Randomized Switch Study From Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief Study

• Status: Completed
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the RELIEF study is to compare symptoms in polycythemia vera (PV) subjects treated with ruxolitinib versus subjects treated with hydroxyurea (HU) as measured by the percent of subjects who achieve a clinically meaningful symptom improvement (ie, total symptom score reduction of ≥ 50% reduction) at Week 16 compared to Baseline. The study is also designed to demonstrate that these responses are durable with continued treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Incyte Corporation
• Treatments: Hydroxyurea

Criteria

Inclusion Criteria:

• Subjects must currently be reporting symptoms while on a stable dose of HU monotherapy and be eligible to continue HU on study after randomization.

• Before screening, the subject must have been receiving HU for at least 12 weeks AND be receiving a stable dose.

• Subjects must meet baseline symptom criteria

• Subjects should meet at least 1 of the following criteria:

• No more than 2 phlebotomies within the 6 months before screening OR

• No palpable splenomegaly.

• Subjects must have a hematocrit that can be controlled within 35% to 48% (inclusive) before randomization.

Exclusion Criteria:

• Subjects with inadequate liver or renal function at screening.

• Subjects with clinically significant infection that requires therapy

• Subjects with known active hepatitis A, B, or C at screening or with known HIV positivity.

• Subjects with an active malignancy over the previous 2 years

• Subjects with clinically significant cardiac disease (Class III or IV).