NCT02953704已完成不适用
Prospective, Longitudinal, Non-Interventional Study of Disease Burden and Treatment of Patients With Low-Risk Myelofibrosis (MF) or High-Risk Essential Thrombocythemia (ET) or ET Patients Receiving ET-Directed Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,469
- 主要终点
- Description of the clinical characteristics and evolution of disease burden in essential thrombocythemia (ET) and myelofibrosis (MF) patients
研究概览
简要总结
The purpose of this prospective, longitudinal, noninterventional study is to describe clinical characteristics, evolution of disease burden, and treatment patterns in patients with select subcategories of essential thrombocythemia (ET) or myelofibrosis (MF).
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
- •MF cohort: Diagnosis of MF and low-risk using DIPSS risk categorization OR intermediate-1 risk by DIPSS by reason of age alone.
- •ET cohort: Diagnosis of ET and age ≥ 60 years OR history of thromboembolic events OR currently receiving ET-directed therapy (eg, hydroxyurea, anagrelide, interferon, busulfan, ruxolitinib, etc).
- •Willing and able to provide written informed consent.
- •Willing and able to complete patient assessment questionnaires either alone or with minimal assistance from a caregiver and/or trained site personnel.
- •Under the supervision of a physician for the current care of MF or ET.
排除标准
- •Individuals who are participating in blinded investigational drug studies.
- •Individuals who are participating in Incyte investigational/interventional drug trials (company- or investigator-sponsored studies) until they have completed the 30-day end of study visit.
- •Life expectancy ≤ 6 months.
- •Diagnosis of secondary acute myeloid leukemia, myelodysplastic syndrome, chronic myelogenous leukemia, or secondary thrombocytosis.
结局指标
主要结局
Description of the clinical characteristics and evolution of disease burden in essential thrombocythemia (ET) and myelofibrosis (MF) patients
时间窗: Approximately every 6 months through end of study, up to approximately 36 months
次要结局
- Description of disease progression over time(Approximately every 3-6 months through end of study, up to at least 36 months)
- Describe hematocrit, hemoglobin, white blood cell (WBC) count, and platelet counts over time(Approximately every 3-6 months through end of study, up to at least 36 months)
- Description of the rate and time to leukemic transformation(Approximately every 3-6 months through end of study, up to at least 36 months)
- Description of changes in patient-reported symptoms and quality of life (QOL)(Approximately every 3-6 months through end of study, up to at least 36 months)
- Description of reasons for patient ineligibility based on Dynamic International Prognostic Scoring System (DIPSS) during screening (MF patients only)(At screening)
- Description of the comorbidities associated with disease and progression(Approximately every 3-6 months through end of study, up to at least 36 months)
- Description of rate of all-cause mortality and aggregate causes of mortality(Approximately every 3-6 months through end of study, up to at least 36 months)
- Description of time to first disease-related intervention or first progression event during the period of observation (MF patients only)(Baseline to end of study, up to 36 months.)
- Description of patterns of treatment, therapies, and clinical management(Approximately every 3-6 months through end of study, up to at least 36 months)
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