Response to Chimeric Antigen Receptor (CAR)-T Cells Therapy in Patients With Hematologic Malignancies (Lymphoma, Acute Lymphoblastic Leukemia, Multiple Myeloma) Depending on Tumor Characteristics
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 主要终点
- Complete response rate
研究概览
简要总结
Immunotherapy with Chimeric Antigen Receptor (CAR) T Cells, T cells whose receptor has been genetically modified, is based on improving the immune response against the tumor. This approach is promising for patients with hematologic malignancies refractory to chemotherapy. Despite impressive results, too many patients are relapsing. The reasons for the relapse, after the injection of CAR T cells, need to be explored. In this context of newly introduced therapeutics, it is essential to better understand the factors associated with the response to treatment with CAR T Cells, especially the characteristics of the tumor and its microenvironment.
The objective of this study is to understand the role of tumor biology, and its microenvironment, in the response to CAR-T Cells therapy in patients with hematologic malignancies
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient with hematological malignancy (lymphoma, ALL, MM)
- •patient integrated into a CAR-T Cells program treatment
- •patient aged 15 years or over
- •patient having signed a written consent; as well as his legal representative if <18 years old
排除标准
- •patient with other hematological malignancies than lymphoma, LAL or MM
- •patient's weight <58 kg
- •patient treated with another treatment than CAR-T Cells
- •patient under tutorship or curatorship
- •patient not covered by a health system
结局指标
主要结局
Complete response rate
时间窗: 90 days after (CAR)-T cell therapy initiation
次要结局
- Progression-free survival(at 1 year)
- Overall Survival rate(1 year)
- Objective response rate(10 years)
- Incidence of adverse events(at 10 years)
- Proportion of patients with an admission in intensive care(at 90 days)
- Severity of neurological toxicities(at 10 years)
- Proportion of patients with a cytokine release syndrome(at 30 days)