| Condition or Disease | Intervention/Treatment |
|---|---|
Large B-Cell Lymphoma | Drug: GlofitamabDrug: Polatuzumab vedotin |
ClinicalTrials.gov processed this data on March 2026. Link to the current ClinicalTrials.gov record .
| Condition or Disease | Intervention/Treatment |
|---|---|
Large B-Cell Lymphoma | Drug: GlofitamabDrug: Polatuzumab vedotin |
| Study Type | Interventional |
|---|---|
| Actual Enrollment | 1130 participants |
| Design Allocation | Randomized |
| Interventional Model | Parallel Assignment |
| Masking | None (Open Label) |
| Primary Purpose | Treatment |
| 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 |
| Study Start Date | September 17, 2023 |
| Actual Primary Completion Date | 1yr 4mos from now |
| Actual Study Completion Date | 4yrs 5mos from now |
| Group/Cohort | Intervention/Treatment |
|---|---|
|
|
|
|
| Ages Eligible for Study | (Adult, Older Adult) |
|---|---|
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | No |
| 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 |
| Sponsors and Collaborators | Hoffmann-La Roche |
|---|---|
| Locations | Alaska Oncology & Hematology, LLC | Anchorage Alaska, United States, 99508Kaiser Permanente - Anaheim (E. La Palma) | Anaheim California, United States, 92806University of California, San Francisco-Fresno | Clovis California, United States, 93611City of Hope National Medical Center | Duarte California, United States, 91010City of Hope - Lennar Foundation Cancer Center | Irvine California, United States, 92618Valkyrie Clinical Trials | Los Angeles California, United States, 90067UCLA Jonsson Comprehensive Cancer Center | Los Angeles California, United States, 90095Kaiser Permanente - Roseville | Roseville California, United States, 95661Kaiser Permanente - Santa Clara | Santa Clara California, United States, 95051Stanford Univ School of Med | Stanford California, United States, 94305-5821Kaiser Permanente Medical Ctr | Vallejo California, United States, 94589University of Colorado Cancer Center | Aurora Colorado, United States, 80045Rocky Mountain Cancer Center - Denver | Littleton Colorado, United States, 80120Yale University School Of Medicine | New Haven Connecticut, United States, 06519Medstar Franklin Square Medical Center | Washington D.C. District of Columbia, United States, 20010Miami Cancer Institute of Baptist Health, Inc. | Miami Florida, United States, 33176Memorial Cancer Institute at Memorial West | Pembroke Pines Florida, United States, 33028Hawaii Cancer Care | Honolulu Hawaii, United States, 96813Robert H. Lurie Comprehensive Cancer Center of Northwestern University | Chicago Illinois, United States, 60637-1447Illinois Cancer Care | Peoria Illinois, United States, 61615Springfield Clinic | Springfield Illinois, United States, 62702University of Iowa | Iowa City Iowa, United States, 52242Ascension Via Christi Research | Wichita Kansas, United States, 67214Ochsner Medical Center | New Orleans Louisiana, United States, 70121Massachusetts General Hospital | Boston Massachusetts, United States, 02114Dana Farber Cancer Institute | Boston Massachusetts, United States, 02115Boston Medical Center | Boston Massachusetts, United States, 02218Henry Ford Health System | Novi Michigan, United States, 48377-3600M Health Fairview University of Minnesota Medical Center | Minneapolis Minnesota, United States, 55455St. Luke's Hospital | Chesterfield Missouri, United States, 63017Washington University School of Medicine | St Louis Missouri, United States, 63110University of Nebraska Medical Center | Omaha Nebraska, United States, 68198-0600NYU Langone Hospital?Brooklyn | Brooklyn New York, United States, 11220NYU Long Island Hospital | Mineola New York, United States, 11501New York University Medical Center PRIME | New York New York, United States, 10016Memorial Sloan Kettering Cancer Center David H Koch Center for Cancer Care | New York New York, United States, 10021Weill Cornell Medical College-New York Presbyterian Hospital | New York New York, United States, 10021University of Rochester Medical Center | Rochester New York, United States, 14642North Shore Hematology Oncology Association PC | Shirley New York, United States, 11967Montefiore Medical Center | The Bronx New York, United States, 10467New York Cancer & Blood Specialists | The Bronx New York, United States, 10469University of North Carolina at Chapel Hill | Chapel Hill North Carolina, United States, 27514Levine Cancer Institute | Charlotte North Carolina, United States, 28204Willamette Valley Cancer Insitute and Research Center | Springfield Oregon, United States, 97477Kimmel Cancer Center Thomas Jefferson University | Philadelphia Pennsylvania, United States, 19107Fox Chase Cancer Center | Philadelphia Pennsylvania, United States, 19111West Penn Hospital | Pittsburgh Pennsylvania, United States, 15224Avera Cancer Institute | Sioux Falls South Dakota, United States, 57105Greco-Hainesworth Tennessee Oncology Centers for Research | Chattanooga Tennessee, United States, 37404West Cancer Center & Research Institute | Germantown Tennessee, United States, 38138Tennessee Oncology | Nashville Tennessee, United States, 37203Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas Texas, United States, 75246USOR - Texas Oncology - San Antonio Northeast | San Antonio Texas, United States, 78217University of Vermont | Burlington Vermont, United States, 05401Virginia Cancer Specialists | Fairfax Virginia, United States, 22031Virginia Oncology Associates | Newport News Virginia, United States, 23606Swedish Medical Center | Seattle Washington, United States, 98104-1360University of Washington - Seattle Cancer Care Alliance | Seattle Washington, United States, 98109West Virginia University | Morgantown West Virginia, United States, 26506Univ of Wisconsin Hosp & Clin | Madison Wisconsin, United States, 53792Instituto Alexander Fleming | Buenos Aires , Argentina, 1426FUNDALEU | Buenos Aires , Argentina, C1114AANHospital Aleman de Buenos Aires | Buenos Aires , Argentina, C1118AATSanatorio Allende | Córdoba , Argentina, X5000JHQConcord Repatriation General Hospital | Concord New South Wales, Australia, 2139Prince of Wales Hospital- Department of Hematology | Randwick New South Wales, Australia, 2031Townsville Hospital | Douglas Queensland, Australia, 4812Princess Alexandra Hospital Woolloongabba | Woolloongabba Queensland, Australia, 4102Flinders Medical Centre | Bedford Park South Australia, Australia, 5042Royal Hobart Hospital | Hobart Tasmania, Australia, 7000Eastern Health | Box Hill Victoria, Australia, 3128St Vincent's Hospital Melbourne | Fitzroy Victoria, Australia, 3065Barwon Health | Geelong Victoria, Australia, 3220Peter Maccallum Cancer Centre | Melbourne Victoria, Australia, 3000Sir Charles Gairdner Hospital | Nedlands Western Australia, Australia, 6009Institut Jules Bordet | Anderlecht , Belgium, 1070UZ Brussel | Brussels , Belgium, 1090AZ Groeninge | Kortrijk , Belgium, 8500CHU de Liège (Sart Tilman) | Liège , Belgium, 4000Hospital Erasto Gaertner | Curitiba Paraná, Brazil, 81520-060Instituto D'Or Pesquisa e Ensino | São Paulo São Paulo, Brazil, 04502-001Hospital das Clinicas - FMUSP, Oncologia | São Paulo São Paulo, Brazil, 05403-000Queen Elizabeth II Health Sciences Centre | Halifax Nova Scotia, Canada, B3H 2Y9William Osler Health Centre - Brampton Civic Hospital | Brampton Ontario, Canada, L6R 3J7Health Sciences North | Greater Sudbury Ontario, Canada, P3E 5J1Centre Hospitalier de l'Universite de Montreal (CHUM) | Montreal Quebec, Canada, H2X 0C2CHA Hopital de I enfant-Jesus | Québec Quebec, Canada, G1J 1Z4Beijing Cancer Hospital | Beijing , China, 100142Peking University Third Hospital | Beijing , China, 100191The First Hospital of Jilin University | Changchun , China, 130021Hunan Cancer Hospital | Changsha , China, 410013West China Hospital, Sichuan University | Chengdu , China, 610041Sichuan Provincial People's Hospital | Chengdu , China, 610072Second Affiliated Hospital of Third Military Medical University | Chongqing , China, 400030Fujian Cancer Hospital | Fuzhou , China, 350014Southern Medical University Nanfang Hospital | Guangdong Province Guangzhou City , China, 510515Sun yat-sen University Cancer Center | Guangzhou , China, 510060Zhujiang Hospital, Southern Medical University | Guangzhou , China, 510280Harbin Medical University Cancer Hospital | Harbin , China, 150081Anhui Province Cancer Hospital | Hefei , China, 230031Shandong Cancer Hospital | Jinan , China, 250117Jiangxi Cancer Hospital | Nanchang , China, 330029Guangxi Cancer Hospital of Guangxi Medical University | Nanning , China, 530021Fudan University Shanghai Cancer Center | Shanghai , China, 200032First Hospital of China Medical University | Shenyang , China, 110001Shengjing Hospital of China Medical University | Shenyang , China, 110004First Affiliated Hospital of Soochow University | Suzhou , China, 215006Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences | Tianjin , China, 300020Tianjin Cancer Hospital | Tianjin , China, 300060Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan , China, 430022Tongji Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan , China, 430030The First Affiliated Hospital of Xiamen University | Xiamen , China, 361003The First Affiliated Hospital of Zhengzhou University | Zhengzhou , China, 450052Aalborg Universitetshospital | Aalborg , Denmark, 9000Aarhus Universitetshospital Skejby | Aarhus N , Denmark, 8200Regionshospitalet Gødstrup | Herning , Denmark, 7400CHRU de Lille - Hopital Claude Huriez | Lille , France, 59037Hospices Civils de Lyon | Lyon , France, 69004Institut Paoli Calmettes | Marseille , France, 13009CHU Montpellier | Montpellier , France, 34295CHU de Nantes - Hotel Dieu | Nantes , France, 44093CHU de Bordeaux | Pessac , France, 33600CHU DE RENNES - CHU Pontchaillou | Rennes , France, 35033Centre Henri Becquerel | Rouen , France, 76038CHU Strasbourg Hpital Hautepierre | Strasbourg , France, 67098IUCT Oncopole | Toulouse , France, 31100Charité Universitätsmedizin Berlin | Berlin , Germany, 13353Staedisches Klinikum Brandenburg | Brandenburg an der Havel , Germany, 14770Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III | Chemnitz , Germany, 09116Universitätsklinikum Köln | Cologne , Germany, 50937Universitätsklinikum Düsseldorf | Düsseldorf , Germany, 40225Universitätsklinikum Erlangen, Medizinische Klinik 5, Hämatologie und Internistische Onkologie | Erlangen , Germany, 91054Universitätsklinikum Essen | Essen , Germany, 45122Universitätsklinikum Frankfurt | Frankfurt , Germany, 60596UKE Universitätsklinikum Hamburg-Eppendorf | Hamburg , Germany, 20251Universitaetsklinikum Schleswig Holstein - Campus Luebeck | Lübeck , Germany, 23538Otto von Guericke Uni Magdeburg Uniklinik | Magdeburg , Germany, 39120Klinikum rechts der Isar der TU München, III. Medizinische Klinik | München , Germany, 81675Universitätsklinikum Münster | Münster , Germany, 48149Klinikum Ernst von Bergman | Potsdam , Germany, 14467Klinikum Stuttgart Katharinenhospital | Stuttgart , Germany, 70174Universitätsklinikum Ulm | Ulm , Germany, 89081Universitätsklinikum Würzburg | Würzburg , Germany, 97080Istituto Nazionale Tumori Irccs Fondazione g. Pascale | Naples Campania, Italy, 80131Policlinico S.Orsola-Malpighi | Bologna Emilia-Romagna, Italy, 40138A.O. Universitaria Policlinico Di Modena | Modena Emilia-Romagna, Italy, 41124A.O. Universitaria S. Martino Di Genova | Genoa Liguria, Italy, 16132Asst Papa Giovanni Xxiii | Bergamo Lombardy, Italy, 24127Fond. IRCCS Istituto Nazionale Tumori | Milan Lombardy, Italy, 20133Istituto Clinico Humanitas | Rozzano Lombardy, Italy, 20089A. O. U. Policlinico G. Rodolico | Catania Sicily, Italy, 95123Ospedale San Bortolo | Vicenza Veneto, Italy, 36100Anjo Kosei Hospital | Aichi , Japan, 446-8602Aichi Cancer Center | Aichi , Japan, 464-8681Nagoya University Hospital | Aichi , Japan, 466-8560Chiba Cancer Center | Chiba , Japan, 260-8717National Cancer Center Hospital East | Chiba , Japan, 277-8577National Hospital Organization Kyushu Cancer Center | Fukuoka , Japan, 811-1395Kyushu University Hospital | Fukuoka , Japan, 812-8582Gifu University Hospital | Gifu , Japan, 501-1194Hokkaido University Hospital | Hokkaido , Japan, 060-8648Kobe City Medical Center General Hospital | Hyōgo , Japan, 650-0047Kanagawa Cancer Center | Kanagawa , Japan, 241-8515Tokai University Hospital | Kanagawa , Japan, 259-1193University Hospital Kyoto Prefectural University of Medicine | Kyoto , Japan, 602-8566Tohoku University Hospital | Miyagi , Japan, 980-8574Okayama University Hospital | Okayama , Japan, 700-8558Osaka Metropolitan University Hospital | Osaka , Japan, 545-8586Kansai Medical University Hospital | Osaka , Japan, 573-1191Kindai University Hospital | Osaka , Japan, 589-8511National Cancer Center Hospital | Tokyo , Japan, 104-0045Komagome Hospital | Tokyo , Japan, 113-8677The Cancer Institute Hospital of JFCR | Tokyo , Japan, 135-8550Keio University Hospital | Tokyo , Japan, 160-8582Yamagata University Hospital | Yamagata , Japan, 990-9585Health Pharma Professional Research | Mexico City Mexico CITY (federal District), Mexico, 03100Inst. Nacional de Cancerologia | Mexico City Mexico CITY (federal District), Mexico, 14000Hospital General de Mexico | Mexico Tlaxcala, Mexico, 06726Szpital Specjalistyczny Podkarpacki O?rodek Onkologiczny | Brzozów , Poland, 36-200Uniwersyteckie Centrum Kliniczne | Gda?sk , Poland, 80-214Pratia Onkologia Katowice | Katowice , Poland, 41-500?wi?tokrzyskie Centrum Onkologii SPZOZ | Kielce , Poland, 25-734PRATIA MCM Kraków | Krakow , Poland, 30-727Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu | Wroc?aw , Poland, 50-367Auxilio Mutuo Cancer Center | San Juan , Puerto Rico, 00918Inje university Haeundae Paik Hospital | Busan , South Korea, 48108Pusan National University Hospital | Busan , South Korea, 602-739Keimyung University Dongsan Medical Center | Daegu , South Korea, 41931Chungnam National University Hospital | Daejeon , South Korea, 35015National Cancer Center | Goyang-si , South Korea, 10408Chonnam National University Hwasun Hospital | Jeollanam-do , South Korea, 58128Korea University Anam Hospital | Seoul , South Korea, 02841Seoul National University Hospital | Seoul , South Korea, 03080Severance Hospital | Seoul , South Korea, 03722Asan Medical Center | Seoul , South Korea, 05505Samsung Medical Center | Seoul , South Korea, 06351Seoul St Mary's Hospital | Seoul , South Korea, 06591Yeouido St. Mary's Hospital | Seoul , South Korea, 07345Complejo Hospitalario Universitario de Santiago (CHUS) | Santiago de Compostela LA Coruna, Spain, 15706Hospital Quiron de Madrid | Pozuelo de Alarcón Madrid, Spain, 28223Clinica Universitaria de Navarra | Pamplona Navarre, Spain, 31008Hospital Universitari Vall d'Hebron | Barcelona , Spain, 08035Hospital General Universitario Gregorio Marañon | Madrid , Spain, 28007Clinica Universidad de Navarra Madrid | Madrid , Spain, 28027Hospital Universitario Virgen del Rocio | Seville , Spain, 41013Hospital Clinico Universitario de Valencia | Valencia , Spain, 46010Universitaetsspital Basel | Basel , Switzerland, 4031Chang Gung Medical Foundation - Chai Yi | Chai Yi , Taiwan, 613Chang Gung Medical Foundation - Kaohsiung;Oncology | Kaoisung , Taiwan, 833E-Da Cancer Hospital | Kaoshiung , Taiwan, 824China Medical University Hospital | Taichung , Taiwan, 404Chi-Mei Hospital, Liouying | Tainan , Taiwan, 736National Taiwan University Hospital | Taipei , Taiwan, 00100Abdurrahman Yurtarslan Onkoloji Training and Research Hospital | Ankara , Turkey (Türkiye), 06200Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi | Ankara , Turkey (Türkiye), 06620Istanbul VKV American Hospital | Istanbul , Turkey (Türkiye), 34365Marmara University Pendik Training and Research Hospital | Istanbul , Turkey (Türkiye), 34890Kocaeli Univesity Medical Faculty | İzmit , Turkey (Türkiye), 41380Barnet Hospital | Barnet , United Kingdom, EN5 3DJBlackpool Victoria Hospital | Blackpool , United Kingdom, FY3 8NREast Kent Hospitals University NHS Foundation Trust | Canterbury , United Kingdom, CT1 3NGRoyal Devon and Exeter Hospital | Exeter , United Kingdom, EX2 5DWBeatson West of Scotland Cancer Centre | Glasgow , United Kingdom, G12 0YNLeeds Teaching Hosp NHS Trust | Leeds , United Kingdom, LS9 7TFUniversity College London Hospitals NHS Foundation Trust - University College Hospital | London , United Kingdom, NW1 2PGGuy'S Hospital | London , United Kingdom, SE1 9RTNewcastle University | Newcastle , United Kingdom, NE1 4LPNottingham University Hospitals NHS Trust | Nottingham , United Kingdom, NG7 2UHChurchill Hospital - Oxford Cancer & Haematology Centre | Oxford , United Kingdom, OX3 7LE |
| Investigators | Study Director: Clinical Trials, Hoffmann-La Roche |
Guideline Central and select third party use “cookies” on this website to enhance the user experience.
This technology helps us gather statistical and analytical information to optimize the relevant content for you.
The user also has the option to opt-out which may have an effect on the browsing experience.