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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
No
Michael Kurman, MD
Study Director
Kyowa Hakko Kirin Pharma, Inc.
United States: Food and Drug Administration
0761-010
NCT01728805
November 2012
September 2015
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
University of Colorado | Denver, Colorado 80217 |
University of Rochester School of Medicine | Rochester, New York 14642 |
Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
Tulane University Medical Center | New Orleans, Louisiana 70112 |
University of Washington | Seattle, Washington 98195 |
University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
Northwestern University | Chicago, Illinois 60611 |
H. Lee Moffitt Cancer Center | Tampa, Florida 33612 |
Cleveland Clinic | Cleveland, Ohio 44195 |
UCLA Medical Center | Los Angeles, California 90095-7059 |
Ohio State University | Columbus, Ohio 43210 |
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
Indiana University | Indianapolis, Indiana 46202 |
Stanford Medical Center | Stanford, California 94303 |
Columbia Presbyterian | New York City, New York 10032 |
M.D.Anderson Cancer Center | Houston, Texas 77030 |
University of Pittsburgh School of Medicine | Pittsburgh, Pennsylvania 15232 |
University of Alabama - Birmingham | Birmingham, Alabama 35294 |
Yale University School of Medicine - Yale Cancer Center | New Haven, Connecticut 06520 |
The Winship Cancer Institute (Emory University) | Atlanta, Georgia 30322 |