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临床试验/NCT03234985
NCT03234985已完成不适用

Study of Intracellular Nucleotide Pools Determination as Biomarker of the Efficacy of the Induction Treatment in Acute Myeloid Leukemia

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 83 人开始时间: 2017年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
83
试验地点
1
主要终点
Complete remission

研究概览

简要总结

Treatment of acute myeloid leukemia (AML) consists in two main phases: induction and consolidation. Standard chemotherapy combination for induction treatment associates cytarabine (AraC), a nucleoside analog, and an anthracycline (most often daunorubucin). About 60-70% of patients achieved complete remission after this standard chemotherapy. As cytarabine competes with endogenous nucleotides to exert its activity, the aim of this protocol is to study in vivo the effect of intracellular nucleotide pools on the efficacy of the induction treatment. Thus, intracellular nucleotides levels will be determined in peripheral blood mononuclear cells of patients with acute myeloid leukemia before treatment, and results will be compared with the efficacy of the treatment. This parameter will be assessed by the achievement of complete remission.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age over 18 years
  • acute myeloid leukemia
  • standard induction chemotherapy with cytarabine and daunorubicin
  • patients who received the information and did not object to participate to the study

排除标准

  • patients with acute myeloid leukemia 3
  • healthy volunteers Inclusion Criteria :
  • adults without known hematological disease,
  • adults who received the information and did not object to participate in the study
  • healthy volunteers Exclusion Criteria :
  • Volunteers with known hematological disease.

结局指标

主要结局

Complete remission

时间窗: 30 days

Primary endpoint will be the achievement of complete remission after induction treatment and bone marrow aplasia.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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