EUCTR2009-011818-21-GB进行中（未招募）不适用
Transplantation of umbilical cord blood from unrelated donors in patients with haematological diseases using a myeloablative conditioning regimen - MAC UCBT
niversity College London0 个研究点目标入组 60 人开始时间: 2010年6月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Age 45 years or younger. Children under the age of 2 years are at an increased risk of long term complications of total body irradiation (TBI) and will therefore not recieve TBI (AML patients aged <16 years will also not receive TBI as chemotherapy-only conditioning is now accepted national practice for this population).
- •. The risk of haemopoietic stem cell transplantation increases with increasing age. Furthermore the myeloablative treatment regimen may be less well tolerated by some patients and therefore patients of advanced age or with impaired organ function are not eligible for this trial. Therfore the upper age limit of 45 years was chosen by consensus of leading UK transplant physicians for reasons of safety.
- •2) Umbilical cord blood graft available with an adequate cell dose and HLA match. The rates of engraftment and survival following umbilical cord blood transplantation are determined by the cell dose (total number of nucleated cells given to the patient) and the closeness of HLA match. A strict algorithm for unit selection will be used based on currently available data. Units selected for every patient will be approved by the 'cord blood selection committee' (CBSC) to ensure consistency and safety.
- •3) Disease for which an allogeneic haemopoietic stem cell transplant (HSCT) is indicated. The disease type and remission status of every patient will comply with internationally agreed criteria.
- •4) The individual patient's disease status is such that there is no alternative therapy likely to achieve cure or provide a significant prolongation of disease-free survival. These patients would have proceeded to a conventional transplant if a blood or marrow donor had been identified.
- •5) Adequate organ function & performance status. Strict criteria for adequate organ function will be used to optimise safety of the procedure. The criteria used in this protocol are more stringent than those used by the University of Minnesota to improve safety further.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1) Availability of a conventional related or unrelated haemopoietic stem cell donor within an acceptable time period. Such donors represent the standard of care in UK transplantation and must remain the first choice where available.
- •2) Current active serious infection. The preparative regimen results in profound suppression of the white count and immune system. Patients with active serious infection, such as invasive fungus, could develop life-threatening infection after transplant and will therefore be excluded.
- •3) Previous irradiation that precludes the safe administration of 13.2Gy- 14.4Gy of total body irradiation (TBI) in patients over 2 years of age and AML patients over the age of 16. Every patient scheduled to recieve TBI will be reviewed by a radiation oncologist to ensure that this dose of TBI will be safe. Children under the age of 2 years are at an increased risk of long term complications and will therefore not recieve TBI (AML patients aged <16 years will also not receive TBI as chemotherapy-only conditioning is now accepted national practice for this population).
- •4) Prior autograft.
研究者
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