Effects of Imatinib Mesylate in Polycythemia Vera

October 7, 2014 updated by: Niguarda Hospital

Glivec (Imatinib Mesylate) in the Treatment of Polycythemia Vera

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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will be continued until 12 months In case of disease progression or treatment failure, experimental drug will be withdrawn and patient will be out of the study

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Imatinib Mesylate
400 mg/day by mouth for 6 months (+ 6 months in case of responsiveness)
Drug: Imatinib Mesylate
400 mg/die for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of Haematocrit to less than 45%.
Time Frame: 6-12 months
6-12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Response duration
Time Frame: 6-12 months
6-12 months
Safety profile
Time Frame: 6-12 months
6-12 months
Reduction in platelet count and spleen size
Time Frame: 6-12 months
6-12 months
Reduction of incidence phlebotomies.
Time Frame: 6-12 months
6-12 months
Symptoms improvement in patients.
Time Frame: 6-12 months
6-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Niguarda Hospital

Investigators

  • Study Director: Enrica Morra, MD, Divisione di Ematologia - Ospedale Niguarda Ca' Granda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

January 31, 2007

First Submitted That Met QC Criteria

January 31, 2007

First Posted (Estimate)

February 1, 2007

Study Record Updates

Last Update Posted (Estimate)

October 8, 2014

Last Update Submitted That Met QC Criteria

October 7, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSTI571POLIVERA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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