Acute Myeloid Leukemia (AML)MLL-LSCNCT07537738
Leukemia Stem Cell-based Assay to Predict Relapse and Survival in Patients With Acute Myeloid Leukemia
An observational study of Acute Myeloid Leukemia (AML) and MLL Rearrangement, run by Peking University People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 60 years
- Conditions the study is for
- Acute Myeloid Leukemia (AML), MLL Rearrangement
- What is being tested?
- Detection of leukemia stem cell using multiparameter flow cytometry
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 7 Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Acute myeloiud leukemia patients with MLL arrangement aging 6-60 years recieving chemoterapy or allo-geneic hematopoietic stem cell transplantation.
Who cannot join
- Patients who cannot recieve chemoterapy or allo-geneic hematopoietic stem cell transplantation.
- Patients who cannot comply with the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing
Siqi Li, PhD, +86 18611944638, tina_li_1995@163.com
YingJun Chang, PhD, 010-86491529, pk200608@126.com
About this study
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
- Acute Myeloid Leukemia (AML), MLL Rearrangement
- Being tested
- Detection of leukemia stem cell using multiparameter flow cytometry
- Keywords
- acute myeloid leukemia, leukemia stem cell, allo-SCT
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Biphenotypic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of leukemia stem cell using multiparameter flow cytometryDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| AML patients with MLL rearrangement | AML patients with MLL rearrangement who recieved chemnoptherapy or unerwent allo-SCT Receives: Diagnostic Test: Detection of leukemia stem cell using multiparameter flow cytometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse
Relapse was defined by the morphological evidence of disease in the peripheral blood, BM or extramedullary sites
Measured: Immediately after chemotheray or allo-SCT, through study completion, median follow-up on an average of 1 year.
Secondary outcomes (2)
leukemia-free survival
Leukemia-free survival was defined as survival in continuous complete remission.
Measured: Immediately after chemotheray or allo-SCT, through study completion, median follow-up on an average of 1 year.
overall survival
Overall survival referred to patients who survived until the final follow-up time point
Measured: Immediately after chemotheray or allo-SCT, through study completion, median follow-up on an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 Jun 2025
- Primary completion7 Apr 2026 (estimated)
- Study completion7 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siqi Li, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537738
- Sponsor's protocol ID
- 2025PHB238-001
- Other IDs
- 2024ZD0536200
- Acronym
- MLL-LSC
- Status last verified
- May 2025
- First submitted
- 7 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 leukemia. Leukemia. 2019 May;33(5):1102-1112. doi: 10.1038/s41375-018-0326-3. Epub 2018 Dec 12.
PubMed 30542144Li 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.
PubMed 40849363Li 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.
PubMed 35613411
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leukemia Stem Cell-based Assay to Predict Relapse and Survival in Patients With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT07537738
- Acronym / sponsor ID
- MLL-LSC / 2025PHB238-001
- Conditions
- Acute Myeloid Leukemia (AML), MLL Rearrangement
- Keywords
- acute myeloid leukemia, leukemia stem cell, allo-SCT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 7 Apr 2026 (estimated)
- Study completion
- 7 Apr 2026 (estimated)
- First posted
- 17 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AML patients with MLL rearrangement | – | Diagnostic Test: Detection of leukemia stem cell using multiparameter flow cytometryAML patients with MLL rearrangement who recieved chemnoptherapy or unerwent allo-SCT |
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- Acute myeloiud leukemia patients with MLL arrangement aging 6-60 years recieving chemoterapy or allo-geneic hematopoietic stem cell transplantation.
Key exclusion criteria (2 listed)
- Patients who cannot recieve chemoterapy or allo-geneic hematopoietic stem cell transplantation.
- Patients who cannot comply with the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detection of leukemia stem cell using multiparameter flow cytometryFor 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. | Diagnostic test | AML patients with MLL rearrangement |
Primary outcome
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
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Background: PubMed 30542144Zeijlemaker 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.
- Background: PubMed 40849363Li 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.
- Background: PubMed 35613411Li 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia (AML) and MLL Rearrangement, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Siqi Li, PhD (+86 18611944638, tina_li_1995@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse (time frame: Immediately after chemotheray or allo-SCT, through study completion, median follow-up on an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07537738, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.