Efficacy and Safety of Ruxolitinib in Patients With Myelofibrosis: A Retrospective Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 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
Ruxolitinib is a Janus kinase (JAK) 1/2 inhibitor currently used in the treatment of Myelofibrosis (MF). Ruxolitinib confirmed improvements in splenomegaly, MF-related symptoms and survival benefit in COMFORT and JUMP studies. At present, the real-world data on the efficacy and safety of ruxolitinib in the treatment of MF in China is still insufficient. The aim of this study was to evaluate the efficacy and safety of ruxolitinib in patients with MF and to provide guidance for the usage of ruxolitinib in MF in China.This was a retrospective, multicenter study of MF patients who received ruxolitinib treatment in Shandong province from August 2012 to December 2021. Data were analyzed using SPSS. Overall survival (OS) and Event-free survival (EFS) were estimated using the Kaplan- Meier method.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
MF patients who received ruxolitinib treatment
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)