Multicenter, One-arm, Phase II Clinical Study of Decitabine Combined With Unrelated Cord Blood Transplantation for the Treatment of Acute Myeloid Leukemia (AML) in the Elderly
试验速览
- 阶段
- 1 期
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Disease free survival (DFS)
研究概览
简要总结
Acute myeloid leukemia (AML) is a clonal disease caused by genetic mutations in Hematopoietic stem progenitor cells. Unfortunately, advanced age (>60 years old) is considered to be one of the most important adverse prognostic factors for AML, and older patients are unable to tolerate high-dose chemotherapy, due to various complications and organ dysfunction. Based on the results of the previous research, we will carry out the pretreatment regimen of decitabine + cytarabine in elderly patients with AML who have achieved disease treatment through induction therapy, and continue the transplantation program of unrelated-blood cord blood. By assessing the patient's DFS,OS,RFS and safety to determine whether the regimen is suitable for the consolidation treatment of elderly acute myeloid leukemia, further clarify the efficacy of this regimen compared with traditional consolidation therapy, and initially confirm the effect of combined with unrelated cord blood transplantation in the treatment of acute myeloid leukemia.
详细描述
A prospective,Multicenter,open,single-arm clinical study.The research process is divided into three phases: the screening phase, the treatment phase, and the follow-up phase. The treatment phase includes pre-transplant pretreatment, cord blood transplantation, and consolidation therapy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AML patients diagnosed by bone marrow morphology and Immunology;
- •Exclusion of APL by Bone marrow morphology or molecular level;
- •A patient who has obtained bone marrow cytology remission after inductive treatment;
- •Aged from 60 to 75 years;
- •Liver and kidney function: blood bilirubin ≤ 35μmol / L, AST or/ALT <2 times the upper limit of normal (ULN), serum creatinine;≤ 150μmol / L;
- •The function of Heart is normal;
- •Physical condition score 0-2 (ECOG score);
- •Get informed consent signed by patient or family member.
排除标准
- •APL patients, treatment-related AML;
- •Retreatment of patients;
- •Allergies to any of the drugs involved in the protocol;
- •There are obvious contraindications to chemotherapy drugs;
- •Liver and kidney function is obviously abnormal, exceeding the inclusion criteria;
- •Serious heart disease, including myocardial infarction, cardiac insufficiency;
- •Suffering from other organ malignant tumors at the same time ;
- •Active period of tuberculosis patients and HIV-positive patients;
- •Suffering from other blood system diseases at the same time;
- •Pregnancy or breastfeeding;
- •Cannot understand or follow the research plan;
- •A history of intolerance or allergies to similar drugs;
- •Patients under 60 years of age or over 75 years of age;
- •Participate in other clinical researchers at the same time;
- •There are other situations that hinder the conduct of the study.
结局指标
主要结局
Disease free survival (DFS)
时间窗: Three years
次要结局
- Overall Survival (OS)(Three years)
- Complete Remission Rate (CR)(Three years)
- Adverse Events (refer to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.03).(Three years)
研究者
Li Junmin
Director of the hematology department
Ruijin Hospital