Efficacy and Safety of Peginterferon in ET and PV.

Recruiting now · Not applicable

Conditions studied: Essential Thrombocythemia, Polycythemia Vera

In brief

This is a single-arm, single-center study aims to recruit 40 participants with Essential Thrombocythemia (ET) and Polycythemia Vera (PV). Eligible participants will receive a subcutaneous injection of Peginterferon α-2b 180 mcg once a week and follow-up，and efficacy and safety will be evaluated.

Key facts

Study ID

NCT06734637

Run by

Zhenya Hong

People needed

40

Starts

2024-11-20

Expected to finish

2027-11-20

Last updated by the study team

2024-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meet the 2016 WHO diagnostic criteria for ET (Essential Thrombocythemia) and PV (Polycythemia Vera)
• ET (Essential Thrombocythemia) major criteria:
• Platelet count > 450 * 10\^9/L; (2) Bone marrow biopsy shows marked megakaryocytic proliferation with increased mature megakaryocyte volume and increased nuclear lobulation. There is no significant granulocytic proliferation, left shift, or erythroid proliferation, with grade 1 fibrosis observed in a few cases; (3) Does not meet the WHO diagnostic criteria for BCR-ABL1+ CML, PV, PMF, MDS, or other myeloproliferative neoplasms; (4) JAK2, CALR, or MPL mutation positive.
• Secondary criteria: (1) Presence of a clonal marker or absence of evidence for reactive thrombocytosis.
• The diagnosis of ET requires the fulfillment of all four main criteria, or the first three main criteria plus one secondary criterion.
• PV (Polycythemia Vera) main criteria: (1) Hemoglobin > 16.5 g/dL in males, > 16 g/dL in females, or Hematocrit > 49% in males, > 48% in females, or an increase in red cell volume of 25% or more above the normal value; (2) Bone marrow biopsy shows increased cellularity inappropriate for age, with marked erythroid, granulocytic, and megakaryocytic proliferation, and the presence of mature megakaryocytes of varying sizes and morphologies; (3) JAK2 V617F mutation positive or JAK2 exon 12 mutation positive.
• Secondary criteria: Serum Epo (Erythropoietin) level below the lower limit of the normal range.
• The diagnosis of PV requires the fulfillment of three major criteria, or the first two main criteria plus one secondary criterion.
• For ET patients, the criteria for cytoreductive therapy must be met, as follows:
• (1) For patients without a history of thrombosis: Age ≥ 60 years, regardless of the presence of cardiovascular risk (CVR) or JAK2V617 mutation; Any age with a platelet count > 1500 × 109/L. (2) For patients with a history of arterial thrombosis: Any age, regardless of the presence of CVR and JAK2V617 mutation; (3) For patients with a history of venous thrombosis: Any age, regardless of the presence of CVR and JAK2V617 mutation; 3.ECOG score ≤ 2. 4.Cardiac ejection fraction (EF) ≥ 60%. 5.The participant voluntarily signs the informed consent form.

You may not qualify if…

• Previous treatment with Peginterferon α-2b.
• ET patients who do not meet the criteria for cytoreductive therapy as per the 2016 Chinese Expert Consensus on Primary Thrombocythemia.
• Allergy to the active ingredient, α-interferon, or any excipients of this product.
• History of psychiatric illness, or allergy to interferon.
• Plasma total bilirubin greater than twice the normal value.
• Severe cardiac disease, liver insufficiency, chronic kidney disease, and neurological disorders (such as depression or mania).
• History of other malignant tumors within the past three years.
• Autoimmune chronic hepatitis.
• Any condition deemed unsuitable for inclusion by the investigator.

Where it is running

• Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)

Full record on ClinicalTrials.gov

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