MPN (Myeloproliferative Neoplasms) Clinical Trial
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)
Verified date | October 2021 |
Source | Incyte Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 12 |
Est. completion date | August 3, 2020 |
Est. primary completion date | August 3, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | St. Agnes Hospital | Baltimore | Maryland |
United States | Montefiore Medical Center | Bronx | New York |
United States | Gabrail Cancer Center- Canton Facility | Canton | Ohio |
United States | Waverly Hem Onc | Cary | North Carolina |
United States | Geisinger - Knapper Clinic | Danville | Pennsylvania |
United States | Vidant Medical Center | Greenville | North Carolina |
United States | Clinical Trials of SWLA LLC | Lake Charles | Louisiana |
United States | Pacific Shores Medical Group | Long Beach | California |
United States | University of Southern California | Los Angeles | California |
United States | Summit Medical Group | Morristown | New Jersey |
United States | Edward Cancer Center | Naperville | Illinois |
United States | Columbia Weill Cornell Cancer Centers - Herbert Irving Comprehensive Cancer Center (HICCC) | New York | New York |
United States | INTEGRIS Cancer Institute Proton Campus | Oklahoma City | Oklahoma |
United States | INTEGRIS Southwest Medical Center | Oklahoma City | Oklahoma |
United States | Ventura County Hematology-Oncology Specialists | Oxnard | California |
United States | Mayo Clinic | Phoenix | Arizona |
United States | Kaiser Permanente Northwest | Portland | Oregon |
United States | Compassionate Cancer Care Medical Group | Riverside | California |
United States | Washington University School of Medicine | Saint Louis | Missouri |
United States | North Shore Cancer Research Association-Skokie | Skokie | Illinois |
United States | Southern Illinois University | Springfield | Illinois |
United States | Renovatio Clinical | The Woodlands | Texas |
United States | Tift Regional | Tifton | Georgia |
United States | Prairie Lakes Health Care System Inc. | Watertown | South Dakota |
United States | Innovative Clinical Research Institute | Whittier | California |
United States | Bond Clinic, PA | Winter Haven | Florida |
Lead Sponsor | Collaborator |
---|---|
Incyte Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment. | Baseline through the end of randomized period -up to 14 months per participant | |
Secondary | Proportion of Subjects Who Achieve Complete Remission or Partial Remission | Defined as proportion of subjects who achieve CR or PR at Week 32 based on European LeukemiaNet (ELN) 2013 response criteria. Per ELN criteria: Complete Remission: durable resolution of disease related signs and symptoms, durable blood count normalization, absence of hemorrhagic or thrombotic events, absence of signs of progressive disease and bone marrow histological remission including disappearance of megakaryocyte hyperplasia and absence of reticulin fibrosis >Grade 1.
Partial remission: durable resolution of disease related signs and symptoms, durable blood count normalization, absence of hemorrhagic or thrombotic events, absence of signs of progressive disease, persistance of megakaryocyte hyperplasia. No response: any response that does not satisfy partial remission. Progressive Disease: transformation in PET-MF, MDS or acute leukemia. |
32 weeks | |
Secondary | Time to Treatment Discontinuation | Defined as the time when treatment is discontinued | 98 weeks | |
Secondary | Duration of Response | Defined as measurement of response from the onset of response to the loss of response for responders. | 142 weeks | |
Secondary | Proportion of Subjects Who Achieve Reduction of Platelet Counts to < 600 × 10^9/L | Defined as Proportion of subjects who achieve reduction of platelet counts to < 600 × 10^9/L for at least 80% of biweekly measurements for a consecutive 12-week period between Weeks 32 and 52. | Between 32 and 52 weeks | |
Secondary | Proportion of Subjects Who Achieve a Reduction of WBC Counts to < 10 × 109/L | Defined as Proportion of subjects who achieve a reduction of WBC counts to < 10 × 109/L for at least 80% of biweekly measurements for a consecutive 12-week period between Weeks 32 and 52. | 52 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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