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NCT Number: NCT07537738

Leukemia Stem Cell-based Assay to Predict Relapse and Survival in Patients With Acute Myeloid Leukemia

The goal of this observational study is to learn about the predict value of leukemia stem cell for acute myeloid leukemia patients with MLL-rearrangement. The main question it aims to answer is:

• Could be leukemia stem cell used for relapse prediction in acute myeloid leukemia patients with MLL-rearrangement? Leukemia stem cell will be detected at the same time for participants who detected minimal residual disease using bone marrow as part of their regular medical care to answer the question.

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Key information

Conditions

Acute Myeloid Leukemia (AML) Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Biphenotypic, Acute Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoproliferative Disorders MLL Rearrangement Neoplasms Neoplasms by Histologic Type

Age range

6 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Acute myeloiud leukemia patients with MLL arrangement aging 6-60 years recieving chemoterapy or allo-geneic hematopoietic stem cell transplantation.

Exclusion criteria

  • Patients who cannot recieve chemoterapy or allo-geneic hematopoietic stem cell transplantation.
  • Patients who cannot comply with the study.

Treatment and study plan

Detection of leukemia stem cell using multiparameter flow cytometry

Diagnostic Test

For AML patients with MLL rearrangement enrolled, leukemia stem cell will be detcted at diagnosis and during follow-up. A traditional Minimal residual disease was deteced as normal medical care, simultaneously, leukemia stem cell will be detcted using the sample bone marrow sample.

Primary outcomes

  1. Relapse

    Time frame: Immediately after chemotheray or allo-SCT, through study completion, median follow-up on an average of 1 year.

    Relapse was defined by the morphological evidence of disease in the peripheral blood, BM or extramedullary sites

Secondary outcomes

  1. leukemia-free survival

    Time frame: Immediately after chemotheray or allo-SCT, through study completion, median follow-up on an average of 1 year.

    Leukemia-free survival was defined as survival in continuous complete remission.

  2. overall survival

    Time frame: Immediately after chemotheray or allo-SCT, through study completion, median follow-up on an average of 1 year.

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

Study contacts

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

Siqi Li, PhD

CONTACT

[email protected]

+86 18611944638

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Acronym: MLL-LSC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

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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