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Brief Title: Study of KW-0761 Versus Vorinostat in Relapsed/Refractory CTCL
Official Title: Open-Label, Multi-Center, Randomized Study of Anti-CCR4 Monoclonal Antibody KW-0761 (Mogamulizumab) Versus Vorinostat in Subjects With Previously Treated Cutaneous T-Cell Lymphoma
Study ID: NCT01728805
Brief Summary: The purpose of this study is to compare the progression free survival of KW-0761 versus vorinostat for subjects with relapsed or refractory CTCL.
Detailed Description: Phase 3 randomized study to compare the progression free survival of subjects with relapsed/refractory CTCL who receive KW-0761 versus those who receive vorinostat. Subjects who progress on vorinostat will be allowed to cross over to KW-0761 upon progression.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama - Birmingham, Birmingham, Alabama, United States
Banner MD Anderson, Gilbert, Arizona, United States
City of Hope National Medical Center, Duarte, California, United States
UCLA Medical Center, Los Angeles, California, United States
Stanford Medical Center, Stanford, California, United States
University of Colorado, Aurora, Colorado, United States
Yale University School of Medicine - Yale Cancer Center, New Haven, Connecticut, United States
H. Lee Moffitt Cancer Center, Tampa, Florida, United States
The Winship Cancer Institute (Emory University), Atlanta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
Indiana University, Indianapolis, Indiana, United States
University of Kansas Cancer Center, Westwood, Kansas, United States
Tulane University Medical Center, New Orleans, Louisiana, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Boston Medical Center, Department of Medicine, Section of Hem/Onc, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Universal Dermatology, PLLC, Fairport, New York, United States
Columbia Presbyterian, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Rochester School of Medicine, Rochester, New York, United States
Wake Forest Baptist Medical Center, Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Ohio State University, Columbus, Ohio, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
M.D.Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
University of Washington, Seattle, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Westmead Hospital, Westmead, New South Wales, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
Parkville Cancer Clinical Trials Unit, Melbourne, Victoria, Australia
Aarhus University Hospital, Aarhus, , Denmark
CHU de Nantes, Nantes, , France
Hôpital Saint Louis, Paris, , France
CHU Bordeaux - Hopital Haut-Leveque, Pessac, , France
Centre Hospitalier Lyon Sud, Pierre-Benite Cedex, , France
University Medical Centre Mannheim, Mannheim, , Germany
University Hospital Muenster, Muenster, , Germany
Institute of Hematology and Oncology Lorenzo e Ariosto Seràgnoli, University of Bologna, Bologna, , Italy
Universita degli Studi di Torino, Turin, , Italy
Nagoya City University Hospital, Nagoya-shi, Aichi, Japan
Fukushima Medical University Hospital, Fukushima-shi, Fukushima, Japan
Gunma University Hospital, Maebashi-shi, Gunma, Japan
Hiroshima University Hospital, Hiroshima-shi, Hiroshima, Japan
Asahikawa Medical University Hospital, Asahikawa, Hokkaido, Japan
Imamura Bun-in Hospital, Kagoshima-shi, Kagoshima, Japan
Yokohama City University Hospital, Yokohama-shi, Kanagawa, Japan
Kochi Medical School Hospital, Nankoku-shi, Kochi, Japan
Mie University Hospital, Tsu-shi, Mie, Japan
Tohoku University Hospital, Sendai-shi, Miyagi, Japan
Shinshu University Hospital, Matsumoto-shi, Nagano, Japan
Okayama University Hospital, Okayama-shi, Okayama, Japan
Kansai Medical University Hospital, Hirakata-shi, Osaka, Japan
Osaka University Hospital, Suita-shi, Osaka, Japan
Hamamatsu University Hospital, Hamamatsu-shi, Shizuoka, Japan
The University of Tokyo Hospital, Bunkyo-ku, Tokyo, Japan
National Cancer Center Hospital, Chuo-ku, Tokyo, Japan
Tokyo Metropolitan Tama Medical Center, Fuchu-shi, Tokyo, Japan
Japanese Foundation for Cancer Research, Koto-ku, Tokyo, Japan
Leiden University Medical Center - Leids Universitair Medisch Centrum (LUMC), Leiden, , Netherlands
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
University Hospital Zurich, Zurich, , Switzerland
The Christie Hospital Foundation NHS Trust, Manchester, Greater Manchester, United Kingdom
University Hospital Birmingham, Birmingham, , United Kingdom
Guys & St. Thomas NHS Trust, London, , United Kingdom
Name: Dmitri O. Grebennik, MD
Affiliation: Kyowa Kirin, Inc.
Role: STUDY_DIRECTOR