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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia
• Intervention / Treatment: Other: MFC for the determination of leukemia stem cell

• Study Type: Observational
• Enrollment (Estimated): 283

Contacts and Locations

• Study Contact: Name: Yingjun Chang Y Prof. Ying-Jun Chang Chang; Phone Number: 8610-88325949; Email: rmcyj@bjmu.edu.cn

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100044
      • Recruiting
      • Peking University People's Hospital
    • Beijing, Beijing Municipality, China, 100044
      • Recruiting
      • People's Hospital of Peking University
      • Contact: Ying-Jun Chang; Phone Number: 8610-88325949; Email: rmcyj@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The study was an exploratory study in search of new biomarkers, based on the previous literature, the recurrence rates of pre-transplant MRD (+) and MRD (-) in pediatric AML were 41% and 23.8% respectively (Br J Haematol.2024;204:585-594), with the ratio of patients in the two groups being 1:1.The calculation was done using PASS 15.0 assuming a two-sided test of α=0.05 and a test efficacy of = 1-β=80%, with the number of people needed being 226, taking into account a 20% censoring rate, the final total sample size was 283 patients.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MRD monitoring	Other: MFC for the determination of leukemia stem cell; MFC for the determination of leukemia stem cell

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary end point was cumulative incidences of relapse (CIR)	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	Overall survival referred to patients who survived until the final follow-up time point.	2 years
Leukemia free survival (LFS)	Leukimia-free survival was defined as days from diagnosis to disease progression after transplantation.	2 years
Non-relapse mortality (NRM)	Non-relapse mortality was defined as all causes of death other than those related directly to malignant disease itself, occurring at any time after CR.	2 years
Transplant related mortality (TRM)	Transplant-related mortality was defined as all causes of death other than those related directly to malignant disease itself, occurring at any time after transplantation.	2 years
Acute GVHD	Acute GVHD was defined and graded from 0 to IV based on the pattern and severity of organ involvement[Sullivan KM. Graft-versus-host-disease. In: Thomas ED, Blume KG, Forman SJ (eds). Hematopoietic Cell Transplantation. 2nd edn. Blackwell Science: Boston, MA, USA, 1999, pp 515-536.]; grades III-IV aGVHD manifest as serious clinical features on the skin, liver and/or gut.	2 years
Chronic GVHD	Chronic GVHD was defined and graded according to the National Institute of Health criteria:[Biol Blood Marrow Transplant,2005,11: 945] that is, mild cGVHD reflects the involvement of no more than 1 or 2 organs/sites (except for lung) with a maximum score of 1; moderate cGVHD involves at least 1 organ/site with a score of 2 or ≥3 organs/sites with a score of 1 (or lung score 1); and severe cGVHD is diagnosed when a score of 3 is given to any organ (or lung score 2). The diagnosis is mainly based on clinical manifestations.	2 years

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: The First Affiliated Hospital of Zhengzhou University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: June 5, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 29, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Leukemia, Myeloid; Leukemia, Lymphoid; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: PekingUPH Chang Ying-Jun

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No