Randomized Trial of Pegylated Interferon Alfa-2a versus Hydroxurea Therapy in the Treatment of High Risk Polycythemia Vera and High Risk Essential Thrombocythemia
ID Number 09-1300-00002Principal Investigator(s)
Department(s) or Division(s)
Hematology and Medical Oncology
This research looks at two conditions, Essential Thrombocythemia (ET) and Polycythemia Vera (PV). ET causes people to produce too many blood cells called platelets and PV causes too many platelets and red blood cells to be made. Platelets are particles which circulate in the blood stream and normally prevent bleeding and bruising. Having too many platelets in the blood increases the risk of developing blood clots, which can result in life threatening events like heart attacks and strokes. When the number of red blood cells is increased in PV this will slow the speed of blood flow in the body and increases the risk of developing blood clots.
The purpose of this study is to look at the effectiveness of giving participants who have been diagnosed with ET or PV one of two different study regimens over time. Your study doctor would want to follow your condition for about 5 years. The study regimens are either ‘PEGASYS’ (or Pegylated Interferon Alfa-2a) or ‘Aspirin and Hydroxyurea’ (also called Hydroxycarbamide). All subjects participating in this study will also receive Aspirin as part of their study regimen regardless of which study drug they will receive. More information on these study regimens will be described later in this information sheet. To enter this study you may be a newly diagnosed patient or are already receiving treatment for either PV or ET. Each of the study drugs used in this study is already being used to treat patients with ET or PV currently but we are unsure which study drug is better.
You may qualify for this study because you have been diagnosed by your study doctor as having the condition ET or PV and are over 18 years of age.
Recruiting Patients: Yes