A Clinical Study to Evaluate the Safety and Efficacy of Unrelated Umbilical Cord Blood Microtransplantation in Patients With Acute Myelocytic Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Hematopoietic recovery time
研究概览
简要总结
This study aimed to evaluate the safety and efficacy of unrelated umbilical cord blood microtransplantation in the treatment of AML patients by observing the factors related to the efficacy and adverse reactions.
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
- 14 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with AML through bone marrow morphology, histochemistry, immunophenotyping, pathological testing, etc. Besides, patients should meet the following conditions:
- •Patients aged 60-80 who newly diagnosed AML with WHO criteria and have not received prior treatment for acute leukemia (hydroxyurea or pre-chemotherapy is allowed for patients with high leukocyte).
- •Patients aged 14-60 who do not meet the indications for hematopoietic stem cell transplantation;
- •Gender and race are not limited;
- •Karnofsky score ≥ 60%, Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;
- •Expected survival time ≥ 3 months;
- •The examination results meet the following requirements:
- •ALT and AST ≤ 3 × Upper limit of normal value (ULN); Total bilirubin ≤ 3 × ULN; Creatinine ≤ 2 × ULN or creatinine clearance rate ≥ 40mL/min; The left ventricular ejection fraction (LVEF) measured by echocardiography or multigated acquisition (MUGA) scanning is within the normal range (>50%);
- •The recipient and selected donor should be 0-3/10 HLA-matched with same blood type;
- •Patients who voluntarily participate in this clinical study and have signed an informed consent.
排除标准
- •Patients who have suffered from malignant tumors;
- •Patients have suffered from hematopoietic failure after chemotherapy, and have undergone ineffective blood transfusion with unknown cause;
- •Patients who have undergone Class II or above surgery within 4 weeks prior to enrollment;
- •Suffering from life-threatening diseases other than AML;
- •Allergic to the drugs in the research;
- •Patient with severe cardiac insufficiency, including uncontrolled or symptomatic arrhythmia, congestive heart failure, myocardial infarction within 6 months, or any grade 3 (moderate) or grade 4 (severe) heart disease;
- •Patients with test positive for HIV, HCV or HBV;
- •Stroke or intracranial hemorrhage occurred within 6 months prior to enrollment;
- •Warfarin or vitamin K antagonists (such as phenprocoumarin) is necessary for anticoagulation;
- •Patients with mental illnesses or cognitive impairments;
- •Patients have participated within the month prior to enrollment or patients are currently participating in other clinical trials;
- •There are other conditions that the investigators consider inappropriate for inclusion.
研究组 & 干预措施
Chemotherapy+unrelated umbilical cord blood microtransplantation
Intermittent infusion of HLA mismatched or incompletely matched granulocyte colony-stimulating factor (G-CSF) mobilized peripheral blood stem cells (G-PBSC) during routine chemotherapy without the use of immunosuppressants, abbreviated as "microtransplantation".
干预措施: Unrelated umbilical cord blood (Biological)
Chemotherapy+unrelated umbilical cord blood microtransplantation
Intermittent infusion of HLA mismatched or incompletely matched granulocyte colony-stimulating factor (G-CSF) mobilized peripheral blood stem cells (G-PBSC) during routine chemotherapy without the use of immunosuppressants, abbreviated as "microtransplantation".
干预措施: Venetoclax (Drug)
Chemotherapy+unrelated umbilical cord blood microtransplantation
Intermittent infusion of HLA mismatched or incompletely matched granulocyte colony-stimulating factor (G-CSF) mobilized peripheral blood stem cells (G-PBSC) during routine chemotherapy without the use of immunosuppressants, abbreviated as "microtransplantation".
干预措施: Decetabine (Drug)
Chemotherapy+unrelated umbilical cord blood microtransplantation
Intermittent infusion of HLA mismatched or incompletely matched granulocyte colony-stimulating factor (G-CSF) mobilized peripheral blood stem cells (G-PBSC) during routine chemotherapy without the use of immunosuppressants, abbreviated as "microtransplantation".
干预措施: Azacitidine (Drug)
结局指标
主要结局
Hematopoietic recovery time
时间窗: 28±7days
The time of absolute neutrophil count\>0.5×10\^9/L and platelet count \>30×10\^9/L for 3 consecutive days.
Complete response (CR) rate
时间窗: 28±7days
CR rate is defined as the percentage of patients who met the following conditions: Myelogram: naïve cells less than 5% (at least 200 nucleated cells); Hemogram: absolute neutrophil count \> 1.0×10\^9/L, platelet count \> 100×10\^9/L; Clinical diagnosis: no symptoms and signs caused by leukemia infiltration, and patients do not rely on blood transfusion.
次要结局
- Early mortality rate(3 months)
- Disease Free Survival（DFS）(1 year)
- Overall Survival（OS）(1 year)
- Time to Progression（TTP）(1 year)
研究者
Xiaoyu Zhu
Principal Investigator
Anhui Provincial Hospital