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Vitro Study of Tigecycline to Treat Chronic Myeloid Leukemia

2016年8月24日 更新者:Xiaoli Liu、Nanfang Hospital of Southern Medical University

Changes of Mitochondrial Biogenesis and Metabolic Characteristics About Tigecycline to Treat Chronic Myeloid Leukemia in Vitro

Chronic myeloid leukemia (CML) is a myeloproliferative neoplasm companies with the BCR-ABL fusion gene encoded by the Philadelphia (Ph) chromosome. The BCR-ABL fusion protein(the formation of the chimeric gene BCR/ABL on chromosome 22 and a reciprocal ABL/BCR on chromosome 9,it has no expanded name) plays key role on CML leukemogenesis by activating its downstream signaling pathway of survival and proliferation. Imatinib, a targeted competitive inhibitor of a BCR-ABL tyrosine kinase, changed the clinical treatment and prognosis of CML. As its optimized generation, other tyrosine kinase inhibitors (TKIs), dasatinib and nilotinib have more potent anti-leukemic activity and less side-effect. However, acquired resistance to TKIs is one of the main obstacles to effective CML treatment and is involved in gene amplication of ABL tyrosine kinase point mutations. The outcomes of patients with these ABL tyrosine kinase point mutations have linked to worse prognosis and higher mortality generally. Metabolic adaptations are common in cancer cells, and cancer cells become more dependent on mitochondrial biogenesis. Tigecycline, as a broad-spectrum antibiotics, inhibits mitochondrial biogenesis as its an interesting "side-effect".In recent study,researchers indicated that tigecycline can eradicate cancer stem cells by targeting mitochondrial.Here, the investigators test tigecycline's anti-leukemic activity to chronic myeloid leukemia in vitro.

研究概览

详细说明

In this study, the investigators collected bone marrow(BM) or/and peripheral blood(PB) mononuclear cells from patients with chronic myeloid leukemia.Patients could be in different stages of chronic myeloid leukemia pre-treatment.Additionally, the investigators also selected some healthy volunteers as comparison.Firstly, the investigators analyzed mitochondrial biogenesis and basal metabolic characteristic of mononuclear cells from patients and healthy volunteers.Secondly, the investigators tested the cell viability and apoptosis after tigecycline treatment.Thirdly,the investigators detected the changes of cell mitochondrial biogenesis and metabolic characteristic in the same study sample after tigecycline stimulation. Finally,the investigators analyzed the correlation between sensitivities of mononuclear cells to tigecycline and patients' clinical parameters and survival outcome.

研究类型

观察性的

注册 (预期的)

100

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。

学习地点

    • Guangdong
      • Guangzhou、Guangdong、中国、510515
        • Department of hematology,Nanfang Hospital

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

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

100 adults patients with chronic myeloid leukemia

描述

Inclusion Criteria:

  • Diagnosis of Philadelphia chromosome positive and/or BCR-ABL positive CML confirmed by cytogenetic and/or molecular analysis;
  • Age >18 years.
  • Eligibility of patients receiving any medications or substances known to affect or determined following review of their case by the Principal Investigator

Exclusion Criteria:

  • Patients may not receive any other antibiotics.
  • Patients may not have received prior treatment with TKIs or hydroxyurea.
  • Major cognitive deficits or psychiatric problems hampering a self-reported evaluation.
  • No prior malignancies or any other cancer from which patient has been disease free for 5 years.

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

队列和干预

团体/队列
干预/治疗
健康志愿者
sampling after diagnosis and the mononuclear cells will be given tigecycline stimulation in vitro
sampling after register and the mononuclear cells will be given tigecycline stimulation in vitro
Patients with chronic myeloid leukemia
100 adult patients(age>18 years),with chronic myeloid leukemia defined by the World Health Organization(WHO) criteria
sampling after diagnosis and the mononuclear cells will be given tigecycline stimulation in vitro
sampling after register and the mononuclear cells will be given tigecycline stimulation in vitro

研究衡量的是什么?

主要结果指标

结果测量
大体时间
mitochondrial biogenesis and metabolic characteristics of Bone Marrow(BM)/ Peripheral Blood(PB) mononuclear cells
大体时间:Through study completion, an average of 1 year
Through study completion, an average of 1 year

次要结果测量

结果测量
大体时间
mitochondrial biogenesis and metabolic characteristics of BM/PB mononuclear cells after tigecycline stimulation
大体时间:After Hour 24 and 48 tigecycline stimulation
After Hour 24 and 48 tigecycline stimulation
cell viability and apoptosis of BM/PB mononuclear cells after tigecycline stimulation
大体时间:After Hour 24 and 48 tigecycline stimulation
After Hour 24 and 48 tigecycline stimulation
Patients' clinical characteristics and survival outcomes
大体时间:Through study completion, an average of 1 year
Through study completion, an average of 1 year

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。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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

2016年9月1日

初级完成 (预期的)

2021年9月1日

研究注册日期

首次提交

2016年8月19日

首先提交符合 QC 标准的

2016年8月24日

首次发布 (估计)

2016年8月30日

研究记录更新

最后更新发布 (估计)

2016年8月30日

上次提交的符合 QC 标准的更新

2016年8月24日

最后验证

2016年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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