Treatment of Polycythemia Vera With Gleevec

Polycythemia Vera Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01120821
• Other study ID #: 0702-375
• Secondary ID: CSTI571AUS41
• Status: Completed
• Phase: Phase 2
• First received: May 7, 2010
• Last updated: May 14, 2010
• Start date: August 2002
• Est. completion date: June 2007

Study information

• Verified date: May 2010
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycythemia
• Polycythemia Vera

Intervention

Drug:
• Gleevec
400 mg once daily for 12 months

Locations

Country	Name	City	State
United States	Weill Cornell Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stabilization of hematocrit		Weekly for the first six week of treatment, then monthly for one year from study entry.	No
Primary	Platelet count maintenance a therapeutic range.		Weekly for the first six weeks of treatment, then monthly for one year from study entry.	No
Secondary	Splenomegaly (if existent)		Weekly for the first six weeks of treatment, then montly for one year from study entry.	No
Secondary	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.	No