Ruxolitinib in Primary Myelofibrosis and Secondary to Essential Thrombocythemia or Polycythemia Vera
NCT Number: NCT06516406
Acronym: RUX-MF
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Myelofibrosis|Primary Myelofibrosis|Secondary Myelofibrosis
Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1055
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-05-06
Completion Date: 2032-05-31
Locations: 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", Roma, Lazio, 00161, Italy|Ospedale S. Eugenio, Roma, Lazio, Italy|Ospedale Belcolle, Viterbo, Lazio, 01100, Italy|IRCCS Azienda Ospedaliera Universitaria "San Martino" - IST, Genova, Liguria, 16132, Italy|Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Lombardia, 20122, Italy|Ospedale San Gerardo, Monza, Lombardia, 20900, Italy|A.O. Ospedali Riuniti Marche Nord - Presidio Ospedaliero San Salvatore, Pesaro, Marche, 61122, Italy|Ospedale San Luigi Gonzaga - Regione Gonzole, Torino, Piemonte, 10043, Italy|Department of Oncology, University of Torino, Torino, Piemonte, 10124, Italy|Città della Salute e della Scienza, Torino, Piemonte, 10126, Italy|A. O. Ordine Mauriziano di Torino, Torino, Piemonte, 10128, Italy|Ospedale "A. Businco" - Dipartimento Scienze Mediche e Sanità Pubblica Università degli Studi di Cagliari, Cagliari, Sardegna, 09131, Italy|A.O.U. "Policlinico-V. Emanuele"- P.O. Ferrarotto, Catania, Sicilia, 95124, Italy|Policlinico S.Maria alle Scotte, Siena, Toscana, 53100, Italy|AOU di Padova, Padova, Veneto, 35128, Italy|A.O.U. Integrata Verona, Verona, Veneto, 37134, Italy

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.

Primary Outcome Measures: 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 Outcome Measures: Significance of peripheral blasts, To assess correlations between amount of peripheral blasts and response to treatment, leukaemic transformation, drug withdrawal and survival., 10 years|Prognostic value of High Molecular Risk (HMR) mutations., To assess the prognostic value of HMRs (via NGS) in MF patients treated with ruxolitinib and to develop a prognostic model that can be applied to patients before and during ruxolitinib therapy., 10 years|To validate the use of the MTSS score, To validate the use of the MTSS score to assess post-ASCT survival of patients with MF, 10 years|Incidence of adverse events, To assess the incidence of adverse events in patients with myelofibrosis treated with ruxolitinib: thrombosis, haemorrhage, second neoplasms, blastic evolution., 10 years|Number of participants with treatment-related adverse events as assessed by CTCAE v4.0, To assess the toxicity of ruxolitinib therapy in the total cohort, 10 years