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

Bristol-Myers Squibb (BMS)

Status: Completed

Conditions: Myelofibrosis

Study type: Observational

Funder types: Industry

Identifiers

NCT05665192

CA054-1014

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

150 participants in 1 patient group

Cohort 1

Description:

Participants that have discontinued RUX therapy and initiated FEDR prospectively