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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

2026-09-11

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

And 129 more locations on ClinicalTrials.gov