EUCTR2015-000946-41-IT进行中（未招募）1 期
Study to Evaluate the Activity of 2 DoseLevels of Imetelstat in Participants with Intermediate-2 or High-Risk Myelofibrosis (MF) previously treated with Janus Kinase (JAK) Inhibitor - MYF2001
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Diagnosis of PMF according to the revised WHO criteria; or PET-MF or PPV-MF according to the IWG-MRT criteria
- •- DIPSS intermediate-2 or high risk MF
- •- Measurable splenomegaly prior to study entry as demonstrated by
- •palpable spleen measuring greater than or equal to (>=) 5 cm below the
- •left costal margin OR spleen volume of >= 450 cm^3 measured by MRI
- •- Active symptoms of MF as demonstrated by a symptom score of at least5 points (on a 0 to 10 scale) on at least one of the symptoms or a score
- •of 3 or greater on at least 2 of the symptoms
- •- Documented progressive disease during or after JAK inhibitor therapy
- •- ECOG performance status 0, 1 or 2
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •Peripheral blood blast count of >= 10% or bone marrow blast count of
- •- Prior treatment with imetelstat
- •- Major surgery within 4 weeks of randomization
- •- Past or present active hepatitis infection of any type or known acute or
- •chronic liver disease including cirrhosis
- •- Prior history of hematopoietic stem cell transplant
研究者
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