A Phase III Study of Ruxolitinib versus Hydroxyurea to Treat Symptoms of Polycythemia Vera: the RELIEF Study

Protocol
13-142
Full Title
Polycythemia Vera Symptom Study Evaluating Ruxolitinib Versus Hydroxyurea in a Randomized, Multicenter, Double-Blind, Double-Dummy, Phase 3 Efficacy and Safety Study of Patient Reported Outcomes
Phase
III
Purpose

Polycythemia vera (PV) is a rare blood disorder in which the bone marrow makes too many red blood cells. The standard treatment is a drug called hydroxyurea along with phlebotomy (blood-letting) to relieve symptoms (such as fatigue, itching, muscle aches, and sweats). However, some patients continue to have symptoms despite this therapy.

In this study, researchers are comparing the effectiveness of ruxolitinib versus hydroxyurea in patients with PV to see if ruxolitinib is more effective for relieving symptoms and reducing the need for phlebotomy. Ruxolitinib is a drug approved for the treatment of myelofibrosis (scarring of the bone marrow); its use in this study is considered investigational. It works by inhibiting a protein called JAK, which may be abnormal in bone marrow disorders such as PV.

Patients will be randomly assigned to receive ruxolitinib plus a placebo or hydroxyurea plus a placebo. Both drugs are taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have PV and be experiencing symptoms despite hydroxyurea treatment.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Raajit Rampal at 212-639-2194.

Disease(s)
Hematology: Hematologic Disorders
Locations