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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

About this trial

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

Qualifiers

Diagnosis of autoimmune cytopenias (AIHA/ITP/CIN/AIN)

age >/= 18 years

ability to sign informed consent

availability to undergo 3 year follow up

Disqualifiers

any condition impeding the acquisition of the informed consent

immune cytopenia diagnosis preceding >/= 6 months the enrolment

Trial design

Treatments tested in this trial

  • cytokine essays
  • NGS
  • Fecal microbiome
  • Erythropoietin
  • Luspatercept
  • Thrombopoietin Receptor Agonist
  • G-CSF

Treatment groups

200 Participants
are divided into 4 treatment groups