The Effect of Chemotherapy on Regulatory T Cells in Children With Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 主要终点
- Change from baseline in number of regulatory T-cells at 15 and 33th day during chemotherapy
研究概览
简要总结
The investigators aimed to study the effect of chemotherapy on regulatory T cells (Tregs) in children with precursor B (PreB) acute lymphoblastic leukemia (ALL) at 15 and 33 days of malignity directed therapy. The investigators will analyze peripheral and bone marrow blood samples of the participants, obtained at diagnosis, 15 and 33 days of treatment, about Treg / non Treg cells and interleukin (IL)-2, IL-6, IL-10, and transforming growth factor (TGF) beta levels. By this means, investigators will search response to chemotherapy. Also, investigators will analyze correlation between Treg population-Treg related cytokines with demographic, clinical and laboratory findings of the participants with ALL at these certain time points. Additionally, the investigators will compare Treg population and minimal residual disease at 15-33 days of malignity directed therapy. Also investigators will compare these Treg-Treg related cytokines obtained from the participants with ALL and a healthy children control group whom are voluntary donors for bone marrow transplantation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children between 1-18 years
- •Recent PreB ALL diagnosis
排除标准
- •Children under 1 or over 18 years
- •Underlying disease e.g. immune deficiency, germline mutations or diseases
- •Tcell ALL or acute myeloid leukemia (AML) patients
结局指标
主要结局
Change from baseline in number of regulatory T-cells at 15 and 33th day during chemotherapy
时间窗: Baseline, 15 and 33th day
The number of regulatory T-cells is measured in fresh peripheral and bone marrow blood by flow cytometry.
次要结局
- Change from baseline IL-2, IL-6, IL-10, and TGF-beta levels at 15 and 33th day during chemotherapy(Baseline, 15 and 33th day)
研究者
Tekin Aksu
Principal Investigator
Ankara Children's Health and Diseases Hematology and Oncology Training and Research Hospital