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Using Multiparametric Flow Cytometry to Detect Peripheral Blood and Bone Marrow Leukaemia Stem Cells for Relapse Prediction in P-AML

NCT06452732 · Peking University People's Hospital
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Official title
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
About this study
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.
Eligibility criteria
Inclusion Criteria: * Newly diagnoses candidates with acute myeloid leukemia. * Lower than or equal to 18 years-old; * Subjects are able to provide written informed consent. Exclusion Criteria: * 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.
Study design
Enrollment target: 283 participants
Age groups: child, adult
Timeline
Starts: 2024-11-01
Estimated completion: 2026-06-30
Last updated: 2025-12-31
Interventions
Other: MFC for the determination of leukemia stem cell
Primary outcomes
  • The primary end point was cumulative incidences of relapse (CIR) (2 years)
Sponsor
Peking University People's Hospital · other
With: The First Affiliated Hospital of Zhengzhou University
Contacts & investigators
ContactYingjun Chang Y Prof. Ying-Jun Chang Chang · contact · rmcyj@bjmu.edu.cn · 8610-88325949
All locations (2)
Peking University People's HospitalRecruiting
Beijing, Beijing Municipality, China
People's Hospital of Peking UniversityRecruiting
Beijing, Beijing Municipality, China