Safety of Post-transplant Alpha-beta Depleted T-cell Infusion Following Haploidentical Stem Cell Transplant (Haplo SCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD)
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of post-transplant cyclophosphamide and a post-transplant infusion of donor cells, that have been specially processed to remove alpha beta t-cells, in patients undergoing a haploidentical allogeneic stem cell transplant to help reduce the risk of relapse without increasing the risk of graft-versus-host disease.
详细描述
Transplant patients participating in this clinical trial will receive one of 3 standard pre-transplant chemotherapy preparative regimens as appropriate for their specific disease. They will then receive a standard non-manipulated donor stem cell infusion on transplant day (day 0) followed by cyclophosphamide (days +3 and +4) and an alpha-beta t-cell reduced donor stem cell infusion on day +7.
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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neoplastic hematological disorder with indication of allogeneic transplant
- •No available suitable HLA-matched donor
- •Adequate cardiac, pulmonary, renal, and hepatic function
- •Karnofsky performance status score greater than or equal to 70%
排除标准
- •Medication non-compliance
- •No appropriate caregiver identified
- •Uncontrolled medical or psychiatric disorder
- •Active central nervous system (CNS) neoplastic involvement
- •Known allergy to Dimethyl Sulfoxide
- •HIV1 or HIV2 positive
- •Pregnant or breastfeeding
研究组 & 干预措施
Alpha-beta depleted T-cell infusion
Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
干预措施: Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide. (Device)
结局指标
主要结局
Number of Participants That Experience Acute Haploidentical Alpha Beta Depleted Transplant (aGVHD)
时间窗: From baseline and before day +100 of transplant.
Patients will be monitored for Grade IV aGVHD and organ toxicity. Acute assessment will be done using the modified Keystone (Glucksberg) consensus criteria.
Number of Participants That Experience Chronic Haploidentical Alpha Beta Depleted Transplant (cGVHD)
时间窗: From baseline and before day +100 of transplant.
Patients will be monitored for Grade IV cGVHD and organ toxicity. Chronic assessment will be done using the conventional criteria.
次要结局
未报告次要终点
研究者
Ayman Saad
Assoc Prof Medicine M.D.
University of Alabama at Birmingham