A Feasibility Study of Ropeginterferon for Treatment Free Remission in CML Patients Who Have a Sustained Deep Molecular Response
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Treatment-Free Remission (TFR) rates by 12 months after TKI discontinuation
研究概览
简要总结
Ropeginterferon is a long-acting next-generation mono-pegylated interferon alfa-2b consisting of one isoform produced by PharmaEssentia Co. and the pegylated (PEG) formulations that require less frequent administration and have improved efficacy and tolerability.
In this study, patients in the investigational arm will receive Ropeginterferon subcutaneously with 250 μg at week 0, 350 μg at week 2, 500 μg at week 4, and thereafter 500 μg bi-weekly until week 24.
详细描述
This is a pilot, randomized, two-arm, prospective study with or without Ropeginterferon in CML patients who have sustained MR4.5 for 24 months or more with TKIs.
The patients will be randomized to either
- Investigational arm with Ropeginterferon (50 patients): Patients will be treated with 250 μg at week 0, 350 μg at week 2, and then 500μg at week 4, and thereafter bi-weekly subcutaneous injection until week 24
- Comparator arm (50 patients): Patients will be followed with no further CML treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A patient must satisfy all the following criteria to be enrolled in the study.
- •New CML-CP at diagnosis
- •Patients aged 19 or more and 75 or less
- •BCR-ABL1 transcripts with e13a2 or e14a2 transcripts
- •Sustained MR4.5 for 24 months or more
- •Signed written informed consent
排除标准
- •Any contraindication to any of the interferon 2) Documented autoimmune disease at screening or in the medical history 3) Clinically relevant pulmonary infiltrates, pneumonia, and pneumonitis at screening 4) Systemic infections, e.g. hepatitis B, hepatitis C, or HIV at screening 5) Any investigational drug less than 6 weeks before the first dose of study drug or not recovered from effects of prior administration of any investigational agent 6) History or presence of depression requiring treatment with antidepressant 7) Any risk of suicide at screening or previous suicide attempts 8) Any significant morbidity or abnormality which may interfere with the study participation 9) Pregnancy and breast-feeding females of reproductive potential and males not using effective means of contraception 10) History of active substance or alcohol abuse within the last year 11) Evidence of severe retinopathy (e.g. cytomegalovirus retinitis, macular degeneration) or clinically relevant ophthalmological disorder (due to diabetes mellitus or hypertension) 12) Thyroid dysfunction not adequately controlled 13) History of major organ transplantation 14) History of uncontrolled severe seizure disorder 15) Leukocytopenia at the time of screening (count: < 4.0 x 109/L) 16) Thrombocytopenia at the time of screening (count: < 100 x 109/L) 17) History of other malignant diseases except for CML, including solid tumors and hematological malignancies (except basal cell and squamous cell carcinomas of the skin and carcinoma in situ of the cervix that has been completely excised and is considered cured) within the last 3 years
研究组 & 干预措施
randomized two-arm prospective study with/without Ropeginterferon in CML patients
The patients will be randomized to a ratio of 1:1 for each group
- Investigational arm with Ropeginterferon (50 patients): Patients will be treated with 250 μg at week 0, 350 μg at week 2, and then 500 μg at week 4, and thereafter bi-weekly subcutaneous injection until week 24
- Comparator arm (50 patients): Patients will be followed with no further CML treatment
干预措施: Ropeginterferon (Drug)
结局指标
主要结局
Treatment-Free Remission (TFR) rates by 12 months after TKI discontinuation
时间窗: the screening and week 4/8/12/16/20/24/32/40/48/60/ 72 then after every 12 weeks.
To assess the preventive efficacy of Ropeginterferon in Major Molecular Response (MMR) loss after TKI discontinuation
次要结局
未报告次要终点
研究者
Dong-Wook Kim
Professor
Eulji University Hospital