A Study of the Metabolic Changes in Leukemia Cells Following Treatment in AML Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Number of mononuclear cells per sample determined by cell isolation
研究概览
简要总结
This research trial studies metabolic changes in blood samples from patients with acute myeloid leukemia. Studying samples of blood from patients with acute myeloid leukemia in the laboratory may help doctors learn more about cancer and the development of drug resistance.
详细描述
PRIMARY OBJECTIVES:
I. To determine the metabolic adaptations that occur following exposure to standard chemotherapeutic agents using peripheral blood mononuclear cells from acute myeloid leukemia (AML) patients.
OUTLINE:
Patients undergo collection of peripheral blood mononuclear cell (PBMC) samples for analysis via cell isolation, glycolytic flux and oxygen consumption assays, viability assays, and western blot at baseline, 24, 48, and 72 hours after starting chemotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Patients scheduled to initiate chemotherapy for either an initial diagnosis of AML or relapsed AML
- •Starting the initial induction phase of therapy
- •Exposure to hydroxyurea is acceptable but must be noted at the time of sample collection
- •Ability to understand and the willingness to sign an institutional review board (IRB)-approved informed consent
排除标准
- •Received at least one dose of chemotherapy during the current cycle (excluding hydroxyurea).
结局指标
主要结局
Number of mononuclear cells per sample determined by cell isolation
时间窗: Up to 72 hours after starting chemotherapy
Results will be analyzed using descriptive statistics. Comparison between groups will be done using t-tests or analysis of variance (ANOVA) procedures. Other inferential statistical analysis will be conducted as appropriate.
Level of pyruvate kinase M2 for phospho-T105 by western blot
时间窗: Up to 72 hours after starting chemotherapy
Results will be analyzed using descriptive statistics. Comparison between groups will be done using t-tests or ANOVA procedures. Other inferential statistical analysis will be conducted as appropriate.
Level of phosphofructokinase-2 by western blot
时间窗: Up to 72 hours after starting chemotherapy
Results will be analyzed using descriptive statistics. Comparison between groups will be done using t-tests or ANOVA procedures. Other inferential statistical analysis will be conducted as appropriate.
Level of fatty acid synthase by western blot
时间窗: Up to 72 hours after starting chemotherapy
Results will be analyzed using descriptive statistics. Comparison between groups will be done using t-tests or ANOVA procedures. Other inferential statistical analysis will be conducted as appropriate.
Oxygen consumption rate
时间窗: Up to 72 hours after starting chemotherapy
Results will be analyzed using descriptive statistics. Comparison between groups will be done using t-tests or ANOVA procedures. Other inferential statistical analysis will be conducted as appropriate.
Glycolytic flux rate
时间窗: Up to 72 hours after starting chemotherapy
Results will be analyzed using descriptive statistics. Comparison between groups will be done using t-tests or ANOVA procedures. Other inferential statistical analysis will be conducted as appropriate.
Number of viable samples
时间窗: Up to 72 hours after starting chemotherapy
Results will be analyzed using descriptive statistics. Comparison between groups will be done using t-tests or ANOVA procedures. Other inferential statistical analysis will be conducted as appropriate.
Level of phosphofructokinase-1 by western blot
时间窗: Up to 72 hours after starting chemotherapy
Results will be analyzed using descriptive statistics. Comparison between groups will be done using t-tests or ANOVA procedures. Other inferential statistical analysis will be conducted as appropriate.
Total level of pyruvate kinase M2 by western blot
时间窗: Up to 72 hours after starting chemotherapy
Results will be analyzed using descriptive statistics. Comparison between groups will be done using t-tests or ANOVA procedures. Other inferential statistical analysis will be conducted as appropriate.
Level of hexokinase by western blot
时间窗: Up to 72 hours after starting chemotherapy
Results will be analyzed using descriptive statistics. Comparison between groups will be done using t-tests or ANOVA procedures. Other inferential statistical analysis will be conducted as appropriate.
Level of phosphoglycerate mutase by western blot
时间窗: Up to 72 hours after starting chemotherapy
Results will be analyzed using descriptive statistics. Comparison between groups will be done using t-tests or ANOVA procedures. Other inferential statistical analysis will be conducted as appropriate.
次要结局
未报告次要终点