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
NCT ID: NCT04002297
Last Updated: 2025-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
510 participants
INTERVENTIONAL
2019-08-20
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: zanubrutinib plus rituximab
Participants will receive zanubrutinib plus rituximab, followed by zanubrutinib monotherapy until Independent Review Committee (IRC)-confirmed disease progression.
zanubrutinib
Administered as two 80 mg capsules by mouth twice a day
rituximab
Administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6
Arm B: bendamustine plus rituximab
Participants will receive bendamustine plus rituximab, followed by observation.
bendamustine
Administered intravenously at a dose of 90 mg/m2/day on Days 1 and 2 of Cycles 1 to 6
rituximab
Administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6
Interventions
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zanubrutinib
Administered as two 80 mg capsules by mouth twice a day
bendamustine
Administered intravenously at a dose of 90 mg/m2/day on Days 1 and 2 of Cycles 1 to 6
rituximab
Administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Histologically confirmed diagnosis of MCL
3. No prior systemic treatments for MCL
4. Measurable disease by CT/MRI
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
6. Adequate marrow and organ function
Exclusion Criteria
2. Participants for whom the goal of therapy is tumor debulking prior to stem cell transplant
3. Clinically significant cardiovascular disease
4. History of severe bleeding disorder
5. Unable to swallow capsules or disease significantly affecting gastrointestinal function
6. Active fungal, bacterial and/or viral infection requiring systemic therapy
7. Requires ongoing treatment with a strong CYP3A inhibitor or inducer
60 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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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 City, , Taiwan
Chi Mei Hospital Liouying
Tainan City, , 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
Countries
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References
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Dreyling M, Tam CS, Wang M, Smith SD, Ladetto M, Huang H, Novotny W, Co M, Romano A, Holmgren E, Huang J, Gouill SL. A Phase III study of zanubrutinib plus rituximab versus bendamustine plus rituximab in transplant-ineligible, untreated mantle cell lymphoma. Future Oncol. 2021 Jan;17(3):255-262. doi: 10.2217/fon-2020-0794. Epub 2020 Sep 28.
Other Identifiers
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2019-000413-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CTR20211594
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-509908-15-00
Identifier Type: CTIS
Identifier Source: secondary_id
BGB-3111-306
Identifier Type: -
Identifier Source: org_study_id
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