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

NCT05731245 | Recruiting Phase 2

• 1 other identifier: 202208080MIPC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pre-fibrotic Myelofibrosis

Keywords

Early or Primary Myelofibrosis

Outcome Measures

Primary Outcomes (1)

• Clinicohematological responses at 24 weeks

  Overall haematological response rate at 6, 12 and 24 months, based on the IWG-MRT and ELN consensus report

  24 months

Secondary Outcomes (1)

• Adverse events

  24 months

Study Arms (1)

Ropeginterferon alfa-2b

EXPERIMENTAL

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

Drug: Ropeginterferon Alfa-2B Prefilled Syringe [Besremi]

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

Ropeginterferon alfa-2b

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥ 18 years (or based on the legal age of the territory) Diagnosed of primary myelofibrosis, post-PV and post-ET myelofibrosis according to the WHO 2016 classification Bone marrow reticulin fibrosis grade of 0-1 or low/intermediate-1 risk according to DIPSS Compensated liver function defined as: bilirubin ≤ 1.5 x upper limit normal (ULN); alanine aminotransferase (ALT) ≤ 2 x ULNor aspartate aminotransferase (AST) ≤ 2 x ULN; prothrombin time versus control \<3 seconds at screening Glomerular filtration rate ≥ 50 mL/min (by MDRD equation or Cockcroft-Gault formula) Men and women of childbearing potential must agree to perform contraception until 28 days after the last dose of ropeg.
• Women must avoid breast-feeding during the study. Able to give a written informed consent and fully comply to the requirements of the study.

You may not qualify if:

• Prior or current use of IFNα preparations for PMF or secondary MF. Prior use of IFNα for antecedent PV or ET is allowed provided that the time from the last dose of IFNα to recruitment is \> 4 weeks.
• Patients currently on other investigational therapy (ies) Contraindications or hypersensitivity to IFNα preparations History of organ transplantation Pregnant or lactating women 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.
• Presence of other active malignancies within three years prior to the time of recruitment. History of malignant disease, including solid tumours and haematological malignancies (except basal cell and squamous cell carcinomas of the skin and carcinoma in situ of the cervix that have been completely excised and are considered cured) within the last 3 years.
• Evidence of alcohol or drug abuse within 6 months

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Primary Myelofibrosis

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Gill Harinder

CONTACT

+852 22554542; gillhsh@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 16, 2023
• Study Start: February 8, 2023
• Primary Completion: October 12, 2024
• Study Completion (Estimated): October 12, 2026
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)