Efficacy and Safety of Peginterferon in ET and PV.

NCT06734637 | Recruiting

• 1 other identifier: 2024S005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Essential Thrombocythemia; Polycythemia Vera

Keywords

Essential thrombocythemia; Polycythemia vera; Peginterferon α-2b

Outcome Measures

Primary Outcomes (1)

• Hematologic remission rate

  Week 12,24

Secondary Outcomes (10)

• Molecular remission rate

  Week 24,48

• Peripheral blood driver genes

  Week 24,48

• Bone marrow-driven genes

  Week 24,48

• The incidence of thrombosis

  Week 24,48

• Incidence of bleeding events

  Week 24,48

Study Arms (1)

Peginterferon α-2b

EXPERIMENTAL

Drug: Peginterferon α-2b injection

Interventions

Peginterferon α-2b injection DRUG

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).

Peginterferon α-2b

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Zhenya Hong: lead

Study Sites (1)

Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

Thrombocythemia, Essential; Polycythemia Vera

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombocytosis; Blood Platelet Disorders; Myeloproliferative Disorders; Bone Marrow Diseases; Hemorrhagic Disorders; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• ZhenYa Hong, Ph.D

  Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ZhenYa Hong, Ph.D

CONTACT

13476158466; hongzhenya@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 16, 2024
• Study Start: November 20, 2024
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): November 20, 2027
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)