Clinical Study on the Safety and Efficacy of Unrelated Umbilical Cord Blood Infusion in Treating Bone Marrow Suppression After Chemotherapy in Elderly Patients With Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) .
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Percentage of patients with bone marrow suppression grade < II.
研究概览
简要总结
The clinical study aims to evaluate the safety and efficacy of umbilical cord blood transfusion in treating bone marrow suppression after chemotherapy in elderly patients with MDS and AML
详细描述
The clinical study aims to evaluate the safety and efficacy of umbilical cord blood （HLA typing 0-3/10 match, TNC ≥ 3×10^7/kg）transfusion in treating bone marrow suppression after chemotherapy in elderly patients with MDS and AML，UCB can be applied in one to multiple doses, and the minimum interval between two cord blood transfusions should be 2 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) Ages 60-80 years , gender unlimited;
- •2) Patients clinically diagnosed with MDS or AML;
- •3) Completed chemotherapy and clinically diagnosed with bone marrow suppression grade 2 or above;
- •4) Patients with no severe impairment of liver and kidney function (total bilirubin (TBIL): ≤ 1.5×ULN; ALT or AST: ≤ 2.5×ULN; Alkaline phosphatase: ≤ 3×ULN; Serum creatinine: ≤ 1.5×ULN);
- •5) Normal cardiac function;
- •6) Patients with ECOG 0-2;
- •7) Patients or their families have been informed and voluntarily signed a written informed consent form.
排除标准
- •1) Other factors that may cause abnormalities in white blood cells and neutrophils, such as concurrent infections, invasive procedures, etc.
- •Presence of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (such as diabetes, hypertension, pulmonary fibrosis, and acute pneumonia, etc.). Any unstable systemic diseases: including but not limited to unstable angina, cerebrovascular accident or transient ischemic attack (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association NYHA classification ≥ III,), severe arrhythmias requiring medication, liver, kidney, or metabolic diseases.
- •3) Any other uncontrolled active diseases that may interfere with participation in the trial;
- •4) Concurrent diagnosis of malignant tumors in other organs;
- •5) Concurrent diagnosis of other hematological disorders;
- •6) Inability to understand or comply with the study protocol;
- •7) Individuals deemed unsuitable for participation in this trial by the investigator.
研究组 & 干预措施
Umbilical cord blood
干预措施: Umbilical cord blood (Biological)
结局指标
主要结局
Percentage of patients with bone marrow suppression grade < II.
时间窗: Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.
Calculate the percentage of patients with bone marrow suppression grade \< II based on recorded hematological parameters.
hematological parameters like hemoglobin level(Hb)
时间窗: Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.
Monitor and record hemoglobin level(g/L), every 2 days in patients, and maintain a record.
hematological parameters like white blood cell count(WBC)
时间窗: Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.
Monitor and record white blood cell count( 10⁹/L)every 2 days in patients, and maintain a record.
hematological parameters like platelet count(PLT)
时间窗: Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.
Monitor and record platelet count ( 10⁹/L)every 2 days in patients, and maintain a record.
hematological parameters like neutrophil count(ANC)
时间窗: Tests should be conducted every two days after umbilical cord blood transfusion, for a maximum of 30 days.
Monitor and record neutrophil count ( 10⁹/L)every 2 days in patients, and maintain a record.
次要结局
- Incidence of bleeding(Up to 30 days after umbilical cord blood treatment)
- Incidence of infection(Up to 30 days after umbilical cord blood treatment.)