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Brief Title: ECHELON-2: A Comparison of Brentuximab Vedotin and CHP With Standard-of-care CHOP in the Treatment of Patients With CD30-positive Mature T-cell Lymphomas
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in the Frontline Treatment of Patients With CD30-positive Mature T-cell Lymphomas
Study ID: NCT01777152
Brief Summary: This is a double-blind, randomized, multicenter, phase 3 clinical trial to compare the efficacy and safety of brentuximab vedotin in combination with CHP with the standard-of-care CHOP in patients with CD30-positive mature T-cell lymphomas.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
City of Hope National Medical Center, Duarte, California, United States
Stanford Cancer Center, Stanford, California, United States
Shands Cancer Center / University of Florida, Gainesville, Florida, United States
Orlando Health, Inc., Orlando, Florida, United States
University of Illinois at Chicago, Chicago, Illinois, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center, Maywood, Illinois, United States
Holden Comprehensive Cancer Center / University of Iowa, Iowa City, Iowa, United States
University of Kansas Cancer Center, Westwood, Kansas, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center - Basking Ridge, Basking Ridge, New Jersey, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Albert Einstein Cancer Center, Bronx, New York, United States
Montefiore Medical Center, Bronx, New York, United States
Memorial Sloan Kettering Cancer Center - Commack, Commack, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
Weill Cornell Medical College, New York, New York, United States
James P. Wilmot Cancer Center / University of Rochester Medical Center, Rochester, New York, United States
Jewish Hospital, The, Cincinnati, Ohio, United States
Cleveland Clinic, The, Cleveland, Ohio, United States
Mercy Clinic Oncology, Oklahoma City, Oklahoma, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Charles A. Sammons Cancer Center / Baylor University Medical Center, Dallas, Texas, United States
MD Anderson Cancer Center / University of Texas, Houston, Texas, United States
University of Virginia, Charlottesville, Virginia, United States
Virginia Commonwealth University Medical Center, Richmond, Virginia, United States
Benaroya Research Institute/Virginia Mason Medical Center, Seattle, Washington, United States
Seattle Cancer Care Alliance / University of Washington, Seattle, Washington, United States
Royal Adelaide Hospital, Adelaide, , Australia
Moorabbin Hospital, Bentleigh East, , Australia
Icon Cancer Care Chermside, Chermside, , Australia
Icon Cancer Care South Brisbane, Chermside, , Australia
Icon Cancer Care Southport, Chermside, , Australia
Icon Cancer Care Wesley, Chermside, , Australia
Monash Medical Centre, Clayton, , Australia
Concord Repatriation General Hospital, Concord, , Australia
St. Vincent's Hospital Sydney, Darlinghurst, , Australia
St Vincent's Public Hospital Sydney - Fitzroy, Fitzroy, , Australia
Western Hospital, Footscray, , Australia
Austin Health, Heidelberg, , Australia
Calvary Mater Newcastle, Waratah, , Australia
McGill University Department of Oncology / McGill University Health Centre, Montreal, , Canada
Jewish General Hospital, Montreal, , Canada
Sunnybrook Health Sciences Centre, Toronto, , Canada
British Columbia Cancer Agency - Vancouver Centre, Vancouver, , Canada
Fakultni nemocnice Brno, Brno, , Czechia
Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie, Hradec Kralove, , Czechia
Fakultni Nemocnice Ostrava, Ostrava - Poruba, , Czechia
Fakultni Nemocnice Kralovske Vinohrady, Praha 10, , Czechia
Vseobecna fakultni nemocnice v Praze, Praha 2, , Czechia
Aarhus University Hospital, Aarhus C., , Denmark
Rigs Hospiltalet, Copenhagen, , Denmark
Odense University Hospital, Odense C, , Denmark
Hôpital Henri Mondor, Créteil, , France
CHD Vendée, Site de La Roche-sur-Yon, Les Oudairies, La Roche-sur-Yon Cedex 9, , France
Centre Hospitalier Universitaire de Grenoble, La Tronche, , France
Clinique Victor Hugo, Le Mans, , France
CHRU de Lille, Lille cedex, , France
Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren, Limoges Cedex, , France
Centre Hospitalier Universitaire Nantes-Hotel Dieu, Nantes cedex 1, , France
Hopital Saint-Louis / Service d'Hematologie, Paris Cedex 10, , France
Groupe Hospitalier Pitié-Salpétrière, Paris, , France
Groupe Hospitalier du Haut Leveque, Pessac, , France
Centre Hospitalier Lyon Sud, Pierre Bénite Cedex, , France
Centre Hospitalier Universitaire de Poitiers, Poitiers Cedex, , France
Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou, Rennes Cedex 9, , France
Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer, Rouen, , France
Charite Universitatsmedizin Berlin, Berlin, , Germany
Charite Campus Benjamin Franklin, Berlin, , Germany
Klinikum Chemnitz gGmbH, Chemnitz, , Germany
Universitatsklinikum Essen, Essen, , Germany
Krankenhaus Nordwest GmbH, Frankfurt am Main, , Germany
Georg-August-Universität Göttingen, Göttingen, , Germany
Universitätsklinikum Heidelberg, Heidelberg, , Germany
Universitätsklinikum des Saarlandes, Homburg/Saar, , Germany
Klinik für Innere Medizin II, Friedrich-Schiller-Universität, Jena, , Germany
Universitatsklinikum Koln, Köln, , Germany
Klinikum der Ludwig-Maximilians-Universität München, München, , Germany
Klinikum Nürnberg, Nürnberg, , Germany
Universitätsklinikum Ulm, Ulm, , Germany
Semmelweis Egyetem, Budapest, , Hungary
Debreceni Egyetem, Debrecen, , Hungary
Somogy Megyei Kaposi Mór Oktató Kórház, Kaposvár, , Hungary
Markusovszky Egyetemi Oktatokorhaz, Szombathely, , Hungary
Soroka Medical Center, Dept. of Oncology, Beer Sheva, , Israel
Rambam Health Corp., Haifa, , Israel
Hadassah Medical Center, Jerusalem, , Israel
Rabin Medical Center, Petach Tikva, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Alessandria, Alessandria, , Italy
Azienda Ospedaliera Papa Giovanni XXIII, Bergamo, , Italy
Instituto di Ematologia ed Oncologia Medica, Bologna, , Italy
Azienda Ospedaliera Spedali Civili di Brescia, Brescia, , Italy
Azienda Ospedaliera-Universitaria Vittorio Emanuele-Ferrarotto-Santo Bambino, Catania, , Italy
Azienda Ospedaliera Universitaria San Martino, Genova, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, , Italy
Ospedale Niguarda Ca' Granda, Milano, , Italy
IRCSS Policlinico San Matteo, Pavia, , Italy
Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, , Italy
Università degli Studi di Roma "La Sapienza, Policlinico Umberto I, Roma, , Italy
Istituto Clinico Humanitas-Humanitas Cancer Center, Rozzano, , Italy
Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino, , Italy
Azienda Ospedaliera Universitaria Integrata di Verona, Verona, , Italy
Keimyung University Dongsan Medical Center, Daegu, , Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul Saint Mary's Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza, Brzozow, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespól Szpitali Miejskich, Chorzów, , Poland
Malopolskie Centrum Medyczne S.C., Krakow, , Poland
Centrum Onkologii Institut im. Marii Sklodowskiej-Curie, Warsaw, , Poland
Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu, Bucharest, , Romania
Spitalul Clinic Coltea, Bucuresti, , Romania
Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj-Napoca, Cluj-Napoca, , Romania
Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular, Targu Mures, , Romania
Hospital de la Santa Creu i Sant Paul, Barcelona, , Spain
Institut Universitari Dexeus, Barcelona, , Spain
Institut Català D'oncologia, L'Hospitalet de Llobregat, , Spain
Hospital de León, León, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Puerta de Hierro Majadahonda, Majadahonda, , Spain
Hospital Universitaro de Salamanca, Salamanca, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Hospital Universitari i Politecnic La Fe de Valencia, Valencia, , Spain
Chang Gung Memorial Hospital - Kaohsiung, Kaohsiung, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
National Cheng-Kung University Hospital, Tainan, , Taiwan
Chang Gung Memorial Hospital - Taoyuan, Taoyuan, , Taiwan
Addenbrooke's Hospital, Cambridge, , United Kingdom
University Hospitals of Leicester NHS Trust, Leicester, , United Kingdom
Saint George's Hospital NHS Trust, London, , United Kingdom
Christie Hospital NHS Foundation Trust, Manchester, , United Kingdom
Freeman Hospital, Newcastle upon Tyne, , United Kingdom
Nottingham University Hospitals NHS Trust, Nottingham, , United Kingdom
Name: Thomas Manley, MD
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR