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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT01632904
First received: June 29, 2012
Last updated: March 26, 2015
Last verified: March 2015
Results First Received: March 26, 2015  
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
Condition: Polycythemia Vera
Interventions: Drug: Ruxolitinib
Drug: Hydroxyurea (HU)
Drug: HU-placebo
Drug: Ruxolitinib-placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ruxolitinib

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.

Hydroxyurea

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.


Participant Flow:   Overall Study
    Ruxolitinib     Hydroxyurea  
STARTED     54     56  
COMPLETED     47 [1]   50 [2]
NOT COMPLETED     7     6  
Adverse Event                 4                 1  
Physician Decision                 0                 1  
Subject decision                 3                 2  
Disease Progression                 0                 1  
Reason for discontinuation not available                 0                 1  
[1] Patients still in the study as of data cutoff, 27MAR2014.
[2] Patients still in the study as of 27MAR2014, including those who crossed over to ruxolitinib



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ruxolitinib

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.

Hydroxyurea

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.

Total Total of all reporting groups

Baseline Measures
    Ruxolitinib     Hydroxyurea     Total  
Number of Participants  
[units: participants]
  54     56     110  
Age  
[units: years]
Mean (Standard Deviation)
  63.1  (11.68)     64.2  (12.68)     63.7  (12.15)  
Gender  
[units: participants]
     
Female     30     22     52  
Male     24     34     58  
Race/Ethnicity, Customized  
[units: participants]
     
White or Caucasian     53     56     109  
Asian     1     0     1  



  Outcome Measures
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1.  Primary:   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   [ Time Frame: Week 16 ]

2.  Secondary:   Percentage of Subjects Achieving ≥ 50% Improvement From Baseline in the Individual Symptom Scores for TSS-C at Week 16   [ Time Frame: Week 16 ]

3.  Secondary:   Percentage of Subjects Achieving a Durable Response on TSS-C   [ Time Frame: Week 48 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Percentage of Subjects Achieving a Durable Response on Individual Symptoms Scores for TSS-C   [ Time Frame: Week 48 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Incyte Corporation
phone: 855 463-3463


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
Results First Received: March 26, 2015
Last Updated: March 26, 2015
Health Authority: United States: Food and Drug Administration