Intra-bone Cord Blood Transplantation in Patients With Haematological Malignancies
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Time to neutrophil recovery
研究概览
简要总结
Cord blood (CB) from an unrelated donor is increasingly used an alternative source of hematopoietic stem cells for adults with hematologic malignancies who lack an HLA-matched donor. However, the utilization of single-unit CB for transplantation of adult patients has been impeded by the low number of nucleated cells available from individual CB units. Direct intrabone CB injection (IBCBi) has been recently investigated as a solution to cell dose problem in adults, with the aims of minimizing non-specific loss of progenitors. We set up a phase I-II study to assess the safety and efficacy of CB transplantation by IBCBi in adult patients with advanced or high-risk hematological malignancies
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
- •Advanced or High Risk Haematological Malignancies
- •Age 18-65 years
- •no suitable unrelated HLA-matched donors identified in a clinically useful time-frame
- •Informed consent
排除标准
- •Active infectious disease at inclusion
- •HIV- positivity or active hepatitis infection
- •Impaired liver function (Bilirubin > upper normal limit; Transaminases > 3.0 x upper normal limit) at inclusion
- •Impaired renal function (Creatinine-clearance <60 ml/min; Serum Creatinine >1.5 x upper normal limit) at inclusion
- •Psychiatric diseases or conditions that might impair the ability to give informed consent
研究组 & 干预措施
Treatment
Patients with high risk haematological malignancies
干预措施: Intrabone Allogeneic Transplant (Procedure)
结局指标
主要结局
Time to neutrophil recovery
时间窗: 28 days after transplantation
次要结局
- Overall Survival(One year after transplantation)
- Acute graft versus host disease(100 days after transplantation)
- Incidence of platelet engraftment(100 days after transplantation)
- Chronic Graft Versus Host Disease(One year after transplantation)
研究者
Roberto Sorasio
MD
Ospedale Santa Croce-Carle Cuneo