Clinical trial · Interventional
Randomized Switch Study From Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief Study
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycythemia Vera | Polycythemia Vera | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HU-placebo | Drug | — | UNRESOLVED |
| Hydroxyurea (HU) | Drug | Hydroxyurea | ALIAS |
| Ruxolitinib | Drug | Ruxolitinib | ALIAS |
| Ruxolitinib-placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ruxolitinib and hydroxyurea (HU)-placebo
- interventionNames
- Drug: Ruxolitinib
- Drug: HU-placebo
- type
- ACTIVE_COMPARATOR
- label
- HU and ruxolitinib-placebo
- interventionNames
- Drug: Hydroxyurea (HU)
- Drug: Ruxolitinib-placebo
Primary outcomes (1)
- measure
- 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
- timeFrame
- From Baseline to Week 16
- description
- Symptoms of polycythemia vera were assessed using a modified Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) electronic diary. Using the diary, patients rated the following symptoms on a scale from 0 (absent) to 10 (worst imaginable): tiredness, itching, muscle aches, night sweats, and sweats while awake. The total symptom score ranged from 0-50 and was calculated as the sum of the 5 symptom scores. A higher score indicates worse symptoms.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available