RecruitingNCT05931718

Prospective Evaluation of Diagnosis and Treatment of Patients With Autoimmune Cytopenias Including Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, and Chronic Idiopathic/Autoimmune Neutropenia

Evaluation of the Diagnostic/Therapeutic Course of Patients With Autoimmune Cytopenias (Autoimmune Hemolytic Anemia AIHA, Immune Thrombocytopenia ITP, Chronic Idiopathic/Autoimmune Neutropenia CIN/AIN) and Identification of Predictive and Prognostic Markers.


Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Enrollment

200 participants

Start Date

Jun 1, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this observational study is to characterize the diagnostic and therapeutic management of autoimmune cytopenias including autoimmune hemolytic anemia, immune thrombocytopenia, and chronic idiopathic/autoimmune neutropenia. The main aims to answer are: * evaluation of traditional and novel diagnostic tools including immunohematology, cytokine essays, bone marrow studies, molecular findings, and fecal microbiome. * evaluation of type and sequence of the therapies administered, the response rates, and the adverse events. * evaluation of clinical and laboratory (immunologic, molecular, and morphologic) predictors of outcome. * evolution of autoimmune cytopenias into myelodysplastic syndromes. * a subgroup of patients with myelodysplastic syndromes will be included to evaluate the presence of immunologic events, autoimmune activation, and red cell metabolism. Participants will receive a clinical/laboratory diagnostic workup as per current clinical practice. Furthermore They will be sampled at baseline (peripheral blood and feces for microbiome) and followed up for at least 3 years to evaluate their clinical course, therapeutic management and outcome.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Diagnosis of autoimmune cytopenias (AIHA/ITP/CIN/AIN)
  • age \>/= 18 years
  • ability to sign informed consent
  • availability to undergo 3 year follow up
  • for the subgroup of patients with myelodysplastic syndrome: bone marrow evaluation showing \>/= 10% dysplastic features of at least one lineage along with MDS defining cytopenia and/or MDS defining cytogenetics.

Exclusion Criteria2

  • any condition impeding the acquisition of the informed consent
  • immune cytopenia diagnosis preceding \>/= 6 months the enrolment

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Interventions

BIOLOGICALcytokine essays

evaluation of immunomodulatory cytokines by ELISA kits on peripheral blood samples

BIOLOGICALNGS

evaluation of somatic mutations commonly associated with myeloid neoplasm and immunodeficiencies by next generation sequencing on peripheral blood samples

BIOLOGICALFecal microbiome

evaluation of fecal microbiome on fecal samples

DRUGErythropoietin

evaluation of recombinant erythropoietin use, safety and efficacy in patients with autoimmune hemolytic anemia according to clinical practice

DRUGLuspatercept

evaluation of cytokine levels, molecular profile and bone marrow microenvironment by single cell analysis in patients treated with luspatercept according to clinical practice

DRUGThrombopoietin Receptor Agonist

evaluation of TPO-RA use, safety and efficacy in patients with ITP according to clinical practice

DRUGG-CSF

evaluation of G-CSF use, safety and efficacy in patients with CIN/AIN according to clinical practice


Locations(1)

Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

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NCT05931718


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