Phase III Clinical Trial of Microtransplantation to Treat Elderly Acute Myeloid Leukemia
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- the remission rate
研究概览
简要总结
Patients enrolled from each center according to confirmed criteria specified in cooperative scheme are randomly assigned to standard induction and consolidation chemotherapy with microtransplantation （MST-group）or without (CT-group).Compare the remission rate and 2-year disease-free survival (DFS) and overall survival(OS) rate of the two groups.
详细描述
Microtransplantation, which combines chemotherapy with adoptive infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC). Data from more than 70 elderly AML patients who received microtransplantation in Beijing showed that the remission rate and 2-year disease-free survival (DFS) reach 75-82% and 32-39% respectively, and microchimerisms (donor cells<1%) were detected without GVHD. The results have been clinically validated in several other centers in China, United States and Australia. Based on these facts, to further validate the therapeutic efficacy, we propose a phase III clinical trial in which the de novo AML patients ≥60 years old are randomly assigned to receive standard induction and consolidation chemotherapy with or without microtransplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have elderly (60-85 ages) AML pathologically confirmed per WHO guidelines.
- •Patients have not been treated before.
- •Patients must have ECOG Performance status of 0,1,or
- •Patients must have a HLA mismatched donor who should be able to provide informed consent.
- •All genders and races are eligible.
- •ALT and AST≤3 ×ULN, TBIL≤1.5 × ULN, Cr≤2 ×ULN or CrCl≥40 mL/min
- •By means of ultrasonic Heartbeat map or multiple gated acquisition (MUGA) scanning determination of LVEF in the normal range.
- •Donors must be able to safely undergo leukapheresis.
排除标准
- •received operation 4 weeks before randomization
- •acute promyelocytic leukemia,Myeloid sarcoma, chronic myeloid leukemia in accelerated phase and blastic phase;
- •active CNS disease, pregnancy, or other major medical or psychiatric illnesses that could compromise tolerance to this protocol
- •occurred stroke or intracranial hemorrhage within 6 months before randomization.
- •Require the use of warfarin or equivalent of vitamin K antagonists (such as phenprocoumon) anticoagulant.
- •There is clinical significance of cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within 6 months before randomization, or any heart function grade 3 (moderate) or 4 (severe ) heart disease in accordance with the functional classification method of New York Heart Association (NYHA).
- •Known to have the following history: human immunodeficiency virus (HIV) or active hepatitis C virus or hepatitis B virus infection
- •Any situation processed by the PI that will be damaged to the patients safety.
- •Patients and / or authorized family member refuse to sign the consent.
- •attend other clinical researchers in 3 months.
- •Donors exclusion criteria include:active infection or malignancy, cardiovascular instability, severe anemia, severe coagulation disorder, pregnancy, inadequate venous access, inability to provide consent, or any other condition deemed unsafe by the treatment staff.
结局指标
主要结局
the remission rate
时间窗: 2 months
①bone marrow: blasts \<5% (with a count of at least 200 Nucleated cells).②Hemogram: absolute neutrophil count of more than 1.0×109/L，platelets of \>100×109/L. ③Clinical: Without the signs and symptoms caused by leukemia infiltration d , and independent of transfusion;
次要结局
- Disease Free Survival(2 years)
- Overall Survival(2 YEAR)