NCT07450313尚未招募2 期
A Clinical Study on the Efficacy and Safety of Luspatercept in Improving Early Anemia After Allogeneic Hematopoietic Stem Cell Transplantation
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Cumulative volume of red blood cell transfusions
研究概览
简要总结
This study aims to evaluate whether luspatercept can improve the efficacy and safety of anemia treatment in patients with hematologic malignancies after allogeneic hematopoietic stem cell transplantation.
详细描述
This study aims to investigate whether the early post-transplant application of luspatercept can improve early anemia and transfusion dependency in patients with hematologic malignancies after hematopoietic stem cell transplantation. Meanwhile, the investigators aim to evaluate the safty of administration of luspatercept post-transplantation, and assess its impact on platelet and neutrophil engraftment, as well as its effect on the incidence of complications such as poor graft function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •1. Diagnosis of malignant hematological tumors and undergoing allogeneic hematopoietic stem cell transplantation.
- •2. Expected survival after transplantation exceeds 1 month.
- •3. Age 18-60 years.
- •4. Hemoglobin ≤60 g/L on day 0 after transplantation.
- •5. Eastern Cooperative Oncology Group (ECOG) score 0-
- •6. Able to independently sign the informed consent form.
- •7. The informed consent form must be signed before the start of the study procedures. For individuals aged 18 years and above, the informed consent form should be signed by the patient themselves or their immediate family members. Considering the patient's condition, if signing by the patient themselves is not conducive to treatment, the legal guardian or immediate family member should sign the informed consent form.
排除标准
- •1. Uncontrolled infection at the time of enrollment, or requiring mechanical ventilation or hemodynamic instability;
- •2. Severe organic damage: hepatic or renal impairment;
- •3. Occurrence of any of the following within 6 months prior to the study: myocardial infarction, severe/unstable angina pectoris, congestive heart failure, or cerebrovascular accident, including transient ischemic attack;
- •4. Presence of psychiatric disorders or other conditions that may compromise compliance with study treatment and monitoring requirements. Failure to sign the informed consent form;
- •5. Inability or unwillingness to sign the consent form;
- •6. Participation in other transplant-related clinical studies;
- •7. Other circumstances deemed by the investigator as potentially affecting the study or ethics, including drug allergies, patient non-compliance with study procedures, or involvement of the research center staff and their immediate relatives.
研究组 & 干预措施
Luspatercept treatment
Experimental
干预措施: Luspatercept (Drug)
结局指标
主要结局
Cumulative volume of red blood cell transfusions
时间窗: 28 days post-HSCT
次要结局
- Cumulative volume of red blood cell transfusions(56 days post-transplantation)
- Platelet and neutrophil counts(2 months post-HSCT)
- Incidence of poor graft function (PGF).(one year post-HSCT)
- Serum/bone marrow GATA1,and GDF11 levels(2 months post-HSCT)
- Levels of inflammatory factors(2 months post-HSCT)
- Incidence of acute graft-versus-host disease (aGVHD).(one year post-HSCT)
- Overall Survival(one year after HSCT)
- disease-free survival(one year after HSCT)
- cumulative incidence of relapse(one year after HSCT)
- treatment-related mortality(one year after HSCT)
研究者
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