Exploring Disease Immunogenicity and the Immunological Effects of Hypomethylating Agents in Acute Myeloid Leukemia
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 14
- 主要终点
- Evaluation of the Immunogenic profile of primary or secondary AML patients in according to the variations in expression of molecules involved in immune checkpoint
研究概览
简要总结
This is a multicenter, prospective, translational study, to evaluate the immunogenic profile of AML cases according to immune checkpoint molecule expression.
详细描述
This is a multicenter, prospective, translational study. Pharmacological treatments will not be object of the present study. Patients will follow the prescribed therapeutic indications according to regular clinical practice. Biological samples and clinical data will be collected at fixed timepoints.
Aim of the study is to evaluate the immunogenic profile of AML cases according to immune checkpoint molecule expression.
A total of 75 AML patients affected by primary or secondary AML, at diagnosis ( 45 patients) or relapse (30 patients) will be enrolled in the protocol (18 months for patient enrolment). Blood,BM and saliva samples will be collected from each patients; for patients enrolled at diagnosis, samples will be collected before and after treatment with hypomethylating agents.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 with new diagnosis of primary or secondary AML candidate to first line treatment with hypomethylating agents (specific for Cohort 1) Patients with primary or secondary AML who relapse after/during first line treatment with hypomethylating agents (specific for Cohort 2)
- •for each cohort:
- •Participant is willing and able to give informed consent for participation in the study
- •Male or Female, aged >18 years
- •Availability of clinical data
排除标准
- •Age < 18 years
- •AML M3 subtype according to FAB classification
结局指标
主要结局
Evaluation of the Immunogenic profile of primary or secondary AML patients in according to the variations in expression of molecules involved in immune checkpoint
时间窗: up to 30 months
The immunogenic profile of AML cases obtained by NeoAgprediction will be related with established biological and clinical parameters (including karyotype, percentage of blasts, clinical outcome) performing RNA sequencing (RNAseq) and whole exome sequencing (WES) analysis
次要结局
- Investigation of the relationship between leukemia immunogenicity and immune checkpoint activation(up to 30 months)
- The investigation of the association of the immune checkpoint status with clinical outcomes(up to 30 months)
- Investigation of the activation of immune checkpoint molecules(up to 30 months)
- The investigation of the association of the immunogenic profile with clinical outcomes(up to 30 months)