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

NCT05665192 | Completed

• 1 other identifier: CA054-1014
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Myelofibrosis

Keywords

Primary Myelofibrosis; Thrombocythemia Myelofibrosis; Fedratinib; Ruxolitinib

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Cohort 1

Participants that have discontinued RUX therapy and initiated FEDR prospectively

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of participants who have discontinued RUX and will be initiating FEDR prospectively.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Cardinal Health Specialty Solutions

Dublin, Ohio, 43017, United States

Location

Related Links

• BMS Clinical Trial Information

MeSH Terms

Conditions

Primary Myelofibrosis

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: December 27, 2022
• Study Start: August 2, 2021
• Primary Completion: July 24, 2023
• Study Completion: July 24, 2023
• Last Updated: April 8, 2025

Record last verified: 2025-04

Locations

US (1)