Phase 3
N=110
Randomized Switch Study From Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief Study
Polycythemia Vera
Bottom Line
View on ClinicalTrials.gov: NCT01632904 ↗Enrolled (actual)
110
Serious AEs
8.2%
Results posted
Apr 2015
Primary outcome: Primary: Percentage of Subjects Achieving a ≥ 50% Improvement From Baseline in Total Symptom Score-Cytokine (TSS-C) at Week 16, as Measured by the Modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) Diary — 43.4; 29.6 Percentage of participants — p=0.139
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ruxolitinib (Drug); Hydroxyurea (HU) (Drug); HU-placebo (Drug); Ruxolitinib-placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Incyte Corporation
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Achieving a ≥ 50% Improvement From Baseline in Total Symptom Score-Cytokine (TSS-C) at Week 16, as Measured by the Modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) Diary |
43.4; 29.6 | 0.139 |
| SECONDARY Percentage of Subjects Achieving ≥ 50% Improvement From Baseline in the Individual Symptom Scores for TSS-C at Week 16 |
40.0; 26.4; 54.2; 32.0; 38.3; 30.6 | — |
| SECONDARY Proportion of Subjects Randomized to Ruxolitinib Who Achieved ≥ 50% Improvement From Baseline in Total Symptom Score-Cytokine and the Individual Symptom Scores at Week 16 That Were Maintained at Week 48 |
31.5; 24.1; 37.0; 20.4; 29.6; 37.0 | — |
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).
Data sourced from ClinicalTrials.gov (NCT01632904). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.