Treatment of Polycythemia Vera With Gleevec

May 14, 2010 updated by: Weill Medical College of Cornell University

A Phase II Trial of the Treatment of Polycythemia Vera With Gleevec

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical College

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:

  • 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).

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stabilization of hematocrit
Time Frame: Weekly for the first six week of treatment, then monthly for one year from study entry.
Weekly for the first six week of treatment, then monthly for one year from study entry.
Platelet count maintenance a therapeutic range.
Time Frame: Weekly for the first six weeks of treatment, then monthly for one year from study entry.
Weekly for the first six weeks of treatment, then monthly for one year from study entry.

Secondary Outcome Measures

Outcome Measure
Time Frame
Splenomegaly (if existent)
Time Frame: Weekly for the first six weeks of treatment, then montly for one year from study entry.
Weekly for the first six weeks of treatment, then montly for one year from study entry.
Quality of life, performance status, side effects and complications during treatment.
Time Frame: Weekly for the first six weeks of treatment, then montly for one year from study entry.
Weekly for the first six weeks of treatment, then montly for one year from study entry.

Collaborators and Investigators

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

Sponsor

Weill Medical College of Cornell University

Investigators

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

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

August 1, 2002

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

May 7, 2010

First Submitted That Met QC Criteria

May 7, 2010

First Posted (Estimate)

May 11, 2010

Study Record Updates

Last Update Posted (Estimate)

May 17, 2010

Last Update Submitted That Met QC Criteria

May 14, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0702-375
  • CSTI571AUS41 (Other Grant/Funding Number: Novartis)

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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