Total Lymphoid Irradiation as Conditioning for Pediatric Haploidentical Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 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 comparative study, the investigators aim to compare prospective pediatric patients who receive total lymphoid irradiation (TLI) using tomotherapy with age- and disease-matched controls who receive conventional total body irradiation (TBI) as part of conditioning for haploidentical hematopoietic stem cell transplantation (HSCT) for both malignant and non-malignant diseases. The investigators shall evaluate graft failure-free, graft-versus-host disease (GVHD)-free survival, overall survival, frequency of rejection, GVHD, relapse of malignancy, adverse effects and post-transplant immunoreconstitution.
详细描述
Radiotherapy at a dose of 6Gy divided into 3 equal fractions (2Gy per fraction) to all lymphoid organs (TLI) over 2 days using tomotherapy will be given to participants as part of the conditioning treatment before haploidentical hematopoietic stem cell transplantation (HSCT). Retrospective patients who are age- and disease-matched with the recruited patients and had received radiotherapy to the whole body (TBI) with or without lung shielding at a total dose of 2-12 Gy delivered as 1-6 equal fractions by conventional opposed fields radiotherapy as part of conditioning will be compared for the outcomes.
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
- •Aged 0-18 years who requires allogeneic HSCT, 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
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 relapse among those with malignant diseases(up to 1 year)
- Proportion of patients who develop acute graft-versus-host disease(up to 1 year)
- Proportion of patients who develop graft failure(up to 1 year)
- Proportion of patients who develop chronic graft-versus-host disease(up to 1 year)
- Overall survival(up to 1 year)
- Proportion of patients who develop adverse events not mentioned in outcomes 4-6(up to 1 year)
- Blood T lymphocyte count at 3 months(at 3 months)
- Blood T lymphocyte count at 1 year(at 1 year)