CD62L Depleted Donor Lymphocyte Infusion With T Cell Depleted Haploidentical Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Graft failure-free, GVHD-free survival
研究概览
简要总结
In this clinical trial, the investigators aim to apply CD62L depleted donor lymphocyte infusion (DLI) together with in vitro T cell depleted haploidentical hematopoietic stem cell transplantation (HSCT) to treat patients with malignant or non-malignant disease in need of HSCT. The investigators shall evaluate the graft failure-free, graft-versus-host disease (GVHD)-free survival at one year, frequency of adverse events and post-transplant complications, and immunoreconstitution.
详细描述
The peripheral stem cell harvest product from the patient's related haploidential donor will be divided into two portions. One portion will undergo T cell receptor (TCR) αβ depletion and the other portion will undergo CD62L depletion. Both depleted products will be infused intravenously to the patient on the same day.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who requires allogeneic hematopoietic stem cell transplant, has no human leukocyte antigen (HLA)-matched sibling donor but has an HLA-haploidentical donor.
- •Adequate organ function to tolerate the conditioning chemotherapy and radiotherapy
- •Karnofsky or Lansky performance status score ≥50
排除标准
- •Pregnant or lactating woman
- •HIV infection
- •Patients for whom alternative treatment is deemed more appropriate by treating physician
- •Patients who are unlikely to benefit from haploidentical hematopoietic stem cell transplantation, e.g., terminal malignancy with multiorgan failure
研究组 & 干预措施
Treatment
CD62L depleted donor lymphocyte infusion
干预措施: CD62L depleted donor lymphocyte infusion (Biological)
结局指标
主要结局
Graft failure-free, GVHD-free survival
时间窗: up to 1 year
From the date of treatment start until the date of graft failure or GVHD or death from any cause, whichever comes first, assessed up to 1 year
次要结局
- Proportion of patients who develop graft failure(up to 1 year)
- Proportion of patients who develop acute graft-versus-host disease(up to 1 year)
- Proportion of patients who develop infection(up to 1 year)
- Proportion of patients who develop chronic graft-versus-host disease(up to 1 year)
- Blood T lymphocyte count at 3 months(at 3 months)
- Overall survival(up to 1 year)
- Proportion of patients who develop relapse among those with malignant diseases(up to 1 year)
- Proportion of patients who develop adverse events not mentioned in outcomes 4-7(up to 1 year)
- Blood T lymphocyte count at 1 year(at 1 year)
研究者
Cheuk Ka Leung Daniel
Consultant
Hong Kong Children's Hospital