NCT07839858已完成不适用
Real-world Use and Effectiveness of Cytoreductive Strategies for the Treatment of Second-line Polycythemia Vera: A Multicenter, Retrospective, Non-interventional Study in France
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 237
- 试验地点
- 51
- 主要终点
- Proportion of Patients per Type of Second-line Cytoreductive Treatment
研究概览
简要总结
The aim of this study was to assess which cytoreductive treatments are currently administered in standard practice as second-line therapy to patients with polycythemia vera (PV) in France and to find out the reasons physicians switch treatments. In addition, the research aimed to describe real-world effectiveness of second-line cytoreductive therapies and the occurrence of adverse events of special interest.
Study data were collected from the medical charts of patients who initiated a second-line cytoreductive agent for the treatment of PV and received their first dose between 1 Jan 2022 and 31 Dec 2023.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient diagnosed with PV after 01 Jan 2014 according to World Health Organization (WHO) criteria.
- •Patient ≥ 18 years of age at the time of PV diagnosis.
- •Patient who received a first dose of a second-line cytoreductive treatment between 01 Jan 2022 and 31 Dec 2023.
排除标准
- •Patient alive at study initiation who opposed to data use for research purposes.
- •Patient who died before study initiation and who had opposed to data use for research purpose prior to their death.
- •Patient who took part in an interventional clinical trial(s) between 01 January 2022 and 31 December 2023.
研究组 & 干预措施
PV Cohort
Adult PV patients who received a first dose of a second-line cytoreductive treatment between 1 January 2022 and 31 December 2023.
结局指标
主要结局
Proportion of Patients per Type of Second-line Cytoreductive Treatment
时间窗: Day 1 (first dose of second-line cytoreductive treatment)
次要结局
- Age(Day 1 (first dose of second-line cytoreductive treatment))
- Proportion of Patients Who Permanently Discontinued Second-line Cytoreductive Treatment(Up to approximately 12 months)
- Proportion of Patients by Reasons for Switching to Second-line Cytoreductive Treatment(Baseline)
- Initial Dose of Second-line Cytoreductive Treatment Received for Each Type of Treatment(Day 1 (first dose of second-line cytoreductive treatment))
- Duration of Each Line of Treatment(Baseline up to approximately 12 months)
- Duration Between PV Diagnosis and Second-line Cytoreductive Treatment Initiation(Baseline)
- Proportion of Patients With Treatment Interruptions and Dose Modification During Second-line Treatment(Up to approximately 12 months)
- Proportion of Patients per Type of First-line Cytoreductive Treatment(Baseline)
- Proportion of Patients per Type of Third-line Cytoreductive Treatment(Up to approximately 12 months)
- Proportion of Patients by Reasons for Switching to Third-line Cytoreductive Treatment(Up to approximately 12 months)
- Proportion of Patients by Number of Dose Modifications During Second-line Cytoreductive Treatment(Up to approximately 12 months)
- Proportion of Patients per Type of Concomitant Treatment/Procedure During Second-line Cytoreductive Treatment(Up to approximately 12 months)
- Proportion of Patients Who had a Bone Marrow Biopsy Following PV Diagnosis and the Timing of Bone Marrow Biopsy in Relation to First-line Cytoreductive Treatment(Baseline)
- Proportion of Patients Who had a Bone Marrow Biopsy Following PV Diagnosis and the Timing of Bone Marrow Biopsy in Relation to Second-line Cytoreductive Treatment(Baseline)
- Proportion of Patients Achieving Hematocrit Control(Approximately 6 months)
- Proportion of Patients Achieving Clinicohematologic Response(Approximately 6 months)
- Proportion of Patients Achieving Symptom Response(Approximately 6 months)
- Proportion of Patients Achieving Molecular Response(Approximately 6 months)
- Proportion of Patients With Occurrence of Disease Progression Events(Up to 6 approximately months)
- Proportion of Patients With Occurrence of Thromboembolic or Hemorrhagic Events(Up to 6 approximately months)
- Proportion of Patients by Sex(Day 1 (first dose of second-line cytoreductive treatment))
- Proportion of Patients With Cardiovascular and Thromboembolic Risk Factors(Baseline)
- Proportion of Patients With a History of Medical Conditions(Baseline)
- Proportion of Patients With Other Ongoing Comorbidities(Baseline)
- Proportion of Patients per Number and Type of Thromboembolic and Hemorrhagic Events Prior to First-line Treatment(Baseline)
- Proportion of Patients per Number and Type of Thromboembolic and Hemorrhagic Events Between First- and Second-line Cytoreductive Treatment(Baseline)
- Duration Between Most Recent Thromboembolic or Hemorrhagic Event and Initiation of First and Second-line Cytoreductive Treatment(Baseline)
- Proportion of Patients by Reason for Initiating First-line Cytoreductive Treatment(Baseline)
- Proportion of Patients per Type of Pre-specified Emergency Treatment/Procedure Administered Prior to Second-line Cytoreductive Treatment Initiation(Baseline)
- Proportion of Patients by Number of Phlebotomies Required in the 3 Months Prior to Second-line Cytoreductive Treatment(Within the 3 months preceding Day 1 (first dose of second-line cytoreductive treatment))
- Proportion of Patients by PV Symptoms(Day 1 (first dose of second-line cytoreductive treatment))
- MPN-SAF TSS Score(Day 1 (first dose of second-line cytoreductive treatment))
- Hemoglobin Level(Within the 3 months preceding Day 1 (first dose of second-line cytoreductive treatment))
- Hematocrit Level(Within the 3 months preceding Day 1 (first dose of second-line cytoreductive treatment))
- Leukocyte Count(Within the 3 months preceding Day 1 (first dose of second-line cytoreductive treatment))
- Platelet Count(Within the 3 months preceding Day 1 (first dose of second-line cytoreductive treatment))
- Proportion of Patients by Type of Mutation(Baseline)
- Mutant Allele Burden(Baseline)
- Proportion of Patients With Pre-specified Adverse Events of Special Interest Occurring After Initiation of the Second-line Cytoreductive Treatment(Up to 12 months)
研究者
研究点 (51)
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