Ropeginterferon Alfa 2b for Early MyelofibrosisDIPSS Low/Intermediate-1 Risk Myelofibrosis

Sponsor
National Taiwan University Hospital
Study ID
NCT05731245
Phase
PHASE2
Status
Recruiting
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Conditions

  • Pre-fibrotic Myelofibrosis

Eligibility Criteria

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

Interventions

  • Ropeginterferon Alfa-2B Prefilled Syringe [Besremi] — DRUG
    Eligible subjects will receive Ropeginterferon alfa-2b subcutaneously (SC) every 2 weeks at the starting dose of 250µg at week 0, 350 µg at week 2, then 500µg at a fixed dose from week 4 onwards

Study Details

This is a multi-centre phase 2 open-label prospective study designed to assess the efficacy and safety of ropeg patients with pre-fibrotic primary myelofibrosis or DIPSS low/intermediate-1 risk myelofibrosis after 24 months of treatment.

Key Dates

Start date
Feb 8, 2023
Status verified
Feb 2023
Primary completion
Oct 12, 2024
Completion
Oct 12, 2026

Study Design

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

Arms

  • Experimental: Ropeginterferon alfa-2b
    Eligible subjects will receive ropeg subcutaneously (SC) every 2 weeks at the starting dose of 250µg at week 0, 350 µg at week 2, then 500µg at a fixed dose from week 4 onwards until week 104. In patients achieving a clinical or molecular response at 24 months (week 104), treatment with ropeg will be continued until disease progression. Intervention: Drug: Ropeginterferon alfa-2b

Primary Outcome Measure

Clinicohematological responses at 24 weeks [ Time Frame: 24 months ]

Central Contacts

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