CAR-T Cells - Real Life Study Of Care Pathway And Total Cost Of Care For Patients Under Car T-Cell Treatment Based On The PMSI French Database
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 273
- 试验地点
- 1
- 主要终点
- Time to next treatment (TTNT) or death analysis: number of events
研究概览
简要总结
This was a Retrospective cohort study based on the PMSI data source
详细描述
A retrospective database analysis was performed using the French national hospital claims database (Medicalized Information System Program - PMSI, 2015-2019), which includes discharge summaries for all hospital admissions in France (~99% of French residents).
The patients were identified based on the CAR-T administration hospital stay, between 2017 and 2019. Based on the exhaustivity of the database, all patients treated with CAR-T (since 2018) were identified.
The study design included multiple periods of analysis based on the CAR-T process. Three main periods were defined: the historical period, the CAR-T period, and the post CAR-T period. The CAR-T period was divided in 2 sub-periods: pre CAR-T (including the apheresis procedure and 15 days before this procedure) and per CAR-T (including the lymphodepletion and CAR-T cell injection hospital stay until the end at the discharge date related to CAR-T cell injection hospital stay). The follow-up period started at the end of CAR-T hospital stay.
CAR-T populations:
KYMRIAH® DLBCL cohort:
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 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients treated with CAR-T cells from 2017 to 2019 and informed as such in the PMSI And
- •Patients diagnosed with ALL or DLBCL when administering CAR-T cells and
- •up to 25 years for patients with ALL
排除标准
- •All patients treated outside the two types of indications presented in the inclusion criteria will be excluded
结局指标
主要结局
Time to next treatment (TTNT) or death analysis: number of events
时间窗: through study completion, approximately 2 years (January 2017 to December 2019)
Time to next treatment or death indicator was defined as the first event occurring between TNTT or death presented during the hospitalization or palliative care.
Overall survival: number of events
时间窗: through study completion, approximately 2 years (January 2017 to December 2019)
Overall survival indicator was defined as all cause death recorded at the hospital (MSO, HAD, SSR). Patients were censored at the date of last hospitalization observed (MSO/HAD/SSR/ACE).
Time to next treatment (TTNT) analysis: number of events
时间窗: through study completion, approximately 2 years (January 2017 to December 2019)
Time to next treatment indicator was defined as the time between CAR-T injection and the date of the hospitalization or palliative care.
Overall cost for CAR-T hospitalization
时间窗: through study completion, approximately 2 years (January 2017 to December 2019)
The CAR-T hospitalization included Medical, Surgical, Obstetrics (MSO) hospitalization tariff and extra tariff linked to CAR-T treatment reimbursed by the health care insurance
Follow-up time between the CAR-T injection and the last hospital stay observed
时间窗: through study completion, approximately 2 years (January 2017 to December 2019)
Follow-up is the time between the CAR-T injection (index date) and the last hospital stay observed.
次要结局
未报告次要终点