Study of the Immunological Infiltrate and Immunometabolic Immunometabolic Profile of Patients with Acute Leukaemia

NCT ID: NCT06814444

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 170 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-11
• Study Completion Date: 2030-12-11

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).

Conditions

Acute Leukemia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Curti, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Locations

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Antonio Curti, MD

Role: CONTACT

antonio.curti2@unibo.it

+39 0512144074

Facility Contacts

Antonio Curti, MD

Role: primary

antonio.curti2@unibo.it

+39 0512144074

Other Identifiers

IMMET-2021

Identifier Type: -

Identifier Source: org_study_id