Phase 2 Study of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272)
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Keep this study
Lead
Incyte Corporation
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
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.
You may not be if
Subjects previously treated with anagrelide or Hydroxyurea (HU).
1. Prior anagrelide use is allowed provided the reason for discontinuation is not AE-related and anagrelide is stopped at least 28 days before the start of study medications (ie, Day 1).
Clareo Health | Phase 2 Study of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272)
