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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05665192
Collaborator
(none)
50
Enrollment
1
Location
53
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Real-World Clinical and Patient Reported Outcomes With Fedratinib for Myelofibrosis Post-Ruxolitinib
    Actual Study Start Date :
    Aug 2, 2021
    Anticipated Primary Completion Date :
    Jun 30, 2024
    Anticipated Study Completion Date :
    Dec 31, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Cohort 1

    Participants that have discontinued RUX therapy and initiated FEDR prospectively

    Outcome Measures

    Primary Outcome Measures

    1. Percentage change in Total Symptom Score (TSS) assessed by Myelofibrosis Symptom Assessment Form (MFSAF) [At Baseline, 3 and 6 months post-FEDR initiation]

    2. Absolute change in TSS assessed by MFSAF [At Baseline, 3 and 6 months post-FEDR initiation]

    3. Proportion of participants reporting individual symptoms in TSS assessed by MFSAF [At Baseline, 3 and 6 months post-FEDR initiation]

    4. Severity of each reported symptom in TSS assessed by MFSAF [At Baseline, 3 and 6 months post-FEDR initiation]

    5. Frequency of report of domain assessed by Patients' Global Impression of Change (PGIC) [At Baseline, 3 and 6 months post-FEDR initiation]

    6. Absolute reduction assessed by Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10) [At Baseline, 3 and 6 months post-FEDR initiation]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Local Institution City State Austria 00000

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT05665192
    Other Study ID Numbers:
    • NDS-MF-001
    First Posted:
    Dec 27, 2022
    Last Update Posted:
    Dec 27, 2022
    Last Verified:
    Dec 1, 2022
    Keywords provided by Bristol-Myers Squibb
    Primary Myelofibrosis
    Thrombocythemia Myelofibrosis
    Fedratinib
    Ruxolitinib
    Additional relevant MeSH terms:
    Primary Myelofibrosis

    Study Results

    No Results Posted as of Dec 27, 2022