Clinical trial NCT01632904: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Polycythemia Vera
Keywords: Polycythemia Vera
PV
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2012-07-03
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
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
Secondary outcomes:
measure: Percentage of Subjects Achieving ≥ 50% Improvement From Baseline in the Individual Symptom Scores for TSS-C at Week 16
timeFrame: From Baseline to Week 16
measure: 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
timeFrame: Week 48
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Fayetteville
country: United States
state: Arkansas
city: Burbank
country: United States
state: California
city: Glendale
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Stamford
country: United States
state: Connecticut
city: Washington, D.C.
country: United States
state: District of Columbia
city: Boynton Beach
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Niles
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Ames
country: United States
state: Iowa
city: Westwood
country: United States
state: Kansas
city: Alexandria
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state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Southfield
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state: Michigan
city: Minneapolis
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state: Minnesota
city: Columbia
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Henderson
country: United States
state: Nevada
city: Las Vegas
country: United States
state: Nevada
city: East Orange
country: United States
state: New Jersey
city: Morristown
country: United States
state: New Jersey
city: Somerville
country: United States
state: New Jersey
city: Albany
country: United States
state: New York
city: Armonk
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: Canton
country: United States
state: Ohio
city: Bethlehem
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Chattanooga
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Bedford
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Garland
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Longview
country: United States
state: Texas
city: Midland
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Alexandria
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Milwaukee
country: United States
state: Wisconsin
city: Antwerpen
country: Belgium
city: Brugge
country: Belgium
city: Aachen
country: Germany
city: Berlin
country: Germany
city: Freiburg
country: Germany
city: Hamburg
country: Germany
city: Stuttgart
country: Germany
city: Ulm
country: Germany
city: Galway
country: Ireland
city: Firenze
country: Italy
city: Reggio Calabria
country: Italy
city: Varese
country: Italy
city: Barcelona
country: Spain
city: Pamplona
country: Spain
city: Salamanca
country: Spain
city: Boston
country: United Kingdom
city: Leicester
country: United Kingdom
city: Nottingham
country: United Kingdom
city: West Bromwich
country: United Kingdom
Study officials:
affiliation: Incyte Corporation
name: Mark Jones, M.D.
role: STUDY_DIRECTOR
References: