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

NCT06569095 | Recruiting

• 1 other identifier: PekingUPH Chang YJ
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 4

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Cumulative positive rate of measurable residual disease (MRD) after transplantation

  through study completion, an average of 1 year

• Disease-free survival (LFS)

  through study completion, an average of 1 year

• Overall survival (OS)

  through study completion, an average of 1 year

• Non-recurrent death (NRM)

  through study completion, an average of 1 year

• Transplant-related death (TRM)

  through study completion, an average of 1 year

Study Arms (1)

MDS-EB

Other: Detection of MDS-SC using MFC

Interventions

Detection of MDS-SC using MFC OTHER

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.

MDS-EB

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wuhan TongJi Hospital: collaborator
• Peking University First Hospital: collaborator
• Chinese PLA General Hospital: collaborator
• Peking University People's Hospital: lead
• The First Affiliated Hospital of Zhengzhou University: collaborator

Study Sites (4)

Chinese PLA General Hospital

Beijing, China

RECRUITING

Peking University People's Hospital

Beijing, China

RECRUITING

Wuhan TongJi Hospital

Wuhan, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

chief physician

CONTACT

13520536738; rmcyj@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief Physician

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: August 23, 2024
• Study Start: December 9, 2024
• Primary Completion (Estimated): December 17, 2027
• Study Completion (Estimated): December 18, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

CN (4)