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

April 13, 2026 updated by: Siqi Li, Peking University People's Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University People's Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Siqi Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AML patients with MLL rearrangement
AML patients with MLL rearrangement who recieved chemnoptherapy or unerwent allo-SCT
Diagnostic test: Detection of leukemia stem cell using multiparameter flow cytometry
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Immediately after chemotheray or allo-SCT, through study completion, median follow-up on an average of 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Immediately after chemotheray or allo-SCT, through study completion, median follow-up on an average of 1 year.
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
Immediately after chemotheray or allo-SCT, through study completion, median follow-up on an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

April 7, 2026

Study Completion (Estimated)

April 7, 2026

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025PHB238-001
  • 2024ZD0536200 (Other Grant/Funding Number: Noncommunicable Chronic Diseases-National Science and Technology Major Project)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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