NCT07249840

Ropeginterferon for High Risk JAK2 Clonal Hematopoiesis

Pilot Study of Ropeginterferon for Patients With JAK2 V617F Clonal Hematopoiesis and High-Risk Features

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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 with JAK2 V617F clonal hematopoiesis and high-risk features for thrombosis or progression. Participants will receive ropeginterferon by subcutaneous injection every 4 weeks for up to 2 years. The primary objective is to assess feasibility (enrollment of 12 patients within 2 years) and evaluate the safety and tolerability of ropeginterferon. Secondary objectives include assessing molecular response rates of thrombosis, bleeding, quality of life, and progression to myeloproliferative neoplasm (MPN). every 6 months through year 2, and again at years 3 and 4 to evaluate durability of response.

Conditions

• JAK2 Mutation

Interventions

Type	Name	Description
DRUG	Ropeginterferon	Patients will receive Ropeginterferon

Timeline

• Start date: 2026-06-01
• Primary completion: 2030-06-01
• Completion: 2030-06-01
• First posted: 2025-11-25
• Last updated: 2025-11-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study