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Treatment of Polycythemia Vera With Gleevec

Primary Purpose

Polycythemia Vera

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gleevec
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycythemia Vera focused on measuring PV

Eligibility Criteria

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

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).

Sites / Locations

  • Weill Cornell Medical College

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study drug

Arm Description

Gleevec treatment

Outcomes

Primary Outcome Measures

Stabilization of hematocrit
Platelet count maintenance a therapeutic range.

Secondary Outcome Measures

Splenomegaly (if existent)
Quality of life, performance status, side effects and complications during treatment.

Full Information

First Posted
May 7, 2010
Last Updated
May 14, 2010
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT01120821
Brief Title
Treatment of Polycythemia Vera With Gleevec
Official Title
A Phase II Trial of the Treatment of Polycythemia Vera With Gleevec
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Study drug
Arm Type
Experimental
Arm Description
Gleevec treatment
Intervention Type
Drug
Intervention Name(s)
Gleevec
Other Intervention Name(s)
STI-571
Intervention Description
400 mg once daily for 12 months
Primary Outcome Measure Information:
Title
Stabilization of hematocrit
Time Frame
Weekly for the first six week of treatment, then monthly for one year from study entry.
Title
Platelet count maintenance a therapeutic range.
Time Frame
Weekly for the first six weeks of treatment, then monthly for one year from study entry.
Secondary Outcome Measure Information:
Title
Splenomegaly (if existent)
Time Frame
Weekly for the first six weeks of treatment, then montly for one year from study entry.
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: total bilirubin <1.5 x upper limit of the normal range (ULN) SGOT (AST) and SGPT (ALT) < 2.5 x ULN creatinine < 1.5 x ULN 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Silver, M.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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Treatment of Polycythemia Vera With Gleevec

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