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
Who is this study for? Patients with relapsed/refractory marginal zone lymphoma
What treatments are being studied? Zanubrutinib+Rituximab
Status: Active_not_recruiting
Location: See all (264) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Ucsf Fresno University of California San Francisco Fresno
Fresno
Kaiser Permanente Southern California
Irvine
Cancer and Blood Specialty Clinic
Los Alamitos
Los Angeles Cancer Network
Los Angeles
UCLA Hematologyoncology
Los Angeles
Valkyrie Clinical Trials
Los Angeles
Scripps Health
San Diego
Sharp Healthcare Sharp Memorial Hospital
San Diego
Florida
Baptist Md Anderson Cancer Center
Jacksonville
Ascension Sacred Heart
Pensacola
Georgia
Northwest Georgia Oncology Centers Marietta
Marietta
Iowa
Mission Cancer and Blood
Waukee
Illinois
Cancer Care Specialists of Illinois
Decatur
Indiana
Fort Wayne Medical Oncology and Hematology
Fort Wayne
Kansas
Cotton Oneil Cancer Center
Topeka
Cancer Center of Kansas
Wichita
Kentucky
Baptist Health Lexington
Lexington
Louisiana
Christus Highland Cancer Treatment Center
Shreveport
Maryland
Luminis Health Anne Arundel Medical Center
Annapolis
Ascension St Agnes Hospital
Baltimore
The University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore
American Oncology Partners of Maryland Pa
Bethesda
Michigan
Henry Ford Hospital
Detroit
Corewell Health the Michigan Cancer Consortium
Grand Rapids
Missouri
University of Missouri Hospital Ellis Fischel Cancer Center
Columbia
Oncology Hematology Associates
Springfield
Mississippi
Hattiesburg Hematology and Oncology Clinic
Hattiesburg
Montana
St Vincent Frontier Cancer Center
Billings
North Carolina
Levine Cancer Institute Wake Forest
Charlotte
Nebraska
Nebraska Cancer Specialists
Omaha
New Jersey
Iyengar Hematology Oncology Medical Center Pa
Bayonne
Summit Medical Group
Florham Park
Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas
New York
New York Cancer and Blood Specialists
Shirley
Suny Upstate Medical University
Syracuse
North Shore Hematology Oncology Associates Eccc Bronx
The Bronx
Optum Medical Care, Pc
Westbury
Ohio
Oncology Hematology Care Clinical Trials, Llc
Cincinnati
Va Northeast Ohio Healthcare System
Cleveland
Toledo Clinic Cancer Center
Toledo
Pennsylvania
Mainline Health Lankenau Institute For Medical Research
Wynnewood
Cancer Care Associates of York
York
South Dakota
Prairie Lakes Healthcare System
Watertown
Texas
Texas Oncology Baylorcharles A Sammons Cancer Center
Dallas
Md Anderson Cancer Center
Houston
Northeast Texas Cancer and Research Institute
Tyler
Washington
University of Washington
Seattle
Medical Oncology Associates
Spokane
Northwest Medical Specialties
Tacoma
Other Locations
Argentina
Hospital Aleman
Caba
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires
Australia
Sunshine Coast Hospital and Health Service
Birtinya
Monash Health
Clayton
Concord Repatriation General Hospital
Concord
Townsville University Hospital
Douglas
Epworth Freemasons
East Melbourne
St Vincents Hospital Melbourne
Fitzroy
Gosford Hospital
Gosford
Austin Health
Heidelberg
St George Hospital
Kogarah
Cabrini Hospital Malvern
Malvern
La Trobe Regional Hospital
Melbourne
The Alfred Hospital
Melbourne
Genesiscare North Adelaide
North Adelaide
Orange Health Hospital
Orange
Royal Perth Hospital
Perth
Port Macquarie Base Hospital
Port Macquarie
Perth Blood Institute
West Perth
Westmead Hospital
Westmead
Austria
Medizinische Universitatsklinik Innsbruck
Innsbruck
Uk St Poelten
Sankt Pölten
Hanusch Krankenhaus
Vienna
Medical Univeristy Vienna
Vienna
Wiener Gesundheitsverbund Klinik Ottakring
Vienna
Belgium
Institut Jules Bordet
Anderlecht
Az Sint Jan Brugge
Bruges
Universitair Ziekenhuis Gent
Ghent
University Hospitals Leuven
Leuven
Brazil
Hospital de Amor Barretos
Barretos
Clinica de Oncologia Reichow
Blumenau
Unesp Faculdade de Medicina Da Universidade Estadual Paulista Campus Botucatu
Botucatu
Instituto Dor de Pesquisa E Ensino Distrito Federal
Brasília
Universidade de Campinas Centro de Hematologia E Hemoterapia
Campinas
Fundacao Universidade de Caxias Do Sul
Caxias Do Sul
Centro Integrado de Oncologia de Curitiba Ss Cionc
Curitiba
Hospital Erasto Gaertner
Curitiba
Centro de Ensino E Pesquisa Em Oncologia de Santa Catarina (Cepen)
Florianópolis
Complexo Hospitalar de Niteroi
Niterói
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre
Instituto Dor de Pesquisa E Ensino Pernambuco
Recife
Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp
Ribeirão Preto
Instituto Americas Ensino, Pesquisa E Inovacao
Rio De Janeiro
Instituto Dor de Pesquisa E Ensino Rio de Janeiro
Rio De Janeiro
Ensino E Terapia de Inovacao Clinica Amo Etica
Salvador
Hospital Sao Rafael Instituto Dor de Pesquisa E Ensino
Salvador
Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
São Paulo
Hospital Nove de Julho Dasa
São Paulo
Instituto Dor de Pesquisa E Ensino Sao Paulo
São Paulo
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo
Hospital Santa Rita de Cassia Afecc
Vitória
Bulgaria
Acibadem City Clinic Tokuda Umhat Ead, Department of Medical Oncology
Sofia
NHATHD
Sofia
Canada
Ciusss Du Saguenay Lac St Jean
Chicoutimi
Queen Elizabeth Ii Health Sciences Centre
Halifax
Juravinski Cancer Centre
Hamilton
London Health Sciences Centre
London
Ciusss de Lest de Lile de Montreal Hopital Maisonneuve Rosemont
Montreal
Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
Québec
Unite de Recherche Clinique Du Cisss Des Laurentides
Saintjerome
Ciusss de Lestrie Chus
Sherbrooke
Newfoundland and Labrador Health Services
St. John's
British Columbia Cancer Agency the Vancouver Centre
Vancouver
China
Anyang Tumor Hospital
Anyang
Beijing Cancer Hospital
Beijing
Beijing Friendship Hospital, Capital Medical University
Beijing
Beijing Friendship Hospital, Capital Medical University(Tongzhou)
Beijing
The First Hospital of Jilin University
Changchun
The First Peoples Hospital of Changde City
Changde
West China Hospital, Sichuan University
Chengdu
Chongqing Cancer Hospital
Chongqing
Dongyang Peoples Hospital
Dongyang
The First Peoples Hospital of Foshan
Foshan
Fujian Medical University Union Hospital
Fuzhou
Sun Yat Sen University Cancer Center
Guangzhou
Zhejiang Cancer Hospital
Hangzhou
Harbin Medical University Cancer Hospital
Harbin
Huizhou Central Peoples Hospital
Huizhou
The First Hospital of Jiaxing
Jiaxing
Jinhua Municipal Central Hospital
Jinhua
Meizhou People Hospital
Meizhou
Jiangxi Province Cancer Hospital
Nanchang
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang
Jiangsu Province Hospital
Nanjing
Affiliated Hospital of Nantong University
Nantong
Peoples Hospital of Rizhao
Rizhao
Fudan University Shanghai Cancer Center
Shanghai
Liaoning Cancer Hospital and Institute
Shenyang
Shengjing Hospital of China Medical University
Shenyang
The First Affiliated Hospital of Soochow University
Suzhou
The Second Affiliated Hospital of Shandong First Medical University
Taian
Shanxi Provincial Cancer Hospital
Taiyuan
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan
The First Affiliated Hospital of Wannan Medical College
Wuhu
Wuxi Peoples Hospital
Wuxi
The First Affiliated Hospital of Xiamen University
Xiamen
Affiliated Hospital of Guangdong Medical University
Zhanjiang
Henan Cancer Hospital
Zhengzhou
France
Hopital Prive Dantony Departement Dhemathologie
Antony
Centre Hospitalier Le Mans
Le Mans
Chu Montpellier Hopital Saint Eloi
Montpellier
Hopital Larchet 2 Chu Nice
Nice
Institut Curie
Paris
Necker University Hospital
Paris
Hopitaux Universitaires de Strasbourg Hopital de Hautepierre (Ancien Icans)
Strasbourg
Chu Nancy Hopital Brabois
Vandoeuvrelesnancy
Georgia
JSC VIAN
Kutaisi
Germany
Universitaetsklinikum Essen
Essen
Universitaetsklinikum Ulm
Ulm
Greece
University Hospital of Alexandroupolis
Alexandroupoli
Evaggelismos
Athens
University Hospital of Patra
Pátrai
Ireland
St Jamess Hospital
Dublin
University Hospital Waterford
Waterford
Israel
Assuta Ashdod Medical Center
Ashdod
Hadassah En Karem Medical Center
Jerusalem
Shaare Zedek Medical Center
Jerusalem
Rabin Medical Center
Petah Tikva
Chaim Sheba Medical Center
Ramat Gan
Assuta Medical Center
Tel Aviv
Sourasky Tel Aviv Medical Center
Tel Aviv
Italy
Cro Irccs Aviano
Aviano
Irccs Azienda Ospedaliero Universitaria Bologna
Bologna
Aou Careggi, Servizio Sanitario Toscana
Florence
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milan
Istituto Europeo Di Oncologia
Milan
Aou Maggiore Della Carita
Novara
Azienda Ospedaliera Di Padova
Padova
Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi
Pavia
Arcispedale S Maria Nuova Ausl Reggio Emilia Hematology Unit
Reggio Emilia
Aou Santa Maria Della Misericordia Di Udine
Udine
Japan
Tokyo Metropolitan Komagome Hospital
Bunkyoku
National Cancer Center Hospital
Chuoku
Kansai Medical University Hospital
Hirakata
Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
Hiroshima
Kagoshima University Hospital
Kagoshima
Cancer Institute Hospital of Jfcr
Kotoku
University Hospital, Kyoto Prefectural Univ of Medicine
Kyotoshi
Matsuyama Red Cross Hospital
Matsuyama
National Hospital Organization Okayama Medical Center
Okayama
Kindai University Hospital
Sakai
National Hospital Organization Hokkaido Cancer Center
Sapporo
Yamagata University Hospital
Yamagata
Kanagawa Cancer Center
Yokohama
Poland
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela
Bydgoszcz
Uniwersyteckie Centrum Kliniczne Klinika Hematologii I Transplantologii
Gdansk
Pratia Onkologia Katowice
Katowice
Pratia McM Krakow
Krakow
Uniwersytecki Szpital Kliniczny W Poznaniu
Poznan
Wojewodzki Szpital Zespolony Im L Rydygiera W Toruniu
Torun
Centralny Szpital Kliniczny Uck Wum
Warsaw
Instytut Hematologii I Transfuzjologii W Warszawie
Warsaw
Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie
Warsaw
Portugal
Hospital de Braga
Braga
Instituto Portugues de Oncologia Do Porto Francisco Gentil, Epe
Porto
Unidade Local de Saude Gaia E Espinho
Vila Nova De Gaia Porto
Puerto Rico
Pan American Oncology Trials, Llc
Rio Piedras
Auxilio Mutuo Cancer Center
San Juan
Republic of Korea
Kyungpook National University Chilgok Hospital
Bukgu
Inje University Busan Paik Hospital
Busanjingu
Samsung Medical Center
Gangnamgu
Chonnam National University Hwasun Hospital
Hwasungun
Gyeongsang National University Hospital
Jinju
The Catholic University of Korea, Seoul St Marys Hospital
Seochogu
Severance Hospital Yonsei University Health System
Seodaemungu
Dong A University Hospital
Seogu
Pusan National University Hospital
Seogu
Seoul National University Bundang Hospital
Seongnam-si
Seoul National University Hospital
Seoul
Asan Medical Center
Songpagu
Soon Chun Hyang University Hospital Seoul
Yongsangu
Romania
Coltea Clinical Hospital
Bucharest
Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca
Clujnapoca
Institutul Regional de Oncologie Iasi
Iași
Spitalul Clinic Judetean de Urgenta Bihor
Oradea
South Africa
Haemalife
Kuils River
Alberts Cellular Therapy
Pretoria
Spain
Ico Badalona
Badalona
Hospital Universitario de Burgos
Burgos
Hospital Universitario Puerta Del Mar
Cadiz
Hospital Universitario Virgen de Las Nieves
Granada
Institut Catala Doncologia Hospital Duran I Reynals
L'hospitalet De Llobregat
Complejo Asistencial Universitario de Leon
León
Clinica Universidad de Navarra
Madrid
Hospital de La Princesa
Madrid
Hospital Universitario Infanta Leonor
Madrid
Hospital Universitario Ramon Y Cajal
Madrid
H Puerta de Hierro Majadahonda
Majadahonda
Hospital Clinico Universitario Virgen de La Arrixaca
Murcia
Clinica Universidad de Navarra Pamplona
Pamplona
Hospital Universitario Quironsalud Madrid
Pozuelo De Alarcón
Hospital Universitario de Salamanca
Salamanca
Hospital Universitario Virgen Del Rocio
Seville
Hospital Universitari Mutua Terrassa
Terrassa
Switzerland
St Claraspital
Basel
Hfr Fribourg
Fribourg
Reseau Hospitalier Neuchatelois
La Chauxdefonds
Universitatsspital Zurich
Zurich
Turkey
Ankara University Medical Faculty
Ankara
Gazi University Medical School
Aociftlii
Bagcilar Medipol Mega Hospital
Istanbul
Kocaeli Universitesi Tip Fakultesi
Kocaeli
Vkv American Hospital
Tevikiye
United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow
The Christie Hospital
Greater Manchester
Huddersfield Royal Infirmary
Huddersfield
Nhs Highland
Inverness
The Leeds Teaching Hospitals Nhs Trust
Leeds
Barts Health Nhs Trust
London
University College Hospital
London
Derriford Hospital
Plymouth
Southampton General Hospital
Southampton
Time Frame
Start Date: 2022-03-10
Completion Date: 2030-06
Participants
Target number of participants: 799
Treatments
Experimental: Follicular Lymphoma Arm A: Zanubrutinib plus Obinutuzumab
Participants 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.
Active_comparator: Follicular Lymphoma Arm B: Lenalidomide plus Rituximab
Participants will receive lenalidomide and rituximab.
Experimental: Marginal Zone Lymphoma Arm C: Zanubrutinib plus Rituximab
Participants 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.
Active_comparator: Marginal Zone Lymphoma Arm D: Lenalidomide plus Rituximab
Participants will receive lenalidomide and rituximab.
Related Therapeutic Areas
Sponsors
Leads: BeOne Medicines