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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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 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). 2. Treatment with HU can be stopped at any time once one of the inclusion criteria for HU refractoriness or resistance have been met, and up to the day before the first dose of study treatment (ie, Day 1). - 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group A : Ruxolitinib and anagrelide placebo 		Ruxolitinib or placebo will be administered orally twice a day at a starting dose of 10 mg.
  • Drug: Ruxolitinib
    Ruxolitinib administered orally twice daily (BID) at the protocol-defined starting dose.
    Other names:
    • Jakafi
    • INCB018424
  • Drug: Placebo
    Anagrelide-placebo administered orally BID
Active Comparator
Group B : Anagrelide and Ruxolitinib PLacebo 		Anagrelide or placebo will be administered orally twice a day at a starting dose of 1 mg. Use of anagrelide will be consistent with approved prescribing information.
  • Drug: Anagrelide
    Anagrelide administered orally at a starting dose of 1 mg BID.
  • Drug: Placebo
    Ruxolitinib-placebo administered orally BID.

More Details

Status
Terminated
Sponsor
Incyte Corporation

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.