A Prospective Single-arm Trial on Human Leukocyte Antigen (HLA) Mismatched Unrelated 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 highly mismatched unrelated HLA mismatched donors. Ultimately, an unrelated human leukocyte antigen (HLA) mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of this group of patients and truly enter the era of "everyone has a donor" for allo HSCT.
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 highly mismatched unrelated HLA mismatched donors. Ultimately, an unrelated human leukocyte antigen (HLA) mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of this group of patients and truly enter the era of "everyone has a donor" for allo HSCT.
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;
- •Non blood donors without human leukocyte antigen (HLA) high-resolution typing ≥ 9/10, or those who have difficulty finding non blood donors due to urgent medical conditions;
- •No suitable HLA matching haploidentical donor available;
- •There are suitable unrelated HLA mismatched (HLA high-resolution typing<9/10) donors;
- •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 Performance Status (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 hematopoietic stem cell transplantation (HSCT) contraindications.
研究组 & 干预措施
HLA mismatch
Myeloablative conditioning regimen was used when patient is below 50 and with a HCT-CI score <2; Reduced intensity conditioning regimen was used when patient is over 50 or with HCT-CI score ≥2.
干预措施: Busulfan (Busulfex) (Drug)
HLA mismatch
Myeloablative conditioning regimen was used when patient is below 50 and with a HCT-CI score <2; Reduced intensity conditioning regimen was used when patient is over 50 or with HCT-CI score ≥2.
干预措施: Cyclophosphamide (CTX) (Drug)
HLA mismatch
Myeloablative conditioning regimen was used when patient is below 50 and with a HCT-CI score <2; Reduced intensity conditioning regimen was used when patient is over 50 or with HCT-CI score ≥2.
干预措施: Fludarabine (Fludara) (Drug)
HLA mismatch
Myeloablative conditioning regimen was used when patient is below 50 and with a HCT-CI score <2; Reduced intensity conditioning regimen was used when patient is over 50 or with HCT-CI score ≥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 (OS) after allogeneic hematopoietic cell transplantation is defined as the proportion of patients who are alive at a specified time point following the transplantation, regardless of disease status or cause of death.
次要结局
- Platelet engraftment rate(28-days)
- GVHD(180 days and 2 year)
- Relapse(1-year)
- Neutrophil engraftment rate(28-days)
- Progression-free survival(1-year)
- Graft-versus-host disease (GVHD)-free, relapse-free survival (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