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NCT Number: NCT06516406

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

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.

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Key information

Conditions

Myelofibrosis Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myeloproliferative Disorders Primary Myelofibrosis Secondary Myelofibrosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera Annunziata, Cosenza, Calabria, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Long Term Survival

    Time frame: 10 years

    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

  1. Significance of peripheral blasts

    Time frame: 10 years

    To assess correlations between amount of peripheral blasts and response to treatment, leukaemic transformation, drug withdrawal and survival.

  2. Prognostic value of High Molecular Risk (HMR) mutations.

    Time frame: 10 years

    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.

  3. To validate the use of the MTSS score

    Time frame: 10 years

    To validate the use of the MTSS score to assess post-ASCT survival of patients with MF

  4. Incidence of adverse events

    Time frame: 10 years

    To assess the incidence of adverse events in patients with myelofibrosis treated with ruxolitinib: thrombosis, haemorrhage, second neoplasms, blastic evolution.

  5. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 10 years

    To assess the toxicity of ruxolitinib therapy in the total cohort

Study contacts

Contact information is provided by the study sponsor or research team.

Francesca Palandri, MD, PhD

CONTACT

[email protected]

+390512143044

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2022
Primary completion
2032
Study completion
2032
First posted
Jul 24, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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