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 (MANGROVE)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Mantle Cell Lymphoma; Non-Hodgkin Lymphoma
• Intervention / Treatment: Drug: zanubrutinib; Drug: rituximab; Drug: bendamustine

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 510
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia, 2605
      • Canberra Hospital
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital
    • Cudgen, New South Wales, Australia, 2487
      • The Tweed Valley Hospital
    • Darlinghurst, New South Wales, Australia, 2010
      • Saint Vincents Hospital Sydney
    • Gosford, New South Wales, Australia, 2250
      • Gosford Hospital
    • Waratah, New South Wales, Australia, 2298
      • Calvary Mater Newcastle
  • Queensland
    • Birtinya, Queensland, Australia, 4575
      • Sunshine Coast Hospital and Health Service
    • South Brisbane, Queensland, Australia, 4101
      • Icon Cancer Foundation
  • South Australia
    • Bedford PK, South Australia, Australia, 5042
      • Flinders Medical Centre
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Royal Hobart Hospital
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Health
    • Fitzroy, Victoria, Australia, 3065
      • St Vincents Hospital Melbourne
    • Frankston, Victoria, Australia, 3199
      • Peninsula Private Hospital
    • Geelong, Victoria, Australia, 3220
      • Barwon Health the Geelong Hospital
  • Western Australia
    • Perth, Western Australia, Australia, 6000
      • Royal Perth Hospital
• Austria
  • Linz, Austria, 4020
    • Ordensklinikum Linz GmbH Elisabethinen
  • Salzburg, Austria, 5020
    • Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg
  • Vienna, Austria, 1090
    • Medical University Vienna Oncology
• Belgium
  • Bruges, Belgium, 8000
    • AZ Sint Jan Brugge
  • Brussels, Belgium, 1090
    • Universitair Ziekenhuis Brussel
  • Edegem, Belgium, 2650
    • UZ Antwerpen
  • Kortrijk, Belgium, 8500
    • Az Groeninge Campus Loofstraat
  • Liège, Belgium, 4000
    • Centre Hospitalier Universitaire (Chu) de Liege Site Du Sart Tilman
  • Yvoir, Belgium, 5530
    • Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne
• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8M2
      • The Ottawa Hospital
  • Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Ciusss de Lestrie Chus
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100050
      • Beijing Friendship Hospital, Capital Medical University
    • Beijing, Beijing Municipality, China, 100044
      • Peking University Peoples Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Medical University Union Hospital
    • Quanzhou, Fujian, China, 362000
      • Quanzhou First Affliated Hospital of Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial Peoples Hospital
    • Guangzhou, Guangdong, China, 510515
      • Nanfang Hospital of Southern Medical University
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat Sen University Cancer Center
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Harbin medical university cancer hospital
  • Henan
    • Zhengzhou, Henan, China, 450000
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital of Tongji Medical College Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School
    • Xuzhou, Jiangsu, China, 221000
      • The Affiliated Hospital of Xuzhou Medical University
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital of Nanchang University Branch Donghu
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
    • Changchun, Jilin, China, 130021
      • Jilin Cancer Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital Of China Medical University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200000
      • Fudan University Shanghai Cancer Center
    • Shanghai, Shanghai Municipality, China, 200120
      • Shanghai East Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Tianjin Medical University Cancer Institute and Hospital
    • Tianjin, Tianjin Municipality, China, 300020
      • Institute of Hematology and Hospital of Blood Disease
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830000
      • Affiliated Cancer Hospital of Xinjiang Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital, Zhejiang University School of Medicine
    • Ningbo, Zhejiang, China, 315000
      • Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No Hospital)
• France
  • Bordeaux, France, 33076
    • Centre de Lutte Contre Le Cancer Institut Bergonie
  • Brest, France, 29200
    • Chru de Brest Hospital Morvan
  • Dijon, France, J4V 2H1
    • CHU Dijon
  • Grenoble, France, 38043
    • CHU Grenoble Alpes
  • Le Mans, France, 72037
    • Centre Hospitalier Le Mans
  • Lille, France, 59000
    • Hopital Claude Huriez Chu Lille
  • Marseille, France, 13009
    • Institut Paoli Calmettes
  • Nantes, France, 44093
    • Centre Hospitalier Universitaire Nantes Hotel Dieu
  • Paris, France, 75005
    • Institut Curie
  • Paris, France, 75015
    • Necker University Hospital
  • PierreBenite, France, 69495
    • Chu Hopital Lyon Sud
  • Poitiers, France, 86000
    • Centre Hospitalier Universitaire de Poitier Hopital de La Miletrie Hopital Jean Bernard
  • Quimper, France, 29000
    • Ch Cornouaille
  • Toulouse, France, 31059
    • Iuc Toulouse Oncopole
• Germany
  • Cologne, Germany, 50937
    • Uniklinik Koln (Aor)
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg
  • Munich, Germany, 81377
    • Dept of Medicine Iii, University Hospitallmu
  • Ulm, Germany, 89081
    • Universitaetsklinikum Ulm, Innere Medizin Iii
  • Wuppertal, Germany, 42283
    • Petrus Krankenhaus Wuppertal
• Ireland
  • Cork, Ireland, t12DC4A
    • Cork University Hospital
  • Dublin, Ireland, D7
    • Mater Misericordiae University Hospital
  • Dublin, Ireland, D8
    • St Jamess Hospital
  • Galway, Ireland, H91 YR71
    • University Hospital Galway
  • Limerick, Ireland, V94F858
    • University Hospital Limerick
  • Waterford, Ireland, X91 ER8E
    • University Hospital Waterford
• Italy
  • Alessandria, Italy, 15121
    • Azienda Ospedaliera Nazionale Ssantonio E Biagio E Cesare Arrigo
  • Bologna, Italy, 40138
    • Policlinico Sorsola Malpighi, Aou Di Bologna
  • Genova, Italy, 16132
    • Azienda Ospedaliera Universitaria San Martino
  • Milan, Italy, 20162
    • Niguarda Cancer Center Division of Hematology
  • Novara, Italy, 28100
    • AOU Maggiore della Carità
  • Palermo, Italy, 90146
    • Aoor Villa Sofia Cervello
  • Pisa, Italy, 56126
    • Aou Pisana, Stabilimento Di Santa Chiara
  • Ravenna, Italy, 48121
    • Unita Di Ematologia, Dipartimento Di Ematologia Ed Oncologia
  • Reggio Emilia, Italy, 42123
    • Azienda Unita Sanitaria Locale Irccs
  • Roma, Italy, 00161
    • Universita Degli Studi La Sapienza
  • Siena, Italy, 53100
    • Aou Senese Policlinico Santa Maria Alle Scotte
  • Torino, Italy, 10126
    • Ao Citta Della Salute E Della Scienza Di Torino Presidio O
  • Verona, Italy, 37142
    • University of Verona
• Japan
  • Yokohama, Japan, 221-0855
    • Yokohama Municipal Citizens Hospital
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 460-0001
      • National Hospital Organization Nagoya Medical Center
    • Toyohashi, Aichi-ken, Japan, 441-8570
      • Toyohashi Municipal Hospital
  • Chiba
    • Chiba, Chiba, Japan, 260-8717
      • Chiba Cancer Center
  • Fukuoka
    • Kurume, Fukuoka, Japan, 830-0011
      • Kurume University Hospital
  • Hiroshima
    • Hiroshima, Hiroshima, Japan, 730-8619
      • Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 241-8515
      • Kanagawa Cancer Center
  • Kumamoto
    • Kumamoto, Kumamoto, Japan, 860-0008
      • National Hospital Organization Kumamoto Medical Center
  • Kyoto
    • Kyoto, Kyoto, Japan, 602-8566
      • University Hospital, Kyoto Prefectural Univ of Medicine
  • Miyagi
    • Sendai, Miyagi, Japan, 980-8574
      • Tohoku University Hospital
  • Okayama-ken
    • Kurashikishi, Okayama-ken, Japan, 710-8602
      • Kurashiki Central Hospital
    • Okayama, Okayama-ken, Japan, 701-1192
      • National Hospital Organization Okayama Medical Center
  • Osaka
    • Osaka, Osaka, Japan, 545-8586
      • Osaka Metropolitan University Hospital
    • Osakashi, Osaka, Japan, 543-8555
      • Osaka Red Cross Hospital
  • Tokyo
    • Chuoku, Tokyo, Japan, 104-0045
      • National Cancer Center Hospital
    • Tokyo, Tokyo, Japan, 113-8519
      • Tokyo Medical and Dental University Hospital
• Netherlands
  • Goes, Netherlands, 4462 RA
    • Admiraal de Ruijter Ziekenhuis
  • Groningen, Netherlands, 9713 GZ
    • University of Medical Center Groningen (Umcg)
  • Nieuwegein, Netherlands, 3435 CM
    • St Antonius Ziekenhuis, Randd Interne Geneeskunde (F)
  • Nijmegen, Netherlands, 6525 GA
    • Albert Schweitzer Ziekenhuis
  • Rotterdam, Netherlands, 3015 GD
    • Erasmus MC
  • The Hague, Netherlands, 2545 CH
    • Hagaziekenhuis
• New Zealand
  • Christchurch, New Zealand, 8011
    • Christchurch Hospital (Canterbury Health Laboratories)
  • Tauranga, New Zealand, 3112
    • Tauranga Hospital
• Poland
  • Bydgoszcz, Poland, 85-168
    • Szpital Uniwersytecki Nr Im Dr Jana Biziela
  • Chorzów, Poland, 41-503
    • Silesian Healthy Blood Clinic
  • Gdansk, Poland, 80-952
    • Uniwersyteckie Centrum Kliniczne
  • Gdask, Poland, 80-219
    • Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii
  • Gdynia, Poland, 81-519
    • Szpitale Pomorskie spolka z ograniczona odpowiedzialnoscia
  • Krakow, Poland, 30-727
    • Pratia MCM Krakow
  • Legnica, Poland, 59-220
    • Wojewodzki Szpital Specjalistyczny w Legnicy
  • Lodz, Poland, 93-510
    • Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi
  • Lublin, Poland, 20-090
    • Centrum Onkologii Ziemi Lubelskiej
  • Warsaw, Poland, 02-776
    • Instytut Hematologii i Transfuzjologii w Warszawie
  • Wałbrzych, Poland, 58-309
    • Specjalistyczny Szpital Im Dr Alfreda Sokolowskiego
  • Wroclaw, Poland, 50-556
    • Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu
• Portugal
  • Lisbon, Portugal, 1099-023
    • Instituto Portugues Oncologia de Lisboa Francisco Gentil, Epe
  • Lisbon, Portugal, 1649-035
    • Chuln Hospital de Santa Maria
  • Porto, Portugal, 4200-072
    • Instituto Português de Oncologia do Porto Francisco Gentil, EPE
  • Porto, Portugal, 4099-001
    • Centro Hospitalar Universitario Porto
• Romania
  • Bucharest, Romania, 022328
    • Institutul Clinic Fundeni
  • Iași, Romania, 700483
    • Institutul Regional de Oncologie Iasi
• Russia
  • Moscow, Russia, 142770
    • Gbuz Mmcc Kommunarka Dzm
  • Moscow
    • Moscow, Moscow, Russia, 125284
      • Clinical Hospital, Sp Botkin
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russia, 191024
      • Fgu Russian Scientific Research Institute of Hematology and Transfusiology
    • Saint Petersburg, Sankt-Peterburg, Russia, 194291
      • Leningrad Regional Clinic and Hospital
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall dHebron
  • Barcelona, Spain, 08916
    • Ico Hug Trias I Pujol
  • Barcelona, Spain, 08908
    • Institut Catala Doncologia
  • Girona, Spain, 17007
    • ICO Girona
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28009
    • Hospital Universitario Gregorio Maranon
  • Madrid, Spain, 28040
    • Start Madrid Fundacion Jimenez Diaz
  • Madrid, Spain, 28033
    • Md Anderson Cancer Center Madrid Spain
  • Málaga, Spain, 29010
    • Hospital Regional Universitario de Malaga
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio
• Taiwan
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Tainan, Taiwan, 736
    • Chi Mei Hospital Liouying
  • Taipei, Taiwan, 114
    • Tri Service General Hospital
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06620
    • Dr Abdurrahman Yurtaslan Oncology Teaching and Research Hospital
  • Ankara, Turkey (Türkiye), 6500
    • Gazi University
  • Ankara, Turkey (Türkiye), 06700
    • Hematoloji Ve Hematolik Onkoloji Tani Ve Tedavi Merezi
  • Edirne, Turkey (Türkiye), 22030
    • Tr Trakya University Health Research and Application Center (Hospital)
  • Istanbul, Turkey (Türkiye), 34365
    • Vkv American Hospital
  • Mersin, Turkey (Türkiye), 33000
    • Mersin Universitesi Tip Fakultesi Hastanesi
• Ukraine
  • Cherkasy, Ukraine, 18009
    • Cherkasy Regional Oncology Dispensary
  • Dnipro, Ukraine, 49102
    • Municipal Non Profit Enterprise City Clinical Hospital
  • Kiev, Ukraine, 3022
    • National Cancer Institute
  • Lviv, Ukraine, 79044
    • Si Institute of Blood Pathology and Transfusion Medicine Nams of Ukraine, Hematology Department
• United Kingdom
  • Abergavenny, United Kingdom, NP7 7EG
    • Aneurin Bevan University Health Board
  • Birmingham, United Kingdom, B9 5SS
    • Birmingham Heartlands Hospital
  • Dudley, United Kingdom, DY1 2HQ
    • Russells Hall Hopsital
  • Sutton, United Kingdom, SM2 5PT
    • Royal Marsden Nhs Foundation Royal Marsden Hospital
• United States
  • California
    • Orange, California, United States, 92868
      • Chao Family Comprehensive Cancer Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02215-5400
      • Beth Israel Deaconess Medical Center (BIDMC)
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Comprehensive Cancer Centers of Nevada
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • Westbury, New York, United States, 11590
      • Clinical Research Alliance, Inc
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • West Penn Hospital
  • Texas
    • Houston, Texas, United States, 77030-4009
      • The University of Texas MD Anderson Cancer Center
    • Lubbock, Texas, United States, 79410
      • Joe Arrington Cancer Research and Treatment Center
  • Washington
    • Seattle, Washington, United States, 98109
      • Seattle Cancer Care Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

1. ≥70 years of age at the time of informed consent, OR ≥60 and <70 years of age with comorbidities precluding autologous stem cell transplantation
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

Key Exclusion Criteria:

1. Known central nervous system involvement by lymphoma
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

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: zanubrutinib plus rituximab; Participants will receive zanubrutinib plus rituximab, followed by zanubrutinib monotherapy until Independent Review Committee (IRC)-confirmed disease progression.	Drug: zanubrutinib; Administered as two 80 mg capsules by mouth twice a day; Other Names: Brukinsa; BGB-3111; Drug: rituximab; Administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6
Active Comparator: Arm B: bendamustine plus rituximab; Participants will receive bendamustine plus rituximab, followed by observation.	Drug: rituximab; Administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6; Drug: bendamustine; Administered intravenously at a dose of 90 mg/m2/day on Days 1 and 2 of Cycles 1 to 6

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival (PFS) determined by independent central review	PFS is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurs first.	Up to approximately 7 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS by investigator assessment	PFS is defined as the time from randomization to the date of first documentation of disease progression or death, whichever occurs first.	Up to approximately 7 years
Overall response rate (ORR)	ORR is defined as the percentage of participants who achieve a complete response (CR) or partial response (PR), determined by independent central review and by investigator assessment.	Up to approximately 7 years
Duration of response (DOR)	DOR, as determined by independent central review and by investigator assessment, and defined as the time from the date that response criteria are first met to the date that disease progression is objectively documented or death, whichever occurs first.	Up to approximately 7 years
Overall survival (OS)	OS is defined as the time from randomization to the date of death due to any reason.	Up to approximately 7 years
Time to Response (TTR)	TTR, as determined by independent central review and by investigator assessment, and defined as the time from randomization to the first documentation of response.	Up to approximately 7 years
Rate of complete response (CR) or complete metabolic response	Rate of CR or complete metabolic response is defined as the percentage of participants who achieve a CR or complete metabolic response, determined by independent central review and by investigator assessment.	Up to approximately 7 years
Participant-reported outcomes (PROs) as assessed by the European Quality of Life 5-Dimension 5 Level Questionnaire (EQ-5D-5L)	EuroQoL-Five Dimensions, Five Levels (EQ-5D-5L) is a generic, self-reported measure of utility that consists of a five-item descriptive system and a visual analogue scale (EQ VAS). The descriptive system involves five health dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Participants may choose from the following response levels: no problems=1; slight problems=2; moderate problems=3; severe problems=4; and unable to/extreme problems=5. Higher values indicate worst health.	Up to approximately 7 years
PROs as assessed by the European Organization for Research on Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)	The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 =Not at all (best) to 4 =Very Much (worst) and 2 questions answered on a 7-point scale where 1 =Very poor (worst) to 7 =Excellent (best).	Up to approximately 7 years
Number of participants with adverse events and serious adverse events	Number of participants with adverse events and serious adverse events, including laboratory values, vital signs, and physical examination findings.	Up to approximately 7 years

Collaborators and Investigators

• Sponsor: BeOne Medicines
• Investigators: Study Director: Study Director, BeOne Medicines

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2019
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 30, 2031

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: June 27, 2019
• First Posted (Actual): June 28, 2019

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: MCL, NHL, BTKi
• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Acids, Acyclic; Carboxylic Acids; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Butyrates; Antibodies, Monoclonal, Murine-Derived; Bendamustine Hydrochloride; Rituximab; zanubrutinib
• Other Study ID Numbers: BGB-3111-306; 2019-000413-36 (EudraCT Number); CTR20211594 (Registry Identifier: ChinaDrugTrials); 2023-509908-15-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.

BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.

Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No