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Trial record 1 of 1 for:    NCT03123588 | RESET-272
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Phase 2 Study of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03123588
Recruitment Status : Completed
First Posted : April 21, 2017
Last Update Posted : November 10, 2020
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
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 or disease Intervention/treatment Phase
MPN (Myeloproliferative Neoplasms) Drug: Ruxolitinib Drug: Anagrelide Drug: Placebo Phase 2

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 (RESET-272)
Actual Study Start Date : April 20, 2017
Actual Primary Completion Date : August 3, 2020
Actual Study Completion Date : August 3, 2020

Arm Intervention/treatment
Experimental: Ruxolitinib 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: Anagrelide Drug: Anagrelide
Anagrelide administered orally at a starting dose of 1 mg BID.

Drug: Placebo
Ruxolitinib-placebo administered orally BID.

Primary Outcome Measures :
  1. Efficacy of ruxolitinib versus anagrelide as measured by proportion of subjects who achieve platelet and white blood cell (WBC) control [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Safety and tolerability of ruxolitinib measured by adverse events [ Time Frame: Baseline through 30-37 days after end of treatment, up to 36 months per subject. ]
  2. Proportion of subjects who achieve complete remission or partial remission based on European LeukemiaNet (ELN) 2013 response criteria [ Time Frame: 32 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03123588

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Sponsors and Collaborators
Incyte Corporation
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Study Director: Albert Assad, MD Incyte Corporation
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Responsible Party: Incyte Corporation Identifier: NCT03123588    
Other Study ID Numbers: INCB 18424-272 (RESET-272)
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Incyte Corporation:
Essential thrombocythemia
Additional relevant MeSH terms:
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Myeloproliferative Disorders
Thrombocythemia, Essential
Bone Marrow Diseases
Hematologic Diseases
Blood Platelet Disorders
Blood Coagulation Disorders
Hemorrhagic Disorders
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors