Clinical Studies of New Model Haploidentical Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- disease free survival at six months
研究概览
简要总结
Building a new haploid transplanted model with high-dose CTX、CD19-CART,donor CD34+ hematopoietic stem cell and Tregs,to prevent graft-versus-host disease(GVHD),reduce the infection,promote the rate of immune reconstruction，seperate graft versus leukemia（GVL）and GVHD，then to reduce the relapse rate after hematopoietic stem cell transplantation（HSCT）for relapsed and/or refractory B cell acute lymphoblastic leukemia（r/r-B-ALL）.
详细描述
compare the new haplo-HSCT model with the traditional haplo-HSCT in DFS、OS、RFS、CR and the degree of GVHD.etc.for the r/r B-ALL patients.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the r/r B-ALL patients
- •have the healthy allo-HSCT donor
- •voluntary and signed the treatment protocol
排除标准
- •not match the inclusion criteria
- •important organ is dysfunction, such as heart and/or renal dysfunction,liver failure
- •Pregnancy or breast-feeding women
- •has virus infection,such as HIV,hepatitis virus,and can not be cleared with anti-virus treatment
结局指标
主要结局
disease free survival at six months
时间窗: six months
the disease free survival of the new model haplo-HSCT will be assessed at 6 months.
acute graft-versus-host disease
时间窗: three months
we will examine the treatment-related acute GVHD at 3 months.
次要结局
未报告次要终点