N-acetyl-L-cysteine for Promoting Hematopoietic Recovery in Patients With Acute Myeloid Leukemia After Chemotherapy--a Prospective Single-arm Clinical Study
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time to hematopoietic recovery post chemotherapy
研究概览
简要总结
This is a prospective single-arm clinical study to evaluate the role of NAC after chemotherapy among patients with AML can promote hematopoietic recovery and does not affect the remission rate of the leukemia.
详细描述
Hematopoietic recovery after chemotherapy is an important factor affecting the prognosis of acute myeloid leukemia. A previous clinical prospective cohort study showed that NAC could improve the function of bone marrow endothelial progenitor cells after chemotherapy, without affecting leukemia cells. Previous animal models have found that chemotherapy can reverse the function of bone marrow endothelial cells in classic AML mice. NAC promotes hematopoietic recovery in AML mice by improving the bone marrow endothelial cells reversed by chemotherapy. Therefore, we hypothesized that the prophylactic administration of NAC after chemotherapy could facilitate the recovery of hematopoietic capacity by improving the bone marrow microenvironment of patients with AML.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed AML (except AML-M3)
- •Low-, intermediate risk AML (according to 2022 ELN)
- •No severe organ injury 1) Creatinine < 1.5mg/dl 2) Hemobilirubin ≤ 1.5 X ULN 3) AST and ALT ≤ 3.0 X ULN 4) Cardiac ejection index ≥ 50%
- •No uncontrolled active infections
- •Sign informed consent form, have the ability to comply with study and follow-up procedures
排除标准
- •Hypersensitivity to NAC
- •History of bronchial asthma
研究组 & 干预措施
NAC group
Low, intermediate risk AML patients were enrolled, and NAC (400mg tid) was administered orally from day1 to day 28 (D1-D28) after the end of induction chemotherapy.
干预措施: N-acetyl-L-cysteine (Drug)
结局指标
主要结局
Time to hematopoietic recovery post chemotherapy
时间窗: Participants will be followed for 2 months post induction chemotherapy
Time to hematopoietic recovery (white blood cell \> 1×10\^9/L, platelet \> 20 ×10\^9/L), the dosages of G-CSF, red blood cell transfusion,platelet transfusion.
次要结局
- complete remission rate(Participants will be followed for 1 year post induction chemotherapy)
- relapse-free survival(Participants will be followed for 1 year post induction chemotherapy)
- overall survival(Participants will be followed for 1 year post diagnosed)
- Adverse reactions(Participants will be closely observed for NAC-related toxicities during the NAC administration until 1-month post induction chemotherapy.)
研究者
Xiao-Jun Huang
Professor
Peking University People's Hospital