Effectiveness and Safety for Re-treatment With Brentuximab-Vedotin (BV) in Patients With Relapsed/Refractory (R/R) CD30+ Malignancies: a Retrospective Medical Chart Review Study in Spain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 30
- 主要终点
- Number of Participants Reporting one or More Adverse Events (AEs)
研究概览
简要总结
Participants in the study are adults with CD30-positive malignancies which include classical Hodgkin lymphoma (cHL), cutaneous T-cell lymphoma (CTCL): mycosis fungoides (MF) or primarily cutaneous anaplastic large cell lymphoma (pcALCL), or systemic anaplastic large cell lymphoma (sALCL).
The main aims of the study are as follows:
- to learn about the response rates of participants with relapsed or refractory CD30+ malignancies when re-treated with BV.
- to check for side effects from re-treatment with BV.
The study will take place in approximately 30 hospitals in Spain.
The study doctors will review each participant's medical record at least 6 months after finishing the last dose of re-treatment with BV. This study is about collecting existing information only; participants will not receive treatment or need to visit a study doctor during this study.
详细描述
This is an observational, non-interventional, retrospective study in participants with R/R CD30 positive cHL, CTCL (MF and pcALCL) and sALCL who have previously achieved a CR or PR with BV treatment and subsequently experienced disease progression were administered BV retreatment.
This study will assess the effectiveness and safety of BV retreatment in the Spanish population in real-world clinical practice. The study will enroll approximately 35 participants.
The data will be collected and recorded from the medical record of participants and also recorded in electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:
• Participants With CD30-positive Lymphoma
This multi-center trial will be conducted in Spain. The overall duration of the study will be approximately 24 months (12 months for medical chart review and 12 until publication submission).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed cHL, CTCL (MF and pcALCL) or sALCL with CD30 positive.
- •Previously treated with BV containing regimen, with evidence of objective response (determined by having achieved CR or PR), and subsequent disease progression or relapse after discontinuing treatment BV retreatment.
- •Participants with data of disease relapse or progression greater than or equal to (>=) 6 months since the last dose of the first treatment with BV.
- •Participant with data available at the participating site since diagnosis of cHL, CTCL (MF and pcALCL) or sALCL.
- •Having received at least, two doses of BV as retreatment and having follow up information available at the site for a minimum period of six months or until death.
排除标准
- •There are no exclusion criteria for this study.
结局指标
主要结局
Number of Participants Reporting one or More Adverse Events (AEs)
时间窗: Up to 12 months
Overall Response Rate (ORR) as Assessed by Investigator Based on Positron Emission Tomography/Computerized Tomography (PET/CT) Status
时间窗: Up to 6 months post-index date or death, whatever come first
ORR is the percentage of participants whose best overall response (graded by favorability in the order of clinical response \[CR\], partial response \[PR\], stable disease \[SD\], progressive disease \[PD\], and not evaluable \[NE\]) from initiation of BV retreatment to the discontinuation or end of treatment according to response criteria is either CR or PR. ORR will be assessed by investigator using 5-point scale for visually assessing response on the pre and end-of-treatment PET/CT scans. The 5-point scale ranges from: 1 (No uptake), 2 (Uptake less than or equal to \[\<=\] mediastinum), 3 (Uptake greater than \[\>\] mediastinum but \<=liver), 4 (Uptake moderately \>liver), and 5 (Uptake markedly higher than liver and/no new lesions). Total score ranges from 0-5. In case of unavailability of PET/CT scans, ORR will be assessed as per Revised Criteria for Response Assessment for Malignant Lymphoma. Index date: eligible participants who start BV as retreatment.
次要结局
- Duration of Response (DOR) Based on PET/CT Status(Up to 6 months post-index date or death, whatever come first)
- Percentage of Participants With Complete Response Based on PET/CT Status(At the end of retreatment (up to 6 months post-index date or death, whatever come first))
- Time to Clinical Response (CR or PR)(From the index date to the date of documented CR or PR (up to 6 months))
- Time to Best Response(From the index date to first documentation of best response documented (up to 6 months))
- Time to Treatment Failure (TTF)(From the index date to first documentation of objective tumor progression or the day of death due to all causes (up to 6 months))
- Overall Survival (OS)(From the index date to the date of death from any cause or end of follow-up (up to 6 months))