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

NCT07537738 | Recruiting

• 2 other identifiers: 2025PHB238-0012024ZD0536200
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

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

MLL Rearrangement; Acute Myeloid Leukemia (AML)

Keywords

acute myeloid leukemia; leukemia stem cell; allo-SCT

Outcome Measures

Primary Outcomes (1)

• Relapse

  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 Outcomes (2)

• leukemia-free survival

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

• overall survival

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

Study Arms (1)

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

Interventions

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.

AML patients with MLL rearrangement

Eligibility Criteria

• Age: 6 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

RECRUITING

Related Publications (3)

• 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 leukemia. Leukemia. 2019 May;33(5):1102-1112. doi: 10.1038/s41375-018-0326-3. Epub 2018 Dec 12.

  PMID: 30542144 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia, Biphenotypic, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Siqi Li, PhD

CONTACT

+86 18611944638; tina_li_1995@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Technician

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 17, 2026
• Study Start: June 1, 2025
• Primary Completion: April 7, 2026
• Study Completion: April 7, 2026
• Last Updated: April 17, 2026

Record last verified: 2025-05

Locations

CN (1)