Clinical trial NCT06814444: Study of the Immunological Infiltrate and Immunometabolic Immunometabolic Profile of Patients with Acute Leukaemia
Official title: Study of the Immunological Infiltrate and Immunometabolic Immunometabolic Profile of Patients with Acute Leukaemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Leukemia
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients belonging to the UOC of Haematology of the IRCCS AOU of Bologna and to the OUs of Haematology OUs of the participating centres, suffering from Acute Leukaemia who, as part of the normal care pathway and completely independently from participation in the study, shall be eligible for a treatment scheme involving either conventional chemotherapy or innovative therapies, such as monoclonal antibodies, molecular therapies with specific targets, therapies metabolic and immunological therapies.

Brief summary: 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:

1. 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.
2. The association between immunometabolic signatures and response to therapies will be assessed.
3. The role of EVs as a vehicle for metabolic units capable of regulating the metabolism of immune system cells will be explored.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

PATIENT

* 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.

Exclusion Criteria:

* no one

Primary outcomes:
measure: 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
timeFrame: Once the sample is collected, through study completion, an average of 1 year
measure: the association between immunometabolic signatures and response to therapies
timeFrame: Once the sample is collected, through study completion, an average of 1 year
measure: the role of EVs as a vehicle for metabolic units capable of regulating the metabolism of immune system cells
timeFrame: Once the sample is collected, through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Antonio Curti, MD
role: PRINCIPAL_INVESTIGATOR
References: