FEDORA
Research type
Research Study
Full title
FEDORA: A phase II study to evaluate the tolerability, safety and activity of fedratinib combined with ropeginterferon alfa-2b in patients with myelofibrosis
IRAS ID
1003972
Contact name
Dr Birgit Whitman
Contact email
Eudract number
2021-004056-42
ISRCTN Number
ISRCTN88102629
Research summary
FEDORA is a prospective, multicentre, open label, phase II clinical trial for patients with myelofibrosis (MF). MF is a rare blood disorder that causes scarring of the bone marrow.
More than 55% of people with MF have a change in a gene called JAK2. JAK2 inhibitors are drugs that slow or stop the growth of cancer cells. Although JAK2 inhibitors have shown promising results for some patients with MF, treatment with a JAK2 inhibitor does not usually cure the patient’s disease. Previous studies have shown that combining a JAK2 inhibitor with a pegylated interferon is safe to administer and may be more effective because the interferon makes the cells that give rise to new blood cells more sensitive to the JAK2 inhibitor.
The FEDORA study will use a selective JAK2 inhibitor (fedratanib), and a next generation pegylated interferon (ropeginterferon alfa-2b). The aims of the study are to gather information about whether this combination is tolerated, and whether it provides a therapeutic benefit to MF patients. Patients will begin with fedratinib monotherapy to establish a stable tolerated dose. After a month of monotherapy, a low starting dose of ropeginterferon alfa-2b will be added to the treatment regimen. The dose of ropeginterferon alfa-2b will be increased every month until a dose combination is achieved that is tolerated by the patient (combination doses will be patient-specific); these doses are then maintained for the duration of the study.
30 patients will be recruited to the study through the Cure Leukaemia-funded Trials Acceleration Programme (TAP); a network of haemato-oncology centres across the UK. Trial treatment will continue for 2 years, and patients will be followed-up every month during treatment, and then 3-monthly for survival, progression and subsequent treatments until the end of the trial.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
21/YH/0300
Date of REC Opinion
7 Jan 2022
REC opinion
Further Information Favourable Opinion