Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2024-11-20
2027-11-20
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Peginterferon α-2b
Peginterferon α-2b injection
Participants will receive Peginterferon α-2b 180 mcg once a week and follow-up. Dose adjustments will be made by the investigator based on the type and severity of adverse event (AE).
Interventions
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Peginterferon α-2b injection
Participants will receive Peginterferon α-2b 180 mcg once a week and follow-up. Dose adjustments will be made by the investigator based on the type and severity of adverse event (AE).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Zhenya Hong
OTHER
Responsible Party
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Zhenya Hong
Professor
Principal Investigators
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ZhenYa Hong, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Tongji Medical College, Huazhong University of Science and Technology
Locations
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Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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ZhenYa Hong
Role: primary
Other Identifiers
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2024S005
Identifier Type: -
Identifier Source: org_study_id