Phase 2 Study of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272)


About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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:
    • 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.

Exclusion Criteria:

  • 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Jeanne Palmer, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


Publications are currently not available

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