Response to Chimeric Antigen Receptor (CAR)-T Cells Therapy in Patients With Hematologic Malignancies Depending on Tumor Characteristics (BIOCART-HM)
2019年12月20日 更新者：Assistance Publique - Hôpitaux de Paris
Response to Chimeric Antigen Receptor (CAR)-T Cells Therapy in Patients With Hematologic Malignancies (Lymphoma, Acute Lymphoblastic Leukemia, Multiple Myeloma) Depending on Tumor Characteristics
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
研究概览
地位
尚未招聘
条件
研究类型
观察性的
注册 (预期的)
600
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Matthieu RESCHE-RIGON
- 电话号码：0142499742 0142499742
- 邮箱：matthieu.resche-rigon@univ-paris-diderot.fr
研究联系人备份
- 姓名：Catherine Thieblemont
- 电话号码：+331 42 49 92 36
- 邮箱：catherine.thieblemont@aphp.fr
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
15年 及以上 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients with hematological malignancy
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
Patients with haematological malignancy
Patients, aged 15 years or over, with haematological malignancy (Lymphoma, ALL, MM) integrated into a CAR-T Cells program treatment
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Complete response rate
大体时间：90 days after (CAR)-T cell therapy initiation
|
90 days after (CAR)-T cell therapy initiation
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
客观反应率
大体时间：2年
|
2年
|
|
|
无进展生存期
大体时间：在 1 年
|
在 1 年
|
|
|
客观反应率
大体时间：1年
|
1年
|
|
|
Overall Survival rate
大体时间：1 year
|
1 year
|
|
|
Objective response rate
大体时间：30 days
|
30 days
|
|
|
Objective response rate
大体时间：90 days
|
90 days
|
|
|
Objective response rate
大体时间：5 years
|
5 years
|
|
|
Objective response rate
大体时间：10 years
|
10 years
|
|
|
Incidence of adverse events
大体时间：at 30 days
|
at 30 days
|
|
|
Incidence of adverse events
大体时间：at 90 days
|
at 90 days
|
|
|
Incidence of adverse events
大体时间：at 1 year
|
at 1 year
|
|
|
Incidence of adverse events
大体时间：at 2 years
|
at 2 years
|
|
|
Incidence of adverse events
大体时间：at 5 years
|
at 5 years
|
|
|
Incidence of adverse events
大体时间：at 10 years
|
at 10 years
|
|
|
Proportion of patients with an admission in intensive care
大体时间：at 30 days
|
at 30 days
|
|
|
Proportion of patients with an admission in intensive care
大体时间：at 90 days
|
at 90 days
|
|
|
Severity of neurological toxicities
大体时间：at 30 days
|
Severity of neurological toxicities will be assessed by physical, and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
|
at 30 days
|
|
Severity of neurological toxicities
大体时间：at 90 days
|
Severity of neurological toxicities will be assessed by physical examination and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
|
at 90 days
|
|
Severity of neurological toxicities
大体时间：at 6 months
|
Severity of neurological toxicities will be assessed by physical, cognitive examination and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
|
at 6 months
|
|
Severity of neurological toxicities
大体时间：at 2 years
|
Severity of neurological toxicities will be assessed by physical examination and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
|
at 2 years
|
|
Severity of neurological toxicities
大体时间：at 5 years
|
Severity of neurological toxicities will be assessed by physical examination and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
|
at 5 years
|
|
Severity of neurological toxicities
大体时间：at 10 years
|
Severity of neurological toxicities will be assessed by physical examination and by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
|
at 10 years
|
|
Proportion of patients with a cytokine release syndrome
大体时间：at baseline
|
Cytokine release syndrome will be assessed by CTCAE v5.0
|
at baseline
|
|
Proportion of patients with a cytokine release syndrome
大体时间：at 7 days
|
Cytokine release syndrome will be assessed by CTCAE v5.0
|
at 7 days
|
|
Proportion of patients with a cytokine release syndrome
大体时间：at 30 days
|
Cytokine release syndrome will be assessed by CTCAE v5.0
|
at 30 days
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2019年12月1日
初级完成 (预期的)
2025年3月1日
研究完成 (预期的)
2035年3月1日
研究注册日期
首次提交
2019年11月22日
首先提交符合 QC 标准的
2019年12月20日
首次发布 (实际的)
2019年12月24日
研究记录更新
最后更新发布 (实际的)
2019年12月24日
上次提交的符合 QC 标准的更新
2019年12月20日
最后验证
2019年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.