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Study of the Immunological Infiltrate and Immunometabolic Immunometabolic Profile of Patients with Acute Leukaemia
NCT06814444 · IRCCS Azienda Ospedaliero-Universitaria di Bologna
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
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
Study design
Enrollment target: 170 participants
Age groups: adult, older_adult
Timeline
Starts: 2023-11-11
Estimated completion: 2030-12-11
Last updated: 2025-02-07
Primary outcomes
- • 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 (Once the sample is collected, through study completion, an average of 1 year)
- • the association between immunometabolic signatures and response to therapies (Once the sample is collected, through study completion, an average of 1 year)
- • the role of EVs as a vehicle for metabolic units capable of regulating the metabolism of immune system cells (Once the sample is collected, through study completion, an average of 1 year)
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna · other
Contacts & investigators
ContactAntonio Curti, MD · contact · antonio.curti2@unibo.it · +39 0512144074
InvestigatorAntonio Curti, MD · principal_investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
All locations (1)
IRCCS Azienda Ospedaliero-Universitaria di BolognaRecruiting
Bologna, Bologna, Italy