About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial 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.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Significance of peripheral blasts
To assess correlations between amount of peripheral blasts and response to treatment, leukaemic transformation, drug withdrawal and survival.
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.
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
Incidence of adverse events
To assess the incidence of adverse events in patients with myelofibrosis treated with ruxolitinib: thrombosis, haemorrhage, second neoplasms, blastic evolution.
Sponsors and contacts
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