Allogeneic Stem Cell Transplantation With Alternative Donor in Treatment of Hematologic Malignancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 876
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of this study is to compare the efficacy of allogeneic hematopoietic stem cell transplantation (allo-HSCT) from matched sibling donor (MSD),matched unrelated donor (MUD) and haploidentical related donors(HRD) in the treatment of hematologic malignancy.
详细描述
Currently, allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only curative therapy for a majority of malignant hematologic diseases, especially acute leukemia. HSCT from MSD offers the best results for these diseases, but lack of this donor resource has restricted its wide application. HSCT from MUD provides another option, but MUDs still cannot satisfy all patients due to unsuccessful donor searches. Almost all patients have an available related donor with whom they share a single HLA haplotype (ie, haploidentical related donor), and it owns the advantage of immediate availability, especially for those who urgently need transplantation.The results of transplantation from HRD have improved significantly over the past few years. However, the results from such haploidentical transplantation have not formally been compared with those of transplantation in patients contemporaneously using MSDs and MUDs for hematologic malignancy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Diagnosis of primary disease is acute leukemia/MDS/CML
- •Receiving allo-HSCT
排除标准
- •cardiac dysfunction (particularly congestive heart failure)
- •hepatic abnormalities (bilirubin ≥ 3 mg/dL, aminotransferase> 2 times the upper limit of normal)
- •renal dysfunction (creatinine clearance rate < 30 mL/min)
- •Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
- •Patients with any conditions not suitable for the trial (investigators' decision)
研究组 & 干预措施
MSD group
The patients will received HSCT from MSD.
干预措施: HSCT from MSD (Procedure)
MSD group
The patients will received HSCT from MSD.
干预措施: Cyclosporin A (Drug)
MSD group
The patients will received HSCT from MSD.
干预措施: Methotrexate (Drug)
MSD group
The patients will received HSCT from MSD.
干预措施: Mycophenolate mofetil (Drug)
MUD group
The patients will received HSCT from MUD.
干预措施: HSCT from MUD (Procedure)
MUD group
The patients will received HSCT from MUD.
干预措施: Cyclosporin A (Drug)
MUD group
The patients will received HSCT from MUD.
干预措施: Methotrexate (Drug)
MUD group
The patients will received HSCT from MUD.
干预措施: Antithymocyte globulin (Drug)
HRD group
The patients will received HSCT from HRD.
干预措施: HSCT from HRD (Procedure)
HRD group
The patients will received HSCT from HRD.
干预措施: Cyclosporin A (Drug)
HRD group
The patients will received HSCT from HRD.
干预措施: Methotrexate (Drug)
HRD group
The patients will received HSCT from HRD.
干预措施: Antithymocyte globulin (Drug)
HRD group
The patients will received HSCT from HRD.
干预措施: Mycophenolate mofetil (Drug)
结局指标
主要结局
Overall Survival
时间窗: 3 year
The primary endpoint is overall survival within 3 years after HSCT.
次要结局
- hematopoietic reconstruction(1 year)
- Disease-free survival(3 year)
- Incidence of transplantation-related mortality(3 year)
- Incidence of graft-versus-host disease(3 year)
- Incidence of infection(3 year)
研究者
Qifa Liu
Professor
Nanfang Hospital, Southern Medical University