Polycythemia Vera (PV) Patients Who Are Resistant to or Intolerant of Hydroxyurea
This study is looking for patients with PV, who can no longer take hydroxyurea. Patients with PV have been identified in prior studies as carrying the JAK2 mutation. INC424 is a JAK2 inhibitor that causes death of cells without any bad effect on the normal production of cells. The purpose of this study is to show that patients taking the INC424 tablets will have a reduction in their spleen size and blood taking need, and at the same time develop blood cell results.
Patients are randomized to either best available therapy or INC424. Patients randomized to best available therapy may be eligible to change their treatment and take INC424 at the 32 week visit. Patients on this study will start and continue until the week 80 visit and if they are benefiting from the study will continue with the medication in a continuing study.
Inclusion Criteria: Diagnosis of PV for at least 24 weeks prior to starting study Spleen must be enlarged and able to find on a physical exam Need for phlebotomy (blood is taken from your arm to decrease the amount of blood cells you have) Your white blood cell and platelet count must be elevated
Harry Staszewski, MD
Patricia Ly RN MSN ANP firstname.lastname@example.org