Randomized Switch Study From Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief Study
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| ClinicalTrials.gov Identifier: NCT01632904 |
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Recruitment Status :
Completed
First Posted : July 3, 2012
Results First Posted : April 7, 2015
Last Update Posted : November 14, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Polycythemia Vera | Drug: Ruxolitinib Drug: Hydroxyurea (HU) Drug: HU-placebo Drug: Ruxolitinib-placebo | Phase 3 |
This is a Phase 3 multicenter, double-blind, double-dummy, randomized study. Only subjects with PV who have received HU for at least 12 weeks, have been receiving a stable dose before screening, and still have symptoms related to PV will be enrolled.
Subjects will be randomized (1:1) to 1 of 2 treatment arms:
A: ruxolitinib and HU-placebo B: HU and ruxolitinib-placebo
Subjects randomized to either arm may be eligible to transition to open-label ruxolitinib after Week 16.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 110 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official 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 |
| Study Start Date : | June 2012 |
| Actual Primary Completion Date : | March 2014 |
| Actual Study Completion Date : | May 2016 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: ruxolitinib and hydroxyurea (HU)-placebo |
Drug: Ruxolitinib
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. Drug: HU-placebo 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. |
| Active Comparator: HU and ruxolitinib-placebo |
Drug: Hydroxyurea (HU)
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. Drug: Ruxolitinib-placebo 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. |
- 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 [ Time Frame: From Baseline to Week 16 ]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.
- Percentage of Subjects Achieving ≥ 50% Improvement From Baseline in the Individual Symptom Scores for TSS-C at Week 16 [ Time Frame: From Baseline to Week 16 ]The TSS-C cluster includes tiredness, itching, muscle aches, night sweats, and sweats while awake.
- 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 [ Time Frame: Week 48 ]Durable Response on TSS-C/individual symptoms defined as a ≥ 50% reduction in TSS-C/individual symptoms at Week 16 that were maintained at Week 48
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01632904
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| Study Director: | Mark Jones, M.D. | Incyte Corporation |
| Responsible Party: | Incyte Corporation |
| ClinicalTrials.gov Identifier: | NCT01632904 |
| Other Study ID Numbers: |
18424-357 |
| First Posted: | July 3, 2012 Key Record Dates |
| Results First Posted: | April 7, 2015 |
| Last Update Posted: | November 14, 2017 |
| Last Verified: | October 2017 |
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Polycythemia Vera PV |
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Polycythemia Vera Polycythemia Hematologic Diseases Bone Marrow Neoplasms Hematologic Neoplasms Neoplasms by Site Neoplasms Bone Marrow Diseases |
Myeloproliferative Disorders Hydroxyurea Antineoplastic Agents Antisickling Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Nucleic Acid Synthesis Inhibitors |