Effects of Imatinib Mesylate in Polycythemia Vera

Glivec (Imatinib Mesylate) in the Treatment of Polycythemia Vera

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.

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will be continued until 12 months In case of disease progression or treatment failure, experimental drug will be withdrawn and patient will be out of the study

Inclusion Criteria:

• Diagnosis of Polycythemia Vera requiring treatment with either phlebotomy or Hydroxyurea
• Age >18 years
• Signed written informed consent form

Exclusion Criteria:

• Pregnancy or breast-feeding
• Creatinine >3 max NV
• Bilirubin >3 max NV
• AST/ALT >3 max NV
• Concomitant and severe psychiatric disorder
• Concomitant neoplastic disease