The Efficacy and Safety of Combined Haploidentical and Umbilical Cord Blood Allogeneic Stem Cell Transplantation in Patients With Acute Leukemia.
试验速览
- 阶段
- 不适用
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Allogeneic stem cell transplantation (Allo-HSCT) is the effective and even the only treatment option for acute leukemia. The haplo-hematopoietic stem cell transplantation(haplo-HSCT) and "GIAC" protocol have crossed HLA barrier and helped more patients find donors. However, the engraftment failure and incidence of graft-versus-host disease(GVHD) limit the prognosis of patients who receive the haplo-HSCT. It is believed that Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation improved hematopoietic reconstitution and reduced the incidence of GVHD, there is still no consensus about the efficacy and safety of this kind of therapy. This prospective, randomized and controlled study is to investigate the efficacy and safety of Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation
详细描述
This prospective, randomized and controlled study is to investigate the efficacy and safety of Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation. Investigators will recruit 116 patients with acute leukemia, with 58 of them entering the haplo-HSCT group and receiving haploidentical hematopoietic stem cell transplantation, while the other 58 entering the combined haploidentical and umbilical cord blood allogeneic stem cell transplantation group and receiving haploidentical and umbilical cord blood allogeneic stem cell transplantation at the same day. Then primary outcomes including overall survival and disease free survival, as well secondary outcomes such as cumulative relapse incidence and cumulative incidence of engraftment will be measured during 12 months after the intervention being finished.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 16-65 years inclusive.
- •Diagnosed as acute leukemia, planning to receive haplo-HSCT
- •Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
- •Presence of an available haploidentical donor
- •Signing written informed consent and agreeing with taking designated umbilical cord blood
排除标准
- •Uncontrolled infections less than 4 weeks prior to enrollment
- •Secondary malignancy
- •Psychiatric illness that would limit compliance with study requirements
- •Impairment of heart, hepatic or renal function to such an extent that the patient, in the opinion of the investigator, will be exposed to an excessive risk if entered into this clinical study
- •Allergic to blood products
- •Other causes which are not suitable for the trial in investigator's consideration
结局指标
主要结局
Overall survival
时间窗: 12 months
Defined as the survival duration starting at the day of transplantation, terminating at the day of death or the end of follow-up
Disease free survival
时间窗: 12 months
Defined as the time starting at the day of transplantation, terminating at the day when the sign of AL is found or the end of follow-up
次要结局
- cumulative incidence of acute graft-versus-host disease(GVHD)(12 months)
- cumulative incidence of chronic GVHD at one year(12 months)
- Cumulative Incidence of hemorrhagic cystitis(12 months)
- Cumulative relapse incidence(12 months)
- Cumulative Incidence of Infectious Complications(12 months)
- Cumulative incidence of engraftment(12 months)
- Cumulative Incidence of lymphoproliferative disease(12 months)