NCT02662647已完成2 期
Decitabine Based Chemotherapy Followed by Haploidentical Lymphocyte Infusion for Elderly Patients With AML
Chinese PLA General Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- complete remission(CR) rate
研究概览
简要总结
Demethylating agent decitabine enhances the immunogenicity of leukemia cells by inducing the expression of cancer testis antigens (CTAs),MHC class I and II molecules,costimulatory molecules and adhesion molecules. The leukemias cells treated by decitabine will become more sensitive to the following adoptive T cell therapy.We proposed a hypothesis that decitabine-based chemotherapy acts in synergestic with haploidentical lymphocyte infusion in eliciting leukemia specific cytotoxic lymphocyte(CTL) and diminishing leukemic cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have a diagnosis of AML based on 2008 World Health Organization (WHO) classification of myeloid malignancies
- •Must have life expectancy >= 3 months
- •Must have the ability to observe the efficacy and events
- •Must have no accompany therapy(including steroid)
- •Patient must have ability to understand and willingness to provide written informed consent prior to participation in the study and any related procedures being performed
- •Must have an Eastern Cooperative Oncology Group (ECOG) performance status =< 3
- •Must have haploidentical donor
- •DONOR Inclusion Criteria:
- •Must have signed the standard informed consent form; if sufficient cryopreserved cells remain from a previous donation, no additional donation or consent is required
- •Both men and women and members of all races and ethnic groups are eligible for this trial
排除标准
- •Must not have an advanced malignant hepatic tumor
- •Must not receive any other forms of chemotherapy after cell infusion during the treatment protocol
- •Must not be receiving any other investigational agents within 14 days of first dose of study drug
- •Must not have uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
- •Must not be pregnant or breastfeeding; pregnant women are excluded from this study because decitabine is a Category D agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with decitabine, breastfeeding should be discontinued if the mother is treated with decitabine; these potential risks may also apply to other agents used in this study
- •Must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to decitabine or other agents used in the study
- •Must not have a known or suspected hypersensitivity to decitabine
- •Must not be human immunodeficiency virus (HIV)-positive and on combination antiretroviral therapy; these patients are ineligible because of the potential for pharmacokinetic interactions with decitabine; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
- •DONOR Exclusion Criteria:
- •Must not have any underlying conditions which would contra-indicate apheresis
- •Must not be pregnant
研究组 & 干预措施
DCAG plus HLI
Experimental
Patient will be treated with decitabine and modified CAG regimen followed by HLA haploidentical peripheral mononuclear blood cells infusion.
干预措施: Decitabine 20 mg/m²/day for 5 days (Drug)
DCAG
Experimental
Patient will be treated with decitabine combining modified CAG regimen without other treatments.
干预措施: Decitabine 20 mg/m²/day for 5 days (Drug)
结局指标
主要结局
complete remission(CR) rate
时间窗: 3 months
次要结局
- overall survival(2 years)
研究者
Li-Xin Wang
MD. PH.D
Chinese PLA General Hospital
研究点 (1)
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