Trial of Immune Reconstitution With CD3/CD28 Bead Activated T-Cells Following Chemo-Immunotherapy in Patients With Chronic Lymphocytic Leukemia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- The ability to complete the outlined course of therapy
研究概览
简要总结
The purpose of this research study is to test whether giving T-cells (type of white blood cell that are also known as immune cells) that have been specially processed in the laboratory will help chronic lymphocytic leukemia (CLL) patients' immune system return to normal faster after chemotherapy. This research study will also look into the ability of the lab to process the T-cells for infusion and the side effects of giving T-cells to patients with chronic lymphocytic leukemia (CLL).
详细描述
Single arm, multi-center trial to evaluate the efficacy of administering CD3/CD28 stimulated T cells to chronic lymphocytic leukemia (CLL) patients following treatment with fludarabine or alemtuzumab based chemo- immunotherapy. All patients will undergo an apheresis to collect peripheral blood mononuclear cells (PBMCs) for generation of expanded T cells post- chemo-immunotherapy. Those subjects who achieve a complete or partial response to the chemoimmunotherapy based regimen will receive an infusion of 1.0 x 1010 (+/- 20%) activated autologous T cells expanded from the collected apheresis unit. Prior to T-cell infusion, at Day +30, +60, and +365 after T cell infusion, blood draws will be performed to assess immune reconstitution and immune function as compared to baseline.
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
- 否
入选标准
- •Diagnosis of CLL by immunophenotyping and flow cytometry analysis of blood or bone marrow.
- •Patients with Rai stage III-IV - OR - Patients with Rai stage 0-II
- •Zubrod performance status of 0-3
- •Prior treatment with fludarabine or alemtuzumab based regimens.
- •No untreated or uncontrolled life-threatening infection
- •Women of childbearing potential must have a negative serum pregnancy test and agree to use a medically accepted form of contraception from the time of initial screening through completion of the study
- •No active CNS disease
- •Negative tests for HIV antibodies, Hepatitis B surface antigen, and hepatitis C antibodies.
排除标准
- •Receipt of glucocorticoids (with the exception of inhaled glucocorticoid steroids for the use of allergic rhinitis or pulmonary disease) within 2 months prior to registration
- •History of autoimmune disease unrelated to CLL (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosis). Autoimmune disease related to CLL, e.g.
- •idiopathic thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia, is permitted if not requiring active treatment
研究组 & 干预措施
Treatment Arm
干预措施: Infusion of CD3/CD28 stimulated T cells (Biological)
结局指标
主要结局
The ability to complete the outlined course of therapy
时间窗: Two years
The ability to harvest, expand, and reinfuse autologous T cells in this target population of patients
时间窗: Two years
The occurrence of treatment-related adverse events or treatment related trial discontinuations, defined as NCI CTC ≥ grade 3 and clinical events that are possible, likely, or definitely related to study treatment at any time
时间窗: Two years
次要结局
未报告次要终点