NCT02488382Unknown1 期
Lonquek (Lipegfilgrastim) for Stem Cell Mobilization of Autologous Hematopoietic Stem Cell Transplantation in Patients With Multiple Myeloma and Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Mobilisation success rate
研究概览
简要总结
The aim of this study is to evaluate the efficacy and tolerability of Lonquek which is a pegylated (long-acting) version of Filgrastim recombinant human G-CSF (G-CSF) in mobilizing sufficient number of stem cells for autologous stem cell transplantation in patients with lymphoma and multiple myeloma.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed multiple myeloma or Hodgkins or non Hodgkin lymphoma at need of autologous stem cell transplantation.
- •Disease must be chemosensitive or stable status to prior therapy before transplant.
- •Age between 18 and 65 years inclusive.
- •ECOG performance status 0, 1 or
- •Written informed consent.
- •Adequate birth control in fertile patients.
排除标准
- •Lymphoma patients that did not fulfill the inclusion criteria.
- •Patients with factors predicting poor mobilization including >3 lines of previous chemotherapy, extensive irradiation, patients that received stem cell toxicity drugs like Melphalan, Fludarabine, >2 courses of Revlimid, age >65 years, platelets counts <100x109/L, WBC<2.5x109/L or WBC > 35x109/L.
- •Previous autologous stem cell transplantation.
- •Inability to tolerate peripheral blood stem cell harvest.
- •Peripheral venous access not possible.
研究组 & 干预措施
Lonquek
Experimental
treatment with Lonquek for autologous stem cell collection
干预措施: Lonquek (Drug)
结局指标
主要结局
Mobilisation success rate
时间窗: 4 weeks
Mobilisation success rate is defined as the mobilisation of a peripheral blood stem cell graft containing \>2x106 CD34+ cells/kg in ≤ 4 apheresis sessions.
次要结局
- Safety(100 days)
- engraftment after transplantation(100 days)
研究者
研究点 (1)
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