NCT06734637招募中不适用
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).
Zhenya Hong1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年11月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Hematologic remission rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≤
- •4.Cardiac ejection fraction (EF) ≥ 60%. 5.The participant voluntarily signs the informed consent form.
排除标准
- •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.
研究组 & 干预措施
Peginterferon α-2b
Experimental
干预措施: Peginterferon α-2b injection (Drug)
结局指标
主要结局
Hematologic remission rate
时间窗: Week 12,24
次要结局
- 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)
- The incidence of progression to myelofibrosis.(Week 24,48)
- The incidence of acute leukemia.(Week 24,48)
- Changes in the burden of driver gene mutations during maintenance therapy.(Week 24,48)
- Hematologic remission(Week 48)
- Spleen enlargement remission rate.(Week 24,48)
研究者
Zhenya Hong
Professor
Tongji Hospital
研究点 (1)
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