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Efficacy and Safety of Peginterferon in ET and PV. | Clinical Trials | Clareo Health

RECRUITINGNA

Efficacy and Safety of Peginterferon in ET and PV.

A Single-arm, Single-center Study to Explore the Safety and Efficacy of Pegylated Interferon Alpha in Chinese Patients With ET (Essential Thrombocythemia) and PV (Polycythemia Vera).

NCT06734637•Zhenya Hong

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Meet the 2016 WHO diagnostic criteria for ET (Essential Thrombocythemia) and PV (Polycythemia Vera)
•* ET (Essential Thrombocythemia) major criteria:
•1. 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.
•2. 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.

Exclusion Criteria

•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.

Locations (1)

Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Key Dates

Start Date

November 20, 2024

Primary Completion Date

November 20, 2026

Completion Date

November 20, 2027

Last Updated

December 16, 2024

Enrollment

ESTIMATED participants

Conditions

Essential ThrombocythemiaPolycythemia Vera

Interventions

Peginterferon α-2b injection

DRUG

Contacts

ZhenYa Hong, Ph.D

CONTACT

13476158466 hongzhenya@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 16, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety of Peginterferon in ET and PV.

Inclusion Criteria

Exclusion Criteria

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