A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma

NCT ID: NCT03274492

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-16

Study Completion Date

2026-07-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This Phase III, randomized, double-blind, placebo-controlled study will compare the efficacy, safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants with previously untreated diffuse large B-cell lymphoma (DLBCL).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diffuse Large B-Cell Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

R-CHP plus Vincristine Placebo plus Polatuzumab Vedotin

Participants will receive polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) intravenously (IV), placebo for vincristine IV, rituximab 375 milligrams per square meter (mg/m\^2) IV, cyclophosphamide 750 mg/m\^2 IV, and doxorubicin 50 mg/m\^2 IV on Day 1 and prednisone 100 milligrams per day (mg/day) orally (PO) on Days 1-5 of every 21-day cycle for 6 cycles. Rituximab 375 mg/m\^2 IV will be administered as monotherapy in Cycles 7 and 8.

Group Type EXPERIMENTAL

Polatuzumab Vedotin

Intervention Type DRUG

Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.

Rituximab

Intervention Type DRUG

Rituximab IV infusion will be administered as per the schedule specified in the respective arm.

Cyclophosphamide

Intervention Type DRUG

Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.

Doxorubicin

Intervention Type DRUG

Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.

Vincristine Placebo

Intervention Type DRUG

Placebo matching to vincristine will be administered as per the schedule specified in the respective arm.

Prednisone

Intervention Type DRUG

Prednisone PO will be administered as per the schedule specified in the respective arm.

R-CHOP plus Polatuzumab Vedotin Placebo

Participants will receive placebo for polatuzumab vedotin, rituximab 375 mg/m\^2 IV, cyclophosphamide 750 mg/m\^2 IV, doxorubicin 50 mg/m\^2 IV, and vincristine 1.4 mg/m\^2 IV (maximum 2 milligrams per dose \[mg/dose\]) on Day 1 and prednisone 100 mg/day PO on Days 1-5 of every 21-day cycle for 6 cycles. Rituximab 375 mg/m\^2 IV will be administered as monotherapy in Cycles 7 and 8.

Group Type PLACEBO_COMPARATOR

Rituximab

Intervention Type DRUG

Rituximab IV infusion will be administered as per the schedule specified in the respective arm.

Cyclophosphamide

Intervention Type DRUG

Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.

Doxorubicin

Intervention Type DRUG

Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.

Vincristine

Intervention Type DRUG

Vincristine IV infusion will be administered as per the schedule specified in the respective arm.

Prednisone

Intervention Type DRUG

Prednisone PO will be administered as per the schedule specified in the respective arm.

Polatuzumab vedotin Placebo

Intervention Type DRUG

Placebo matching to polatuzumab vedotin will be administered as per the schedule specified in the respective arm.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Polatuzumab Vedotin

Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.

Intervention Type DRUG

Rituximab

Rituximab IV infusion will be administered as per the schedule specified in the respective arm.

Intervention Type DRUG

Cyclophosphamide

Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.

Intervention Type DRUG

Doxorubicin

Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.

Intervention Type DRUG

Vincristine

Vincristine IV infusion will be administered as per the schedule specified in the respective arm.

Intervention Type DRUG

Vincristine Placebo

Placebo matching to vincristine will be administered as per the schedule specified in the respective arm.

Intervention Type DRUG

Prednisone

Prednisone PO will be administered as per the schedule specified in the respective arm.

Intervention Type DRUG

Polatuzumab vedotin Placebo

Placebo matching to polatuzumab vedotin will be administered as per the schedule specified in the respective arm.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

DCDS4501A; anti-CD79b-VC-MMAE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Southern Cancer Center

Daphne, Alabama, United States

Site Status

City of Hope

Duarte, California, United States

Site Status

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Site Status

Rocky Mountain Cancer Centers, LLP

Aurora, Colorado, United States

Site Status

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status

Florida Cancer Specialists - Fort Myers (New Hampshire Ct)

Fort Myers, Florida, United States

Site Status

Florida Cancer Specialists & Research Institute

St. Petersburg, Florida, United States

Site Status

Florida Cancer Specialists

West Palm Beach, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Illinois Cancer Specialists

Arlington Heights, Illinois, United States

Site Status

University of Louisville Hospital

Louisville, Kentucky, United States

Site Status

Ochsner Medical Center

New Orleans, Louisiana, United States

Site Status

University of Maryland

Baltimore, Maryland, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

University of Michigan Health System

Ann Arbor, Michigan, United States

Site Status

Karmanos Cancer Center

Detroit, Michigan, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Site Status

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center - Commack

Commack, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center at Westchester

Harrison, New York, United States

Site Status

New York University Cancer Cen

New York, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

University of Rochester Medical Center

Rochester, New York, United States

Site Status

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Levine Cancer Institute - Clincal Trials Administration

Charlotte, North Carolina, United States

Site Status

Oncology/Hematology Care Clinical Trials LLC

Cincinnati, Ohio, United States

Site Status

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Oncology Associates of Oregon, P.C

Eugene, Oregon, United States

Site Status

Northwest Cancer Specialists - Portland (SW Barnes Rd)

Portland, Oregon, United States

Site Status

Oregon HSU

Portland, Oregon, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center Cancer Center

Pittsburgh, Pennsylvania, United States

Site Status

Medical University of South Carolina Hospital

Charleston, South Carolina, United States

Site Status

Prisma Health ? Upstate

Greenville, South Carolina, United States

Site Status

Greco-Hainesworth Centers for Research

Chattanooga, Tennessee, United States

Site Status

Tennessee Oncology - Nashville

Nashville, Tennessee, United States

Site Status

Texas Oncology-Austin Midtown

Austin, Texas, United States

Site Status

Texas Oncology San Antonio Medical Center

San Antonio, Texas, United States

Site Status

Texas Oncology-Tyler

Tyler, Texas, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

Oncology Associates of Southwest Virginia, Inc.

Blacksburg, Virginia, United States

Site Status

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

Site Status

Seattle Cancer Care Alliance

Seattle, Washington, United States

Site Status

West Virginia Uni Med. Center - Robert Byrd Health Science

Morgantown, West Virginia, United States

Site Status

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Site Status

St George Hospital

Kigarah, New South Wales, Australia

Site Status

Prince of Wales Hospital

Randwick, New South Wales, Australia

Site Status

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Site Status

Westmead Hospital

Westmead, New South Wales, Australia

Site Status

Princess Alexandra Hospital Woolloongabba

Woolloongabba, Queensland, Australia

Site Status

Ashford Cancer Center Research

Kurralta Park, South Australia, Australia

Site Status

The University of Adelaide - The Queen Elizabeth Hospital (TQEH)

Woodville South, South Australia, Australia

Site Status

Monash Medical Centre

Clayton, Victoria, Australia

Site Status

Austin Hospital

Heidelberg, Victoria, Australia

Site Status

Paracelsus Medizinischen Privatuniversitaet-Salzburger Landeskliniken (SALK)

Salzburg, , Austria

Site Status

Medizinische Universität Wien

Vienna, , Austria

Site Status

Wiener Gesundheitsverbund ? Klinik Ottakring

Vienna, , Austria

Site Status

UZ Gent

Ghent, , Belgium

Site Status

CH Jolimont - Lobbes (Jolimont)

Haine-Saint-Paul, , Belgium

Site Status

CHU UCL Mont-Godinne

Mont-godinne, , Belgium

Site Status

Hospital Erasto Gaertner

Curitiba, Paraná, Brazil

Site Status

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Centro de Hematologia e Hemoterapia - HEMOCENTRO UNICAMP

Campinas, São Paulo, Brazil

Site Status

Hospital das Clinicas - FMUSP

São Paulo, São Paulo, Brazil

Site Status

University of Alberta Hospital

Edmonton, Alberta, Canada

Site Status

BC Cancer ? Vancouver

Vancouver, British Columbia, Canada

Site Status

CancerCare Manitoba (CCMB)

Winnipeg, Manitoba, Canada

Site Status

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Site Status

CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont

Montreal, Quebec, Canada

Site Status

CHU de Quebec-Universite Laval

Québec, , Canada

Site Status

Beijing Cancer Hospital

Beijing, , China

Site Status

The First Hospital of Jilin University

Changchun, , China

Site Status

Fujian Provincial Cancer Hospital

Fuzhou, , China

Site Status

Sun Yet-sen University Cancer Center

Guangzhou, , China

Site Status

The First Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, , China

Site Status

Jiangsu Cancer Hospital

Nanjing, , China

Site Status

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, , China

Site Status

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status

Shanghai East Hospital, Tongji University

Shanghai, , China

Site Status

Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences

Tianjin, , China

Site Status

Tianjin Medical University Cancer Institute & Hospital

Tianjing, , China

Site Status

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, , China

Site Status

Henan Cancer Hospital

Zhengzhou, , China

Site Status

Fakultni Nemocnice Hradec Kralove (FNHK)

Hradec Králové, , Czechia

Site Status

Fakultni nemocnice Olomouc

Olomouc, , Czechia

Site Status

Fakultni nemocnice Ostrava

Ostrava - Poruba, , Czechia

Site Status

Fakultni Nemocnice Kralovske Vinohrady (FNKV)

Prague, , Czechia

Site Status

Všeobecná fakultní nemocnice v Praze

Prague, , Czechia

Site Status

CHU Amiens - Hopital Sud

Amiens, , France

Site Status

CHU Angers

Angers, , France

Site Status

Centre Hospitalier de La Cote Basque

Bayonne, , France

Site Status

Hopital Jean Minjoz

Besançon, , France

Site Status

Institut Bergonie

Bordeaux, , France

Site Status

Institut d'Hématologie de Basse Normandie

Caen, , France

Site Status

CH Metropole de Savoie

Chambéry, , France

Site Status

Hopital Henri Mondor

Créteil, , France

Site Status

CHU de Dijon - Hopital le Bocage

Dijon, , France

Site Status

L'Union Mutualiste de la Gestion des Eaux Claires - Institut Daniel Hollard

Grenoble, , France

Site Status

CHD Vendée

La Roche-sur-Yon, , France

Site Status

Hôpital Albert Michallon

La Tronche, , France

Site Status

Clinique Victor Hugo - Centre Jean Bernard

Le Mans, , France

Site Status

Hôpital Saint Vincent de Paul

Lille, , France

Site Status

Hopital Claude Huriez

Lille, , France

Site Status

Hopital Uni Ire Dupuytren

Limoges, , France

Site Status

Centre Leon Berard

Lyon, , France

Site Status

CHU Montpellier - Saint ELOI

Montpellier, , France

Site Status

CHU de Nantes - Hotel Dieu

Nantes, , France

Site Status

Centre Antoine Lacassagne

Nice, , France

Site Status

CHU de Nîmes - Hôpital Carémeau

Nîmes, , France

Site Status

Hôpital Saint-Louis

Paris, , France

Site Status

Gh Necker Enfants Malades

Paris, , France

Site Status

Hopital Saint Jean

Perpignan, , France

Site Status

Hopital Haut-Leveque - Centre Francois Magendie

Pessac, , France

Site Status

CHU Lyon Sud - Service Hématologie

Pierre-Bénite, , France

Site Status

CHU de Poitiers

Poitiers, , France

Site Status

Centre Hospitalier de Quimper Cornouaille (CHIC)

Quimper, , France

Site Status

Hopital Pontchaillou

Rennes, , France

Site Status

Centre Henri Becquerel

Rouen, , France

Site Status

Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll

Saint-Brieuc, , France

Site Status

Pôle de Cancérologie ? CHU de Saint?Etienne'

Saint-Priest-en-Jarez, , France

Site Status

Chru de Strasbourg

Strasbourg, , France

Site Status

Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O)

Toulouse, , France

Site Status

CHU Bretonneau

Tours, , France

Site Status

CHU de Brabois

Vandœuvre-lès-Nancy, , France

Site Status

CH Bretagne Atlantique

Vannes, , France

Site Status

Institut Gustave Roussy

Villejuif, , France

Site Status

Vivantes Klinikum Am Urban

Berlin, , Germany

Site Status

Städtisches Klinikum Dessau

Dessau, , Germany

Site Status

Universitätsklinikum Essen

Essen, , Germany

Site Status

Universitaetsklinikum Halle (Saale)

Halle, , Germany

Site Status

Universitaetsklinikum Heidelberg

Heidelberg, , Germany

Site Status

InVO - Institut für Versorgungsforschung in der Onkologie GbR

Koblenz, , Germany

Site Status

Universitatsklinikum Munster

Münster, , Germany

Site Status

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, Abruzzo, Italy

Site Status

Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia

Brescia, Abruzzo, Italy

Site Status

Universita degli Studi di Roma ''La Sapienza" - Clinica Ematologica

Rome, Abruzzo, Italy

Site Status

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

Reggio Emilia, Emilia-Romagna, Italy

Site Status

IRCCS AOU San Martino - IST

Genoa, Liguria, Italy

Site Status

Istituto Nazionale dei Tumori

Monza, Lombardy, Italy

Site Status

Azienda Ospedaliero Universitaria Maggiore della Carita di Novara

Novara, Piedmont, Italy

Site Status

Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

Turin, Piedmont, Italy

Site Status

Aichi Cancer Center

Aichi, , Japan

Site Status

Chiba Cancer Center

Chiba, , Japan

Site Status

National Cancer Center Hospital East

Chiba, , Japan

Site Status

Chiba University Hospital

Chūōku, , Japan

Site Status

National Hospital Organization Kyushu Cancer Center

Fukuoka, , Japan

Site Status

Kyushu University Hospital

Fukuoka, , Japan

Site Status

Hiroshima University Hospital

Hiroshima, , Japan

Site Status

Hokkaido University Hospital

Hokkaido, , Japan

Site Status

Kobe City Medical Center General Hospital

Hyōgo, , Japan

Site Status

Tokai University Hospital

Isehara-shi, , Japan

Site Status

Kumamoto University Hospital

Kumamoto, , Japan

Site Status

University Hospital Kyoto Prefectural University of Medicine

Kyoto, , Japan

Site Status

Tohoku University Hospital

Miyagi, , Japan

Site Status

Osaka Metropolitan University Hospital

Osaka, , Japan

Site Status

The University of Osaka Hospital

Osaka, , Japan

Site Status

Kindai University Hospital

Osaka, , Japan

Site Status

Jichi Medical University Hospital

Tochigi, , Japan

Site Status

National Cancer Center Hospital

Tokyo, , Japan

Site Status

The Cancer Institute Hospital of JFCR

Tokyo, , Japan

Site Status

Auckland City Hospital, Cancer and Blood Research

Auckland, , New Zealand

Site Status

Canterbury Health Laboratories

Christchurch, , New Zealand

Site Status

Waikato Hospital

Hamilton, , New Zealand

Site Status

Wojewódzki Szpital Specjalistyczny im. M. Kopernika

?ód?, , Poland

Site Status

Samodzielny Publiczny Zak?ad Opieki Zdrowotnej Zespó? Szpitali Miejskich w Chorzowie

Chorzów, , Poland

Site Status

PRATIA MCM Kraków

Krakow, , Poland

Site Status

SPZOZ Ministerstwa Spraw Wewn?trznych i Administracji w Poznaniu

Późna, , Poland

Site Status

Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy

Warsaw, , Poland

Site Status

Leningrad Regional Clinical Hospital

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

Pusan National University Hospital

Busan, , South Korea

Site Status

National Cancer Center

Gyeonggi-do, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Severance Hospital

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Pusan National University Yangsan Hospital

Yangsan, , South Korea

Site Status

Complejo Hospitalario de Navarra

Pamplona, Navarre, Spain

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Clinic Barcelona

Barcelona, , Spain

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Institut Catala d Oncologia Hospitalet

Barcelona, , Spain

Site Status

Hospital San Pedro de Alcantara

Cáceres, , Spain

Site Status

Hospital Universitari Dr. Josep Trueta

Girona, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Fundación Jimenez Díaz

Madrid, , Spain

Site Status

Hospital Quiron Madrid

Madrid, , Spain

Site Status

Hospital Universitario Virgen de la Victoria

Málaga, , Spain

Site Status

Hospital Universitario Virgen del Rocío

Seville, , Spain

Site Status

Universitätsspital Basel Gynäkologie - Onkologie

Basel, , Switzerland

Site Status

Kaohsiung Medical University Hospital, Cancer Center

Kaohsiung City, , Taiwan

Site Status

China Medical University Hospital

Taichung, , Taiwan

Site Status

Chi-Mei Hospital, Liouying

Tainan, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Ankara University Faculty of Medicine Cebeci Hospital

Ankara, , Turkey (Türkiye)

Site Status

Ege Üniversitesi Tip Fakültesi

Lzmir, , Turkey (Türkiye)

Site Status

Dokuz Eylul Universitesi Tip Fakultesi

Lzmir, , Turkey (Türkiye)

Site Status

Communal Institution 'Cherkassy Regional Oncology Dispensary' of the Cherkassy Regional Council

Cherkassy, Chernihiv Governorate, Ukraine

Site Status

MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care

Lviv, Chernihiv Governorate, Ukraine

Site Status

Khmelnytskyi Regional Hospital

Khmelnytskyi, Kharkiv Governorate, Ukraine

Site Status

Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

Cambridge, , United Kingdom

Site Status

East Kent Hospitals University NHS Foundation Trust

Canterbury, , United Kingdom

Site Status

University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary

Leicester, , United Kingdom

Site Status

Barts Health NHS Trust

London, , United Kingdom

Site Status

The Christie NHS Foundation Trust

Manchester, , United Kingdom

Site Status

The Newcastle upon Tyne Hospitals NHS Foundation Trust. Freeman Hospital

Newcastle upon Tyne, , United Kingdom

Site Status

Nottingham City Hospital

Nottingham, , United Kingdom

Site Status

Oxford University Hospitals NHS Foundation Trust

Oxford, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Hong Kong Israel United States Australia Austria Belgium Brazil Canada China Czechia France Germany Italy Japan New Zealand Poland Russia South Korea Spain Switzerland Taiwan Turkey (Türkiye) Ukraine United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Morschhauser F, Salles G, Sehn LH, Herrera AF, Friedberg JW, Trneny M, Lenz G, Sharman JP, Herbaux C, Burke JM, Matasar M, Collins GP, Mehta-Shah N, Oberic L, Chauchet A, Jurczak W, Song Y, Pinto A, Rai S, Izutsu K, Greil R, Mykhalska L, Bergua-Burgues JM, Cheung MC, Shin HJ, Hapgood G, Munhoz E, Abrisqueta P, Gau JP, Jiang Y, McCall B, Chohan S, Sugidono M, Yan M, Batlevi CL, Tilly H, Flowers CR. Five-Year Outcomes of the POLARIX Study Comparing Pola-R-CHP and R-CHOP in Patients With Diffuse Large B-Cell Lymphoma. J Clin Oncol. 2025 Dec 10;43(35):3698-3705. doi: 10.1200/JCO-25-00925. Epub 2025 Sep 24.

Reference Type DERIVED
PMID: 40991874 (View on PubMed)

Hu B, Reagan PM, Sehn LH, Sharman JP, Hertzberg M, Zhang H, Kim A, Herbaux C, Molina L, Maruyama D, Stenner F, Chohan S, Kothari R, Lee Batlevi C, Hirata J, Sahin D, Lee C, Sugidono M, Tilly H. Subgroup analysis of older patients >/=60 years with diffuse large B-cell lymphoma in the phase 3 POLARIX study. Blood Adv. 2025 May 27;9(10):2489-2499. doi: 10.1182/bloodadvances.2024014707.

Reference Type DERIVED
PMID: 40085955 (View on PubMed)

Liao MZ, Deng R, Gibiansky L, Lu T, Agarwal P, Dere R, Lee C, Hirata J, Herbaux C, Salles G, Li C, Miles D. Ethnic sensitivity assessment: Polatuzumab vedotin pharmacokinetics in Asian and non-Asian patients with previously untreated diffuse large B-cell lymphoma in POLARIX. Clin Transl Sci. 2023 Dec;16(12):2744-2755. doi: 10.1111/cts.13669. Epub 2023 Oct 31.

Reference Type DERIVED
PMID: 37864313 (View on PubMed)

Song Y, Tilly H, Rai S, Zhang H, Jin J, Goto H, Terui Y, Shin HJ, Kim WS, Cao J, Feng J, Eom HS, Kim TM, Tsai XC, Gau JP, Koh H, Zhang L, Song Y, Yang Y, Li W, Huang H, Ando K, Sharman JP, Sehn LH, Bu L, Wang X, Jiang Y, Hirata J, Lee C, Zhu J, Izutsu K. Polatuzumab vedotin in previously untreated DLBCL: an Asia subpopulation analysis from the phase 3 POLARIX trial. Blood. 2023 Apr 20;141(16):1971-1981. doi: 10.1182/blood.2022017734.

Reference Type DERIVED
PMID: 36626583 (View on PubMed)

Varma G, Wang J, Diefenbach C. Polatuzumab vedotin in relapsed / refractory aggressive B-cell lymphoma. Expert Rev Anticancer Ther. 2022 Aug;22(8):795-803. doi: 10.1080/14737140.2022.2093191. Epub 2022 Jun 27.

Reference Type DERIVED
PMID: 35726803 (View on PubMed)

Tilly H, Morschhauser F, Sehn LH, Friedberg JW, Trneny M, Sharman JP, Herbaux C, Burke JM, Matasar M, Rai S, Izutsu K, Mehta-Shah N, Oberic L, Chauchet A, Jurczak W, Song Y, Greil R, Mykhalska L, Bergua-Burgues JM, Cheung MC, Pinto A, Shin HJ, Hapgood G, Munhoz E, Abrisqueta P, Gau JP, Hirata J, Jiang Y, Yan M, Lee C, Flowers CR, Salles G. Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. N Engl J Med. 2022 Jan 27;386(4):351-363. doi: 10.1056/NEJMoa2115304. Epub 2021 Dec 14.

Reference Type DERIVED
PMID: 34904799 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-002023-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GO39942

Identifier Type: -

Identifier Source: org_study_id