Ropeginterferon Alfa 2b Plus Ruxolitinib for Myelofibrosis

Sponsor
The University of Hong Kong
Study ID
NCT06770842
Phase
PHASE2
Status
Recruiting
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Conditions

  • Post Essential Thrombocythaemia Myelofibrosis (PET-MF)
  • Post Polycythemia Myelofibrosis (PPV MF)
  • Primary Myelofibrosis (PMF)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ropeginterferon alfa-2b (BESREMi®) — DRUG
    Ropeginterferon alfa 2b is administered subcutaneously once every 2 weeks. The dosing will be 250mcg at Week 0, 350mcg at Week 2, 500mcg at Week 4, and 500mcg every 2 weeks thereafter

Study Details

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.

Key Dates

Start date
Mar 1, 2025
Status verified
Dec 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ropeginterferon alfa 2b
    Ropeginterferon alfa 2b is administered subcutaneously once every 2 weeks in addition to standard of care with Ruxolitinib which will be self-administered orally as described below. Both medications will continue uninterrupted in 28-day cycles. Subjects will continue combination treatment through the Initial Treatment Period (ITP) (first 6 cycles), which includes a Qualification Assessment. Those deriving clinical benefit in the opinion of the treating physician may continue receiving combination treatment in the Additional Treatment Period (6 cycles). Qualification Assessments will be performed at the end of each Additional Treatment Period, which is iterative, and may repeat for as long as clinical benefit is sustained, at the discretion of the treating physician.

Primary Outcome Measure

Adverse events [ Time Frame: 24 months ]

Central Contacts

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