Tests ropeginterferon with ruxolitinib in myelofibrosis patients with limited response to ruxolitinib
Adds ropeginterferon alfa-2b to ruxolitinib in adults with myelofibrosis not responding well to ruxolitinib alone.
Plain-language title generated from the registry record
Registry title: Ropeginterferon Alfa 2b Plus Ruxolitinib for Myelofibrosis
Key facts
- Where
- Hong Kong, Hong KongSee the site
- Phase
- Phase 2
Where in Hong Kong
- Department of Medicine, Queen Mary HospitalHong Kong, Hong KongTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The University of Hong Kong
- Trial code
- NCT06770842
- Record updated
- 11 June 2025
- Original description
In this open-label single arm phase 2 study, approximately 20 patients with MF demonstrating suboptimal response to ruxolitinib monotherapy will be enrolled. Patients will continue to receive ruxolitinib at a stable dose and ropeginterferon alfa 2b will be added to the regimen.Read full original descriptionShow less
Safety and Efficacy of Ropeginterferon Alfa-2b in Combination With Ruxolitinib in Patients With Myelofibrosis Demonstrating Suboptimal Response to Ruxolitinib Monotherapy
In this open-label single arm phase 2 study, approximately 20 patients with MF demonstrating suboptimal response to ruxolitinib monotherapy will be enrolled. Patients will continue to receive ruxolitinib at a stable dose and ropeginterferon alfa 2b will be added to the regimen.
Inclusion: Willing and able to provide informed consent; Age ≥18 years; Diagnosis of Overt Myelofibrosis (primary, post-ET, or post-PV) per World Health Organization (WHO) 2022 diagnostic criteria; Intermediate-1, Intermediate-2, or high-risk disease by Dynamic International Prognostic Scoring System (DIPSS); Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; Platelet count ≥75 x 109/L prior to dosing on Cycle 1 Day 1; Absolute neutrophil count ≥0.5 x 109/L prior to dosing on Cycle 1 Day 1; Peripheral blast count ≤10% prior to dosing on Cycle 1 Day 1; Women of childbearing potential and fertile men must agree to use an approved method of contraception from screening until 30 days after the last dose of ropeginterferon and ruxolitinib; Patients with suboptimal response to ruxolitinib as per one of the below:; Relapsed: Ruxolitinib treatment for ≥3 months with spleen regrowth, defined as <10% SVR or <30% decrease in spleen size from baseline, following an initial response* ii. Refractory: Ruxolitinib treatment for ≥3 months with <10% SVR or <30% decrease in spleen size from baseline; Response to ruxolitinib is defined as a ≥35% reduction in spleen volume from baseline, or a ≥50% reduction in spleen size for baseline spleen sizes >10 cm below left costal margin (LCM); a non-palpable spleen for baseline spleen sizes between 5-10 cm below LCM; or not eligible for spleen response for baseline spleen <5 cm below LCM.
Exclusion: Prior or current use of interferon alfa (IFNα) preparations for MPN; Patients currently on other investigational therapy (ies); Concurrent second active and non-stable malignancy (patients with a concurrent second active but stable malignancy, i.e., non-melanoma skin cancers, are eligible); Evidence of alcohol or drug abuse within 6 months; Contraindications or hypersensitivity to IFNα preparations; History of organ and haematopoietic stem cell transplantation; History of splenectomy; Documented autoimmune disease at screening; Infection with human immunodeficiency virus (HIV); Active and uncontrolled infections with hepatitis B virus (HBV) and hepatitis C virus (HCV). Please note that patients on antiviral therapy with undetectable HBV DNA and HCV RNA may be recruited; History of clinically significant neuropsychiatric conditions including but not limited to depression and epilepsy; Clinically significant neuropsychiatric conditions including but not limited to depression and epilepsy; Evidence at the time of Screening of significant renal or hepatic insufficiency (unless due to hemolysis) as defined by any of the following local lab parameters:; Calculated glomerular filtration rate (GFR; using the Cockcroft-Gault equation) <40 mL/min or serum creatinine >1.5 x the local upper limit of normal; Aspartate transaminase (AST) or alanine aminotransferase (ALT) ≥2.5 x the local upper limit of normal; Subjects will not be eligible for participation if they meet any of the following exclusion criteria:; Pregnant or lactating females, or females planning to become pregnant at any time during the study; Evidence of severe retinopathy including but not limited to macular degeneration, diabetic retinopathy and hypertensive retinopathy; Unwilling or unable to comply with the study protocol.