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NCT Number: NCT06814444

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

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.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Antonio Curti, MD

CONTACT

[email protected]

+39 0512144074

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: Once the sample is collected, through study completion, an average of 1 year

    molecular and metabolic characterisation of the bone marrow infiltrate

  2. the association between immunometabolic signatures and response to therapies

    Time frame: Once the sample is collected, through study completion, an average of 1 year

    evaluation of the immunometabolic profile pre- and post therapy and possible relapse

  3. the role of EVs as a vehicle for metabolic units capable of regulating the metabolism of immune system cells

    Time frame: Once the sample is collected, through study completion, an average of 1 year

    Characterisation of the vesicular component EV and by modulating various metabolic

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Curti, MD

CONTACT

[email protected]

+39 0512144074

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2023
Primary completion
2029
Study completion
2030
First posted
Feb 7, 2025
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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