A Prospective Single-arm Trial on Human Leukocyte Antigen (HLA) Mismatched Related Allogeneic Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
This study is a single center, prospective, single arm exploratory clinical trial that includes patients with hematological malignancies who are indicated for allogeneic hematopoietic stem cell transplantation (allo HSCT) but lack suitable donors. This project plans to use human leukocyte antigen (HLA) mismatched donors. Ultimately, a HLA mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of these patients and truly enter the era of "everyone has a donor".
详细描述
This study is a single center, prospective, single arm exploratory clinical trial that includes patients with hematological malignancies who are indicated for allogeneic hematopoietic stem cell transplantation (allo HSCT) but lack suitable donors. This project plans to use human leukocyte antigen (HLA) mismatched donors. Ultimately, a HLA mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of these patients and truly enter the era of "everyone has a donor".
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18-60 years old) with hematological malignancies and indications for hematopoietic stem cell transplantation with no available related human leukocyte antigen (HLA) identical sibling donors;
- •No available donor with HLA high-resolution typing ≥ 9/10 or those who have difficulty finding donors due to urgent medical conditions;
- •No suitable HLA matching haploidentical donor available;
- •There is a suitable donor with mismatched HLA typing;
- •The subjects or their legal representatives shall sign an informed consent form before the start of the clinical study.
排除标准
- •Patients with severe liver and kidney function (alanine aminotransferase>2.5 times the upper limit of normal, blood creatinine>1.5 times the upper limit of normal) and cardiopulmonary dysfunction (New York Heart Association (NYHA) III/IV heart function, ejection fraction<50%, severe obstructive or restrictive ventilation dysfunction);
- •Merge active infections;
- •Eastern Cooperative Oncology Group (ECOG) score ≥ 2 points;
- •Secondary tumors with merged activity;
- •Severe central nervous system or mental illness leading to the inability to autonomously choose to enter or exit clinical trials;
- •Combine other allo HSCT contraindications.
研究组 & 干预措施
HLA-mismatch related
The myeloablative conditioning is used when the patient is below 50 and with an HCT-CI<2. The reduced intensity conditioning is used when the patient is over 50 or with an HCT-CI≥2.
干预措施: Busulfan (Busulfex) (Drug)
HLA-mismatch related
The myeloablative conditioning is used when the patient is below 50 and with an HCT-CI<2. The reduced intensity conditioning is used when the patient is over 50 or with an HCT-CI≥2.
干预措施: Cyclophosphamide (CTX) (Drug)
HLA-mismatch related
The myeloablative conditioning is used when the patient is below 50 and with an HCT-CI<2. The reduced intensity conditioning is used when the patient is over 50 or with an HCT-CI≥2.
干预措施: Fludarabine (Fludara) (Drug)
HLA-mismatch related
The myeloablative conditioning is used when the patient is below 50 and with an HCT-CI<2. The reduced intensity conditioning is used when the patient is over 50 or with an HCT-CI≥2.
干预措施: Semustine (MeCCNU) (Drug)
结局指标
主要结局
Overall survival
时间窗: 1-year
Overall survival after allogeneic cell transplantation refers to the length of time a patient remains alive from the date of transplantation, regardless of disease status or complications.
次要结局
- Neutrophil engraftment rate(28 days)
- Platelet engraftment rate(28 days)
- Relapse(1-year)
- Cumulative incidence of relapse(1-year)
- Progression free survival(1-year)
- GRFS(1-year)
研究者
He Huang
Professor, Director of the Bone Marrow Transplantation Center, The First Affiliated Hospital, Zhejiang University School of Medicine
Zhejiang University