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

July 22, 2026 updated by: BeOne Medicines

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

Study Type

Interventional

Enrollment (Actual)

799

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • CABA, Argentina, 1425
        • Hospital Aleman
      • Ciudad Autonoma Buenos Aires, Argentina, 1413
        • Hospital Italiano de Buenos Aires
  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, NSW 2139
        • Concord Repatriation General Hospital
      • Gosford, New South Wales, Australia, NSW 2250
        • Gosford Hospital
      • Kogarah, New South Wales, Australia, NSW 2217
        • St George Hospital
      • Orange, New South Wales, Australia, NSW 2800
        • Orange Health Hospital
      • Port Macquarie, New South Wales, Australia, NSW 2444
        • Port Macquarie Base Hospital
      • Westmead, New South Wales, Australia, NSW 2145
        • Westmead Hospital
    • Queensland
      • Birtinya, Queensland, Australia, QLD 4575
        • Sunshine Coast Hospital and Health Service
      • Douglas, Queensland, Australia, QLD 4814
        • Townsville University Hospital
    • South Australia
      • North Adelaide, South Australia, Australia, SA 5006
        • Genesiscare North Adelaide
    • Victoria
      • Clayton, Victoria, Australia, VIC 3168
        • Monash Health
      • East Melbourne, Victoria, Australia, VIC 3002
        • Epworth Freemasons
      • Fitzroy, Victoria, Australia, VIC 3065
        • St Vincents Hospital Melbourne
      • Heidelberg, Victoria, Australia, VIC 3084
        • Austin Health
      • Malvern, Victoria, Australia, VIC 3144
        • Cabrini Hospital Malvern
      • Melbourne, Victoria, Australia, VIC 3004
        • The Alfred Hospital
      • Melbourne, Victoria, Australia, VIC 3844
        • La Trobe Regional Hospital
    • Western Australia
      • Perth, Western Australia, Australia, WA 6000
        • Royal Perth Hospital
      • West Perth, Western Australia, Australia, WA 6005
        • Perth Blood Institute
  • Austria
      • Innsbruck, Austria, 6020
        • Medizinische Universitatsklinik Innsbruck
      • Sankt Pölten, Austria, 3100
        • Uk St Poelten
      • Vienna, Austria, 1140
        • Hanusch Krankenhaus
      • Vienna, Austria, 1160
        • Wiener Gesundheitsverbund Klinik Ottakring
      • Vienna, Austria, 1090
        • Medical Univeristy Vienna
  • Belgium
      • Anderlecht, Belgium, 1070
        • Institut Jules Bordet
      • Bruges, Belgium, 8000
        • AZ Sint Jan Brugge
      • Ghent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium, 3000
        • University Hospitals Leuven
  • Brazil
      • Barretos, Brazil, 14784-400
        • Hospital de Amor Barretos
      • Blumenau, Brazil, 89010-340
        • Clinica de Oncologia Reichow
      • Botucatu, Brazil, 18618687
        • Unesp Faculdade de Medicina Da Universidade Estadual Paulista Campus Botucatu
      • Brasília, Brazil, 70390140
        • Instituto Dor de Pesquisa E Ensino Distrito Federal
      • Campinas, Brazil, 13083-878
        • Universidade de Campinas Centro de Hematologia E Hemoterapia
      • Caxias do Sul, Brazil, 95070-560
        • Fundacao Universidade de Caxias Do Sul
      • Curitiba, Brazil, 81520-060
        • Hospital Erasto Gaertner
      • Curitiba, Brazil, 80810-050
        • Centro Integrado de Oncologia de Curitiba Ss Cionc
      • Florianópolis, Brazil, 88020-210
        • Centro de Ensino E Pesquisa Em Oncologia de Santa Catarina (Cepen)
      • Niterói, Brazil, 24020-096
        • Complexo Hospitalar de Niteroi
      • Porto Alegre, Brazil, 90110-270
        • Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
      • Recife, Brazil, 50070-170
        • Instituto Dor de Pesquisa E Ensino Pernambuco
      • Ribeirão Preto, Brazil, 14051-140
        • Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp
      • Rio de Janeiro, Brazil, 22775-001
        • Instituto Americas Ensino, Pesquisa E Inovacao
      • Rio de Janeiro, Brazil, 22281-100
        • Instituto Dor de Pesquisa E Ensino Rio de Janeiro
      • Salvador, Brazil, 41253-190
        • Hospital Sao Rafael Instituto Dor de Pesquisa E Ensino
      • Salvador, Brazil, 41950-640
        • Ensino E Terapia de Inovacao Clinica Amo Etica
      • São Paulo, Brazil, 05652-900
        • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
      • São Paulo, Brazil, 05402-000
        • Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
      • São Paulo, Brazil, 01401-004
        • Instituto Dor de Pesquisa E Ensino Sao Paulo
      • São Paulo, Brazil, 01409-001
        • Hospital Nove de Julho Dasa
      • Vitória, Brazil, 29043-260
        • Hospital Santa Rita de Cassia Afecc
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Umhat Svgeorgi Ead
      • Sofia, Bulgaria, 1407
        • Acibadem City Clinic Tokuda Umhat Ead, Department of Medical Oncology
      • Sofia, Bulgaria, 1407
        • University Multiprofile Hospital For Active Treatment Saint Ivan Rilski
      • Sofia, Bulgaria, 1756
        • NHATHD
  • Canada
      • Québec, Canada, G1J 1Z4
        • Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • British Columbia Cancer Agency the Vancouver Centre
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Newfoundland and Labrador Health Services
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Queen Elizabeth II Health Sciences Centre
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Ciusss Du Saguenay Lac St Jean
      • Lévis, Quebec, Canada, G6V 3Z1
        • Centre Integre de Sante Et de Services Sociaux de Chaudiere Appalaches
      • Montreal, Quebec, Canada, H1T 2M4
        • Ciusss de Lest de Lile de Montreal Hopital Maisonneuve Rosemont
      • SaintJerome, Quebec, Canada, J7Z 5T3
        • Unite de Recherche Clinique Du Cisss Des Laurentides
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Ciusss de Lestrie Chus
  • China
    • Anhui
      • Wuhu, Anhui, China, 241001
        • The First Affiliated Hospital of Wannan Medical College
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Beijing Cancer Hospital
      • Beijing, Beijing Municipality, China, 100050
        • Beijing Friendship Hospital, Capital Medical University
      • Beijing, Beijing Municipality, China, 101100
        • Beijing Friendship Hospital, Capital Medical University(Tongzhou)
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Chongqing Cancer Hospital
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Medical University Union Hospital
      • Xiamen, Fujian, China, 361003
        • The First Affiliated Hospital of Xiamen University
    • Guangdong
      • Foshan, Guangdong, China, 528000
        • The First Peoples Hospital of Foshan
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat Sen University Cancer Center
      • Huizhou, Guangdong, China, 516001
        • Huizhou Central Peoples Hospital
      • Meizhou, Guangdong, China, 514031
        • Meizhou People Hospital
      • Zhanjiang, Guangdong, China, 524000
        • Affiliated Hospital of Guangdong Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Harbin Medical University Cancer Hospital
    • Henan
      • Anyang, Henan, China, 455001
        • Anyang Tumor Hospital
      • Zhengzhou, Henan, China, 450000
        • Henan Cancer Hospital
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
    • Hunan
      • Changde, Hunan, China, 415000
        • The First Peoples Hospital of Changde City
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Province Hospital
      • Nantong, Jiangsu, China, 201203
        • Affiliated Hospital of Nantong University
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University
      • Wuxi, Jiangsu, China, 214023
        • Wuxi Peoples Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University Branch Donghu
      • Nanchang, Jiangxi, China, 330029
        • Jiangxi Province Cancer Hospital
      • Nanchang, Jiangxi, China, 332000
        • The First Affiliated Hospital of Nanchang University Branch Xianghu
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Shengjing Hospital Of China Medical University
      • Shenyang, Liaoning, China, 110042
        • Liaoning Cancer Hospital and Institute
    • Shandong
      • Rizhao, Shandong, China, 276827
        • Peoples Hospital of Rizhao
      • Taian, Shandong, China, 271099
        • The Second Affiliated Hospital of Shandong First Medical University
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200000
        • Fudan University Shanghai Cancer Center
    • Shanxi
      • Taiyuan, Shanxi, China, 030013
        • Shanxi Provincial Cancer Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University
    • Zhejiang
      • Dongyang, Zhejiang, China, 322103
        • Dongyang Peoples Hospital
      • Hangzhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
      • Jiaxing, Zhejiang, China, 314001
        • The First Hospital of Jiaxing
      • Jinhua, Zhejiang, China, 321000
        • Jinhua Municipal Central Hospital
      • Wenzhou, Zhejiang, China, 325000
        • The First Affiliated Hospital Of Wenzhou Medical University
  • Czechia
      • Hradec Králové, Czechia, 500 03
        • Fakultni Nemocnice Hradec Kralove
      • Olomouc, Czechia, 77900
        • Fakultni nemocnice Olomouc
  • France
      • Antony, France, 92160
        • Hopital Prive Dantony, Departement Dhemathologie
      • Le Mans, France, 72037
        • Centre Hospitalier Le Mans
      • Montpellier, France, 34090
        • Chu Montpellier Hopital Saint Eloi
      • Nice, France, 06200
        • Hopital Larchet 2 Chu Nice
      • Paris, France, 75005
        • Institut Curie
      • Paris, France, 75015
        • Necker University Hospital
      • Strasbourg, France, 67200
        • Hopitaux Universitaires de Strasbourg Hopital de Hautepierre (Ancien Icans)
      • VandoeuvrelesNancy, France, 54511
        • Chu Nancy Hopital Brabois
  • Georgia
      • Kutaisi, Georgia, 4600
        • JSC VIAN
  • Germany
      • Essen, Germany, 45147
        • Universitaetsklinikum Essen
      • Ulm, Germany, 89081
        • Universitaetsklinikum Ulm
  • Greece
      • Alexandroupoli, Greece, 68100
        • University Hospital of Alexandroupolis
      • Athens, Greece, 115 28
        • General Hospital of Athens Alexandra
      • Athens, Greece, 106 76
        • Evaggelismos
      • Pátrai, Greece, 26504
        • University Hospital of Patra
  • Ireland
      • Dublin, Ireland, D08 NHY1
        • St Jamess Hospital
      • Waterford, Ireland, X91 ER8E
        • University Hospital Waterford
  • Israel
      • Ashdod, Israel, 7747629
        • Assuta Ashdod Medical Center
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Jerusalem, Israel, 9112001
        • Hadassah En Karem Medical Center
      • Petah Tikva, Israel, 49100
        • Rabin Medical Center
      • Ramat Gan, Israel, 5265601
        • Chaim Sheba Medical Center
      • Tel Aviv, Israel, 60000
        • Assuta Medical Center
      • Tel Aviv, Israel, 6423906
        • Sourasky Tel Aviv Medical Center
  • Italy
      • Aviano, Italy, 33081
        • Cro Irccs Aviano
      • Bologna, Italy, 40138
        • Irccs Azienda Ospedaliero Universitaria Bologna
      • Florence, Italy, 50134
        • Aou Careggi, Servizio Sanitario Toscana
      • Milan, Italy, 20141
        • Istituto Europeo Di Oncologia
      • Milan, Italy, 20162
        • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
      • Novara, Italy, 28100
        • Aou Maggiore Della Carita
      • Padova, Italy, 35128
        • Azienda Ospedaliera Di Padova
      • Pavia, Italy, 27100
        • IRCCS Policlinico San Matteo, Università degli studi di Pavi
      • Reggio Emilia, Italy, 42123
        • Arcispedale S Maria Nuova Ausl Reggio Emilia Hematology Unit
      • Udine, Italy, 33100
        • Aou Santa Maria Della Misericordia Di Udine
  • Japan
      • Okayama, Japan, 701-1192
        • National Hospital Organization Okayama Medical Center
    • Ehime
      • Matsuyama, Ehime, Japan, 790 8524
        • Matsuyama Red Cross Hospital
    • Hiroshima
      • Hiroshima, Hiroshima, Japan, 730-8619
        • Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0804
        • National Hospital Organization Hokkaido Cancer Center
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 890-8520
        • Kagoshima University Hospital
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Kanagawa Cancer Center
    • Kyoto
      • KyotoShi, Kyoto, Japan, 602-8566
        • University Hospital, Kyoto Prefectural Univ of Medicine
    • Osaka
      • Hirakata, Osaka, Japan, 573-1191
        • Kansai Medical University Hospital
      • Sakai, Osaka, Japan, 590-0197
        • Kindai University Hospital
    • Tokyo
      • Bunkyoku, Tokyo, Japan, 113-8677
        • Tokyo Metropolitan Komagome Hospital
      • ChuoKu, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
      • Kotoku, Tokyo, Japan, 135-8550
        • Cancer Institute Hospital of Jfcr
    • Yamagata
      • Yamagata, Yamagata, Japan, 990-9585
        • Yamagata University Hospital
  • Poland
      • Bydgoszcz, Poland, 85-168
        • Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela
      • Gdansk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne Klinika Hematologii I Transplantologii
      • Katowice, Poland, 40-519
        • Pratia Onkologia Katowice
      • Krakow, Poland, 30-727
        • Pratia McM Krakow
      • Poznan, Poland, 61-131
        • Uniwersytecki Szpital Kliniczny w Poznaniu
      • Torun, Poland, 87-100
        • Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu
      • Warsaw, Poland, 02-776
        • Instytut Hematologii I Transfuzjologii W Warszawie
      • Warsaw, Poland, 02-097
        • Centralny Szpital Kliniczny Uck Wum
      • Warsaw, Poland, 02-781
        • Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie Hematology Unit
  • Portugal
      • Braga, Portugal, 4710-243
        • Hospital de Braga
      • Porto, Portugal, 4200-072
        • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
      • VILA NOVA de GAIA Porto, Portugal, 4434-502
        • Unidade Local de Saude Gaia E Espinho
  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00935
        • Pan American Oncology Trials, Llc
      • San Juan, Puerto Rico, 00917
        • Auxilio Mutuo Cancer Center
  • Romania
      • Bucharest, Romania, 30171
        • Coltea Clinical Hospital
      • ClujNapoca, Romania, 400015
        • Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca
      • Iași, Romania, 700483
        • Institutul Regional de Oncologie Iasi
      • Oradea, Romania, 410469
        • Spitalul Clinic Judetean De Urgenta Bihor
  • South Africa
      • Kuils River, South Africa, 7579
        • Haemalife
      • Pretoria, South Africa, '0181
        • Alberts Cellular Therapy
  • South Korea
    • Busan Gwang'yeogsi
      • BusanjinGu, Busan Gwang'yeogsi, South Korea, 47392
        • Inje University Busan Paik Hospital
      • Seogu, Busan Gwang'yeogsi, South Korea, 49201
        • Dong A University Hospital
      • Seogu, Busan Gwang'yeogsi, South Korea, 49241
        • Pusan National University Hospital
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital
    • Gyeongsangbukdo
      • BukGu, Gyeongsangbukdo, South Korea, 41404
        • Kyungpook National University Chilgok Hospital
    • Gyeongsangnam-do
      • Jinju, Gyeongsangnam-do, South Korea, 52727
        • Gyeongsang National University Hospital
    • Jeollanam-do
      • HwasunGun, Jeollanam-do, South Korea, 58128
        • Chonnam National University Hwasun Hospital
    • Seoul Teugbyeolsi
      • GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
        • Samsung Medical Center
      • SeochoGu, Seoul Teugbyeolsi, South Korea, 06591
        • The Catholic University of Korea, Seoul St Marys Hospital
      • SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, Seoul Teugbyeolsi, South Korea, 03080
        • Seoul National University Hospital
      • SongpaGu, Seoul Teugbyeolsi, South Korea, 05505
        • Asan Medical Center
      • YongsanGu, Seoul Teugbyeolsi, South Korea, 04401
        • Soon Chun Hyang University Hospital Seoul
  • Spain
      • Badalona, Spain, 08916
        • Ico Badalona
      • Burgos, Spain, 09006
        • Hospital Universitario De Burgos
      • Cadiz, Spain, 11009
        • Hospital Universitario Puerta Del Mar
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves
      • L'Hospitalet de Llobregat, Spain, 8908
        • Institut Catala Doncologia Hospital Duran I Reynals
      • León, Spain, 24071
        • Complejo Asistencial Universitario de Leon
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28006
        • Hospital de La Princesa
      • Madrid, Spain, 28027
        • Clínica Universidad de Navarra
      • Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor
      • Majadahonda, Spain, 28222
        • H Puerta de Hierro Majadahonda
      • Murcia, Spain, 30120
        • Hospital Clinico Universitario Virgen de La Arrixaca
      • Pamplona, Spain, 31008
        • Clinica Universidad de Navarra Pamplona
      • Pozuelo de Alarcón, Spain, 28223
        • Hospital Universitario Quironsalud Madrid
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Terrassa, Spain, 8221
        • Hospital Universitari Mutua Terrassa
  • Switzerland
      • Basel, Switzerland, 4058
        • St Claraspital
      • Fribourg, Switzerland, 1708
        • Hfr Fribourg
      • La ChauxdeFonds, Switzerland, 2300
        • Réseau Hospitalier Neuchâtelois
      • Zurich, Switzerland, 8091
        • Universitätsspital Zürich
  • Turkey (Türkiye)
      • AOCiftlii, Turkey (Türkiye), 06560
        • Gazi University Medical School
      • Ankara, Turkey (Türkiye), 06620
        • Ankara University Medical Faculty
      • Istanbul, Turkey (Türkiye), 34214
        • Bagcilar Medipol Mega Hospital
      • Kocaeli, Turkey (Türkiye), 41380
        • Kocaeli Universitesi Tip Fakultesi
      • Tevikiye, Turkey (Türkiye), 34365
        • Vkv American Hospital
  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
        • Beatson West of Scotland Cancer Centre
      • Greater Manchester, United Kingdom, M20 4BX
        • The Christie Hospital
      • Huddersfield, United Kingdom, HD3 3EA
        • Huddersfield Royal Infirmary
      • Inverness, United Kingdom, IV2 3BW
        • Nhs Highland
      • Leeds, United Kingdom, LS9 7TF
        • The Leeds Teaching Hospitals Nhs Trust
      • London, United Kingdom, EC1A 7BE
        • Barts Health Nhs Trust
      • London, United Kingdom, NW1 2PG
        • University College Hospital
      • Plymouth, United Kingdom, PL6 8DH
        • Derriford Hospital
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital
  • United States
    • California
      • Fresno, California, United States, 93730-3595
        • Ucsf Fresno University of California San Francisco Fresno
      • Irvine, California, United States, 92618-3734
        • Kaiser Permanente Southern California
      • Los Alamitos, California, United States, 90720-3302
        • Cancer and Blood Specialty Clinic
      • Los Angeles, California, United States, 90017-4803
        • Los Angeles Cancer Network
      • Los Angeles, California, United States, 90067-2011
        • Valkyrie Clinical Trials
      • Los Angeles, California, United States, 90095-3075
        • UCLA Hematologyoncology
      • San Diego, California, United States, 92103-2106
        • Scripps Health
      • San Diego, California, United States, 92123-2701
        • Sharp Healthcare Sharp Memorial Hospital
    • Florida
      • Jacksonville, Florida, United States, 32207-8432
        • Baptist MD Anderson Cancer Center
      • Pensacola, Florida, United States, 32504-8615
        • Ascension Sacred Heart
    • Georgia
      • Marietta, Georgia, United States, 30060-1152
        • Northwest Georgia Oncology Centers Marietta
    • Illinois
      • Decatur, Illinois, United States, 62526-5858
        • Cancer Care Specialists of Illinois
    • Indiana
      • Fort Wayne, Indiana, United States, 46804
        • Fort Wayne Medical Oncology and Hematology
    • Iowa
      • Waukee, Iowa, United States, 50263
        • Mission Cancer and Blood
    • Kansas
      • Topeka, Kansas, United States, 66606-1535
        • Cotton Oneil Cancer Center
      • Wichita, Kansas, United States, 67214-3728
        • Cancer Center of Kansas
    • Kentucky
      • Lexington, Kentucky, United States, 40503-1466
        • Baptist Health Lexington
    • Louisiana
      • Shreveport, Louisiana, United States, 71105-6800
        • Christus Highland Cancer Treatment Center
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Luminis Health Anne Arundel Medical Center
      • Baltimore, Maryland, United States, 21201
        • The University of Maryland Greenebaum Comprehensive Cancer Center
      • Baltimore, Maryland, United States, 21229-5201
        • Ascension St Agnes Hospital
      • Bethesda, Maryland, United States, 20817-7847
        • American Oncology Partners of Maryland Pa
    • Michigan
      • Detroit, Michigan, United States, 48202-2608
        • Henry Ford Hospital
      • Grand Rapids, Michigan, United States, 49503-2560
        • Corewell Health the Michigan Cancer Consortium
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401-7233
        • Hattiesburg Hematology and Oncology Clinic
    • Missouri
      • Columbia, Missouri, United States, 65212-1000
        • University of Missouri Hospital, Ellis Fischel Cancer Center
      • Springfield, Missouri, United States, 65807-5288
        • Oncology Hematology Associates
    • Montana
      • Billings, Montana, United States, 59102-6746
        • St Vincent Frontier Cancer Center
    • Nebraska
      • Omaha, Nebraska, United States, 68130-2042
        • Nebraska Cancer Specialists
    • Nevada
      • Las Vegas, Nevada, United States, 89169-3321
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • Bayonne, New Jersey, United States, 07002-4654
        • Iyengar Hematology Oncology Medical Center Pa
      • Florham Park, New Jersey, United States, 07932-1049
        • Summit Medical Group
    • New York
      • Shirley, New York, United States, 11967
        • New York Cancer and Blood Specialists
      • Syracuse, New York, United States, 13210-2306
        • SUNY Upstate Medical University
      • The Bronx, New York, United States, 10469-5930
        • North Shore Hematology Oncology Associates Eccc Bronx
      • Westbury, New York, United States, 11590-5119
        • Optum Medical Care, Pc
    • North Carolina
      • Charlotte, North Carolina, United States, 28204-2990
        • Levine Cancer Institute Wake Forest
    • Ohio
      • Cincinnati, Ohio, United States, 45245-1995
        • Oncology Hematology Care Clinical Trials, LLC
      • Cleveland, Ohio, United States, 44106-1702
        • Va Northeast Ohio Healthcare System
      • Toledo, Ohio, United States, 43623-3536
        • Toledo Clinic Cancer Center
    • Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096
        • Mainline Health Lankenau Institute For Medical Research
      • York, Pennsylvania, United States, 17403-5049
        • Cancer Care Associates of York
    • South Dakota
      • Watertown, South Dakota, United States, 57201-1548
        • Prairie Lakes Healthcare System
    • Texas
      • Dallas, Texas, United States, 75246-2003
        • Texas Oncology Baylorcharles A Sammons Cancer Center
      • Houston, Texas, United States, 77030-3907
        • MD Anderson Cancer Center
      • Tyler, Texas, United States, 75702-7522
        • Northeast Texas Cancer and Research Institute
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington
      • Spokane, Washington, United States, 99208-1129
        • Medical Oncology Associates
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • 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

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
  • Prior treatment with lenalidomide or drug from same class, if without response (partial or complete) or short remission duration (< 24 months)

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: 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.
Drug: 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.
Other Names:
  • Brukinsa
  • BGB-3111
Active Comparator: Follicular Lymphoma Arm B: Lenalidomide plus Rituximab
Participants will receive lenalidomide and rituximab.
Drug: 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.
Other Names:
  • Rituxan
  • MabThera
  • Ruxience
  • Truxima
Drug: 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.
Other Names:
  • Revlimid
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.
Drug: 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.
Other Names:
  • Rituxan
  • MabThera
  • Ruxience
  • Truxima
Drug: 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.
Other Names:
  • Brukinsa
  • BGB-3111
Active Comparator: Marginal Zone Lymphoma Arm D: Lenalidomide plus Rituximab
Participants will receive lenalidomide and rituximab.
Drug: 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.
Other Names:
  • Rituxan
  • MabThera
  • Ruxience
  • Truxima
Drug: 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.
Other Names:
  • Revlimid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free Survival As Determined By A Blinded Independent Review Committee (BIRC)
Time Frame: Approximately 78 months
Approximately 78 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival As Determined By Investigator Assessment
Time Frame: Approximately 87 months
Approximately 87 months
Time to Next Ant-Lymphoma Treatment
Time Frame: Approximately 87 months
Approximately 87 months
Overall Survival
Time Frame: Approximately 87 months
Approximately 87 months
Health-related Quality Of Life (HRQoL) Using EORTC QLQ-C30)
Time Frame: Approximately 87 months
HRQ0L assessed by The European Organization For Research On Treatment Of Cancer Quality Of Life Questionnaire-core 30 (EORTC QLQ-C30) consists of 30 questions that are associated with 5 functional scales (physical, role, cognitive, emotional, and social), 3 symptom scales (fatigue, pain, and nausea and vomiting), and 6 single symptom items ( dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The scores range from 0 to 100 and higher score indicates better quality of life.
Approximately 87 months
HRQoL Using European Quality of Life 5 Dimension 5 Level Questionnaire [EQ 5D 5L)
Time Frame: Approximately 87 months
The EQ-5D-5L is comprised of a descriptive module and a visual analogue scale. The EQ-5D-5L descriptive module comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The visual analogue scale records the respondent's self-rated health on a 0 to 100 scale, with 100 labeled "the best health you can imagine" and 0 labeled "the worst health you can imagine. Higher scores indicate better quality of life.
Approximately 87 months
HRQoL Using National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Symptom Index-18 [FLymSI 18)
Time Frame: Approximately 87 months
The FLymSI-18 is comprised of 18 questions which cover 4 sub-scales: physical symptoms, emotional symptoms, side effects, and functional well-being. Scores are based on the 5-level Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and is divided into a total score. Higher score indicates better quality of life.
Approximately 87 months
Number of Participants Experiencing Adverse Events (AEs)
Time Frame: From first dose to 28 days after the last dose of zanubrutinib or lenalidomide, 90 days after the last dose of obinutuzumab or rituximab, or until the date of confirmed disease progression, whichever comes later (Approximately 87 months)
From first dose to 28 days after the last dose of zanubrutinib or lenalidomide, 90 days after the last dose of obinutuzumab or rituximab, or until the date of confirmed disease progression, whichever comes later (Approximately 87 months)
Duration Of Response As Determined By BIRC And By Investigator Assessment
Time Frame: Approximately 87 months
Approximately 87 months
Overall Response Rate As Determined By BIRC And By Investigator Assessment
Time Frame: Approximately 87 months
Approximately 87 months
Complete Response Rate As Determined By BIRC And By Investigator Assessment
Time Frame: Approximately 87 months
Approximately 87 months
Time To Response As Determined By BIRC And By Investigator Assessment
Time Frame: Approximately 87 months
Approximately 87 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BeOne Medicines

Investigators

  • Study Director: Study Director, BeOne Medicines
  • Principal Investigator: Study Director, BeOne Medicines

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2022

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

September 27, 2021

First Submitted That Met QC Criteria

October 21, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Actual)

July 23, 2026

Last Update Submitted That Met QC Criteria

July 22, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BGB-3111-308
  • CTR20232545 (Registry Identifier: ChinaDrugTrials)
  • 2022-502548-12-00 (Registry Identifier: EU CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Time Frame

See plan description

IPD Sharing Access Criteria

See plan description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Marginal Zone Lymphoma

Clinical Trials on Obinutuzumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe