NCT01980030已完成1 期
Using ROMIPLOSTINE for Persistent Thrombocytopenia With Transfusion-dependent Patients Who Received Allogeneic Hematopoietic Stem Cell
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This is a Phase I/II multicenter study which aims to assess the toxicity profile of Romiplostim in patients with transfusion-dependent thrombocytopenia after allogeneic HSCT.
A total of 24 patients with transfusion-dependent thrombocytopenia after allogeneic HSCT will be included.
The main endpoint is the incidence and severity of adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subjects must be ≥ 18 years, willing and able to sign informed consent
- •Patients could have been transplanted for hematological disorder (malignant or non-malignant) excepted myelodysplastic syndromes patients and had received either a myeloablative or a reduced intensity conditioning. All sources of allogeneic stem cells are allowed.
- •Prolonged (> 2 months) transfusion-dependent thrombocytopenia
- •Screenings mean platelet count≤ 20 x giga/L or screenings mean platelet count ≤ 50 x giga/L with a history of bleeding.
- •(ECOG) performance status of 0-2
- •Adequate liver function
- •Serum creatinine ≤ 176.8 μmol/L
- •Bone marrow aspirate with cytogenetics within 6 days of the first dose of romiplostim
- •Written informed consent
排除标准
- •Relapse/progression of hematological malignancy (marrow examination required)
- •Non-controlled acute and/or chronic graft versus host disease (GvHD)
- •Active or uncontrolled infections
- •Cardiac pathology - Thrombosis
- •Pregnancy or breast feeding
- •Received interleukin-11 (IL-11) within 4 weeks of screening or previously received any thrombopoietic growth factor
- •Patients on anticoagulant therapy
- •Receipt or planned receipt of Pegylated Granulocyte Colony Stimulating Factor (PEG-G-CSF), or Granulocyte macrophage-colony stimulating factor (GM-CSF) within 4 weeks of the first dose of investigational product
- •Subject not using adequate contraceptive precautions, in the judgment of the investigator
- •Sensitivity to any Escherichia coli-derived product
- •Inability to comply with study procedures.
- •Subject currently is enrolled in or has not yet completed 30 days since ending other investigational device or drug study
- •No medical insurance in the French Health system
研究组 & 干预措施
Romiplostim
Experimental
Weekly Romiplostim for 12 weeks with intra-patient weekly dose escalation from 1µg/Kg to a maximum dose of 10 µg/Kg with a dose reduction schema in case of platelet overshoot
干预措施: Romiplostim (Drug)
结局指标
主要结局
Adverse events
时间窗: 12 months
Incidence and severity of all adverse events
次要结局
- Dose of Romiplostim(12 months)
- number of platelet transfusions(12 months)
- Durable platelet response after transplant:(12 months)
- Relapse rate(12 months)
- Graft versus host disease (GVHD)(12 months)
- Non relapse mortality rate(12 months)
- Overall number of bleeding events(12 months)
- platelet hematological improvements(12 months)
研究者
研究点 (1)
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