Autoimmune Hemolytic AnemiaAIHA ITP CINNCT05931718
Prospective Evaluation of Diagnosis and Treatment of Patients With Autoimmune Cytopenias Including Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, and Chronic Idiopathic/Autoimmune Neutropenia
An observational study of Autoimmune Hemolytic Anemia and Immune Thrombocytopenia, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, Chronic Idiopathic Neutropenia
- What is being tested?
- cytokine essays, NGS and Fecal microbiome
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2019to Jun 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- any condition impeding the acquisition of the informed consent
- immune cytopenia diagnosis preceding >/= 6 months the enrolment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
Milan, 20100
Bruno Fattizzo, MD, +390255033477, brunofattizzo@gmail.com
About this study
Official title: 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.
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:
Read more
- 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.
Read the detailed 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.
- Conditions
- Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, Chronic Idiopathic Neutropenia, Autoimmune Neutropenia, Myelodysplastic Syndromes, Cold Agglutinin Disease
- Being tested
- cytokine essays, NGS, Fecal microbiome, Erythropoietin, Luspatercept
- Keywords
- autoimmune hemolytic anemia, immune thrombocytopenia, chronic idiopathic neutropenia, autoimmune neutropenia, cold agglutinin disease, myelodysplastic syndromes, rituximab, thrombopoietin receptor agonists, erythropoietin, steroids, splenectomy, red cell metabolism, cytokines, luspatercept, microbiome, single cell analysis, next generation sequencing
- Medical subject headings
- Anemia, Hemolytic, Autoimmune, Purpura, Thrombocytopenic, Idiopathic, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytokine essaysBiological
evaluation of immunomodulatory cytokines by ELISA kits on peripheral blood samples
NGSBiological
evaluation of somatic mutations commonly associated with myeloid neoplasm and immunodeficiencies by next generation sequencing on peripheral blood samples
Fecal microbiomeBiological
evaluation of fecal microbiome on fecal samples
ErythropoietinDrug
evaluation of recombinant erythropoietin use, safety and efficacy in patients with autoimmune hemolytic anemia according to clinical practice
LuspaterceptDrug
evaluation of cytokine levels, molecular profile and bone marrow microenvironment by single cell analysis in patients treated with luspatercept according to clinical practice
Thrombopoietin Receptor AgonistDrug
evaluation of TPO-RA use, safety and efficacy in patients with ITP according to clinical practice
G-CSFDrug
evaluation of G-CSF use, safety and efficacy in patients with CIN/AIN according to clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Autoimmune hemolytic anemia | 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). Receives: Biological: cytokine essays; Biological: NGS; Biological: Fecal microbiome; Drug: Erythropoietin | |
| Immune thrombocytopenia | 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). Receives: Biological: cytokine essays; Biological: NGS; Biological: Fecal microbiome; Drug: Thrombopoietin Receptor Agonist | |
| Chronic idiopathic neutropenia/Autoimmune neutropenia | 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). Receives: Biological: cytokine essays; Biological: NGS; Biological: Fecal microbiome; Drug: G-CSF | |
| Myelodysplastic syndromes | 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. Receives: Biological: cytokine essays; Biological: NGS; Biological: Fecal microbiome; Drug: Luspatercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensitivity of autoantibody testing in autoimmune cytopenias
to define the sensitivity of autoantibody testing in autoimmune cytopenias
Measured: 2021-2026
specificity of autoantibody testing in autoimmune cytopenias
to define the specificity of autoantibody testing in autoimmune cytopenias
Measured: 2021-2026
sensitivity of bone marrow trephine in autoimmune cytopenias
to define the sensitivity of bone marrow trephine in autoimmune cytopenias
Measured: 2021-2026
Secondary outcomes (6)
overall response rate
to define response rates to treatment of autoimmune cytopenias and myelodysplastic syndromes
Measured: 2021-2026
Evaluation of somatic mutations
to define somatic mutations in autoimmune cytopenias and myelodysplastic syndromes by NGS
Measured: 2021-2026
Evaluation of pyruvate kinase activity
to define pyruvate kinase activity in myelodysplastic syndromes
Measured: 2021-2026
Evaluation of microbiome
to define microbiome composition in autoimmune cytopenias and myelodysplastic syndromes
Measured: 2021-2026
Single cell RNA expression
to define bone marrow composition by single cell analysis in autoimmune cytopenias and myelodysplastic syndromes
Measured: 2021-2026
Evaluation of cytokine levels
to define cytokine levels in autoimmune cytopenias and myelodysplastic syndromes by ELISA
Measured: 2021-2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 Jun 2019
- Primary completionSep 2030 (estimated)
- Study completionJun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autoimmune Hemolytic AnemiaStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931718
- Sponsor's protocol ID
- CYTOPAN
- Acronym
- AIHA ITP CIN
- Status last verified
- Oct 2024
- First submitted
- 29 May 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fattizzo B, Pedone GL, Brambilla C, Pettine L, Zaninoni A, Passamonti F, Barcellini W. Recombinant erythropoietin in autoimmune hemolytic anemia with inadequate bone marrow response: a prospective analysis. Blood Adv. 2024 Mar 12;8(5):1322-1327. doi: 10.1182/bloodadvances.2023011798.
PubMed 38029356Versino F, Revelli N, Villa S, Pettine L, Zaninoni A, Prati D, Passamonti F, Barcellini W, Fattizzo B. Transfusions in autoimmune hemolytic anemias: Frequency and clinical significance of alloimmunization. J Intern Med. 2024 Mar;295(3):369-374. doi: 10.1111/joim.13753. Epub 2023 Nov 27.
PubMed 38013593
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05931718
- Acronym / sponsor ID
- AIHA ITP CIN / CYTOPAN
- Conditions
- Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, Chronic Idiopathic Neutropenia, Autoimmune Neutropenia, Myelodysplastic Syndromes, Cold Agglutinin Disease
- Keywords
- autoimmune hemolytic anemia, immune thrombocytopenia, chronic idiopathic neutropenia, autoimmune neutropenia, cold agglutinin disease, myelodysplastic syndromes, rituximab, thrombopoietin receptor agonists
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Jun 2035 (estimated)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Autoimmune hemolytic anemia | – | Biological: cytokine essays, Biological: NGS, Biological: Fecal microbiome, Drug: ErythropoietinAIHA 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). |
| Immune thrombocytopenia | – | Biological: cytokine essays, Biological: NGS, Biological: Fecal microbiome, Drug: Thrombopoietin Receptor AgonistITP 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). |
| Chronic idiopathic neutropenia/Autoimmune neutropenia | – | Biological: cytokine essays, Biological: NGS, Biological: Fecal microbiome, Drug: G-CSFCIN/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). |
| Myelodysplastic syndromes | – | Biological: cytokine essays, Biological: NGS, Biological: Fecal microbiome, Drug: LuspaterceptMDS 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- any condition impeding the acquisition of the informed consent
- immune cytopenia diagnosis preceding >/= 6 months the enrolment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cytokine essaysevaluation of immunomodulatory cytokines by ELISA kits on peripheral blood samples | Biological | Autoimmune hemolytic anemia, Chronic idiopathic neutropenia/Autoimmune neutropenia, Immune thrombocytopenia, Myelodysplastic syndromes |
| NGSevaluation of somatic mutations commonly associated with myeloid neoplasm and immunodeficiencies by next generation sequencing on peripheral blood samples | Biological | Autoimmune hemolytic anemia, Chronic idiopathic neutropenia/Autoimmune neutropenia, Immune thrombocytopenia, Myelodysplastic syndromes |
| Fecal microbiomeevaluation of fecal microbiome on fecal samples | Biological | Autoimmune hemolytic anemia, Chronic idiopathic neutropenia/Autoimmune neutropenia, Immune thrombocytopenia, Myelodysplastic syndromes |
| Erythropoietinevaluation of recombinant erythropoietin use, safety and efficacy in patients with autoimmune hemolytic anemia according to clinical practice | Drug | Autoimmune hemolytic anemia |
| Luspaterceptevaluation of cytokine levels, molecular profile and bone marrow microenvironment by single cell analysis in patients treated with luspatercept according to clinical practice | Drug | Myelodysplastic syndromes |
| Thrombopoietin Receptor Agonistevaluation of TPO-RA use, safety and efficacy in patients with ITP according to clinical practice | Drug | Immune thrombocytopenia |
| G-CSFevaluation of G-CSF use, safety and efficacy in patients with CIN/AIN according to clinical practice | Drug | Chronic idiopathic neutropenia/Autoimmune neutropenia |
Primary outcome
sensitivity of autoantibody testing in autoimmune cytopenias
Time frame: 2021-2026
to define the sensitivity of autoantibody testing in autoimmune cytopenias
specificity of autoantibody testing in autoimmune cytopenias
Time frame: 2021-2026
to define the specificity of autoantibody testing in autoimmune cytopenias
sensitivity of bone marrow trephine in autoimmune cytopenias
Time frame: 2021-2026
to define the sensitivity of bone marrow trephine in autoimmune cytopenias
6 secondary outcomes
overall response rate
Time frame: 2021-2026
Evaluation of somatic mutations
Time frame: 2021-2026
Evaluation of pyruvate kinase activity
Time frame: 2021-2026
Evaluation of microbiome
Time frame: 2021-2026
Single cell RNA expression
Time frame: 2021-2026
Evaluation of cytokine levels
Time frame: 2021-2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Derived from this study: PubMed 38029356Fattizzo B, Pedone GL, Brambilla C, Pettine L, Zaninoni A, Passamonti F, Barcellini W. Recombinant erythropoietin in autoimmune hemolytic anemia with inadequate bone marrow response: a prospective analysis. Blood Adv. 2024 Mar 12;8(5):1322-1327. doi: 10.1182/bloodadvances.2023011798.
- Derived from this study: PubMed 38013593Versino F, Revelli N, Villa S, Pettine L, Zaninoni A, Prati D, Passamonti F, Barcellini W, Fattizzo B. Transfusions in autoimmune hemolytic anemias: Frequency and clinical significance of alloimmunization. J Intern Med. 2024 Mar;295(3):369-374. doi: 10.1111/joim.13753. Epub 2023 Nov 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Hemolytic Anemia and Immune Thrombocytopenia, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensitivity of autoantibody testing in autoimmune cytopenias (time frame: 2021-2026). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05931718, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024; AzTrials last refreshed its copy on 8 Nov 2026.