Clinical trial NCT06516406: Ruxolitinib in Primary Myelofibrosis and Secondary to Essential Thrombocythemia or Polycythemia Vera
Official title: Ruxolitinib in Primary Myelofibrosis and Secondary to Essential Thrombocythemia or Polycythemia Vera
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myelofibrosis
Primary Myelofibrosis
Secondary Myelofibrosis
Keywords: Safety
Efficacy
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 1055
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Detailed description: 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. Laboratory tests and histological, cytogenetic, molecular, and radiological investigations performed by the patient and collected for study will be conducted in accordance with clinical practice, independent of the patient's participation in the study. In particular. data on systemic symptoms and splenomegaly will be collected at diagnosis and disease reassessments performed in the context of normal clinical practice. The minimum planned duration of individual patient observation is 3 months and the planned duration of the study is 10 years.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* None

Primary outcomes:
measure: Long Term Survival
timeFrame: 10 years
Secondary outcomes:
measure: Significance of peripheral blasts
timeFrame: 10 years
measure: Prognostic value of High Molecular Risk (HMR) mutations.
timeFrame: 10 years
measure: To validate the use of the MTSS score
timeFrame: 10 years
measure: Incidence of adverse events
timeFrame: 10 years
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 10 years
Other outcomes:
Locations:
city: Cosenza
country: Italy
facility: Azienda Ospedaliera Annunziata
state: Calabria
city: Reggio Calabria
country: Italy
facility: Grande Ospedale Metropolitano "Bianchi Melacrino Morelli"
state: Calabria
city: Napoli
country: Italy
facility: Università degli Studi di Napoli Federico II U.O.C. di Ematologia e Trapianti di midollo
state: Campania
city: Bologna
country: Italy
facility: IRCCS Policlinico Sant'Orsola
state: Emilia Romagna
city: Ferrara
country: Italy
facility: Università degli studi di Ferrara - Nuovo Polo Ospedaliero di Cona - A.O.U. Arcispedale S. Anna
state: Emilia-Romagna
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
state: Emilia-Romagna
city: Piacenza
country: Italy
facility: AUSL di Piacenza - Palazzine Medicine Specialistiche
state: Emilia-Romagna
city: Ravenna
country: Italy
facility: Dipartimento Oncoematologico - AUSL della Romagna
state: Emilia-Romagna
city: Rimini
country: Italy
facility: Ospedale Infermi di Rimini
state: Emilia-Romagna
city: Udine
country: Italy
facility: A.O.U. Integrata di Udine
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: A.O.U. Policlinico Umberto I - Università degli Studi di Roma "La Sapienza"
state: Lazio
city: Roma
country: Italy
facility: Ospedale S. Eugenio
state: Lazio
city: Viterbo
country: Italy
facility: Ospedale Belcolle
state: Lazio
city: Genova
country: Italy
facility: IRCCS Azienda Ospedaliera Universitaria "San Martino" - IST
state: Liguria
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
state: Lombardia
city: Monza
country: Italy
facility: Ospedale San Gerardo
state: Lombardia
city: Pesaro
country: Italy
facility: A.O. Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore
state: Marche
city: Torino
country: Italy
facility: Ospedale San Luigi Gonzaga - Regione Gonzole
state: Piemonte
city: Torino
country: Italy
facility: Department of Oncology, University of Torino
state: Piemonte
city: Torino
country: Italy
facility: Città della Salute e della Scienza
state: Piemonte
city: Torino
country: Italy
facility: A. O. Ordine Mauriziano di Torino
state: Piemonte
city: Cagliari
country: Italy
facility: Ospedale "A. Businco" - Dipartimento Scienze Mediche e Sanità Pubblica Università degli Studi di Cagliari
state: Sardegna
city: Catania
country: Italy
facility: A.O.U. "Policlinico-V. Emanuele"- P.O. Ferrarotto
state: Sicilia
city: Siena
country: Italy
facility: Policlinico S.Maria alle Scotte
state: Toscana
city: Padova
country: Italy
facility: AOU di Padova
state: Veneto
city: Verona
country: Italy
facility: A.O.U. Integrata Verona
state: Veneto
Study officials:
References: