Ropeginterferon Alfa 2b for Early Myelofibrosis

Sponsor
The University of Hong Kong
Study ID
NCT04988815
Phase
PHASE2
Status
Unknown

Conditions

  • Myelofibrosis
  • Primary Myelofibrosis, Prefibrotic Stage

Eligibility Criteria

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

Interventions

  • Ropeginterferon alfa-2b — 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
Sep 1, 2021
Status verified
Oct 2022
Primary completion
Jul 31, 2025
Completion
Dec 31, 2025

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.

Primary Outcome Measure

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

Central Contacts

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