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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT01632904
First received: June 29, 2012
Last updated: August 22, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Polycythemia Vera
Drug: ruxolitinib
Drug: hydroxyurea (HU)
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Proportion of subjects with ≥ 50% reduction in a cluster of PV-related symptoms, measured using a patient questionnaire, at week 16 compared to Baseline. [ Time Frame: Baseline and Week 16. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects with ≥ 50% reduction in individual PV-related symptoms at Week 16 compared to Baseline [ Time Frame: Baseline and Week 16. ] [ Designated as safety issue: No ]
  • Duration of symptomatic improvement in subjects experiencing relief from the cluster of PV-related symptoms [ Time Frame: Week 16 and Week 48. ] [ Designated as safety issue: No ]
  • Duration of symptomatic improvement in subjects experiencing relief from individual symptoms [ Time Frame: Week 16 and Week 48. ] [ Designated as safety issue: No ]
  • Safety of ruxolitinib and HU as measured by adverse events. [ Time Frame: Screening through the end of study participation (estimated 18 months). ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 110
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ruxolitinib and hydroxyurea (HU)-placebo Drug: ruxolitinib
Ruxolitinib will be self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day by mouth. Doses increases of 5 mg (1 tablet) in twice daily increments are permitted after 4 weeks and again after 8 weeks of therapy.
Drug: placebo
All placebo will be self-administered and dosing will the same as with the blinded dose and comparator arm.
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 pre-specified criteria.
Drug: placebo
All placebo will be self-administered and dosing will the same as with the blinded dose and comparator arm.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 1 phlebotomy 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632904

  Show 65 Study Locations
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Mark Jones, M.D. Incyte Corporation
  More Information

No publications provided

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT01632904     History of Changes
Other Study ID Numbers: 18424-357
Study First Received: June 29, 2012
Last Updated: August 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Incyte Corporation:
Polycythemia Vera
PV

Additional relevant MeSH terms:
Polycythemia
Polycythemia Vera
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Hydroxyurea
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antisickling Agents
Hematologic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014