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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Large B-Cell Lymphoma
• Intervention / Treatment: Drug: Glofitamab; Drug: Polatuzumab vedotin; Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone

• Study Type: Interventional
• Enrollment (Actual): 1130
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1426
    • Instituto Alexander Fleming
  • Buenos Aires, Argentina, C1114AAN
    • Fundaleu
  • Buenos Aires, Argentina, C1118AAT
    • Hospital Aleman de Buenos Aires
  • Córdoba, Argentina, X5000JHQ
    • Sanatorio Allende
• Australia
  • New South Wales
    • Concord, New South Wales, Australia, 2139
      • Concord Repatriation General Hospital
    • Randwick, New South Wales, Australia, 2031
      • Prince of Wales Hospital- Department of Hematology
  • Queensland
    • Douglas, Queensland, Australia, 4812
      • Townsville Hospital
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital Woolloongabba
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Medical Centre
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Royal Hobart Hospital
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Eastern Health
    • Fitzroy, Victoria, Australia, 3065
      • St Vincent's Hospital Melbourne
    • Geelong, Victoria, Australia, 3220
      • Barwon Health
    • Melbourne, Victoria, Australia, 3000
      • Peter MacCallum Cancer Centre
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Sir Charles Gairdner Hospital
• Belgium
  • Anderlecht, Belgium, 1070
    • Institut Jules Bordet
  • Brussels, Belgium, 1090
    • UZ Brussel
  • Kortrijk, Belgium, 8500
    • Az Groeninge
  • Liège, Belgium, 4000
    • CHU de Liège (Sart Tilman)
• Brazil
  • Paraná
    • Curitiba, Paraná, Brazil, 81520-060
      • Hospital Erasto Gaertner
  • São Paulo
    • São Paulo, São Paulo, Brazil, 04502-001
      • Instituto D'Or Pesquisa e Ensino
    • São Paulo, São Paulo, Brazil, 05403-000
      • Hospital das Clinicas - FMUSP, Oncologia
• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Queen Elizabeth II Health Sciences Centre
  • Ontario
    • Brampton, Ontario, Canada, L6R 3J7
      • William Osler Health Centre - Brampton Civic Hospital
    • Greater Sudbury, Ontario, Canada, P3E 5J1
      • Health Sciences North
  • Quebec
    • Montreal, Quebec, Canada, H2X 0C2
      • Centre hospitalier de l'Université de Montréal (CHUM)
    • Québec, Quebec, Canada, G1J 1Z4
      • CHA Hopital de I enfant-Jesus
• China
  • Beijing, China, 100142
    • Beijing Cancer Hospital
  • Beijing, China, 100191
    • Peking University Third Hospital
  • Changchun, China, 130021
    • The First Hospital of Jilin University
  • Changsha, China, 410013
    • Hunan Cancer hospital
  • Chengdu, China, 610041
    • West China Hospital, Sichuan University
  • Chengdu, China, 610072
    • Sichuan Provincial People's Hospital
  • Chongqing, China, 400030
    • Second Affiliated Hospital of Third Military Medical University
  • Fuzhou, China, 350014
    • Fujian Cancer Hospital
  • Guangdong Province Guangzhou City, China, 510515
    • Southern Medical University Nanfang Hospital
  • Guangzhou, China, 510060
    • Sun Yat-sen University Cancer Center
  • Guangzhou, China, 510280
    • Zhujiang Hospital, Southern Medical University
  • Harbin, China, 150081
    • Harbin medical university cancer hospital
  • Hefei, China, 230031
    • Anhui Province Cancer Hospital
  • Jinan, China, 250117
    • Shandong Cancer Hospital
  • Nanchang, China, 330029
    • Jiangxi Cancer Hospital
  • Nanning, China, 530021
    • Guangxi Cancer Hospital of Guangxi Medical University
  • Shanghai, China, 200032
    • Fudan University Shanghai Cancer Center
  • Shenyang, China, 110004
    • Shengjing Hospital Of China Medical University
  • Shenyang, China, 110001
    • First Hospital of China Medical University
  • Suzhou, China, 215006
    • First Affiliated Hospital of Soochow University
  • Tianjin, China, 300060
    • Tianjin cancer hospital
  • Tianjin, China, 300020
    • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
  • Wuhan, China, 430022
    • Union Hospital Tongji Medical College Huazhong University of Science and Technology
  • Wuhan, China, 430030
    • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
  • Xiamen, China, 361003
    • The First Affiliated Hospital of Xiamen University
  • Zhengzhou, China, 450052
    • The First Affiliated Hospital of Zhengzhou University
• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg Universitetshospital
  • Aarhus N, Denmark, 8200
    • Aarhus Universitetshospital Skejby
  • Herning, Denmark, 7400
    • Regionshospitalet Gødstrup
• France
  • Lille, France, 59037
    • CHRU de Lille - Hopital Claude Huriez
  • Lyon, France, 69004
    • Hospices Civils de Lyon
  • Marseille, France, 13009
    • Institut Paoli Calmettes
  • Montpellier, France, 34295
    • CHU Montpellier
  • Nantes, France, 44093
    • CHU de Nantes - Hotel Dieu
  • Pessac, France, 33600
    • CHU de Bordeaux
  • Rennes, France, 35033
    • CHU DE RENNES - CHU Pontchaillou
  • Rouen, France, 76038
    • Centre Henri Becquerel
  • Strasbourg, France, 67098
    • CHU Strasbourg Hpital Hautepierre
  • Toulouse, France, 31100
    • IUCT Oncopole
• Germany
  • Berlin, Germany, 13353
    • Charité Universitätsmedizin Berlin
  • Brandenburg, Germany, 14770
    • Staedisches Klinikum Brandenburg
  • Chemnitz, Germany, 09116
    • Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III
  • Cologne, Germany, 50937
    • Universitatsklinikum Koln
  • Düsseldorf, Germany, 40225
    • Universitätsklinikum Düsseldorf
  • Erlangen, Germany, 91054
    • Universitätsklinikum Erlangen, Medizinische Klinik 5, Hämatologie und Internistische Onkologie
  • Essen, Germany, 45122
    • Universitätsklinikum Essen
  • Frankfurt, Germany, 60596
    • Universitatsklinikum Frankfurt
  • Hamburg, Germany, 20251
    • UKE Universitätsklinikum Hamburg-Eppendorf
  • Lübeck, Germany, 23538
    • Universitaetsklinikum Schleswig Holstein - Campus Luebeck
  • Magdeburg, Germany, 39120
    • Otto von Guericke Uni Magdeburg Uniklinik
  • München, Germany, 81675
    • Klinikum rechts der Isar der TU München, III. Medizinische Klinik
  • Münster, Germany, 48149
    • Universitätsklinikum Münster
  • Potsdam, Germany, 14467
    • Klinikum Ernst von Bergman
  • Stuttgart, Germany, 70174
    • Klinikum Stuttgart Katharinenhospital
  • Ulm, Germany, 89081
    • Universitatsklinikum Ulm
  • Würzburg, Germany, 97080
    • Universitatsklinikum Wurzburg
• Italy
  • Campania
    • Napoli, Campania, Italy, 80131
      • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • Policlinico S.Orsola-Malpighi
    • Modena, Emilia-Romagna, Italy, 41124
      • A.O. Universitaria Policlinico Di Modena
  • Liguria
    • Genoa, Liguria, Italy, 16132
      • A.O. Universitaria S. Martino Di Genova
  • Lombardy
    • Bergamo, Lombardy, Italy, 24127
      • Asst Papa Giovanni XXIII
    • Milan, Lombardy, Italy, 20133
      • Fond. IRCCS Istituto Nazionale Tumori
    • Rozzano, Lombardy, Italy, 20089
      • Istituto Clinico Humanitas
  • Sicily
    • Catania, Sicily, Italy, 95123
      • A. O. U. Policlinico G. Rodolico
  • Veneto
    • Vicenza, Veneto, Italy, 36100
      • Ospedale San Bortolo
• Japan
  • Aichi, Japan, 464-8681
    • Aichi Cancer Center
  • Aichi, Japan, 466-8560
    • Nagoya University Hospital
  • Aichi, Japan, 446-8602
    • Anjo Kosei Hospital
  • Chiba, Japan, 260-8717
    • Chiba Cancer Center
  • Chiba, Japan, 277-8577
    • National Cancer Center Hospital East
  • Fukuoka, Japan, 811-1395
    • National Hospital Organization Kyushu Cancer Center
  • Fukuoka, Japan, 812-8582
    • Kyushu University Hospital
  • Gifu, Japan, 501-1194
    • Gifu University Hospital
  • Hokkaido, Japan, 060-8648
    • Hokkaido University Hospital
  • Hyōgo, Japan, 650-0047
    • Kobe City Medical Center General Hospital
  • Kanagawa, Japan, 241-8515
    • Kanagawa Cancer Center
  • Kanagawa, Japan, 259-1193
    • Tokai University Hospital
  • Kyoto, Japan, 602-8566
    • University Hospital Kyoto Prefectural University of Medicine
  • Miyagi, Japan, 980-8574
    • Tohoku University Hospital
  • Okayama, Japan, 700-8558
    • Okayama University Hospital
  • Osaka, Japan, 589-8511
    • Kindai University Hospital
  • Osaka, Japan, 545-8586
    • Osaka Metropolitan University Hospital
  • Osaka, Japan, 573-1191
    • Kansai Medical University Hospital
  • Tokyo, Japan, 104-0045
    • National Cancer Center Hospital
  • Tokyo, Japan, 160-8582
    • Keio University Hospital
  • Tokyo, Japan, 135-8550
    • The Cancer Institute Hospital of JFCR
  • Tokyo, Japan, 113-8677
    • Komagome Hospital
  • Yamagata, Japan, 990-9585
    • Yamagata University Hospital
• Mexico
  • Mexico CITY (federal District)
    • Mexico City, Mexico CITY (federal District), Mexico, 03100
      • Health Pharma Professional Research
    • Mexico City, Mexico CITY (federal District), Mexico, 14000
      • Inst. Nacional de Cancerologia
  • Tlaxcala
    • Mexico, Tlaxcala, Mexico, 06726
      • Hospital General De Mexico
• Poland
  • Brzozów, Poland, 36-200
    • Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny
  • Gda?sk, Poland, 80-214
    • Uniwersyteckie Centrum Kliniczne
  • Katowice, Poland, 41-500
    • Pratia Onkologia Katowice
  • Kielce, Poland, 25-734
    • ?wi?tokrzyskie Centrum Onkologii SPZOZ
  • Krakow, Poland, 30-727
    • Pratia MCM Krakow
  • Wroc?aw, Poland, 50-367
    • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
• Puerto Rico
  • San Juan, Puerto Rico, 00918
    • Auxilio Mutuo Cancer Center
• South Korea
  • Busan, South Korea, 48108
    • Inje University Haeundae Paik Hospital
  • Busan, South Korea, 602-739
    • Pusan National University Hospital
  • Daegu, South Korea, 41931
    • Keimyung University Dongsan Medical Center
  • Daejeon, South Korea, 35015
    • Chungnam National University Hospital
  • Goyang-si, South Korea, 10408
    • National Cancer Center
  • Jeollanam-do, South Korea, 58128
    • Chonnam National University Hwasun Hospital
  • Seoul, South Korea, 03080
    • Seoul National University Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 06351
    • Samsung Medical Center
  • Seoul, South Korea, 03722
    • Severance Hospital
  • Seoul, South Korea, 02841
    • Korea University Anam Hospital
  • Seoul, South Korea, 06591
    • Seoul St Mary's Hospital
  • Seoul, South Korea, 07345
    • Yeouido St. Mary's Hospital
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañón
  • Madrid, Spain, 28027
    • Clinica Universidad de Navarra Madrid
  • Seville, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
  • LA Coruna
    • Santiago de Compostela, LA Coruna, Spain, 15706
      • Complejo Hospitalario Universitario de Santiago (CHUS)
  • Madrid
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Hospital Quiron de Madrid
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Clinica Universitaria de Navarra
• Switzerland
  • Basel, Switzerland, 4031
    • Universitaetsspital Basel
• Taiwan
  • Chai Yi, Taiwan, 613
    • Chang Gung Medical Foundation - Chai Yi
  • Kaoisung, Taiwan, 833
    • Chang Gung Medical Foundation - Kaohsiung;Oncology
  • Kaoshiung, Taiwan, 824
    • E-Da Cancer Hospital
  • Taichung, Taiwan, 404
    • China Medical University Hospital
  • Tainan, Taiwan, 736
    • Chi-Mei Hospital, Liouying
  • Taipei, Taiwan, 00100
    • National Taiwan University Hospital
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06200
    • Abdurrahman Yurtarslan Onkoloji Training and Research Hospital
  • Ankara, Turkey (Türkiye), 06620
    • Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi
  • Istanbul, Turkey (Türkiye), 34890
    • Marmara University Pendik Training and Research Hospital
  • Istanbul, Turkey (Türkiye), 34365
    • Istanbul VKV American Hospital
  • İzmit, Turkey (Türkiye), 41380
    • Kocaeli Univesity Medical Faculty
• United Kingdom
  • Barnet, United Kingdom, EN5 3DJ
    • Barnet Hospital
  • Blackpool, United Kingdom, FY3 8NR
    • Blackpool Victoria Hospital
  • Canterbury, United Kingdom, CT1 3NG
    • East Kent Hospitals University NHS Foundation Trust
  • Exeter, United Kingdom, EX2 5DW
    • Royal Devon and Exeter Hospital
  • Glasgow, United Kingdom, G12 0YN
    • Beatson West of Scotland Cancer Centre
  • Leeds, United Kingdom, LS9 7TF
    • Leeds Teaching Hosp NHS Trust
  • London, United Kingdom, SE1 9RT
    • Guy's Hospital
  • London, United Kingdom, NW1 2PG
    • University College London Hospitals NHS Foundation Trust - University College Hospital
  • Newcastle, United Kingdom, NE1 4LP
    • Newcastle University
  • Nottingham, United Kingdom, NG7 2UH
    • Nottingham University Hospitals NHS Trust
  • Oxford, United Kingdom, OX3 7LE
    • Churchill Hospital - Oxford Cancer & Haematology Centre
• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Oncology & Hematology, LLC
  • California
    • Anaheim, California, United States, 92806
      • Kaiser Permanente - Anaheim (E. La Palma)
    • Clovis, California, United States, 93611
      • University of California, San Francisco-Fresno
    • Duarte, California, United States, 91010
      • City Of Hope National Medical Center
    • Irvine, California, United States, 92618
      • City of Hope - Lennar Foundation Cancer Center
    • Los Angeles, California, United States, 90095
      • UCLA Jonsson Comprehensive Cancer Center
    • Los Angeles, California, United States, 90067
      • Valkyrie Clinical Trials
    • Roseville, California, United States, 95661
      • Kaiser Permanente - Roseville
    • Santa Clara, California, United States, 95051
      • Kaiser Permanente - Santa Clara
    • Stanford, California, United States, 94305-5821
      • Stanford Univ School of Med
    • Vallejo, California, United States, 94589
      • Kaiser Permanente Medical Ctr
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Cancer Center
    • Littleton, Colorado, United States, 80120
      • Rocky Mountain Cancer Center - Denver
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale University School of Medicine
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20010
      • MedStar Franklin Square Medical Center
  • Florida
    • Miami, Florida, United States, 33176
      • Miami Cancer Institute of Baptist Health, Inc.
    • Pembroke Pines, Florida, United States, 33028
      • Memorial Cancer Institute at Memorial West
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
      • Hawaii Cancer Care
  • Illinois
    • Chicago, Illinois, United States, 60637-1447
      • Robert H. Lurie Comprehensive Cancer Center of Northwestern University
    • Peoria, Illinois, United States, 61615
      • Illinois Cancer Care
    • Springfield, Illinois, United States, 62702
      • Springfield Clinic
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Ascension via Christi Research
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Institute
    • Boston, Massachusetts, United States, 02218
      • Boston Medical Center
  • Michigan
    • Novi, Michigan, United States, 48377-3600
      • Henry Ford Health System
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • M Health Fairview University of Minnesota Medical Center
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • St. Luke's Hospital
    • St Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68198-0600
      • University of Nebraska Medical Center
  • New York
    • Brooklyn, New York, United States, 11220
      • NYU Langone Hospital?Brooklyn
    • Mineola, New York, United States, 11501
      • NYU Long Island Hospital
    • New York, New York, United States, 10016
      • New York University Medical Center PRIME
    • New York, New York, United States, 10021
      • Weill Cornell Medical College-New York Presbyterian Hospital
    • New York, New York, United States, 10021
      • Memorial Sloan Kettering Cancer Center David H Koch Center for Cancer Care
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
    • Shirley, New York, United States, 11967
      • North Shore Hematology Oncology Association PC
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center
    • The Bronx, New York, United States, 10469
      • New York Cancer & Blood Specialists
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina at Chapel Hill
    • Charlotte, North Carolina, United States, 28204
      • Levine Cancer Institute
  • Oregon
    • Springfield, Oregon, United States, 97477
      • Willamette Valley Cancer Insitute and Research Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19107
      • Kimmel Cancer Center Thomas Jefferson University
    • Pittsburgh, Pennsylvania, United States, 15224
      • West Penn Hospital
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Cancer Institute
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404
      • Greco-Hainesworth Tennessee Oncology Centers for Research
    • Germantown, Tennessee, United States, 38138
      • West Cancer Center & Research Institute
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas Oncology - Baylor Charles A. Sammons Cancer Center
    • San Antonio, Texas, United States, 78217
      • USOR - Texas Oncology - San Antonio Northeast
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists
    • Newport News, Virginia, United States, 23606
      • Virginia Oncology Associates
  • Washington
    • Seattle, Washington, United States, 98109
      • University of Washington - Seattle Cancer Care Alliance
    • Seattle, Washington, United States, 98104-1360
      • Swedish Medical Center
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • Univ of Wisconsin Hosp & Clin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Previously untreated participants with CD20-positive LBCL
• 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:

• Contraindication to any of the individual components of Pola-R-CHP or glofitamab, including prior receipt of anthracyclines, or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glofitamab + Pola-R-CHP; Participants will receive glofitamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP).	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
Active Comparator: Pola-R-CHP; Participants will receive Pola-R-CHP.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival (PFS) as determined by Independent Review Facility (IRF)	From randomization to the first occurrence of disease progression or relapse, or death due to any cause, whichever occurs first (up to approximately 65 months)

Secondary Outcome Measures

Outcome Measure	Time Frame
PFS as determined by the investigator	From randomization to the first occurrence of disease progression or relapse or death from any cause, whichever occurs first (up to approximately 65 months)
PFS as determined by the investigator and IRF for participants with international prognostic index (IPI) 3-5	From randomization to the first occurrence of disease progression or relapse or death from any cause, whichever occurs first (up to 65 months)
Event-free survival efficacy causes (EFSeff)	From randomization to the earliest occurrence of disease progression or relapse; death due to any cause; initiation of new anti-lymphoma treatment; or positive biopsy for residual disease after treatment completion (up to approximately 65 months)
Complete response (CR) rate	At the end of treatment (up to approximately 65 months)
Objective response rate (ORR)	At treatment completion or discontinuation (up to approximately 65 months)
Overall survival (OS)	From randomization to death from any cause (up to approximately 65 months)
Duration of response (DOR)	From the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first (up to approximately 65 months)
Duration of complete response (DOCR)	From the first occurrence of a documented complete response (CR) to disease progression or death, whichever occurs first (up to approximately 65 months)
Disease-free survival (DFS)	From a documented CR at the end of treatment to disease progression or death, whichever occurs first (up to approximately 65 months)
Serum concentration of glofitamab	Up to approximately 65 months
Incidence of anti-drug antibodies (ADAs)	Baseline up to approximately 65 months
Proportion of participants experiencing a clinically meaningful improvement in physical functioning and fatigue (EORTC QLQ-C30) and lymphoma symptoms (FACT-Lym LymS)	Up to approximately 65 months
Time to deterioration in physical functioning and fatigue (EORTC QLQ-C30) and lymphoma symptoms (FACT-Lym LymS)	Up to approximately 65 months
Percentage of Participants with Adverse Events (AEs)	From randomization to the end of study (up to approximately 65 months)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 30, 2030

Study Registration Dates

• First Submitted: September 14, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Amino Acids, Peptides, and Proteins; Proteins; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Carbohydrates; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glycosides; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Pregnadienediols; Anthracyclines; Naphthacenes; Aminoglycosides; Antibodies, Monoclonal, Murine-Derived; Daunorubicin; Rituximab; Prednisone; Cyclophosphamide; Doxorubicin; polatuzumab vedotin; glofitamab
• Other Study ID Numbers: GO44145

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No