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NCT05665192 Clinical Trial

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

Myelofibrosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05665192
Other study ID # NDS-MF-001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 2, 2021
Est. completion date December 31, 2025

Study information
Verified date December 2022
Source Bristol-Myers Squibb
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone 855-907-3286
Email Clinical.Trials@bms.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date December 31, 2025
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Austria Local Institution City State

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Austria, 

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