The purpose of this clinical trial is to learn if the study drug ropeginterferon alfa- 2b added to, standard of care, ruxolitinib is safe and effective in treating patients with Myelofibrosis.
Male or female subject aged ≥ 18 years.
Diagnosed with PMF, post-PV MF, or post-ET MF per WHO 2016 or 2022 criteria, bearing one of these MPN phenotype defining mutations (JAK2, CALR, and MPL), and with a DIPSS score of low, intermediate-1 or intermediate-2.
Subjects must be already on standard of care ruxolitinib per the treating physician for at least 3 months or more, and on a stable dose for at least 6 weeks prior to screening.
Subjects must have spleen volume of > 450ml by either MRI or CT scan
PV or ET patients who progressed while on pegylated interferon or ropeginterferon therapy.
Receiving other investigational agents.
Existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation, or suicide attempt (Patients with pre-existing depression who are well-controlled and on stable doses of antidepressants are eligible).
Evidence of severe retinopathy or clinically significant eye disease.
University of Utah
Lead sponsor
PharmaEssentia
Collaborator