Predictive Value of Myelodysplastic Syndrome Stem Cells Determined by Multiparameter Flow Cytometry in Patients Receiving Allotransplantation: a Multi-center, Prospective Clinical Study
Overview
- Phase
- Not Applicable
- Intervention
- Detection of MDS-SC using MFC
- Conditions
- Myelodysplastic Syndromes
- Sponsor
- Peking University People's Hospital
- Enrollment
- 163
- Locations
- 4
- Primary Endpoint
- 1 year-cumulative relapse rate
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
Chang Yingjun
Professor and Chief Physician
Peking University People's Hospital
Eligibility Criteria
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.
Arms & Interventions
MDS-EB
Intervention: Detection of MDS-SC using MFC
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)
- Acute graft-versus-host disease (GVHD)(through study completion, an average of 1 year)
- Chronic graft-versus-host disease (GVHD)(through study completion, an average of 1 year)