Ruxolitinib in Primary Myelofibrosis and Secondary to Essential Thrombocythemia or Polycythemia Vera
1 other identifier
observational
1,055
1 country
26
Brief Summary
The study is observational multicenter retrospective and prospective cohort study of patients with primary or secondary myelofibrosis who have initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. The primary purpose is to determine the impact of clinical and laboratory characteristics of myelofibrosis on the prognosis of patients treated with ruxolitinib, understood as long-term survival.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
Longer than P75 for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 6, 2022
CompletedFirst Submitted
Initial submission to the registry
October 5, 2023
CompletedFirst Posted
Study publicly available on registry
July 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2032
December 5, 2024
February 1, 2024
10.1 years
October 5, 2023
December 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Long Term Survival
To determine the impact of clinical and laboratory characteristics of myelofibrosis on the prognosis of patients treated with ruxolitinib, in terms of long-term survival.
10 years
Secondary Outcomes (5)
Significance of peripheral blasts
10 years
Prognostic value of High Molecular Risk (HMR) mutations.
10 years
To validate the use of the MTSS score
10 years
Incidence of adverse events
10 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
10 years
Eligibility Criteria
The study is observational multicenter retrospective and prospective cohort will be offered consecutively to any patient with primary or secondary myelofibrosis who has initiated therapy with ruxolitinib, prescribed as part of the normal course of care and completely independent of study participation. The study will be conducted in the study-participating OUs of Hematology, and an estimated total of 1015 patients who initiated therapy with Ruxolitinib between 2008 and the end of the study are expected to participate in this study.
You may qualify if:
- Age ≥ 18 years
- Patients diagnosed with Primary Myelofibrosis or secondary to Essential Thrombocythemia/Polycythemia vera who are being treated or have been treated with ruxolitinib therapy in accordance with normal clinical practice.
- Availability of data on clinical history prior to initiation of Ruxolitinib therapy
- Obtaining informed consent for data collection and processing
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Azienda Ospedaliera Annunziata
Cosenza, Calabria, 87100, Italy
Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"
Reggio Calabria, Calabria, 89124, Italy
Università degli Studi di Napoli Federico II U.O.C. di Ematologia e Trapianti di midollo
Napoli, Campania, 80131, Italy
IRCCS Policlinico Sant'Orsola
Bologna, Emilia-Romagna, 40138, Italy
Università degli studi di Ferrara - Nuovo Polo Ospedaliero di Cona - A.O.U. Arcispedale S. Anna
Ferrara, Emilia-Romagna, 44124, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, Emilia-Romagna, 43126, Italy
AUSL di Piacenza - Palazzine Medicine Specialistiche
Piacenza, Emilia-Romagna, 29121, Italy
Dipartimento Oncoematologico - AUSL della Romagna
Ravenna, Emilia-Romagna, 48121, Italy
Ospedale Infermi di Rimini
Rimini, Emilia-Romagna, 47923, Italy
A.O.U. Integrata di Udine
Udine, Friuli Venezia Giulia, 33100, Italy
A.O.U. Policlinico Umberto I - Università degli Studi di Roma "La Sapienza"
Rome, Lazio, 00161, Italy
Ospedale S. Eugenio
Rome, Lazio, Italy
Ospedale Belcolle
Viterbo, Lazio, 01100, Italy
IRCCS Azienda Ospedaliera Universitaria "San Martino" - IST
Genoa, Liguria, 16132, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122, Italy
Ospedale San Gerardo
Monza, Lombardy, 20900, Italy
Ospedale San Luigi Gonzaga - Regione Gonzole
Turin, Piedmont, 10043, Italy
Department of Oncology, University of Torino
Turin, Piedmont, 10124, Italy
Città della Salute e della Scienza
Turin, Piedmont, 10126, Italy
A. O. Ordine Mauriziano di Torino
Turin, Piedmont, 10128, Italy
Ospedale "A. Businco" - Dipartimento Scienze Mediche e Sanità Pubblica Università degli Studi di Cagliari
Cagliari, Sardinia, 09131, Italy
A.O.U. "Policlinico-V. Emanuele"- P.O. Ferrarotto
Catania, Sicily, 95124, Italy
A.O. Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore
Pesaro, The Marches, 61122, Italy
Policlinico S.Maria alle Scotte
Siena, Tuscany, 53100, Italy
AOU di Padova
Padua, Veneto, 35128, Italy
A.O.U. Integrata Verona
Verona, Veneto, 37134, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2023
First Posted
July 24, 2024
Study Start
May 6, 2022
Primary Completion (Estimated)
May 31, 2032
Study Completion (Estimated)
May 31, 2032
Last Updated
December 5, 2024
Record last verified: 2024-02