Ropeginterferon for High Risk JAK2 Clonal Hematopoiesis
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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
Sponsor: Brigham and Women's Hospital
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ Meeting WHO 2016 criteria for a MPN.
- ✕ Pregnant or lactating.
- ✕ Any active malignancy in the past 2 years prior to C1D1, with the exception of non-melanoma skin cancer, or cervical carcinoma in situ or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis. Any malignancy treated with curative intent and no evidence for active disease in the last 2 years are eligible.
- ✕ Evidence of severe retinopathy or clinically relevant ophthalmologic disorder.
- ✕ Participation in an investigational drug or device trial within 2 weeks prior to C1D1
- ✕ Documented autoimmune disease at screening or in the medical history which is active and serious
- ✕ History of significant and clinically relevant psychiatric illnesses, including prior suicide attempts or risk of suicide on screening
- ✕ History of thyroid dysfunction not adequately controlled
Where it's recruiting
Boston
Source: ClinicalTrials.gov · NCT07249840 · last updated 2026-07-28