Predictive Value of Myelodysplastic Syndrome Stem Cells Determined by Multiparameter Flow Cytometry
- Conditions
- Myelodysplastic Syndromes
- Interventions
- Other: Multiparametric Flow Cytometry for the detection of Myelodysplastic syndromes with Measurable residual disease
- Registration Number
- NCT06569095
- Lead Sponsor
- Peking University People's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 163
- Patients with Myelodysplastic syndromes;
- Between 15 and 70 years old;
- Subjects are able to provide written informed consent.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description MDS-MRD Multiparametric Flow Cytometry for the detection of Myelodysplastic syndromes with Measurable residual disease -
- Primary Outcome Measures
Name Time Method 1 year-cumulative relapse rate 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 Outcome Measures
Name Time Method Cumulative positive rate of measurable residual disease (MRD) after transplantation through study completion, an average of 1 year The proportion of MRD positive patients after treatment.
Disease-free survival (LFS) through study completion, an average of 1 year Disease-free survival was defined as days from transplantation to disease progression after transplantation.
Overall survival (OS) through study completion, an average of 1 year Overall survival referred to patients who survived until the final follow-up time point.
Non-recurrent death (NRM) through study completion, an average of 1 year 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.
Transplant-related death (TRM) through study completion, an average of 1 year 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.
Acute graft-versus-host disease (GVHD) through study completion, an average of 1 year 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.
Chronic graft-versus-host disease (GVHD) through study completion, an average of 1 year 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.
Trial Locations
- Locations (4)
Chinese PLA General Hospital
🇨🇳Beijing, China
Peking University People's Hospital
🇨🇳Beijing, China
Wuhan TongJi Hospital
🇨🇳Wuhan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, China