Real-world Observation of Momelotinib Effectiveness in Myelofibrosis (ROME)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 93
- 主要终点
- Efficacy of momelotinib in splenic response improving
研究概览
简要总结
Observational study aimed at evaluating the use of momelotinib in patients with primary or post polycythemia vera (PV) or post essential thrombocythemia myelofibrosis (post-ET MF) in a real-world setting.
详细描述
This is a multicenter prospective and retrospective observational clinical study in adult patients with primary or post polycythemia vera (PV) or post essential thrombocythemia myelofibrosis (post-ET MF) being treated with momelotinib in a real-world setting. The aim of the study is to evaluate the efficacy of momelotinib in terms of splenic response. All patients are managed according to the clinical practice of the participating Center.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients aged 18 years or older.
- •Patients diagnosed with primary or post-polycythemia vera/post-essential thrombocythemia myelofibrosis start treatment with MMB according to clinical practice from AIFA authorization.
- •Patients with palpable splenomegaly at baseline of momelotinib treatment.
- •Informed consent signed, if applicable.
排除标准
- •Diagnosis of MPN, unclassifiable, myelodysplastic/myeloproliferative neoplasms, myelodysplastic syndromes, essential thrombocythemia, polycythemia vera.
- •Accelerated/blast phase of MF.
- •Patients with platelets <20 x10(9)/L at baseline of MMB treatment.
- •Patients JAK inhibitors-exposed for other diseases apart from MF.
结局指标
主要结局
Efficacy of momelotinib in splenic response improving
时间窗: Six months
To assess the splenic response in terms of rate of patients with more or equal than 50% palpatory reduction compared to baseline at 6 months.
次要结局
未报告次要终点