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Brief Title: A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL
Official Title: A Randomized Phase IIb Placebo-controlled Study of R-ICE Chemotherapy With and Without SGN-40 (Anti-CD40 Humanized Monoclonal Antibody) for Second-line Treatment of Patients With Diffuse Large B-Cell Lymphoma (DLBCL)
Study ID: NCT00529503
Brief Summary: This is a randomized trial to estimate the activity of R-ICE plus SGN-40 vs. R-ICE plus placebo in patients with DLBCL. The study will assess safety and tolerability and will measure any additional clinical benefit observed in patients receiving SGN-40.
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
University of California at Los Angeles, Los Angeles, California, United States
Stanford University Medical Center, Stanford, California, United States
Christiana Care Health Systems, Newark, Delaware, United States
Georgetown University, Washington, District of Columbia, United States
MD Anderson Cancer Center, Orlando, Orlando, Florida, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
University of Louisville - James Graham Brown Cancer Center, Louisville, Kentucky, United States
Sparrow Regional Cancer Center, Lansing, Michigan, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
Park Nicollet Institute, St. Louis Park, Minnesota, United States
Washington University School of Medicine, St. Louis, Missouri, United States
San Juan Oncology Associates, Farmington, New Mexico, United States
St. Luke's Roosevelt Hospital Center, New York, New York, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Ohio State University, Columbus, Ohio, United States
Providence Portland Medical Center, Portland, Oregon, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Baylor Sammons Cancer Center, Dallas, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
MultiCare Health System, Tacoma, Washington, United States
West Virginia University, Morgantown, West Virginia, United States
St. Vincent's Hospital - Sydney, Darlinghurst, New South Wales, Australia
Gosford & Wyong Hospital, Gosford, New South Wales, Australia
Royal North Shore Hospital, St. Leonards, New South Wales, Australia
The Royal Brisbane and Women's Hospital, Herston, Queensland, Australia
St. Vincent's Hospital, Melbourne, Fitzroy, Victoria, Australia
Royal Perth Hospital, Perth, Western Australia, Australia
Universite de Gent, Gent, , Belgium
AZ Sint-Augustinus, Wilrijk, , Belgium
Cliniques Universitaires UCL de Mont-Goddine, Yvoir, , Belgium
Fakultni nemocnice Hradec Kralove, Hradec Kralove, , Czech Republic
Vseobecna fakultni nemocnice v Praze, Praha 2, , Czech Republic
Fakultni nemocnice v Motole, Praha 5, , Czech Republic
Centre Hospitalier Andre Mignot, Le Chesnay, , France
Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes, Lyon, , France
Hopital Hotel Dieu, Nantes, , France
Groupe Hospitalier Necker - Enfants Malades, Paris, , France
Hopitaux du Haut Leveque, Pessac, , France
Centre Hospitalier Lyon Sud, Pierre Benite, , France
Centre Henri Becquerel, Rouen, , France
Hematologie CHU Purpan, Toulouse, , France
Institut Gustave-Roussy, Villejuif, , France
Johannes-Gutenberg Universitat Mainz, Mainz, , Germany
KH Maria Hilf-Franziskushaus, Monchengladbach, , Germany
Universitatsklinikum Ulm, Ulm, , Germany
Debreceni Egyetem Orvos - es Egeszsegtudomanyi Centrum, Debrecen, , Hungary
Petz Aladar Megyei Oktato Korhaz, IInd Department of Internal Medicine, Gyor, , Hungary
Kaposi Mor Oktato Korhaz, Kaposvar, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikat Kozpont, Szeged, , Hungary
Azienda Ospedaliera Universitaria Careggi, Florence, , Italy
Azienda Ospedaliera Universitaria San Martino, Genova, , Italy
Azienda Ospedaliera Universitaria Senese, Siena, , Italy
Szpital Akademii Medycznej w Gdansku, Gdansk, , Poland
Szpital Uniwersytecki w Krakowie, Krakow, , Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi, Lodz, , Poland
Instytut Hematologii i Transfuzjologii, Warszawa, , Poland
Centrum Onkologii Institut im. Marii Sklodowskiej-Curie, Warszawa, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1, Wroclaw, , Poland
Hospital Clinic i Provincial, Barcelona, , Spain
Hospital de la Santa Creu i Sant Paul, Barcelona, , Spain
H. Duran y Reynals Institue Catala D'Oncologia, Barcelona, , Spain
Hospital Ramon y Cajal, Madrid, , Spain
Hospital Universitario La Fe, Valencia, , Spain
Name: Jonathan Drachman, MD
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR