Polycythemia Vera
Conditions
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will be continued until 12 months In case of disease progression or treatment failure, experimental drug will be withdrawn and patient will be out of the study
Interventions
DRUGImatinib Mesylate
400 mg/die for 6 months
Sponsors
Niguarda Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of Haematocrit to less than 45%. | 6-12 months |
Secondary
| Measure | Time frame |
|---|---|
| Response duration | 6-12 months |
| Safety profile | 6-12 months |
| Reduction in platelet count and spleen size | 6-12 months |
| Reduction of incidence phlebotomies. | 6-12 months |
| Symptoms improvement in patients. | 6-12 months |
Outcome results
None listed