Pilot Study of Ropeginterferon for Patients With JAK2 V617F Clonal Hematopoiesis and High-Risk Features
Brigham and Women's Hospital
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
Description
Myeloproliferative neoplasms (MPNs) are driven by dysregulation of the JAK/STAT signaling pathway, most commonly due to the JAK2 V617F mutation. Recent data suggest that JAK2 mutations can arise decades before overt disease, representing an early "precursor" state known as JAK2 clonal hematopoiesis. Individuals with JAK2 clonal hematopoiesis have increased risks of both thrombosis and future MPN development. Early intervention to reduce the malignant clone may therefore improve long-term outcomes. This is a prospective cohort feasibility study evaluating ropeginterferon alfa-2b in patients wi…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 of diagnosis of JAK2 clonal hematopoiesis * Patients with elevated laboratory parameters above normal limits at…
Interventions
- DrugRopeginterferon
Patients will receive Ropeginterferon
Location
- Mass General BrighamBoston, Massachusetts