Autoimmune Cytopenias as a Sign of Primary Immunodeficiency.

Status unconfirmed · Not applicable

Conditions studied: Cytopenia

In brief

Autoimmune cytopenias resistant to treatment are among the most common clinical manifestations observed in patients with congenital alterations of the immune system, such as primary immunodeficiencies (PI). The exact contribution of immune system alterations to the pathogenesis of autoimmune cytopenias has not yet been fully elucidated. Moreover, conventionally employed therapeutic strategies often fail, leading to increased healthcare costs, high morbidity, and even mortality. Therefore, there is a need to establish clinical guidelines for diagnosis and to identify early biomarkers capable of identifying individuals responsive to therapy. Thus, a systematic approach to the study of such pathologies will allow for the identification of early biomarkers and facilitate the development of targeted therapeutic strategies

Key facts

Study ID

NCT06276036

Run by

Meyer Children's Hospital IRCCS

People needed

53

Starts

2019-07-23

Expected to finish

2025-06-01

Last updated by the study team

2024-03-29

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical and hematological diagnosis of autoimmune cytopenia
• Additional inclusion criteria for classification into responder vs. non-responder:
• For immune thrombocytopenic purpura: platelet count increase >30,000 with at least a twofold increase from pre-treatment value
• For autoimmune hemolytic anemia: Hb ≥10 g/dL with an increase of at least 2 g/dL compared to baseline

You may not qualify if…

• Transient cytopenia without confirmation of autoimmunity where frontline treatment is not necessary

Where it is running

• University of South Florida — Tampa, Florida, United States
• Ghent University Hospital — Ghent, Belgium
• Clinica Pediatrica - Università di Catania — Catania, Italy
• Meyer Children's Hospital IRCCS — Florence, Italy
• IRCCS Istituto Giannina Gaslini — Genova, Italy
• Azienda Ospedaliero Universitaria Pisana — Pisa, Italy

Full record on ClinicalTrials.gov

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