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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)
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)
1 other identifier
interventional
12
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2017
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2017
CompletedFirst Posted
Study publicly available on registry
April 21, 2017
CompletedStudy Start
First participant enrolled
November 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 3, 2020
CompletedResults Posted
Study results publicly available
November 19, 2021
CompletedNovember 19, 2021
October 1, 2021
2.7 years
April 17, 2017
August 2, 2021
October 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Subjects Who Achieve Platelet and White Blood Cell (WBC) Control
Defined as proportion of subjects who achieve a simultaneous reduction of platelet counts to \< 600 × 10\^9/L with a reduction of WBC counts to \< 10 × 10\^9/L for at least 80% of biweekly measurements for a consecutive 12-week period between Weeks 32 and 52.
52 weeks
Secondary Outcomes (6)
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Baseline through the end of randomized period -up to 14 months per participant
Proportion of Subjects Who Achieve Complete Remission or Partial Remission
32 weeks
Time to Treatment Discontinuation
98 weeks
Duration of Response
142 weeks
Proportion of Subjects Who Achieve Reduction of Platelet Counts to < 600 × 10^9/L
Between 32 and 52 weeks
- +1 more secondary outcomes
Study Arms (2)
Group A : Ruxolitinib and anagrelide placebo
EXPERIMENTALRuxolitinib or placebo will be administered orally twice a day at a starting dose of 10 mg.
Group B : Anagrelide and Ruxolitinib PLacebo
ACTIVE COMPARATORAnagrelide 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.
Interventions
Ruxolitinib administered orally twice daily (BID) at the protocol-defined starting dose.
Anagrelide administered orally at a starting dose of 1 mg BID.
Eligibility Criteria
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).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Mayo Clinic
Phoenix, Arizona, 85054, United States
Pacific Shores Medical Group
Long Beach, California, 90813, United States
University of Southern California
Los Angeles, California, 90033, United States
Ventura County Hematology-Oncology Specialists
Oxnard, California, 93030, United States
Compassionate Cancer Care Medical Group
Riverside, California, 92501, United States
Innovative Clinical Research Institute
Whittier, California, 90603, United States
Bond Clinic, PA
Winter Haven, Florida, 33880, United States
Tift Regional
Tifton, Georgia, 31794, United States
Edward Cancer Center
Naperville, Illinois, 60540, United States
North Shore Cancer Research Association-Skokie
Skokie, Illinois, 60076, United States
Southern Illinois University
Springfield, Illinois, 62702, United States
Clinical Trials of SWLA LLC
Lake Charles, Louisiana, 70601, United States
St. Agnes Hospital
Baltimore, Maryland, 21229, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Summit Medical Group
Morristown, New Jersey, 07960, United States
Columbia Weill Cornell Cancer Centers - Herbert Irving Comprehensive Cancer Center (HICCC)
New York, New York, 10032, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Waverly Hem Onc
Cary, North Carolina, 27518, United States
Vidant Medical Center
Greenville, North Carolina, 27858, United States
Gabrail Cancer Center- Canton Facility
Canton, Ohio, 44718, United States
INTEGRIS Southwest Medical Center
Oklahoma City, Oklahoma, 73109, United States
INTEGRIS Cancer Institute Proton Campus
Oklahoma City, Oklahoma, 73142, United States
Kaiser Permanente Northwest
Portland, Oregon, 97227, United States
Geisinger - Knapper Clinic
Danville, Pennsylvania, 17822, United States
Prairie Lakes Health Care System Inc.
Watertown, South Dakota, 57201, United States
Renovatio Clinical
The Woodlands, Texas, 77401, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Call Center
- Organization
- Incyte Corporation
Study Officials
- STUDY DIRECTOR
Albert Assad, MD
Incyte Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
April 17, 2017
First Posted
April 21, 2017
Study Start
November 14, 2017
Primary Completion
August 3, 2020
Study Completion
August 3, 2020
Last Updated
November 19, 2021
Results First Posted
November 19, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share