Randomized Switch Study From Hydroxyurea to Ruxolitinib for RELIEF of Polycythemia Vera Symptoms: The Relief Study
NCT ID: NCT01632904
Last Updated: 2017-11-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
110 participants
INTERVENTIONAL
2012-06-30
2016-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ruxolitinib and hydroxyurea (HU)-placebo
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.
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.
HU and ruxolitinib-placebo
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.
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.
Interventions
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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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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).
18 Years
ALL
No
Sponsors
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Incyte Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Jones, M.D.
Role: STUDY_DIRECTOR
Incyte Corporation
Locations
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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
St 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
Antwerp, , Belgium
Bruges, , Belgium
Aachen, , Germany
Berlin, , Germany
Freiburg im Breisgau, , Germany
Hamburg, , Germany
Stuttgart, , Germany
Ulm, , Germany
Galway, , Ireland
Florence, , 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
Countries
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Other Identifiers
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18424-357
Identifier Type: -
Identifier Source: org_study_id