Treatment of Polycythemia Vera With Gleevec

Completed · Phase 2

Conditions studied: Polycythemia Vera

In brief

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

Key facts

Study ID: NCT01120821
Run by: Weill Medical College of Cornell University
People needed: 36
Starts: 2002-08-01
Expected to finish: 2007-06-01
Last updated by the study team: 2010-05-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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).

Where it is running

Weill Cornell Medical College — New York, New York, United States

Full record on ClinicalTrials.gov

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