Phase II Study of Autologous Lymphocyte Infusions After Radiation Therapy to Mitigate Radiation Induced Lymphopenia and Enhance Immune Reconstitution in Patients With Solid Tumor Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- To evaluate the absolute lymphocyte counts in lung and esophageal cancer patients who had undergone chemoradiation. (CRT)
研究概览
简要总结
The goal of this clinical research study is to learn if giving autologous lymphocyte infusions to patients who are receiving chemotherapy and radiation for non-small cell lung cancer or esophageal cancer is safe and effective.
详细描述
The purpose of this study is to determine the safety and preliminary efficacy of un-manipulated autologous lymphocyte infusion (ALI) using the patient's own lymphocytes collected using apheresis, and infused after the completion of radiation/chemoradiation. Primary Objective To investigate the preliminary efficacy of autologous lymphocyte infusion (ALI) in improving the absolute lymphocyte counts in lung and esophageal cancer patients who had undergone chemo-radiation (CRT). Secondary Objectives
- To evaluate the feasibility and safety of ALI in patients who had undergone chemoradiation.
- To identify lymphocyte clonal populations in the tissue that are specific for tumor cells
- To identify immune reconstitution in the peripheral blood shaped by ALI.
- To conduct clonal analysis using T-cell receptor (TCR) sequencing from tumor and from peripheral blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 是
入选标准
- •Histologically or cytologically documented NSCLC or esophageal cancers Stage II-IVA disease where definitive chemoradiation is the standard of care Age 18
排除标准
- •Prior radiotherapy to the chest Life expectancy<6 months Any systemic therapy, aside from standard of care immunotherapy, that is planned to be administered prior to 6 weeks after ALI. Pregnancy
结局指标
主要结局
To evaluate the absolute lymphocyte counts in lung and esophageal cancer patients who had undergone chemoradiation. (CRT)
时间窗: Baseline to 6 weeks
The primary outcome is the change between the two measures, i.e., absolute lymphocyte counts at week 6 (+/- 14 days) minus baseline ALC, referred as ALC change. Recently, we reviewed 755 patients with stage I-III esophageal carcinoma who received concurrent CRT with or without surgery in 2004-2015 \[1\]. The means of the absolute lymphocyte counts were 1,570 cells/µL (SD=610) and 980 cells/µL (SD=600) at based line and at the first follow-up visit post-CRT, respectively. We incorporate this clinical evidence in our sample size justification.
次要结局
- To evaluate the safety of ALI in patients who had undergone chemoradiation.(Baseline to 6 weeks)
- To evaluate the feasibility of ALI in patients who had undergone chemoradiation.(Baseline to 6 weeks)