Non Hodgkin Lymphoma Clinical Trial

A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma

Summary

The purpose of the study is to compare the efficacy of zanubrutinib plus rituximab versus lenalidomide plus rituximab in participants with relapsed/refractory marginal zone lymphoma (R/R MZL), 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.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Histologically confirmed grade 1-3a FL or MZL
Previously received ≥ 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

Key Exclusion Criteria:

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

750

Study ID:

NCT05100862

Recruitment Status:

Recruiting

Sponsor:

BeiGene

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There are 262 Locations for this study

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California Cancer Associates For Research and Excellence, Ccare Encinitas
Encinitas California, 92024, United States
Ucsf Fresno University of California San Francisco Fresno
Fresno California, 93730, United States
Kaiser Permanente Southern California
Irvine California, 92618, United States
Cancer and Blood Specialty Clinic
Los Alamitos California, 90720, United States
Valkyrie Clinical Trials
Los Angeles California, 90067, United States
Scripps Health
San Diego California, 92103, United States
Baptist Md Anderson Cancer Center
Jacksonville Florida, 32207, United States
Tampa General Hospital Cancer Institute
Tampa Florida, 33606, United States
Northwest Georgia Oncology Centers Marietta
Marietta Georgia, 30060, United States
Alliance For Multispeciality Research
Merriam Kansas, 66204, United States
Cotton Oneil Cancer Center
Topeka Kansas, 66606, United States
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore Maryland, 21201, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Hattiesburg Hematology and Oncology Clinic
Hattiesburg Mississippi, 39401, United States
Oncology Hematology Associates
Springfield Missouri, 65807, United States
Nebraska Cancer Specialists
Grand Island Nebraska, 68803, United States
Summit Medical Group
Florham Park New Jersey, 07932, United States
Clinical Research Alliance, Inc
Westbury New York, 11590, United States
Va Northeast Ohio Healthcare System
Cleveland Ohio, 44106, United States
Mainline Health Lankenau Institute For Medical Research
Wynnewood Pennsylvania, 19096, United States
Cancer Care Associates of York
York Pennsylvania, 17403, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37232, United States
Md Anderson Cancer Center
Houston Texas, 77030, United States
Virginia Commonwealth University Massey Cancer Center
Richmond Virginia, 23298, United States
Hospital Italiano de Buenos Aires
Caba , 1181, Argentina
Centro Barrio Parque
Caba , 1425, Argentina
Hospital Aleman
Caba , 1425, Argentina
Clinica Zabala
Caba , C1426, Argentina
CEMIC
Caba , C1431, Argentina
FUNDALEU
Caba , CP111, Argentina
Instituto de Investigaciones Clinicas Cordoba
Cordoba , 5000, Argentina
Hospital Italiano La Plata
La Plata , 1900, Argentina
Hospital Universitario Austral
Pilar , 1629, Argentina
Concord Repatriation General Hospital
Concord New South Wales, 2139, Australia
Gosford Hospital
Gosford New South Wales, 2250, Australia
St George Hospital
Kogarah New South Wales, 2217, Australia
Port Macquarie Base Hospital
Port Macquarie New South Wales, 2444, Australia
Westmead Hospital
Westmead New South Wales, 2145, Australia
Sunshine Coast Hospital and Health Service
Birtinya Queensland, 4575, Australia
Townsville University Hospital
Douglas Queensland, 4814, Australia
Eastern Health Haematology
Box Hill Victoria, 3128, Australia
Monash Health
Clayton Victoria, 3168, Australia
St Vincents Hospital Melbourne
Fitzroy Victoria, 3065, Australia
Austin Health
Heidelberg Victoria, 3084, Australia
Cabrini Hospital Malvern
Malvern Victoria, 3144, Australia
Epworth Freemasons
Melbourne Victoria, 3002, Australia
The Alfred Hospital
Melbourne Victoria, 3004, Australia
Perth Blood Institute
West Perth Western Australia, 6005, Australia
La Trobe Regional Hospital
Melbourne , 3844, Australia
Uk St Poelten
St Poelten , 3100, Austria
Hanusch Krankenhaus
Vienna , 1140, Austria
Wiener Gesundheitsverbund Klinik Ottakring
Vienna , 1160, Austria
Medical Univeristy Vienna
Wien , 1090, Austria
Institut Jules Bordet
Anderlecht , 1070, Belgium
Az Sint Jan Brugge
Brugge , 8000, Belgium
Universitair Ziekenhuis Gent
Gent , 9000, Belgium
University Hospitals Leuven
Leuven , 3000, Belgium
Hospital de Amor Barretos
Barretos , 14784, Brazil
Clinica de Oncologia Reichow
Blumenau , 89010, Brazil
Unesp Faculdade de Medicina Da Universidade Estadual Paulista Campus Botucatu
Botucatu , 18618, Brazil
Instituto Dor de Pesquisa E Ensino Distrito Federal
Brasilia , 70390, Brazil
Universidade de Campinas Centro de Hematologia E Hemoterapia
Campinas , 13083, Brazil
Fundacao Universidade de Caxias Do Sul
Caxias do Sul , 95070, Brazil
Centro Integrado de Oncologia de Curitiba Ss Cionc
Curitiba , 80810, Brazil
Centro de Ensino E Pesquisa Em Oncologia de Santa Catarina (Cepen)
Florianopolis , 88020, Brazil
Hospital Erasto Gaertner
Jardim Das Americas , 81520, Brazil
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre , 90110, Brazil
Hospital Ernesto Dornelles
Porto Alegre , 90160, Brazil
Instituto Dor de Pesquisa E Ensino Pernambuco
Recife , 50070, Brazil
Instituto Dor de Pesquisa E Ensino
Recife , 50070, Brazil
Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp
Ribeirao Preto , 14051, Brazil
Hospital Sao Lucas
Rio de Janeiro , 22061, Brazil
Oncoclinicas Rio de Janeiro Sa
Rio de Janeiro , 22250, Brazil
Instituto Americas Ensino, Pesquisa E Inovacao
Rio de Janeiro , 22775, Brazil
Complexo Hospitalar de Niteroi
Rio de Janeiro , 24020, Brazil
Hospital Sao Rafaelinstituto Dor de Pesquisa E Ensino
Salvador , 41253, Brazil
Ensino E Terapia de Inovacao Clinica Amo Etica
Salvador , 41950, Brazil
Hospital Beneficencia Portuguesa de Sao Paulo
Sao Paulo , 01323, Brazil
Hospital Nove de Julho Dasa
Sao Paulo , 01409, Brazil
Instituto Dor de Pesquisa E Ensino Sao Paulo
Sao Paulo , 04501, Brazil
Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
Sao Paulo , 05403, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Sao Paulo , 05652, Brazil
Iepe Unimed Sorocaba
Sorocaba , 18618, Brazil
Hospital Santa Rita de Cassia Afecc
Vitoria , 29043, 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
Umhat Sveta Marina
Varna , 9010, Bulgaria
Centre Integre de Sante Et de Services Sociaux de La Monteregie Centre
Greenfiled Park Quebec, J4V 2, Canada
Hopital de La Cite de La Sante
Laval Quebec, H7M 3, Canada
Ciusss de Lest de Lile de Montreal Hopital Maisonneuve Rosemont
Montreal Quebec, H1T 2, Canada
Ciusss Nim Hscm
Montreal Quebec, H4J 1, Canada
Saskatoon Cancer Centre
Saskatoon Saskatchewan, S7N 4, Canada
Cisss de La Monteregie Centre
Quebec , G1S 1, Canada
The First Affiliated Hospital of Wannan Medical College
Wuhu Anhui, 24100, China
Beijing Friendship Hospital, Capital Medical University
Beijing Beijing, 10005, China
Beijing Cancer Hospital
Beijing Beijing, 10014, China
Chongqing Cancer Hospital
Chongqing Chongqing, 40003, China
Fujian Medical University Union Hospital
Fuzhou Fujian, 35000, China
The First Affiliated Hospital of Xiamen University
Xiamen Fujian, 36100, China
Gansu Provincial Hospital
Lanzhou Gansu, 73000, China
Gansu Provincial Cancer Hospital
Lanzhou Gansu, 73005, China
Foshan First Peoples Hospital
Foshan Guangdong, 52800, China
Sun Yat Sen University Cancer Center
Guangzhou Guangdong, 51006, China
Huizhou Central Peoples Hospital
Huizhou Guangdong, 51600, China
Meizhou Hospital Affiliated to Sun Yat Sen University
Meizhou Guangdong, 51403, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang Guangdong, 52400, China
Harbin Medical University Cancer Hospital
Harbin Heilongjiang, 15000, China
Anyang Cancer Hospital
Anyang Henan, 45500, China
Henan Cancer Hospital
Zhengzhou Henan, 45000, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan Hubei, 43002, China
Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
Wuhan Hubei, 43003, China
The First Peoples Hospital of Changde City
Changde Hunan, 41500, China
Jiangsu Province Hospital
Nanjing Jiangsu, 21002, China
Affiliated Hospital of Nantong University
Nantong Jiangsu, 20120, China
The First Affiliated Hospital of Soochow University
Suzhou Jiangsu, 21500, China
Wuxi Peoples Hospital
Wuxi Jiangsu, 21402, China
First Affiliated Hospital of Gannan Medical University
Ganzhou Jiangxi, 34100, China
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang Jiangxi, 33000, China
Jiangxi Province Cancer Hospital
Nanchang Jiangxi, 33002, China
The First Hospital of Jilin University
Changchun Jilin, 13002, China
Affiliated Zhongshan Hospital of Dalian University
Dalian Liaoning, 11600, China
Shengjing Hospital of China Medical University
Shenyang Liaoning, 11000, China
Peoples Hospital of Rizhao
Rizhao Shandong, 27682, China
The Second Affiliated Hospital of Shandong First Medical University
Taian Shandong, 27109, China
Weihai Municipal Hospital
Weihai Shandong, 26420, China
Fudan University Shanghai Cancer Center
Shanghai Shanghai, 20000, China
Shanxi Provincial Cancer Hospital
Taiyuan Shanxi, 03001, China
West China Hospital, Sichuan University
Chengdu Sichuan, 61004, China
Dongyang Peoples Hospital
Dongyang Zhejiang, 32210, China
Zhejiang Cancer Hospital
Hangzhou Zhejiang, 31002, China
The First Hospital of Jiaxing
Jiaxing Zhejiang, 31400, China
Jinhua Municipal Central Hospital
Jinhua Zhejiang, 32100, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou Zhejiang, 32500, China
Fakultni Nemocnice Hradec Kralove
Hradec Kralove , 50005, 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 Cedex , 34295, France
Hopital Larchet Chu Nice
Nice , 6200, France
Necker University Hospital
Paris , 75015, France
Institut Curie
SaintCloud , 92210, France
Icans Institut de Cancerologie Strasbourg Europe
Strasbourg , 67033, France
Centre Hospitalier Universitaire de Nancy Hopital de Brabois
VandoeuvrelesNancy , 54511, France
High Technology Hospital Medcenter Ltd
Batumi , 6000, Georgia
Jsc Evex Hospitals Kutaisi
Kutaisi , 4600, Georgia
Ltd Mzodelava Hematology Centre
Tbilisi , 0112, Georgia
Mardaleishvili Medical Center
Tbilisi , 177, Georgia
Vivantes Klinikum Am Urban
Berlin , 10967, Germany
Charite Universitatsmedizin Berlin
Berlin , 13353, Germany
Universitaetsklinikum Essen
Essen , 45147, Germany
Uniklinik Koln (Aor)
Koln , 50937, Germany
University Department of Hematology and Oncology, Medical Faculty Otto Von Guericke Universitat
Magdeburg , 39120, Germany
Universitaetsklinikum Ulm, Innere Medizin Iii
Ulm , 89081, Germany
Hamatologisch Onkologische Schwerpunktpraxis
Wurzburg , 97080, Germany
University Hospital of Alexandroupolis
Alexandroupolis , 68100, Greece
Evaggelismos
Athens , 10676, Greece
General Hospital of Athens Alexandra
Athens , 11528, Greece
University Hospital of Patra
Patras , 26504, Greece
General Hospital George Papanikolaou
Thessaloniki , 57010, Greece
St Jamess Hospital
Dublin , D8, Ireland
University Hospital Galway
Galway , H91 Y, Ireland
University Hospital Waterford
Waterford , X91 E, Ireland
Haemek Medical Center
Afula , 18341, Israel
Assuta Ashdod Medical Center
Ashdod , 77476, Israel
Shaare Zedek Medical Center
Jerusalem , 91031, Israel
Hadassah En Karem Medical Center
Jerusalem , 91120, Israel
Rabin Medical Centre
Petach Tikva , 49100, Israel
Chaim Sheba Medical Center
Ramat gan , 52656, Israel
Assuta Medical Center
Tel Aviv , 69714, Israel
Cro Irccs Aviano
Aviano , 33081, Italy
Irccs Azienda Ospedaliero Universitaria Bologna
Bologna , 40138, Italy
Istituto Europeo Di Oncologia
Milano , 20141, Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milano , 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
Unita Di Ematologia, Dipartimento Di Ematologia Ed Oncologia
Ravenna , 48121, Italy
Arcispedale S Maria Nuova Ausl Reggio Emilia Hematology Unit
Reggio Emilia , 42123, Italy
Aou Santa Maria Della Misericordia Di Udine
Udine , 33100, Italy
Ospedale Di Circolo E Fondazione Macchi
Varese , 21100, Italy
Dong A University Hospital
Busan Busan Gwang'yeogsi, 49201, Korea, Republic of
Pusan National University Hospital
Busan Busan Gwang'yeogsi, 49241, Korea, Republic of
Inje University Busan Paik Hospital
Susan Busan Gwang'yeogsi, 614-7, Korea, Republic of
Seoul National University Bundang Hospital
Seongnamsi Gyeonggido, 13620, Korea, Republic of
Korea University Anam Hospital
Seoul Gyeonggido, 02841, Korea, Republic of
Kyungpook National University Chilgok Hospital
Daegu Gyeongsangbukdo, 41404, Korea, Republic of
Gyeongsang National University Hospital
Jinjusi Gyeongsangnamdo, 52727, Korea, Republic of
Gachon University Gil Medical Center
Incheon Incheon Gwang'yeogsi, 21565, Korea, Republic of
Chonnam National University Hwasun Hospital
Hwasungun Jeonranamdo, 58128, Korea, Republic of
Severance Hospital Yonsei University Health System
Seoul Seoul Teugbyeolsi, 03722, Korea, Republic of
Soon Chun Hyang University Hospital Seoul
Seoul Seoul Teugbyeolsi, 04401, Korea, Republic of
Asan Medical Center
Seoul Seoul Teugbyeolsi, 05505, Korea, Republic of
Samsung Medical Center
Seoul Seoul Teugbyeolsi, 06351, Korea, Republic of
The Catholic University of Korea, Seoul St Marys Hospital
Seoul Seoul Teugbyeolsi, 06591, Korea, Republic of
Seoul National University Hospital
Seoul Seoul Teugbyeolsi, 3080, Korea, Republic of
Flevoziekenhuis
Almere , 1315 , Netherlands
Slingeland Ziekenhuis
Doetinchem , 7009 , Netherlands
Ziekenhuis Gelderse Vallei
Ede , 6716R, Netherlands
Stichting Rivas Zorggroep Beatrixziekenhuis
Gorinchem , 4204 , Netherlands
Bravis Ziekenhuis
Noord Brabant , 4708 , Netherlands
Ikazia Ziekenhuis
Rotterdam , 3083 , Netherlands
Gelre Ziekenhuizen Zutphen
Zutphen , 7207 , Netherlands
Szpital Uniwersytecki Nr Im Dr Jana Biziela
Bydgoszcz , 85-16, Poland
Pratia Onkologia Katowice
Katowice , 40-05, Poland
Pratia McM Krakow
Krakow , 30-72, Poland
Szpital Kliniczny Przemienienia Paskiego
Poznan , 60-56, Poland
Centrum Medyczne Pratia Poznan
Skorzewo Poznan , 60-18, Poland
Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie
Warsaw , 02-78, Poland
Centralny Szpital Kliniczny Uck Wum
Warszawa , 02-09, Poland
Instytut Hematologii I Transfuzjologii
Warszawa , 02-77, Poland
Hospital Garcia de Orta
Almada , 4200-, Portugal
Hospital de Braga
Braga , 4710-, Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil, Epe
Porto , 4200-, Portugal
Centro Hospitalar Vila Nova de Gaia Espinho
VILA NOVA DE GAIA Porto , 4434-, Portugal
Pan American Oncology Trials, Llc
Rio Piedras , 00935, Puerto Rico
Coltea Clinical Hospital
Bucharest , 30171, Romania
Colentina Clinical Hospit
Bucharest , O2012, Romania
Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca
ClujNapoca , 40001, Romania
Municipal Hospital Filantropia
Craiova , 20014, Romania
Institutul Regional de Oncologie Iasi
Iasi , 70085, Romania
Clinical Emergency County Hospital
Oradea , 41046, Romania
University of Cape Town
Cape Town , 7925, South Africa
King Edward Vlll Hospital
Durban , 4001, South Africa
Haemalife
Kuils River , 7579, South Africa
Alberts Cellular Therapy
Pretoria , O181, South Africa
Curo Oncology
Pretoria , OO84, South Africa
University of Pretoria
Pretoria , OO84, South Africa
Wits Clinical Research
Soweto , 2013, South Africa
Ico Badalona
Badalona , 08916, Spain
Hospital Universitario de Burgos
Burgos , 9006, 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
Hospitalet de LLobregat , 8908, Spain
Complejo Asistencial Universitario de Leon
Leon , 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
Madrid , 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 Alarcon , 28223, Spain
Hospital Universitario de Salamanca
Salamanca , 37007, Spain
Hospital Universitario Virgen Del Rocio
Sevilla , 41013, Spain
Hospital Universitari Mutua Terrassa
Terassa , 8221, Spain
Hfr Fribourg
Fribourg , 1708, Switzerland
Reseau Hospitalier Neuchatelois
La ChauxdeFonds , 2300, Switzerland
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
Ankara Oncology Abdurrahman Yurtaslan Hospital , 06200, Turkey
Ankara University Medical Faculty
Ankara , 06620, Turkey
Ondokuz Mayis University Medicine Faculty Hospital
Atakum Samsun , 55200, Turkey
Gazi University Hospital
Golba Ankara , 6830, Turkey
Bagcilar Medipol Mega Hospital
Istanbul , 34214, Turkey
Vkv American Hospital
Istanbul , 34365, Turkey
Istanbul Medeniyet University Goztepe Prof Dr Suleyman Yalcin City Hospital
Istanbul , 34722, Turkey
Ege University Medical Faculty
Izmir , 35100, Turkey
Dokuz Eylul University
Izmir , 35340, Turkey
Kocaeli Universitesi Tip Fakultesi
Kocaeli , 41380, Turkey
Mersin University
Mersin , 33000, Turkey
The Royal Bournemouth and Christchurch Hospitals Nhs Foundation
Bournemouth , BH7 7, United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow , G12 0, United Kingdom
The Christie Hospital
Greater Manchester , M20 4, United Kingdom
Huddersfield Royal Infirmary
Huddersfield , HD3 3, United Kingdom
The Leeds Teaching Hospitals Nhs Trust
Leeds , LS9 7, United Kingdom
University College Hospital
London , NW1 2, United Kingdom
Freeman Hospital
NewCastle Upon Tyne , NE7 7, United Kingdom
Derriford Hospital
Plymouth , PL6 8, United Kingdom
Southampton General Hospital
Southampton , SO16 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

750

Study ID:

NCT05100862

Recruitment Status:

Recruiting

Sponsor:


BeiGene

How clear is this clinincal trial information?

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