LOW-PV Continuation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 26
- 主要终点
- Maintenance of Treatment response
研究概览
简要总结
This multicenter longitudinal observational study focuses on Italian patients with Polycythemia Vera (PV) who were enrolled in the Low-PV RCT and continued receiving Ropeginterferon alfa-2b until the study's conclusion on March 31, 2023. It includes patients who were responders to Ropeginterferon alfa-2b after two years in the phase II randomized trial "LOW-PV." Data will be collected retrospectively every 6 months from March 31, 2023 to November 30, 2024 and prospectively from December 1, 2024 to March 31, 2026.
详细描述
Multicentre longitudinal observational Italian study of patients with Polycythemia Vera (PV) enrolled in Low-PV RCT and still receiving the experimental drug (i.e., Ropeginterferon alfa-2b) at study end (31-03-2023). Thirty-six patients who completed the Low-PV RCT and were responders to Interferon, continued treatment with the drug and are followed at their respective centers in Italy. The "LOW-PV Continuation" study aims to collect after 1,2,3 years the data on these patients, regardless of the treatment they were undergoing at the time of enrollment in the current study, after their informed consent. In details, data will be collected retrospectively from March 31, 2023 to November 2024 and prospectively from December 1, 2024 to March 31, 2026.
Given the descriptive nature of the study, no formal statistical hypothesis will be made.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients enrolled in the LOW-PV RCT study who continued to receive Ropeginterferon alfa-2b until the conclusion of the study on March 31,
- •These patients will be included regardless of the treatment they are undergoing at the time of enrollment in the current study.
- •Patients who have signed the written informed consent for study participation.
排除标准
- 未提供
结局指标
主要结局
Maintenance of Treatment response
时间窗: From date of randomization until the date of follow up assessed up to 6 months.
Median HCT lower than 45% without disease progression
次要结局
- Complete hematological (CHR) and clinical remission (CR)(From date of randomization until the date of follow up assessed up to 6 months)
- Change in JAK2 variant allele frequency (VAF) since treatment start(From date of randomization until the date of follow up assessed up to 6 months)
- Frequency of phlebotomies(From date of randomization until the date of follow up assessed up to 6 months)
- Change in spleen size since treatment start(From date of randomization until the date of follow up assessed up to 6 months)
- Incidence of any of the following: o arterial and venous thrombotic events; o hemorrhagic events; o disease related symptoms; o disease evolutions into myelofibrosis and acute leukemia; o secondary malignancies o death(During the follow up every 6months per patient.)
- Discontinuation of Ropeginterferon alfa-2b for any reason(From date of randomization until the date of follow up assessed up to 6 months)
- Incidence and grading of any adverse event related to Ropeginterferon alfa-2b(From date of randomization until the date of follow up assessed up to 6 months)