Phase 2 Study of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272)
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.
- MPN (Myeloproliferative Neoplasms)
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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:
- 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.
- Platelet count > 400 × 10^9/L and WBC count < 2.5 × 10^9/L or hemoglobin < 10 g/dL at any dose of hydroxyurea.
- Presence of leg ulcers or other unacceptable mucocutaneous manifestations at any dose of hydroxyurea.
- Hydroxyurea-related fever.
- Platelet count > 650 × 10^9/L at screening.
- WBC > 11.0 × 10^9/L at screening.
- Subjects previously treated with anagrelide or JAK inhibitors.
- Inadequate liver function at screening and Day 1 (before drug administration) as demonstrated by:
- Total bilirubin > 1.5 × upper limit of normal (ULN)
- Aspartate aminotransferase or alanine aminotransferase > 1.5 × ULN
- Hepatocellular disease (eg, cirrhosis)
- Inadequate renal function at screening as demonstrated by creatinine clearance < 40 mL/min calculated by Cockcroft-Gault equation.
- Phase 2
- Study Type
- Intervention Model
- Crossover Assignment
- Primary Purpose
- Double (Participant, Investigator)
- NCT ID
- Incyte Corporation
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