Randomized Switch Study From Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief Study
Condition: Polycythemia Vera
MeSH terms: Polycythemia Vera; Polycythemia
Intervention: Ruxolitinib; Hydroxyurea (HU); HU-placebo; Ruxolitinib-placebo
Intervention description: Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.; Hydroxyurea (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.; All placebo will be self-administered, and dosing will be the same as with the blinded dose.
When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently.; All placebo will be self-administered, and dosing will be the same as with the blinded dose.
When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently.
Intervention MeSH terms: Hydroxyurea
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Polycythemia Vera; PV

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.
    

Eligibility 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).