Patient-reported and Clinical Outcomes in Adults With Relapsed or Refractory Hodgkin's Lymphoma Receiving Brentuximab Vedotin: a Multicenter, Prospective, Observational Study in a Real World Setting
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 9
- 主要终点
- Change in QoL and symptom severity while treatment with BV
研究概览
简要总结
The goal of this is study is focusing on assessment of patient-reported outcomes in terms of quality of life (QoL) and symptom profile as well on evaluation of clinical efficacy and safety of BV in patients with refractory/resistant HL in a real-world setting.
详细描述
Information on QoL in patients with refractory/relapsed HL treated with BV is quite limited till now. Moreover, PRO data in patients treated for refractory/relapsed HL with BV, including long-term effects of BV on patient's QoL in a real-world setting are lacking.
The goal of this is study is focusing on assessment of patient-reported outcomes in terms of QoL and symptom profileas well on evaluation of clinical efficacy and safety of BV in patients with refractory/resistant HL in a real-world setting.
For PROs assessment QoL and symptom data will be received from patients' reports before and at 3, 6, 9, 12 months after BV treatment start and in 3 months at follow-up (15 months after base-line). The maximum duration of PRO monitoring - 15 months. To evaluate PROs the followings tools will be used: RAND SF-36 for quality of life assessment, Edmonton Symptom Assessment System (ESAS-R) for symptom assessment and Patient Global Impression of Change (PGIC) for assessment of a patient's belief about the effect of treatment.
For evaluation of response rates, duration of response, PFS and for analysis of AEs/SAEs during BV treatment the clinical data will be collected from health records at base-line, at 3, 6, 9, 12 months after BV treatment start and at 15 months of follow-up or till the last dose of BV.
No randomization and stratification will be applied. The analysis of primary (PROs assessment) and secondary outcomes (clinical outcomes) will be provided in the total patient population (n=70) and in two subgroups. The subgroups of interest will be: patients with relapsed or refractory HL who are not candidates for ASCT with prescribed treatment with BV as ≥2nd line therapy, and patients with relapse after ASCT with prescribed treatment with BV.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with confirmed diagnosis of relapsed or refractory HL
- •At least 18 years of age at time of BV treatment decision
- •Patients with relapsed or refractory HL who are not candidates for ASCT with prescribed treatment with BV as ≥2nd line therapy, and patients with relapse after ASCT with prescribed treatment with BV
- •Patients with given informed consent
- •Patients who are capable to fill out questionnaires
- •Patients with expected life duration of at least 6 months
排除标准
- •Patients enrolled in clinical trials
- •Patients with contraindications to BV in accordance with instruction for use
结局指标
主要结局
Change in QoL and symptom severity while treatment with BV
时间窗: At 3, 6, 9 and 12 months of BV treatment and at 15 months after treatment start
The change in QoL will be assessed as the difference in QoL scales of RAND SF-36 as compared to their baseline and the difference in proportion of patients with significant negative impact on QoL. The change in symptom severity will be assessed as the difference in the severity of each ESAS-R scale and the symptom distress score as compared with their baseline value. The proportion of patients with ≥1 point improvement on ESAS-R scale will be analyzed as well.
次要结局
- Progression-free survival (PFS)(15 months)
- Adverse events (AEs)/serious AEs(At 3, 6, 9 and 12 months of BV treatment)
- Overall response rate(At 3, 6, 9 and 12 months of BV treatment at treatment discontinuation)