Effects of Imatinib Mesylate in Polycythemia Vera

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2012-09-30

Brief Summary

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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.

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Detailed Description

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will be continued until 12 months In case of disease progression or treatment failure, experimental drug will be withdrawn and patient will be out of the study

Conditions

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Polycythemia Vera

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Imatinib Mesylate

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

Group Type EXPERIMENTAL

Imatinib Mesylate

Intervention Type DRUG

400 mg/die for 6 months

Interventions

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Imatinib Mesylate

400 mg/die for 6 months

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No