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A phase II study to evaluate the tolerability, safety and activity of fedratinib combined with ropeginterferon alfa-2b in patients with myelofibrosis

Study ID: 53036
Short Title: FEDORA
Trust Name: UHS
Recruitment Site: Southampton General Hospital
Disease Area: Haematology
Phase: II
Expected End Date: 31/08/2026
Postcode: SO16 6YD
Contact Name: Amanda Pattie
Contact Email: studysupport1and3.crnwessex@nihr.ac.uk
Active: Yes

• Age 18 or over at trial entry • Confirmed diagnosis of JAK2 V617F positive primary or secondary MF, according to WHO 2016 diagnostic criteria • Require treatment, as clinically determined by local investigator • Intermediate-2 or high risk according to DIPSS, or intermediate-1 according to DIPSS with palpable splenomegaly > 5cm • Peripheral blood or bone marrow blasts < 10% • Adequate blood counts: platelets ≥75 x10-9/L, neutrophils ≥1.0 x10-9/L • Adequate organ function • ECOG performance score ≤2

• Previous treatment with a JAK2 inhibitor or interferon alpha • Chemotherapy or biologic therapy within 2 weeks of commencing the trial treatment, or ongoing toxicity relating to prior therapy • Blood thiamine concentration below lower limit of normal • Active malignancy treated in the last 2 years • Pre-existing and uncontrolled thyroid disease, diabetes or autoimmune disease • History of severe psychiatric disorder, including severe depression, suicidal ideation and suicide attempt • Current severe or uncontrolled cardiovascular disease • Previous organ transplantation receiving ongoing immunosuppression • Evidence of active HIV, HBV or HCV infection • Pregnant and breast feeding patients and those unwilling to use effective contraception

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.

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