jRCT2031240668招募中不适用
A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician's Choice in Patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post Essential Thrombocythemia Myelofibrosis with Severe Thrombocytopenia (Platelet Counts <50,000/microL)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 16
- 主要终点
- SVR reduction
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age 0month 0week old over 至 No limit（—）
- 性别
- All
入选标准
- •Primary MF, post-polycythemia vera MF, or post-essential thrombocythemia MF
- •Platelet count of <50,000/microL at Screening (Day -35 to Day -3)
- •Dynamic International Prognostic Scoring System Intermediate-1, Intermediate 2, or High-Risk
- •Palpable splenomegaly >-5 cm below the lower costal margin in the midclavicular line as assessed by physical examination
- •TSS of >-10 on the MPN-SAF TSS 2.0 or a single symptom score of >-5 or two symptoms of >-3, including only the symptoms of left upper quadrant pain, bone pain, itching, or night sweats. The TSS criteria need only to be met on a single day.
- •Age >-18 years
- •Eastern Cooperative Oncology Group performance status 0 to 2
- •Provision of signed informed consent
排除标准
- •Life expectancy <6 months
- •Completed allogeneic stem cell transplant, or are eligible for and willing to complete other approved available therapy including allogeneic stem cell transplant
- •History of splenectomy or planning to undergo splenectomy
- •Splenic irradiation within the last 6 months
- •Previously treated with pacritinib
- •Treatment with any MF-directed therapy within 14 days prior to treatment Day 1
- •Prior treatment with more than one JAK2 inhibitor
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
结局指标
主要结局
SVR reduction
时间窗: Week 24
proportion of patients achieving a >-35% SVR from baseline at Week 24 as measured by MRI (preferred) or CT scans
TSS reduction
时间窗: Week 24
proportion of patients achieving a >-50% reduction in TSS from baseline at Week 24
次要结局
- Patient Global Impression of Change (PGIC)
- Overall Survival (OS)
- Safety
研究者
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