Efficacy and Safety of Direct Intrabone Transplantation of Peripheral Blood Haematopoietic Stem Cells Form HLA-matched Sibling Donors in Patients With Myeloid and Lymphoid Malignancies.
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Neutrophil engraftment (ANC > 0,5 G/l)
研究概览
简要总结
The purpose of the study is to evaluate efficacy and safety of direct intrabone transplantation procedure of peripheral blood haematopoietic stem cells form HLA-matched sibling donors in patients with myeloid and lymphoid malignancies.
详细描述
Allogenic haematopoietic stem cell transplantation is an established treatment option for haematologic malignancies, especially leukaemias and lymphomas, providing curative potential. The optimal donor is HLA-matched sibling and G-CSF stimulated peripheral blood is nowadays the most common source of stem cells. Routinely used route of stem cell transplantation is intravenous infusion via central venous catheter. Based on the animal studies, only 10-15% of intravenously transplanted stem cells migrate to haematopoietic sites while the rest is lost in other organs. Results of studies of direct intrabone allogenic cord-blood cells transplantation in humans confirm that this route of transplantation is associated with less probability of graft failure and moreover may reduce risk of graft-versus-host disease and malignancy relapse. For those purposes in the current study we investigate intrabone route of allogenic peripheral blood stem cell transplantation. Our intention is to achieve fast engraftment and minimize risk of relapse and graft graft-versus-host disease.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-55 years
- •Diagnosis of leukaemia or lymphoma
- •Indication for allogenic stem cell transplantation according to European Group for Blood and Marrow Transplantation guidelines
- •HLA-matched sibling donor qualified for peripheral blood stem cell donation
- •Performance status WHO 0-1
- •Written informed consent
排除标准
- •Organ dysfunction: elevated ALT, AST, bilirubin, AF; creatinine >1.5 upper normal limit; LVEF <45%
- •Active infection
- •Unstable diabetes
- •Psychiatric diseases
- •Obesity or anatomical obstacle for direct intrabone transplantation
结局指标
主要结局
Neutrophil engraftment (ANC > 0,5 G/l)
时间窗: 28 days
次要结局
- Lineage chimerism of peripheral blood T-cell lymphocytes(1 year)
- Platelet engraftment (Plt > 20 G/l)(28 days)
- Adverse reactions related with intrabone transplantation procedure(28 days)