Spots Global Cancer Trial Database for A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial)
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Trial Identification
Brief Title: A Phase 3 Study of Brentuximab Vedotin (SGN-35) in Patients at High Risk of Residual Hodgkin Lymphoma Following Stem Cell Transplant (The AETHERA Trial)
Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of SGN-35 and Best Supportive Care (BSC) Versus Placebo and BSC in the Treatment of Patients at High Risk of Residual Hodgkin Lymphoma Following Autologous Stem Cell Transplant
Study ID: NCT01100502
Conditions
Study Description
Brief Summary: This is a randomized, double-blind, placebo-controlled, multicenter phase 3 trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) and best supportive care (BSC) compared to placebo and BSC in treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope National Medical Center, Duarte, California, United States
University of California at San Francisco, San Francisco, California, United States
Stanford Cancer Center, Stanford, California, United States
Colorado Blood Cancer Institute, Denver, Colorado, United States
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
Northside Hospital, Atlanta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
University of Chicago Section of Hematology/Oncology Lymphoma Program, Chicago, Illinois, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center, Maywood, Illinois, United States
Indiana University School of Medicine Simon Cancer Center 535 Barnhill Drive, RT 380, Indianapolis, Indiana, United States
Johns Hopkins Medical Center, Baltimore, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Karmanos Cancer Institute / Wayne State University, Detroit, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
New York University Cancer Institute, 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
UNC Lineberger Comprehensive Cancer Center / University of North Carolina, Chapel Hill, North Carolina, United States
Cleveland Clinic, The, Cleveland, Ohio, United States
James Cancer Hospital / Ohio State University, Columbus, Ohio, United States
Oregon Health and Science University / Center for Hematologic Malignancies, Portland, Oregon, United States
Temple Bone Marrow Transplant Program, Philadelphia, Pennsylvania, United States
Western Pennsylvania Cancer Institute, Pittsburgh, Pennsylvania, United States
Saint Francis Hospital, Greenville, South Carolina, United States
Cancer Center of the Carolinas, Greenville, South Carolina, United States
Baylor University Medical Center, Dallas, Texas, United States
MD Anderson Cancer Center / University of Texas, Houston, Texas, United States
Virginia Commonwealth University Medical Center, Richmond, Virginia, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Specializirana bolnica aktivno lechenie detsa ohcohematologichni zabolyavania Hematologichno, Sofia, , Bulgaria
Specializirana bolnica za aktivno lechenie na hematologichni zabolyavania, Sofia, , Bulgaria
Fakultni nemocnice Hradec Kralove-oddeleni klinicke hematologie, Hradec Kralove, , Czechia
Fakultni nemocnice Kralovske Vinohrady-oddeleni klinicke hematologie, Praha, , Czechia
Vseobecni fakultni nemocnice v Prahe-I. interni klinika, Praha, , Czechia
CHU Nantes - Hopital Hotel Dieu Service Hematologie, Nantes, , France
Service des Maladies du Sang / Hospital Saint Louis, Paris, , France
CHU Bordeaux Hopital Haut-Levaque, Pessac, , France
Centre Hospitalier Lyon Sud, Pierre Benite, , France
Centre Henri Becquerel / Centre Regional de Lutte Contre le Cancer, Rouen, , France
University Hospital of Cologne, Koeln, , Germany
Szent Istvan es Szent Laszlo Korhaz Rendelointezet Haematologiai es Ossejt-transzplantacios osztaly, Budapest, , Hungary
Debreceni Egyetem Orvos és Egeszsegtudomanyi Centrum, III. sz. Belgyogyaszati Klinika, Debrecen, , Hungary
Medical Center of the University of Pecs, 1st Clinic for Internal Medicine, Pecs, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont, Szeged, , Hungary
Instituto di Ematologia ed Oncologia Medica, Bologna, , Italy
Azienda Ospedaliera Universitaria San Martino, Genova, , Italy
Istituto Nazionale dei Tumori, Milano, , Italy
Klinika Hematologii i Transplantologii, Uniwersyteckie Centrum Kliniczne, Gdansk, , Poland
Oddzial Transplantacji Szpiku Centrum Onkologii- Instytut M. Sklodowskiej-Curie, Oddzial Gliwicach, Gliwice, , Poland
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego, Katowice, , Poland
Szpital Uniwersytecki w Krakowie, Krakow, , Poland
Klinika Hematologii, Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi, Lodz, , Poland
Oddzial Hematoonkologii, Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie, Lublin, , Poland
MTZ Clinical Research Sp. z o.o., Warsaw, , Poland
Klinika Hematologii, Instytut Hematologii i Transfuzjologii, Warsaw, , Poland
Centrum Onkologii Institut im. Marii Sklodowskiej-Curie, Warsaw, , Poland
Spitalul Clinic Judetean de Urgenta Targu Mures, Sectia Clinica Hematologie si Transplant Medular, Targu Mures, Judetul Mures, Romania
Spitalul Clinic de Urgenta pentru Copii Louis Turcanu, Clinica III Pediatrie, Timisoara, Judetul Timis, Romania
Fundeni Clinical Institute, Bucharest, , Romania
Institutul Clinic Fundeni, Centrul de Hematologie si Transplant Medular Stefan Berceanu, Bucharest, , Romania
Burdenko Central Military Clinical Hospital, Moscow, , Russian Federation
Rossijskij onkologicheskij nauchnyj centr im. N.N. Blokhina RAMN, Moscow, , Russian Federation
Federal Medical Biophysical Center n.a. A.I. Burnazyan, Moscow, , Russian Federation
Gematologicheskj nauchnyj centr RAMN, Moscow, , Russian Federation
Uchrezhdenie Rossijskoj nauk Nauchno-issledovatel'skij institut klinicheskoj immunologii, Novosibirsk, , Russian Federation
Respublikanskaja bol'nica im. V.A. Baranova, Petrozavodsk, , Russian Federation
Leningradskaja oblastnaja klinicheskaja bol'nica, St. Petersburg, , Russian Federation
Sankt-Peterburgskij gosudarstvennyj medicinskij universitet im. akademika I. P. Pavlova, St. Petersburg, , Russian Federation
St. Petersburg Pavlov State Medical University, St. Petersburg, , Russian Federation
Gorodskaya bol'nica #31, St. Petersburg, , Russian Federation
Federal Center of Heart, Blood and Endocrinology n.a. V.A. Almazov under the Federal Agency for High, St. Petersburg, , Russian Federation
Sverdlovskaja oblastnaja klinicheskaja bol'nica #1, Yekaterinburg, , Russian Federation
Klinicki centar Srbije, Klinika za hematologiju, Belgrad, , Serbia
Vojnomedicinska akademija, Klinika za hematologiju, Belgrad, , Serbia
Klinicko bolnicki centar "Vojvodina", Klinika za hematologiju, Novi Sad, , Serbia
Complejo Hospitalano de Navarra Servicio Hematologia, Pamplona, Navarra, Spain
Hospital de la Santa Creu i Sant Paul, Barcelona, , Spain
Hospital Clinic i Provincial Servicio Hematologia, Barcelona, , Spain
Centro Oncologico MD Anderson, Madrid, , Spain
Hospital Universitaro de Salamanca, Salamanca, , Spain
Addenbrooke's Hospital, Cambridge, , United Kingdom
St James University Hospital, Leeds, , United Kingdom
Guy's Hospital Haematology Department, 4th Floor Southwark Wing, London, , United Kingdom
Christie Hospital NHS Foundation Trust, Manchester, , United Kingdom
Contact Details
Name: Julie Lisano, PharmD
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR
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