Effects of Imatinib Mesylate in Polycythemia Vera

Niguarda Hospital9 enrolled

Overview

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will be continued until 12 months In case of disease progression or treatment failure, experimental drug will be withdrawn and patient will be out of the study

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Polycythemia Vera

Interventions

Imatinib MesylateDRUG

400 mg/die for 6 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Reduction of Haematocrit to less than 45%.

Time frame: 6-12 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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