Effects of Imatinib Mesylate in Polycythemia Vera

Niguarda Hospital

Status and phase: Completed; Phase 2

Conditions: Polycythemia Vera

Treatments: Drug: Imatinib Mesylate

Study type: Interventional

Funder types: Other

Identifiers

NCT00430066

CSTI571POLIVERA

Details and patient eligibility

About

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.

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will be continued until 12 months In case of disease progression or treatment failure, experimental drug will be withdrawn and patient will be out of the study

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Imatinib Mesylate

Experimental group

Description:

400 mg/day by mouth for 6 months (+ 6 months in case of responsiveness)

Treatment:

Drug: Imatinib Mesylate