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Effects of Imatinib Mesylate in Polycythemia Vera

Primary Purpose

Polycythemia Vera

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Imatinib Mesylate
Sponsored by
Niguarda Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycythemia Vera

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Imatinib Mesylate

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Reduction of Haematocrit to less than 45%.

    Secondary Outcome Measures

    Response duration
    Safety profile
    Reduction in platelet count and spleen size
    Reduction of incidence phlebotomies.
    Symptoms improvement in patients.

    Full Information

    First Posted
    January 31, 2007
    Last Updated
    October 7, 2014
    Sponsor
    Niguarda Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00430066
    Brief Title
    Effects of Imatinib Mesylate in Polycythemia Vera
    Official Title
    Glivec (Imatinib Mesylate) in the Treatment of Polycythemia Vera
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2007 (undefined)
    Primary Completion Date
    November 2009 (Actual)
    Study Completion Date
    September 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Niguarda Hospital

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Polycythemia Vera

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    9 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Imatinib Mesylate
    Arm Type
    Experimental
    Arm Description
    400 mg/day by mouth for 6 months (+ 6 months in case of responsiveness)
    Intervention Type
    Drug
    Intervention Name(s)
    Imatinib Mesylate
    Intervention Description
    400 mg/die for 6 months
    Primary Outcome Measure Information:
    Title
    Reduction of Haematocrit to less than 45%.
    Time Frame
    6-12 months
    Secondary Outcome Measure Information:
    Title
    Response duration
    Time Frame
    6-12 months
    Title
    Safety profile
    Time Frame
    6-12 months
    Title
    Reduction in platelet count and spleen size
    Time Frame
    6-12 months
    Title
    Reduction of incidence phlebotomies.
    Time Frame
    6-12 months
    Title
    Symptoms improvement in patients.
    Time Frame
    6-12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Enrica Morra, MD
    Organizational Affiliation
    Divisione di Ematologia - Ospedale Niguarda Ca' Granda
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Effects of Imatinib Mesylate in Polycythemia Vera

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