Actively Recruiting
Ropeginterferon Alfa 2b Plus Ruxolitinib for Myelofibrosis
Led by The University of Hong Kong · Updated on 2025-06-11
20
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Ropeginterferon Alfa 2b Plus Ruxolitinib for Myelofibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide informed consent
- Age 18 years or older
- Diagnosis of overt myelofibrosis (primary, post-ET, or post-PV) according to WHO 2022 criteria
- Intermediate-1, Intermediate-2, or high-risk disease by DIPSS
- ECOG performance status of 0 to 2
- Platelet count at least 75 x 10^9/L before dosing on Cycle 1 Day 1
- Absolute neutrophil count at least 0.5 x 10^9/L before dosing on Cycle 1 Day 1
- Peripheral blast count 10% or less before dosing on Cycle 1 Day 1
- Women of childbearing potential and fertile men agree to use approved contraception from screening until 30 days after last dose
- Suboptimal response to ruxolitinib after at least 3 months as defined by relapse or refractory criteria
You will not qualify if you...
- Prior or current use of interferon alfa preparations for MPN
- Currently on other investigational therapies
- Contraindications or hypersensitivity to interferon alfa preparations
- History of organ or hematopoietic stem cell transplantation
- History of splenectomy
- Pregnant or breastfeeding females, or planning pregnancy during the study
- Documented autoimmune disease at screening
- Infection with HIV
- Active uncontrolled hepatitis B or C infections (patients with undetectable viral load on antiviral therapy may participate)
- Severe retinopathy including macular degeneration, diabetic or hypertensive retinopathy
- History or presence of significant neuropsychiatric conditions such as depression or epilepsy
- Concurrent second active and non-stable malignancy (stable malignancies like non-melanoma skin cancers are allowed)
- Evidence of alcohol or drug abuse within 6 months
- Significant kidney or liver dysfunction as defined by local lab parameters
- Unwilling or unable to comply with study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Medicine, Queen Mary Hospital
Hong Kong, Hong Kong
Actively Recruiting
Research Team
H
Hainder Gill, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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