Assessing the safety of fedratinib in Korean patients with myelofibrosis
Official title: Inrebic® (Fedratinib) Post-Marketing Surveillance in Korean Patients With Myelofibrosis
Run by Bristol-Myers Squibb · NCT06073847 · Data updated 2026-11-12
This study is testing the safety of a drug called fedratinib in adults with myelofibrosis who haven't responded well to or can't tolerate another treatment called ruxolitinib.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 137 (estimated) |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | fedratinib, ruxolitinib |
| Locations | 3 sites (Seoul and 2 other locations) |
| Status | Recruiting |
| Started | June 13, 2023 |
| Main results expected | December 20, 2027 |
| Study ends | December 20, 2027 |
| Registry record updated | November 6, 2024 |
| Trial ID | NCT06073847 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 19 and older with primary myelofibrosis or related conditions who have previously been treated with ruxolitinib.
✕Probably not a fit
Patients who have been prescribed fedratinib for unapproved indications or at unapproved doses will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the real-world safety of fedratinib in adult patients diagnosed with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis who have previously been treated with ruxolitinib. Participants will be registered if they have lost adequate response to or are intolerant to ruxolitinib, following specific criteria set by the Ministry of Food and Drug Safety. The study will include patients aged 19 and older who consent to participate and will monitor their safety outcomes over time.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety profile of fedratinib for patients with myelofibrosis who have not responded well to ruxolitinib.
How similar studies have gone: Other studies assessing the safety of treatments for myelofibrosis have shown promising results, but this specific approach with fedratinib in the Korean population is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants 19 years of age or older * Participants who will receive fedratinib according to the approved label * For the first 2 years after marketing authorization, all participants who have received or are receiving fedratinib will also be registered * Participants who signed the informed consent form Exclusion Criteria: * Participants who have been prescribed fedratinib for an indication not approved in Korea * Participants who have been prescribed fedratinib at a dose not approved in Korea * Participants for whom fedratinib is contraindicated as clarified in Korean prescribing information approved by the Ministry of Food and Drug Safety
Where it's running
-
Bristol-Myers Squibb YH
Seoul, South Korea Recruiting -
Novotech Laboratory Korea Co., Ltd.
Seoul, South Korea Recruiting -
Local Institution - 0001
Seoul, South Korea Terminated
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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MPN PROGRESSion Registry — tracking symptoms, treatments, and disease progression in people with MPNs.
Track long-term symptoms, treatments, and disease progression in adults with myeloproliferative neoplasms to see how these conditions evolve over time.
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Combining Momelotinib and Luspatercept for Myelofibrosis Treatment
This study is testing if combining two medications, momelotinib and luspatercept, can help people with myelofibrosis who need blood transfusions feel better and reduce their transfusion needs.
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National registry for people with myelofibrosis and anemia in Germany.
This project will collect health, treatment, and quality-of-life information from people in Germany with primary or secondary myelofibrosis and anemia to see how their care and symptoms change over time.
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Evaluating the safety and effectiveness of bomedemstat for blood disorders
This study is trying to see how safe and effective bomedemstat is for people with blood disorders like essential thrombocythemia and myelofibrosis who have been doing well on the treatment for at least six months.
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Combining Pacritinib and Talazoparib for Patients with Myeloproliferative Neoplasms Not Responding to JAK2 Therapy
This study is testing a combination of two medications, pacritinib and talazoparib, to see if they can help patients with certain blood cancers who haven't responded to other treatments.
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Registry of Asian patients with myeloproliferative neoplasms
This study is collecting information from Asian patients with myeloproliferative neoplasms to learn more about their condition and how different treatments work for them.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.