Bone Marrow Supernatant IL-6 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
- 72
- 试验地点
- 1
- 主要终点
- ORR
研究概览
简要总结
Acute myeloid leukemia (AML) is a clonal malignancy that arises from the primitive hematopoietic cells within the hematopoietic system. According to SEER cancer statistics, the 5-year survival rate for AML patients stands at a concerning 30%. Despite therapeutic advancements, the development of chemotherapy resistance and the risk of disease relapse pose significant barriers to curative outcomes. Evidence has linked elevated interleukin-6 (IL-6) levels in plasma and bone marrow to a poorer prognosis in AML, with IL-6 potentially fostering chemotherapy resistance through the enhancement of fatty acid uptake and the induction of stromal-like morphological changes in AML cells. However, the role of IL-6 as a potential biomarker for monitoring chemotherapy sensitivity in AML has not been fully elucidated. This study seeks to investigate the correlation between IL-6 levels in bone marrow supernatant and the sensitivity to chemotherapy, offering a clinical perspective that could pave the way for improved prognostic markers and personalized treatment strategies.
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 Interleukin-6 (IL-6). Our aim is to explore whether elevated IL-6 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 year
The primary endpoint of this study is the overall response rate (ORR) after Chemotherapy
次要结局
- CR(1 year)
- CRi(1 year)
- PR(1 year)
- OS(2 year)
研究者
Huifang Huang, MD
Professor
Fujian Medical University Union Hospital