Ropeginterferon for High Risk JAK2 Clonal Hematopoiesis (NCT07249840) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Ropeginterferon for High Risk JAK2 Clonal Hematopoiesis
United States12 participantsStarted 2026-08
Plain-language summary
The goal of this clinical trial is to learn if the drug ropeginterferon alfa-2b can be used safely to treat patients with a JAK2 mutation and high risk features, but do not yet have a myeloproliferative neoplasm. The main questions it aims to answer are:
* Can we enroll 12 patients with JAK2 mutations and high risk features without a myeloproliferative neoplasm on a clinical trial evaluating the drug ropeginterferon?
* Is ropeginterferon safe to use in these patients?
Participants will:
* Receive ropeginterferon as an injection under the skin once every 4 weeks
* Visit the clinic every 1-3 months for checkups and tests
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults age 18 years or older
* Evidence of JAK2 V617F clonal hematopoiesis of indeterminate potential, as defined by a JAK2 V617F mutation detected on quantitative PCR. By definition, these patients do NOT have a diagnosis of an MPN, and must have at least one additional high-risk feature.
* Have high-risk clinical/laboratory features, as defined as at least ONE of the following criteria:
* Patients with a venous or arterial thrombotic event within 1 year prior to or any time after diagnosis of JAK2 clonal hematopoiesis
* Patients with elevated laboratory parameters above normal limits at screening, but not meeting criteria for an MPN by WHO 2016 criteria. This would include patients with elevated laboratory parameters but an otherwise normal bone marrow biopsy.
* White blood cell count \> 10 K/uL OR
* Hemoglobin \> 16 g/dL in women and \> 16.5 g/dL in men; OR hematocrit \>48% for women and \>49% for men OR
* Platelets \>400 K/uL
* Patients with JAK2 VAF \>20%
* Willing to have a bone marrow biopsy at study entry to exclude an MPN diagnosis. Screening bone marrow biopsy must not be diagnostic of any overt hematologic malignancy by morphologic assessment and must be consistent with a diagnosis of clonal hematopoiesis as determined by multi-institutional hematopathology review. A historical bone marrow biopsy is allowed if within 3 months of C1D1 and records and pathology can be obtained. In cases where the bone marrow biopsy results a…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as Phase 1 and hasn't started recruiting yet — what does that mean for how much is already known about the safety and effectiveness of ropeginterferon specifically for JAK2 clonal hematopoiesis, as opposed to other conditions it's been used for?
2Since one of the main things this trial is measuring is whether they can successfully enroll patients — rather than whether the treatment works — does that change how you'd weigh it against just monitoring my JAK2 mutation or pursuing standard treatment options?
3The trial is tracking side effects using a formal safety scale called CTCAE, which suggests they're still gathering basic safety data in this population — what kinds of treatment-related adverse effects from ropeginterferon should I be prepared to discuss before deciding if this is right for me?
4Because this trial isn't recruiting yet, what's the realistic timeline for when it might open, and is there any risk that waiting to see if I qualify could affect my current condition or delay other treatment decisions?
5Is my specific JAK2 mutation considered 'high risk' clonal hematopoiesis in the way this trial defines it, and how would you assess whether my situation warrants an experimental Phase 1 approach versus watchful waiting or other management strategies?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients consented and enrolled within 2 years of study opening
Timeframe: 2 years
2
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0