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DCHA as Postremission Therapy for AML With t(8;21)

2018年3月1日 更新者:Li Yu、Chinese PLA General Hospital

Decitabine in Combination With Chidamide, Homoharringtonine and Ara-c (DCHA) as Postremission Therapy for Acute Myeloid Leukemia With t(8;21) :A Multicenter Prospective Study

Acute myelocytic leukemia ( AML) is a highly heterogeneous group of malignant hematopathy. Chromosomal translocation with t (8; 21) (q22; q22) , about 10 ~ 15% incidence in AML and 40% incidence in the AML-M2 type of leukemia, is a karyotype that is considered to have a good prognosis. The National Comprehensive Cancer Network (NCCN) guidelines recommend that high-dose Ara-c regimens may benefit for patients, but with 30 to 40% relapse and serious risks on myelosuppression, infection and bleeding in high-dose Ara-c consolidation chemotherapy and more than 70% recurrence rate with (tyrosine kinase)KIT mutation. So the exploration of a relatively safe and efficient consolidation therapy is one of the difficult problems to be solved in the treatment of mitigatory t (8; 21) AML.

研究概览

地位

未知

条件

详细说明

Treatment regimen

HA:

homoharringtonine 2mg IV d1-5 cytarabine( Ara-C) 1500mg/m2(<60 year old) ; 1000mg/m2(>60 year old) IV q12h

DCHA:

Decitabine 20mg/m2 d8-12 Chidamide 30mg twice/week P.O. for two weeks per cycle (four doses totally) cytarabine( Ara-C) 1500mg/m2(<60 year old) ; 1000mg/m2(>60 year old) IV q12h d1,3,5 homoharringtonine 2mg IV d10-14

研究类型

介入性

注册 (预期的)

120

阶段

  • 阶段2
  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

      • Beijing、中国、100853
        • 招聘中
        • Chinese PLA General Hospital
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

14年 至 65年 (孩子、成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • • Written informed consent provided.

    • The patients were diagnosed AML-M2 with t(8;21) (q22;q22) chromosomal changes and positive acute myeloid leukemia(AML1)-eight twenty one(ETO) fusion gene according to the 2008 World Health Organization (WHO) diagnostic criteria for malignant myeloid diseases.
    • Males or females aged ≥18 years, < 65 years.
    • Eastern Cooperative Oncology Group(ECOG) performance status 0-3.
    • Life expectancy ≥3 months.
    • The morphology was Complete remission (CR) or Cri after 2 cycles of anthracycline induced chemotherapy.
    • No serious disease with heart, lung, liver and kidney.
    • The ability to understand and be willing to sign the Informed Consent Form of the experiment.
    • Patient who can start the investigational therapy within 3-6 weeks after the complete resection
    • Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN in subjects without liver metastases; ≤ 5 x ULN in subjects with liver metastases.
    • Adequate renal function: Serum creatinine ≤ 1.25 x ULN, or ≥ 60 ml/min.
    • Female subjects should not be pregnant or breast-feeding.

Exclusion Criteria:

  • Known allergic to prior treatment with drugs contained by the trial programme or with a chemical structure similar medicine.
  • Pregnancy, breast-feeding women and childbearing age patients who do not want to take contraceptive measures.
  • Active serious infection.
  • Patients with extramedullary lesions.
  • Patients who use drugs or drink alcohol for a long time to influence the evaluation of results.
  • Patients with mental illness or other conditions are unable to obtain knowledge and consent, and can not cooperate with the requirements of the completion of the test treatment and examination steps.
  • Patients with a history of the clinical significance of Q and T interval(QTc) prolongation (male > 450ms, female >470ms), ventricular tachycardia (VT), atrial fibrillation (AF), degree of heart block, muscle infarction (MI) within 1 years, congestive heart failure (CHF), with symptoms and drug therapy in patients with coronary heart disease.
  • Patients with abnormal liver function (total bilirubin > 1.5 x ULN, ALT/AST > 2.5 x ULN, or liver invasion ALT/AST > 5x ULN ), renal function abnormality (serum creatinine > 1.5 x ULN).
  • The researchers decided that patient was not appropriate to take part in the experiment.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:t(8;21)AML
chemotherapy 5-Aza-2'-deoxycytidine IV 20mg/m2 d8-12 homoharringtonine IV 2mg d1-5 chidamide P.O. 30mg twice/W cytarabine IV 1000mg/m2(<60 year old) 500mg/m2(>60 year old) IV q12h d1,3,5
chidamide, decitabine, homoharringtonine, cytarabine
其他名称:
  • DCHA

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Progression free survival
大体时间:2 years
To evaluate the disease progression free survival of DCHA as postremission therapy for acute myeloid leukemia with t(8;21) . Progression free survival (PFS)- defined as the time from remission for the first time to the first documented disease progression.
2 years

次要结果测量

结果测量
措施说明
大体时间
Overall survival
大体时间:2 years
Overall survival (OS)- defined as the length of time from trial treatment to death.
2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Li Yu, MD. Ph.D、Chinese PLA General Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年1月1日

初级完成 (预期的)

2019年12月31日

研究完成 (预期的)

2020年12月31日

研究注册日期

首次提交

2018年2月23日

首先提交符合 QC 标准的

2018年3月1日

首次发布 (实际的)

2018年3月5日

研究记录更新

最后更新发布 (实际的)

2018年3月5日

上次提交的符合 QC 标准的更新

2018年3月1日

最后验证

2018年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • 301-XYK-004

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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