MPD-RC 111: Single Arm Salvage Therapy with Pegylated Interferon Alfa-2a for Patients with High Risk PV or High Risk ET who are Either Hydroxurea Resistent or Intolerant or Have Had Abdominal Vein Thrombosis
ID Number 09-1300Principal 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 increase the risk of developing blood clots.
The purpose of this study is to look at the effectiveness of giving patients who have been diagnosed with ET and PV a study drug regimen using Aspirin and Pegylated interferon alfa-2a, instead of the standard treatment drug called Hydroxyurea, for whom this drug may not be suitable. The drug may not be suitable either because it is not adequately controlling the number of blood cells or some specific side effects occur. All subjects participating in this study will receive Aspirin as part of their study regimen. The exact definition of the drug not being suitable for a patient is defined in the trial protocol; your study doctor will be able to discuss this in more detail with you. More information will be given on these treatments later in this information sheet. To enter this study you will already have had treatment with a drug known as hydroxyurea for either PV or PTET, but this drug is either not working well enough or may be causing certain side effects.
You may qualify to take part in this research study because you have been diagnosed as having the condition either ET or PV and are over 18 years of age.
Recruiting Patients: Yes