A Phase 1b Study of Safety, Tolerability of Ropeginterferon Alfa-2b Add-on to Ongoing Ruxolitinib Therapy in Myelofibrosis (RopeRux in Myelofibrosis)
University of Utah
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Subject must have a JAK2, CALR, or MPL allelic burden of ≥20% a…
Interventions
- Drugropeginterferon alfa- 2b
Ropeginterferon alfa- 2b will be administered as a subcutaneous injection every two weeks.
- DrugRuxolitinib
Ruxolitinib will be administered per standard of care.
Location
- Huntsman Cancer Institute at University of UtahSalt Lake City, Utah