A Prospective, Non-interventional Study of JAKAVI® (Ruxolitinib) Treatment in Patients With Polycythemia Vera (PAVE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 467
- 试验地点
- 1
- 主要终点
- Hematology
研究概览
简要总结
Jakavi® therapy for polycythemia vera (PV) has so far been studied exclusively in clinical trials and at selected clinical trial centres. This observational study is intended to document the therapy of PV in daily practice with a broad patient population and a geographically representative selection of German centres (both hospitals and practices). The prospective mapping of daily practice reality is thus the main goal of this project.
详细描述
To achieve meaningful results in accordance with the study objective and to obtain long-term data from daily clinical practice in a real-world setting, the observation period under Jakavi® therapy is specified as 36 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male and female patients with PV for whom Jakavi® therapy is indicated according to the European summary of product characteristics
- •Patients who have been informed about this NIS and gave written consent
排除标准
- 未提供
结局指标
主要结局
Hematology
时间窗: Up to 36 months
Number of patients with changes in different blood count values over time (hematocrit, erythrocytes, thrombocytes, leukocytes)
Dosing
时间窗: Up to 36 months
Number of patients by initial dosing and number of patients with dose modifications will be provided
Change in spleen size (or volume)
时间窗: Up to 36 months
Measured by palpation/sonography/CT/MRI
Treatment interruptions
时间窗: Up to 36 months
Number of patients with treatment interruptions
Overall survival
时间窗: Up to 36 months
Overall survival for JAK inhibitor naive and pretreated patients
Quality of Life (QoL) - MPN-SAF TSS; MPN-10
时间窗: Up to 36 months
The Myeloproliferative Neoplasm (MPN) Symptom Assessment Form Total Symptom Score (MPN-SAF TSS; MPN-10) questionnaire contains the ten most clinically relevant symptoms reported by patients with MPNs. It includes disease related symptoms each scored from 0 (absent) to 10 (worst imaginable). Total Scores range from 0-100, with higher scores indicating a greater number of symptoms and severity.
Number of phlebotomies
时间窗: Up to 36 months
Total number of phlebotomies
Thromboembolic events
时间窗: Up to 36 months
Number of patients with thromboembolic events.
次要结局
- Change in constitutional symptoms(Up to 36 months)
- Eastern Cooperative Oncology Group (ECOG) performance status(Up to 36 months)
- Molecular examination(Up to 36 months)
- Quality of Life (QoL) - (SF-36)(Up to 36 months)
- Bone marrow aspiration and biopsy(Up to 36 months)