Clinical Trial: Phase 2 Study of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: A Double-Blind, Double-Dummy Phase 2 Randomized Study to Evaluate the Efficacy and Safety of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who A
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of ruxolitinib versus anagrelide in subjects with essential thrombocythemia who are resistant to or intolerant of hydroxyurea.
Detailed Summary:
Sponsor: Incyte Corporation
Current Primary Outcome: Efficacy of ruxolitinib versus anagrelide as measured by proportion of subjects who achieve platelet and white blood cell (WBC) control [ Time Frame: 52 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Safety and tolerability of ruxolitinib measured by adverse events [ Time Frame: Baseline through 30-37 days after end of treatment, up to 36 months per subject. ]
- Proportion of subjects who achieve complete remission or partial remission based on European LeukemiaNet (ELN) 2013 response criteria [ Time Frame: 32 weeks ]
Original Secondary Outcome: Same as current
Information By: Incyte Corporation
Dates:
Date Received: April 17, 2017
Date Started: May 2017
Date Completion: June 2020
Last Updated: May 12, 2017
Last Verified: May 2017
