Portugal
Unidade Local de Saude Gaia E Espinho
VILA NOVA de GAIA Porto, 4434-502, Portugal
Pan American Oncology Trials, Llc
Rio Piedras, 00935, Puerto Rico
Auxilio Mutuo Cancer Center
San Juan, 00917, Puerto Rico
Coltea Clinical Hospital
Bucharest, 30171, Romania
Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca
ClujNapoca, 400015, Romania
Institutul Regional de Oncologie Iasi
Iași, 700483, Romania
Spitalul Clinic Judetean de Urgenta Bihor
Oradea, 410469, Romania
Haemalife
Kuils River, 7579, South Africa
Alberts Cellular Therapy
Pretoria, '0181, South Africa
Inje University Busan Paik Hospital
BusanjinGu, Busan Gwang'yeogsi, 47392, South Korea
Dong A University Hospital
Seogu, Busan Gwang'yeogsi, 49201, South Korea
Pusan National University Hospital
Seogu, Busan Gwang'yeogsi, 49241, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620, South Korea
Kyungpook National University Chilgok Hospital
BukGu, Gyeongsangbukdo, 41404, South Korea
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, 52727, South Korea
Chonnam National University Hwasun Hospital
HwasunGun, Jeollanam-do, 58128, South Korea
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, 06351, South Korea
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, 06591, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 03080, South Korea
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, 05505, South Korea
Soon Chun Hyang University Hospital Seoul
YongsanGu, Seoul Teugbyeolsi, 04401, South Korea
Ico Badalona
Badalona, 08916, Spain
Hospital Universitario de Burgos
Burgos, 09006, Spain
Hospital Universitario Puerta Del Mar
Cadiz, 11009, Spain
Hospital Universitario Virgen de Las Nieves
Granada, 18014, Spain
Institut Catala Doncologia Hospital Duran I Reynals
L'Hospitalet de Llobregat, 8908, Spain
Complejo Asistencial Universitario de Leon
León, 24071, Spain
Hospital de La Princesa
Madrid, 28006, Spain
Clinica Universidad de Navarra
Madrid, 28027, Spain
Hospital Universitario Infanta Leonor
Madrid, 28031, Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034, Spain
H Puerta de Hierro Majadahonda
Majadahonda, 28222, Spain
Hospital Clinico Universitario Virgen de La Arrixaca
Murcia, 30120, Spain
Clinica Universidad de Navarra Pamplona
Pamplona, 31008, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, 28223, Spain
Hospital Universitario de Salamanca
Salamanca, 37007, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Hospital Universitari Mutua Terrassa
Terrassa, 8221, Spain
St Claraspital
Basel, 4058, Switzerland
Hfr Fribourg
Fribourg, 1708, Switzerland
Reseau Hospitalier Neuchatelois
La ChauxdeFonds, 2300, Switzerland
Universitatsspital Zurich
Zurich, 8091, Switzerland
Ankara University Medical Faculty
Ankara, 06620, Turkey (Türkiye)
Gazi University Medical School
AOCiftlii, 06560, Turkey (Türkiye)
Bagcilar Medipol Mega Hospital
Istanbul, 34214, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, 41380, Turkey (Türkiye)
Vkv American Hospital
Tevikiye, 34365, Turkey (Türkiye)
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN, United Kingdom
The Christie Hospital
Greater Manchester, M20 4BX, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, HD3 3EA, United Kingdom
Nhs Highland
Inverness, IV2 3BW, United Kingdom
The Leeds Teaching Hospitals Nhs Trust
Leeds, LS9 7TF, United Kingdom
Barts Health Nhs Trust
London, EC1A 7BE, United Kingdom
University College Hospital
London, NW1 2PG, United Kingdom
Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
Southampton General Hospital
Southampton, SO16 6YD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
BeOne Medicines
- PRINCIPAL INVESTIGATOR
Study Director
BeOne Medicines
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2021
First Posted
October 29, 2021
Study Start
March 10, 2022
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
June 1, 2030
Last Updated
July 23, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- See plan description
- Access Criteria
- See plan description
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.