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New treatment option for Primary Myelofibrosis (PMF)
Official title Ropeginterferon Alfa 2b Plus Ruxolitinib for Myelofibrosis
ClinicalTrials.gov ID: NCT06770842
What this study is testing
What is Ropeginterferon alfa-2b (BESREMi®)?
Ropeginterferon alfa-2b (BESREMi®) is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for primary myelofibrosis (pmf).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Willing and able to provide informed consent
- Age ≥18 years
- Diagnosis of Overt Myelofibrosis (primary, post-ET, or post-PV) per World Health Organization (WHO) 2022 diagnostic criteria
- Intermediate-1, Intermediate-2, or high-risk disease by Dynamic International Prognostic Scoring System (DIPSS)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
You likely can't join if
- people will not be eligible for participation if they meet any of the following exclusion criteria:
- Prior or current use of interferon alfa (IFNα) preparations for MPN
- Patients currently on other investigational therapy (ies)
- Contraindications or hypersensitivity to IFNα preparations
- History of organ and haematopoietic stem cell transplantation
- History of splenectomy
See the full eligibility criteria
- Willing and able to provide informed consent
- Age ≥18 years
- Diagnosis of Overt Myelofibrosis (primary, post-ET, or post-PV) per World Health Organization (WHO) 2022 diagnostic criteria
- Intermediate-1, Intermediate-2, or high-risk disease by Dynamic International Prognostic Scoring System (DIPSS)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Platelet count ≥75 x 109/L prior to dosing on Cycle 1 Day 1
- Absolute neutrophil count ≥0.5 x 109/L prior to dosing on Cycle 1 Day 1
- Peripheral blast count ≤10% prior to dosing on Cycle 1 Day 1
- Women of childbearing potential and fertile men must agree to use an approved method of contraception from screening until 30 days after the last dose of ropeginterferon and ruxolitinib.
- Patients with suboptimal response to ruxolitinib as per one of the below: i. Relapsed: Ruxolitinib treatment for ≥3 months with spleen regrowth, defined as \ 10 cm below left costal margin (LCM); a non-palpable spleen...
- people will not be eligible for participation if they meet any of the following exclusion criteria:
- Prior or current use of interferon alfa (IFNα) preparations for MPN
- Patients currently on other investigational therapy (ies)
- Contraindications or hypersensitivity to IFNα preparations
- History of organ and haematopoietic stem cell transplantation
- History of splenectomy
- Pregnant or lactating females, or females planning to become pregnant at any time during the study
- 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.
- Concurrent second active and non-stable malignancy (patients with a concurrent second active but stable malignancy, i.e., non-melanoma skin cancers, are eligible)
- Evidence of alcohol or drug abuse within 6 months
- Evidence at the time of Screening of significant renal or hepatic insufficiency (unless due to hemolysis) as defined by any of the following local lab parameters:
- Calculated glomerular filtration rate (GFR; using the Cockcroft-Gault equation) \ 1.5 x the local upper limit of normal
- Aspartate transaminase (AST) or alanine aminotransferase (ALT) ≥2.5 x the local upper limit of normal
- Unwilling or unable to comply with the study protocol
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.