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.
Study Type
OBSERVATIONAL
Enrollment
163
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.
Chinese PLA General Hospital
Beijing, China
RECRUITINGPeking University People's Hospital
Beijing, China
RECRUITINGWuhan TongJi Hospital
Wuhan, China
RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
RECRUITING1 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.
Time frame: through study completion, an average of 1 year
Cumulative positive rate of measurable residual disease (MRD) after transplantation
The proportion of MRD positive patients after treatment.
Time frame: through study completion, an average of 1 year
Disease-free survival (LFS)
Disease-free survival was defined as days from transplantation to disease progression after transplantation.
Time frame: through study completion, an average of 1 year
Overall survival (OS)
Overall survival referred to patients who survived until the final follow-up time point.
Time frame: through study completion, an average of 1 year
Non-recurrent death (NRM)
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.
Time frame: through study completion, an average of 1 year
Transplant-related death (TRM)
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.
Time frame: through study completion, an average of 1 year
Acute graft-versus-host disease (GVHD)
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.
Time frame: through study completion, an average of 1 year
Chronic graft-versus-host disease (GVHD)
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.
Time frame: through study completion, an average of 1 year
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