Study of the Immunological Infiltrate and Immunometabolic Immunometabolic Profile of Patients with Acute Leukaemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- the association between the molecular and metabolic characteristics of leukaemic cells and those of the surrounding immune system, in order to identify immuno-modulatory metabolic mechanisms implemented by malignant cells
研究概览
简要总结
LThe main aim of this project is to provide an immunophenotypic and immunometabolic characterisation of patients with Acute Leukaemia, before and after therapy, and to understand how changes in the immune system impact the response to therapy.
Specifically:
- The association between the molecular and metabolic characteristics of leukaemic cells and those of the surrounding immune system will be assessed, in order to identify immune-modulatory metabolic mechanisms activated by malignant cells.
- The association between immunometabolic signatures and response to therapies will be assessed.
- The role of EVs as a vehicle for metabolic units capable of regulating the metabolism of immune system cells will be explored.
详细描述
Multicentre biological study, aimed at collecting and characterising human tissue isolated from acute leukaemia patients. In the context of routine care visits, peripheral blood (PB) and bone marrow (BM) samples will be taken from these patients at different time-points, which will be compared with samples obtained from healthy control subjects.Patients belonging to the haematology OU of the IRCCS AOU of Bologna and to the haematology OUs of the participating centres, suffering from acute leukaemia, will be enrolled. They must be eligible for a treatment scheme that includes either conventional chemotherapy or innovative therapies, such as monoclonal antibodies, molecular therapies with specific targets, metabolic and immunological therapies, as part of the normal care pathway. It is also planned to enrol healthy donors whose samples will be provided by:
- IRCCS AOU of Bologna Immunohaematology and Transfusion Medicine Service (buffy coat)
- Italian Association against Leukaemia, Lymphoma and Myeloma in Bologna (AIL BOLOGNA ODV), within the Haematology Unit of the IRCCS AOU of Bologna (peripheral blood).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of Acute Leukaemia.
- •Eligibility for a treatment scheme involving either conventional chemotherapy or innovative therapies, such as monoclonal antibodies, molecular therapies with specific targets, metabolic and immunological therapies.
- •age ≥ 18 years.
- •Signature of informed consent by patients at the time of diagnosis.
- •Healthy donors (AIL BOLOGNA ODV volunteers)
- •age ≥ 18 years.
- •Signature of informed consent.
排除标准
- 未提供
结局指标
主要结局
the association between the molecular and metabolic characteristics of leukaemic cells and those of the surrounding immune system, in order to identify immuno-modulatory metabolic mechanisms implemented by malignant cells
时间窗: Once the sample is collected, through study completion, an average of 1 year
molecular and metabolic characterisation of the bone marrow infiltrate
the association between immunometabolic signatures and response to therapies
时间窗: Once the sample is collected, through study completion, an average of 1 year
evaluation of the immunometabolic profile pre- and post therapy and possible relapse
the role of EVs as a vehicle for metabolic units capable of regulating the metabolism of immune system cells
时间窗: Once the sample is collected, through study completion, an average of 1 year
Characterisation of the vesicular component EV and by modulating various metabolic
次要结局
未报告次要终点