Actively Recruiting
Safety and Efficacy of Ropeginterferon Alfa-2b Combined With Ruxolitinib for Patients With Myelofibrosis Showing Suboptimal Response to Ruxolitinib
Led by The University of Hong Kong · Updated on 2025-06-11
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
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 therapy's 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.
CONDITIONS
Brief 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) per WHO 2022 criteria
- Intermediate-1, Intermediate-2, or high-risk disease by DIPSS
- ECOG performance status of 0-2
- Platelet count 75 x 10^9/L or higher before dosing on Cycle 1 Day 1
- Absolute neutrophil count 0.5 x 10^9/L or higher 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 must agree to use approved contraception from screening until 30 days after last dose
- Suboptimal response to ruxolitinib after at least 3 months of treatment, defined as relapsed or refractory with specific spleen volume or size criteria
You will not qualify if you...
- Prior or current use of interferon alfa preparations for myeloproliferative neoplasms
- Current use of other investigational therapies
- Contraindications or hypersensitivity to interferon alfa preparations
- History of organ or hematopoietic stem cell transplantation
- History of splenectomy
- Pregnant, lactating females, or females planning pregnancy during study
- Documented autoimmune disease at screening
- Infection with HIV
- Active, uncontrolled hepatitis B or C infection (patients with undetectable viral loads on therapy may participate)
- Severe retinopathy including macular degeneration or diabetic retinopathy
- History or presence of significant neuropsychiatric conditions such as depression or epilepsy
- Concurrent active and unstable second malignancy (stable non-melanoma skin cancers allowed)
- Evidence of alcohol or drug abuse within 6 months
- Significant renal or hepatic insufficiency as defined by specific lab values
- Unwillingness or inability to comply with study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles with an Initial Treatment Period of 6 cycles followed by iterative Additional Treatment Periods of 6 cycles each as long as clinical benefit is sustained
Participants receive Ropeginterferon alfa 2b administered subcutaneously once every 2 weeks in addition to self-administered oral Ruxolitinib as part of their standard care. Treatment is given in 28-day cycles with an Initial Treatment Period of 6 cycles followed by an Additional Treatment Period of 6 cycles. Participants who continue to derive clinical benefit may repeat the Additional Treatment Period as determined by their physician.
Biweekly subcutaneous injections and ongoing oral medication; Qualification Assessments at the end of Initial and Additional Treatment Periods
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
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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