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Brief Title: 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
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 ID: NCT06047080
Brief 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).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Alaska Oncology & Hematology, LLC, Anchorage, Alaska, United States
University of California, San Francisco-Fresno, Fresno, California, United States
Medstar Franklin Square Medical Center, Baltimore, Maryland, United States
St. Luke's Hospital, Chesterfield, Missouri, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Instituto Alexander Fleming, Buenos Aires, , Argentina
Fundaleu; Haematology, Buenos Aires, , Argentina
Hospital Aleman de Buenos Aires; Servicio de Oncologia, Buenos Aires, , Argentina
Sanatorio Allende; Haematology, Cordoba, , Argentina
Concord Repatriation General Hospital, Concord, New South Wales, Australia
Prince of Wales Hospital- Department of Hematology, Randwick, New South Wales, Australia
Townsville Hospital; Haematology and Oncology, Douglas, Queensland, Australia
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology, Woolloongabba, Queensland, Australia
Flinders Medical Centre; Dept of Haematology, 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, Brussel, , Belgium
UZ Antwerpen, Edegem, , Belgium
UZ Gent, Gent, , Belgium
AZ Groeninge, Kortrijk, , Belgium
CHU Sart-Tilman, Liège, , Belgium
Hospital Erasto Gaertner, Curitiba, PR, Brazil
Instituto D'Or Pesquisa e Ensino, Sao Paulo, SP, Brazil
BC Cancer ? Victoria, Victoria, British Columbia, Canada
Centre Hospitalier de l'Universite de Montreal (CHUM), Montreal, Quebec, Canada
CHA Hopital de I enfant-Jesus, Quebec City, Quebec, Canada
Beijing Cancer Hospital, Beijing, , China
Peking University Third Hospital, Beijing, , China
The First Hospital of Jilin University, Changchun City, , China
Hunan Cancer Hospital, Changsha CITY, , 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; Internal Medicine of Oncology, Guangzhou, , China
Zhujiang Hospital, Southern Medical University, Guangzhou, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Anhui Province Cancer Hospital, Hefei City, , China
Shandong Cancer Hospital, Jinan, , China
Jiangxi Cancer Hospital, Nanchang City, , China
Jiangsu Cancer Hospital, Nanjing City, , China
Guangxi Cancer Hospital of Guangxi Medical University, Nanning City, , China
Fudan University Shanghai Cancer Center, Shanghai City, , China
Shengjing Hospital of China Medical University, Shenyang City, , China
First 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 City, , China
Tianjin Cancer Hospital, Tianjin, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan City, , China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan City, , China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University, Xi'an, , China
The First Affiliated Hospital of Xiamen University, Xiamen, , China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, , China
Aalborg Universitetshospital; Hæmatologisk afdeling, Aalborg, , Denmark
Aarhus Universitetshospital Skejby; Blodsygdomme, Aarhus N, , Denmark
Regionshospitalet Gødstrup; Medicinsk Afdeling, Klinik for Blodsygdomme, 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; Service d'Hématologie Clinique Adulte, Rennes, , France
Centre Henri Becquerel, Rouen, , France
CHU Strasbourg Hôpital Hautepierre, Strasbourg, , France
IUCT Oncopole, Toulouse, , France
Charité Universitätsmedizin Berlin; Hämatologie/Onkologie und Tumorimmunologie, Berlin, , Germany
Staedisches Klinikum Brandenburg, Brandenburg an der Havel, , Germany
Klinikum Chemnitz gGmbH, Klinik f. Innere Medizin III, Chemnitz, , Germany
Universitätsklinikum Erlangen, Medizinische Klinik 5, Hämatologie und Internistische Onkologie, Erlangen, , Germany
Universitätsklinikum Essen; Klinik für Hämatologie, Essen, , Germany
UKE Universitätsklinikum Hamburg-Eppendorf; II. Medizinische Klinik und Poliklinik, Hamburg, , Germany
Städtisches Krankenhaus Kiel GmbH, Kiel, , Germany
Universitätsklinikum Köln; Klinik I für Innere Medizin - Onkologie, Hämatologie, Koeln, , Germany
Universitaetsklinikum Schleswig Holstein - Campus Luebeck; Haematologie, Onkologie, Luebeck, , Germany
Otto von Guericke Uni Magdeburg Uniklinik; Hämatologie/Onkologie, Magdeburg, , Germany
Klinikum rechts der Isar der TU München, III. Medizinische Klinik; Hämatologie und intern. Onkologie, München, , Germany
Universitätsklinikum Münster; Med. Klinik A; Hämatologie, Hämostaseologie, Onkologie & Pneumologie, Münster, , Germany
Klinikum Ernst von Bergman; Klinik für Hämatologie, Onkologie und Palliativmedizin, Potsdam, , Germany
Klinikum Stuttgart Katharinenhospital; Klinik f. Hämatologie, Onkologie u. Palliativmedizin, Stuttgart, , Germany
Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo., Ulm, , Germany
Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie, Würzburg, , Germany
Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica, Napoli, Campania, Italy
Policlinico S.Orsola-Malpighi;Istituto di Ematologia "Seragnoli", Bologna, Emilia-Romagna, Italy
A.O. Universitaria Policlinico Di Modena; Ematologia, Modena, Emilia-Romagna, Italy
A.O. Universitaria S. Martino Di Genova; Ematologia 1, Genova, Liguria, Italy
ASST PAPA GIOVANNI XXIII; Ematologia, Bergamo, Lombardia, Italy
Fond. IRCCS Istituto Nazionale Tumori; S. C. Ematologia, Milano, Lombardia, Italy
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia, Rozzano, Lombardia, Italy
A. O. U. Policlinico G. Rodolico; Ematologia, Catania, Sicilia, Italy
USL 4 di Prato - Nuovo Ospeale di Prato, Prato, Toscana, Italy
Ospedale San Bortolo; UOC di Ematologia', Vicenza, Veneto, Italy
Aichi Cancer Center, Aichi, , Japan
Kobe City Medical Center General Hospital, Hyogo, , Japan
Tokai University Hospital, Kanagawa, , Japan
University Hospital Kyoto Prefectural University of Medicine, Kyoto, , Japan
Kindai University Hospital, Osaka, , Japan
National Cancer Center Hospital, Tokyo, , Japan
The Cancer Institute Hospital of JFCR, Tokyo, , Japan
Yamagata University Hospital, Yamagata, , Japan
Inje university Haeundae Paik Hospital, Busan, , Korea, Republic of
Pusan National University Hospital, Busan, , Korea, Republic of
Keimyung University Dongsan Medical Center, Daegu, , Korea, Republic of
Chungnam National University Hospital, Daejeon, , Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
Chonnam National University Hwasun Hospital, Jeollanam-do, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital; Yonsei University Health System, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul St Mary's Hospital, Seoul, , Korea, Republic of
Yeouido St. Mary's Hospital, Seoul, , Korea, Republic of
Health Pharma Professional Research, Cdmx, Mexico CITY (federal District), Mexico
Inst. Nacional de Cancerologia; Investigacion Clinica, 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; Klinika Hematologii i Transplantologii, Gda?sk, , Poland
Pratia Onkologia Katowice, Katowice, , Poland
?wi?tokrzyskie Centrum Onkologii SPZOZ; Klinika Hematologii i Transplantacji Szpiku, Kielce, , Poland
PRATIA MCM Kraków, Kraków, , Poland
Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku, Wroc?aw, , Poland
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Hematologia, Santiago de Compostela, LA Coruña, Spain
Hospital Quiron de Madrid; Servicio de Hematologia, Pozuelo de Alarcon, Madrid, Spain
Clinica Universitaria de Navarra; Servicio de Hematologia, Pamplona, Navarra, Spain
Hospital Universitari Vall d'Hebron; Servicio de Hematologia, Barcelona, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Hematología, Madrid, , Spain
Clinica Universidad de Navarra Madrid; Servicio de Hematología, Madrid, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Hematologia, Sevilla, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia, , Spain
CHANG GUNG MEDICAL FOUNDATION - CHAI YI;HEMATOLOGY and ONCOLOGY, Chai Yi, , Taiwan
Chang Gung Medical Foundation - Kaohsiung; Oncology; Division of Hematology-Oncology, Kaoisung, , Taiwan
E-Da Cancer Hospital; Hematology- Oncology Department, Kaoshiung, , Taiwan
China Medical University Hospital; Oncology and Hematology, Taichung, , Taiwan
Chi-Mei Hospital, Liouying, Tainan, , Taiwan
National Taiwan University Hospital; Internal Medicince, Taipei, , Taiwan
Abdurrahman Yurtarslan Onkoloji Training and Research Hospital, Ankara, , Turkey
Ankara Universitesi Tip Fakultesi Hastaneleri - Cebeci Hastanesi, Ankara, , Turkey
Istanbul VKV American Hospital; Haematology, Istanbul, , Turkey
Marmara University Pendik Training and Research Hospital, Istanbul, , Turkey
Kocaeli Univesity Medical Faculty; Department of Internal Medicine, Izmit, , Turkey
Barnet Hospital; ROYAL FREE LONDON NHS FOUNDATION TRUST, Barnet, , United Kingdom
BLACKPOOL VICTORIA HOSPITAL; Clinical Research Centre, Blackpool, , United Kingdom
East Kent Hospitals University NHS Foundation Trust, Canterbury, , United Kingdom
Royal Devon and Exeter Hospital; Oncology, Exeter, , United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Leeds Teaching Hosp NHS Trust;St James's Institute of Onc, Leeds, , United Kingdom
University College London Hospitals NHS Foundation Trust - University College Hospital, London, , United Kingdom
Guy'S Hospital; Oncology Unit, London, , United Kingdom
Newcastle University; Northern Institute For Cancer Research Paul O'gorman Building, Newcastle, , United Kingdom
Nottingham University Hospitals NHS Trust, Nottingham, , United Kingdom
Churchill Hospital - Oxford Cancer & Haematology Centre; Department of Oncology, Oxford, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR