Pilot Study for Quality Of Life and Drug Use Assessment in Patients With CAR-T Cells
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change of Mean quality of life score using the EORTC-QLQ C30 questionnaire
研究概览
简要总结
CAR-T cells are a major therapeutic innovation in the management of patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) in 3rd line or more. Kymriah® and Yescarta® are the first CAR-T with Marketing Authorization and coverage by the French Health Insurance. Their clinical interest has been demonstrated in non-comparative phase 1-2 trials.
The non-comparative design of the pivotal trials, the lack of data on patients' quality of life and drug consumption, as well as the very high cost of CAR-T (about € 320,000 for one treatment) warrant further studies.
This prospective non-comparative study aims to describe in real life the quality of life of patients treated with CAR-T cells, real world drug use and patients' experience feedback.
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
- •Over 18 years old
- •Eligible for treatment with CAR-T cells (outside any clinical trial) in an indication of DLBCL and for which treatment is scheduled
- •Follow-up in the Hematology department of the Hospices Civils de Lyon
- •Without major psychiatric disorder likely to interfere with the conduct of the study, in the opinion of the investigator
- •Having given his non-opposition to participate in the study.
排除标准
- •In an institution
- •Under legal protection
研究组 & 干预措施
Patients with diffuse large B-cell lymphoma treated with CART-cells
干预措施: Semi-structured interviews and self-administered questionnaires (Other)
结局指标
主要结局
Change of Mean quality of life score using the EORTC-QLQ C30 questionnaire
时间窗: Inclusion (the day before lymphodepletion chemotherapy), Month 3 and Month 6 after the administration of CART-T cells
Self-administered questionnaire EORTC-QLQ C30 (European Organisation for Research and Treatment of Cancer), developed to assess the quality of life of cancer patients, with 30 items. Score ranges from 0 (the worse) to 100 (the best).
次要结局
未报告次要终点