Exploration of Adaptive Antitumoral Immune Cells Through Lymphapheresis in Cancer Patients : ALCYTA
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Evaluation of the presence of tumor-antigen specific T cells for Cohorts B
研究概览
简要总结
The study will evaluate the detection of tumor-antigen specific immune cells in cancer patients in whom the role of the immune system is suspected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- None
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
- •Patient aged 18 or over,
- •Patient presenting an invasive tumor pathology (proven or suspected). The location and / or stage of which are defined for each cohort through an amendment to the protocol,
- •Patient treated with immune-modulators or other treatments likely to modify immunological parameters,
- •Suspicion of immune mediated response or toxicities (assessed by the immunologists),
- •Peripheral venous capital usable and compatible with the realization of 2 venous accesses for lymphapheresis and absence of cardiovascular problem (heart failure, arrhythmia ...), per investigator assessement,
- •Total circulating lymphocytes> 1000 / mm3,
- •Availability of DNA and RNA from the tumor,
- •Information to the patient and signature of informed consent or his legal representative,
- •Affiliated with a social security scheme or such a scheme.
排除标准
- •Inability to undergo study follow-up for geographical, social or psychological reasons,
- •Infection with HIV or hepatitis B or C viruses,
- •Patients on high dose corticosteroid treatment (> 1 mg / kg continuously),
- •Any concomitant serious illness that may interfere with participation in the study or significantly affect the results of the study (pulmonary, heart or liver disease),
- •Contraindication to performing lymphapheresis (coagulation disorder, cardiovascular problems, venous access, hypocalcemia, psychological inability to undergo extracorporeal circulation, cachexia, etc.),
- •Pregnant patient or of childbearing age without effective contraception,
- •Persons deprived of their liberty, under guardianship or legal protection.
研究组 & 干预措施
first type, called "A" Cohorts
The first type, called "A" Cohorts, corresponds to indications for which the treatment induces a high response rate (>30%). These patients will have a lymphapheresis before and during treatment with immunotherapy. In addition, a blood sample in CellSave® tubes (15mL) will be taken at baseline and three weeks, and EDTA tubes (15mL) will be taken at baseline, 3 weeks after treatment start and at progression.
干预措施: blood sample (Other)
second type, called "B" Cohorts
The second type, called "B" Cohorts, corresponds to indications for which a role of the immune system is suspected. Only the so-called "informative" patients (responders or surprising evolution) will have one lymphapheresis during treatment. The lymphapheresis will be performed between 8 weeks and 18 months after the start of treatment and depending on the clinical course determined by the clinicians in consultation with at least one immunologist (Olivier Lantz, Emanuela Romano, Marion Alcantara).
干预措施: blood sample (Other)
结局指标
主要结局
Evaluation of the presence of tumor-antigen specific T cells for Cohorts B
时间窗: between 8 weeks and 18 months after the start of treatment
Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs.
Evaluation of the presence of tumor-antigen specific T cells for Cohorts A
时间窗: at progression (up to 100 weeks)
Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs.
Evaluation of the presence of tumor-antigen specific T cells for Cohorts A
时间窗: before treatment
Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs.
Evaluation of the presence of tumor-antigen specific T cells for Cohorts A
时间窗: During treatment
Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs.
Evaluation of the presence of tumor-antigen specific T cells for Cohorts A
时间窗: at baseline
Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs.
Evaluation of the presence of tumor-antigen specific T cells for Cohorts A
时间窗: 3 weeks after treatment start
Presence of tumor-antigen specific T cells using multiplex tetramers and ELISPOTs.
次要结局
未报告次要终点