Spots Global Cancer Trial Database for Randomized Switch Study From Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief Study
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Trial Identification
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 ID: NCT01632904
Conditions
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Scottsdale, Arizona, United States
, Fayetteville, Arkansas, United States
, Burbank, California, United States
, Glendale, California, United States
, La Jolla, California, United States
, Los Angeles, California, United States
, San Diego, California, United States
, Aurora, Colorado, United States
, Stamford, Connecticut, United States
, Washington, D.C., District of Columbia, United States
, Boynton Beach, Florida, United States
, Orlando, Florida, United States
, Atlanta, Georgia, United States
, Chicago, Illinois, United States
, Niles, Illinois, United States
, Springfield, Illinois, United States
, Ames, Iowa, United States
, Westwood, Kansas, United States
, Alexandria, Louisiana, United States
, Baltimore, Maryland, United States
, Southfield, Michigan, United States
, Minneapolis, Minnesota, United States
, Columbia, Missouri, United States
, Saint Louis, Missouri, United States
, Henderson, Nevada, United States
, Las Vegas, Nevada, United States
, East Orange, New Jersey, United States
, Morristown, New Jersey, United States
, Somerville, New Jersey, United States
, Albany, New York, United States
, Armonk, New York, United States
, Mineola, New York, United States
, New York, New York, United States
, Canton, Ohio, United States
, Bethlehem, Pennsylvania, United States
, Charleston, South Carolina, United States
, Chattanooga, Tennessee, United States
, Amarillo, Texas, United States
, Bedford, Texas, United States
, Dallas, Texas, United States
, Garland, Texas, United States
, Houston, Texas, United States
, Longview, Texas, United States
, Midland, Texas, United States
, San Antonio, Texas, United States
, Temple, Texas, United States
, Tyler, Texas, United States
, Salt Lake City, Utah, United States
, Alexandria, Virginia, United States
, Seattle, Washington, United States
, Milwaukee, Wisconsin, United States
, Antwerpen, , Belgium
, Brugge, , Belgium
, Aachen, , Germany
, Berlin, , Germany
, Freiburg, , Germany
, Hamburg, , Germany
, Stuttgart, , Germany
, Ulm, , Germany
, Galway, , Ireland
, Firenze, , Italy
, Reggio Calabria, , Italy
, Varese, , Italy
, Barcelona, , Spain
, Pamplona, , Spain
, Salamanca, , Spain
, Boston, , United Kingdom
, Leicester, , United Kingdom
, Nottingham, , United Kingdom
, West Bromwich, , United Kingdom
Contact Details
Name: Mark Jones, M.D.
Affiliation: Incyte Corporation
Role: STUDY_DIRECTOR
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