Measurable Residual Disease Assessment of Cells With Leukemic Stem Cells Associated Phenotype in Patients With Myelodysplastic Syndrome: a Multi-center, Prospective Clinical Study
NCT Number: NCT06569095
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Myelodysplastic Syndromes
Interventions: OTHER: Multiparametric Flow Cytometry for the detection of Myelodysplastic syndromes with Measurable residual disease
Sponsor: Peking University People's Hospital
Sex: ALL
Age: CHILD, ADULT
Enrollment: 163
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-01
Completion Date: 2027-08-01

Summary:
At present, multiparameter flow cytometry (MFC) and polymerase chain reaction (PCR) are recommended for measurable residual disease (MRD) monitoring in China. Due to the lack of fusion genes detectable by PCR in some patients, MFC is the most commonly used MRD monitoring method. Both leukemia-associated immunophenotype (LAIP) and different from normal (DfN) immunophenotype in traditional MFC methods have false positives and false negatives; Therefore, a new MFC-MRD evaluation method is needed to address these issues. Some studies have reported that using MFC to detect MRD may improve the sensitivity and predictive value of MRD . Our research aims to observe whether bone marrow(BM) and peripheral blood(PB) MRD monitoring can predict the prognosis of Myelodysplastic syndromes (MDS) patients.

Primary Outcome Measures: 2-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., through study completion, an average of 2 years
Secondary Outcome Measures: Cumulative positive rate of measurable residual disease (MRD) after transplantation, The proportion of MRD positive patients after treatment., through study completion, an average of 2 years|Disease-free survival (LFS), Disease-free survival was defined as days from transplantation to disease progression after transplantation., through study completion, an average of 2 years|Overall survival (OS), Overall survival referred to patients who survived until the final follow-up time point., through study completion, an average of 2 years|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., through study completion, an average of 2 years|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., through study completion, an average of 2 years|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., through study completion, an average of 2 years|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., through study completion, an average of 2 years