Allogeneic Bone Marrow Transplantation (Allo-BMT) From Human Leukocyte Antigen (HLA) - Identical Related and Unrelated Donors in Patients With Hematological Malignancies With High Risk of Relapse Using Cyclophosphamide (CY) and Mesenchymal Stromal Cells (MSC) as aGVHD Prophylaxis
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Evaluating the effectiveness of the new protocol which replace the standard immunosuppressive therapy with use of MSCs and CY in patients at high risk of relapse.
详细描述
This trial try to find a new way of refractory hematological malignancies treatment. Aim of this study evaluating the effectiveness of the new protocol which replace the standard immunosuppressive therapy with use of MSCs and CY in patients at high risk of relapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Refractory forms of acute leukemia, but in complete remission (CR)
- •Second and third remission of acute leukemia
- •2nd and 3rd chronic phase chronic myelogenous leukemia (CML) (or Ph + ALL)
- •relapsed multiple myeloma
- •advanced leukemia
排除标准
- •Mechanical ventilation
研究组 & 干预措施
MSC+CY
Cyclophosphamide 50 mg/kg/day at +3, +4 day once daily after BMT Mesenchymal stromal cells 1*10^6/kg at day of recovery
干预措施: Cyclophosphamide (Drug)
MSC+CY
Cyclophosphamide 50 mg/kg/day at +3, +4 day once daily after BMT Mesenchymal stromal cells 1*10^6/kg at day of recovery
干预措施: Mesenchymal stromal cells (Biological)
结局指标
主要结局
Overall survival
时间窗: 1 year
次要结局
未报告次要终点
研究者
Elena N.Parovichnikova
PI
National Research Center for Hematology, Russia