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

RecruitingOBSERVATIONAL
Enrollment

200

Participants

Timeline

Start Date

June 1, 2019

Primary Completion Date

September 30, 2030

Study Completion Date

June 30, 2035

Conditions
Autoimmune Hemolytic AnemiaImmune ThrombocytopeniaChronic Idiopathic NeutropeniaAutoimmune NeutropeniaMyelodysplastic SyndromesCold Agglutinin Disease
Interventions
BIOLOGICAL

cytokine essays

evaluation of immunomodulatory cytokines by ELISA kits on peripheral blood samples

BIOLOGICAL

NGS

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

BIOLOGICAL

Fecal microbiome

evaluation of fecal microbiome on fecal samples

DRUG

Erythropoietin

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

DRUG

Luspatercept

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

DRUG

Thrombopoietin Receptor Agonist

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

DRUG

G-CSF

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

Trial Locations (1)

20100

RECRUITING

Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico, Milan

All Listed Sponsors
lead

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER