Trial of Immune Reconstitution With Activated T-Cells in Patients With Chronic Lymphocytic Leukemia (CLL)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Treatment Success and Feasibility of Autologous Activated T-cells Infusion, Determined by Number of Participants That Achieved Target-Activated T-cell Dose Without DLT.
研究概览
简要总结
This phase II trial studies the side effects of ex vivo-activated autologous lymph node lymphocytes infusion and to see how well they work in treating patients with chronic lymphocytic leukemia. Biological therapies, such as ex vivo-activated autologous lymph node lymphocytes, use substances made from living organisms that may stimulate or suppress the immune system in different ways and stop tumor cells from growing.
详细描述
PRIMARY OBJECTIVES:
I. To assess the feasibility and safety of infusion of autologous activated T-cells (ex vivo-activated autologous lymph node lymphocytes) in patients with chronic lymphocytic leukemia.
SECONDARY OBJECTIVES:
I. To study immune reconstitution following infusion of activated T-cells in patients with chronic lymphocytic leukemia.
II. To study the incidence of infections for up to 1 year following activated T cell infusion.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients must have a diagnosis of chronic lymphocytic leukemia (CLL) by immunophenotyping and flow cytometry analysis of blood or bone marrow
- •Patients must meet criteria for treatment based on the criteria proposed by National Cancer Institute (NCI)-sponsored CLL Working Group to include at least one of the following:
- •Weight loss of more than 10% over the preceding 6 months; or
- •Extreme fatigue attributable to progressive disease; or
- •Fever or night sweats without evidence of infection; or
- •Worsening anemia (Rai stage Ill) or thrombocytopenia (Rai stage IV); or
- •Massive lymphadenopathy (> 10 cm) or rapidly progressive lymphocytosis (lymphocyte doubling time < 6 months); or
- •Prolymphocytic or Richter's transformation; or
- •Patients with CLL who have received at least one prior line of therapy; or
- •Patients with CLL who have frequent infections and/or recurrent secondary cancers
- •No active central nervous system (CNS) disease
- •All patients must have a Karnofsky performance score > 60%
- •Calculated creatinine clearance (by Cockcroft-Gault) of > 50 ml/min
- •Patients must not have untreated or uncontrolled life-threatening infection
- •Patients must sign informed consent
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 weeks of registration
- •Autoimmune disease related to CLL, e.g., idiopathic thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia, is permitted if not requiring active treatment
结局指标
主要结局
Treatment Success and Feasibility of Autologous Activated T-cells Infusion, Determined by Number of Participants That Achieved Target-Activated T-cell Dose Without DLT.
时间窗: Enrollment up to day 100 post T cell infusion for each arm.
Success will be defined as achievement of a target activated T-cell dose of 1x108 +/-20% without DLT and the lack of dose limiting toxicity (DLT). DLT for this trial is defined as any Grade 4 or higher non-hematologic toxicity or grade 3 or 4 allergy/immunology toxicity, allergic reaction or urticaria grade 3 or higher by +90 days after T cell infusion, Grade 2 or greater autoimmune phenomena, or Grade 4 or higher hematologic toxicity (with the exception of any preexisting AE due to prior treatment or due to disease) deemed related to T cells and occurring by day +90 after T cell infusion. Feasibility is defined as achievement of the target T-cell dose (1x108 +/-20% ) without DLT in \>50% of patients enrolled.
次要结局
- Incidence of Infections(Up to 1 year)
- Immune Reconstitution(Up to 1 year)
- Overall Response Rates(Up to 1 year)