A Prospective, Multicenter, Randomized Controlled Clinical Trial of Pegylated Interferon Alfa-2b Versus Interferon Alfa Therapy in the Treatment of Adult Essential Thrombocythemia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Complete hematological remission (CHR) rates
研究概览
简要总结
Objectives: To compare the efficacy and safety in Adult patients (≥18 years) diagnosed as essential thrombocythemia treated with the Pegylated Interferon Alfa-2b vs. Interferon Alfa. Study Design: A prospective, open-label, multicenter, randomized controlled clinical trial.
详细描述
This is a prospective, open-label, multicenter, randomized controlled clinical trial between Interferon Alfa and Pegylated Interferon Alfa-2b in adult essential thrombocythemia (≥18 years).
Patients will be randomly divided into the following two treatment groups: 1. Recombinant Interferon Alpha, with an initial dose of 300 wu three times a week. Other interferons that have been listed can be used if Recombinant Interferon Alpha (300 wu) is not available. 2. Pegylated Interferon Alfa-2b, with an initial dose of 135 ug at week 0 , and then 180 ug once a week from week 1 to week 52.
The dosage will be adjusted according to the results of laboratory examinations and patient tolerance. The patient will be transferred to the other group if intolerance or resistance occurs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •≥18 years old.
- •Male or Female.
- •Diagnosis of essential thrombocythemia according to the 2016 World Health Organization criteria.
- •Those who have not use interferon within 4 weeks before the first medication.
- •Patients with indications for cytoreductive therapy.
- •Men and women with reproductive potential, as well as all women with menopause less than 2 years, must agree to use acceptable contraceptive methods until 28 days after the last dose of study drug, and women must agree not to breastfeed during the study period.
- •Voluntary written informed consent.
排除标准
- •Resistance, or intolerance, or any contraindications to interferon.
- •Patients with active thrombosis or active bleeding.
- •Neutrophil count < 1.0x10^9/L.
- •Hemoglobin < 11g/dL for male, or < 10g/dL for female.
- •Poor control of thyroid dysfunction.
- •Patients with a prior malignancy within the last 3 years.
- •Patients with severe cardiac or pulmonary dysfunction.
- •Severe renal damage (creatinine clearance < 30 ml / min).
- •Severe liver dysfunction (ALT or AST > 2.5×ULN).
- •Patients with hepatitis B virus, hepatitis C virus replication or HIV infection.
- •Patients with a history of drug / alcohol abuse (within 2 years before the study).
- •Patients that have participated in other experimental researches within one month before enrollment.
- •History of psychiatric disorder.
- •Any other circumstances that the investigator considers that the patient is not suitable to participate in the trial.
研究组 & 干预措施
Recombinant Interferon Alpha
Recombinant Interferon Alpha, with an initial dose of 300 wu three times a week. Other interferons that have been listed can be used if Recombinant Interferon Alpha (300 wu) is not available.
干预措施: Recombinant Interferon Alpha (Drug)
Pegylated Interferon Alfa-2b
Pegylated Interferon Alfa-2b, with an initial dose of 135 ug at week 0 , and then 180 ug once a week from week 1 to week 52.
干预措施: Pegylated interferon alfa-2b (Drug)
结局指标
主要结局
Complete hematological remission (CHR) rates
时间窗: From the start of study treatment (Week 0) up to the end of Week 52
The CHR rates defined as European Leukemia Net will be compared between the two groups.
次要结局
- Impact of therapy on non-driver mutations(From the start of study treatment (Week 0) up to the end of Week 52.)
- The incidence of progressing to bone marrow fibrosis(From the start of study treatment (Week 0) up to the end of Week 52.)
- CHR rates at week 24 and 36(From the start of study treatment (Week 0) up to the end of Week 24 and Week 36, respectively)
- Time to CHR(From the start of study treatment (Week 0) up to the end of Week 52.)
- Change of bone marrow pathology(From the start of study treatment (Week 0) up to the end of Week 52.)
- The incidence of major bleeding events(From the start of study treatment (Week 0) up to the end of Week 52.)
- The proportion of patients crossed to the contralateral group(From the start of study treatment (Week 0) up to the end of Week 52.)
- The CHR rates after crossover(From the start of study treatment (Week 0) up to the end of Week 52.)
- Change of splenomegaly(From the start of study treatment (Week 0) up to the end of Week 52.)
- The incidence of major thrombotic events(From the start of study treatment (Week 0) up to the end of Week 52.)
- Impact of therapy on driver mutations(From the start of study treatment (Week 0) up to the end of Week 52.)
- The incidence of progressing to acute leukemia(From the start of study treatment (Week 0) up to the end of Week 52.)
- Change in Myeloproliferative Neoplasm Symptom Assessment Form total symptom score(From the start of study treatment (Week 0) up to the end of Week 52.)
- Change of quality of life(From the start of study treatment (Week 0) up to the end of Week 52.)
- Change of microcirculation disturbance(From the start of study treatment (Week 0) up to the end of Week 52.)
- Specific pre-defined toxicity(From the start of study treatment (Week 0) up to the end of Week 52.)