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

Primary Purpose

Polycythemia Vera

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ruxolitinib
Hydroxyurea (HU)
HU-placebo
Ruxolitinib-placebo
Sponsored by
Incyte Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycythemia Vera focused on measuring Polycythemia Vera, PV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ruxolitinib and hydroxyurea (HU)-placebo

HU and ruxolitinib-placebo

Arm Description

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Percentage of Subjects Achieving ≥ 50% Improvement From Baseline in the Individual Symptom Scores for TSS-C at 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
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

Full Information

First Posted
June 29, 2012
Last Updated
October 12, 2017
Sponsor
Incyte Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01632904
Brief Title
Randomized Switch Study From Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief Study
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 Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycythemia Vera
Keywords
Polycythemia Vera, PV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ruxolitinib and hydroxyurea (HU)-placebo
Arm Type
Experimental
Arm Title
HU and ruxolitinib-placebo
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib
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.
Intervention Type
Drug
Intervention Name(s)
Hydroxyurea (HU)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
HU-placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib-placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
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.
Time Frame
From Baseline to Week 16
Secondary Outcome Measure Information:
Title
Percentage of Subjects Achieving ≥ 50% Improvement From Baseline in the Individual Symptom Scores for TSS-C at Week 16
Description
The TSS-C cluster includes tiredness, itching, muscle aches, night sweats, and sweats while awake.
Time Frame
From Baseline to Week 16
Title
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
Description
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
Time Frame
Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Jones, M.D.
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
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Scottsdale
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Fayetteville
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Burbank
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Las Vegas
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East Orange
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Somerville
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Mineola
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Bethlehem
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Charleston
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Amarillo
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Bedford
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Garland
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Houston
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Longview
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Midland
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San Antonio
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Temple
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Tyler
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Salt Lake City
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Alexandria
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Seattle
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Milwaukee
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Antwerpen
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Belgium
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Brugge
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Freiburg
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Ulm
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Galway
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Firenze
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Reggio Calabria
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Italy
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Varese
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Barcelona
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Pamplona
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Salamanca
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Leicester
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Nottingham
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United Kingdom
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West Bromwich
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United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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