Real-World Clinical and Patient Reported Outcomes With Fedratinib for Myelofibrosis Post-Ruxolitinib
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Percentage change in Total Symptom Score (TSS) assessed by Myelofibrosis Symptom Assessment Form (MFSAF)
研究概览
简要总结
The purpose of this study is to determine real-world patient-reported outcomes with fedratinib (FEDR) therapy for myelofibrosis (MF) in the real-world (RW) setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosed with Primary myelofibrosis (PMF), post- Essential thrombocythemia (ET) Myelofibrosis (MF), or post- Polycythemia vera (PV) MF
- •Treated with FEDR and initiated treatment after 16 August
- •Received prior treatment with RUX.
- •Had spleen assessed at time of initiation of FEDR by palpation.
- •Able to read and speak English
- •Willing to provide informed consent
- •Willing to provide permission to the site to release her/his medical information to the study investigators according to the study-specific eCRF
- •Willing to complete the baseline survey prior to first FEDR
排除标准
- •Past or current participant in any FEDR-related clinical trial
结局指标
主要结局
Percentage change in Total Symptom Score (TSS) assessed by Myelofibrosis Symptom Assessment Form (MFSAF)
时间窗: Percentage change in Total Symptom Score (TSS) assessed by Myelofibrosis Symptom Assessment Form (MFSAF)
Absolute change in TSS assessed by MFSAF
时间窗: At Baseline, 3 and 6 months post-FEDR initiation
Proportion of participants reporting individual symptoms in TSS assessed by MFSAF
时间窗: At Baseline, 3 and 6 months post-FEDR initiation
Severity of each reported symptom in TSS assessed by MFSAF
时间窗: At Baseline, 3 and 6 months post-FEDR initiation
Frequency of report of domain assessed by Patients' Global Impression of Change (PGIC)
时间窗: At Baseline, 3 and 6 months post-FEDR initiation
Absolute reduction assessed by Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10)
时间窗: At Baseline, 3 and 6 months post-FEDR initiation
次要结局
未报告次要终点