Multi-Center, Open-Label, Randomized Study of Anti-CCR4 Monoclonal Antibody KW 0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)
CCR4 expression in ATL patients has been demonstrated to be very high and has been
associated with shorter survival compared with CCR4-negative patients. KW-0761, a monoclonal
antibody targeted to CCR4, has been shown to be safe and tolerable in several clinical
trials in subjects with a variety of T-cell malignancies, including ATL, mycosis fungoides
and Sézary syndrome. The objective of this study is to estimate the overall response rate of
KW-0761 for subjects with relapsed or refractory ATL.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate
every 8 weeks
No
Michael Kurman, MD
Study Director
Kyowa Hakko Kirin Pharma, Inc.
United States: Food and Drug Administration
PROTOCOL 0761-009
NCT01626664
June 2012
June 2015
Name | Location |
---|---|
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Cedars-Sinai Medical Center | Los Angeles, California 90048 |
Montefiore Medical Center | Bronx, New York 10467-2490 |
Northwestern University | Chicago, Illinois 60611 |
Memorial Sloan Kettering | New York, New York 10021 |
National Cancer Institute | Bethesda, Maryland 20892-1922 |
The Winship Cancer Institute | Atlanta, Georgia 30322 |
Columbia Presbyterian - Harlem | New York, New York 10032 |
University of Miami / Sylvester Comprehensive Cancer Center | Miami, Florida 33136 |