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Treatment of Polycythemia Vera With Gleevec

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Completed
CT.gov ID
NCT01120821
Collaborator
(none)
36
Enrollment
1
Location
1
Arm
58
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this research study is to evaluate the safety and effectiveness of patients with Polycythemia Vera treated with Gleevec.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Phlebotomy is a standard temporizing treatment for Polycythemia Vera. Performing repeated phlebotomies may lead to iron deficiency and can contribute to a rising platelet count. This may create additional problems, such as clots particularly in patients older than 50. There is reason to believe that the use of Gleevec may cause a decrease in the activity of the marrow so that patients may not require as many or any phlebotomies. Thus, spleen function may possibly improve by decreasing in size and patients' platelet counts may also improve.

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial of the Treatment of Polycythemia Vera With Gleevec
Study Start Date :
Aug 1, 2002
Actual Primary Completion Date :
Jan 1, 2007
Actual Study Completion Date :
Jun 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: Study drug

Gleevec treatment

Drug: Gleevec
400 mg once daily for 12 months
Other Names:
  • STI-571

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Stabilization of hematocrit [Weekly for the first six week of treatment, then monthly for one year from study entry.]

    2. Platelet count maintenance a therapeutic range. [Weekly for the first six weeks of treatment, then monthly for one year from study entry.]

    Secondary Outcome Measures

    1. Splenomegaly (if existent) [Weekly for the first six weeks of treatment, then montly for one year from study entry.]

    2. Quality of life, performance status, side effects and complications during treatment. [Weekly for the first six weeks of treatment, then montly for one year from study entry.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients have diagnosis of Polycythemia Vera (PV). Patients may have newly diagnosed PV.

    • Patients may have previously interferon-alfa treated PV with documented resistance, refractoriness or intolerance to interferon-alfa.

    • Patients may have PV with inadequate control on hydroxyurea.

    • Performance status of 0, 1, or 2

    • Adequate end organ function, defined as the following:

    1. total bilirubin <1.5 x upper limit of the normal range (ULN)

    2. SGOT (AST) and SGPT (ALT) < 2.5 x ULN

    3. creatinine < 1.5 x ULN

    4. ANC > 1.5 x 109/L

    • Written voluntary informed consent.
    Exclusion Criteria:

    • Female patients who are pregnant or breast-feeding.

    • Patients receiving busulfan within 6 weeks of Study Day 1.

    • Patients receiving interferon-alpha within 4 weeks of Study Day 1.

    • Patients receiving hydroxyurea within 2 weeks of Study Day 1.

    • Patients with Grade III or IV cardiac problems as defined by the New York Heart Association Criteria.

    • Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable.

    • Patients previously treated with Gleevec.

    • Serum erythropoietin level > or = 25 units/microliter

    • Abnormal O2 saturation (by pulse oximetry) or arterial pO2 (by arterial blood gas).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Weill Cornell Medical College New York New York United States 10021

    Sponsors and Collaborators

    • Weill Medical College of Cornell University

    Investigators

    • Principal Investigator: Richard Silver, M.D., Weill Medical College of Cornell University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01120821
    Other Study ID Numbers:
    • 0702-375
    • CSTI571AUS41
    First Posted:
    May 11, 2010
    Last Update Posted:
    May 17, 2010
    Last Verified:
    May 1, 2010
    Keywords provided by , ,
    PV
    Additional relevant MeSH terms:
    Polycythemia Vera
    Polycythemia
    Imatinib Mesylate

    Study Results

    No Results Posted as of May 17, 2010