Study of Ropeginterferon Alfa-2b Added to Ruxolitinib for Adults with Myelofibrosis Showing Limited Response to Ruxolitinib Alone

What this Trial Is About

This research aims to evaluate the safety and efficacy of adding ropeginterferon alfa 2b to ruxolitinib treatment in patients with myelofibrosis who have shown a suboptimal response to ruxolitinib alone. The study focuses on patients diagnosed with primary, post-polycythemia vera, or post-essential thrombocythaemia myelofibrosis, classified as intermediate or high-risk based on prognostic scoring. Approximately 20 patients will participate in this open-label phase 2 trial to assess this combination therapys potential benefits and safety profile. Participants will continue taking their stable dose of ruxolitinib orally as part of their standard care while receiving ropeginterferon alfa 2b via subcutaneous injection every two weeks. The dosing of ropeginterferon alfa 2b starts at 250mcg at Week 0, increasing to 350mcg at Week 2, 500mcg at Week 4, and then 500mcg every two weeks thereafter. Treatment cycles last 28 days, and patients will undergo an Initial Treatment Period of six cycles followed by an Additional Treatment Period of six cycles if clinical benefit is observed. Qualification assessments are performed after each treatment period, allowing continued treatment if benefits persist. Throughout the study, participants will have regular assessments to monitor safety, including adverse events over 24 months, spleen volume changes at 24 weeks, and symptom responses. These evaluations may involve clinical exams and laboratory tests to track disease status and treatment effects. Patients will be monitored closely for any side effects or changes in health, with the opportunity to continue treatment based on physician judgment. The total study duration includes ongoing treatment cycles and follow-up assessments to ensure comprehensive safety and efficacy evaluation.

Ropeginterferon Alfa 2b Plus Ruxolitinib for Myelofibrosis