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

Peking University

Status: Enrolling

Conditions: Myelodysplastic Syndromes

Treatments: Other: Detection of MDS-SC using MFC

Study type: Observational

Funder types: Other

Identifiers

NCT06569095

PekingUPH Chang YJ

Details and patient eligibility

About

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.

Enrollment: 163 estimated patients

Sex: All

Ages: 15 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

163 participants in 1 patient group

MDS-EB

Treatment:

Other: Detection of MDS-SC using MFC