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

Last updated: October 8, 2024
Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Overall Status: Active - Recruiting

Phase

N/A

Condition

Thrombocytopenia And Thrombocytopenia Prevention

Myelodysplastic Syndromes (Mds)

Thrombosis

Treatment

Fecal microbiome

Erythropoietin

Luspatercept

Clinical Study ID

NCT05931718
CYTOPAN
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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 evaluationshowing >/= 10% dysplastic features of at least one lineage along with MDS definingcytopenia and/or MDS defining cytogenetics.

Exclusion

Exclusion Criteria:

  • any condition impeding the acquisition of the informed consent

  • immune cytopenia diagnosis preceding >/= 6 months the enrolment

Study Design

Total Participants: 200
Treatment Group(s): 7
Primary Treatment: Fecal microbiome
Phase:
Study Start date:
June 01, 2019
Estimated Completion Date:
June 30, 2035

Study Description

This observational study will characterize the diagnostic and therapeutic management of autoimmune cytopenias including autoimmune hemolytic anemia, immune thrombocytopenia, and chronic idiopathic/autoimmune neutropenia to evaluate predictors of outcome. Additionally, a subgroup of patients with myelodysplastic syndromes (diagnosed according to current WHO 5th edition 2022) will be included to evaluate the presence of autoimmune activation, and red cell metabolism.

Connect with a study center

  • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico

    Milano, 20100
    Italy

    Active - Recruiting

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