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New hope for lymphoma patients who Can't have transplants

NCT ID NCT04002297

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a new drug combination (zanubrutinib plus rituximab) works better than standard chemotherapy (bendamustine plus rituximab) for people with untreated mantle cell lymphoma who cannot have a stem cell transplant. About 510 participants will be randomly assigned to one of the two treatments. The main goal is to see how long the cancer stays under control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

510 people

The number who actually took part.

Started

Aug 2019

Expected to finish

Sep 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Admiraal de Ruijter Ziekenhuis

    Goes, 4462 RA, Netherlands

  • Affiliated Cancer Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000, China

  • Albert Schweitzer Ziekenhuis

    Nijmegen, 6525 GA, Netherlands

  • Aneurin Bevan University Health Board

    Abergavenny, NP7 7EG, United Kingdom

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

    Torino, 10126, Italy

  • Aoor Villa Sofia Cervello

    Palermo, 90146, Italy

  • Aou Maggiore Della Carita

    Novara, 28100, Italy

  • Aou Pisana, Stabilimento Di Santa Chiara

    Pisa, 56126, Italy

  • Aou Senese Policlinico Santa Maria Alle Scotte

    Siena, 53100, Italy

  • Az Groeninge Campus Loofstraat

    Kortrijk, 8500, Belgium

  • Az Sint Jan Brugge

    Bruges, 8000, Belgium

  • Azienda Ospedaliera Nazionale Ssantonio E Biagio E Cesare Arrigo

    Alessandria, 15121, Italy

  • Azienda Ospedaliera Universitaria San Martino

    Genova, 16132, Italy

  • Azienda Unita Sanitaria Locale Irccs

    Reggio Emilia, 42123, Italy

  • Barwon Health the Geelong Hospital

    Geelong, Victoria, 3220, Australia

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050, China

  • Beth Israel Deaconess Medical Center (Bidmc)

    Boston, Massachusetts, 02215-5400, United States

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS, United Kingdom

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298, Australia

  • Canberra Hospital

    Garran, Australian Capital Territory, 2605, Australia

  • Centre Hospitalier Le Mans

    Le Mans, 72037, France

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

    Liège, 4000, Belgium

  • Centre Hospitalier Universitaire Nantes Hotel Dieu

    Nantes, 44093, France

  • Centre Hospitalier Universitaire Universite Catholique de Louvain Site Godinne

    Yvoir, 5530, Belgium

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

    Poitiers, 86000, France

  • Centre de Lutte Contre Le Cancer Institut Bergonie

    Bordeaux, 33076, France

  • Centro Hospitalar Universitario Porto

    Porto, 4099-001, Portugal

  • Centrum Onkologii Ziemi Lubelskiej

    Lublin, 20-090, Poland

  • Ch Cornouaille

    Quimper, 29000, France

  • Chao Family Comprehensive Cancer Center

    Orange, California, 92868, United States

  • Cherkasy Regional Oncology Dispensary

    Cherkasy, 18009, Ukraine

  • Chi Mei Hospital Liouying

    Tainan, 736, Taiwan

  • Chiba Cancer Center

    Chiba, Chiba, 260-8717, Japan

  • Christchurch Hospital (Canterbury Health Laboratories)

    Christchurch, 8011, New Zealand

  • Chru de Brest Hospital Morvan

    Brest, 29200, France

  • Chu Dijon

    Dijon, J4V 2H1, France

  • Chu Grenoble Alpes

    Grenoble, 38043, France

  • Chu Hopital Lyon Sud

    PierreBenite, 69495, France

  • Chuln Hospital de Santa Maria

    Lisbon, 1649-035, Portugal

  • Ciusss de Lestrie Chus

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Clinical Hospital, Sp Botkin

    Moscow, Moscow, 125284, Russia

  • Clinical Research Alliance, Inc

    Westbury, New York, 11590, United States

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89169, United States

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139, Australia

  • Copernicus Podmiot Leczniczy Sp Z Oo Wojewodzkie Centrum Onkologii

    Gdask, 80-219, Poland

  • Cork University Hospital

    Cork, t12DC4A, Ireland

  • Dept of Medicine Iii, University Hospitallmu

    Munich, 81377, Germany

  • Dr Abdurrahman Yurtaslan Oncology Teaching and Research Hospital

    Ankara, 06620, Turkey (Türkiye)

  • Erasmus Mc

    Rotterdam, 3015 GD, Netherlands

  • Fgu Russian Scientific Research Institute of Hematology and Transfusiology

    Saint Petersburg, Sankt-Peterburg, 191024, Russia

  • Flinders Medical Centre

    Bedford PK, South Australia, 5042, Australia

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000, China

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001, China

  • Gazi University

    Ankara, 6500, Turkey (Türkiye)

  • Gbuz Mmcc Kommunarka Dzm

    Moscow, 142770, Russia

  • Gosford Hospital

    Gosford, New South Wales, 2250, Australia

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong, 510080, China

  • Hagaziekenhuis

    The Hague, 2545 CH, Netherlands

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000, China

  • Hematoloji Ve Hematolik Onkoloji Tani Ve Tedavi Merezi

    Ankara, 06700, Turkey (Türkiye)

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000, China

  • Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital

    Hiroshima, Hiroshima, 730-8619, Japan

  • Hopital Claude Huriez Chu Lille

    Lille, 59000, France

  • Hospital Regional Universitario de Malaga

    Málaga, 29010, Spain

  • Hospital Universitario Gregorio Maranon

    Madrid, 28009, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Vall Dhebron

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013, Spain

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013, China

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

    Ningbo, Zhejiang, 315000, China

  • Icahn School of Medicine At Mount Sinai

    New York, New York, 10029, United States

  • Ico Girona

    Girona, 17007, Spain

  • Ico Hug Trias I Pujol

    Barcelona, 08916, Spain

  • Icon Cancer Foundation

    South Brisbane, Queensland, 4101, Australia

  • Institut Catala Doncologia

    Barcelona, 08908, Spain

  • Institut Curie

    Paris, 75005, France

  • Institut Paoli Calmettes

    Marseille, 13009, France

  • Institute of Hematology and Hospital of Blood Disease

    Tianjin, Tianjin Municipality, 300020, China

  • Instituto Portugues Oncologia de Lisboa Francisco Gentil, Epe

    Lisbon, 1099-023, Portugal

  • Instituto Portugues de Oncologia Do Porto Francisco Gentil, Epe

    Porto, 4200-072, Portugal

  • Institutul Clinic Fundeni

    Bucharest, 022328, Romania

  • Institutul Regional de Oncologie Iasi

    Iași, 700483, Romania

  • Instytut Hematologii I Transfuzjologii W Warszawie

    Warsaw, 02-776, Poland

  • Iuc Toulouse Oncopole

    Toulouse, 31059, France

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029, China

  • Jilin Cancer Hospital

    Changchun, Jilin, 130021, China

  • Joe Arrington Cancer Research and Treatment Center

    Lubbock, Texas, 79410, United States

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515, Japan

  • Kurashiki Central Hospital

    Kurashikishi, Okayama-ken, 710-8602, Japan

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011, Japan

  • Leningrad Regional Clinic and Hospital

    Saint Petersburg, Sankt-Peterburg, 194291, Russia

  • Mater Misericordiae University Hospital

    Dublin, D7, Ireland

  • Md Anderson Cancer Center Madrid Spain

    Madrid, 28033, Spain

  • Medical University Vienna Oncology

    Vienna, 1090, Austria

  • Mersin Universitesi Tip Fakultesi Hastanesi

    Mersin, 33000, Turkey (Türkiye)

  • Monash Health

    Clayton, Victoria, 3168, Australia

  • Municipal Non Profit Enterprise City Clinical Hospital

    Dnipro, 49102, Ukraine

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515, China

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

    Nanjing, Jiangsu, 210008, China

  • National Cancer Center Hospital

    Chuoku, Tokyo, 104-0045, Japan

  • National Cancer Institute

    Kiev, 3022, Ukraine

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, Kumamoto, 860-0008, Japan

  • National Hospital Organization Nagoya Medical Center

    Nagoya, Aichi-ken, 460-0001, Japan

  • National Hospital Organization Okayama Medical Center

    Okayama, Okayama-ken, 701-1192, Japan

  • Necker University Hospital

    Paris, 75015, France

  • Niguarda Cancer Center Division of Hematology

    Milan, 20162, Italy

  • Ordensklinikum Linz Gmbh Elisabethinen

    Linz, 4020, Austria

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, 545-8586, Japan

  • Osaka Red Cross Hospital

    Osakashi, Osaka, 543-8555, Japan

  • Peking University Peoples Hospital

    Beijing, Beijing Municipality, 100044, China

  • Peninsula Private Hospital

    Frankston, Victoria, 3199, Australia

  • Petrus Krankenhaus Wuppertal

    Wuppertal, 42283, Germany

  • Policlinico Sorsola Malpighi, Aou Di Bologna

    Bologna, 40138, Italy

  • Pratia McM Krakow

    Krakow, 30-727, Poland

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • Quanzhou First Affliated Hospital of Fujian Medical University

    Quanzhou, Fujian, 362000, China

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000, Australia

  • Royal Marsden Nhs Foundation Royal Marsden Hospital

    Sutton, SM2 5PT, United Kingdom

  • Royal Perth Hospital

    Perth, Western Australia, 6000, Australia

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Russells Hall Hopsital

    Dudley, DY1 2HQ, United Kingdom

  • Saint Vincents Hospital Sydney

    Darlinghurst, New South Wales, 2010, Australia

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109, United States

  • Shanghai East Hospital

    Shanghai, Shanghai Municipality, 200120, China

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004, China

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

    Lviv, 79044, Ukraine

  • Silesian Healthy Blood Clinic

    Chorzów, 41-503, Poland

  • Specjalistyczny Szpital Im Dr Alfreda Sokolowskiego

    Wałbrzych, 58-309, Poland

  • St Antonius Ziekenhuis, Randd Interne Geneeskunde (F)

    Nieuwegein, 3435 CM, Netherlands

  • St Jamess Hospital

    Dublin, D8, Ireland

  • St Vincents Hospital Melbourne

    Fitzroy, Victoria, 3065, Australia

  • Start Madrid Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

  • Sunshine Coast Hospital and Health Service

    Birtinya, Queensland, 4575, Australia

  • Szpital Uniwersytecki Nr Im Dr Jana Biziela

    Bydgoszcz, 85-168, Poland

  • Szpitale Pomorskie Spolka Z Ograniczona Odpowiedzialnoscia

    Gdynia, 81-519, Poland

  • Tauranga Hospital

    Tauranga, 3112, New Zealand

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000, China

  • The First Affiliated Hospital of Nanchang University Branch Donghu

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021, China

  • The Ottawa Hospital

    Ottawa, Ontario, K1H 8M2, Canada

  • The Tweed Valley Hospital

    Cudgen, New South Wales, 2487, Australia

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas, 77030-4009, United States

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574, Japan

  • Tokyo Medical and Dental University Hospital

    Tokyo, Tokyo, 113-8519, Japan

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

    Wuhan, Hubei, 430030, China

  • Toyohashi Municipal Hospital

    Toyohashi, Aichi-ken, 441-8570, Japan

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

    Edirne, 22030, Turkey (Türkiye)

  • Tri Service General Hospital

    Taipei, 114, Taiwan

  • Uniklinik Koln (Aor)

    Cologne, 50937, Germany

  • Unita Di Ematologia, Dipartimento Di Ematologia Ed Oncologia

    Ravenna, 48121, Italy

  • Universita Degli Studi La Sapienza

    Roma, 00161, Italy

  • Universitaetsklinikum Ulm, Innere Medizin Iii

    Ulm, 89081, Germany

  • Universitair Ziekenhuis Brussel

    Brussels, 1090, Belgium

  • Universitatsklinik Fur Innere Medizin Iii Universitatsklinikum Der Pmu Landeskrankenhaus Salzburg

    Salzburg, 5020, Austria

  • Universitatsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • University Hospital Galway

    Galway, H91 YR71, Ireland

  • University Hospital Limerick

    Limerick, V94F858, Ireland

  • University Hospital Waterford

    Waterford, X91 ER8E, Ireland

  • University Hospital, Kyoto Prefectural Univ of Medicine

    Kyoto, Kyoto, 602-8566, Japan

  • University of Medical Center Groningen (Umcg)

    Groningen, 9713 GZ, Netherlands

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109, United States

  • University of Verona

    Verona, 37142, Italy

  • Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu

    Wroclaw, 50-556, Poland

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952, Poland

  • Uz Antwerpen

    Edegem, 2650, Belgium

  • Vkv American Hospital

    Istanbul, 34365, Turkey (Türkiye)

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224, United States

  • Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

    Lodz, 93-510, Poland

  • Wojewodzki Szpital Specjalistyczny W Legnicy

    Legnica, 59-220, Poland

  • Yokohama Municipal Citizens Hospital

    Yokohama, 221-0855, Japan

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China