Treatment of Polycythemia Vera With Gleevec

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Treatments: Imatinib Mesylate

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:

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).