Leukemia Stem Cell-based Assay to Predict Relapse and Survival in Patients With Acute Myeloid Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Detection of leukemia stem cell using multiparameter flow cytometry.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia (AML), MLL Rearrangement. Basic parameters: 6 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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.
Primary outcome measures
- Relapse [Time frame: Immediately after chemotheray or allo-SCT, through study completion, median follow-up on an average of 1 year.]
Secondary outcome measures (2)
- leukemia-free survival [Time frame: 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Publications
- Zeijlemaker W, Grob T, Meijer R, Hanekamp D, Kelder A, Carbaat-Ham JC, Oussoren-Brockhoff YJM, Snel AN, Veldhuizen D, Scholten WJ, Maertens J, Breems DA, Pabst T, Manz MG, van der Velden VHJ, Slomp J, Preijers F, Cloos J, van de Loosdrecht AA, Lowenberg B, Valk PJM, Jongen-Lavrencic M, Ossenkoppele GJ, Schuurhuis GJ. CD34+CD38- leukemic stem cell frequency to predict outcome in acute myeloid leuke PMID 30542144
- Li SQ, Xu LP, Wang Y, Zhang XH, Chen H, Chen YH, Wang FR, Han W, Sun YQ, Yan CH, Lv M, Tang FF, Mo XD, Liu KY, Huang XJ, Chang YJ. Leukemia stem cells for relapse prediction in AML patients receiving allografts: long-term follow-up of a prospective study. Bone Marrow Transplant. 2025 Nov;60(11):1472-1479. doi: 10.1038/s41409-025-02699-8. Epub 2025 Aug 23. PMID 40849363
- Li SQ, Xu LP, Wang Y, Zhang XH, Chen H, Chen YH, Wang FR, Han W, Sun YQ, Yan CH, Lv M, Tang FF, Mo XD, Liu YR, Liu KY, Chang YJ, Huang XJ. An LSC-based MRD assay to complement the traditional MFC method for prediction of AML relapse: a prospective study. Blood. 2022 Aug 4;140(5):516-520. doi: 10.1182/blood.2021014604. No abstract available. PMID 35613411
Identifiers
NCT: NCT07537738 · 2025PHB238-001 · 2024ZD0536200