Primary MyelofibrosisNCT06073847
A Post-Marketing Surveillance Study to Assess the Safety of Fedratinib in Korean Patients With Myelofibrosis
An observational study of Primary Myelofibrosis and Post-polycythemia Vera Myelofibrosis, run by Bristol-Myers Squibb at 3 sites in South Korea.
Trial summary
The purpose of this study is to assess the real-world safety of fedratinib for the treatment of adult participants with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (post-PV MF), or post essential thrombocythemia myelofibrosis (post-ET MF) who were previously treated with ruxolitinib. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
- What is being tested?
- Fedratinib
- How many people
- 137 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 13 Jun 2023to 20 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis who were previously treated with ruxolitinib
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
First line of the email MUST contain NCT # and Site #. contact
South Korea3 sites, 2 recruiting
- Recruiting
Bristol-Myers Squibb YH
Seoul, 06178
Ji-Hyun Kim, +82-3404-1300, Ji-hyun.kim@bms.com
- Terminated
Local Institution - 0001
Seoul, 06234
- Recruiting
Novotech Laboratory Korea Co., Ltd.
Seoul, 06234
South Korea Generic Country, Site 0002, 0000000000
About this study
Official title: Inrebic® (Fedratinib) Post-Marketing Surveillance in Korean Patients With Myelofibrosis
The purpose of this study is to assess the real-world safety of fedratinib for the treatment of adult participants with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (post-PV MF), or post essential thrombocythemia myelofibrosis (post-ET MF) who were previously treated with ruxolitinib. Participants will represent the overall patient population with PMF, post-PV MF or post-ET MF who lost adequate response to and/or are intolerant to ruxolitinib. Inadequate response definitions will follow Ministry of Food and Drug Safety-approved label and reimbursement criteria of the Health Insurance Review \& Assessment Service.
- Conditions
- Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
- Being tested
- Fedratinib
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FedratinibDrug
According to the approved label
| Study group | Role | What they receive |
|---|---|---|
| Participants with myelofibrosis receiving fedratinib | Not described Receives: Drug: Fedratinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
The type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to Inrebic® (fedratinib)
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start13 Jun 2023
- Primary completion20 Dec 2027 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary MyelofibrosisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 137 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073847
- Sponsor's protocol ID
- CA054-005
- Status last verified
- Nov 2024
- First submitted
- 3 Oct 2023
- Last updated
- 6 Nov 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inrebic® (Fedratinib) Post-Marketing Surveillance in Korean Patients With Myelofibrosis
- ClinicalTrials.gov ID
- NCT06073847
- Acronym / sponsor ID
- CA054-005
- Conditions
- Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 20 Dec 2027 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the real-world safety of fedratinib for the treatment of adult participants with primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (post-PV MF), or post essential thrombocythemia myelofibrosis (post-ET MF) who were previously treated with ruxolitinib. Participants will represent the overall patient population with PMF, post-PV MF or post-ET MF who lost adequate response to and/or are intolerant to ruxolitinib. Inadequate response definitions will follow Ministry of Food and Drug Safety-approved label and reimbursement criteria of the Health Insurance Review \& Assessment Service.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with myelofibrosis receiving fedratinib | – | Drug: Fedratinib |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with primary myelofibrosis, post-polycythemia vera myelofibrosis, or post-essential thrombocythemia myelofibrosis who were previously treated with ruxolitinib
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FedratinibAccording to the approved label | Drug | Participants with myelofibrosis receiving fedratinib |
Primary outcome
Number of participants with adverse events
Time frame: Up to 6 months
The type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to Inrebic® (fedratinib)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Primary Myelofibrosis
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Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF)
RecruitingPhase 3
A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib
Myelofibrosis, Anemia
Active, not recruitingPhase 3
Study of Selinexor in Combination With Ruxolitinib in Myelofibrosis
Myelofibrosis
RecruitingPhase 2
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
Primary Myelofibrosis, Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
Not yet recruitingPhase 1
Maintenance Treatment With Imetelstat in Patients With High-Risk Myeloid Neoplasms After Allo-SCT
High-risk Myeloid Malignancy, Allogenic Stem Cell Transplantation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Myelofibrosis and Post-polycythemia Vera Myelofibrosis, run by Bristol-Myers Squibb at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.