TevaGastrim for Stem Cell Mobilization of HLA Matched Sibling Donors for Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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 of TevaGastrim which is a biosimilar version of Filgrastim recombinant human G-CSF (G-CSF) in mobilizing sufficient number of stem cells from normal sibling donors for allogeneic stem cell transplantation.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 70 years.
- •Normal sibling donor that is HLA matched to a patient with AML or MDS that needs and is eligible for allogeneic stem cell transplantation
- •Written informed consent.
排除标准
- •Inability to tolerate PBPC harvest.
- •Peripheral venous access not possible.
- •Positive pregnancy test for female donors.
- •Positive serology for hepatitis C and/or HBSAg, unless negative for antigen PCR.
- •Psychiatric, addictive, or any disorder which compromises ability to give truly informed consent for participation in this study.
- •Treatment with other investigational drugs.
- •Known sensitivity to CHO derived products.
- •HIV positive.
- •History of malignant disease or current malignancy.
研究组 & 干预措施
TevaGastrim
treatment with TevaGastrim for allogeneic stem cell collection
干预措施: TevaGastrim (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 PBSC graft containing \>2x106 CD34+ cells/kg in ≤ 4 apheresis sessions. We will evaluate the time from chemotherapy to stem cell collection,number of collections required to reach \>2x106 CD34+ cells/kg, number of CD34+ cells collected and percentage of patients reaching \>5x10 CD34+ cells/kg in ≤ 4 apheresis sessions.
次要结局
- Donor safety(100 days)
- engraftment after transplantation(100 days)