Clinical Trial: Effects of Imatinib Mesylate in Polycythemia Vera
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Glivec (Imatinib Mesylate) in the Treatment of Polycythemia Vera
Brief Summary:
The purpose of this study is to determine the activity of Glivec 400 mg po daily, as single agent, in inducing a haematological response in Polycythemia Vera.
The patients will be asked to have additional bone marrow and blood samples collected: these samples will be used to evaluate how the disease is responding to the drug.
Detailed Summary: Hematocrit <45% in men or <42% in women at 1°evaluation within 6 months In case of complete or partial responsiveness, experimental treatment will be continued until 12 months In case of disease progression or treatment failure, experimental drug will be withdrawn and patient will be out of the study
Sponsor: Niguarda Hospital
Current Primary Outcome: Reduction of Haematocrit to less than 45%. [ Time Frame: 6-12 months ]
Original Primary Outcome:
- Reduction of Haematocrit to less than 45%.
- Reduction in platelet count and spleen size.
- Reduction of incidence phlebotomies.
- Symptoms improvement in patients.
Current Secondary Outcome:
- Response duration [ Time Frame: 6-12 months ]
- Safety profile [ Time Frame: 6-12 months ]
- Reduction in platelet count and spleen size [ Time Frame: 6-12 months ]
- Reduction of incidence phlebotomies. [ Time Frame: 6-12 months ]
- Symptoms improvement in patients. [ Time Frame: 6-12 months ]
Original Secondary Outcome:
- Response duration
- Safety profile
Information By: Niguarda Hospital
Dates:
Date Received: January 31, 2007
Date Started: February 2007
Date Completion:
Last Updated: October 7, 2014
Last Verified: October 2014
