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OpenTrials
Completed

NCT Number: NCT05665192

A Study to Assess Real-World Patient-Reported Outcomes With Fedratinib for Myelofibrosis Post-Ruxolitinib

The purpose of this study is to determine real-world patient-reported outcomes with fedratinib (FEDR) therapy for myelofibrosis (MF) in the real-world (RW) setting.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardinal Health Specialty Solutions

Dublin, Ohio, 43017, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with Primary myelofibrosis (PMF), post- Essential thrombocythemia (ET) Myelofibrosis (MF), or post- Polycythemia vera (PV) MF
  • Treated with FEDR and initiated treatment after 16 August 2019.
  • Received prior treatment with RUX.
  • Had spleen assessed at time of initiation of FEDR by palpation.
  • Able to read and speak English
  • Willing to provide informed consent
  • Willing to provide permission to the site to release her/his medical information to the study investigators according to the study-specific eCRF
  • Willing to complete the baseline survey prior to first FEDR

Exclusion criteria

  • Past or current participant in any FEDR-related clinical trial

Treatment and study plan

Primary outcomes

  1. Percentage change in Total Symptom Score (TSS) assessed by Myelofibrosis Symptom Assessment Form (MFSAF)

    Time frame: Percentage change in Total Symptom Score (TSS) assessed by Myelofibrosis Symptom Assessment Form (MFSAF)

  2. Absolute change in TSS assessed by MFSAF

    Time frame: At Baseline, 3 and 6 months post-FEDR initiation

  3. Proportion of participants reporting individual symptoms in TSS assessed by MFSAF

    Time frame: At Baseline, 3 and 6 months post-FEDR initiation

  4. Severity of each reported symptom in TSS assessed by MFSAF

    Time frame: At Baseline, 3 and 6 months post-FEDR initiation

  5. Frequency of report of domain assessed by Patients' Global Impression of Change (PGIC)

    Time frame: At Baseline, 3 and 6 months post-FEDR initiation

  6. Absolute reduction assessed by Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10)

    Time frame: At Baseline, 3 and 6 months post-FEDR initiation

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Real-World Clinical and Patient Reported Outcomes With Fedratinib for Myelofibrosis Post-Ruxolitinib

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 27, 2022
Registry last updated
Apr 8, 2025

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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