AzTrials
AzTrials

Relapsed/Refractory Follicular LymphomaPhase 3MAHOGANYNCT05100862

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

A Phase 3 study testing Zanubrutinib, Rituximab and Lenalidomide in people with Relapsed/Refractory Follicular Lymphoma and Marginal Zone Lymphoma, run by BeOne Medicines at 264 sites in 28 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of the study is to compare the efficacy of zanubrutinib plus obinutuzumab versus lenalidomide plus rituximab (R^2) in participants with relapsed/refractory (R/R) follicular lymphoma (FL), as measured by progression-free survival as determined by an independent review committee in accordance with the 2014… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Zanubrutinib, Rituximab and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
799 participants
Where
264 sitesin 28 countries
Study dates
10 Mar 2022to Jun 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

264 sites in 28 countries.

264 sites in 28 countries

United States50 sites

  • Luminis Health Anne Arundel Medical Center

    Annapolis, Maryland, 21401

  • The University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • Ascension St Agnes Hospital

    Baltimore, Maryland, 21229-5201

  • Iyengar Hematology Oncology Medical Center Pa

    Bayonne, New Jersey, 07002-4654

  • American Oncology Partners of Maryland Pa

    Bethesda, Maryland, 20817-7847

  • St Vincent Frontier Cancer Center

    Billings, Montana, 59102-6746

  • Levine Cancer Institute Wake Forest

    Charlotte, North Carolina, 28204-2990

  • Oncology Hematology Care Clinical Trials, Llc

    Cincinnati, Ohio, 45245-1995

  • Va Northeast Ohio Healthcare System

    Cleveland, Ohio, 44106-1702

  • University of Missouri Hospital Ellis Fischel Cancer Center

    Columbia, Missouri, 65212-1000

  • Texas Oncology Baylor Charles A Sammons Cancer Center

    Dallas, Texas, 75246-2003

  • Henry Ford Hospital

    Detroit, Michigan, 48202-2608

  • Summit Medical Group

    Florham Park, New Jersey, 07932-1049

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46804

  • Ucsf Fresno University of California San Francisco Fresno

    Fresno, California, 93730-3595

  • Corewell Health the Michigan Cancer Consortium

    Grand Rapids, Michigan, 49503-2560

  • Hattiesburg Hematology and Oncology Clinic

    Hattiesburg, Mississippi, 39401-7233

  • Md Anderson Cancer Center

    Houston, Texas, 77030-3907

  • Kaiser Permanente Southern California

    Irvine, California, 92618-3734

  • Baptist Md Anderson Cancer Center

    Jacksonville, Florida, 32207-8432

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169-3321

  • Baptist Health Lexington

    Lexington, Kentucky, 40503-1466

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720-3302

  • Los Angeles Cancer Network

    Los Angeles, California, 90017-4803

  • Valkyrie Clinical Trials

    Los Angeles, California, 90067-2011

  • UCLA Hematologyoncology

    Los Angeles, California, 90095-3075

  • Northwest Georgia Oncology Centers Marietta

    Marietta, Georgia, 30060-1152

  • Tennessee Oncology Nashville St Thomas Midtown Clinic

    Nashville, Tennessee, 37205

  • Cancer Care Specialists of Illinois

    OFallon, Illinois, 62269

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130-2042

  • Ascension Sacred Heart

    Pensacola, Florida, 32504-8615

  • Scripps Health

    San Diego, California, 92103-2106

  • Sharp Healthcare Sharp Memorial Hospital

    San Diego, California, 92123-2701

  • University of Washington

    Seattle, Washington, 98195

  • New York Cancer and Blood Specialists

    Shirley, New York, 11967

  • Christus Highland Cancer Treatment Center

    Shreveport, Louisiana, 71105-6800

  • Medical Oncology Associates

    Spokane, Washington, 99208-1129

  • Oncology Hematology Associates

    Springfield, Missouri, 65807-5288

  • Suny Upstate Medical University

    Syracuse, New York, 13210-2306

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

  • North Shore Hematology Oncology Associates Eccc Bronx

    The Bronx, New York, 10469-5930

  • Toledo Clinic Cancer Center

    Toledo, Ohio, 43623-3536

  • Cotton Oneil Cancer Center

    Topeka, Kansas, 66606-1535

  • Northeast Texas Cancer and Research Institute

    Tyler, Texas, 75702-7522

  • Prairie Lakes Healthcare System

    Watertown, South Dakota, 57201-1548

  • Mission Cancer and Blood

    Waukee, Iowa, 50263

  • Optum Medical Care, Pc

    Westbury, New York, 11590-5119

  • Cancer Center of Kansas

    Wichita, Kansas, 67214-3728

  • Mainline Health Lankenau Institute For Medical Research

    Wynnewood, Pennsylvania, 19096

  • Cancer Care Associates of York

    York, Pennsylvania, 17403-5049

Other trials in United States

China38 sites

  • Anyang Tumor Hospital

    Anyang, Henan, 455001

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Beijing Friendship Hospital, Capital Medical University(Tongzhou)

    Beijing, Beijing Municipality, 101100

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • The First Peoples Hospital of Changde City

    Changde, Hunan, 415000

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

  • Dongyang Peoples Hospital

    Dongyang, Zhejiang, 322103

  • The First Peoples Hospital of Foshan

    Foshan, Guangdong, 528000

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • Huizhou Central Peoples Hospital

    Huizhou, Guangdong, 516001

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang, 314001

  • Jinhua Municipal Central Hospital

    Jinhua, Zhejiang, 321000

  • Meizhou People Hospital

    Meizhou, Guangdong, 514031

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006

  • Jiangxi Province Cancer Hospital

    Nanchang, Jiangxi, 330029

  • The First Affiliated Hospital of Nanchang University Branch Xianghu

    Nanchang, Jiangxi, 332000

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Affiliated Hospital of Nantong University

    Nantong, Jiangsu, 201203

  • Peoples Hospital of Rizhao

    Rizhao, Shandong, 276827

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • The Second Affiliated Hospital of Shandong First Medical University

    Taian, Shandong, 271099

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030013

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui, 241001

  • Wuxi Peoples Hospital

    Wuxi, Jiangsu, 214023

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong, 524000

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

Other trials in China

Brazil22 sites

  • Hospital de Amor Barretos

    Barretos, 14784-400

  • Clinica de Oncologia Reichow

    Blumenau, 89010-340

  • Unesp Faculdade de Medicina Da Universidade Estadual Paulista Campus Botucatu

    Botucatu, 18618687

  • Instituto Dor de Pesquisa E Ensino Distrito Federal

    Brasília, 70390140

  • Universidade de Campinas Centro de Hematologia E Hemoterapia

    Campinas, 13083-878

  • Fundacao Universidade de Caxias Do Sul

    Caxias do Sul, 95070-560

  • Centro Integrado de Oncologia de Curitiba Ss Cionc

    Curitiba, 80810-050

  • Hospital Erasto Gaertner

    Curitiba, 81520-060

  • Centro de Ensino E Pesquisa Em Oncologia de Santa Catarina (Cepen)

    Florianópolis, 88020-210

  • Complexo Hospitalar de Niteroi

    Niterói, 24020-096

  • Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

    Porto Alegre, 90110-270

  • Instituto Dor de Pesquisa E Ensino Pernambuco

    Recife, 50070-170

  • Hospital Das Clinicas Da Faculdade de Medicina de Ribeirao Preto Usp

    Ribeirão Preto, 14051-140

  • Instituto Dor de Pesquisa E Ensino Rio de Janeiro

    Rio de Janeiro, 22281-100

  • Instituto Americas Ensino, Pesquisa E Inovacao

    Rio de Janeiro, 22775-001

  • Hospital Sao Rafael Instituto Dor de Pesquisa E Ensino

    Salvador, 41253-190

  • Ensino E Terapia de Inovacao Clinica Amo Etica

    Salvador, 41950-640

  • Instituto Dor de Pesquisa E Ensino Sao Paulo

    São Paulo, 01401-004

  • Hospital Nove de Julho Dasa

    São Paulo, 01409-001

  • Hcfmusp Pesquisa Clinica Do Servico de Hematologia E Terapia Celular

    São Paulo, 05403-010

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05652-900

  • Hospital Santa Rita de Cassia Afecc

    Vitória, 29043-260

Other trials in Brazil

Australia17 sites

  • Monash Health

    Clayton, Victoria, VIC 3168

  • Concord Repatriation General Hospital

    Concord, New South Wales, NSW 2139

  • Townsville University Hospital

    Douglas, Queensland, QLD 4814

  • Epworth Freemasons

    East Melbourne, Victoria, VIC 3002

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, VIC 3065

  • Gosford Hospital

    Gosford, New South Wales, NSW 2250

  • Austin Health

    Heidelberg, Victoria, VIC 3084

  • St George Hospital

    Kogarah, New South Wales, NSW 2217

  • Cabrini Hospital Malvern

    Malvern, Victoria, VIC 3144

  • The Alfred Hospital

    Melbourne, Victoria, VIC 3004

  • La Trobe Regional Hospital

    Melbourne, Victoria, VIC 3844

  • Genesiscare North Adelaide

    North Adelaide, South Australia, SA 5006

  • Orange Health Hospital

    Orange, New South Wales, NSW 2800

  • Royal Perth Hospital

    Perth, Western Australia, WA 6000

  • Port Macquarie Base Hospital

    Port Macquarie, New South Wales, NSW 2444

  • Perth Blood Institute

    West Perth, Western Australia, WA 6005

  • Westmead Hospital

    Westmead, New South Wales, NSW 2145

Other trials in Australia

Spain16 sites

  • Ico Badalona

    Badalona, 08916

  • Hospital Universitario de Burgos

    Burgos, 09006

  • Hospital Universitario Puerta Del Mar

    Cadiz, 11009

  • Hospital Universitario Virgen de Las Nieves

    Granada, 18014

  • Institut Catala Doncologia Hospital Duran I Reynals

    L'Hospitalet de Llobregat, 8908

  • Complejo Asistencial Universitario de Leon

    León, 24071

  • Hospital de La Princesa

    Madrid, 28006

  • Clinica Universidad de Navarra

    Madrid, 28027

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

  • H Puerta de Hierro Majadahonda

    Majadahonda, 28222

  • Hospital Clinico Universitario Virgen de La Arrixaca

    Murcia, 30120

  • Clinica Universidad de Navarra Pamplona

    Pamplona, 31008

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, 28223

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

  • Hospital Universitari Mutua Terrassa

    Terrassa, 8221

Other trials in Spain

Japan13 sites

  • Tokyo Metropolitan Komagome Hospital

    Bunkyoku, Tokyo, 113-8677

  • National Cancer Center Hospital

    ChuoKu, Tokyo, 104-0045

  • Kansai Medical University Hospital

    Hirakata, Osaka, 573-1191

  • Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital

    Hiroshima, Hiroshima, 730-8619

  • Kagoshima University Hospital

    Kagoshima, Kagoshima-ken, 890-8520

  • Cancer Institute Hospital of Jfcr

    Kotoku, Tokyo, 135-8550

  • University Hospital, Kyoto Prefectural Univ of Medicine

    KyotoShi, Kyoto, 602-8566

  • Matsuyama Red Cross Hospital

    Matsuyama, Ehime, 790 8524

  • National Hospital Organization Okayama Medical Center

    Okayama, Okayama-ken, 701-1192

  • Kindai University Hospital

    Sakai, Osaka, 590-0197

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

  • Yamagata University Hospital

    Yamagata, Yamagata, 990-9585

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

Other trials in Japan

South Korea13 sites

  • Kyungpook National University Chilgok Hospital

    BukGu, Gyeongsangbukdo, 41404

  • Inje University Busan Paik Hospital

    BusanjinGu, Busan Gwang'Yeogsi, 47392

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi, 06351

  • Chonnam National University Hwasun Hospital

    HwasunGun, Jeonnam-Gwangju S.M. City, 58128

  • Gyeongsang National University Hospital

    Jinju, Gyeongsangnam-do, 52727

  • The Catholic University of Korea, Seoul St Marys Hospital

    SeochoGu, Seoul Teugbyeolsi, 06591

  • Severance Hospital Yonsei University Health System

    SeodaemunGu, Seoul Teugbyeolsi, 03722

  • Dong A University Hospital

    Seogu, Busan Gwang'Yeogsi, 49201

  • Pusan National University Hospital

    Seogu, Busan Gwang'Yeogsi, 49241

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080

  • Asan Medical Center

    SongpaGu, Seoul Teugbyeolsi, 05505

  • Soon Chun Hyang University Hospital Seoul

    YongsanGu, Seoul Teugbyeolsi, 04401

Other trials in South Korea

Canada10 sites

  • Ciusss Du Saguenay Lac St Jean

    Chicoutimi, Quebec, G7H 5H6

  • Queen Elizabeth Ii Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

  • Ciusss de Lest de Lile de Montreal Hopital Maisonneuve Rosemont

    Montreal, Quebec, H1T 2M4

  • Chu de Quebec Universite Laval, Hopital de Lenfant Jesus, Centre Integre de Cancerologie (Cic)

    Québec, Quebec, G1J 1Z4

  • Unite de Recherche Clinique Du Cisss Des Laurentides

    SaintJerome, Quebec, J7Z 5T3

  • Ciusss de Lestrie Chus

    Sherbrooke, Quebec, J1H 5N4

  • Newfoundland and Labrador Health Services

    St. John's, Newfoundland and Labrador, A1B 3V6

  • British Columbia Cancer Agency the Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Italy10 sites

  • Cro Irccs Aviano

    Aviano, 33081

  • Irccs Azienda Ospedaliero Universitaria Bologna

    Bologna, 40138

  • Aou Careggi, Servizio Sanitario Toscana

    Florence, 50134

  • Istituto Europeo Di Oncologia

    Milan, 20141

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • Aou Maggiore Della Carita

    Novara, 28100

  • Azienda Ospedaliera Di Padova

    Padova, 35128

  • Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi

    Pavia, 27100

  • Arcispedale S Maria Nuova Ausl Reggio Emilia Hematology Unit

    Reggio Emilia, 42123

  • Aou Santa Maria Della Misericordia Di Udine

    Udine, 33100

Other trials in Italy

Poland9 sites

  • Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela

    Bydgoszcz, 85-168

  • Uniwersyteckie Centrum Kliniczne Klinika Hematologii I Transplantologii

    Gdansk, 80-214

  • Pratia Onkologia Katowice

    Katowice, 40-519

  • Pratia McM Krakow

    Krakow, 30-727

  • Uniwersytecki Szpital Kliniczny W Poznaniu

    Poznan, 61-131

  • Wojewodzki Szpital Zespolony Im L Rydygiera W Toruniu

    Torun, 87-100

  • Centralny Szpital Kliniczny Uck Wum

    Warsaw, 02-097

  • Instytut Hematologii I Transfuzjologii W Warszawie

    Warsaw, 02-776

  • Narodowy Instytut Onkologii Im Marii Sklodowskiej Curie W Warszawie

    Warsaw, 02-781

Other trials in Poland

United Kingdom9 sites

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • The Christie Hospital

    Greater Manchester, M20 4BX

  • Huddersfield Royal Infirmary

    Huddersfield, HD3 3EA

  • Nhs Highland

    Inverness, IV2 3BW

  • The Leeds Teaching Hospitals Nhs Trust

    Leeds, LS9 7TF

  • Barts Health Nhs Trust

    London, EC1A 7BE

  • University College Hospital

    London, NW1 2PG

  • Derriford Hospital

    Plymouth, PL6 8DH

  • Southampton General Hospital

    Southampton, SO16 6YD

Other trials in United Kingdom

France8 sites

  • Hopital Prive Dantony Departement Dhemathologie

    Antony, 92160

  • Centre Hospitalier Le Mans

    Le Mans, 72037

  • Chu Montpellier Hopital Saint Eloi

    Montpellier, 34090

  • Hopital Larchet 2 Chu Nice

    Nice, 06200

  • Institut Curie

    Paris, 75005

  • Necker University Hospital

    Paris, 75015

  • Hopitaux Universitaires de Strasbourg Hopital de Hautepierre (Ancien Icans)

    Strasbourg, 67200

  • Chu Nancy Hopital Brabois

    VandoeuvrelesNancy, 54511

Other trials in France

Israel7 sites

  • Assuta Ashdod Medical Center

    Ashdod, 7747629

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Hadassah En Karem Medical Center

    Jerusalem, 9112001

  • Rabin Medical Center

    Petah Tikva, 49100

  • Chaim Sheba Medical Center

    Ramat Gan, 5265601

  • Assuta Medical Center

    Tel Aviv, 60000

  • Sourasky Tel Aviv Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Austria5 sites

  • Medizinische Universitatsklinik Innsbruck

    Innsbruck, 6020

  • Uk St Poelten

    Sankt Pölten, 3100

  • Medical Univeristy Vienna

    Vienna, 1090

  • Hanusch Krankenhaus

    Vienna, 1140

  • Wiener Gesundheitsverbund Klinik Ottakring

    Vienna, 1160

Other trials in Austria

Turkey (Türkiye)5 sites

  • Ankara University Medical Faculty

    Ankara, 06620

  • Gazi University Medical School

    AOCiftlii, 06560

  • Bagcilar Medipol Mega Hospital

    Istanbul, 34214

  • Kocaeli Universitesi Tip Fakultesi

    Kocaeli, 41380

  • Vkv American Hospital

    Tevikiye, 34365

Other trials in Turkey (Türkiye)

Belgium4 sites

  • Institut Jules Bordet

    Anderlecht, 1070

  • Az Sint Jan Brugge

    Bruges, 8000

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • University Hospitals Leuven

    Leuven, 3000

Other trials in Belgium

Romania4 sites

  • Coltea Clinical Hospital

    Bucharest, 30171

  • Institutul Oncologic Prof Dr Ion Chiricuta Cluj Napoca

    ClujNapoca, 400015

  • Institutul Regional de Oncologie Iasi

    Iași, 700483

  • Spitalul Clinic Judetean de Urgenta Bihor

    Oradea, 410469

Other trials in Romania

Greece3 sites

  • University Hospital of Alexandroupolis

    Alexandroupoli, 68100

  • Evaggelismos

    Athens, 106 76

  • University Hospital of Patra

    Pátrai, 26504

Other trials in Greece

Portugal3 sites

  • Hospital de Braga

    Braga, 4710-243

  • Instituto Portugues de Oncologia Do Porto Francisco Gentil, Epe

    Porto, 4200-072

  • Unidade Local de Saude Gaia E Espinho

    VILA NOVA de GAIA Porto, 4434-502

Other trials in Portugal

Switzerland3 sites

  • Hfr Fribourg

    Fribourg, 1708

  • Reseau Hospitalier Neuchatelois

    La ChauxdeFonds, 2300

  • Universitatsspital Zurich

    Zurich, 8091

Other trials in Switzerland

Argentina2 sites

  • Hospital Aleman

    Caba, 1425

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma Buenos Aires, 1413

Other trials in Argentina

Bulgaria2 sites

  • Acibadem City Clinic Tokuda Umhat Ead, Department of Medical Oncology

    Sofia, 1407

  • NHATHD

    Sofia, 1756

Other trials in Bulgaria

Czechia2 sites

  • Fakultni Nemocnice Hradec Kralove

    Hradec Králové, 500 03

  • Fakultni Nemocnice Olomouc

    Olomouc, 77900

Other trials in Czechia

Germany2 sites

  • Universitaetsklinikum Essen

    Essen, 45147

  • Universitaetsklinikum Ulm

    Ulm, 89081

Other trials in Germany

Ireland2 sites

  • St Jamess Hospital

    Dublin, D08 NHY1

  • University Hospital Waterford

    Waterford, X91 ER8E

Other trials in Ireland

Puerto Rico2 sites

  • Pan American Oncology Trials, Llc

    Rio Piedras, 00935

  • Auxilio Mutuo Cancer Center

    San Juan, 00917

Other trials in Puerto Rico

South Africa2 sites

  • Haemalife

    Kuils River, 7579

  • Alberts Cellular Therapy

    Pretoria, '0181

Other trials in South Africa

Georgia1 site

  • JSC VIAN

    Kutaisi, 4600

Other trials in Georgia

About this study

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

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.

Read the 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.

Being tested
Zanubrutinib, Rituximab, Lenalidomide, Obinutuzumab
Keywords
Zanubrutinib, BGB-3111, Rituximab, Lenalidomide, Obinutuzumab
Medical subject headings
Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ZanubrutinibDrug

    Also called BGB-3111, Brukinsa

    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.

  • RituximabDrug

    Also called Rituxan, MabThera, Ruxience, Truxima

    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.

  • LenalidomideDrug

    Also called Revlimid

    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.

  • ObinutuzumabDrug

    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.

Study groups in NCT05100862
Study groupRoleWhat they receive
Follicular Lymphoma Arm A: Zanubrutinib plus ObinutuzumabExperimentalParticipants 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.
Receives: Drug: Zanubrutinib; Drug: Obinutuzumab
Follicular Lymphoma Arm B: Lenalidomide plus RituximabActive comparatorParticipants will receive lenalidomide and rituximab.
Receives: Drug: Rituximab; Drug: Lenalidomide
Marginal Zone Lymphoma Arm C: Zanubrutinib plus RituximabExperimentalParticipants 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.
Receives: Drug: Zanubrutinib; Drug: Rituximab
Marginal Zone Lymphoma Arm D: Lenalidomide plus RituximabActive comparatorParticipants will receive lenalidomide and rituximab.
Receives: Drug: Rituximab; Drug: Lenalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival As Determined By A Blinded Independent Review Committee (BIRC)

    Measured: Approximately 78 months

Secondary outcomes (11)

  1. Progression-free Survival As Determined By Investigator Assessment

    Measured: Approximately 87 months

  2. Duration Of Response As Determined By BIRC And By Investigator Assessment

    Measured: Approximately 87 months

  3. Overall Response Rate As Determined By BIRC And By Investigator Assessment

    Measured: Approximately 87 months

  4. Complete Response Rate As Determined By BIRC And By Investigator Assessment

    Measured: Approximately 87 months

  5. Time To Response As Determined By BIRC And By Investigator Assessment

    Measured: Approximately 87 months

  6. Time to Next Ant-Lymphoma Treatment

    Measured: Approximately 87 months

  7. Overall Survival

    Measured: Approximately 87 months

  8. 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.

    Measured: Approximately 87 months

  9. 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.

    Measured: Approximately 87 months

  10. 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.

    Measured: Approximately 87 months

  11. Number of Participants Experiencing Adverse Events (AEs)

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2021
  2. Study start10 Mar 2022
  3. Primary completionJul 2028 (estimated)
  4. Study completionJun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
799 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05100862
Sponsor's protocol ID
BGB-3111-308
Other IDs
CTR20232545, 2022-502548-12-00
Acronym
MAHOGANY
Status last verified
Sep 2026
First submitted
27 Sep 2021
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zanubrutinib, Rituximab and Lenalidomide in people with Relapsed/Refractory Follicular Lymphoma and Marginal Zone Lymphoma, run by BeOne Medicines at 264 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 264 sites in United States, China, Brazil, Australia, Spain and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival As Determined By A Blinded Independent Review Committee (BIRC) (time frame: Approximately 78 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05100862.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.

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