Clinical trial · Observational
Leukemia Stem Cell-based Assay to Predict Relapse and Survival in Patients With Acute Myeloid Leukemia
NCT07537738CI-TRIAL-00108626MLL-LSCrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| MLL Rearrangement | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Detection of leukemia stem cell using multiparameter flow cytometry | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- AML patients with MLL rearrangement
- description
- AML patients with MLL rearrangement who recieved chemnoptherapy or unerwent allo-SCT
- interventionNames
- Diagnostic Test: Detection of leukemia stem cell using multiparameter flow cytometry
Primary outcomes (1)
- measure
- Relapse
- timeFrame
- Immediately after chemotheray or allo-SCT, through study completion, median follow-up on an average of 1 year.
- description
- Relapse was defined by the morphological evidence of disease in the peripheral blood, BM or extramedullary sites
Secondary outcomes (2)
- measure
- leukemia-free survival
- timeFrame
- Immediately after chemotheray or allo-SCT, through study completion, median follow-up on an average of 1 year.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDZeijlemaker 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 leukemia. Leukemia. 2019 May;33(5):1102-1112. doi: 10.1038/s41375-018-0326-3. Epub 2018 Dec 12. PMID 30542144
- BACKGROUNDLi 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
- BACKGROUNDLi 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