Clinical Trial: KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: 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-Lymp
Brief Summary: The purpose of this study is to estimate the overall response rate of subjects with relapsed or refractory Adult T-cell Leukemia-Lymphoma (ATL).
Detailed Summary: 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.
Sponsor: Kyowa Hakko Kirin Pharma, Inc.
Current Primary Outcome: Overall Response Rate [ Time Frame: every 8 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- progression free survival [ Time Frame: From date of randomization until the date of first documented progression, start of alternative therapy, or date of death from any cause, whichever came first, up to 36 months ]
- overall survival [ Time Frame: up to 36 months ]
- Quality of Life assessments [ Time Frame: up tp 36 months ]
Original Secondary Outcome:
Information By: Kyowa Kirin Pharmaceutical Development, Inc.
Dates:
Date Received: June 19, 2012
Date Started: June 2012
Date Completion: December 2017
Last Updated: January 26, 2017
Last Verified: January 2017
