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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,055
Azienda Ospedaliera Annunziata
Cosenza, Calabria, Italy
RECRUITINGGrande Ospedale Metropolitano "Bianchi Melacrino Morelli"
Reggio Calabria, Calabria, Italy
RECRUITINGUniversità degli Studi di Napoli Federico II U.O.C. di Ematologia e Trapianti di midollo
Napoli, Campania, Italy
RECRUITINGIRCCS Policlinico Sant'Orsola
Bologna, Emilia-Romagna, Italy
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.
Time frame: 10 years
Significance of peripheral blasts
To assess correlations between amount of peripheral blasts and response to treatment, leukaemic transformation, drug withdrawal and survival.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 10 years
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Università degli studi di Ferrara - Nuovo Polo Ospedaliero di Cona - A.O.U. Arcispedale S. Anna
Ferrara, Emilia-Romagna, Italy
RECRUITINGAzienda Ospedaliero-Universitaria di Parma
Parma, Emilia-Romagna, Italy
RECRUITINGAUSL di Piacenza - Palazzine Medicine Specialistiche
Piacenza, Emilia-Romagna, Italy
RECRUITINGDipartimento Oncoematologico - AUSL della Romagna
Ravenna, Emilia-Romagna, Italy
RECRUITINGOspedale Infermi di Rimini
Rimini, Emilia-Romagna, Italy
RECRUITINGA.O.U. Integrata di Udine
Udine, Friuli Venezia Giulia, Italy
RECRUITING...and 16 more locations