Phase 2 Study of Ruxolitinib Versus Anagrelide in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea (RESET-272)
Stopped early · Phase 2 · Has a placebo group
Conditions studied: MPN (Myeloproliferative Neoplasms)
In brief
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.
Key facts
- Study ID
- NCT03123588
- Run by
- Incyte Corporation
- People needed
- 12
- Starts
- 2017-11-14
- Expected to finish
- 2020-08-03
- Last updated by the study team
- 2021-11-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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.
You may not qualify if…
- Subjects previously treated with anagrelide or Hydroxyurea (HU).
- 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).
- 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.
Where it is running
- Mayo Clinic — Phoenix, Arizona, United States
- Pacific Shores Medical Group — Long Beach, California, United States
- University of Southern California — Los Angeles, California, United States
- Ventura County Hematology-Oncology Specialists — Oxnard, California, United States
- Compassionate Cancer Care Medical Group — Riverside, California, United States
- Innovative Clinical Research Institute — Whittier, California, United States
- Bond Clinic, PA — Winter Haven, Florida, United States
- Tift Regional — Tifton, Georgia, United States
- Edward Cancer Center — Naperville, Illinois, United States
- North Shore Cancer Research Association-Skokie — Skokie, Illinois, United States
- Southern Illinois University — Springfield, Illinois, United States
- Clinical Trials of SWLA LLC — Lake Charles, Louisiana, United States
- St. Agnes Hospital — Baltimore, Maryland, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Summit Medical Group — Morristown, New Jersey, United States
- Columbia Weill Cornell Cancer Centers - Herbert Irving Comprehensive Cancer Center (HICCC) — New York, New York, United States
- Montefiore Medical Center — The Bronx, New York, United States
- Waverly Hem Onc — Cary, North Carolina, United States
- Vidant Medical Center — Greenville, North Carolina, United States
- Gabrail Cancer Center- Canton Facility — Canton, Ohio, United States
- INTEGRIS Southwest Medical Center — Oklahoma City, Oklahoma, United States
- INTEGRIS Cancer Institute Proton Campus — Oklahoma City, Oklahoma, United States
- Kaiser Permanente Northwest — Portland, Oregon, United States
- Geisinger - Knapper Clinic — Danville, Pennsylvania, United States
- Prairie Lakes Health Care System Inc. — Watertown, South Dakota, United States
Full record on ClinicalTrials.gov
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