An observational study in Autoimmune Hemolytic Anemia, Immune Thrombocytopenia and Chronic Idiopathic Neutropenia, sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Observational
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Among 22 studies in Anemia, Hemolytic, Autoimmune with a site in Italy — 4 open to participants now, 9 under way, 5 of them phase 3. Anemia, Hemolytic, Autoimmune · Italy.
Among the 22 studies in Anemia, Hemolytic, Autoimmune with a site in Italy, this one is one of 5 that started in 2019, is one of 2 observational ones, and was the 21st registered.
103 studies on the registry are indexed under Anemia, Hemolytic, Autoimmune; 39 are open to participants now.
Browse Anemia, Hemolytic, Autoimmune studies →4 of the 22 studies in Anemia, Hemolytic, Autoimmune with a site in Italy are open now. Recruiting first, the newest first:
Sanofi · Sites in Italy, United States, Argentina and 15 more countries
Ages 18+
Gruppo Italiano Malattie EMatologiche dell'Adulto · Sites in Italy
Ages 18+
Rigel Pharmaceuticals · Sites in Italy, United States, Australia and 15 more countries
Ages 18–100
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 24 Anemia, Hemolytic, Autoimmune studies recruiting now, 12 (50%) set no upper age limit and 10 (42%) stop at 75 or younger; 5 take children under 18; none take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
22 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 9 · Phase 3 10
First in 2012; this study’s year is marked. 5 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 200 is above the median of 175 across 20 observational studies indexed under Anemia, Hemolytic, Autoimmune.
Median enrollment 25 across the 20 interventional studies, 315 across the 2 observational. Of the 12 that completed or were terminated, 8 (67%) have results posted.
This tab as a report to print or save as PDF → With an account.
19 of 22 have an industry lead sponsor. The 10 most frequent:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico is the lead sponsor of 234 studies on the registry; 78 are open to participants now.
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico has 1 study filed under Anemia, Hemolytic, Autoimmune — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 22 studies in Anemia, Hemolytic, Autoimmune with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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:
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.
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.
Patients with anemia (Hb \<12 g/dL), thrombocytopenia (PLT\<100.000/mmc) and/or neutropenia (neutrophils\<1000/mmc) attending the inpatient or outpatient facility of Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Cytopenia diagnosis will be based on current guidelines for AIHA (evidence of hemolysis and positive direct Coombs test or negative once excluded other causes), for ITP (exclusion of other thrombocytopenia causes) and for CIN/AIN (exclusion of other neutropenia causes). Patients will be classified according to the degree of the cytopenia and, for AIHA, according to thermal characteristics (warm, cold, mixed, atypical).
For the substudy of patients with MDS patients will be stratified according to WHO 2022 classification of myeloid neoplasms.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
AIHA patients will be enrolled at diagnosis and stratified according to AIHA type (i.e. warm, cold, mixed, and atypical forms), sampled for peripheral blood for cytokine and NGS studies, and for feces for microbiome studies. If clinically indicated, bone marrow evaluation will be performed and a sample for single cell analysis will be collected. Patients will be followed up to collect treatments, responses, relapses, and complications (particularly thromboses and infections).
Biological: cytokine essays · Biological: NGS · Biological: Fecal microbiome · Drug: Erythropoietin
ITP patients will be enrolled at diagnosis and sampled for peripheral blood for cytokine and NGS studies, and for feces for microbiome studies. If clinically indicated, bone marrow evaluation will be performed and a sample for single cell analysis will be collected.Patients will be followed up to collect treatments, responses, relapses, and complications (particularly thromboses and infections).
Biological: cytokine essays · Biological: NGS · Biological: Fecal microbiome · Drug: Thrombopoietin Receptor Agonist
CIN/AIN patients will be enrolled at diagnosis and sampled for peripheral blood for cytokine and NGS studies, and for feces for microbiome studies. If clinically indicated, bone marrow evaluation will be performed and a sample for single cell analysis will be collected.Patients will be followed up to collect treatments, responses, relapses, and complications (particularly infections).
Biological: cytokine essays · Biological: NGS · Biological: Fecal microbiome · Drug: G-CSF
MDS patients will be enrolled at diagnosis and sampled for peripheral blood for cytokine and NGS studies, and to evaluate red cell metabolism. If clinically indicated, bone marrow evaluation will be performed and a sample for single cell analysis will be collected. Patients will be followed up to collect treatments, responses, relapses, and outcome.
Biological: cytokine essays · Biological: NGS · Biological: Fecal microbiome · Drug: Luspatercept
evaluation of immunomodulatory cytokines by ELISA kits on peripheral blood samples
evaluation of somatic mutations commonly associated with myeloid neoplasm and immunodeficiencies by next generation sequencing on peripheral blood samples
evaluation of fecal microbiome on fecal samples
evaluation of recombinant erythropoietin use, safety and efficacy in patients with autoimmune hemolytic anemia according to clinical practice
evaluation of cytokine levels, molecular profile and bone marrow microenvironment by single cell analysis in patients treated with luspatercept according to clinical practice
evaluation of TPO-RA use, safety and efficacy in patients with ITP according to clinical practice
evaluation of G-CSF use, safety and efficacy in patients with CIN/AIN according to clinical practice
sensitivity of autoantibody testing in autoimmune cytopenias
to define the sensitivity of autoantibody testing in autoimmune cytopenias
Time frame: 2021-2026
specificity of autoantibody testing in autoimmune cytopenias
to define the specificity of autoantibody testing in autoimmune cytopenias
Time frame: 2021-2026
sensitivity of bone marrow trephine in autoimmune cytopenias
to define the sensitivity of bone marrow trephine in autoimmune cytopenias
Time frame: 2021-2026
overall response rate
to define response rates to treatment of autoimmune cytopenias and myelodysplastic syndromes
Time frame: 2021-2026
Evaluation of somatic mutations
to define somatic mutations in autoimmune cytopenias and myelodysplastic syndromes by NGS
Time frame: 2021-2026
Evaluation of pyruvate kinase activity
to define pyruvate kinase activity in myelodysplastic syndromes
Time frame: 2021-2026
Evaluation of microbiome
to define microbiome composition in autoimmune cytopenias and myelodysplastic syndromes
Time frame: 2021-2026
Single cell RNA expression
to define bone marrow composition by single cell analysis in autoimmune cytopenias and myelodysplastic syndromes
Time frame: 2021-2026
Evaluation of cytokine levels
to define cytokine levels in autoimmune cytopenias and myelodysplastic syndromes by ELISA
Time frame: 2021-2026
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2019 (actual). Primary completion is estimated for Sep 2030, 135 months after the start.
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Anemia, Hemolytic, Autoimmune →
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