Haploidentical Peripheral Blood Stem Cell Transplantation for Acute Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- engraftment rate
研究概览
简要总结
Allogeneic stem cell transplantation (Allo-HSCT) is the effective and even the only treatment for hematological malignancies. The "GIAC" protocol established by our center has successfully crossed the HLA barrier in HLA-mismatched/haploidentical HSCT. The protocol entails the following: treating donors with granulocyte colony-stimulating factor (G-CSF) to induce donor immune tolerance, intensified immunologic suppression to both promote engraftment and to prevent GVHD, antithymocyte globulin (ATG) was included for the prophylaxis of GVHD and graft rejection, and combination of G-CSF-primed bone marrow harvest (G-BM) and G-CSF-mobilized peripheral blood stem cell harvest (G-PB) as the source of stem cell grafts. But peripheral blood transplantation is still prevalent. Compared with BM, G-PB is more convenient to collect, and the number of T lymphocytes and CD34+ cells is higher. It is reported that G-PB has a higher implantation rate and even a higher disease-free survival rate in sibiling-identical transplantation compared with BM transplantation, whereas there were also reports with different conclusions. This prospective, one-arm clinical cohort study aims to evaluate the safety and efficacy of haplotype peripheral blood stem cell transplantation (PBSCT) in the treatment of acute leukemia.
详细描述
Allogeneic stem cell transplantation (Allo-HSCT) is the effective and even the only treatment for hematological malignancies. The "GIAC" protocol established by our center has successfully crossed the HLA barrier in HLA-mismatched/haploidentical HSCT. The protocol entails the following: treating donors with granulocyte colony-stimulating factor (G-CSF) to induce donor immune tolerance, intensified immunologic suppression to both promote engraftment and to prevent GVHD, antithymocyte globulin (ATG) was included for the prophylaxis of GVHD and graft rejection, and combination of G-CSF-primed bone marrow harvest (G-BM) and G-CSF-mobilized peripheral blood stem cell harvest (G-PB) as the source of stem cell grafts. But peripheral blood transplantation is still prevalent. Compared with BM, G-PB is more convenient to collect, and the number of T lymphocytes and CD34+ cells is higher. It is reported that G-PB has a higher implantation rate and even a higher disease-free survival rate in sibiling-identical transplantation compared with BM transplantation, whereas there were also reports with different conclusions. This prospective, one-arm clinical cohort study aims to evaluate the safety and efficacy of haplotype peripheral blood stem cell transplantation (PBSCT) in the treatment of acute leukemia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •2-60 years old, all genders;
- •the first complete remission phase (CR1) of acute leukemia;
- •planning to receive haplotype PBSCT;
- •no uncontrolled current infections (new infections, body temperature still above 38 ℃ after treatment with broad-spectrum antibiotics for 72h, except for other non-infectious factors);
- •no organ failure.
排除标准
- •with poor compliance;
- •with uncontrolled current infections；
- •pregnancy;
- •donors with contraindications of mobilization and collection of peripheral blood stem cells;
- •with mental sickness
结局指标
主要结局
engraftment rate
时间窗: one year after transplantation
Neutrophil recovery was defined as an absolute neutrophil count(ANC) of 0.5×10\^9/L or more for three consecutive days and platelet recovery, as 20×10\^9/L or more for seven consecutive days without transfusion.
次要结局
- cumulative incidence of acute graft-versus-host disease(GVHD)(one year after transplantation)
- cumulative incidence of chronic GVHD at one year(one year after transplantation)
- cumulative incidence of relapse at one year(one year after transplantation)
- cumulative incidence of non-relapse mortality (NRM) at one year(one year after transplantation)
- overall survival at one year(one year after transplantation)
研究者
Xiaojun Huang,MD
Supervisor of Hematology, Peking University People's Hospital
Peking University People's Hospital