Prospective Randomized Controlled Phase III Clinical Study on the Impact of Stem Cell Infusion Timing on the Incidence of Acute Graft-versus-host Disease in Patients With Hematologic Malignancies Following Single-unit Umbilical Cord Blood Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- The incidence of grade III to IV aGVHD
研究概览
简要总结
To observe the effect of stem cell infusion on the development of acute graft- versus-host disease (aGVHD) in patients with malignant hematologic diseases after single-unit unrelated cord blood transplantation (sUCBT).
详细描述
Acute graft-versus-host disease (aGVHD) is a major complication and cause of non-relapse mortality following allogeneic hematopoietic stem cell transplantation (allo-HSCT). The human circadian clock utilizes recurring environmental cues such as light exposure and food intake to establish 24-hour rhythmic variations in sleep, hormone secretion, metabolism, body temperature, and immune function. Current clinical strategies for aGVHD prevention primarily focus on pharmacological or immunomodulatory suppression of donor lymphocyte activity, often overlooking the impact of recipient physiological fluctuations on graft outcomes. Our preliminary studies revealed that the timing of stem cell infusion significantly influences the incidence and severity of aGVHD after sUCBT. Given the lack of prospective clinical trial data internationally regarding the effect of infusion timing on aGVHD development post-allo-HSCT, coupled with potential confounding factors in existing retrospective studies and pilot experiments, this study proposes to randomize patients based on umbilical cord blood infusion timing. The investigation will evaluate how infusion time affects aGVHD incidence, other transplantation-related complications, and long-term survival rates in hematologic malignancy patients undergoing sUCBT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Definite diagnosis of malignant hematologic disease before transplantation, age, gender and race are not limited;
- •Participants were required to have achieved complete remission with negative minimal residual disease (MRD) prior to transplantation;
- •Participants who are proposed to receive sUCBT for the first time;
- •Eastern Cooperative Oncology Group (ECOG) score 0-2;
- •No serious organ failure and active infection;
- •Voluntary open randomized controlled study to observe whether the time of stem cell infusion affects the occurrence of aGVHD after transplantation;
- •Each subject must sign an informed consent form (ICF) indicating that he/ she understands the purpose and procedures of the study and is willing to participate in the study; in view of the subject's condition, if the participant's own signature is not conducive to the treatment of his/her condition, the ICF will be signed by the legal representative.
排除标准
- •Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas;
- •Any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise participant safety and put the results of the study at unnecessary risk; drug-dependent individuals; participants with uncontrolled psychiatric disorders; and individuals with cognitive dysfunction;
- •Participants in other clinical studies that may affect aGVHD within 3 months;
- •Those whom the investigator considers unsuitable for enrollment (e.g., those who anticipate that patients will not be able to adhere to the examination and treatment due to financial and other issues).
结局指标
主要结局
The incidence of grade III to IV aGVHD
时间窗: 100 days post transplantation
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 Mount Sinai Acute GVHD International Consortium criteria.
The incidence of grade III to IV aGVHD
时间窗: 100 days post transplantation
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 Mount Sinai Acute GVHD International Consortium criteria.
次要结局
- The incidence of grade II to IV aGVHD(100 days post transplantation)
- The cumulative incidence of transplant-related mortality at 360 days after transplantation(360 days post transplantation)
- The cumulative incidence of relapse at 360 days after transplantation(360 days post transplantation)
- The cumulative incidence of overall chronic GVHD at 360 days after transplantation(360 days post transplantation)
- The cumulative incidence of neutrophil engraftment at 42 days after transplantation(42 days post transplantation)
- The cumulative incidence of platelet engraftment at 60 days after transplantation(60 days post transplantation)
- The probability of GVHD-free, relapse-free survival(GRFS)(360 days post transplantation)
- The probability of disease-free survival(DFS)(360 days post transplantation)
- The probability of overall survival(OS)(360 days post transplantation)
- The cumulative incidence of platelet engraftment at 60 days after transplantation(60 days post transplantation)
- The cumulative incidence of transplant-related mortality at 360 days after transplantation(360 days post transplantation)
- The cumulative incidence of relapse at 360 days after transplantation(360 days post transplantation)
- The cumulative incidence of overall chronic GVHD at 360 days after transplantation(360 days post transplantation)
- The incidence of grade II to IV aGVHD(100 days post transplantation)
- The cumulative incidence of neutrophil engraftment at 42 days after transplantation(42 days post transplantation)
- The probability of GVHD-free, relapse-free survival(GRFS)(360 days post transplantation)
- The probability of disease-free survival(DFS)(360 days post transplantation)
- The probability of overall survival(OS)(360 days post transplantation)