Predictive Value of Myelodysplastic Syndrome Stem Cells Determined by Multiparameter Flow Cytometry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Detection of MDS-SC using MFC.
- Who it may be relevant to
- Registry conditions: Myelodysplastic Syndromes. Basic parameters: 15 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Predictive Value of Myelodysplastic Syndrome Stem Cells Determined by Multiparameter Flow Cytometry in Patients Receiving Allotransplantation: a Multi-center, Prospective Clinical Study
Overview
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.
Interventions
- 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.
Primary outcome measures
- 1 year-cumulative relapse rate [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (7)
- 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]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 4 centers
- Chinese PLA General Hospital — Beijing
- Peking University People's Hospital — Beijing
- Wuhan TongJi Hospital — Wuhan
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou
Identifiers
NCT: NCT06569095 · PekingUPH Chang YJ