Bone Marrow Supernatant Leptin as A Predictor of Chemotherapy Sensitivity in AML Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
Acute Myeloid Leukemia (AML) is a malignant clonal disorder of hematopoietic stem/progenitor cells, with a five-year survival rate of approximately 30%. Chemotherapy resistance and relapse remain major challenges. Increased bone marrow adipocytes contribute to AML cell drug resistance.This study found that elevated levels of the adipokine leptin enhance oxidative phosphorylation (OXPHOS) in AML cells, accompanied by increased mitochondrial reactive oxygen species (mtROS), which stimulates antioxidant capacity and thereby induces chemotherapy resistance. By establishing a correlation between leptin levels in bone marrow supernatant and clinical outcomes in AML patients, this research provides novel strategic insights for targeting drug resistance and improving prognostic evaluation.
详细描述
In this prospective study, we will collect bone marrow supernatant samples from patients diagnosed with Acute Myeloid Leukemia (AML) to evaluate the levels of leptin. Our aim is to explore whether elevated leptin levels can serve as a predictive biomarker for poor treatment outcomes following standard chemotherapy regimens. The findings may help in stratifying patient risk and personalizing therapeutic approaches in AML treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis aligns with the "Chinese guidelines for diagnosis and treatment of adult acute myeloid leukemia (not APL) (2023)";
- •All patients are experiencing their first onset of the disease and have not received any related chemotherapy prior to the study;
- •Patients participate in the study accompanied by family members and sign informed consent documents.
排除标准
- •Patients with concurrent malignancies requiring treatment;
- •Presence of infectious diseases, including SARS, viral hepatitis, or HIV/ AIDS;
- •Major surgery performed within the last 21 days;
- •Performance Status (PS) score >3;
- •Severe liver or kidney dysfunction or serious infection;
- •Severe psychiatric conditions that impair understanding of the study protocol or voluntary withdrawal.
结局指标
主要结局
ORR
时间窗: 1 month
The primary endpoint of this study is the overall response rate (ORR) after Chemotherapy
次要结局
- CR(1 month)
- CRi(1 month)
- PR(1 month)