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A Double-Blind, Double-Dummy Phase 2 Randomized Study to Evaluate the Efficacy and Safety of Ruxolitinib Versus Anagrelide in Subjects with Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Double-Blind, Double-Dummy Phase 2 Randomized Study to Evaluate the Efficacy and Safety of Ruxolitinib Versus Anagrelide in Subjects with Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea
 
Region Sponsors
Northwest
Incyte Corporation
 
Acronym KP IRB No.
RESET-272 STUDY00000697
 
Study Type Phase
Clinical Trial Phase II
 
Study Population Description
Essential Thrombocythemia;
 
Purpose
The purpose of this study is to evaluate the efficacy and safety of ruxolitinib versus anagrelide in subjects with essential thrombocythemia who are resistant to or intolerant of hydroxyurea.
 
Detailed Description
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Diagnosis of essential thrombocythemia according to revised World Health Organization (WHO) 2016 criteria.
  • Resistant to or intolerant of hydroxyurea, that is, fulfilling at least 1 of the following criteria:
  • 1. Platelet count > 600 × 10^9/L after 3 months of at least 2 g/day of hydroxyurea (2.5 g/day in subjects with a body weight over 80 kg) OR at the subject's maximally tolerated dose if that dose is < 2 g/day.
  • 2. Platelet count > 400 × 10^9/L and WBC count < 2.5 × 10^9/L or hemoglobin < 10 g/dL at any dose of hydroxyurea.
  • 3. Presence of leg ulcers or other unacceptable mucocutaneous manifestations at any dose of hydroxyurea.
  • 4. Hydroxyurea-related fever.
  • Platelet count > 650 × 10^9/L at screening.
  • WBC > 11.0 × 10^9/L at screening.
 
Exclusion Criteria
  • Subjects previously treated with anagrelide or JAK inhibitors.
  • Inadequate liver function at screening and Day 1 (before drug administration) as demonstrated by:
  • 1. Total bilirubin > 1.5 × upper limit of normal (ULN)
  • 2. Aspartate aminotransferase or alanine aminotransferase > 1.5 × ULN
  • 3. Hepatocellular disease (eg, cirrhosis)
  • Inadequate renal function at screening as demonstrated by creatinine clearance < 40 mL/min calculated by Cockcroft-Gault equation.

 
Keywords and/or Specific Medical Conditions
  • Essential Thrombocythemia
  • Oncology (Adult)
  • Hematology
 
KP Clinical Facility
 
Clinical Area
  • Hematology
  • Oncology (Adult)


Principal Investigator:
Abdul Hai Mansoor, MD
Contact Information:
- Rhonda Stephenson, RN
-503-331-6537
-rhonda.stephenson@kpchr.org
-Central Interstate Medical Office


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