AzTrials
AzTrials

Mantle Cell Lymphoma; Non-Hodgkin LymphomaPhase 3MANGROVENCT04002297

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

A Phase 3 study testing zanubrutinib, bendamustine and rituximab in people with Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, run by BeOne Medicines at 176 sites in 22 countries.

Active, not recruiting

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

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
zanubrutinib, bendamustine and rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
510 participants
Where
176 sitesin 22 countries
Study dates
20 Aug 2019to 30 Sep 2031
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥70 years of age at the time of informed consent, OR ≥60 and <70 years of age with comorbidities precluding autologous stem cell transplantation
  • Histologically confirmed diagnosis of MCL
  • No prior systemic treatments for MCL
  • Measurable disease by CT/MRI
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Adequate marrow and organ function

Who cannot join

  • Known central nervous system involvement by lymphoma
  • Participants for whom the goal of therapy is tumor debulking prior to stem cell transplant
  • Clinically significant cardiovascular disease
  • History of severe bleeding disorder
  • Unable to swallow capsules or disease significantly affecting gastrointestinal function
  • Active fungal, bacterial and/or viral infection requiring systemic therapy
  • Requires ongoing treatment with a strong CYP3A inhibitor or inducer
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

176 sites in 22 countries.

176 sites in 22 countries

China27 sites

  • Peking University Peoples Hospital

    Beijing, Beijing Municipality, 100044

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Jilin Cancer Hospital

    Changchun, Jilin, 130021

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong, 510080

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006

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

    Nanjing, Jiangsu, 210008

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

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

    Ningbo, Zhejiang, 315000

  • Quanzhou First Affliated Hospital of Fujian Medical University

    Quanzhou, Fujian, 362000

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

  • Institute of Hematology and Hospital of Blood Disease

    Tianjin, Tianjin Municipality, 300020

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000

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

    Wuhan, Hubei, 430030

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

Other trials in China

Japan16 sites

  • Chiba Cancer Center

    Chiba, Chiba, 260-8717

  • National Cancer Center Hospital

    Chuoku, Tokyo, 104-0045

  • Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital

    Hiroshima, Hiroshima, 730-8619

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, Kumamoto, 860-0008

  • Kurashiki Central Hospital

    Kurashikishi, Okayama-ken, 710-8602

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011

  • University Hospital, Kyoto Prefectural Univ of Medicine

    Kyoto, Kyoto, 602-8566

  • National Hospital Organization Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001

  • National Hospital Organization Okayama Medical Center

    Okayama, Okayama-ken, 701-1192

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, 545-8586

  • Osaka Red Cross Hospital

    Osakashi, Osaka, 543-8555

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Tokyo Medical and Dental University Hospital

    Tokyo, Tokyo, 113-8519

  • Toyohashi Municipal Hospital

    Toyohashi, Aichi-ken, 441-8570

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515

  • Yokohama Municipal Citizens Hospital

    Yokohama, 221-0855

Other trials in Japan

Australia15 sites

  • Flinders Medical Centre

    Bedford PK, South Australia, 5042

  • Sunshine Coast Hospital and Health Service

    Birtinya, Queensland, 4575

  • Monash Health

    Clayton, Victoria, 3168

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • The Tweed Valley Hospital

    Cudgen, New South Wales, 2487

  • Saint Vincents Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Peninsula Private Hospital

    Frankston, Victoria, 3199

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Barwon Health the Geelong Hospital

    Geelong, Victoria, 3220

  • Gosford Hospital

    Gosford, New South Wales, 2250

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Icon Cancer Foundation

    South Brisbane, Queensland, 4101

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

Other trials in Australia

France14 sites

  • Centre de Lutte Contre Le Cancer Institut Bergonie

    Bordeaux, 33076

  • Chru de Brest Hospital Morvan

    Brest, 29200

  • Chu Dijon

    Dijon, J4V 2H1

  • Chu Grenoble Alpes

    Grenoble, 38043

  • Centre Hospitalier Le Mans

    Le Mans, 72037

  • Hopital Claude Huriez Chu Lille

    Lille, 59000

  • Institut Paoli Calmettes

    Marseille, 13009

  • Centre Hospitalier Universitaire Nantes Hotel Dieu

    Nantes, 44093

  • Institut Curie

    Paris, 75005

  • Necker University Hospital

    Paris, 75015

  • Chu Hopital Lyon Sud

    PierreBenite, 69495

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

    Poitiers, 86000

  • Ch Cornouaille

    Quimper, 29000

  • Iuc Toulouse Oncopole

    Toulouse, 31059

Other trials in France

Italy13 sites

  • Azienda Ospedaliera Nazionale Ssantonio E Biagio E Cesare Arrigo

    Alessandria, 15121

  • Policlinico Sorsola Malpighi, Aou Di Bologna

    Bologna, 40138

  • Azienda Ospedaliera Universitaria San Martino

    Genova, 16132

  • Niguarda Cancer Center Division of Hematology

    Milan, 20162

  • Aou Maggiore Della Carita

    Novara, 28100

  • Aoor Villa Sofia Cervello

    Palermo, 90146

  • Aou Pisana, Stabilimento Di Santa Chiara

    Pisa, 56126

  • Unita Di Ematologia, Dipartimento Di Ematologia Ed Oncologia

    Ravenna, 48121

  • Azienda Unita Sanitaria Locale Irccs

    Reggio Emilia, 42123

  • Universita Degli Studi La Sapienza

    Roma, 00161

  • Aou Senese Policlinico Santa Maria Alle Scotte

    Siena, 53100

  • Ao Citta Della Salute E Della Scienza Di Torino Presidio O

    Torino, 10126

  • University of Verona

    Verona, 37142

Other trials in Italy

United States12 sites

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Beth Israel Deaconess Medical Center (Bidmc)

    Boston, Massachusetts, 02215-5400

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410

  • Icahn School of Medicine At Mount Sinai

    New York, New York, 10029

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Clinical Research Alliance, Inc

    Westbury, New York, 11590

Other trials in United States

Poland12 sites

  • Szpital Uniwersytecki Nr Im Dr Jana Biziela

    Bydgoszcz, 85-168

  • Silesian Healthy Blood Clinic

    Chorzów, 41-503

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952

  • Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii

    Gdask, 80-219

  • Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia

    Gdynia, 81-519

  • Pratia McM Krakow

    Krakow, 30-727

  • Wojewodzki Szpital Specjalistyczny W Legnicy

    Legnica, 59-220

  • Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

    Lodz, 93-510

  • Centrum Onkologii Ziemi Lubelskiej

    Lublin, 20-090

  • Specjalistyczny Szpital Im Dr Alfreda Sokolowskiego

    Wałbrzych, 58-309

  • Instytut Hematologii I Transfuzjologii W Warszawie

    Warsaw, 02-776

  • Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu

    Wroclaw, 50-556

Other trials in Poland

Spain10 sites

  • Hospital Universitario Vall Dhebron

    Barcelona, 08035

  • Institut Catala Doncologia

    Barcelona, 08908

  • Ico Hug Trias I Pujol

    Barcelona, 08916

  • Ico Girona

    Girona, 17007

  • Hospital Universitario Gregorio Maranon

    Madrid, 28009

  • Md Anderson Cancer Center Madrid Spain

    Madrid, 28033

  • Start Madrid Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Regional Universitario de Malaga

    Málaga, 29010

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

Other trials in Spain

Belgium6 sites

  • Az Sint Jan Brugge

    Bruges, 8000

  • Universitair Ziekenhuis Brussel

    Brussels, 1090

  • Uz Antwerpen

    Edegem, 2650

  • Az Groeninge Campus Loofstraat

    Kortrijk, 8500

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

    Liège, 4000

  • Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne

    Yvoir, 5530

Other trials in Belgium

Ireland6 sites

  • Cork University Hospital

    Cork, t12DC4A

  • Mater Misericordiae University Hospital

    Dublin, D7

  • St Jamess Hospital

    Dublin, D8

  • University Hospital Galway

    Galway, H91 YR71

  • University Hospital Limerick

    Limerick, V94F858

  • University Hospital Waterford

    Waterford, X91 ER8E

Other trials in Ireland

Netherlands6 sites

  • Admiraal de Ruijter Ziekenhuis

    Goes, 4462 RA

  • University of Medical Center Groningen (Umcg)

    Groningen, 9713 GZ

  • St Antonius Ziekenhuis, Randd Interne Geneeskunde (F)

    Nieuwegein, 3435 CM

  • Albert Schweitzer Ziekenhuis

    Nijmegen, 6525 GA

  • Erasmus Mc

    Rotterdam, 3015 GD

  • Hagaziekenhuis

    The Hague, 2545 CH

Other trials in Netherlands

Turkey (Türkiye)6 sites

  • Dr Abdurrahman Yurtaslan Oncology Teaching and Research Hospital

    Ankara, 06620

  • Hematoloji Ve Hematolik Onkoloji Tani Ve Tedavi Merezi

    Ankara, 06700

  • Gazi University

    Ankara, 6500

  • Tr Trakya University Health Research and Application Center (Hospital)

    Edirne, 22030

  • Vkv American Hospital

    Istanbul, 34365

  • Mersin Universitesi Tip Fakultesi Hastanesi

    Mersin, 33000

Other trials in Turkey (Türkiye)

Germany5 sites

  • Uniklinik Koln (Aor)

    Cologne, 50937

  • Universitatsklinikum Heidelberg

    Heidelberg, 69120

  • Dept of Medicine Iii, University Hospitallmu

    Munich, 81377

  • Universitaetsklinikum Ulm, Innere Medizin Iii

    Ulm, 89081

  • Petrus Krankenhaus Wuppertal

    Wuppertal, 42283

Other trials in Germany

Portugal4 sites

  • Instituto Portugues Oncologia de Lisboa Francisco Gentil, Epe

    Lisbon, 1099-023

  • Chuln Hospital de Santa Maria

    Lisbon, 1649-035

  • Centro Hospitalar Universitario Porto

    Porto, 4099-001

  • Instituto Portugues de Oncologia Do Porto Francisco Gentil, Epe

    Porto, 4200-072

Other trials in Portugal

Russia4 sites

  • Clinical Hospital, Sp Botkin

    Moscow, Moscow, 125284

  • Gbuz Mmcc Kommunarka Dzm

    Moscow, 142770

  • Fgu Russian Scientific Research Institute of Hematology and Transfusiology

    Saint Petersburg, Sankt-Peterburg, 191024

  • Leningrad Regional Clinic and Hospital

    Saint Petersburg, Sankt-Peterburg, 194291

Other trials in Russia

Ukraine4 sites

  • Cherkasy Regional Oncology Dispensary

    Cherkasy, 18009

  • Municipal Non Profit Enterprise City Clinical Hospital

    Dnipro, 49102

  • National Cancer Institute

    Kiev, 3022

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

    Lviv, 79044

Other trials in Ukraine

United Kingdom4 sites

  • Aneurin Bevan University Health Board

    Abergavenny, NP7 7EG

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS

  • Russells Hall Hopsital

    Dudley, DY1 2HQ

  • Royal Marsden Nhs Foundation Royal Marsden Hospital

    Sutton, SM2 5PT

Other trials in United Kingdom

Austria3 sites

  • Ordensklinikum Linz Gmbh Elisabethinen

    Linz, 4020

  • Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg

    Salzburg, 5020

  • Medical University Vienna Oncology

    Vienna, 1090

Other trials in Austria

Taiwan3 sites

  • National Cheng Kung University Hospital

    Tainan, 704

  • Chi Mei Hospital Liouying

    Tainan, 736

  • Tri Service General Hospital

    Taipei, 114

Other trials in Taiwan

Canada2 sites

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8M2

  • Ciusss de Lestrie Chus

    Sherbrooke, Quebec, J1H 5N4

Other trials in Canada

New Zealand2 sites

  • Christchurch Hospital (Canterbury Health Laboratories)

    Christchurch, 8011

  • Tauranga Hospital

    Tauranga, 3112

Other trials in New Zealand

Romania2 sites

  • Institutul Clinic Fundeni

    Bucharest, 022328

  • Institutul Regional de Oncologie Iasi

    Iași, 700483

Other trials in Romania

About this study

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

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.

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, bendamustine, rituximab
Keywords
MCL, NHL, BTKi
Medical subject headings
Lymphoma, Mantle-Cell, Lymphoma, Non-Hodgkin

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

    Administered as two 80 mg capsules by mouth twice a day

  • bendamustineDrug

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

  • rituximabDrug

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

Study groups in NCT04002297
Study groupRoleWhat they receive
Arm A: zanubrutinib plus rituximabExperimentalParticipants will receive zanubrutinib plus rituximab, followed by zanubrutinib monotherapy until Independent Review Committee (IRC)-confirmed disease progression.
Receives: Drug: zanubrutinib; Drug: rituximab
Arm B: bendamustine plus rituximabActive comparatorParticipants will receive bendamustine plus rituximab, followed by observation.
Receives: Drug: bendamustine; Drug: rituximab

What is being measured

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

  1. 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.

    Measured: Up to approximately 7 years

Secondary outcomes (9)

  1. 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.

    Measured: Up to approximately 7 years

  2. 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.

    Measured: Up to approximately 7 years

  3. 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.

    Measured: Up to approximately 7 years

  4. Overall survival (OS)

    OS is defined as the time from randomization to the date of death due to any reason.

    Measured: Up to approximately 7 years

  5. 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.

    Measured: Up to approximately 7 years

  6. 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.

    Measured: Up to approximately 7 years

  7. 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.

    Measured: Up to approximately 7 years

  8. 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).

    Measured: Up to approximately 7 years

  9. 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.

    Measured: Up to approximately 7 years

Timeline

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

  1. First posted28 Jun 2019
  2. Study start20 Aug 2019
  3. Primary completion27 Apr 2026
  4. Study completion30 Sep 2031 (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
510 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04002297
Sponsor's protocol ID
BGB-3111-306
Other IDs
2019-000413-36, CTR20211594, 2023-509908-15-00, 2023, 2019
Acronym
MANGROVE
Status last verified
Sep 2026
First submitted
27 Jun 2019
Last updated
30 Sep 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.

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.

    PubMed 32985902

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing zanubrutinib, bendamustine and rituximab in people with Mantle Cell Lymphoma; Non-Hodgkin Lymphoma, run by BeOne Medicines at 176 sites in 22 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 6 inclusion and 8 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 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 176 sites in China, Japan, Australia, France, Italy and 17 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 (PFS) determined by independent central review (time frame: Up to approximately 7 years). 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 NCT04002297, which also lists 1 linked publication.

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 30 Sep 2026.

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