Acute Leukemia, CML, MDS, MDS/MPN
Conditions
Keywords
dPCR, MRD, allo-HSCT, leukemia
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTDigital PCR
digital Polymerase Chain Reaction (dPCR)
DIAGNOSTIC_TESTQuantitative PCR
Real-time Polymerase Chain Reaction (real-time PCR)
DIAGNOSTIC_TESTMFC
Multicolor Flow Cytometry
Sponsors
Peking University People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* The presence of at least one fusion gene or hematological tumor-associated mutation detected at diagnosis by NGS or real-time PCR provided for posttransplant MRD monitoring. * Neutrophil engraftment * Received at least one MRD monitoring by digital PCR after HSCT
Exclusion criteria
* Patients who relapsed or died before the first digital PCR monitoring * Patients only with mutations in DNMT3A, TET2, and ASXL1 (DTA mutations) or only germline mutations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Threshold of dPCR to predict conventional MRD | 2-year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of relapse (CIR) | 2-year | The interval from the transplantation date to hematological recurrence |
| Overall survival (OS) | 2-year | The time from HSCT to the Death from any cause |
| Relapse-free survival (RFS) | 2-year | The time from the date of HSCT to the occurrence of any of the following: Death from any cause Disease recurrence |
| Non-Relapse Mortality(NRM) | 2-year | The time from the date of HSCT to deaths that result from complications other than a relapse of the underlying disease. |
Countries
China
Contacts
Primary ContactMeng Lv, M.D,Ph.D
Backup ContactYa-zhen Qin, Ph.D
Outcome results
None listed