Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06770842

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Department of Medicine, Queen Mary Hospital

Hong Kong, Hong Kong

Actively Recruiting

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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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Ropeginterferon Alfa 2b Plus Ruxolitinib for Myelofibrosis | DecenTrialz