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
NCT ID: NCT06047080
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1130 participants
INTERVENTIONAL
2023-09-18
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Glofitamab + Pola-R-CHP
Participants will receive glofitamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP).
Glofitamab
Participants will receive intravenous (IV) glofitamab
Polatuzumab vedotin
Participants will receive IV polatuzumab vedotin in combination with R-CHP
Rituximab
Participants will receive IV rituximab
Cyclophosphamide
Participants will receive cyclophosphamide as part of CHP chemotherapy
Doxorubicin
Participants will receive IV doxorubicin
Prednisone
Participants will receive oral prednisone as part of CHP chemotherapy
Pola-R-CHP
Participants will receive Pola-R-CHP.
Polatuzumab vedotin
Participants will receive IV polatuzumab vedotin in combination with R-CHP
Rituximab
Participants will receive IV rituximab
Cyclophosphamide
Participants will receive cyclophosphamide as part of CHP chemotherapy
Doxorubicin
Participants will receive IV doxorubicin
Prednisone
Participants will receive oral prednisone as part of CHP chemotherapy
Interventions
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Glofitamab
Participants will receive intravenous (IV) glofitamab
Polatuzumab vedotin
Participants will receive IV polatuzumab vedotin in combination with R-CHP
Rituximab
Participants will receive IV rituximab
Cyclophosphamide
Participants will receive cyclophosphamide as part of CHP chemotherapy
Doxorubicin
Participants will receive IV doxorubicin
Prednisone
Participants will receive oral prednisone as part of CHP chemotherapy
Eligibility Criteria
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Inclusion Criteria
* Ability to provide tumor tissue
* International prognostic index (IPI) score 2-5
* Eastern cooperative oncology group (ECOG) performance status of 0, 1, or 2
* At least one bi-dimensionally measurable lesion, defined as \> 1.5 cm in its longest dimension as measured by CT or MRI
* Left ventricular ejection fraction (LVEF) \>/=50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
* Adequate hematologic function
* Negative HIV test at screening with exceptions as defined by the protocol
* Negative SARS-CoV-2 antigen or PCR test
Exclusion Criteria
* Prior solid organ transplantation
* Participants receiving systemic immunosuppressive agent such as, but not limited to cyclosporin, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents within 4 weeks prior to first dose of study treatment
* Current Grade \> 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
* History of indolent lymphoma (e.g., Follicular Lymphoma, Marginal Zone Lymphoma, Waldenstrom macroglobulinemia)
* Current diagnosis of the following: Follicular lymphoma grade 3B; transformations of indolent B-cell lymphomas (e.g., de novo transformed follicular lymphoma); mediastinal grey zone lymphoma; primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; primary large B-cell lymphoma of immune-privileged sites (encompassing primary diffuse large B-cell lymphoma of the CNS, primary large B-cell lymphoma of the vitreoretina and primary large B-cell lymphoma of the testis); primary effusion DLBCL; and primary cutaneous DLBCL, leg type
* Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma
* Prior treatment with systemic immunotherapeutic agents
* Prior use of any monoclonal antibody for the purposes of treating cancer within 3 months of the start of Cycle 1
* Any investigational therapy for the purposes of treating cancer within 28 days prior to the start of Cycle 1
* Prior radiotherapy to the mediastinal/pericardial region
* Prior therapy for LBCL, with the exception of corticosteriods
* Corticosteroid use \> 30 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control
* History of other malignant or non-malignant diseases that could affect compliance with the protocol or interpretation of results
* Significant or extensive history of cardiovascular disease
* Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
* Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
* Known or suspected chronic active Epstein-Barr viral infection
* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
* Active autoimmune disease requiring treatment
* Clinically significant liver disease
* Live, attenuated vaccine within 4 weeks before study treatment infusion on Day 1 of Cycle 1 or anticipation that such a live, attenuated vaccine will be required during the study. Live vaccines during the study and until participants B cells recover are prohibited
* Any active infection within 7 days prior to Cycle 1 Day 1 that would impact participant safety
* Suspected active or latent tuberculosis
* Positive test results for chronic hepatitis B infection, hepatitis C, or the human T-lymphotropic virus type 1 (HTLV-1)
* History of progressive multifocal leukoencephalopathy
18 Years
80 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Napoli, 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
Shimane University Hospital
Shimane, , 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
Hospital de Especialidades Centro Medico Nacional La Raza
Mexico City, , 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
Countries
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Other Identifiers
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GO44145
Identifier Type: -
Identifier Source: org_study_id