Clinical Trial: Dasatinib in Polycythemia Vera
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II, Non-Randomized Study of the Use of Desatinib (Sprycel) in Treating Patients With Polycythemia Vera (PV) BMS Protocol Number: CA180-104
Brief Summary: The purpose for conducting this research study is to determine the feasibility of using dasatinib as a treatment for polycythemia vera and to determine the optimum treatment regimen.
Detailed Summary:
Sponsor: Weill Medical College of Cornell University
Current Primary Outcome:
- To evaluate the effect of dasatinib on the platelet count and the stabilization of hematocrit when restored by phlebotomy to normal range (HCT <45% for men, <42% for women). [ Time Frame: Lab tests will be performed weekly for the first month, then every 2 weeks for months 2 and 3 and monthly thereafter. ]
- To determine change in performance status and development of side effects and complications in patients treated under this protocol. [ Time Frame: Patients will evaluated weekly for the first month, then every two weeks forr months 2 and 3, and monthly thereafter. ]
Original Primary Outcome:
Current Secondary Outcome:
- To determine changes in marrow cellularity, reticulin and fibrous content. [ Time Frame: Bone marrow analysis will be performed at baseline and month 6. ]
- To determine change in cytogenetics if initially abnormal. [ Time Frame: Cytogenetics analysis will be performed at baseline and month 6. ]
- To determine if quantitative change in JAK2 expression occurs as measured by quantitative pyrosequencing. [ Time Frame: JAK2 analysis will be performed at baseline and month 3. ]
Original Secondary Outcome:
Information By: Weill Medical College of Cornell University
Dates:
Date Received: October 2, 2007
Date Started: April 30, 2007
Date Completion:
Last Updated: March 2, 2017
Last Verified: March 2017
