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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05665192

Enrollment

150

Registered

2022-12-27

Start date

2021-08-02

Completion date

2023-07-24

Last updated

2025-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelofibrosis

Keywords

Primary Myelofibrosis, Thrombocythemia Myelofibrosis, Fedratinib, Ruxolitinib

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Severity of each reported symptom in TSS assessed by MFSAF	At Baseline, 3 and 6 months post-FEDR initiation
Percentage change in Total Symptom Score (TSS) assessed by Myelofibrosis Symptom Assessment Form (MFSAF)	Percentage change in Total Symptom Score (TSS) assessed by Myelofibrosis Symptom Assessment Form (MFSAF)
Absolute change in TSS assessed by MFSAF	At Baseline, 3 and 6 months post-FEDR initiation
Proportion of participants reporting individual symptoms in TSS assessed by MFSAF	At Baseline, 3 and 6 months post-FEDR initiation
Frequency of report of domain assessed by Patients' Global Impression of Change (PGIC)	At Baseline, 3 and 6 months post-FEDR initiation
Absolute reduction assessed by Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10)	At Baseline, 3 and 6 months post-FEDR initiation

Countries

United States

Outcome results