NCT01898663招募中1 期
Safety and Therapeutic Efficacy of DCs Vaccine Combined With Cytokine-induced Killer Cells in Patients With AML: a Phase Ⅰ/Ⅱ Study
Affiliated Hospital to Academy of Military Medical Sciences2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- PFS/OS
研究概览
简要总结
The aim of this Phase Ⅰ/Ⅱ study is to evaluate the safety and efficacy of dendritic cells (DCs) vaccine combined with cytokine-induced killer (CIK) cells in patients with AML. Experimental recombinant adenovirus-transfected DCs, which engineered to express MUC1 and Survivin are used for DCs-based immunotherapy. Based on the results of our previously performed preclinical study with DCs vaccine combined with CIK cells, the investigators plan to perform the clinical trial.
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
- •Consistent with the diagnosis of AML
- •Age≥18 years at time of consent
- •KPS(Karnofsky Performance Scale) ≥70
- •Patient's written informed consent
- •No steroid therapy within 4 weeks of first DC vaccination
- •Stable disease, complete response and partial response(WHO, RECIST)
- •Predicted survival≥3 months
排除标准
- •Serious dysfunction of vital organs(heart, liver or kidney)
- •Received organ transplantation
- •Patients with other malignancies or brain metastases
- •History of autoimmune diseases
- •Pregnant and breast-feeding patient
- •Active or chronic infectious diseases
- •History of allergy or hypersensitivity to study product excipients
- •Currently participating in another clinical trial
- •Received chemotherapy, radiotherapy, immune inhibitor (such as corticosteroid) or other immunotherapy (such as vaccine) during prior 4 weeks
- •Unfit for participating in this clinical trial in investigators' opinions
结局指标
主要结局
PFS/OS
时间窗: 1 years after DC/CIK treatment
次要结局
- Number of participants with adverse events(3 days within DC/CIK treatment)
研究者
研究点 (2)
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