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

A Phase 3 Randomized, Open-Label Multicenter Study of Zanubrutinib (BGB-3111) Plus Anti-CD20 Antibodies Versus Lenalidomide Plus Rituximab in Patients With Relapsed/Refractory Follicular or Marginal Zone Lymphoma

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: Recruiting
• Conditions: Marginal Zone Lymphoma; Relapsed/Refractory Follicular Lymphoma
• Intervention / Treatment: Drug: Obinutuzumab; Drug: Rituximab; Drug: Zanubrutinib; Drug: Lenalidomide

• Study Type: Interventional
• Enrollment (Estimated): 780
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Study Director BeiGene; Phone Number: 1-877-828-5568; Email: clinicaltrials@beigene.com

Study Locations

• Argentina
  • CABA, Argentina, 1425
    • Active, not recruiting
    • Hospital Aleman
  • Ciudad Autonoma Buenos Aires, Argentina, 1413
    • Active, not recruiting
    • Hospital Italiano de Buenos Aires
• Australia
  • New South Wales
    • Concord, New South Wales, Australia, NSW 2139
      • Active, not recruiting
      • Concord Repatriation General Hospital
    • Gosford, New South Wales, Australia, NSW 2250
      • Active, not recruiting
      • Gosford Hospital
    • Kogarah, New South Wales, Australia, NSW 2217
      • Active, not recruiting
      • St George Hospital
    • Orange, New South Wales, Australia, NSW 2800
      • Active, not recruiting
      • Orange Health Hospital
    • Port Macquarie, New South Wales, Australia, NSW 2444
      • Active, not recruiting
      • Port Macquarie Base Hospital
    • Westmead, New South Wales, Australia, NSW 2145
      • Active, not recruiting
      • Westmead Hospital
  • Queensland
    • Birtinya, Queensland, Australia, QLD 4575
      • Completed
      • Sunshine Coast Hospital and Health Service
    • Douglas, Queensland, Australia, QLD 4814
      • Active, not recruiting
      • Townsville University Hospital
  • South Australia
    • North Adelaide, South Australia, Australia, SA 5006
      • Active, not recruiting
      • Genesiscare North Adelaide
  • Victoria
    • Clayton, Victoria, Australia, VIC 3168
      • Active, not recruiting
      • Monash Health
    • East Melbourne, Victoria, Australia, VIC 3002
      • Active, not recruiting
      • Epworth Freemasons
    • Fitzroy, Victoria, Australia, VIC 3065
      • Active, not recruiting
      • St Vincents Hospital Melbourne
    • Heidelberg, Victoria, Australia, VIC 3084
      • Active, not recruiting
      • Austin Health
    • Malvern East, Victoria, Australia, VIC 3144
      • Active, not recruiting
      • Cabrini Hospital Malvern
    • Melbourne, Victoria, Australia, VIC 3004
      • Active, not recruiting
      • The Alfred Hospital
    • Melbourne, Victoria, Australia, VIC 3844
      • Active, not recruiting
      • La Trobe Regional Hospital
  • Western Australia
    • Perth, Western Australia, Australia, WA 6000
      • Active, not recruiting
      • Royal Perth Hospital
    • West Perth, Western Australia, Australia, WA 6005
      • Active, not recruiting
      • Perth Blood Institute
• Austria
  • Innsbruck, Austria, 6020
    • Active, not recruiting
    • Medizinische Universitatsklinik Innsbruck
  • Sankt Pölten, Austria, 3100
    • Active, not recruiting
    • Uk St Poelten
  • Vienna, Austria, 1140
    • Active, not recruiting
    • Hanusch Krankenhaus
  • Vienna, Austria, 1090
    • Active, not recruiting
    • Medical Univeristy Vienna
  • Vienna, Austria, 1160
    • Active, not recruiting
    • Wiener Gesundheitsverbund Klinik Ottakring
• Belgium
  • Anderlecht, Belgium, 1070
    • Active, not recruiting
    • Institut Jules Bordet
  • Bruges, Belgium, 8000
    • Active, not recruiting
    • Az Sint Jan Brugge
  • Ghent, Belgium, 9000
    • Active, not recruiting
    • Universitair Ziekenhuis Gent
  • Leuven, Belgium, 3000
    • Active, not recruiting
    • University Hospitals Leuven
• Brazil
  • Barretos, Brazil, 14784-400
    • Active, not recruiting
    • Hospital de Amor Barretos
  • Blumenau, Brazil, 89010-340
    • Active, not recruiting
    • Clínica de Oncologia Reichow
  • Botucatu, Brazil, 18618687
    • Active, not recruiting
    • Unesp Faculdade de Medicina Da Universidade Estadual Paulista Campus Botucatu
  • Brasília, Brazil, 70390140
    • Active, not recruiting
    • Instituto Dor de Pesquisa E Ensino Distrito Federal
  • Campinas, Brazil, 13083-878
    • Active, not recruiting
    • Universidade de Campinas Centro de Hematologia E Hemoterapia
  • Caxias do Sul, Brazil, 95070-560
    • Active, not recruiting
    • Fundação Universidade de Caxias do Sul
  • Curitiba, Brazil, 80810-050
    • Active, not recruiting
    • Centro Integrado de Oncologia de Curitiba Ss Cionc
  • Curitiba, Brazil, 81520-060
    • Active, not recruiting
    • Hospital Erasto Gaertner
  • Florianópolis, Brazil, 88020-210
    • Active, not recruiting
    • Centro de Ensino E Pesquisa Em Oncologia de Santa Catarina (Cepen)
  • Niterói, Brazil, 24020-096
    • Active, not recruiting
    • Complexo Hospitalar de Niteroi
  • Porto Alegre, Brazil, 90110-270
    • Active, not recruiting
    • Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
  • Recife, Brazil, 50070-170
    • Active, not recruiting
    • Instituto Dor de Pesquisa E Ensino Pernambuco
  • Recife, Brazil, 50070-170
    • Active, not recruiting
    • Instituto Dor de Pesquisa e Ensino
  • Ribeirão Preto, Brazil, 14051-140
    • Active, not recruiting
    • Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp
  • Rio de Janeiro, Brazil, 22775-001
    • Active, not recruiting
    • Instituto Americas Ensino, Pesquisa E Inovacao
  • Salvador, Brazil, 41950-640
    • Active, not recruiting
    • Ensino e Terapia de Inovacao Clinica AMO Etica
  • Salvador, Brazil, 41253-190
    • Active, not recruiting
    • Hospital Sao Rafael Instituto Dor de Pesquisa E Ensino
  • São Paulo, Brazil, 05652-900
    • Active, not recruiting
    • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
  • São Paulo, Brazil, 01409-001
    • Active, not recruiting
    • Hospital Nove de Julho Dasa
  • São Paulo, Brazil, 05402-000
    • Active, not recruiting
    • Hcfmusp Servico de Hematologia, Hemoterapia E Terapia Celular
  • São Paulo, Brazil, 01401-004
    • Active, not recruiting
    • Instituto Dor de Pesquisa E Ensino Sao Paulo
  • Vitória, Brazil, 29043-260
    • Active, not recruiting
    • Hospital Santa Rita de Cassia Afecc
• Bulgaria
  • Plovdiv, Bulgaria, 4002
    • Completed
    • Umhat Svgeorgi Ead
  • Sofia, Bulgaria, 1407
    • Active, not recruiting
    • Acibadem City Clinic Tokuda Umhat Ead, Department of Medical Oncology
  • Sofia, Bulgaria, 1407
    • Completed
    • University Multiprofile Hospital For Active Treatment Saint Ivan Rilski
  • Sofia, Bulgaria, 1756
    • Active, not recruiting
    • NHATHD
• Canada
  • Québec, Canada, G1J 1Z4
    • Active, not recruiting
    • Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 4E6
      • Active, not recruiting
      • British Columbia Cancer Agency the Vancouver Centre
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
      • Active, not recruiting
      • Newfoundland and Labrador Health Services
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Active, not recruiting
      • Queen Elizabeth II Health Sciences Centre
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Active, not recruiting
      • Juravinski Cancer Centre
    • London, Ontario, Canada, N6A 5W9
      • Active, not recruiting
      • London Health Sciences Centre
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 5H6
      • Active, not recruiting
      • Ciusss Du Saguenay Lac St Jean
    • Lévis, Quebec, Canada, G6V 3Z1
      • Active, not recruiting
      • Centre Integre de Sante Et de Services Sociaux de Chaudiere Appalaches
    • Montreal, Quebec, Canada, H1T 2M4
      • Active, not recruiting
      • Ciusss de Lest de Lile de Montreal Hopital Maisonneuve Rosemont
    • SaintJerome, Quebec, Canada, J7Z 5T3
      • Active, not recruiting
      • Unité de Recherche Clinique du CISSS des Laurentides
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Active, not recruiting
      • Ciusss de Lestrie Chus
• China
  • Anhui
    • Wuhu, Anhui, China, 241001
      • Completed
      • The First Affiliated Hospital of Wannan Medical College
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100050
      • Active, not recruiting
      • Beijing Friendship Hospital, Capital Medical University
    • Beijing, Beijing Municipality, China, 100142
      • Active, not recruiting
      • Beijing Cancer Hospital
    • Beijing, Beijing Municipality, China, 101100
      • Active, not recruiting
      • Beijing Friendship Hospital, Capital Medical University(Tongzhou)
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400030
      • Active, not recruiting
      • Chongqing Cancer Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Completed
      • Fujian Medical University Union Hospital
    • Xiamen, Fujian, China, 361003
      • Active, not recruiting
      • The First Affiliated Hospital of Xiamen University
  • Guangdong
    • Foshan, Guangdong, China, 528000
      • Active, not recruiting
      • The First Peoples Hospital of Foshan
    • Guangzhou, Guangdong, China, 510060
      • Active, not recruiting
      • Sun Yat Sen University Cancer Center
    • Huizhou, Guangdong, China, 516001
      • Completed
      • Huizhou Central Peoples Hospital
    • Meizhou, Guangdong, China, 514031
      • Active, not recruiting
      • Meizhou People Hospital
    • Zhanjiang, Guangdong, China, 524000
      • Completed
      • Affiliated Hospital of Guangdong Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Active, not recruiting
      • Harbin Medical University Cancer Hospital
  • Henan
    • Anyang, Henan, China, 455001
      • Active, not recruiting
      • AnYang Tumor Hospital
    • Zhengzhou, Henan, China, 450000
      • Active, not recruiting
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Active, not recruiting
      • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
    • Wuhan, Hubei, China, 430022
      • Completed
      • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
  • Hunan
    • Changde, Hunan, China, 415000
      • Active, not recruiting
      • The First Peoples Hospital of Changde City
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Completed
      • Jiangsu Province Hospital
    • Nantong, Jiangsu, China, 201203
      • Active, not recruiting
      • Affiliated Hospital of Nantong University
    • Suzhou, Jiangsu, China, 215006
      • Active, not recruiting
      • The First Affiliated Hospital of Soochow University
    • Wuxi, Jiangsu, China, 214023
      • Active, not recruiting
      • Wuxi Peoples Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Active, not recruiting
      • The First Affiliated Hospital of Nanchang University Branch Donghu
    • Nanchang, Jiangxi, China, 330029
      • Active, not recruiting
      • Jiangxi Province Cancer Hospital
    • Nanchang, Jiangxi, China, 332000
      • Active, not recruiting
      • The First Affiliated Hospital of Nanchang University Branch Xianghu
  • Jilin
    • Changchun, Jilin, China, 130021
      • Active, not recruiting
      • The First Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Active, not recruiting
      • Shengjing Hospital of China Medical University
    • Shenyang, Liaoning, China, 110042
      • Active, not recruiting
      • Liaoning Cancer Hospital and Institute
  • Shandong
    • Rizhao, Shandong, China, 276827
      • Active, not recruiting
      • Peoples Hospital of Rizhao
    • Taian, Shandong, China, 271099
      • Active, not recruiting
      • The Second Affiliated Hospital of Shandong First Medical University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200000
      • Active, not recruiting
      • Fudan University Shanghai Cancer Center
  • Shanxi
    • Taiyuan, Shanxi, China, 030013
      • Active, not recruiting
      • Shanxi Provincial Cancer Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Active, not recruiting
      • West China Hospital, Sichuan University
  • Zhejiang
    • Dongyang, Zhejiang, China, 322103
      • Active, not recruiting
      • Dongyang Peoples Hospital
    • Hangzhou, Zhejiang, China, 310022
      • Active, not recruiting
      • Zhejiang Cancer Hospital
    • Jiaxing, Zhejiang, China, 314001
      • Active, not recruiting
      • The First Hospital of Jiaxing
    • Jinhua, Zhejiang, China, 321000
      • Active, not recruiting
      • Jinhua Municipal Central Hospital
    • Wenzhou, Zhejiang, China, 325000
      • Active, not recruiting
      • The First Affiliated Hospital of Wenzhou Medical University
• Czechia
  • Hradec Králové, Czechia, 500 03
    • Active, not recruiting
    • Fakultni nemocnice Hradec Kralove
  • Olomouc, Czechia, 77900
    • Active, not recruiting
    • Fakultni Nemocnice Olomouc
• France
  • Antony, France, 92160
    • Active, not recruiting
    • Hopital Prive Dantony, Departement Dhemathologie
  • Le Mans, France, 72037
    • Active, not recruiting
    • Centre Hospitalier Le Mans
  • Montpellier, France, 34090
    • Active, not recruiting
    • Chu Montpellier Hopital Saint Eloi
  • Nice, France, 06200
    • Active, not recruiting
    • Hopital Larchet 2 Chu Nice
  • Paris, France, 75005
    • Active, not recruiting
    • Institut Curie
  • Paris, France, 75015
    • Active, not recruiting
    • Necker University Hospital
  • Strasbourg, France, 67200
    • Active, not recruiting
    • Hopitaux Universitaires de Strasbourg Hopital de Hautepierre (Ancien Icans)
  • VandoeuvrelesNancy, France, 54511
    • Active, not recruiting
    • Chu Nancy Hopital Brabois
• Georgia
  • Kutaisi, Georgia, 4600
    • Active, not recruiting
    • JSC Vian
• Germany
  • Essen, Germany, 45147
    • Completed
    • Universitaetsklinikum Essen
  • Ulm, Germany, 89081
    • Completed
    • Universitaetsklinikum Ulm
• Greece
  • Alexandroupoli, Greece, 68100
    • Active, not recruiting
    • University Hospital of Alexandroupolis
  • Athens, Greece, 115 28
    • Completed
    • General Hospital of Athens Alexandra
  • Athens, Greece, 106 76
    • Active, not recruiting
    • Evaggelismos
  • Pátrai, Greece, 26504
    • Active, not recruiting
    • University Hospital of Patra
• Ireland
  • Dublin, Ireland, D08 NHY1
    • Active, not recruiting
    • St Jamess Hospital
  • Waterford, Ireland, X91 ER8E
    • Active, not recruiting
    • University Hospital Waterford
• Israel
  • Ashdod, Israel, 7747629
    • Active, not recruiting
    • Assuta Ashdod Medical Center
  • Jerusalem, Israel, 9103102
    • Active, not recruiting
    • Shaare Zedek Medical Center
  • Jerusalem, Israel, 9112001
    • Active, not recruiting
    • Hadassah En Karem Medical Center
  • Petah Tikva, Israel, 49100
    • Active, not recruiting
    • Rabin Medical Center
  • Ramat Gan, Israel, 5265601
    • Active, not recruiting
    • Chaim Sheba Medical Center
  • Tel Aviv, Israel, 60000
    • Active, not recruiting
    • Assuta Medical Center
  • Tel Aviv, Israel, 6423906
    • Active, not recruiting
    • Sourasky Tel Aviv Medical Center
• Italy
  • Aviano, Italy, 33081
    • Active, not recruiting
    • Cro Irccs Aviano
  • Bologna, Italy, 40138
    • Active, not recruiting
    • Irccs Azienda Ospedaliero Universitaria Bologna
  • Florence, Italy, 50134
    • Active, not recruiting
    • Aou Careggi, Servizio Sanitario Toscana
  • Milan, Italy, 20141
    • Active, not recruiting
    • Istituto Europeo di Oncologia
  • Milan, Italy, 20162
    • Active, not recruiting
    • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
  • Novara, Italy, 28100
    • Active, not recruiting
    • AOU Maggiore della Carità
  • Padova, Italy, 35128
    • Active, not recruiting
    • Azienda Ospedaliera di Padova
  • Pavia, Italy, 27100
    • Active, not recruiting
    • Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi
  • Reggio Emilia, Italy, 42123
    • Active, not recruiting
    • Arcispedale S Maria Nuova Ausl Reggio Emilia Hematology Unit
  • Udine, Italy, 33100
    • Active, not recruiting
    • Aou Santa Maria Della Misericordia Di Udine
• Japan
  • Kumamoto, Japan, 860-8556
    • Recruiting
    • Kumamoto University Hospital
  • Okayama, Japan, 701-1192
    • Recruiting
    • National Hospital Organization Okayama Medical Center
  • Yokohama, Japan, 221-0855
    • Recruiting
    • Yokohama Municipal Citizens Hospital
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 464-8681
      • Recruiting
      • Aichi Cancer Center Hospital Clinical Oncology
  • Chiba
    • Chiba, Chiba, Japan, 260-8717
      • Recruiting
      • Chiba Cancer Center
  • Ehime
    • Matsuyama, Ehime, Japan, 790 8524
      • Recruiting
      • Matsuyama Red Cross Hospital
  • Hiroshima
    • Hiroshima, Hiroshima, Japan, 730-8619
      • Recruiting
      • Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 003-0804
      • Recruiting
      • National Hospital Organization Hokkaido Cancer Center
    • Sapporo, Hokkaido, Japan, 064-0804
      • Recruiting
      • Aiiku Hospital
  • Kagoshima-ken
    • Kagoshima, Kagoshima-ken, Japan, 890-8520
      • Recruiting
      • Kagoshima University Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 241-8515
      • Recruiting
      • Kanagawa Cancer Center
  • Kyoto
    • KyotoShi, Kyoto, Japan, 602-8566
      • Recruiting
      • University Hospital, Kyoto Prefectural Univ of Medicine
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Recruiting
      • Tohoku University Hospital
  • Okayama-ken
    • Kurashikishi, Okayama-ken, Japan, 710-8602
      • Recruiting
      • Kurashiki Central Hospital
  • Osaka
    • Hirakata, Osaka, Japan, 573-1191
      • Recruiting
      • Kansai Medical University Hospital
    • Sakai, Osaka, Japan, 590-0197
      • Recruiting
      • Kindai University Hospital
  • Tokyo
    • Bunkyoku, Tokyo, Japan, 113-8677
      • Recruiting
      • Tokyo Metropolitan Komagome Hospital
    • ChuoKu, Tokyo, Japan, 104-0045
      • Recruiting
      • National Cancer Center Hospital
    • Kotoku, Tokyo, Japan, 135-8550
      • Recruiting
      • Cancer Institute Hospital of JFCR
  • Yamagata
    • Yamagata, Yamagata, Japan, 990-9585
      • Recruiting
      • Yamagata University Hospital
• Poland
  • Bydgoszcz, Poland, 85-168
    • Completed
    • Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela
  • Gdansk, Poland, 80-214
    • Completed
    • Uniwersyteckie Centrum Kliniczne Klinika Hematologii I Transplantologii
  • Katowice, Poland, 40-519
    • Active, not recruiting
    • Pratia Onkologia Katowice
  • Krakow, Poland, 30-727
    • Active, not recruiting
    • Pratia MCM Kraków
  • Poznan, Poland, 60-569
    • Active, not recruiting
    • Uniwersytecki Szpital Kliniczny W Poznaniu Oddzial Hematologii I Transplantacji Szpiku
  • Torun, Poland, 87-100
    • Active, not recruiting
    • Wojewodzki Szpital Zespolony im L Rydygiera w Toruniu
  • Warsaw, Poland, 02-097
    • Completed
    • Centralny Szpital Kliniczny Uck Wum
  • Warsaw, Poland, 02-776
    • Active, not recruiting
    • Instytut Hematologii i Transfuzjologii
  • Warsaw, Poland, 02-781
    • Active, not recruiting
    • Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie Hematology Unit
• Portugal
  • Braga, Portugal, 4710-243
    • Active, not recruiting
    • Hospital de Braga
  • Porto, Portugal, 4200-072
    • Active, not recruiting
    • Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE
  • VILA NOVA de GAIA Porto, Portugal, 4434-502
    • Active, not recruiting
    • Unidade Local de Saude Gaia E Espinho
• Puerto Rico
  • Rio Piedras, Puerto Rico, 00935
    • Completed
    • Pan American Oncology Trials, Llc
  • San Juan, Puerto Rico, 00917
    • Active, not recruiting
    • Auxilio Mutuo Cancer Center
• Romania
  • Bucharest, Romania, 30171
    • Active, not recruiting
    • Coltea Clinical Hospital
  • ClujNapoca, Romania, 400015
    • Active, not recruiting
    • Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca
  • Iași, Romania, 700483
    • Active, not recruiting
    • Institutul Regional de Oncologie Iasi
  • Oradea, Romania, 410469
    • Completed
    • Spitalul Clinic Judetean De Urgenta Bihor
• South Africa
  • Kuils River, South Africa, 7579
    • Active, not recruiting
    • Haemalife
  • Pretoria, South Africa, '0181
    • Active, not recruiting
    • Alberts Cellular Therapy
• South Korea
  • Busan Gwang'yeogsi
    • BusanjinGu, Busan Gwang'yeogsi, South Korea, 47392
      • Active, not recruiting
      • Inje University Busan Paik Hospital
    • Seogu, Busan Gwang'yeogsi, South Korea, 49201
      • Active, not recruiting
      • Dong A University Hospital
    • Seogu, Busan Gwang'yeogsi, South Korea, 49241
      • Active, not recruiting
      • Pusan National University Hospital
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, South Korea, 13620
      • Active, not recruiting
      • Seoul National University Bundang Hospital
  • Gyeongsangbukdo
    • BukGu, Gyeongsangbukdo, South Korea, 41404
      • Active, not recruiting
      • Kyungpook National University Chilgok Hospital
  • Gyeongsangnam-do
    • Jinju, Gyeongsangnam-do, South Korea, 52727
      • Active, not recruiting
      • Gyeongsang National University Hospital
  • Jeollanam-do
    • HwasunGun, Jeollanam-do, South Korea, 58128
      • Active, not recruiting
      • Chonnam National University Hwasun Hospital
  • Seoul Teugbyeolsi
    • GangnamGu, Seoul Teugbyeolsi, South Korea, 06351
      • Active, not recruiting
      • Samsung Medical Center
    • SeochoGu, Seoul Teugbyeolsi, South Korea, 06591
      • Active, not recruiting
      • The Catholic University of Korea, Seoul St Marys Hospital
    • SeodaemunGu, Seoul Teugbyeolsi, South Korea, 03722
      • Active, not recruiting
      • Severance Hospital Yonsei University Health System
    • Seoul, Seoul Teugbyeolsi, South Korea, 03080
      • Active, not recruiting
      • Seoul National University Hospital
    • SongpaGu, Seoul Teugbyeolsi, South Korea, 05505
      • Active, not recruiting
      • Asan Medical Center
    • YongsanGu, Seoul Teugbyeolsi, South Korea, 04401
      • Active, not recruiting
      • Soon Chun Hyang University Hospital Seoul
• Spain
  • Badalona, Spain, 08916
    • Active, not recruiting
    • ICO Badalona
  • Burgos, Spain, 09006
    • Active, not recruiting
    • Hospital Universitario de Burgos
  • Cadiz, Spain, 11009
    • Active, not recruiting
    • Hospital Universitario Puerta del Mar
  • Granada, Spain, 18014
    • Active, not recruiting
    • Hospital Universitario Virgen de Las Nieves
  • L'Hospitalet de Llobregat, Spain, 8908
    • Active, not recruiting
    • Institut Catala Doncologia Hospital Duran I Reynals
  • León, Spain, 24071
    • Active, not recruiting
    • Complejo Asistencial Universitario de Leon
  • Madrid, Spain, 28027
    • Active, not recruiting
    • Clinica Universidad de Navarra
  • Madrid, Spain, 28034
    • Active, not recruiting
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28031
    • Active, not recruiting
    • Hospital Universitario Infanta Leonor
  • Madrid, Spain, 28006
    • Active, not recruiting
    • Hospital de la Princesa
  • Majadahonda, Spain, 28222
    • Active, not recruiting
    • H Puerta de Hierro Majadahonda
  • Murcia, Spain, 30120
    • Active, not recruiting
    • Hospital Clinico Universitario Virgen de La Arrixaca
  • Pamplona, Spain, 31008
    • Active, not recruiting
    • Clinica Universidad de Navarra Pamplona
  • Pozuelo de Alarcón, Spain, 28223
    • Active, not recruiting
    • Hospital Universitario Quironsalud Madrid
  • Salamanca, Spain, 37007
    • Active, not recruiting
    • Hospital Universitario de Salamanca
  • Seville, Spain, 41013
    • Active, not recruiting
    • Hospital Universitario Virgen del Rocío
  • Terrassa, Spain, 8221
    • Active, not recruiting
    • Hospital Universitari Mutua Terrassa
• Switzerland
  • Basel, Switzerland, 4058
    • Completed
    • St Claraspital
  • Fribourg, Switzerland, 1708
    • Completed
    • HFR Fribourg
  • La ChauxdeFonds, Switzerland, 2300
    • Active, not recruiting
    • Reseau Hospitalier Neuchatelois
  • Zurich, Switzerland, 8091
    • Active, not recruiting
    • Universitätsspital Zürich
• Turkey (Türkiye)
  • AOCiftlii, Turkey (Türkiye), 06560
    • Active, not recruiting
    • Gazi University Medical School
  • Ankara, Turkey (Türkiye), 06620
    • Active, not recruiting
    • Ankara University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34214
    • Active, not recruiting
    • Bagcilar Medipol Mega Hospital
  • Kocaeli, Turkey (Türkiye), 41380
    • Active, not recruiting
    • Kocaeli Universitesi Tip Fakultesi
  • Tevikiye, Turkey (Türkiye), 34365
    • Active, not recruiting
    • Vkv American Hospital
• United Kingdom
  • Glasgow, United Kingdom, G12 0YN
    • Active, not recruiting
    • Beatson West of Scotland Cancer Centre
  • Greater Manchester, United Kingdom, M20 4BX
    • Active, not recruiting
    • The Christie Hospital
  • Huddersfield, United Kingdom, HD3 3EA
    • Active, not recruiting
    • Huddersfield Royal Infirmary
  • Inverness, United Kingdom, IV2 3BW
    • Completed
    • Nhs Highland
  • Leeds, United Kingdom, LS9 7TF
    • Active, not recruiting
    • The Leeds Teaching Hospitals Nhs Trust
  • London, United Kingdom, NW1 2PG
    • Active, not recruiting
    • University College Hospital
  • London, United Kingdom, EC1A 7BE
    • Completed
    • Barts Health NHS Trust
  • Plymouth, United Kingdom, PL6 8DH
    • Active, not recruiting
    • Derriford Hospital
  • Southampton, United Kingdom, SO16 6YD
    • Active, not recruiting
    • Southampton General Hospital
• United States
  • California
    • Fresno, California, United States, 93730-3595
      • Active, not recruiting
      • Ucsf Fresno University of California San Francisco Fresno
    • Irvine, California, United States, 92618-3734
      • Completed
      • Kaiser Permanente Southern California
    • Los Alamitos, California, United States, 90720-3302
      • Active, not recruiting
      • Cancer and Blood Specialty Clinic
    • Los Angeles, California, United States, 90017-4803
      • Active, not recruiting
      • Los Angeles Cancer Network
    • Los Angeles, California, United States, 90067-2011
      • Active, not recruiting
      • Valkyrie Clinical Trials
    • Los Angeles, California, United States, 90095-3075
      • Completed
      • UCLA Hematologyoncology
    • San Diego, California, United States, 92123-2701
      • Active, not recruiting
      • Sharp Healthcare Sharp Memorial Hospital
    • San Diego, California, United States, 92103-2106
      • Completed
      • Scripps Health
  • Florida
    • Jacksonville, Florida, United States, 32207-8432
      • Completed
      • Baptist MD Anderson Cancer Center
    • Pensacola, Florida, United States, 32504-8615
      • Completed
      • Ascension Sacred Heart
  • Georgia
    • Marietta, Georgia, United States, 30060-1152
      • Active, not recruiting
      • Northwest Georgia Oncology Centers Marietta
  • Illinois
    • Decatur, Illinois, United States, 62526-5858
      • Completed
      • Cancer Care Specialists of Illinois
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Active, not recruiting
      • Fort Wayne Medical Oncology and Hematology
  • Iowa
    • Waukee, Iowa, United States, 50263
      • Active, not recruiting
      • Mission Cancer and Blood
  • Kansas
    • Topeka, Kansas, United States, 66606-1535
      • Completed
      • Cotton Oneil Cancer Center
    • Wichita, Kansas, United States, 67214-3728
      • Active, not recruiting
      • Cancer Center of Kansas
  • Kentucky
    • Lexington, Kentucky, United States, 40503-1466
      • Active, not recruiting
      • Baptist Health Lexington
  • Louisiana
    • Shreveport, Louisiana, United States, 71105-6800
      • Active, not recruiting
      • Christus Highland Cancer Treatment Center
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Completed
      • Luminis Health Anne Arundel Medical Center
    • Baltimore, Maryland, United States, 21201-1544
      • Active, not recruiting
      • University of Maryland Greenebaum Comprehensive Cancer Center
    • Baltimore, Maryland, United States, 21229-5201
      • Completed
      • Ascension St Agnes Hospital
    • Bethesda, Maryland, United States, 20817-7847
      • Active, not recruiting
      • American Oncology Partners of Maryland PA
  • Michigan
    • Detroit, Michigan, United States, 48202-2608
      • Active, not recruiting
      • Henry Ford Hospital
    • Grand Rapids, Michigan, United States, 49503-2560
      • Active, not recruiting
      • Corewell Health the Michigan Cancer Consortium
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401-7233
      • Active, not recruiting
      • Hattiesburg Hematology and Oncology Clinic
  • Missouri
    • Columbia, Missouri, United States, 65212-1000
      • Active, not recruiting
      • University of Missouri Hospital, Ellis Fischel Cancer Center
    • Springfield, Missouri, United States, 65807-5288
      • Active, not recruiting
      • Oncology Hematology Associates
  • Montana
    • Billings, Montana, United States, 59102
      • Completed
      • St Vincent Frontier Cancer Center
  • Nebraska
    • Omaha, Nebraska, United States, 68130-2042
      • Active, not recruiting
      • Nebraska Cancer Specialists
  • Nevada
    • Las Vegas, Nevada, United States, 89169-3321
      • Completed
      • Comprehensive Cancer Centers of Nevada
  • New Jersey
    • Bayonne, New Jersey, United States, 07002-4654
      • Active, not recruiting
      • Iyengar Hematology Oncology Medical Center Pa
    • Florham Park, New Jersey, United States, 07932-1049
      • Completed
      • Summit Medical Group
  • New York
    • Shirley, New York, United States, 11967
      • Active, not recruiting
      • New York Cancer and Blood Specialists
    • Syracuse, New York, United States, 13210-2306
      • Completed
      • SUNY Upstate Medical University
    • The Bronx, New York, United States, 10469-5930
      • Completed
      • North Shore Hematology Oncology Associates Eccc Bronx
    • Westbury, New York, United States, 11590-5119
      • Active, not recruiting
      • Clinical Research Alliance, Inc
  • North Carolina
    • Charlotte, North Carolina, United States, 28204-2990
      • Active, not recruiting
      • Levine Cancer Institute Wake Forest
  • Ohio
    • Cincinnati, Ohio, United States, 45245-1995
      • Completed
      • Oncology Hematology Care Clinical Trials, LLC
    • Cleveland, Ohio, United States, 44106-1702
      • Completed
      • VA Northeast Ohio Healthcare System
    • Toledo, Ohio, United States, 43623-3536
      • Completed
      • Toledo Clinic Cancer Center
  • Pennsylvania
    • Wynnewood, Pennsylvania, United States, 19096
      • Completed
      • Mainline Health Lankenau Institute For Medical Research
    • York, Pennsylvania, United States, 17403-5049
      • Active, not recruiting
      • Cancer Care Associates of York
  • South Dakota
    • Watertown, South Dakota, United States, 57201-1548
      • Active, not recruiting
      • Prairie Lakes Healthcare System
  • Texas
    • Dallas, Texas, United States, 75246-2003
      • Active, not recruiting
      • Texas Oncology Baylorcharles A Sammons Cancer Center
    • Houston, Texas, United States, 77030-3907
      • Active, not recruiting
      • MD Anderson Cancer Center
    • Tyler, Texas, United States, 75702-7522
      • Active, not recruiting
      • Northeast Texas Cancer and Research Institute
  • Washington
    • Seattle, Washington, United States, 98195
      • Active, not recruiting
      • University of Washington
    • Spokane, Washington, United States, 99208-1129
      • Completed
      • Medical Oncology Associates
    • Tacoma, Washington, United States, 98405
      • Completed
      • Northwest Medical Specialties

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

4

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)	Approximately 78 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival As Determined By Investigator Assessment		Approximately 87 months
Time to Next Ant-Lymphoma Treatment		Approximately 87 months
Overall Survival		Approximately 87 months
Health-related Quality Of Life (HRQoL) Using EORTC QLQ-C30)	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)	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)	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)		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		Approximately 87 months
Overall Response Rate As Determined By BIRC And By Investigator Assessment		Approximately 87 months
Complete Response Rate As Determined By BIRC And By Investigator Assessment		Approximately 87 months
Time To Response As Determined By BIRC And By Investigator Assessment		Approximately 87 months

Collaborators and Investigators

• Sponsor: BeiGene
• Investigators: Study Director: Study Director, BeiGene; Principal Investigator: Study Director, BeiGene

Study record dates

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): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Rituximab; Lenalidomide; Obinutuzumab; Zanubrutinib; BGB-3111
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Piperidines; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Murine-Derived; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Isoindoles; Lenalidomide; Rituximab; zanubrutinib; obinutuzumab
• 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

BeiGene 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.

BeiGene 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 BeiGene 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