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ACTIVE NOT RECRUITING
NCT03274492
PHASE3

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

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).

Official title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Polatuzumab Vedotin in Combination With Rituximab and CHP (R-CHP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With Diffuse Large B-Cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1000

Start Date

2017-11-16

Completion Date

2026-04-30

Last Updated

2026-02-06

Healthy Volunteers

No

Interventions

DRUG

Polatuzumab Vedotin

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

DRUG

Rituximab

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

DRUG

Cyclophosphamide

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

DRUG

Doxorubicin

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

DRUG

Vincristine

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

DRUG

Vincristine Placebo

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

DRUG

Prednisone

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

DRUG

Polatuzumab vedotin Placebo

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

Locations (215)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Southern Cancer Center

Daphne, Alabama, United States

City of Hope

Duarte, California, United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Rocky Mountain Cancer Centers, LLP

Aurora, Colorado, United States

Georgetown University Medical Center

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

Florida Cancer Specialists - Fort Myers (New Hampshire Ct)

Fort Myers, Florida, United States

Florida Cancer Specialists & Research Institute

St. Petersburg, Florida, United States

Florida Cancer Specialists

West Palm Beach, Florida, United States

Emory University

Atlanta, Georgia, United States

Illinois Cancer Specialists

Arlington Heights, Illinois, United States

University of Louisville Hospital

Louisville, Kentucky, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

University of Maryland

Baltimore, Maryland, United States

Johns Hopkins University

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Karmanos Cancer Center

Detroit, Michigan, United States

Washington University

St Louis, Missouri, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Memorial Sloan Kettering Cancer Center - Commack

Commack, New York, United States

Memorial Sloan Kettering Cancer Center at Westchester

Harrison, New York, United States

New York University Cancer Cen

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

University of North Carolina School of Medicine

Chapel Hill, North Carolina, United States

Levine Cancer Institute - Clincal Trials Administration

Charlotte, North Carolina, United States

Oncology/Hematology Care Clinical Trials LLC

Cincinnati, Ohio, United States

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Oncology Associates of Oregon, P.C

Eugene, Oregon, United States

Northwest Cancer Specialists - Portland (SW Barnes Rd)

Portland, Oregon, United States

Oregon HSU

Portland, Oregon, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center Cancer Center

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina Hospital

Charleston, South Carolina, United States

Prisma Health ? Upstate

Greenville, South Carolina, United States

Greco-Hainesworth Centers for Research

Chattanooga, Tennessee, United States

Tennessee Oncology - Nashville

Nashville, Tennessee, United States

Texas Oncology-Austin Midtown

Austin, Texas, United States

Texas Oncology San Antonio Medical Center

San Antonio, Texas, United States

Texas Oncology-Tyler

Tyler, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Oncology Associates of Southwest Virginia, Inc.

Blacksburg, Virginia, United States

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

Seattle Cancer Care Alliance

Seattle, Washington, United States

West Virginia Uni Med. Center - Robert Byrd Health Science

Morgantown, West Virginia, United States

Concord Repatriation General Hospital

Concord, New South Wales, Australia

St George Hospital

Kogarah, New South Wales, Australia

Prince of Wales Hospital

Randwick, New South Wales, Australia

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Princess Alexandra Hospital Woolloongabba

Woolloongabba, Queensland, Australia

Ashford Cancer Center Research

Kurralta Park, South Australia, Australia

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

Woodville South, South Australia, Australia

Monash Medical Centre

Clayton, Victoria, Australia

Austin Hospital

Heidelberg, Victoria, Australia

Paracelsus Medizinischen Privatuniversitaet-Salzburger Landeskliniken (SALK)

Salzburg, Austria

Medizinische Universität Wien

Vienna, Austria

Wiener Gesundheitsverbund ? Klinik Ottakring

Vienna, Austria

UZ Gent

Ghent, Belgium

CH Jolimont - Lobbes (Jolimont)

Haine-Saint-Paul, Belgium

CHU UCL Mont-Godinne

Mont-godinne, Belgium

Hospital Erasto Gaertner

Curitiba, Paraná, Brazil

Hospital das Clinicas - UFRGS

Porto Alegre, Rio Grande do Sul, Brazil

Centro de Hematologia e Hemoterapia - HEMOCENTRO UNICAMP

Campinas, São Paulo, Brazil

Hospital das Clinicas - FMUSP

São Paulo, São Paulo, Brazil

University of Alberta Hospital

Edmonton, Alberta, Canada

BC Cancer ? Vancouver

Vancouver, British Columbia, Canada

CancerCare Manitoba (CCMB)

Winnipeg, Manitoba, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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

Montreal, Quebec, Canada

CHU de Quebec-Universite Laval

Québec, Canada

Beijing Cancer Hospital

Beijing, China

The First Hospital of Jilin University

Changchun, China

Fujian Provincial Cancer Hospital

Fuzhou, China

Sun Yet-sen University Cancer Center

Guangzhou, China

The First Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, China

Jiangsu Cancer Hospital

Nanjing, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Fudan University Shanghai Cancer Center

Shanghai, China

Shanghai East Hospital, Tongji University

Shanghai, China

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

Tianjin, China

Tianjin Medical University Cancer Institute & Hospital

Tianjing, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

Henan Cancer Hospital

Zhengzhou, China

Fakultni Nemocnice Hradec Kralove (FNHK)

Hradec Králové, Czechia

Fakultni nemocnice Olomouc

Olomouc, Czechia

Fakultni nemocnice Ostrava

Ostrava - Poruba, Czechia

Fakultni Nemocnice Kralovske Vinohrady (FNKV)

Prague, Czechia

Všeobecná fakultní nemocnice v Praze

Prague, Czechia

CHU Amiens - Hopital Sud

Amiens, France

CHU Angers

Angers, France

Centre Hospitalier de La Cote Basque

Bayonne, France

Hopital Jean Minjoz

Besançon, France

Institut Bergonie

Bordeaux, France

Institut d'Hématologie de Basse Normandie

Caen, France

CH Metropole de Savoie

Chambéry, France

Hopital Henri Mondor

Créteil, France

CHU de Dijon - Hopital le Bocage

Dijon, France

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

Grenoble, France

CHD Vendée

La Roche-sur-Yon, France

Hôpital Albert Michallon

La Tronche, France

Clinique Victor Hugo - Centre Jean Bernard

Le Mans, France

Hôpital Saint Vincent de Paul

Lille, France

Hopital Claude Huriez

Lille, France

Hopital Uni Ire Dupuytren

Limoges, France

Centre Leon Berard

Lyon, France

CHU Montpellier - Saint ELOI

Montpellier, France

CHU de Nantes - Hotel Dieu

Nantes, France

Centre Antoine Lacassagne

Nice, France

CHU de Nîmes - Hôpital Carémeau

Nîmes, France

Hôpital Saint-Louis

Paris, France

Gh Necker Enfants Malades

Paris, France

Hopital Saint Jean

Perpignan, France

Hopital Haut-Leveque - Centre Francois Magendie

Pessac, France

CHU Lyon Sud - Service Hématologie

Pierre-Bénite, France

CHU de Poitiers

Poitiers, France

Centre Hospitalier de Quimper Cornouaille (CHIC)

Quimper, France

Hopital Pontchaillou

Rennes, France

Centre Henri Becquerel

Rouen, France

Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll

Saint-Brieuc, France

Pôle de Cancérologie ? CHU de Saint?Etienne'

Saint-Priest-en-Jarez, France

Chru de Strasbourg

Strasbourg, France

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

Toulouse, France

CHU Bretonneau

Tours, France

CHU de Brabois

Vandœuvre-lès-Nancy, France

CH Bretagne Atlantique

Vannes, France

Institut Gustave Roussy

Villejuif, France

Vivantes Klinikum Am Urban

Berlin, Germany

Städtisches Klinikum Dessau

Dessau, Germany

Universitätsklinikum Essen

Essen, Germany

Universitaetsklinikum Halle (Saale)

Halle, Germany

Universitaetsklinikum Heidelberg

Heidelberg, Germany

InVO - Institut für Versorgungsforschung in der Onkologie GbR

Koblenz, Germany

Universitatsklinikum Munster

Münster, Germany

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, Abruzzo, Italy

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

Brescia, Abruzzo, Italy

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

Rome, Abruzzo, Italy

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

Reggio Emilia, Emilia-Romagna, Italy

IRCCS AOU San Martino - IST

Genoa, Liguria, Italy

Istituto Nazionale dei Tumori

Monza, Lombardy, Italy

Azienda Ospedaliero Universitaria Maggiore della Carita di Novara

Novara, Piedmont, Italy

Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

Turin, Piedmont, Italy

Aichi Cancer Center

Aichi, Japan

Chiba Cancer Center

Chiba, Japan

National Cancer Center Hospital East

Chiba, Japan

Chiba University Hospital

Chūōku, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

Kyushu University Hospital

Fukuoka, Japan

Hiroshima University Hospital

Hiroshima, Japan

Hokkaido University Hospital

Hokkaido, Japan

Kobe City Medical Center General Hospital

Hyōgo, Japan

Tokai University Hospital

Isehara-shi, Japan

Kumamoto University Hospital

Kumamoto, Japan

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Japan

Tohoku University Hospital

Miyagi, Japan

Osaka Metropolitan University Hospital

Osaka, Japan

The University of Osaka Hospital

Osaka, Japan

Kindai University Hospital

Osaka, Japan

Jichi Medical University Hospital

Tochigi, Japan

National Cancer Center Hospital

Tokyo, Japan

The Cancer Institute Hospital of JFCR

Tokyo, Japan

Auckland City Hospital, Cancer and Blood Research

Auckland, New Zealand

Canterbury Health Laboratories

Christchurch, New Zealand

Waikato Hospital

Hamilton, New Zealand

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

Chorzów, Poland

PRATIA MCM Kraków

Krakow, Poland

Uniwersytet Medyczny w Lodzi

Lodz, Poland

SPZOZ Ministerstwa Spraw Wewn?trznych i Administracji w Poznaniu

Późna, Poland

Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy

Warsaw, Poland

Leningrad Regional Clinical Hospital

Saint Petersburg, Sankt-Peterburg, Russia

Pusan National University Hospital

Busan, South Korea

National Cancer Center

Gyeonggi-do, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Pusan National University Yangsan Hospital

Yangsan, South Korea

Complejo Hospitalario de Navarra

Pamplona, Navarre, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Clinic Barcelona

Barcelona, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Institut Catala d Oncologia Hospitalet

Barcelona, Spain

Hospital San Pedro de Alcantara

Cáceres, Spain

Hospital Universitari Dr. Josep Trueta

Girona, Spain

Hospital Universitario La Paz

Madrid, Spain

Fundación Jimenez Díaz

Madrid, Spain

Hospital Quiron Madrid

Madrid, Spain

Hospital Universitario Virgen de la Victoria

Málaga, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

Universitätsspital Basel Gynäkologie - Onkologie

Basel, Switzerland

Kaohsiung Medical University Hospital, Cancer Center

Kaohsiung City, Taiwan

China Medical University Hospital

Taichung, Taiwan

Chi-Mei Hospital, Liouying

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Ankara University Faculty of Medicine Cebeci Hospital

Ankara, Turkey (Türkiye)

Ege Üniversitesi Tip Fakültesi

Lzmir, Turkey (Türkiye)

Dokuz Eylul Universitesi Tip Fakultesi

Lzmir, Turkey (Türkiye)

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

Cherkassy, Chernihiv Governorate, Ukraine

MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care

Lviv, Chernihiv Governorate, Ukraine

Khmelnytskyi Regional Hospital

Khmelnytskyi, Kharkiv Governorate, Ukraine

Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital

Cambridge, United Kingdom

East Kent Hospitals University NHS Foundation Trust

Canterbury, United Kingdom

University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary

Leicester, United Kingdom

Barts Health NHS Trust

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

The Newcastle upon Tyne Hospitals NHS Foundation Trust. Freeman Hospital

Newcastle upon Tyne, United Kingdom

Nottingham City Hospital

Nottingham, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom