Clinical Epidemiology in Contemporary Patients With Myelofibrosis. (ERNEST-3)

December 19, 2025 updated by: FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Clinical Epidemiology in Contemporary Patients With Myelofibrosis (ERNEST-3): A European LeukemiaNet (ELN) Observational Study

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Myeloproliferative neoplasms (MPNs) are rare bone marrow disorders characterized by clonal proliferation of hematopoietic cell lineages, and include polycythemia vera (PV), essential thrombocythemia (ET), and myelofibrosis (MF). MF has worse prognosis, with main causes of death including acute leukemia transformation, comorbid conditions, and consequences of cytopenia. MF is characterized by progressive anemia, bone marrow fibrosis, and extramedullary hematopoiesis with splenomegaly. Moreover, the disease is associated with a heavy symptom burden including night sweats, fever, bone pain, and weight loss and worsening the quality of life.

On the beginning of 2013 the European Registry for Myeloproliferative Neoplasms (ERNEST) observational study was launched and approved by several IRBs of European hematological centers. The study focused on overt Primary (PMF) and Secondary myelofibrosis (SMF; i.e., post-Essential Thrombocythemia myelofibrosis (post-ET MF) and post-polycythemia (post-PV MF)) and aimed at describing the clinical epidemiology of large series of patients observed in clinical practice. This research was justified as the landscape of both pathophysiological and clinical knowledge in MPNs was rapidly evolving, prompting to revise diagnostic criteria, prognostication and therapy recommendations.

ERNEST retrospectively enrolled 1292 patients in whom the proposed prognostic models were confirmed to differentiate treatments in clinical practice, while ERNEST-2 reported results on critical events observed in 1010 of these cases during a median follow-up period of 5.4 years.4,5 The two studies closed in December 2022.

In the last decade, new diagnostic and prognostic findings have been accumulated and the availability of new approved drugs, based on results of several new clinical trials, influenced the therapy decision making in the real-world clinical practice. Therefore, the continuation of observational studies in present ERNEST-3 on large multicenter case series of patients with MF is timely and might refine the results of clinical trials.

The purpose of this study observational retrospective/prospective study is to gain information on MF associated cytopenias that represent a significant challenge in the contemporary patients with MF. Currently, there are few agents aimed at treating cytopenic MF, including immunomodulatory drugs, hypomethylating agents, and JAK inhibitors such as momelotinib and pacritinib, and development of new agents specifically tailored to this patient population remains an unmet need. Therefore, this study can provide data on these patients, focusing on clinical status, quality of life, comorbidities, and treatment results over time.

Study Type

Observational

Enrollment (Estimated)

617

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Armenia
      • Yerevan, Armenia
        • Recruiting
        • Hematology Center after Prof.R.H. Yeolyan
        • Contact:
        • Principal Investigator:
          • Maria Badikyan, MD
  • Denmark
      • Copenhagen, Denmark
        • Not yet recruiting
        • University of Copenhagen's Roskilde Hospital
        • Contact:
        • Principal Investigator:
          • Hans Carl Hasselbalch, MD
  • France
      • Paris, France
        • Not yet recruiting
        • Clinical Investigation Center of the Saint Louis Hospital
        • Contact:
        • Principal Investigator:
          • Jean Jacques Kiladjian, MD
  • Germany
      • Greifswald, Germany
        • Not yet recruiting
        • Internal Medicine C, Hematology, Oncology, Stem Cell Transplantation and Palliative Care, University Medicine Greifswald
        • Contact:
        • Principal Investigator:
          • Florian Heidel, MD
      • Halle, Germany
        • Not yet recruiting
        • University Hospital Halle Department of Hematology/Oncology
        • Contact:
        • Principal Investigator:
          • Haifa Kathrin Al-Ali, MD
      • Minden, Germany
        • Not yet recruiting
        • University Clinic for Hematology, Oncology, Hemostaseology and Palliative Care Johannes Wesling Medical Center Minden UKRUB, University of Bochum
        • Contact:
        • Principal Investigator:
          • Martin Griesshammer, MD
  • Israel
      • Ashdod, Israel
        • Not yet recruiting
        • Division of Haematology, Sasson University Hospital Assuta Ashdod, Ashdod, Ben-Gurion University of Negev
        • Contact:
        • Principal Investigator:
          • Adrian Duek, MD
  • Italy
      • Alessandria, Italy, 15121
        • Recruiting
        • A.S.O. SS. Antonio e Biagio e C.Arrigo, SC Ematologia
        • Principal Investigator:
          • Monia Marchetti
        • Contact:
      • Bergamo, Italy
        • Recruiting
        • ASST Papa Giovanni XXIII, SC Ematologia
        • Contact:
        • Principal Investigator:
          • Alessandro Rambaldi, MD
      • Bologna, Italy
        • Recruiting
        • Policlinico S. Orsola - Malpighi, Unità di Ematologia
        • Principal Investigator:
          • Francesca Palandri, MD
        • Contact:
      • Catania, Italy
        • Not yet recruiting
        • Azienda Ospedaliero - Universitaria "Policlinico Vittorio Emanuele" - PO Gaspare Rodolico, Dipartimento di Ematologia con Trapianto di midollo Osseo
        • Principal Investigator:
          • Giuseppe Palumbo, MD
      • Florence, Italy
        • Recruiting
        • AOU Careggi di Firenze, Divisione di Ematologia
        • Contact:
        • Principal Investigator:
          • Alessandro M Vannucchi, MD
        • Sub-Investigator:
          • Paola Guglielmelli, MD
      • Milan, Italy
        • Not yet recruiting
        • ASST Grande Ospedale Metropolitano Niguarda, Divisione di Ematologia
        • Contact:
        • Principal Investigator:
          • Marianna Caramella, MD
      • Milan, Italy
        • Recruiting
        • Ospedale San Raffaele, Unità Operativa di Ematologia e Trapianto Midollo Osseo
        • Contact:
        • Principal Investigator:
          • Francesca Lunghi, MD
      • Milan, Italy
        • Recruiting
        • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Ematologia
        • Contact:
        • Principal Investigator:
          • Alessandra Iurlo, MD
      • Monza, Italy
        • Recruiting
        • Fondazione IRCCS San Gerardo Dei Tintori
        • Contact:
        • Principal Investigator:
          • Elena Elli, MD
      • Napoli, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Federico II, Divisione di Ematologia
        • Principal Investigator:
          • Fabrizio Pane, MD
        • Contact:
        • Contact:
      • Novara, Italy
        • Recruiting
        • Azienda Ospedaliero Universitaria Maggiore della Carità, SCDU Ematologia
        • Contact:
        • Principal Investigator:
          • Andrea Patriarca, MD
      • Padua, Italy
        • Not yet recruiting
        • Azienda Ospedale-Università di Padova, Dipartimento di Medicina
        • Contact:
        • Principal Investigator:
          • Gianni Binotto, MD
      • Padua, Italy
        • Not yet recruiting
        • Università degli Studi di Padova - Policlinico Universitario, Clinica Medica 1
        • Contact:
        • Principal Investigator:
          • Irene Bertozzi, MD
      • Pavia, Italy
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo, Divisione di Ematologia
        • Contact:
        • Principal Investigator:
          • ELisa Rumi, MD
      • Roma, Italy
        • Recruiting
        • Policlinico Umberto I, Dipartimento Ematologia, Oncologia e Dermatologia
        • Contact:
        • Principal Investigator:
          • Massimo Breccia, MD
      • Roma, Italy
      • Torino, Italy, 10126
        • Not yet recruiting
        • A.O.U. Città della Salute e della Scienza di Torino - Ospedale Molinette- S.C. Ematologia U
        • Contact:
        • Principal Investigator:
          • Giulia Benevolo, Dr
      • Varese, Italy
        • Not yet recruiting
        • ASST dei Sette Laghi (Ospedale di Circolo e F. Macchi), Divisione U.O. Ematologia
        • Contact:
        • Principal Investigator:
          • Margherita Maffioli, MD
      • Verona, Italy
        • Recruiting
        • Azienda Ospedaliera Universitaria Integrata - Ospedale Borgo Roma, Unità di Ematologia
        • Contact:
        • Principal Investigator:
          • Massimiliano Bonifacio, MD
      • Vicenza, Italy
  • Moldova
      • Chisinau, Moldova
        • Not yet recruiting
        • Institute of Oncology, State University of Medicine and Pharmacy - Department of Oncology, Hematology and Radiotherapy
        • Contact:
        • Principal Investigator:
          • Vasile Musteata, MD
  • Poland
      • Krakow, Poland
        • Recruiting
        • Department of Hematology, University Hospital, Jagiellonian University Medical College
        • Contact:
        • Principal Investigator:
          • Weronika Lebowa, MD
      • Wroclaw, Poland
        • Recruiting
        • Department and Clinic of Haematology, Blood Neoplasms, and Bone Marrow Transplantation, Wroclaw Medical University
        • Contact:
        • Principal Investigator:
          • Marta Sobas, MD
  • Romania
      • Bucharest, Romania
        • Recruiting
        • Department of Hematology and Bone Marrow Transplantation, Fundeni Clinical Institute
        • Contact:
        • Principal Investigator:
          • Daniel Coriu
  • Spain
      • Barcelona, Spain
        • Recruiting
        • Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS) - Hospital Clinic
        • Contact:
        • Principal Investigator:
          • Alberto Alvarez-Larran, MD
      • Madrid, Spain
        • Recruiting
        • Hematology and Hemotherapy Department, 12 de Octubre University Hospital
        • Contact:
        • Principal Investigator:
          • Gonzalo Carreno Gomez-Tarragona, MD
      • Valencia, Spain
        • Not yet recruiting
        • Servicio de Hematología - Hospital Clínico Universitario de Valencia
        • Contact:
        • Principal Investigator:
          • Juan Carlos HernandezBoluda, MD
  • United Kingdom
      • Belfast, United Kingdom
        • Not yet recruiting
        • School of Medicine, Dentistry and Biomedical Sciences Queen's University Belfast
        • Contact:
        • Principal Investigator:
          • Mary Frances McMullin, MD
      • London, United Kingdom
        • Not yet recruiting
        • Guy's and St. Thomas' NHS Foundation Trust.
        • Contact:
        • Principal Investigator:
          • Harrison Claire, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study 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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival according to the presence of cytopenias at diagnosis
Time Frame: At diagnosis during the baseline
Obtained by medical health records normally filled out in clinical practice
At diagnosis during the baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency and types of cytopenias
Time Frame: At baseline; 1 year follow-up.
Obtained by medical health records normally filled out in clinical practice
At baseline; 1 year follow-up.
Treatments response and duration (according to modified IWG-MRT and ELN 2013 criteria, overall and by presence of cytopenias
Time Frame: At baseline; 1 year follow-up.
Obtained by medical health records normally filled out in clinical practice
At baseline; 1 year follow-up.
Incidence of major CV events (thrombosis and bleeding), overall and by presence of cytopenias and treatments received
Time Frame: At baseline; 1 year follow-up.
Obtained by medical health records normally filled out in clinical practice
At baseline; 1 year follow-up.
Incidence of disease progressions (MF accelerated phase, MF blast phase/acute myeloid leukemia (AML)), overall and by presence of cytopenias and treatments received
Time Frame: At baseline; 1 year follow-up.
Obtained by medical health records normally filled out in clinical practice
At baseline; 1 year follow-up.
Incidence of secondary neoplasia, overall, by site and by presence of cytopenias and treatments received
Time Frame: At baseline; 1 year follow-up.
Obtained by medical health records normally filled out in clinical practice
At baseline; 1 year follow-up.
Incidence of infections, overall and by presence of cytopenias and treatments received
Time Frame: At baseline; 1 year follow-up.
Obtained by medical health records normally filled out in clinical practice
At baseline; 1 year follow-up.
Incidence of adverse events (AEs) of interest, overall, by type, severity and treatments received
Time Frame: At baseline; 1 year follow-up.
Obtained by medical health records normally filled out in clinical practice
At baseline; 1 year follow-up.
Incidence of death, overall, by cause and by presence of cytopenias and treatments received
Time Frame: At baseline; 1 year follow-up.
Obtained by medical health records normally filled out in clinical practice
At baseline; 1 year follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Collaborators

GlaxoSmithKline

Investigators

  • Study Director: TIZIANO BARBUI, MD, FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2024

Primary Completion (Actual)

December 19, 2025

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

July 30, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Actual)

December 26, 2025

Last Update Submitted That Met QC Criteria

December 19, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERNEST-3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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