Actively Recruiting
Ropeginterferon Alfa 2b for Early MyelofibrosisDIPSS Low/Intermediate-1 Risk Myelofibrosis
Led by National Taiwan University Hospital · Updated on 2023-02-16
50
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Ropeginterferon Alfa 2b for Early MyelofibrosisDIPSS Low/Intermediate-1 Risk Myelofibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older (or legal age in your area)
- Diagnosed with primary myelofibrosis, post-polycythaemia vera, or post-essential thrombocythaemia myelofibrosis per WHO 2016 classification
- Bone marrow fibrosis grade 0-1 or DIPSS low/intermediate-1 risk
- Liver function within specified normal limits (bilirubin 3 1.5 times upper limit, ALT and AST 3 2 times upper limit, prothrombin time < 3 seconds over control at screening)
- Glomerular filtration rate of at least 50 mL/min
- Men and women able to practice contraception until 28 days after last dose of ropeginterferon alfa-2b
- Women must not breastfeed during the study
- Able to give written informed consent and comply with study requirements
You will not qualify if you...
- Prior or current use of interferon alpha for primary or secondary myelofibrosis (prior use for antecedent PV or ET allowed if last dose was more than 4 weeks before recruitment)
- Currently receiving other investigational treatments
- Allergic or intolerant to interferon alpha
- History of organ transplantation
- Pregnant or breastfeeding women
- Known autoimmune disease at screening
- Infection with HIV
- Active uncontrolled hepatitis B or C infections (patients on antiviral therapy with undetectable virus levels may participate)
- Severe eye diseases such as macular degeneration, diabetic or hypertensive retinopathy
- History or presence of serious neuropsychiatric conditions including depression and epilepsy
- Presence of other active cancers within the past 3 years (except certain skin and cervical cancers that are cured)
- Evidence of alcohol or drug abuse within the past 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Taiwan University Hospital
Taipei, Taiwan, 100, Taiwan
Actively Recruiting
Research Team
G
Gill Harinder
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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