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A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma
Sponsor: BeiGene
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
780
Start Date
2022-03-10
Completion Date
2030-06
Last Updated
2026-03-18
Healthy Volunteers
No
Interventions
Zanubrutinib
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
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
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
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.
Locations (277)
Ucsf Fresno University of California San Francisco Fresno
Fresno, California, United States
Kaiser Permanente Southern California
Irvine, California, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, United States
Los Angeles Cancer Network
Los Angeles, California, United States
Valkyrie Clinical Trials
Los Angeles, California, United States
UCLA Hematologyoncology
Los Angeles, California, United States
Scripps Health
San Diego, California, United States
Sharp Healthcare Sharp Memorial Hospital
San Diego, California, United States
Baptist Md Anderson Cancer Center
Jacksonville, Florida, United States
Ascension Sacred Heart
Pensacola, Florida, United States
Northwest Georgia Oncology Centers Marietta
Marietta, Georgia, United States
Cancer Care Specialists of Illinois
Decatur, Illinois, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Mission Cancer and Blood
Waukee, Iowa, United States
Cotton Oneil Cancer Center
Topeka, Kansas, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Baptist Health Lexington
Lexington, Kentucky, United States
Christus Highland Cancer Treatment Center
Shreveport, Louisiana, United States
Luminis Health Anne Arundel Medical Center
Annapolis, Maryland, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Ascension St Agnes Hospital
Baltimore, Maryland, United States
American Oncology Partners of Maryland Pa
Bethesda, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
Corewell Health the Michigan Cancer Consortium
Grand Rapids, Michigan, United States
Hattiesburg Hematology and Oncology Clinic
Hattiesburg, Mississippi, United States
University of Missouri Hospital, Ellis Fischel Cancer Center
Columbia, Missouri, United States
Oncology Hematology Associates
Springfield, Missouri, United States
St Vincent Frontier Cancer Center
Billings, Montana, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
Iyengar Hematology Oncology Medical Center Pa
Bayonne, New Jersey, United States
Summit Medical Group
Florham Park, New Jersey, United States
New York Cancer and Blood Specialists
Shirley, New York, United States
Suny Upstate Medical University
Syracuse, New York, United States
North Shore Hematology Oncology Associates Eccc Bronx
The Bronx, New York, United States
Clinical Research Alliance, Inc
Westbury, New York, United States
Levine Cancer Institute Wake Forest
Charlotte, North Carolina, United States
Oncology Hematology Care Clinical Trials, Llc
Cincinnati, Ohio, United States
Va Northeast Ohio Healthcare System
Cleveland, Ohio, United States
Toledo Clinic Cancer Center
Toledo, Ohio, United States
Mainline Health Lankenau Institute For Medical Research
Wynnewood, Pennsylvania, United States
Cancer Care Associates of York
York, Pennsylvania, United States
Prairie Lakes Healthcare System
Watertown, South Dakota, United States
Texas Oncology Baylorcharles A Sammons Cancer Center
Dallas, Texas, United States
Md Anderson Cancer Center
Houston, Texas, United States
Northeast Texas Cancer and Research Institute
Tyler, Texas, United States
University of Washington
Seattle, Washington, United States
Medical Oncology Associates
Spokane, Washington, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Hospital Aleman
CABA, Argentina
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, Argentina
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Gosford Hospital
Gosford, New South Wales, Australia
St George Hospital
Kogarah, New South Wales, Australia
Orange Health Hospital
Orange, New South Wales, Australia
Port Macquarie Base Hospital
Port Macquarie, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Sunshine Coast Hospital and Health Service
Birtinya, Queensland, Australia
Townsville University Hospital
Douglas, Queensland, Australia
Genesiscare North Adelaide
North Adelaide, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
Epworth Freemasons
East Melbourne, Victoria, Australia
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Cabrini Hospital Malvern
Malvern East, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
La Trobe Regional Hospital
Melbourne, Victoria, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Perth Blood Institute
West Perth, Western Australia, Australia
Medizinische Universitatsklinik Innsbruck
Innsbruck, Austria
Uk St Poelten
Sankt Pölten, Austria
Medical Univeristy Vienna
Vienna, Austria
Hanusch Krankenhaus
Vienna, Austria
Wiener Gesundheitsverbund Klinik Ottakring
Vienna, Austria
Institut Jules Bordet
Anderlecht, Belgium
Az Sint Jan Brugge
Bruges, Belgium
Universitair Ziekenhuis Gent
Ghent, Belgium
University Hospitals Leuven
Leuven, Belgium
Hospital de Amor Barretos
Barretos, Brazil
Clinica de Oncologia Reichow
Blumenau, Brazil
Unesp Faculdade de Medicina Da Universidade Estadual Paulista Campus Botucatu
Botucatu, Brazil
Instituto Dor de Pesquisa E Ensino Distrito Federal
Brasília, Brazil
Universidade de Campinas Centro de Hematologia E Hemoterapia
Campinas, Brazil
Fundacao Universidade de Caxias Do Sul
Caxias do Sul, Brazil
Centro Integrado de Oncologia de Curitiba Ss Cionc
Curitiba, Brazil
Hospital Erasto Gaertner
Curitiba, Brazil
Centro de Ensino E Pesquisa Em Oncologia de Santa Catarina (Cepen)
Florianópolis, Brazil
Complexo Hospitalar de Niteroi
Niterói, Brazil
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, Brazil
Instituto Dor de Pesquisa E Ensino Pernambuco
Recife, Brazil
Instituto Dor de Pesquisa E Ensino
Recife, Brazil
Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp
Ribeirão Preto, Brazil
Instituto Americas Ensino, Pesquisa E Inovacao
Rio de Janeiro, Brazil
Hospital Sao Rafaelinstituto Dor de Pesquisa E Ensino
Salvador, Brazil
Ensino E Terapia de Inovacao Clinica Amo Etica
Salvador, Brazil
Hospital Nove de Julho Dasa
São Paulo, Brazil
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo, Brazil
Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
São Paulo, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, Brazil
Hospital Santa Rita de Cassia Afecc
Vitória, Brazil
Umhat Svgeorgi Ead
Plovdiv, Bulgaria
Acibadem City Clinic Tokuda Umhat Ead, Department of Medical Oncology
Sofia, Bulgaria
University Multiprofile Hospital For Active Treatment Saint Ivan Rilski
Sofia, Bulgaria
NHATHD
Sofia, Bulgaria
British Columbia Cancer Agency the Vancouver Centre
Vancouver, British Columbia, Canada
Newfoundland and Labrador Health Services
St. John's, Newfoundland and Labrador, Canada
Queen Elizabeth Ii Health Sciences Centre
Halifax, Nova Scotia, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Ciusss Du Saguenay Lac St Jean
Chicoutimi, Quebec, Canada
Centre Integre de Sante Et de Services Sociaux de Chaudiere Appalaches
Lévis, Quebec, Canada
Ciusss de Lest de Lile de Montreal Hopital Maisonneuve Rosemont
Montreal, Quebec, Canada
Unite de Recherche Clinique Du Cisss Des Laurentides
SaintJerome, Quebec, Canada
Ciusss de Lestrie Chus
Sherbrooke, Quebec, Canada
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
Québec, Canada
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University(Tongzhou)
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
The First Peoples Hospital of Foshan
Foshan, Guangdong, China
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong, China
Huizhou Central Peoples Hospital
Huizhou, Guangdong, China
Meizhou People Hospital
Meizhou, Guangdong, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Anyang Tumor Hospital
Anyang, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
The First Peoples Hospital of Changde City
Changde, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Wuxi Peoples Hospital
Wuxi, Jiangsu, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi, China
Jiangxi Province Cancer Hospital
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Liaoning Cancer Hospital and Institute
Shenyang, Liaoning, China
Peoples Hospital of Rizhao
Rizhao, Shandong, China
The Second Affiliated Hospital of Shandong First Medical University
Taian, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Dongyang Peoples Hospital
Dongyang, Zhejiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
The First Hospital of Jiaxing
Jiaxing, Zhejiang, China
Jinhua Municipal Central Hospital
Jinhua, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Fakultni Nemocnice Hradec Kralove
Hradec Králové, Czechia
Fakultni Nemocnice Olomouc
Olomouc, Czechia
Hopital Prive Dantony, Departement Dhemathologie
Antony, France
Centre Hospitalier Le Mans
Le Mans, France
Chu Montpellier Hopital Saint Eloi
Montpellier, France
Hopital Larchet 2 Chu Nice
Nice, France
Institut Curie
Paris, France
Necker University Hospital
Paris, France
Hopitaux Universitaires de Strasbourg Hopital de Hautepierre (Ancien Icans)
Strasbourg, France
Chu Nancy Hopital Brabois
VandoeuvrelesNancy, France
JSC VIAN
Kutaisi, Georgia
Universitaetsklinikum Essen
Essen, Germany
Universitaetsklinikum Ulm
Ulm, Germany
University Hospital of Alexandroupolis
Alexandroupoli, Greece
Evaggelismos
Athens, Greece
General Hospital of Athens Alexandra
Athens, Greece
University Hospital of Patra
Pátrai, Greece
St Jamess Hospital
Dublin, Ireland
University Hospital Waterford
Waterford, Ireland
Assuta Ashdod Medical Center
Ashdod, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Hadassah En Karem Medical Center
Jerusalem, Israel
Rabin Medical Center
Petah Tikva, Israel
Chaim Sheba Medical Center
Ramat Gan, Israel
Assuta Medical Center
Tel Aviv, Israel
Sourasky Tel Aviv Medical Center
Tel Aviv, Israel
Cro Irccs Aviano
Aviano, Italy
Irccs Azienda Ospedaliero Universitaria Bologna
Bologna, Italy
Aou Careggi, Servizio Sanitario Toscana
Florence, Italy
Istituto Europeo Di Oncologia
Milan, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan, Italy
Aou Maggiore Della Carita
Novara, Italy
Azienda Ospedaliera Di Padova
Padova, Italy
Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi
Pavia, Italy
Arcispedale S Maria Nuova Ausl Reggio Emilia Hematology Unit
Reggio Emilia, Italy
Aou Santa Maria Della Misericordia Di Udine
Udine, Italy
Aichi Cancer Center Hospital Clinical Oncology
Nagoya, Aichi-ken, Japan
Chiba Cancer Center
Chiba, Chiba, Japan
Matsuyama Red Cross Hospital
Matsuyama, Ehime, Japan
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
Hiroshima, Hiroshima, Japan
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Aiiku Hospital
Sapporo, Hokkaido, Japan
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
University Hospital, Kyoto Prefectural Univ of Medicine
KyotoShi, Kyoto, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Kurashiki Central Hospital
Kurashikishi, Okayama-ken, Japan
Kansai Medical University Hospital
Hirakata, Osaka, Japan
Kindai University Hospital
Sakai, Osaka, Japan
Tokyo Metropolitan Komagome Hospital
Bunkyoku, Tokyo, Japan
National Cancer Center Hospital
ChuoKu, Tokyo, Japan
Cancer Institute Hospital of Jfcr
Kotoku, Tokyo, Japan
Yamagata University Hospital
Yamagata, Yamagata, Japan
Kumamoto University Hospital
Kumamoto, Japan
National Hospital Organization Okayama Medical Center
Okayama, Japan
Yokohama Municipal Citizens Hospital
Yokohama, Japan
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela
Bydgoszcz, Poland
Uniwersyteckie Centrum Kliniczne Klinika Hematologii I Transplantologii
Gdansk, Poland
Pratia Onkologia Katowice
Katowice, Poland
Pratia McM Krakow
Krakow, Poland
Uniwersytecki Szpital Kliniczny W Poznaniu Oddzial Hematologii I Transplantacji Szpiku
Poznan, Poland
Wojewodzki Szpital Zespolony Im L Rydygiera W Toruniu
Torun, Poland
Centralny Szpital Kliniczny Uck Wum
Warsaw, Poland
Instytut Hematologii I Transfuzjologii
Warsaw, Poland
Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie Hematology Unit
Warsaw, Poland
Hospital de Braga
Braga, Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil, Epe
Porto, Portugal
Unidade Local de Saude Gaia E Espinho
VILA NOVA de GAIA Porto, Portugal
Pan American Oncology Trials, Llc
Rio Piedras, Puerto Rico
Auxilio Mutuo Cancer Center
San Juan, Puerto Rico
Coltea Clinical Hospital
Bucharest, Romania
Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca
ClujNapoca, Romania
Institutul Regional de Oncologie Iasi
Iași, Romania
Spitalul Clinic Judetean de Urgenta Bihor
Oradea, Romania
Haemalife
Kuils River, South Africa
Alberts Cellular Therapy
Pretoria, South Africa
Inje University Busan Paik Hospital
BusanjinGu, Busan Gwang'yeogsi, South Korea
Dong A University Hospital
Seogu, Busan Gwang'yeogsi, South Korea
Pusan National University Hospital
Seogu, Busan Gwang'yeogsi, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Kyungpook National University Chilgok Hospital
BukGu, Gyeongsangbukdo, South Korea
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, South Korea
Chonnam National University Hwasun Hospital
HwasunGun, Jeollanam-do, South Korea
Samsung Medical Center
GangnamGu, Seoul Teugbyeolsi, South Korea
The Catholic University of Korea, Seoul St Marys Hospital
SeochoGu, Seoul Teugbyeolsi, South Korea
Severance Hospital Yonsei University Health System
SeodaemunGu, Seoul Teugbyeolsi, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Asan Medical Center
SongpaGu, Seoul Teugbyeolsi, South Korea
Soon Chun Hyang University Hospital Seoul
YongsanGu, Seoul Teugbyeolsi, South Korea
Ico Badalona
Badalona, Spain
Hospital Universitario de Burgos
Burgos, Spain
Hospital Universitario Puerta Del Mar
Cadiz, Spain
Hospital Universitario Virgen de Las Nieves
Granada, Spain
Institut Catala Doncologia Hospital Duran I Reynals
L'Hospitalet de Llobregat, Spain
Complejo Asistencial Universitario de Leon
León, Spain
Hospital de La Princesa
Madrid, Spain
Clinica Universidad de Navarra
Madrid, Spain
Hospital Universitario Infanta Leonor
Madrid, Spain
Hospital Universitario Ramon Y Cajal
Madrid, Spain
H Puerta de Hierro Majadahonda
Majadahonda, Spain
Hospital Clinico Universitario Virgen de La Arrixaca
Murcia, Spain
Clinica Universidad de Navarra Pamplona
Pamplona, Spain
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital Universitario Virgen Del Rocio
Seville, Spain
Hospital Universitari Mutua Terrassa
Terrassa, Spain
St Claraspital
Basel, Switzerland
Hfr Fribourg
Fribourg, Switzerland
Reseau Hospitalier Neuchatelois
La ChauxdeFonds, Switzerland
Universitatsspital Zurich
Zurich, Switzerland
Ankara University Medical Faculty
Ankara, Turkey (Türkiye)
Gazi University Medical School
AOCiftlii, Turkey (Türkiye)
Bagcilar Medipol Mega Hospital
Istanbul, Turkey (Türkiye)
Kocaeli Universitesi Tip Fakultesi
Kocaeli, Turkey (Türkiye)
Vkv American Hospital
Tevikiye, Turkey (Türkiye)
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
The Christie Hospital
Greater Manchester, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, United Kingdom
Nhs Highland
Inverness, United Kingdom
The Leeds Teaching Hospitals Nhs Trust
Leeds, United Kingdom
Barts Health Nhs Trust
London, United Kingdom
University College Hospital
London, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Southampton General Hospital
Southampton, United Kingdom