New lymphoma combo shows promise in major trial

NCT ID NCT03274492

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

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

Summary

This large Phase 3 trial tested whether adding polatuzumab vedotin to standard chemotherapy (R-CHP) works better than the usual treatment (R-CHOP) for people with untreated diffuse large B-cell lymphoma. About 1000 participants received either the new combo or the standard regimen. The main goal was to see if the new treatment delays cancer progression. While the study aims to improve disease control, lifelong monitoring or additional therapy may still be needed.

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

1,000 people

The number who actually took part.

Started

Nov 2017

Finished

Apr 2026

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

18 to 80 years

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.

Inclusion Criteria: * Previously untreated participants with cluster of differentiation 20 (CD20)-positive DLBCL, including one of the following diagnoses by 2016 World Health Organization (WHO) classification of lymphoid neoplasms: DLBCL, not otherwise specified (NOS) including germinal center B-cell type, activated B-cell type; T-cell/histiocyte-rich large B-cell lymphoma; Epstein-Barr virus-positive DLBCL, NOS; anaplastic lymphoma kinase (ALK)-positive large B-cell lymphoma; human herpesvirus-8 (HHV8)-positive DLBCL, NOS; High-grade B-cell lymphoma with MYC and B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) rearrangements (double-hit or triple-hit lymphoma); High-grade B-cell lymphoma, NOS * Availability of archival or freshly collected tumor tissue before study enrolment * International Prognostic Index (IPI) score of 2-5 * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2 * Life expectancy greater than or equal to (\>/=)12 months * Left ventricular ejection fraction (LVEF) \>/= 50 percent (%) on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO) * Adequate hematologic function * Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods and refrain from donating eggs. * Male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom and agreement to refrain from donating sperm. Exclusion Criteria: * History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products * Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines * Prior organ transplantation * Current Grade greater than (\>) 1 peripheral neuropathy by clinical examination * Demyelinating form of Charcot-Marie-Tooth disease * History of indolent lymphoma * History of follicular lymphoma grade 3B * B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey-zone lymphoma) * Primary mediastinal (thymic) large B-cell lymphoma * Burkitt lymphoma * Prior treatment with cytotoxic drugs within 5 years of screening for any condition (example \[e.g.\], cancer, rheumatoid arthritis) or prior use of any anti-CD20 antibody * Prior use of any monoclonal antibody within 3 months of the start of Cycle 1 * Prior therapy for DLBCL, with the exception of nodal biopsy * Corticosteroid use \>30 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control * Participants with central nervous system (CNS) lymphoma (primary or secondary involvement), primary effusion DLBCL, and primary cutaneous DLBCL * Vaccination with live vaccines within 28 days prior to the start of Cycle 1 * Any investigational therapy within 28 days prior to the start of Cycle 1 * History of other malignancy that could affect compliance with the protocol or interpretation of results * Evidence of significant, uncontrolled, concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease or pulmonary disease * Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis * History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction * Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or significant infections within 2 weeks before the start of Cycle 1 * Clinically significant liver disease, including active viral or other hepatitis, current alcohol abuse, or cirrhosis * Prior radiotherapy to the mediastinal/pericardial region * Participants with suspected active or latent tuberculosis * Positive test results for chronic hepatitis B and hepatitis C infection * Known history of human immunodeficiency virus (HIV) seropositive status * Positive results for the human T-lymphotrophic 1 virus (HTLV-1) * Participants with a history of progressive multifocal leukoencephalopathy

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma

As listed by the trial registrant

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

Diffuse large B-cell lymphoma

Contacts and locations

Locations

AUSL di Reggio Emilia, IRCCS, P.O. Arcispedale Santa Maria Nuova

Reggio Emilia, Emilia-Romagna, DUMMY_VALUE, Italy
Aichi Cancer Center

Aichi, 464-8681, Japan
Ankara University Faculty of Medicine Cebeci Hospital

Ankara, 06700, Turkey (Türkiye)
Asan Medical Center

Seoul, 05505, South Korea
Ashford Cancer Center Research

Kurralta Park, South Australia, 5037, Australia
Asst Degli Spedali Civili Di Brescia

Brescia, Abruzzo, 25123, Italy
Asst Papa Giovanni XXIII

Bergamo, Abruzzo, 24127, Italy
Auckland City Hospital, Cancer and Blood Research

Auckland, 1023, New Zealand
Austin Hospital

Heidelberg, Victoria, 3084, Australia
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

Turin, Piedmont, 10126, Italy
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara

Novara, Piedmont, 28100, Italy
BC Cancer Agency Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada
Barts Health NHS Trust - St Bartholomew's Hospital

London, EC1M 6BQ, United Kingdom
Beijing Cancer Hospital

Beijing, 100142, China
CH Bretagne Atlantique

Vannes, 56017, France
CH Jolimont - Lobbes (Jolimont)

Haine-Saint-Paul, 7100, Belgium
CH Metropole de Savoie

Chambéry, 73011, France
CHD Vendée

La Roche-sur-Yon, 85025, France
CHU Amiens - Hopital Sud

Amiens, 80054, France
CHU Angers

Angers, 49933, France
CHU Bretonneau

Tours, 37044, France
CHU Lyon Sud - Service Hématologie

Pierre-Bénite, 69310, France
CHU Montpellier - Saint ELOI

Montpellier, 34295, France
CHU UCL Mont-Godinne

Mont-godinne, 5530, Belgium
CHU de Brabois

Vandœuvre-lès-Nancy, 54511, France
CHU de Dijon - Hopital le Bocage

Dijon, 21000, France
CHU de Nantes - Hotel Dieu

Nantes, 44093, France
CHU de Nîmes - Hôpital Carémeau

Nîmes, 30029, France
CHU de Poitiers

Poitiers, 86021, France
CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont

Montreal, Quebec, H1T 2M4, Canada
Calvary Mater Newcastle

Waratah, New South Wales, 2298, Australia
Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

Cambridge, CB2 0QQ, United Kingdom
Cancer Trials New Zealand

Hamilton, WKO, 3204, New Zealand
CancerCare Manitoba (CCMB)

Winnipeg, Manitoba, MB R3E 0V9, Canada
Canterbury Health Laboratories

Christchurch, 8011, New Zealand
Centre Antoine Lacassagne

Nice, 06189, France
Centre Henri Becquerel

Rouen, 76038, France
Centre Hospitalier de La Cote Basque

Bayonne, 64109, France
Centre Hospitalier de Quimper Cornouaille (CHIC)

Quimper, 29107, France
Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll

Saint-Brieuc, 22027, France
Centre Leon Berard

Lyon, 69008, France
Centro de Hematologia e Hemoterapia - HEMOCENTRO UNICAMP

Campinas, São Paulo, 13083-878, Brazil
Chi-Mei Hospital, Liouying

Tainan, 736, Taiwan
Chiba Cancer Center

Chiba, 260-8717, Japan
Chiba University Hospital

Chūōku, 260-8670, Japan
China Medical University Hospital

Taichung, 40447, Taiwan
Chru de Strasbourg

Strasbourg, 67091, France
City of Hope

Duarte, California, 91010, United States
Clinique Victor Hugo - Centre Jean Bernard

Le Mans, 72015, France
Communal Institution 'Cherkassy Regional Oncology Dispensary' of the Cherkassy Regional Council

Cherkassy, Chernihiv Governorate, DUMMY_VALUE, Ukraine
Complejo Hospitalario de Navarra

Pamplona, Navarre, 31008, Spain
Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia
Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada
Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States
Dokuz Eylul Universitesi Tip Fakultesi

Balçova, 35330, Turkey (Türkiye)
East Kent Hospitals University NHS Foundation Trust

Canterbury, CT1 3NG, United Kingdom
Ege Üniversitesi Tip Fakültesi

Lzmir, 35100, Turkey (Türkiye)
Emory University

Atlanta, Georgia, 30322, United States
Fakultni Nemocnice Hradec Kralove (FNHK)

Hradec Králové, 500 05, Czechia
Fakultni Nemocnice Kralovske Vinohrady (FNKV)

Prague, 100 34, Czechia
Fakultní nemocnice Olomouc

Olomouc, 779 00, Czechia
Florida Cancer Specialists & Research Institute

St. Petersburg, Florida, 33705-1455, United States
Florida Cancer Specialists & Research Institute

St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists - Fort Myers (New Hampshire Ct)

Fort Myers, Florida, 33901-8101, United States
Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States
Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom
Fudan University Shanghai Cancer Center

Shanghai, 200032, China
Fundación Jimenez Díaz

Madrid, 28040, Spain
Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States
Gh Necker Enfants Malades

Paris, 75743, France
Greco-Hainesworth Centers for Research

Chattanooga, Tennessee, 37403, United States
Henan Cancer Hospital

Zhengzhou, 450008, China
Hiroshima University Hospital

Hiroshima, 734-8551, Japan
Hokkaido University Hospital

Hokkaido, 060-8648, Japan
Hopital Claude Huriez

Lille, 59037, France
Hopital Haut-Leveque - Centre Francois Magendie

Pessac, 33604, France
Hopital Henri Mondor

Créteil, 94010, France
Hopital Pontchaillou

Rennes, 35033, France
Hopital Saint Jean

Perpignan, 66046, France
Hopital Uni Ire Dupuytren

Limoges, 87042, France
Hospital Clinic Barcelona

Barcelona, 08036, Spain
Hospital Erasto Gaertner

Curitiba, Paraná, 81520-060, Brazil
Hospital Quiron Madrid

Madrid, 28233, Spain
Hospital San Pedro de Alcantara

Cáceres, 10003, Spain
Hospital Universitari Dr. Josep Trueta

Girona, 17007, Spain
Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain
Hospital Universitario La Paz

Madrid, 280146, Spain
Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain
Hospital Universitario Virgen del Rocío

Seville, 41013, Spain
Hospital das Clinicas - FMUSP

São Paulo, São Paulo, 05403-000, Brazil
Hospital de Clínicas de Porto Alegre X

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain
Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States
Hôpital Albert Michallon

La Tronche, 38700, France
Hôpital Saint Vincent de Paul

Lille, 59000, France
Hôpital Saint-Louis

Paris, 75475, France
Hôpital de l'Enfant-Jésus

Québec, Quebec, G1J 1Z4, Canada
IRCCS AOU San Martino - IST

Genoa, Liguria, 16132, Italy
Illinois Cancer Specialists

Arlington Heights, Illinois, 60005, United States
InVO - Institut für Versorgungsforschung in der Onkologie GbR

Koblenz, 56068, Germany
Institut Bergonie

Bordeaux, 33076, France
Institut Catala d Oncologia Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Institut Gustave Roussy

Villejuif, 94805, France
Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

Toulouse, 31059, France
Institut d'Hématologie de Basse Normandie

Caen, 14000, France
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, 300020, China
Istituto Nazionale dei Tumori

Monza, Lombardy, 20052, Italy
James Graham Brown Cancer Center

Louisville, Kentucky, 40202-3229, United States
Jiangsu Cancer Hospital

Nanjing, 210009, China
Jichi Medical University Hospital

Tochigi, 329-0498, Japan
Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan
Karmanos Cancer Center

Detroit, Michigan, 48201, United States
Khmelnytskyi Regional Hospital

Khmelnytskyi, Kharkiv Governorate, 29000, Ukraine
Kindai University Hospital

Osaka, 589-8511, Japan
Kobe City Medical Center General Hospital

Hyōgo, 650-0047, Japan
Kumamoto University Hospital

Kumamoto, 860-8556, Japan
Kyushu University Hospital

Fukuoka, 812-8582, Japan
L'Union Mutualiste de la Gestion des Eaux Claires - Institut Daniel Hollard

Grenoble, 38000, France
Leningrad Regional Clinical Hospital

Saint Petersburg, Sankt-Peterburg, 194291, Russia
Levine Cancer Institute - Clincal Trials Administration

Charlotte, North Carolina, 28204, United States
MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care

Lviv, Chernihiv Governorate, 79007, Ukraine
Massachusetts General Hospital

Boston, Massachusetts, 02114, United States
Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States
Medizinische Universität Wien

Vienna, 1090, Austria
Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States
Memorial Sloan Kettering Cancer Center - Commack

New York, New York, 10087-9049, United States
Memorial Sloan Kettering Cancer Center at Westchester

Harrison, New York, 10604-3200, United States
Monash Medical Centre Clayton

Clayton, Victoria, 3168, Australia
National Cancer Center

Gyeonggi-do, 410-769, South Korea
National Cancer Center Hospital

Tokyo, 104-0045, Japan
National Cancer Center Hospital East

Chiba, 277-8577, Japan
National Hospital Organization Kyushu Cancer Center

Fukuoka, 811-1395, Japan
National Taiwan University Hospital

Taipei, 10002, Taiwan
New York University Cancer Cen

New York, New York, 10016, United States
Northwest Cancer Specialists - Portland (SW Barnes Rd)

Portland, Oregon, 97225, United States
Nottingham University Hospitals NHS Trust - City Hospital

Nottingham, NG5 1PB, United Kingdom
Ochsner Medical Center

New Orleans, Louisiana, 70121, United States
Oncology Associates of Oregon, P.C

Eugene, Oregon, 97401, United States
Oncology Associates of Southwest Virginia, Inc.

Blacksburg, Virginia, 24060, United States
Oncology Hematology Care

Cincinnati, Ohio, 45242, United States
Oregon Health & Science University

Portland, Oregon, 97239, United States
Osaka Metropolitan University Hospital

Osaka, 545-8586, Japan
Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 7LE, United Kingdom
Paracelsus Medizinischen Privatuniversitaet-Salzburger Landeskliniken (SALK)

Salzburg, 5020, Austria
Pratia Ma?opolskie Centrum Medyczne (MCM) Kraków

Krakow, 30-727, Poland
Prince of Wales Hospital

Randwick, New South Wales, 2031, Australia
Princess Alexandra Hospital Woolloongabba

Woolloongabba, Queensland, 4102, Australia
Prisma Health ? Upstate

Greenville, South Carolina, 29615, United States
Pusan National University Hospital

Busan, 49241, South Korea
Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea
Pôle de Cancérologie ? CHU de Saint?Etienne'

Saint-Priest-en-Jarez, 42270, France
Rocky Mountain Cancer Centers, LLP

Aurora, Colorado, 80012, United States
Ronald Reagan UCLA Medical Center

Los Angeles, California, 90024-6997, United States
Roswell Park Cancer Institute

Buffalo, New York, 14263, United States
Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200025, China
SPZOZ Ministerstwa Spraw Wewn?trznych i Administracji w Poznaniu

Późna, 60-631, Poland
Samodzielny Publiczny Zak?ad Opieki Zdrowotnej Zespó? Szpitali Miejskich w Chorzowie

Chorzów, 41-500, Poland
Samsung Medical Center

Seoul, 06351, South Korea
Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States
Seoul National University Hospital

Seoul, 03080, South Korea
Severance Hospital

Seoul, 03722, South Korea
Shanghai East Hospital, Tongji University

Shanghai, 200120, China
Southern Cancer Center

Daphne, Alabama, 36526, United States
St George Hospital

Kogarah, New South Wales, 2217, Australia
Städtisches Klinikum Dessau

Dessau, 06847, Germany
Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada
Taipei Veterans General Hospital

Taipei, 11211, Taiwan
Tennessee Oncology

Nashville, Tennessee, 37203-1625, United States
Texas Oncology San Antonio Medical Center

San Antonio, Texas, 78229, United States
Texas Oncology-Austin Midtown

Austin, Texas, 78705, United States
Texas Oncology-Tyler

Tyler, Texas, 75702, United States
The Cancer Institute Hospital of JFCR

Tokyo, 135-8550, Japan
The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom
The First Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, 310003, China
The First Hospital of Jilin University

Changchun, 130021, China
The Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States
The Ohio State University Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States
The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada
The University of Adelaide - The Queen Elizabeth Hospital (TQEH)

Woodville South, South Australia, 5011, Australia
The University of Osaka Hospital

Osaka, 565-0871, Japan
Tohoku University Hospital

Miyagi, 980-8574, Japan
Tokai University Hospital

Isehara-shi, 259-1193, Japan
UZ Gent

Ghent, 9000, Belgium
Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430022, China
Universita degli Studi di Roma ''La Sapienza" - Clinica Ematologica

Rome, Abruzzo, DUMMY_VALUE, Italy
Universitaetsklinikum Heidelberg

Heidelberg, 69120, Germany
Universitatsklinikum Munster

Münster, 48149, Germany
University Hospital Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan
University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States
University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom
University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States
University of Maryland

Baltimore, Maryland, 21201, United States
University of Michigan Health System

Ann Arbor, Michigan, 48109, United States
University of North Carolina School of Medicine

Chapel Hill, North Carolina, 27514-4221, United States
University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15232-1309, United States
University of Rochester Medical Center

Rochester, New York, 14642, United States
University of Utah

Salt Lake City, Utah, 84112, United States
Universitätsklinikum Essen

Essen, 45147, Germany
Universitätsklinikum Halle (Saale)

Halle, 6097, Germany
Universitätsspital Basel

Basel, 4031, Switzerland
Uniwersytet Medyczny w Lodzi

Lodz, 93-510, Poland
Virginia Cancer Specialists, PC

Fairfax, Virginia, 22031-4618, United States
Vivantes Klinikum Am Urban

Berlin, 10967, Germany
Všeobecná fakultní nemocnice v Praze

Prague, 128 08, Czechia
Washington University

St Louis, Missouri, 63110, United States
West Virginia Uni Med. Center - Robert Byrd Health Science

Morgantown, West Virginia, 26505, United States
Westmead Hospital

Westmead, New South Wales, 2145, Australia
Wiener Gesundheitsverbund ? Klinik Ottakring

Vienna, 1160, Austria
Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MON

Warsaw, 04-359, Poland

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