NCT05447260Unknown4 期
A New Prognostic Stratification-based Safety and Efficacy Study of Ruxolitinib in Myelofibrosis: a Multicenter, Prospective, Single-arm Clinical Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 87
- 试验地点
- 1
- 主要终点
- The proportion of patients with a ≥35% reduction in palpable spleen volume from baseline.
研究概览
简要总结
This is a multi-center, prospective, single-arm study to assess safety and efficacy of Ruxolitinib in myelofibrosis (MF) based on a new prognostic stratification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female patients aged ≥18 years with a diagnosis of primary or secondary MF by World Health Organization and International Working Group for Myeloproliferative Neoplasms Research and Treat- ment (IWG-MRT) criteria;
- •Received ruxolitinib treatment for ≥3 months.
排除标准
- •Malignant tumors with other progression or myelofibrosis secondary to other diseases;
- •Exclude myelofibrosis patients after splenectomy;
- •Patients with poor compliance with case follow-up or lost to follow-up.
研究组 & 干预措施
Ruxolitinib
Experimental
干预措施: Ruxolitinib (Drug)
结局指标
主要结局
The proportion of patients with a ≥35% reduction in palpable spleen volume from baseline.
时间窗: From Week 0 through Week 24
Reduction in spleen volume is measured by magnetic resonance imaging/computerized tomography (MRI/CT).
次要结局
- The proportion of patients with ≥50% reduction in Total Symptom Score (TSS) from baseline.(From Week 0 through Week 24)
研究者
研究点 (1)
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