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ACTIVE NOT RECRUITING
NCT06047080
PHASE3

An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the efficacy and safety of glofitamab in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) vs Pola-R-CHP in participants with previously untreated CD20-positive large B-cell lymphoma (LBCL).

Official title: A Phase III, Multicenter, Randomized, Open-Label Study Comparing the Efficacy and Safety of Glofitamab (RO7082859) in Combination With Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1130

Start Date

2023-09-18

Completion Date

2030-10-30

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

DRUG

Glofitamab

Participants will receive intravenous (IV) glofitamab

DRUG

Polatuzumab vedotin

Participants will receive IV polatuzumab vedotin in combination with R-CHP

DRUG

Rituximab

Participants will receive IV rituximab

DRUG

Cyclophosphamide

Participants will receive cyclophosphamide as part of CHP chemotherapy

DRUG

Doxorubicin

Participants will receive IV doxorubicin

DRUG

Prednisone

Participants will receive oral prednisone as part of CHP chemotherapy

Locations (229)

Alaska Oncology & Hematology, LLC

Anchorage, Alaska, United States

Kaiser Permanente - Anaheim (E. La Palma)

Anaheim, California, United States

University of California, San Francisco-Fresno

Clovis, California, United States

City of Hope National Medical Center

Duarte, California, United States

City of Hope - Lennar Foundation Cancer Center

Irvine, California, United States

Valkyrie Clinical Trials

Los Angeles, California, United States

UCLA Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Kaiser Permanente - Roseville

Roseville, California, United States

Kaiser Permanente - Santa Clara

Santa Clara, California, United States

Stanford Univ School of Med

Stanford, California, United States

Kaiser Permanente Medical Ctr

Vallejo, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Rocky Mountain Cancer Center - Denver

Littleton, Colorado, United States

Yale University School Of Medicine

New Haven, Connecticut, United States

Medstar Franklin Square Medical Center

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

Miami Cancer Institute of Baptist Health, Inc.

Miami, Florida, United States

Memorial Cancer Institute at Memorial West

Pembroke Pines, Florida, United States

Hawaii Cancer Care

Honolulu, Hawaii, United States

Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Chicago, Illinois, United States

Illinois Cancer Care

Peoria, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

Ascension Via Christi Research

Wichita, Kansas, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

Henry Ford Health System

Novi, Michigan, United States

M Health Fairview University of Minnesota Medical Center

Minneapolis, Minnesota, United States

St. Luke's Hospital

Chesterfield, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

NYU Langone Hospital?Brooklyn

Brooklyn, New York, United States

NYU Long Island Hospital

Mineola, New York, United States

New York University Medical Center PRIME

New York, New York, United States

Memorial Sloan Kettering Cancer Center David H Koch Center for Cancer Care

New York, New York, United States

Weill Cornell Medical College-New York Presbyterian Hospital

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

North Shore Hematology Oncology Association PC

Shirley, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

New York Cancer & Blood Specialists

The Bronx, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Willamette Valley Cancer Insitute and Research Center

Springfield, Oregon, United States

Kimmel Cancer Center Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

West Penn Hospital

Pittsburgh, Pennsylvania, United States

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Greco-Hainesworth Tennessee Oncology Centers for Research

Chattanooga, Tennessee, United States

West Cancer Center & Research Institute

Germantown, Tennessee, United States

Tennessee Oncology

Nashville, Tennessee, United States

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

USOR - Texas Oncology - San Antonio Northeast

San Antonio, Texas, United States

University of Vermont

Burlington, Vermont, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Virginia Oncology Associates

Newport News, Virginia, United States

Swedish Medical Center

Seattle, Washington, United States

University of Washington - Seattle Cancer Care Alliance

Seattle, Washington, United States

West Virginia University

Morgantown, West Virginia, United States

Univ of Wisconsin Hosp & Clin

Madison, Wisconsin, United States

Instituto Alexander Fleming

Buenos Aires, Argentina

FUNDALEU

Buenos Aires, Argentina

Hospital Aleman de Buenos Aires

Buenos Aires, Argentina

Sanatorio Allende

Córdoba, Argentina

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Prince of Wales Hospital- Department of Hematology

Randwick, New South Wales, Australia

Townsville Hospital

Douglas, Queensland, Australia

Princess Alexandra Hospital Woolloongabba

Woolloongabba, Queensland, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Royal Hobart Hospital

Hobart, Tasmania, Australia

Eastern Health

Box Hill, Victoria, Australia

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Barwon Health

Geelong, Victoria, Australia

Peter Maccallum Cancer Centre

Melbourne, Victoria, Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Institut Jules Bordet

Anderlecht, Belgium

UZ Brussel

Brussels, Belgium

AZ Groeninge

Kortrijk, Belgium

CHU de Liège (Sart Tilman)

Liège, Belgium

Hospital Erasto Gaertner

Curitiba, Paraná, Brazil

Instituto D'Or Pesquisa e Ensino

São Paulo, São Paulo, Brazil

Hospital das Clinicas - FMUSP, Oncologia

São Paulo, São Paulo, Brazil

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

William Osler Health Centre - Brampton Civic Hospital

Brampton, Ontario, Canada

Health Sciences North

Greater Sudbury, Ontario, Canada

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

CHA Hopital de I enfant-Jesus

Québec, Quebec, Canada

Beijing Cancer Hospital

Beijing, China

Peking University Third Hospital

Beijing, China

The First Hospital of Jilin University

Changchun, China

Hunan Cancer Hospital

Changsha, China

West China Hospital, Sichuan University

Chengdu, China

Sichuan Provincial People's Hospital

Chengdu, China

Second Affiliated Hospital of Third Military Medical University

Chongqing, China

Fujian Cancer Hospital

Fuzhou, China

Southern Medical University Nanfang Hospital

Guangdong Province Guangzhou City, China

Sun yat-sen University Cancer Center

Guangzhou, China

Zhujiang Hospital, Southern Medical University

Guangzhou, China

Harbin Medical University Cancer Hospital

Harbin, China

Anhui Province Cancer Hospital

Hefei, China

Shandong Cancer Hospital

Jinan, China

Jiangxi Cancer Hospital

Nanchang, China

Guangxi Cancer Hospital of Guangxi Medical University

Nanning, China

Fudan University Shanghai Cancer Center

Shanghai, China

First Hospital of China Medical University

Shenyang, China

Shengjing Hospital of China Medical University

Shenyang, China

First Affiliated Hospital of Soochow University

Suzhou, China

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

Tianjin, China

Tianjin Cancer Hospital

Tianjin, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

The First Affiliated Hospital of Xiamen University

Xiamen, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Aalborg Universitetshospital

Aalborg, Denmark

Aarhus Universitetshospital Skejby

Aarhus N, Denmark

Regionshospitalet Gødstrup

Herning, Denmark

CHRU de Lille - Hopital Claude Huriez

Lille, France

Hospices Civils de Lyon

Lyon, France

Institut Paoli Calmettes

Marseille, France

CHU Montpellier

Montpellier, France

CHU de Nantes - Hotel Dieu

Nantes, France

CHU de Bordeaux

Pessac, France

CHU DE RENNES - CHU Pontchaillou

Rennes, France

Centre Henri Becquerel

Rouen, France

CHU Strasbourg Hpital Hautepierre

Strasbourg, France

IUCT Oncopole

Toulouse, France

Charité Universitätsmedizin Berlin

Berlin, Germany

Staedisches Klinikum Brandenburg

Brandenburg, Germany

Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III

Chemnitz, Germany

Universitätsklinikum Köln

Cologne, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Universitätsklinikum Erlangen, Medizinische Klinik 5, Hämatologie und Internistische Onkologie

Erlangen, Germany

Universitätsklinikum Essen

Essen, Germany

Universitätsklinikum Frankfurt

Frankfurt, Germany

UKE Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Universitaetsklinikum Schleswig Holstein - Campus Luebeck

Lübeck, Germany

Otto von Guericke Uni Magdeburg Uniklinik

Magdeburg, Germany

Klinikum rechts der Isar der TU München, III. Medizinische Klinik

München, Germany

Universitätsklinikum Münster

Münster, Germany

Klinikum Ernst von Bergman

Potsdam, Germany

Klinikum Stuttgart Katharinenhospital

Stuttgart, Germany

Universitätsklinikum Ulm

Ulm, Germany

Universitätsklinikum Würzburg

Würzburg, Germany

Istituto Nazionale Tumori Irccs Fondazione g. Pascale

Naples, Campania, Italy

Policlinico S.Orsola-Malpighi

Bologna, Emilia-Romagna, Italy

A.O. Universitaria Policlinico Di Modena

Modena, Emilia-Romagna, Italy

A.O. Universitaria S. Martino Di Genova

Genoa, Liguria, Italy

Asst Papa Giovanni Xxiii

Bergamo, Lombardy, Italy

Fond. IRCCS Istituto Nazionale Tumori

Milan, Lombardy, Italy

Istituto Clinico Humanitas

Rozzano, Lombardy, Italy

A. O. U. Policlinico G. Rodolico

Catania, Sicily, Italy

Ospedale San Bortolo

Vicenza, Veneto, Italy

Anjo Kosei Hospital

Aichi, Japan

Aichi Cancer Center

Aichi, Japan

Nagoya University Hospital

Aichi, Japan

Chiba Cancer Center

Chiba, Japan

National Cancer Center Hospital East

Chiba, Japan

National Hospital Organization Kyushu Cancer Center

Fukuoka, Japan

Kyushu University Hospital

Fukuoka, Japan

Gifu University Hospital

Gifu, Japan

Hokkaido University Hospital

Hokkaido, Japan

Kobe City Medical Center General Hospital

Hyōgo, Japan

Kanagawa Cancer Center

Kanagawa, Japan

Tokai University Hospital

Kanagawa, Japan

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Japan

Tohoku University Hospital

Miyagi, Japan

Okayama University Hospital

Okayama, Japan

Osaka Metropolitan University Hospital

Osaka, Japan

Kansai Medical University Hospital

Osaka, Japan

Kindai University Hospital

Osaka, Japan

National Cancer Center Hospital

Tokyo, Japan

Komagome Hospital

Tokyo, Japan

The Cancer Institute Hospital of JFCR

Tokyo, Japan

Keio University Hospital

Tokyo, Japan

Yamagata University Hospital

Yamagata, Japan

Health Pharma Professional Research

Mexico City, Mexico CITY (federal District), Mexico

Inst. Nacional de Cancerologia

Mexico City, Mexico CITY (federal District), Mexico

Hospital General de Mexico

Mexico, Tlaxcala, Mexico

Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny

Brzozów, Poland

Uniwersyteckie Centrum Kliniczne

Gda?sk, Poland

Pratia Onkologia Katowice

Katowice, Poland

?wi?tokrzyskie Centrum Onkologii SPZOZ

Kielce, Poland

PRATIA MCM Kraków

Krakow, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

Wroc?aw, Poland

Auxilio Mutuo Cancer Center

San Juan, Puerto Rico

Inje university Haeundae Paik Hospital

Busan, South Korea

Pusan National University Hospital

Busan, South Korea

Keimyung University Dongsan Medical Center

Daegu, South Korea

Chungnam National University Hospital

Daejeon, South Korea

National Cancer Center

Goyang-si, South Korea

Chonnam National University Hwasun Hospital

Jeollanam-do, South Korea

Korea University Anam Hospital

Seoul, 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

Seoul St Mary's Hospital

Seoul, South Korea

Yeouido St. Mary's Hospital

Seoul, South Korea

Complejo Hospitalario Universitario de Santiago (CHUS)

Santiago de Compostela, LA Coruna, Spain

Hospital Quiron de Madrid

Pozuelo de Alarcón, Madrid, Spain

Clinica Universitaria de Navarra

Pamplona, Navarre, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Clinica Universidad de Navarra Madrid

Madrid, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital Clinico Universitario de Valencia

Valencia, Spain

Universitaetsspital Basel

Basel, Switzerland

Chang Gung Medical Foundation - Chai Yi

Chai Yi, Taiwan

Chang Gung Medical Foundation - Kaohsiung;Oncology

Kaoisung, Taiwan

E-Da Cancer Hospital

Kaoshiung, Taiwan

China Medical University Hospital

Taichung, Taiwan

Chi-Mei Hospital, Liouying

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Abdurrahman Yurtarslan Onkoloji Training and Research Hospital

Ankara, Turkey (Türkiye)

Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi

Ankara, Turkey (Türkiye)

Istanbul VKV American Hospital

Istanbul, Turkey (Türkiye)

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

Kocaeli Univesity Medical Faculty

İzmit, Turkey (Türkiye)

Barnet Hospital

Barnet, United Kingdom

Blackpool Victoria Hospital

Blackpool, United Kingdom

East Kent Hospitals University NHS Foundation Trust

Canterbury, United Kingdom

Royal Devon and Exeter Hospital

Exeter, United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Leeds Teaching Hosp NHS Trust

Leeds, United Kingdom

University College London Hospitals NHS Foundation Trust - University College Hospital

London, United Kingdom

Guy'S Hospital

London, United Kingdom

Newcastle University

Newcastle, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Churchill Hospital - Oxford Cancer & Haematology Centre

Oxford, United Kingdom