临床试验/NCT03123588

NCT03123588终止2 期

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)

Incyte Corporation26 个研究点分布在 1 个国家目标入组 12 人开始时间: 2017年11月14日最近更新: 2021年11月19日

适应症

干预措施

试验速览

阶段: 2 期
状态: 终止
发起方: Incyte Corporation
入组人数: 12
试验地点: 26
主要终点: Proportion of Subjects Who Achieve Platelet and White Blood Cell (WBC) Control

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•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.

研究组 & 干预措施

Group A : Ruxolitinib and anagrelide placebo

Experimental

Ruxolitinib or placebo will be administered orally twice a day at a starting dose of 10 mg.

干预措施: Ruxolitinib (Drug)

Group A : Ruxolitinib and anagrelide placebo

Experimental

Ruxolitinib or placebo will be administered orally twice a day at a starting dose of 10 mg.

干预措施: Placebo (Drug)

Group B : Anagrelide and Ruxolitinib PLacebo

Active Comparator

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.

干预措施: Anagrelide (Drug)

Group B : Anagrelide and Ruxolitinib PLacebo

Active Comparator

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.

干预措施: Placebo (Drug)

结局指标

主要结局

Proportion of Subjects Who Achieve Platelet and White Blood Cell (WBC) Control

时间窗: 52 weeks

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.

次要结局

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)
Proportion of Subjects Who Achieve a Reduction of WBC Counts to < 10 × 109/L(52 weeks)

研究者

发起方

Incyte Corporation

申办方类型

Industry

责任方

Sponsor

研究点 (26)

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