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

NCT06452732 | Recruiting

• 1 other identifier: PekingUPH Chang Ying-Jun
• Study Type: observational
• Target: 283
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Leukemia free survival (LFS)

  2 years

• Overall survival (OS)

  2 years

• Non-relapse mortality (NRM)

  2 years

• Transplant related mortality (TRM)

  2 years

• Acute GVHD

  2 years

Study Arms (1)

MRD monitoring

Other: MFC for the determination of leukemia stem cell

Interventions

MFC for the determination of leukemia stem cell OTHER

MFC for the determination of leukemia stem cell

MRD monitoring

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: collaborator
• Peking University People's Hospital: lead

Study Sites (2)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

People's Hospital of Peking University

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Yingjun Chang Y Prof. Ying-Jun Chang Chang

CONTACT

8610-88325949; rmcyj@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

CN (2)