Myeloproliferative DiseaseNCT07204366
Autoantibodies Against Type I Interferon in Patients Affected With Ph-negative Myeloproliferative Neoplasms (MPN-IFN Study)
An observational study of Myeloproliferative Disease and COVID - 19, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
The classic Ph-negative myeloproliferative neoplasms (MPN) are a group of clonal hematopoietic disorders caused by a dysregulated JAK/STAT signal transduction because of acquired somatic mutations of JAK2, CALR or MPL genes. Chronic inflammation may predispose to MPN development. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Disease, COVID - 19
- How many people
- 219 participants
- Where
- 1 siteItaly
- Study dates
- 6 May 2022to 31 Dec 2030
- 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: A cohort of patients with myeloproliferative neoplasms
Who may be able to join
- A diagnosis of PV, ET, prePMF, overt PMF or MPN-U according to 2016 WHO criteria
- Characterization of the MPN driver mutation performed at any moment before enrolment
- A peripheral blood (PB) sample collected at the enrolment visit suitable for plasma extraction and functional evaluation of anti-cytokine auto-Abs
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The classic Ph-negative myeloproliferative neoplasms (MPN) are a group of clonal hematopoietic disorders caused by a dysregulated JAK/STAT signal transduction because of acquired somatic mutations of JAK2, CALR or MPL genes. Chronic inflammation may predispose to MPN development.
SARS-CoV-2 infection displays extreme interindividual clinical variability, ranging from asymptomatic infection to life-threatening coronavirus disease (COVID-19). Age is a major risk factor for severe disease. Male sex and medical comorbidities have minor impact. It was demonstrated that at least 3.5% of patients with life-threatening COVID-19 have monogenic inborn errors of TLR3- or TLR7-dependent type I interferons (IFN-I) immunity. It has also been described that at least 15% of patients with life-threatening COVID-19 have neutralizing autoantibodies (AAbs) against IFN-I, that precede SARS-CoV-2 infection.
Read more
As regard MPN, COVID-19 is associated with a mortality as high as 33%. Patients with MF had the highest mortality (48%), while patients with ET had the greatest risk of venous thromboembolism (16.7%).
In this prospective study, we want to search for AAbs against IFN-I in a cohort of MPN patients to evaluate their prevalence in the MPN population and to look for clinical correlations, including COVID-19 severity.
- Conditions
- Myeloproliferative Disease, COVID - 19
- Medical subject headings
- Myeloproliferative Disorders, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate for the prevalence of AAbs neutralizing IFN-I in a cohort of Ph-neg MPN patients.
Measured: 2 years
Secondary outcomes (4)
To compare the prevalence of AAbs neutralizing IFN-I in a cohort of Ph-neg MPN patients to that estimated in the general population.
Measured: 2 years
To check for association between the presence/subtype/title of AAbs to IFN-I and both clinical and molecular features of MPN patients
Measured: 2 years
To check for association between use of specific cytoreductive therapy and the presence of AAbs to IFN-I in MPN patients
Measured: 2 years
To check for association between presence/subtype/title of AAbs to IFN-I and COVID-19 severity among MPN patients who get SARS-CoV-2 infection
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start6 May 2022
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisa Rumi, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07204366
- Sponsor's protocol ID
- MPN_IFN
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autoantibodies Against Type I Interferon in Patients Affected With Ph-negative Myeloproliferative Neoplasms (MPN-IFN Study)
- ClinicalTrials.gov ID
- NCT07204366
- Acronym / sponsor ID
- MPN_IFN
- Conditions
- Myeloproliferative Disease, COVID - 19
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 6 May 2022 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 2 Oct 2025 (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 classic Ph-negative myeloproliferative neoplasms (MPN) are a group of clonal hematopoietic disorders caused by a dysregulated JAK/STAT signal transduction because of acquired somatic mutations of JAK2, CALR or MPL genes. Chronic inflammation may predispose to MPN development.
SARS-CoV-2 infection displays extreme interindividual clinical variability, ranging from asymptomatic infection to life-threatening coronavirus disease (COVID-19). Age is a major risk factor for severe disease. Male sex and medical comorbidities have minor impact. It was demonstrated that at least 3.5% of patients with life-threatening COVID-19 have monogenic inborn errors of TLR3- or TLR7-dependent type I interferons (IFN-I) immunity. It has also been described that at least 15% of patients with life-threatening COVID-19 have neutralizing autoantibodies (AAbs) against IFN-I, that precede SARS-CoV-2 infection.
As regard MPN, COVID-19 is associated with a mortality as high as 33%. Patients with MF had the highest mortality (48%), while patients with ET had the greatest risk of venous thromboembolism (16.7%).
In this prospective study, we want to search for AAbs against IFN-I in a cohort of MPN patients to evaluate their prevalence in the MPN population and to look for clinical correlations, including COVID-19 severity.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of patients with myeloproliferative neoplasms
Key inclusion criteria (3 listed)
- A diagnosis of PV, ET, prePMF, overt PMF or MPN-U according to 2016 WHO criteria
- Characterization of the MPN driver mutation performed at any moment before enrolment
- A peripheral blood (PB) sample collected at the enrolment visit suitable for plasma extraction and functional evaluation of anti-cytokine auto-Abs
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate for the prevalence of AAbs neutralizing IFN-I in a cohort of Ph-neg MPN patients.
Time frame: 2 years
4 secondary outcomes
To compare the prevalence of AAbs neutralizing IFN-I in a cohort of Ph-neg MPN patients to that estimated in the general population.
Time frame: 2 years
To check for association between the presence/subtype/title of AAbs to IFN-I and both clinical and molecular features of MPN patients
Time frame: 2 years
To check for association between use of specific cytoreductive therapy and the presence of AAbs to IFN-I in MPN patients
Time frame: 2 years
To check for association between presence/subtype/title of AAbs to IFN-I and COVID-19 severity among MPN patients who get SARS-CoV-2 infection
Time frame: 2 years
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 2 Oct 2025.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Myeloproliferative Disease and COVID - 19, run by Fondazione IRCCS Policlinico San Matteo di Pavia 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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate for the prevalence of AAbs neutralizing IFN-I in a cohort of Ph-neg MPN patients. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Oct 2025.