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NCT Number: NCT06452732

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

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.

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Key information

Conditions

Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University People's Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MFC for the determination of leukemia stem cell

Other

MFC for the determination of leukemia stem cell

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Leukemia free survival (LFS)

    Time frame: 2 years

    Leukimia-free survival was defined as days from diagnosis to disease progression after transplantation.

  2. Overall survival (OS)

    Time frame: 2 years

    Overall survival referred to patients who survived until the final follow-up time point.

  3. Non-relapse mortality (NRM)

    Time frame: 2 years

    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.

  4. Transplant related mortality (TRM)

    Time frame: 2 years

    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.

  5. Acute GVHD

    Time frame: 2 years

    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.

  6. Chronic GVHD

    Time frame: 2 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yingjun Chang Y Prof. Ying-Jun Chang Chang

CONTACT

[email protected]

8610-88325949

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

  • The First Affiliated Hospital of Zhengzhou University

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2024
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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