Etude de l'efficacité et de la tolérance de l'interféron-pégylé Dans Les myélofibroses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 12
- 主要终点
- Efficiency of the interferon in Myelofibrosis
研究概览
简要总结
Patients who carried primary or secondary myelofibrosis from Philadelphia negative MPNs (PMF/SMF) and who are treated or are about to be treated with pegylated-interferon (mostly α2a) are eligible to this prospective study. Biological and clinical parameters will be collected from the beginning of the drug use until last news.
A non-opposition consent form need to be signed before entering this study.
详细描述
In all centres interested, patients who were diagnosed for PMF/SMF can be treated with oral or sub-cutaneous drugs in order to reduce clinical symptoms and biological abnormalities belonging to these diseases.
Pegylated-interferon is one of the better weapons that can be used in these cases. These treatments are well known and used from many years in french hematological centres.
The investigators to collect clinical and biological data from patients treated with pegylated-interferon α2a (the most use) in case of PMF/SMF in order to assess efficacity and tolerance to this drug. The prescription of the product and the dose are under the responsibility of each practician.
Clinical data collected: disease and patients characteristics at the time of diagnosis and at the beginning of the drug use, spleen and liver size, presence of constitutive symptoms, transfusion needs.
Biological data collected: complete hemogram, CD34+ cells count, allele burden of JAK2V617F and calreticulin clones if DNA samples are collected.
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
- •Primary or secondary Myelofibrosis
- •Prescription of pegylated interferon α2a
- •Age > 18 years-old
排除标准
- •Other MPNs treated with pegylated interferon α2a
- •Patients treated for PMF or SMF but without pegylated interferon
结局指标
主要结局
Efficiency of the interferon in Myelofibrosis
时间窗: Evaluation at 1 year
Evaluation on the presence or not of splenomegaly and physical signs or the normalization of blood counts.
次要结局
- Rate of survival of patients with Myelofibrosis under interferon(Evaluation at 5 years)
- Tolerance of Interferon(Evaluation at 1 year)