The Study of Anti-CD25 Antibody for Prophylaxis of GVHD in Patients Underwent Haploid Transplantation Conditioning With Low-dose ATG
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The incidence of aGVHD
研究概览
简要总结
The risk of Graft-versus-host Disease(GVHD) is significantly associated with the mortality rate of patients undergoing allogeneic hematopoietic stem cell transplantation. The occurrence of GVHD increases the hospitalization rate and economic burden of patients. In order to explore better methods for controlling GVHD, we designed a clinical trial using CD25 monoclonal antibody for GVHD prevention. Our previous studies have shown that reduced-dose anti-thymocyte globulin(ATG) in the conditioning regimen can achieve the same effect as full-dose ATG. Here, we try to explore the preventive effect of CD25 antibody on acute and chronic GHVD under low-dose ATG pretreatment condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a clear diagnosis of hematologic disease, weighing ≥30kg, aged 18-60, of any gender and race;
- •Willing to undergo haploidentical hematopoietic stem cell transplantation;
- •Voluntarily participate in this study;
- •Each subject must sign an informed consent form (ICF) indicating their understanding of the purpose and procedures of the study, and their willingness to participate. Considering the patient 's condition, if the patient' s signature is unfavorable for disease treatment, the informed consent form should be signed by the legal guardian or the patient 's immediate family member.
排除标准
- •Those with severe organ dysfunction or diseases, such as heart, liver, kidney, and pancreatic diseases;
- •Patients who cannot tolerate CD25 monoclonal antibody treatment;
- •Subjects and/or authorized family members who refuse allo-HSCT treatment;
- •Any life-threatening diseases, physical conditions, or organ system dysfunctions that the researcher believes may jeopardize the safety of the subject and pose unnecessary risks to the study; drug dependence; uncontrolled mental illness in subjects; cognitive dysfunction;
- •Those who have participated in other similar clinical studies within the past 3 months;
- •Those deemed unsuitable for inclusion by the researcher (such as patients expected to be unable to adhere to treatment due to financial issues, etc.).
研究组 & 干预措施
CD25 treatment
The humanized CD25 antibody was administered at 1 mg/kg iv on days+4 and +7 after HSCT.
干预措施: CD25 treatment (Drug)
CD25 treatment
The humanized CD25 antibody was administered at 1 mg/kg iv on days+4 and +7 after HSCT.
干预措施: low-dose ATG (Drug)
control group
干预措施: low-dose ATG (Drug)
结局指标
主要结局
The incidence of aGVHD
时间窗: 100 days after HSCT
The time of aGVHD occurrence
The incidence of cGVHD
时间窗: 1 year after HSCT
The time of cGVHD occurrence
次要结局
- the time of donor cell engraftment(2 years after HSCT)
- the time of disease relapse(2 years after HSCT)
- the time of death of transplant patient(2 years after HSCT)
- the time of immune reconstitution in haploidentical transplant(2 years after HSCT)
- the time of infection occurrence(2 years after HSCT)
研究者
Wang Xin
Director of Department of Hematology
Shandong Provincial Hospital