Analysis of T Cell Metabolism and Immune Phenotype in Relapsed Acute Myeloid Leukemia Patients Receiving Donor Lymphocyte Infusions and Bicanorm (Sodium Bicarbonate)
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- T cell glycolytic activity
研究概览
简要总结
In this study, the outcomes of relapsed AML patients receiving DLIs and Bicanorm (Sodium bicarbonate) were analyzed including T cell metabolism and immune phenotype.
详细描述
Acute myeloid leukemia (AML) patients suffering from relapse after allogeneic hematopoietic cell transplantation (allo-HCT) have a poor survival outcome. Donor lymphocyte infusions (DLIs) to induce graft-versus-leukemia (GvL) effects have a limited survival benefit.
Extensive preclinical studies have shown a beneficial effect of sodium bicarbonate on metabolic fitness of leukemia-reactive T cells in GvL AML models. Therefore, the investigators aimed to investigate a potential benefit of Bicanorm (Sodium bicarbonate) treatment accompanying DLIs in relapsed AML patients. The investigators determined the metabolic and immune phenotype of T cells isolated from patients receiving DLIs before and after Bicanorm (Sodium bicarbonate) treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •confirmed AML relapse after allo-HCT
- •patients receiving DLIs
- •age ≥ 18 years
- •written informed consent
- •ability to understand the nature of the study and the study related procedures and to comply with them
排除标准
- •age < 18 years
- •lack of informed consent
研究组 & 干预措施
AML relapse under DLI and Bicanorm treatment
Analysis of T cell metabolism, immune phenotype and serum pH before and after Bicanorm (Sodium bicarbonate) treatment.
干预措施: Bicanorm (Drug)
结局指标
主要结局
T cell glycolytic activity
时间窗: 2 months
Extracellular acidification rate (ECAR) determined by live-cell metabolic assay using the Seahorse Analyzer
T cell respiratory activity
时间窗: 2 months
Oxygen consumption rate (OCR) determined by live-cell metabolic assay using the Seahorse Analyzer
T cell phenotype
时间窗: 2 months
T cell cytokine and effector molecule production determined by flow cytometric analysis
次要结局
- Serum pH(2 months)
研究者
Robert Zeiser
Director of the Division of Tumor Immunology
University of Freiburg