Ropeginterferon Alfa-2b with Ruxolitinib for Myelofibrosis
This study is looking at whether adding ropeginterferon alfa-2b to your current ruxolitinib treatment is safe for people with Myelofibrosis. Myelofibrosis is a condition where your bone marrow doesn't make enough healthy blood cells. The main goal of this study is to track any side effects (adverse events) you might experience over two years. You may be able to join if you are 18 or older, have been diagnosed with certain types of Myelofibrosis, and have specific genetic changes (JAK2, CALR, or MPL). The study is currently recruiting participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 15 participants.
- What's involved
- Ropeginterferon alfa-2b will be given as an injection under the skin every two weeks. Ruxolitinib will be given as usual.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track side effects for two years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07521046
Tolerability of Ropeginterferon Alfa-2b Add-on to Ongoing Ruxolitinib Therapy in Myelofibrosis (RopeRux in Myelofibrosis)
Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatmentUniversity of UtahInvestigator-initiated
~15 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:ropeginterferon alfa- 2bRuxolitinib
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type
Measured over 2 years
+4 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesUtah1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Male or female subject aged ≥ 18 years.
Diagnosed with PMF, post-PV MF, or post-ET MF per WHO 2016 or 2022 criteria, bearing one of these MPN phenotype defining mutations (JAK2, CALR, and MPL), and with a DIPSS score of low, intermediate-1 or intermediate-2.
Subjects must be already on standard of care ruxolitinib per the treating physician for at least 3 months or more, and on a stable dose for at least 6 weeks prior to screening.
Subjects must have spleen volume of \> 450ml by either MRI or CT scan
Subject must have a JAK2, CALR, or MPL allelic burden of ≥20% at screening
Prior treatment for PV or ET with hydroxyurea or ruxolitinib is allowed. If the patient was on pegylated interferon in the past, the progression from PV/ ET to post-PV/ET MF must not have occurred while on pegylated interferon therapy.
ECOG Performance Status ≤ 2.
Adequate organ function as defined as:
Hematologic:
WBC count ≥ 4 x 109/L
Absolute neutrophil count (ANC) ≥1500/mm3
Platelet count ≥ 75,000/mm3
Hemoglobin ≥ 8 g/dL
Hepatic:
Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)
AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN
Renal:
Estimated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault formula
Recovery to baseline or ≤ Grade 1 CTCAE v 6.0 from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy per the treating investigator.
Participants must adhere to the following sex and contraceptive/barrier requirements:
If participant is of childbearing potential, they must have a negative pregnancy test
For participants of non-childbearing potential: The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
\< 50 years of age:
Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution
≥ 50 years of age:
Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
Had radiation-induced menopause with last menses \>1 year ago; or
Had chemotherapy-induced menopause with last menses \>1 year ago
Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution
Participants of childbearing potential and participants with a sexual partner of childbearing potential must agree to use a highly effective method of contraception and lactation requirements as described in Sections 6.4.1 and 6.4.3.
Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Exclusion
PV or ET patients who progressed while on pegylated interferon or ropeginterferon therapy.
Receiving other investigational agents.
Existence of, or history of severe psychiatric disorders, particularly severe depression, suicidal ideation, or suicide attempt (Patients with pre-existing depression who are well-controlled and on stable doses of antidepressants are eligible).
Evidence of severe retinopathy or clinically significant eye disease.
History or presence of active serious or untreated autoimmune disease.
History of solid organ transplant.
Liver cirrhosis Child-Pugh score B or C. -≥ 5% blasts in peripheral blood or bone marrow.
Prior systemic anti-cancer therapy or any investigational therapy ≤ 14 days or within five half-lives prior to starting study treatment, whichever is shorter.
Major surgery 4 weeks prior to starting study drug or who have not fully recovered from major surgery.
The diagnosis of another malignancy which, in the investigator's opinion, is likely to significantly impact study participation.
Current evidence of uncontrolled, significant intercurrent illness including, but not limited to, the following conditions:
Cardiovascular disorders:
Uncontrolled hypertension, in the opinion of the investigator
Congestive heart failure New York Heart Association Class II or greater, unstable angina pectoris, serious cardiac arrhythmias.
Stroke or myocardial infarction within the past 3 months
Significant coronary stenosis, in the opinion of the investigator
QTc prolongation defined as a QTcF \> 500 ms.
Known congenital long QT.
Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures (e.g., infection/inflammation, intestinal obstruction, unable to swallow medication, \[subjects may not receive the drug through a feeding tube\], social/ psychological issues, etc.)
Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment.
Active infection requiring systemic therapy, including, but not limited to: tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), or hepatitis C.
Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol or complete the study.
Known prior severe hypersensitivity to investigational product (IP) or any component in its formulations (NCI CTCAE v 6.0 Grade ≥ 3).
Subjects taking prohibited medications as described in Section 7.8. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.
What this trial measures
- The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type2 years
To assess the safety and tolerability of ropeginterferon alfa- 2b add-on to ruxolitinib in the study population.
- The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 6.0).2 years
To assess the safety and tolerability of ropeginterferon alfa- 2b add-on to ruxolitinib in the study population.
- The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.2 years
To assess the safety and tolerability of ropeginterferon alfa- 2b add-on to ruxolitinib in the study population.
- The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.2 years
To assess the safety and tolerability of ropeginterferon alfa- 2b add-on to ruxolitinib in the study population.
- The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by the relationship to study treatment.2 years
To assess the safety and tolerability of ropeginterferon alfa- 2b add-on to ruxolitinib in the study population.