A research investigation into the efficacy of digital Polymerase Chain Reaction (dPCR) for monitoring measurable residual disease (MRD) during allogeneic hematopoietic stem cell transplantation, with a focus on predicting relapse in patients diagnosed with leukemia, myelodysplastic syndromes (MDS), and related hematological conditions.
This prospective clinical study focuses on patients diagnosed with leukemia, myelodysplastic syndromes (MDS), and related hematological conditions post-allogeneic hematopoietic stem cell transplantation. The primary objective is to assess the efficacy of digital Polymerase Chain Reaction (dPCR) in monitoring measurable residual disease (MRD), including markers such as BCR::ABL, KMT2A, etc., as compared to other MRD monitoring methods such as conventional quantitative PCR or multicolor Flow Cytometry (MFC). Key endpoints include the recurrence of MRD using conventional methods, hematological relapse, disease-free survival, overall survival, and non-relapse mortality.
Study Type
OBSERVATIONAL
Enrollment
300
digital Polymerase Chain Reaction (dPCR)
Real-time Polymerase Chain Reaction (real-time PCR)
Multicolor Flow Cytometry
Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGThreshold of dPCR to predict conventional MRD
To establish an optimal threshold for digital PolyTo establish an optimal threshold for digital Polymerase Chain Reaction (dPCR) in predicting Measurable Residual Disease (MRD) recurrence after allogeneic hematopoietic stem cell transplantation (allo-HSCT). MRD recurrence is defined as the reappearance or elevation of minimal residual disease, as assessed by other MRD monitoring methods such as conventional quantitative PCR or multi-color Flow Cytometry (MFC), which served as indications of pre-emptive intervention by current consensus or guideline.
Time frame: 2-year
Cumulative incidence of relapse (CIR)
The interval from the transplantation date to hematological recurrence
Time frame: 2-year
Overall survival (OS)
The time from HSCT to the Death from any cause
Time frame: 2-year
Relapse-free survival (RFS)
The time from the date of HSCT to the occurrence of any of the following: Death from any cause Disease recurrence
Time frame: 2-year
Non-Relapse Mortality(NRM)
The time from the date of HSCT to deaths that result from complications other than a relapse of the underlying disease.
Time frame: 2-year
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