Randomized Trial of Anti-thymocyte Globulin Plus Low-dose Post-transplant Cyclophosphamide for GVHD Prevention in Haploidentical Donor HCT
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The incidence of acute graft versus host disease.
研究概览
简要总结
During the past decades, the wider application of easily available haploidentical donor hematopoietic cell transplant (haplo-HCT) has been made possible through the T cell-replete (TCR) regimens including T cell regulation with anti-thymocyte globulin (ATG)/granulocyte colony-stimulating factor (GCSF) and post-transplant cyclophosphamide (PTCy). To achieve decreased non-relapse mortality (NRM) and improved long-term outcomes in haploidentical transplant, the joint use of ATG and PTCy might effectively reduce graft versus host disease (GVHD) and mortality associated with severe forms of GVHD. Recently, investigators established a regimen using low-dose PTCy in conjunction with standard-dose ATG in order to lower the risk of GVHD without compromising engraftment and disease relapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute leukemia and/or myelodysplastic syndrome undergoing their first allogeneic hematopoietic stem cell transplantation;
- •Male or female , aged 12-55 years;
- •Haploidentical donor transplantation;
- •ECOG score ≤3; The basic organ function tests met the following standards;
- •Cardiac ejection index >55% 2) Creatinine ≤1.5 times the highest normal value (ULN)
排除标准
- •Severe brain, heart, kidney or liver dysfunction;
- •Refractory malignant state;
- •Patients with other malignant tumors requiring treatment;
- •Clinically uncontrolled severe active infection;
- •The expected survival time was less than 3 months.
- •A history of severe anaphylaxis.
- •Pregnant or lactating women;
- •Any condition considered by the investigators to be unsuitable for enrollment.
研究组 & 干预措施
ATG-PTCy cohort
The conditioning regimen is ATG/G-CSF based protocol (the so-called Beijing protocol). The rabbit ATG (Sangstat-Genzyme) 2.5mg/kg/day i.v., on days from - 5 to - 2 were administered.Two doses of 14.5 mg/kg Cy were given on days 3 and 4 post-HCT in ATG-PTCy cohort.
干预措施: Cyclophosphamid (Drug)
ATG-PTCy cohort
The conditioning regimen is ATG/G-CSF based protocol (the so-called Beijing protocol). The rabbit ATG (Sangstat-Genzyme) 2.5mg/kg/day i.v., on days from - 5 to - 2 were administered.Two doses of 14.5 mg/kg Cy were given on days 3 and 4 post-HCT in ATG-PTCy cohort.
干预措施: ATG (Drug)
ATG cohort
The conditioning regimen is ATG/G-CSF based protocol (the so-called Beijing protocol). The rabbit ATG (Sangstat-Genzyme) 2.5mg/kg/day i.v., on days from - 5 to - 2 were administered.
干预措施: ATG (Drug)
结局指标
主要结局
The incidence of acute graft versus host disease.
时间窗: 100 days post HSCT.
The incidence of acute graft versus host disease. The severity of acute GVHD was evaluated according to standard international criteria.
次要结局
- Overall survival(1 year post HSCT.)
- The incidence of non-relapse mortality(1 year post HSCT.)
- The incidence of infection(1 year post HSCT.)
- Engraftment(30 days post HSCT.)
- The incidence of chronic GvHD(1 year post HSCT.)
- Immune reconstitution(1 year post HSCT.)
- The incidence of relapse(1 year post HSCT.)
- Disease free survival(1 year post HSCT.)
- GvHD relapse free survival(1 year post HSCT.)
研究者
Xiao-Jun Huang
Professor
Peking University People's Hospital