Role of T Lymphocytes in Hypersensitivity Reactions to Asparaginase in Patients Treated for Acute Lymphoblastic Leukemia. ASTRA - Asparaginase T Cell Response Analysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Percentage of T lymphocytes producing IFN-γ in response to asparaginase stimulation, compared with background (unstimulated) levels and the maximal response induced by PMA/ionomycin within the same patient.
研究概览
简要总结
Acute lymphoblastic leukemia is a type of blood cancer that primarily affects children. Fortunately, current treatments are highly effective. One of the key drugs used is asparaginase, which works by depriving leukemic cells of a substance that is essential for their survival.
However, asparaginase can also cause adverse effects, including severe allergic reactions in some patients. These reactions may be related to specific genetic factors and/or individual differences in immune responses.
The aim of this research project is to better understand why certain patients develop poor tolerance to asparaginase. To achieve this, the investigators plan to collect blood cells from patients during treatment and then re-expose these cells to the drug in the laboratory. the investigators will assess whether specific immune cells-particularly T lymphocytes-become abnormally activated, which could help explain hypersensitivity reactions.
Ultimately, our goal is to develop a biological assay capable of predicting which patients are at increased risk of reacting adversely to asparaginase, so that they can be offered a more tailored and safer treatment strategy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Confirmed diagnosis of B- or T-lineage acute lymphoblastic leukemia (ALL) according to current morphological, immunophenotypic, and molecular criteria.
- •Treatment according to a standard therapeutic protocol including administration of asparaginase (PEG-asparaginase or native E. coli asparaginase).
- •Age ≥ 1 year.
- •Inclusion prior to the consolidation phase (sampling scheduled between induction and consolidation).
排除标准
- •Prior hematopoietic stem cell transplantation (HSCT).
- •Trisomy 21 (Down syndrome), due to distinct immunological features and potentially different tolerance to asparaginase.
- •Emergency situation or clinical context not allowing appropriate patient information and informed consent.
研究组 & 干预措施
In vitro exposure to asparaginase
Flow cytometric analysis of asparaginase-specific T-cell activation, compared with an unstimulated control condition and a non-antigen-dependent (polyclonal) stimulation condition. Comparison of asparaginase-specific T-cell activation between patients who developed a clinical reaction to asparaginase and patients who did not.
干预措施: Asparaginase-induced in vitro T-cell stimulation (Drug)
结局指标
主要结局
Percentage of T lymphocytes producing IFN-γ in response to asparaginase stimulation, compared with background (unstimulated) levels and the maximal response induced by PMA/ionomycin within the same patient.
时间窗: At inclusion (baseline) day 1
Absolute number of T lymphocytes producing IFN-? in response to asparaginase stimulation
次要结局
未报告次要终点