NCT06156774招募中不适用
SARcopenia and Simplified Geriatric Assessment in Lymphoma Patients Undergoing CAR-T Cell Therapy: the FIL_SAR-CAR Project
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 21
- 主要终点
- Best Overall Response Rates (ORR)
研究概览
简要总结
This is a multicenter prospective observational study lead by the FIL on sarcopenia and sGA as possible predictors of efficacy and toxicity outcomes in patients undergoing CAR-T cells treatment.
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 (≥ 18 years old).
- •Patients with B-cell non-Hodgkin Lymphoma scheduled to received CAR-T cell product according to Agenzia Italiana del Farmaco (AIFA) indications and technical data sheet of the drug
- •Availability of a 18F-FDG PET/CT scan or a full dose CT scan (without contrast media) pre-treatment with CART
- •Written informed consent voluntarily provided
排除标准
- •Patients not fulfilling the eligibility criteria
结局指标
主要结局
Best Overall Response Rates (ORR)
时间窗: up to 28 months
Best Overall Response Rates (ORR) after CAR-T therapy according to the presence or absence of sarcopenic status
次要结局
- Overall Survival (OS)(up to 28 months)
- Progression-Free Survival (PFS)(up to 28 months)
- Best Complete Remission Rates (CRR)(up to 28 months)
- Incidence of CAR-T related toxicities(up to 28 months)
- Rate of admission to Intensive Care Units (ICU)(up to 28 months)
研究者
研究点 (21)
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