Ropeginterferon for High Risk JAK2 Clonal Hematopoiesis
ConditionJAK2 Mutation
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital
About this trial
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
Eligibility criteria
Qualifiers
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.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Ropeginterferon
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov