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Brief Title: A Study Comparing the Efficacy and Safety of Polatuzumab Vedotin With Rituximab-Cyclophosphamide, Doxorubicin, and Prednisone (R-CHP) Versus Rituximab-Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Diffuse Large B-Cell Lymphoma
Official Title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of Polatuzumab Vedotin in Combination With Rituximab and CHP (R-CHP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With Diffuse Large B-Cell Lymphoma
Study ID: NCT03274492
Brief Summary: This Phase III, randomized, double-blind, placebo-controlled study will compare the efficacy, safety, and pharmacokinetics of polatuzumab vedotin plus R-CHP versus R-CHOP in participants with previously untreated diffuse large B-cell lymphoma (DLBCL).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
Southern Cancer Center, Daphne, Alabama, United States
City of Hope, Duarte, California, United States
Ronald Reagan UCLA Medical Center; Drug Information Center, Los Angeles, California, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
Florida Cancer Specialists - Fort Myers (New Hampshire Ct), Fort Myers, Florida, United States
Florida Cancer Specialists & Research Institute, Saint Petersburg, Florida, United States
Florida Cancer Specialists, West Palm Beach, Florida, United States
Emory University; Investigational Drug Service, Atlanta, Georgia, United States
Illinois Cancer Specialists, Arlington Heights, Illinois, United States
University of Louisville Hospital; The James Graham Brown Cancer Center, Louisville, Kentucky, United States
Ochsner Medical Center, New Orleans, Louisiana, United States
University of Maryland, Baltimore, Maryland, United States
Johns Hopkins University, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute; Lymphoma Program, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
University of Michigan Health System; UMH Internal Medicine/Hematology-Oncology, Ann Arbor, Michigan, United States
Karmanos Cancer Center, Detroit, Michigan, United States
HCA Midwest Division, Kansas City, Missouri, United States
Washington University; Wash Uni. Sch. Of Med, Saint Louis, Missouri, United States
Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States
Roswell Park Cancer Institute; Grace Cancer Drug Center, Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center - Commack, Commack, New York, United States
Memorial Sloan Kettering Cancer Center at Westchester, Harrison, New York, United States
New York University Cancer Cen, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Levine Cancer Institute - Clincal Trials Administration, Charlotte, North Carolina, United States
University Hospitals Case Medical Center, Cleveland, Ohio, United States
Ohio State University; B406 Starling-Loving Hall, Columbus, Ohio, United States
Oncology/Hematology Care Clinical Trials LLC, Fairfield, Ohio, United States
Oncology Associates of Oregon, P.C, Eugene, Oregon, United States
Oregon HSU; Bld-Brain Barr/Neuro-Onc, Portland, Oregon, United States
Northwest Cancer Specialists - Portland (SW Barnes Rd), Tigard, Oregon, United States
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center; Hematology/Oncology, Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center Cancer Center; Pharmacy, Pittsburgh, Pennsylvania, United States
Medical University of South Carolina Hospital, Charleston, South Carolina, United States
Prisma Health ? Upstate, Greenville, South Carolina, United States
Greco-Hainesworth Centers for Research; ETN (East Tennessee), Chattanooga, Tennessee, United States
SCRI Oncology Partners, Nashville, Tennessee, United States
Texas Oncology-Austin Midtown, Austin, Texas, United States
Rocky Mountain Cancer Centers, LLP, Irving, Texas, United States
Texas Oncology-Tyler, Irving, Texas, United States
Texas Oncology San Antonio Medical Center, San Antonio, Texas, United States
University of Utah; Huntsman Cancer Hospital, Salt Lake City, Utah, United States
Oncology Associates of Southwest Virginia, Inc., Blacksburg, Virginia, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Shenandoah Oncology Associates, Winchester, Virginia, United States
Seattle Cancer Care Alliance; Investigational Drug Service, Seattle, Washington, United States
North Star Lodge, Yakima, Washington, United States
West Virginia Uni Med. Center - Robert Byrd Health Science, Morgantown, West Virginia, United States
Concord Repatriation General Hospital, Concord, New South Wales, Australia
St George Hospital, Kogarah, New South Wales, Australia
Prince of Wales Hospital; Haematology, Randwick, New South Wales, Australia
Calvary Mater Newcastle, Waratah, New South Wales, Australia
Westmead Hospital; Outpatient Pharmacy University Clinic, Westmead, New South Wales, Australia
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology, Woolloongabba, Queensland, Australia
Ashford Cancer Center Research, Kurralta Park, South Australia, Australia
The University of Adelaide - The Queen Elizabeth Hospital (TQEH), Woodville South, South Australia, Australia
Monash Medical Centre, Clayton, Victoria, Australia
Austin Hospital; Cancer Clinical Trials Centre, Melbourne, Victoria, Australia
Medizinische Universitaet Innsbruck - Universitaetsklinik fuer Innere Medizin III, Innsbruck, , Austria
Landesklinikum Krems, Krems, , Austria
Paracelsus Medizinischen Privatuniversitaet-Salzburger Landeskliniken (SALK), Salzburg, , Austria
Medizinische Universität Wien, Wien, , Austria
Wiener Gesundheitsverbund ? Klinik Ottakring, Wien, , Austria
UZ Gent, Gent, , Belgium
CH Jolimont - Lobbes (Jolimont), Haine-Saint-Paul, , Belgium
CHU UCL Mont-Godinne, Mont-godinne, , Belgium
Hospital Erasto Gaertner, Curitiba, PR, Brazil
Hospital Sao Vicente de Paulo, Passo Fundo, RS, Brazil
Hospital das Clinicas - UFRGS, Porto Alegre, RS, Brazil
Centro de Hematologia e Hemoterapia - HEMOCENTRO UNICAMP, Campinas, SP, Brazil
Hospital das Clinicas - FMUSP, Sao Paulo, SP, Brazil
University of Alberta Hospital, Edmonton, Alberta, Canada
BC Cancer ? Vancouver, Vancouver, British Columbia, Canada
CancerCare Manitoba (CCMB), Winnipeg, Manitoba, Canada
McMaster University Medical Center, Juravinski Cancer Centre, Hamilton Health Sciences, Hamilton, Ontario, Canada
The Ottawa Hospital, Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
University Health Network; Princess Margaret Hospital; Medical Oncology Dept, Toronto, Ontario, Canada
CIUSSS de l Est de l Ile de Montreal - Hopital Maisonneuve Rosemont, Montreal, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal - Pavillon E (PEA), Montreal, Quebec, Canada
CHU de Quebec-Universite Laval, Quebec, , Canada
Peking Union Medical College Hospital, Beijing City, , China
Beijing Cancer Hospital, Beijing, , China
The First Hospital of Jilin University, Changchun City, , China
Fujian Provincial Cancer Hospital, Fuzhou City, , China
Sun Yet-sen University Cancer Center, Guangzhou City, , China
The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou, , China
Jiangsu Cancer Hospital, Nanjing City, , China
Jiangsu Province Hospital, Nanjing, , China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai City, , China
Shanghai East Hospital, Tongji University, Shanghai City, , China
Fudan University Shanghai Cancer Center, Shanghai City, , China
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences, Tianjin City, , China
Tianjin Medical University Cancer Institute & Hospital, Tianjin, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan City, , China
Henan Cancer Hospital, Zhengzhou, , China
Fakultni Nemocnice Hradec Kralove (FNHK); IV. Interni Hematologicka Klinika, Hradec Kralove, , Czechia
Fakultni Nemocnice Kralovske Vinohrady (FNKV); Interni Hematologicka Klinika, Hradec Kralove, , Czechia
Fakultni nemocnice Olomouc, Olomouc, , Czechia
Fakultni nemocnice Ostrava, Ostrava - Poruba, , Czechia
Univerzita Karlova v Praze 1. Lekarska Fakulta, Prague, , Czechia
CHU Amiens - Hopital Sud; Hematologie Clinique et Therapie Cellulaire, Amiens, , France
CHU Angers, Angers, , France
Centre Hospitalier de La Cote Basque; Hematologie, Bayonne, , France
Hopital Jean Minjoz; Hematologie, Besancon, , France
Institut Bergonie, Bordeaux, , France
Institut d'Hématologie de Basse Normandie, Caen, , France
CH Metropole de Savoie, CHAMBERY Cedex, , France
Hopital Henri Mondor; Hematologie Clinique, Creteil, , France
CHU de Dijon - Hopital le Bocage, Dijon, , France
L'Union Mutualiste de la Gestion des Eaux Claires - Institut Daniel Hollard, Grenoble, , France
CHD Vendée, La Roche Sur Yon, , France
Hôpital Albert Michallon; Hematologie Clinique, La Tronche, , France
Clinique Victor Hugo - Centre Jean Bernard, Le Mans Cedex 02, , France
Hôpital Saint Vincent de Paul, Lille, , France
Hopital Claude Huriez; Hematologie, Lille, , France
Hopital Uni Ire Dupuytren; Hematologie, Limoges, , France
Centre Leon Berard, Lyon, , France
CHU Montpellier - Saint ELOI, Montpellier, , France
CHU de Nantes - Hotel Dieu, Nantes, , France
Centre Antoine Lacassagne, Nice, , France
CHU de Nîmes - Hôpital Carémeau, Nimes, , France
Hôpital Saint-Louis; Service d'Hématologie, Paris, , France
Gh Necker Enfants Malades; Hematologie Clinique, Paris, , France
Hopital Saint Jean; Hematologie, Perpignan, , France
Hopital Haut-Leveque - Centre Francois Magendie; Service d'Hematologie Clinique, Pessac, , France
CHU Lyon Sud - Service Hématologie, Pierre Benite, , France
CHU de Poitiers, Poitiers, , France
Centre Hospitalier de Quimper Cornouaille (CHIC); Médecine interne-Maladies du sang, Quimper Cedex, , France
Hopital Pontchaillou; Hematologie Clinique, Rennes, , France
Centre Henri Becquerel; Hematologie, Rouen, , France
Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll, St Brieuc, , France
Pôle de Cancérologie ? CHU de Saint?Etienne', St Priest en Jarez, , France
CHRU DE STRASBOURG; Département d?Hématologie et Oncologie, Strasbourg, , France
Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O), Toulouse, , France
CHU Bretonneau, Tours, , France
CHU de Brabois, Vandoeuvre Les Nancy, , France
CH Bretagne Atlantique; Médecine interne, Vannes Cedex, , France
Institut Gustave Roussy; Unite D'Hematologie, Villejuif, , France
Vivantes Klinikum Am Urban, Berlin, , Germany
Städtisches Klinikum Dessau, Dessau-Roßlau, , Germany
Universitätsklinikum Essen, Essen, , Germany
Universitaetsklinikum Halle (Saale), Halle, , Germany
Universitaetsklinikum Heidelberg, Heidelberg, , Germany
InVO - Institut für Versorgungsforschung in der Onkologie GbR, Koblenz, , Germany
University of Munich, München, , Germany
Universitatsklinikum Munster, Münster, , Germany
Queen Mary Hospital, Hong Kong, , Hong Kong
Queen Elizabeth Hospital, Kowloon, , Hong Kong
Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, Abruzzo, Italy
Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia, Brescia, Abruzzo, Italy
Universita degli Studi di Roma ''La Sapienza" - Clinica Ematologica, Rome, Abruzzo, Italy
Azienda Ospedaliera Universitaria Senese, Siena, Abruzzo, Italy
AUSL di Reggio Emilia, IRCCS, P.O. Arcispedale Santa Maria Nuova, Reggio Emilia, Emilia-Romagna, Italy
IRCCS AOU San Martino - IST, Genova, Liguria, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori - s.c. Ematologia, Milano, Lombardia, Italy
Istituto Nazionale dei Tumori, Monza, Lombardia, Italy
Azienda Ospedaliero Universitaria Maggiore della Carita di Novara, Novara, Piemonte, Italy
Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino; Ospedale Molinette, Torino, Piemonte, Italy
Aichi Cancer Center, Aichi, , Japan
Chiba University Hospital, Chiba, , 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
Hiroshima University Hospital, Hiroshima, , Japan
Hokkaido University Hospital, Hokkaido, , Japan
Kobe City Medical Center General Hospital, Hyogo, , Japan
Tokai University Hospital, Kanagawa, , Japan
Kumamoto University Hospital, Kumamoto, , Japan
University Hospital Kyoto Prefectural University of Medicine, Kyoto, , Japan
Tohoku University Hospital, Miyagi, , Japan
Osaka Metropolitan University Hospital, Osaka, , Japan
Osaka University Hospital, Osaka, , Japan
Kindai University Hospital, Osaka, , Japan
Jichi Medical University Hospital, Tochigi, , Japan
National Cancer Center Hospital, Tokyo, , Japan
The Cancer Institute Hospital of JFCR, Tokyo, , Japan
Inje University Busan Paik Hospital, Busan, , Korea, Republic of
Pusan National University Hospital, Busan, , Korea, Republic of
National Cancer Center; Medical Oncology, Gyeonggi-do, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Pusan National University Yangsan Hospital; hemato-oncology, Yangsan, , Korea, Republic of
Auckland City Hospital, Cancer and Blood Research, Auckland, , New Zealand
Canterbury Health Laboratories; Immunology/Rheumatology, Christchurch, , New Zealand
Waikato Hospital, Hamilton, , New Zealand
Palmerston North Hospital, Palmerston North, , New Zealand
Wojewódzki Szpital Specjalistyczny im. M. Kopernika; Klinika Hematologii UM w ?odzi, ?ód?, , Poland
Samodzielny Publiczny Zak?ad Opieki Zdrowotnej Zespó? Szpitali Miejskich w Chorzowie, Chorzów, , Poland
PRATIA MCM Kraków, Kraków, , Poland
SPZOZ Ministerstwa Spraw Wewn?trznych i Administracji w Poznaniu; Oddzia? Hematologii, Pozna?, , Poland
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie, Warszawa, , Poland
Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Warszawa, , Poland
Leningrad Regional Clinical Hospital, St Petersburg, Sankt Petersburg, Russian Federation
Republican Clinical Oncology Dispensary of Ministry of Healthcare of Tatarstan Republic, Kazan, Tatarstan, Russian Federation
Penza Regional Oncology Dispensary, Penza, , Russian Federation
Institut Catala d Oncologia Hospitalet, Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Puerta de Hierro - Majadahonda, Majadahonda, Madrid, Spain
Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Clinic Barcelona, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital San Pedro de Alcantara, Caceres, , Spain
Hospital Universitari Dr. Josep Trueta, Girona, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Quiron Madrid, Madrid, , Spain
Fundación Jimenez Díaz, Madrid, , Spain
Hospital Universitario Virgen de la Victoria, Malaga, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Hirslanden Medical Center - Tumorzentrum, Aarau, , Switzerland
Universitätsspital Basel Gynäkologie - Onkologie, Basel, , Switzerland
Hopital Cantonal Universitaire De Geneve, Genève, , Switzerland
Kaohsiung Medical University Hospital, Cancer Center, Kaohsiung, , Taiwan
China Medical University Hospital; Clinical Research Center Clinical Pharmacy, Taichung, , Taiwan
Chi-Mei Hospital, Liouying, Tainan, , Taiwan
Taipei Veterans General Hospital, Taipei City, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Ankara University Faculty of Medicine Cebeci Hospital, Ankara, , Turkey
Ege Üniversitesi Tip Fakültesi, Lzmir, , Turkey
Dokuz Eylul Universitesi Tip Fakultesi, Lzmir, , Turkey
Vehbi Koc Vakfi (VKV) - Amerikan Hastanesi, Te?v?k?ye, , Turkey
Communal Institution 'Cherkassy Regional Oncology Dispensary' of the Cherkassy Regional Council, Cherkassy, Chernihiv Governorate, Ukraine
MNE Lviv Territorial Medical Association Clinical Hospital for Palliative Care, Lviv, Chernihiv Governorate, Ukraine
Khmelnytskyi Regional Hospital; Department of Hemathology, Khmelnytskyi, Kharkiv Governorate, Ukraine
Feofaniya Center of Haematology and Chemotherapy of Haemoblastosis, Kyiv, Volhynian Governorate, Ukraine
Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital, Cambridge, , United Kingdom
East Kent Hospitals University NHS Foundation Trust, Canterbury, , United Kingdom
University Hospitals of Leicester NHS Trust - Leicester Royal Infirmary, Leicester, , United Kingdom
Barts Health NHS Trust; Bartholomew's H., King George V Building, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust. Freeman Hospital, Newcastle upon Tyne, , United Kingdom
Nottingham City Hospital; Dept of Haematology, Nottingham, , United Kingdom
Oxford University Hospitals NHS Foundation Trust, Oxford, , United Kingdom
University Hospital Southampton NHS Foundation Trust, Southhampton, , United Kingdom
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR