Ruxolitinib in Primary Myelofibrosis and Secondary to Essential Thrombocythemia or Polycythemia Vera
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Myelofibrosis, Primary Myelofibrosis, Secondary Myelofibrosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Long Term Survival [Time frame: 10 years]
Secondary outcome measures (5)
- Significance of peripheral blasts [Time frame: 10 years]
- Prognostic value of High Molecular Risk (HMR) mutations. [Time frame: 10 years]
- To validate the use of the MTSS score [Time frame: 10 years]
- Incidence of adverse events [Time frame: 10 years]
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time frame: 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 26 centers
- Azienda Ospedaliera Annunziata — Cosenza
- Grande Ospedale Metropolitano "Bianchi Melacrino Morelli" — Reggio Calabria
- Università degli Studi di Napoli Federico II U.O.C. di Ematologia e Trapianti di midollo — Naples
- IRCCS Policlinico Sant'Orsola — Bologna
- Università degli studi di Ferrara - Nuovo Polo Ospedaliero di Cona - A.O.U. Arcispedale S. — Ferrara
- Azienda Ospedaliero-Universitaria di Parma — Parma
- AUSL di Piacenza - Palazzine Medicine Specialistiche — Piacenza
- Dipartimento Oncoematologico - AUSL della Romagna — Ravenna
- … and 18 more centers
Identifiers
NCT: NCT06516406 · RUX-MF