Effectiveness and Safety of a Single-Center Clinical Study on a CD25 Monoclonal Antibody-Containing GVHD Prophylaxis Scheme to Reduce the Incidence of Severe Acute GVHD After Umbilical Cord Blood Transplantation for Malignant Hematologic Diseases
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- The cumulative incidence of grade III-IV acute graft-versus-host disease (aGVHD)
研究概览
简要总结
Evaluating the safety and effectiveness of a CD25 monoclonal antibody-based prophylactic acute graft-versus-host-disease (aGVHD) regimen following unrelated umbilical cord blood transplantation (UCBT) for malignant hematologic disorders in reducing severe aGVHD.
详细描述
Acute graft-versus-host disease (aGVHD) is a major complication and leading cause of non-relapse mortality following allogeneic hematopoietic stem cell transplantation (allo-HSCT). Preliminary research findings suggest that the addition of CD25 monoclonal antibody at +3 days post unrelated umbilical cord blood transplantation (UCBT) has reduced the incidence of grade III-IV aGVHD compared to previous protocols. In order to further explore how to improve prevention strategies of aGVHD and reduce the incidence of severe aGVHD, we performed this study to evaluate the safety and effectiveness of a prophylactic GVHD regimen utilizing CD25 monoclonal antibody post-UCBT for malignant hematologic disorders, aimed at reducing the incidence of severe aGVHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Malignant hematologic disorders;
- •Patients undergoing UCBT;
- •Female patients of childbearing potential must have a negative pregnancy test and agree to use effective contraception during treatment and for the following year.
排除标准
- •Non-malignant hematologic disorders;
- •History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
- •Uncontrolled bacterial, viral, or fungal infections. "Uncontrolled" is defined as lack of clinical improvement or progression despite adequate antimicrobial therapy;
- •HIV infection or active hepatitis B or C virus infection;
- •Pregnant or lactating women;
- •Substance abusers; subjects with uncontrolled psychiatric disorders; individuals with cognitive dysfunction;
- •Participation in similar clinical studies within the past 3 months;
- •Subjects deemed unsuitable by the investigator (e.g., those expected to be unable to adhere to treatment due to financial constraints).
研究组 & 干预措施
basiliximab group
干预措施: Basiliximab (Drug)
结局指标
主要结局
The cumulative incidence of grade III-IV acute graft-versus-host disease (aGVHD)
时间窗: within 100 days post-UCBT
The primary endpoint of the study will be the development of aGVHD in the first 100 days post-transplant. Acute GVHD was graded according to the International Consortium criteria.
次要结局
- The cumulative incidence of neutrophil engraftment at 28 days after transplantation(within 28 days post-UCBT)
- The incidence rate and occurrence time of pre-engraftment syndrome (PES)(within 30 days post-UCBT)
- The cumulative incidence of platelet engraftment at 100 days after transplantation(within 100 days post-UCBT)
- The incidence of grade II to IV aGVHD(within 100 days post-UCBT)
- The cumulative incidence of chronic GVHD at 360 days after transplantation(360 days)
- The cumulative incidence of transplant-related mortality at 180 days after transplantation(180 days)
- The cumulative incidence of relapse(1 year)
- The probability of disease-free survival(DFS)(1 year)
- The probability of overall survival(OS)(1 year)
- The probability of GVHD-free, relapse-free survival(GRFS)(1 year)