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临床试验/NCT06452732
NCT06452732招募中不适用

Using Multiparametric Flow Cytometry to Detect Peripheral Blood and Bone Marrow Leukaemia Stem Cells for Relapse Prediction in Pediatric Acute Myeloid Leukaemia: a Prospective Study

Peking University People's Hospital2 个研究点 分布在 1 个国家目标入组 283 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
283
试验地点
2
主要终点
The primary end point was cumulative incidences of relapse (CIR)

研究概览

简要总结

Leukaemia is a major disease that seriously endangers human health, the long-term survival rate of acute myeloid leukaemia receiving conventional chemotherapy is only 10% to 45%, haematological relapse is the main cause of treatment failure in acute myeloid leukaemia, reducing the relapse rate is the key to improving the efficacy of acute leukaemia, biomarker-guided preemptive therapy is an effective way to reduce the recurrence of leukaemia, existing markers to predict the recurrence has a high false Existing markers have high false-negative and false-positive rates for predicting relapse, and improving the accuracy of leukaemia relapse prediction is a major clinical problem that needs to be solved urgently. The group has found that circulating leukaemia stem cells remaining after chemotherapy are the key to relapse, therefore, we propose to conduct a multicentre prospective clinical study on the prediction of acute leukaemia relapse by circulating leukaemia stem cells.

研究设计

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

入排标准

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

入选标准

  • Newly diagnoses candidates with acute myeloid leukemia.
  • Lower than or equal to 18 years-old;
  • Subjects are able to provide written informed consent.

排除标准

  • Subjects who cannot comply with the study;
  • Subjects with severe cardiac disease (ejection fraction<50% ), liver disease (total bilirubin >34umol/L, ALT and AST>1.5×upper limit normal) or kidney disease (Serum creatinine>130umol/L).
  • Subjects with severe infection.
  • Subjects with other conditions that cannot receive chemotherapy or transplantation.

结局指标

主要结局

The primary end point was cumulative incidences of relapse (CIR)

时间窗: 2 years

Relapse was defined by the morphological evidence of disease in the peripheral blood, BM or extramedullary sites. Time to relapse was defined from the date of diagnosis to the date of disease recurrence. Patients exhibiting minimal residual disease were not classified as having relapsed.

次要结局

  • Transplant related mortality (TRM)(2 years)
  • Non-relapse mortality (NRM)(2 years)
  • Chronic GVHD(2 years)
  • Overall survival (OS)(2 years)
  • Leukemia free survival (LFS)(2 years)
  • Acute GVHD(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chang Yingjun

Chief Physician

Peking University People's Hospital

研究点 (2)

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