Health TrialsbyHealthPanel

Efficacy and Safety of Peginterferon in ET and PV.

ConditionsEssential ThrombocythemiaPolycythemia Vera
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhenya Hong

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Meet the 2016 WHO diagnostic criteria for ET (Essential Thrombocythemia) and PV (Polycythemia Vera)

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.

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Peginterferon α-2bExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Hematologic remission rate

Time frame
Week 12,24

Secondary outcomes

1

Molecular remission rate

Time frame
Week 24,48
2

Peripheral blood driver genes

Time frame
Week 24,48
3

Bone marrow-driven genes

Time frame
Week 24,48
4

The incidence of thrombosis

Time frame
Week 24,48

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhenya Hong

Lead sponsor

Tongji Hospital

Sponsor institution

Source ClinicalTrials.gov
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