About this trial
Multicenter retrospective and prospective European observational study. At each site, all consecutive patients with a 2016- or 2022 World Health Organization (WHO) confirmed diagnosis of myelofibrosis (MF) established from 01/01/2018 to 31/12/2027 will be enrolled into the study. Yearly follow-up updates will be scheduled until the end of data collection on 31/12/2028 or until the last available patient visit, whichever comes first. At least 1 year of follow-up will be ensured from the last patient enrolled.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of primary myelofibrosis (PMF) or secondary (i.e., post-ET/PV MF) myelofibrosis according to 2016- or 2022-WHO criteria ascertained between 01/01/2018 and 31/12/2027
Age ≥ 18 years
Signed informed consent where applicable, in line with current European General Data Protection Regulation (GDPR) directives
Disqualifiers
Diagnosis of early/prefibrotic primary myelofibrosis
Concurrent participation to interventional clinical trials in MF
Trial population
Patients with a 2016- or 2022-WHO confirmed diagnosis of MF established from 01/01/2018 to 31/12/2027 will be enrolled into the study. Patients with primary and secondary to ET and PV myelofibrosis, annotated for genetic and histological features, in relation to the presence of baseline (i.e., at MF diagnosis) or treatment-related cytopenias (i.e., reduced count of blood cells manifesting as anemia, thrombocytopenia and/or neutropenia).
Trial design
Case-control
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Overall survival according to the presence of cytopenias at diagnosis
Obtained by medical health records normally filled out in clinical practice
Secondary outcomes
Frequency and types of cytopenias
Obtained by medical health records normally filled out in clinical practice
Treatments response and duration (according to modified IWG-MRT and ELN 2013 criteria, overall and by presence of cytopenias
Obtained by medical health records normally filled out in clinical practice
Incidence of major CV events (thrombosis and bleeding), overall and by presence of cytopenias and treatments received
Obtained by medical health records normally filled out in clinical practice
Incidence of disease progressions (MF accelerated phase, MF blast phase/acute myeloid leukemia (AML)), overall and by presence of cytopenias and treatments received
Obtained by medical health records normally filled out in clinical practice
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Lead sponsor
GlaxoSmithKline
Collaborator