An observational study in Acute Leukemia, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
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:
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:
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 170 is above the median of 120 across 744 observational studies indexed under Leukemia.
Browse Leukemia studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 493 studies on the registry; 273 are open to participants now.
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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.
PATIENT
Healthy donors (AIL BOLOGNA ODV volunteers)
Exclusion Criteria:
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
molecular and metabolic characterisation of the bone marrow infiltrate
Time frame: Once the sample is collected, through study completion, an average of 1 year
the association between immunometabolic signatures and response to therapies
evaluation of the immunometabolic profile pre- and post therapy and possible relapse
Time frame: 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
Characterisation of the vesicular component EV and by modulating various metabolic
Time frame: Once the sample is collected, through study completion, an average of 1 year
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IRCCS Azienda Ospedaliero-Universitaria di Bologna