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

Completed

• Conditions: Myelofibrosis

• Registration Number: NCT05665192
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-02
• Study First Submitted: 2022-12-16
• Study First Submitted QC: 2022-12-16
• Study First Posted: 2022-12-27
• Primary Completion: 2023-07-24
• Study Completion: 2023-07-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Severity of each reported symptom 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

Trial Locations

Locations (1)

Cardinal Health Specialty Solutions; 🇺🇸 Dublin, Ohio, United States