Clinical Trial: Treatment of Polycythemia Vera With Gleevec

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase II Trial of the Treatment of Polycythemia Vera With Gleevec

Brief Summary: The purpose of this research study is to evaluate the safety and effectiveness of patients with Polycythemia Vera treated with Gleevec.

Detailed Summary: Phlebotomy is a standard temporizing treatment for Polycythemia Vera. Performing repeated phlebotomies may lead to iron deficiency and can contribute to a rising platelet count. This may create additional problems, such as clots particularly in patients older than 50. There is reason to believe that the use of Gleevec may cause a decrease in the activity of the marrow so that patients may not require as many or any phlebotomies. Thus, spleen function may possibly improve by decreasing in size and patients' platelet counts may also improve.
Sponsor: Weill Medical College of Cornell University

Current Primary Outcome:

  • Stabilization of hematocrit [ Time Frame: Weekly for the first six week of treatment, then monthly for one year from study entry. ]
  • Platelet count maintenance a therapeutic range. [ Time Frame: Weekly for the first six weeks of treatment, then monthly for one year from study entry. ]


Original Primary Outcome:

  • To evaluate the effect of Gleevec on the stabilization of hematocrit when restored to normal range by phlebotomy. [ Time Frame: Weekly for the first six week of treatment, then monthly for one year from study entry. ]
  • To evaluate the effect of Gleevec on the platelet count and to maintain in at a therapeutic range. [ Time Frame: Weekly for the first six weeks of treatment, then monthly for one year from study entry. ]


Current Secondary Outcome:

  • Splenomegaly (if existent) [ Time Frame: Weekly for the first six weeks of treatment, then montly for one year from study entry. ]
  • Quality of life, performance status, side effects and complications during treatment. [ Time Frame: Weekly for the first six weeks of treatment, then montly for one year from study entry. ]


Original Secondary Outcome:

  • To reduce and or stabilize splenomegaly (if existent). [ Time Frame: Weekly for the first six weeks of treatment, then montly for one year from study entry. ]
  • To determine the quality of life, performance status, side effects and complications in patients so treated. [ Time Frame: Weekly for the first six weeks of treatment, then montly for one year from study entry. ]


Information By: Weill Medical College of Cornell University

Dates:
Date Received: May 7, 2010
Date Started: August 2002
Date Completion:
Last Updated: May 14, 2010
Last Verified: May 2010