Predictive Value of Myelodysplastic Syndrome Stem Cells Determined by Multiparameter Flow Cytometry

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.

Study Overview

• Status: Recruiting
• Conditions: Myelodysplastic Syndromes
• Intervention / Treatment: Other: Detection of MDS-SC using MFC

• Study Type: Observational
• Enrollment (Estimated): 163

Contacts and Locations

• Study Contact: Name: chief physician; Phone Number: 13520536738; Email: rmcyj@bjmu.edu.cn

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Chinese PLA General Hospital
    • Contact: Hai-Yan Zhu; Phone Number: 861013910020121; Email: zhy301@yeah.net
  • Beijing, China
    • Recruiting
    • Peking University People's Hospital
    • Contact: Ying-Jun Chang, PhD; Phone Number: 861013520536738; Email: rmcyj@bjmu.edu.cn
  • Wuhan, China
    • Recruiting
    • Wuhan Tongji Hospital
    • Contact: Yi-Cheng Zhang; Phone Number: 18607140317; Email: yczhang@tjh.tjmu.edu.cn
  • Zhengzhou, China
    • Recruiting
    • The First Affiliated Hospital of Zhengzhou University
    • Contact: Zhi-Lei Bian, PhD; Email: bianzhilei@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

• Patients with Myelodysplastic syndromes;
• Between 15 and 70 years old;
• Subjects are able to provide written informed consent.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MDS-EB	Other: Detection of MDS-SC using MFC; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative positive rate of measurable residual disease (MRD) after transplantation	The proportion of MRD positive patients after treatment.	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.	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.	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.	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.	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.	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.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: Peking University First Hospital; Chinese PLA General Hospital; The First Affiliated Hospital of Zhengzhou University; Wuhan TongJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2024
• Primary Completion (Estimated): December 17, 2027
• Study Completion (Estimated): December 18, 2027

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 23, 2024

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Bone Marrow Diseases; Hemic and Lymphatic Diseases; Myelodysplastic Syndromes
• Other Study ID Numbers: PekingUPH Chang YJ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No