Myelodysplastic SyndromesNCT06569095
Predictive Value of Myelodysplastic Syndrome Stem Cells Determined by Multiparameter Flow Cytometry
An observational study of Myelodysplastic Syndromes, run by Peking University People's Hospital at 4 sites in China.
Trial summary
Presently, multiparameter flow cytometry (MFC) and polymerase chain reaction (PCR) have been used for disease load, including measurable residual disease (MRD), monitoring in patients with myelodysplastic syndrome (MDS). MFC is the most commonly method for disease load evaluation. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Myelodysplastic Syndromes
- What is being tested?
- Detection of MDS-SC using MFC
- How many people
- 163 participants
- Where
- 4 sitesChina
- Study dates
- 9 Dec 2024to 18 Dec 2027
- 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 15 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: To determine whether there was any difference in relapse between the pre-transplant MRD-positive and -negative groups, the cumulative incidence approach was used with a test for equivalence of CIF for the difference in the Kaplan-Meier estimate of the 1-year CIR. With a planned sample size of 163 AML/MDS patients, 80% power can be achieved against the hypothesis of CIR as 18.3% and 3.6% for cases in the pre-transplant MRD-positive and -negative groups at a significance level of P = 0.05 in Student's one-tailed t-test.
Who may be able to join
- Patients with Myelodysplastic syndromes;
- Between 15 and 70 years old;
- Subjects are able to provide written informed consent.
Who cannot join
- Subjects who cannot comply with the study;
- Patient has severe cardiac (ejection fraction <50%), hepatic (total bilirubin >34μmol/L, ALT, AST >2x upper limit of normal) or renal (blood creatinine >130μmol/L) disease；
- Uncontrolled serious infection;
- Other conditions that do not tolerate transplantation or other therapies.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing
Hai-Yan Zhu, 861013910020121, zhy301@yeah.net
- Recruiting
Peking University People's Hospital
Beijing
Ying-Jun Chang, PhD, 861013520536738, rmcyj@bjmu.edu.cn
- Recruiting
Wuhan TongJi Hospital
Wuhan
Yi-Cheng Zhang, 18607140317, yczhang@tjh.tjmu.edu.cn
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou
Zhi-Lei Bian, PhD, bianzhilei@sina.com
About this study
Official title: Predictive Value of Myelodysplastic Syndrome Stem Cells Determined by Multiparameter Flow Cytometry in Patients Receiving Allotransplantation: a Multi-center, Prospective Clinical Study
Presently, multiparameter flow cytometry (MFC) and polymerase chain reaction (PCR) have been used for disease load, including measurable residual disease (MRD), monitoring in patients with myelodysplastic syndrome (MDS). MFC is the most commonly method for disease load evaluation. In patients with acute myeloid leukemia, leukemia stem cells (LSCs) determined using MFC for leukemia load and MRD detection is superior to traditional MFC method. In the investigators previous single center study, the investigators demonstrated that detection of disease load, including MRD, by MFC in patients with MDS-EB is superior to predict outcomes after allogeneic stem cell transplantation. Here, the investigators will perform a multi-center, prospective clinical trial to investigate the predictive values of MDS-SC in patients with MDS-EB who received allografting.
- Conditions
- Myelodysplastic Syndromes
- Being tested
- Detection of MDS-SC using MFC
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of MDS-SC using MFCOther
The aim of this study is to investigate the predictive values of MDS-SC determined by MFC for patients with MDS-EB who underwent allotransplantation.
| Study group | Role | What they receive |
|---|---|---|
| MDS-EB | Not described Receives: Other: Detection of MDS-SC using MFC |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year-cumulative relapse rate
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 transplantation to the date of disease recurrence. Patients exhibiting minimal residual disease were not classified as having relapsed.
Measured: through study completion, an average of 1 year
Secondary outcomes (7)
Cumulative positive rate of measurable residual disease (MRD) after transplantation
The proportion of MRD positive patients after treatment.
Measured: through study completion, an average of 1 year
Disease-free survival (LFS)
Disease-free survival was defined as days from transplantation to disease progression after transplantation.
Measured: through study completion, an average of 1 year
Overall survival (OS)
Overall survival referred to patients who survived until the final follow-up time point.
Measured: through study completion, an average of 1 year
Non-recurrent death (NRM)
Non-recurrent mortality was defined as all causes of death other than those related directly to malignant disease itself, occurring at any time after CR.
Measured: through study completion, an average of 1 year
Transplant-related death (TRM)
Transplant-related death was defined as all causes of death other than those related directly to malignant disease itself, occurring at any time after transplantation.
Measured: through study completion, an average of 1 year
Acute graft-versus-host disease (GVHD)
Acute GVHD was defined and graded from 0 to IV based on the pattern and severity of organ involvement; grades III-IV aGVHD manifest as serious clinical features on the skin, liver and/or gut.
Measured: through study completion, an average of 1 year
Chronic graft-versus-host disease (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: through study completion, 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 posted23 Aug 2024
- Study start9 Dec 2024
- Primary completion17 Dec 2027 (estimated)
- Study completion18 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromesStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- 163 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University First Hospital, The First Affiliated Hospital of Zhengzhou University, Chinese PLA General Hospital, Wuhan TongJi Hospital
- Responsible party
- Principal investigator, Chang Yingjun, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569095
- Sponsor's protocol ID
- PekingUPH Chang YJ
- Status last verified
- Feb 2026
- First submitted
- 15 Jul 2024
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Myelodysplastic Syndrome Stem Cells Determined by Multiparameter Flow Cytometry in Patients Receiving Allotransplantation: a Multi-center, Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT06569095
- Acronym / sponsor ID
- PekingUPH Chang YJ
- Conditions
- Myelodysplastic Syndromes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 163 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Peking University First Hospital, The First Affiliated Hospital of Zhengzhou University, Chinese PLA General Hospital, Wuhan TongJi Hospital
- Study start
- 9 Dec 2024 (actual)
- Primary completion
- 17 Dec 2027 (estimated)
- Study completion
- 18 Dec 2027 (estimated)
- First posted
- 23 Aug 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.
Presently, multiparameter flow cytometry (MFC) and polymerase chain reaction (PCR) have been used for disease load, including measurable residual disease (MRD), monitoring in patients with myelodysplastic syndrome (MDS). MFC is the most commonly method for disease load evaluation. In patients with acute myeloid leukemia, leukemia stem cells (LSCs) determined using MFC for leukemia load and MRD detection is superior to traditional MFC method. In the investigators previous single center study, the investigators demonstrated that detection of disease load, including MRD, by MFC in patients with MDS-EB is superior to predict outcomes after allogeneic stem cell transplantation. Here, the investigators will perform a multi-center, prospective clinical trial to investigate the predictive values of MDS-SC in patients with MDS-EB who received allografting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDS-EB | – | Other: Detection of MDS-SC using MFC |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- To determine whether there was any difference in relapse between the pre-transplant MRD-positive and -negative groups, the cumulative incidence approach was used with a test for equivalence of CIF for the difference in the Kaplan-Meier estimate of the 1-year CIR. With a planned sample size of 163 AML/MDS patients, 80% power can be achieved against the hypothesis of CIR as 18.3% and 3.6% for cases in the pre-transplant MRD-positive and -negative groups at a significance level of P = 0.05 in Student's one-tailed t-test.
Key inclusion criteria (3 listed)
- Patients with Myelodysplastic syndromes;
- Between 15 and 70 years old;
- Subjects are able to provide written informed consent.
Key exclusion criteria (4 listed)
- Subjects who cannot comply with the study;
- Patient has severe cardiac (ejection fraction <50%), hepatic (total bilirubin >34μmol/L, ALT, AST >2x upper limit of normal) or renal (blood creatinine >130μmol/L) disease；
- Uncontrolled serious infection;
- Other conditions that do not tolerate transplantation or other therapies.
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 MDS-SC using MFCThe aim of this study is to investigate the predictive values of MDS-SC determined by MFC for patients with MDS-EB who underwent allotransplantation. | Other | MDS-EB |
Primary outcome
1 year-cumulative relapse rate
Time frame: through study completion, an average of 1 year
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 transplantation to the date of disease recurrence. Patients exhibiting minimal residual disease were not classified as having relapsed.
7 secondary outcomes
Cumulative positive rate of measurable residual disease (MRD) after transplantation
Time frame: through study completion, an average of 1 year
Disease-free survival (LFS)
Time frame: through study completion, an average of 1 year
Overall survival (OS)
Time frame: through study completion, an average of 1 year
Non-recurrent death (NRM)
Time frame: through study completion, an average of 1 year
Transplant-related death (TRM)
Time frame: through study completion, an average of 1 year
Acute graft-versus-host disease (GVHD)
Time frame: through study completion, an average of 1 year
Chronic graft-versus-host disease (GVHD)
Time frame: through study completion, 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 24 Feb 2026.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelodysplastic Syndromes, run by Peking University People's Hospital at 4 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 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 chief physician (13520536738, rmcyj@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1 year-cumulative relapse rate (time frame: through study completion, 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?
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 24 Feb 2026.