Observational study on patients with myelofibrosis in Europe
Clinical Epidemiology in Contemporary Patients With Myelofibrosis (ERNEST-3): A European LeukemiaNet (ELN) Observational Study
This study is collecting information from patients with myelofibrosis across Europe to better understand the disease and improve how it's diagnosed and treated.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 617 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS Academic / other |
| Drugs / interventions | momelotinib, pacritinib |
| Locations | 36 sites (Yerevan and 35 other locations) |
| Trial ID | NCT06533813 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study aims to enroll consecutive patients diagnosed with myelofibrosis according to the 2016 or 2022 WHO criteria from various European hematological centers. The study will collect data from both retrospective and prospective patient visits, with yearly follow-ups scheduled until the end of data collection in 2028. The goal is to describe the clinical epidemiology of myelofibrosis, a rare bone marrow disorder with significant symptom burden and poor prognosis, and to refine diagnostic criteria and treatment recommendations based on evolving knowledge in the field.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of primary or secondary myelofibrosis.
Not a fit: Patients with early or prefibrotic primary myelofibrosis or those currently participating in interventional clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of myelofibrosis and improve patient management and treatment outcomes.
How similar studies have performed: Previous studies, such as the ERNEST observational study, have successfully enrolled large patient cohorts and confirmed prognostic models in myelofibrosis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Diagnosis of early/prefibrotic primary myelofibrosis * Concurrent participation to interventional clinical trials in MF
Where this trial is running
Yerevan and 35 other locations
- Hematology Center after Prof.R.H. Yeolyan — Yerevan, Armenia (Recruiting)
- University of Copenhagen's Roskilde Hospital — Copenhagen, Denmark (Not_yet_recruiting)
- Clinical Investigation Center of the Saint Louis Hospital — Paris, France (Not_yet_recruiting)
- Internal Medicine C, Hematology, Oncology, Stem Cell Transplantation and Palliative Care, University Medicine Greifswald — Greifswald, Germany (Not_yet_recruiting)
- University Hospital Halle Department of Hematology/Oncology — Halle, Germany (Not_yet_recruiting)
- University Clinic for Hematology, Oncology, Hemostaseology and Palliative Care Johannes Wesling Medical Center Minden UKRUB, University of Bochum — Minden, Germany (Not_yet_recruiting)
- Division of Haematology, Sasson University Hospital Assuta Ashdod, Ashdod, Ben-Gurion University of Negev — Ashdod, Israel (Not_yet_recruiting)
- A.S.O. SS. Antonio e Biagio e C.Arrigo, SC Ematologia — Alessandria, Italy (Recruiting)
- ASST Papa Giovanni XXIII, SC Ematologia — Bergamo, Italy (Recruiting)
- Policlinico S. Orsola - Malpighi, Unità di Ematologia — Bologna, Italy (Recruiting)
- Azienda Ospedaliero - Universitaria "Policlinico Vittorio Emanuele" - PO Gaspare Rodolico, Dipartimento di ematologia con Trapianto di midollo Osseo — Catania, Italy (Not_yet_recruiting)
- AOU Careggi di Firenze, Divisione di Ematologia — Florence, Italy (Recruiting)
- ASST Grande Ospedale Metropolitano Niguarda, Divisione di Ematologia — Milan, Italy (Not_yet_recruiting)
- Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Ematologia — Milan, Italy (Recruiting)
- Ospedale San Raffaele, Unità Operativa di Ematologia e Trapianto Midollo Osseo — Milan, Italy (Recruiting)
- Fondazione IRCCS San Gerardo dei Tintori — Monza, Italy (Recruiting)
- Azienda Ospedaliera Universitaria Federico II, Divisione di Ematologia — Naples, Italy (Recruiting)
- Azienda Ospedaliero Universitaria Maggiore della Carità, SCDU Ematologia — Novara, Italy (Recruiting)
- Azienda Ospedale-Università di Padova, Dipartimento di Medicina — Padova, Italy (Not_yet_recruiting)
- Università degli Studi di Padova - Policlinico Universitario, Clinica Medica 1 — Padova, Italy (Not_yet_recruiting)
- Fondazione IRCCS Policlinico San Matteo, Divisione di Ematologia — Pavia, Italy (Recruiting)
- Fondazione Policlinico Universitario A. Gemelli - Università Cattolica del Sacro Cuore, UCSC Ematologia — Roma, Italy (Not_yet_recruiting)
- Policlinico Umberto I, Dipartimento Ematologia, Oncologia e Dermatologia — Roma, Italy (Recruiting)
- A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia U — Torino, Italy (Not_yet_recruiting)
- ASST dei Sette Laghi (Ospedale di Circolo e F. Macchi), Divisione U.O. Ematologia — Varese, Italy (Not_yet_recruiting)
- Azienda Ospedaliera Universitaria Integrata - Ospedale Borgo Roma, Unità di Ematologia — Verona, Italy (Recruiting)
- Azienda ULSS 8 Berica - Ospedale San Bortolo, Divisione di Ematologia — Vicenza, Italy (Not_yet_recruiting)
- Institute of Oncology, State University of Medicine and Pharmacy - Department of Oncology, Hematology and Radiotherapy — Chisinau, Moldova (Not_yet_recruiting)
- Department of Hematology, University Hospital, Jagiellonian University Medical College — Krakow, Poland (Recruiting)
- Department and Clinic of Haematology, Blood Neoplasms, and Bone Marrow Transplantation, Wroclaw Medical University — Wroclaw, Poland (Recruiting)
- Department of Hematology and Bone Marrow Transplantation, Fundeni Clinical Institute — Bucharest, Romania (Recruiting)
- Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) - Hospital Clinic — Barcelona, Spain (Recruiting)
- Hematology and Hemotherapy Department, 12 de Octubre University Hospital — Madrid, Spain (Recruiting)
- Servicio de Hematología - Hospital Clínico Universitario de Valencia — Valencia, Spain (Not_yet_recruiting)
- School of Medicine, Dentistry and Biomedical Sciences Queen's University Belfast — Belfast, United Kingdom (Not_yet_recruiting)
- Guy's and St. Thomas' NHS Foundation Trust. — London, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Tiziano Barbui, Md
- Email: tbarbui@fondazionefrom.it
- Phone: 0352675134
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.