Ruxolitinib in Primary Myelofibrosis and Secondary to Essential Thrombocythemia or Polycythemia Vera

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

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