Effects of Imatinib Mesylate in Polycythemia Vera
- Registration Number
- NCT00430066
- Lead Sponsor
- Niguarda Hospital
- 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 Description
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will be continued until 12 months In case of disease progression or treatment failure, experimental drug will be withdrawn and patient will be out of the study
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Imatinib Mesylate Imatinib Mesylate 400 mg/day by mouth for 6 months (+ 6 months in case of responsiveness)
- Primary Outcome Measures
Name Time Method Reduction of Haematocrit to less than 45%. 6-12 months
- Secondary Outcome Measures
Name Time Method Reduction of incidence phlebotomies. 6-12 months Symptoms improvement in patients. 6-12 months Response duration 6-12 months Safety profile 6-12 months Reduction in platelet count and spleen size 6-12 months