NCT01758367Unknown1 期
Decitabine Followed by Donor Lymphocyte Infusion for Patients With Relapsed Acute Myeloblastic Leukemia(AML) After Allogeneic Stem Cell Transplantation
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: 2012年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- complete remission rate
研究概览
简要总结
Decitabine can up-regulate a series of immune associated proteins, including cancer testis antigens (CTA), major histocompatibility complex (MHC), co-stimulatory molecules and adhesion molecules, which suggests a potential benefit for a following adoptive T cell therapy. In addition, decitabine induce FOXP3 expression in CD4+ T cells and convert CD4+ T cells into T regulatory cells(Tregs). As a result, Graft versus host disease(GVHD) can be reduced by treatment of decitabine.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 60 years
- •Histologically or cytologically documented relapse of acute myeloid leukemia after a stem cell transplant
- •Must have the ability to observe the efficacy and events
- •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 suitable donor
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
研究组 & 干预措施
Decitabine+DLI
Experimental
Patients with relapsed AML after Allo-HSCT will be treated with decitabine and DLI.
干预措施: Deciatbine(DAC) (Drug)
结局指标
主要结局
complete remission rate
时间窗: 4 months
次要结局
- overall survival(3 Years)
研究者
Li Yu
Director of Department of Hematology
Chinese PLA General Hospital
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Decitabine Combining Modified CAG Followed by HLA Haploidentical Peripheral Blood Mononuclear Cells Infusion for Elderly Patients With Acute Myeloid Leukemia(AML）MDSAMLNCT01690507Chinese PLA General Hospital29
进行中（未招募）
1 期
Oral Decitabine/Cedazuridine (DEC-C) in Combination With Nivolumab for Patients With Mucosal MelanomaMalignant MelanomaNCT05089370University of Colorado, Denver8
已完成
2 期
A Trial of Intravenous Denileukin Diftitox in Stage III or IV Ovarian CancerExtraovarian Peritoneal CancerEpithelial Ovarian CancerFallopian Tube CarcinomaNCT00880360The University of Texas Health Science Center at San Antonio19
已完成
2 期
Decitabine Based Chemotherapy Followed by Haploidentical Lymphocyte Infusion for Elderly Patients With AMLAMLNCT02662647Chinese PLA General Hospital30
已完成
1 期
Denileukin Diftitox Used in Treating Patients With Advanced Refractory Ovarian Cancer, Primary Peritoneal Carcinoma, or Epithelial Fallopian Tube CancerFallopian Tube CancerOvarian Clear Cell CystadenocarcinomaOvarian Endometrioid AdenocarcinomaOvarian Mixed Epithelial CarcinomaOvarian Mucinous CystadenocarcinomaOvarian Serous CystadenocarcinomaOvarian Undifferentiated AdenocarcinomaPeritoneal Cavity CancerRecurrent Ovarian Epithelial CancerStage III Ovarian Epithelial CancerStage IV Ovarian Epithelial CancerNCT00357448University of Washington11