NCT06770842 Ropeginterferon Alfa 2b Plus Ruxolitinib for Myelofibrosis
| NCT ID | NCT06770842 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The University of Hong Kong |
| Condition | Primary Myelofibrosis (PMF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2025-03-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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: i. 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 Criteria: Subjects will not be eligible for participation if they meet any of the following exclusion criteria: * Prior or current use of interferon alfa (IFNα) preparations for MPN * Patients currently on other investigational therapy (ies) * Contraindications or hypersensitivity to IFNα preparations * History of organ and haematopoietic stem cell transplantation * History of splenectomy * Pregnant or lactating females, or females planning to become pregnant at any time during the study * 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. * Evidence of severe retinopathy including but not limited to macular degeneration, diabetic retinopathy and hypertensive retinopathy. * 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. * 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 * 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 * Unwilling or unable to comply with the study protocol
Contact & Investigator
Harinder Gill, MD
PRINCIPAL INVESTIGATOR
The University of Hong Kong
Frequently Asked Questions
Who can join the NCT06770842 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Primary Myelofibrosis (PMF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06770842 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06770842 currently recruiting?
Yes, NCT06770842 is actively recruiting participants. Contact the research team at gillhsh@hku.hk for enrollment information.
Where is the NCT06770842 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT06770842 clinical trial?
NCT06770842 is sponsored by The University of Hong Kong. The principal investigator is Harinder Gill, MD at The University of Hong Kong. The trial plans to enroll 20 participants.