Acute Myeloid LeukemiaNCT06452732
Using Multiparametric Flow Cytometry to Detect Peripheral Blood and Bone Marrow Leukaemia Stem Cells for Relapse Prediction in P-AML
An observational study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Peking University People's Hospital at 2 sites in China.
Trial summary
Leukaemia is a major disease that seriously endangers human health, the long-term survival rate of acute myeloid leukaemia receiving conventional chemotherapy is only 10% to 45%, haematological relapse is the main cause of treatment failure in acute myeloid leukaemia, reducing the relapse rate is the key to improving… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
- What is being tested?
- MFC for the determination of leukemia stem cell
- How many people
- 283 participants
- Where
- 2 sitesChina
- Study dates
- 1 Nov 2024to 30 Jun 2026
- How long will I take part?
- 2 Years
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study was an exploratory study in search of new biomarkers, based on the previous literature, the recurrence rates of pre-transplant MRD (+) and MRD (-) in pediatric AML were 41% and 23.8% respectively (Br J Haematol.2024;204:585-594), with the ratio of patients in the two groups being 1:1.The calculation was done using PASS 15.0 assuming a two-sided test of α=0.05 and a test efficacy of = 1-β=80%, with the number of people needed being 226, taking into account a 20% censoring rate, the final total sample size was 283 patients.
Who may be able to join
- Newly diagnoses candidates with acute myeloid leukemia.
- Lower than or equal to 18 years-old;
- Subjects are able to provide written informed consent.
Who cannot join
- Subjects who cannot comply with the study;
- Subjects with severe cardiac disease (ejection fraction<50% ), liver disease (total bilirubin >34umol/L, ALT and AST>1.5×upper limit normal) or kidney disease (Serum creatinine>130umol/L).
- Subjects with severe infection.
- Subjects with other conditions that cannot receive chemotherapy or transplantation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
- Recruiting
People's Hospital of Peking University
Beijing, Beijing Municipality, 100044
Ying-Jun Chang, 8610-88325949, rmcyj@bjmu.edu.cn
About this study
Official title: Using Multiparametric Flow Cytometry to Detect Peripheral Blood and Bone Marrow Leukaemia Stem Cells for Relapse Prediction in Pediatric Acute Myeloid Leukaemia: a Prospective Study
Leukaemia is a major disease that seriously endangers human health, the long-term survival rate of acute myeloid leukaemia receiving conventional chemotherapy is only 10% to 45%, haematological relapse is the main cause of treatment failure in acute myeloid leukaemia, reducing the relapse rate is the key to improving the efficacy of acute leukaemia, biomarker-guided preemptive therapy is an effective way to reduce the recurrence of leukaemia, existing markers to predict the recurrence has a high false Existing markers have high false-negative and false-positive rates for predicting relapse, and improving the accuracy of leukaemia relapse prediction is a major clinical problem that needs to be solved urgently. The group has found that circulating leukaemia stem cells remaining after chemotherapy are the key to relapse, therefore, we propose to conduct a multicentre prospective clinical study on the prediction of acute leukaemia relapse by circulating leukaemia stem cells.
- Being tested
- MFC for the determination of leukemia stem cell
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MFC for the determination of leukemia stem cellOther
MFC for the determination of leukemia stem cell
| Study group | Role | What they receive |
|---|---|---|
| MRD monitoring | Not described Receives: Other: MFC for the determination of leukemia stem cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point was cumulative incidences of relapse (CIR)
Relapse was defined by the morphological evidence of disease in the peripheral blood, BM or extramedullary sites. Time to relapse was defined from the date of diagnosis to the date of disease recurrence. Patients exhibiting minimal residual disease were not classified as having relapsed.
Measured: 2 years
Secondary outcomes (6)
Leukemia free survival (LFS)
Leukimia-free survival was defined as days from diagnosis to disease progression after transplantation.
Measured: 2 years
Overall survival (OS)
Overall survival referred to patients who survived until the final follow-up time point.
Measured: 2 years
Non-relapse mortality (NRM)
Non-relapse mortality was defined as all causes of death other than those related directly to malignant disease itself, occurring at any time after CR.
Measured: 2 years
Transplant related mortality (TRM)
Transplant-related mortality was defined as all causes of death other than those related directly to malignant disease itself, occurring at any time after transplantation.
Measured: 2 years
Acute GVHD
Acute GVHD was defined and graded from 0 to IV based on the pattern and severity of organ involvement[Sullivan KM. Graft-versus-host-disease. In: Thomas ED, Blume KG, Forman SJ (eds). Hematopoietic Cell Transplantation. 2nd edn. Blackwell Science: Boston, MA, USA, 1999, pp 515-536.]; grades III-IV aGVHD manifest as serious clinical features on the skin, liver and/or gut.
Measured: 2 years
Chronic GVHD
Chronic GVHD was defined and graded according to the National Institute of Health criteria:[Biol Blood Marrow Transplant,2005,11: 945] that is, mild cGVHD reflects the involvement of no more than 1 or 2 organs/sites (except for lung) with a maximum score of 1; moderate cGVHD involves at least 1 organ/site with a score of 2 or ≥3 organs/sites with a score of 1 (or lung score 1); and severe cGVHD is diagnosed when a score of 3 is given to any organ (or lung score 2). The diagnosis is mainly based on clinical manifestations.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Nov 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies 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
- Prospective
- Enrolment
- 283 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University
- Responsible party
- Principal investigator, Chang Yingjun, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452732
- Sponsor's protocol ID
- PekingUPH Chang Ying-Jun
- Status last verified
- Dec 2025
- First submitted
- 5 Jun 2024
- Last updated
- 31 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Multiparametric Flow Cytometry to Detect Peripheral Blood and Bone Marrow Leukaemia Stem Cells for Relapse Prediction in Pediatric Acute Myeloid Leukaemia: a Prospective Study
- ClinicalTrials.gov ID
- NCT06452732
- Acronym / sponsor ID
- PekingUPH Chang Ying-Jun
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 283 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 11 Jun 2024 (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.
Leukaemia is a major disease that seriously endangers human health, the long-term survival rate of acute myeloid leukaemia receiving conventional chemotherapy is only 10% to 45%, haematological relapse is the main cause of treatment failure in acute myeloid leukaemia, reducing the relapse rate is the key to improving the efficacy of acute leukaemia, biomarker-guided preemptive therapy is an effective way to reduce the recurrence of leukaemia, existing markers to predict the recurrence has a high false Existing markers have high false-negative and false-positive rates for predicting relapse, and improving the accuracy of leukaemia relapse prediction is a major clinical problem that needs to be solved urgently. The group has found that circulating leukaemia stem cells remaining after chemotherapy are the key to relapse, therefore, we propose to conduct a multicentre prospective clinical study on the prediction of acute leukaemia relapse by circulating leukaemia stem cells.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRD monitoring | – | Other: MFC for the determination of leukemia stem cell |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study was an exploratory study in search of new biomarkers, based on the previous literature, the recurrence rates of pre-transplant MRD (+) and MRD (-) in pediatric AML were 41% and 23.8% respectively (Br J Haematol.2024;204:585-594), with the ratio of patients in the two groups being 1:1.The calculation was done using PASS 15.0 assuming a two-sided test of α=0.05 and a test efficacy of = 1-β=80%, with the number of people needed being 226, taking into account a 20% censoring rate, the final total sample size was 283 patients.
Key inclusion criteria (3 listed)
- Newly diagnoses candidates with acute myeloid leukemia.
- Lower than or equal to 18 years-old;
- Subjects are able to provide written informed consent.
Key exclusion criteria (4 listed)
- Subjects who cannot comply with the study;
- Subjects with severe cardiac disease (ejection fraction<50% ), liver disease (total bilirubin >34umol/L, ALT and AST>1.5×upper limit normal) or kidney disease (Serum creatinine>130umol/L).
- Subjects with severe infection.
- Subjects with other conditions that cannot receive chemotherapy or transplantation.
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 |
|---|---|---|
| MFC for the determination of leukemia stem cellMFC for the determination of leukemia stem cell | Other | MRD monitoring |
Primary outcome
The primary end point was cumulative incidences of relapse (CIR)
Time frame: 2 years
Relapse was defined by the morphological evidence of disease in the peripheral blood, BM or extramedullary sites. Time to relapse was defined from the date of diagnosis to the date of disease recurrence. Patients exhibiting minimal residual disease were not classified as having relapsed.
6 secondary outcomes
Leukemia free survival (LFS)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Non-relapse mortality (NRM)
Time frame: 2 years
Transplant related mortality (TRM)
Time frame: 2 years
Acute GVHD
Time frame: 2 years
Chronic GVHD
Time frame: 2 years
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 31 Dec 2025.
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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.
2 sites 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 and Acute Lymphoblastic Leukemia, run by Peking University People's Hospital at 2 sites 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 3 inclusion and 4 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 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Yingjun Chang Y Prof. Ying-Jun Chang Chang (8610-88325949, rmcyj@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end point was cumulative incidences of relapse (CIR) (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2025.