Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT04002297
PHASE3

A Study to Investigate the Efficacy of Zanubrutinib Plus Rituximab Compared With Bendamustine Plus Rituximab in Adults With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation

Sponsor: BeiGene

View on ClinicalTrials.gov

Summary

This is a randomized study to compare the efficacy and safety of zanubrutinib plus rituximab versus bendamustine plus rituximab in previously untreated participants with mantle cell lymphoma (MCL) who are not eligible for stem cell transplantation.

Official title: A Phase 3 Randomized, Open-Label, Multicenter Study Comparing Zanubrutinib (BGB-3111) Plus Rituximab Versus Bendamustine Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

510

Start Date

2019-08-20

Completion Date

2027-12

Last Updated

2025-09-26

Healthy Volunteers

No

Interventions

DRUG

zanubrutinib

Administered as two 80 mg capsules by mouth twice a day

DRUG

bendamustine

Administered intravenously at a dose of 90 mg/m2/day on Days 1 and 2 of Cycles 1 to 6

DRUG

rituximab

Administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6

Locations (176)

Chao Family Comprehensive Cancer Center

Orange, California, United States

Rush University Medical Center

Chicago, Illinois, United States

Beth Israel Deaconess Medical Center (Bidmc)

Boston, Massachusetts, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Icahn School of Medicine At Mount Sinai

New York, New York, United States

Clinical Research Alliance, Inc

Westbury, New York, United States

Providence Portland Medical Center

Portland, Oregon, United States

West Penn Hospital

Pittsburgh, Pennsylvania, United States

The University of Texas Md Anderson Cancer Center

Houston, Texas, United States

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

Canberra Hospital

Garran, Australian Capital Territory, Australia

Concord Repatriation General Hospital

Concord, New South Wales, Australia

The Tweed Valley Hospital

Cudgen, New South Wales, Australia

Saint Vincents Hospital Sydney

Darlinghurst, New South Wales, Australia

Gosford Hospital

Gosford, New South Wales, Australia

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Sunshine Coast Hospital and Health Service

Birtinya, Queensland, Australia

Icon Cancer Foundation

South Brisbane, Queensland, Australia

Flinders Medical Centre

Bedford PK, South Australia, Australia

Royal Hobart Hospital

Hobart, Tasmania, Australia

Monash Health

Clayton, Victoria, Australia

St Vincents Hospital Melbourne

Fitzroy, Victoria, Australia

Peninsula Private Hospital

Frankston, Victoria, Australia

Barwon Health the Geelong Hospital

Geelong, Victoria, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Ordensklinikum Linz Gmbh Elisabethinen

Linz, Austria

Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg

Salzburg, Austria

Medical University Vienna Oncology

Vienna, Austria

Az Sint Jan Brugge

Bruges, Belgium

Universitair Ziekenhuis Brussel

Brussels, Belgium

Uz Antwerpen

Edegem, Belgium

Az Groeninge Campus Loofstraat

Kortrijk, Belgium

Centre Hospitalier Universitaire (Chu) de Liege Site Du Sart Tilman

Liège, Belgium

Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne

Yvoir, Belgium

The Ottawa Hospital

Ottawa, Ontario, Canada

Ciusss de Lestrie Chus

Sherbrooke, Quebec, Canada

Peking University Peoples Hospital

Beijing, Beijing Municipality, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Quanzhou First Affliated Hospital of Fujian Medical University

Quanzhou, Fujian, China

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong, China

Guangdong Provincial Peoples Hospital

Guangzhou, Guangdong, China

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

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

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University Branch Donghu

Nanchang, Jiangxi, China

Jilin Cancer Hospital

Changchun, Jilin, China

The First Hospital of Jilin University

Changchun, Jilin, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Institute of Hematology and Hospital of Blood Disease

Tianjin, Tianjin Municipality, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Affiliated Cancer Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No Hospital)

Ningbo, Zhejiang, China

Centre de Lutte Contre Le Cancer Institut Bergonie

Bordeaux, France

Chru de Brest Hospital Morvan

Brest, France

Chu Dijon

Dijon, France

Chu Grenoble Alpes

Grenoble, France

Centre Hospitalier Le Mans

Le Mans, France

Hopital Claude Huriez Chu Lille

Lille, France

Institut Paoli Calmettes

Marseille, France

Centre Hospitalier Universitaire Nantes Hotel Dieu

Nantes, France

Institut Curie

Paris, France

Necker University Hospital

Paris, France

Chu Hopital Lyon Sud

PierreBenite, France

Centre Hospitalier Universitaire de Poitier Hopital de La Miletrie Hopital Jean Bernard

Poitiers, France

Ch Cornouaille

Quimper, France

Iuc Toulouse Oncopole

Toulouse, France

Uniklinik Koln (Aor)

Cologne, Germany

Universitatsklinikum Heidelberg

Heidelberg, Germany

Dept of Medicine Iii, University Hospitallmu

Munich, Germany

Universitaetsklinikum Ulm, Innere Medizin Iii

Ulm, Germany

Petrus Krankenhaus Wuppertal

Wuppertal, Germany

Cork University Hospital

Cork, Ireland

Mater Misericordiae University Hospital

Dublin, Ireland

St Jamess Hospital

Dublin, Ireland

University Hospital Galway

Galway, Ireland

University Hospital Limerick

Limerick, Ireland

University Hospital Waterford

Waterford, Ireland

Azienda Ospedaliera Nazionale Ssantonio E Biagio E Cesare Arrigo

Alessandria, Italy

Policlinico Sorsola Malpighi, Aou Di Bologna

Bologna, Italy

Azienda Ospedaliera Universitaria San Martino

Genova, Italy

Niguarda Cancer Center Division of Hematology

Milan, Italy

Aou Maggiore Della Carita

Novara, Italy

Aoor Villa Sofia Cervello

Palermo, Italy

Aou Pisana, Stabilimento Di Santa Chiara

Pisa, Italy

Unita Di Ematologia, Dipartimento Di Ematologia Ed Oncologia

Ravenna, Italy

Azienda Unita Sanitaria Locale Irccs

Reggio Emilia, Italy

Universita Degli Studi La Sapienza

Roma, Italy

Aou Senese Policlinico Santa Maria Alle Scotte

Siena, Italy

Ao Citta Della Salute E Della Scienza Di Torino Presidio O

Torino, Italy

University of Verona

Verona, Italy

National Hospital Organization Nagoya Medical Center

Nagoya, Aichi-ken, Japan

Toyohashi Municipal Hospital

Toyohashi, Aichi-ken, Japan

Chiba Cancer Center

Chiba, Chiba, Japan

Kurume University Hospital

Kurume, Fukuoka, Japan

Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital

Hiroshima, Hiroshima, Japan

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

National Hospital Organization Kumamoto Medical Center

Kumamoto, Kumamoto, Japan

Tohoku University Hospital

Sendai, Miyagi, Japan

Kurashiki Central Hospital

Kurashikishi, Okayama-ken, Japan

Osaka Red Cross Hospital

Osakashi, Osaka, Japan

National Cancer Center Hospital

Chuoku, Tokyo, Japan

University Hospital, Kyoto Prefectural Univ of Medicine

Kyoto, Japan

National Hospital Organization Okayama Medical Center

Okayama, Japan

Osaka Metropolitan University Hospital

Osaka, Japan

Tokyo Medical and Dental University Hospital

Tokyo, Japan

Yokohama Municipal Citizens Hospital

Yokohama, Japan

Admiraal de Ruijter Ziekenhuis

Goes, Netherlands

University of Medical Center Groningen (Umcg)

Groningen, Netherlands

St Antonius Ziekenhuis, Randd Interne Geneeskunde (F)

Nieuwegein, Netherlands

Albert Schweitzer Ziekenhuis

Nijmegen, Netherlands

Erasmus Mc

Rotterdam, Netherlands

Hagaziekenhuis

The Hague, Netherlands

Christchurch Hospital (Canterbury Health Laboratories)

Christchurch, New Zealand

Tauranga Hospital

Tauranga, New Zealand

Szpital Uniwersytecki Nr Im Dr Jana Biziela

Bydgoszcz, Poland

Silesian Healthy Blood Clinic

Chorzów, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii

Gdask, Poland

Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia

Gdynia, Poland

Pratia McM Krakow

Krakow, Poland

Wojewodzki Szpital Specjalistyczny W Legnicy

Legnica, Poland

Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

Lodz, Poland

Centrum Onkologii Ziemi Lubelskiej

Lublin, Poland

Instytut Hematologii I Transfuzjologii W Warszawie

Warsaw, Poland

Specjalistyczny Szpital Im Dr Alfreda Sokolowskiego

Wałbrzych, Poland

Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu

Wroclaw, Poland

Instituto Portugues Oncologia de Lisboa Francisco Gentil, Epe

Lisbon, Portugal

Chuln Hospital de Santa Maria

Lisbon, Portugal

Centro Hospitalar Universitario Porto

Porto, Portugal

Instituto Portugues de Oncologia Do Porto Francisco Gentil, Epe

Porto, Portugal

Institutul Clinic Fundeni

Bucharest, Romania

Institutul Regional de Oncologie Iasi

Iași, Romania

Clinical Hospital, Sp Botkin

Moscow, Moscow, Russia

Fgu Russian Scientific Research Institute of Hematology and Transfusiology

Saint Petersburg, Sankt-Peterburg, Russia

Leningrad Regional Clinic and Hospital

Saint Petersburg, Sankt-Peterburg, Russia

Gbuz Mmcc Kommunarka Dzm

Moscow, Russia

Hospital Universitario Vall Dhebron

Barcelona, Spain

Institut Catala Doncologia

Barcelona, Spain

Ico Hug Trias I Pujol

Barcelona, Spain

Ico Girona

Girona, Spain

Hospital Universitario Gregorio Maranon

Madrid, Spain

Md Anderson Cancer Center Madrid Spain

Madrid, Spain

Start Madrid Fundacion Jimenez Diaz

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Regional Universitario de Malaga

Málaga, Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain

National Cheng Kung University Hospital

Tainan, Taiwan

Chi Mei Hospital Liouying

Tainan, Taiwan

Tri Service General Hospital

Taipei, Taiwan

Dr Abdurrahman Yurtaslan Oncology Teaching and Research Hospital

Ankara, Turkey (Türkiye)

Hematoloji Ve Hematolik Onkoloji Tani Ve Tedavi Merezi

Ankara, Turkey (Türkiye)

Gazi University

Ankara, Turkey (Türkiye)

Tr Trakya University Health Research and Application Center (Hospital)

Edirne, Turkey (Türkiye)

Vkv American Hospital

Istanbul, Turkey (Türkiye)

Mersin Universitesi Tip Fakultesi Hastanesi

Mersin, Turkey (Türkiye)

Cherkasy Regional Oncology Dispensary

Cherkasy, Ukraine

Municipal Non Profit Enterprise City Clinical Hospital

Dnipro, Ukraine

National Cancer Institute

Kiev, Ukraine

Si Institute of Blood Pathology and Transfusion Medicine Nams of Ukraine, Hematology Department

Lviv, Ukraine

Aneurin Bevan University Health Board

Abergavenny, United Kingdom

Birmingham Heartlands Hospital

Birmingham, United Kingdom

Russells Hall Hopsital

Dudley, United Kingdom

Royal Marsden Nhs Foundation Royal Marsden Hospital

Sutton, United Kingdom