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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06332196
Other study ID # L-IEI
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 18, 2023
Est. completion date October 18, 2025

Study information

Verified date March 2024
Source Meyer Children's Hospital IRCCS
Contact Eleonora Gambineri
Phone 0555662624
Email eleonora.gambineri@meyer.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Inborn Errors of Immunity (IEI) are a heterogeneous group of disorders characterised not only by an infectious diathesis, but by a wide variety of other clinical manifestations. Lymphoma is one of the most common malignancies in children and may be the first clinical manifestation of IEI, thereby 'hiding' the immune defect and delaying genetic/immunological diagnosis. Lymphomas, especially non-Hodgkin's lymphomas (NHL) are frequently associated with congenital defects of the immune system, in particular diffuse large B-cell lymphoma and Burkitt's lymphoma. Preliminary analyses conducted on 6 patients diagnosed with NHL allowed the identification of genetic variants in genes associated with IEI. In clinical practice, the diagnosis and choice of therapeutic treatment in patients with immunodeficiency-associated lymphoma are decisive and, due to the complex pathophysiology of the disease, it is not always possible to identify the boundary between benign and malignant proliferation. The identification of an undiagnosed immunodeficiency in patients with lymphoma will ensure the opportunity to apply targeted therapies, such as allogeneic haematopoietic stem cell transplantation, instead of standard clinical management based mainly on chemotherapy. The study aims to identify possible congenital defects of immunity, i.e. genetic disorders affecting the immune system, as responsible for the development of haematological malignancies. Through a multidisciplinary approach involving immunological analyses, genetic analyses and a thorough examination of clinical manifestations, we aim to characterise the immunological component underlying the development of paediatric lymphomas.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date October 18, 2025
Est. primary completion date June 18, 2025
Accepts healthy volunteers No
Gender All
Age group 1 Day to 24 Years
Eligibility Inclusion Criteria: - Patients with a clinical diagnosis of Hodgkin's lymphoma (HL) or non-Hodgkin's lymphoma (NEIL) with or without signs of immune dysregulation (lymphoproliferation, autoimmunity, hypogammaglobulinaemia, family history of immunodeficiency). - Patients with previous HL or NEIL lymphoma who have developed, concomitantly with the tumour or subsequently, clinical manifestations mentioned above attributable to a congenital defect of immunity. Exclusion Criteria: - Patients with known genetic diseases, or who do not consent to participate in the study

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Analysis of biological sample and clinical data
Analysis of biological sample and clinical data

Locations

Country Name City State
Italy AOU Malpighi IRCCS Bologna
Italy Meyer Children's Hospital IRCCS Florence
Italy AOU Pisana Pisa
Italy Ospedale Pediatrico Bambin Gesù IRCCS Roma

Sponsors (1)

Lead Sponsor Collaborator
Meyer Children's Hospital IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary To unravel inborn error of immunity behind Lymphoid neoplasm in children Characterizing the role of the immune system in the pathogenesis of polyclonal and clonal lymphoproliferation. In particular, the main aim of our study will be the identification, by means of second-generation genetic analysis and functional validation studies of the identified variants, of congenital immune system defects in patients with lymphoid neoplasia Through study completion, an average of 1 year
Secondary Identification of lymphoma-specific biomarkers Investigating Cell-Free DNA for specific molecular alterations in lymphomas, in order to monitor the follow-up of patients affected by lymphoma and to identify early onset of clonality in patients with already diagnosed congenital defects of the immune system at risk of developing malignant lymphoproliferation. Through study completion, an average of 1 year
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