Assessment of Measurable Residual Disease in Allo-HSCT Using Digital Polymerase Chain Reaction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital PCR, Quantitative PCR, MFC.
- Who it may be relevant to
- Registry conditions: Acute Leukemia, MDS, MDS/MPN, CML. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Predicting Patient Relapse After Allogeneic Hematopoietic Stem Cell Transplantation: A Comparison of Measurable Residual Disease (MRD) Assessment by Digital Polymerase Chain Reaction and Conventional MRD
Overview
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 test Digital PCR
digital Polymerase Chain Reaction (dPCR) - Diagnostic test Quantitative PCR
Real-time Polymerase Chain Reaction (real-time PCR) - Diagnostic test MFC
Multicolor Flow Cytometry
Primary outcome measures
- Threshold of dPCR to predict conventional MRD [Time frame: 2-year]
Secondary outcome measures (4)
- Cumulative incidence of relapse (CIR) [Time frame: 2-year]
- Overall survival (OS) [Time frame: 2-year]
- Relapse-free survival (RFS) [Time frame: 2-year]
- Non-Relapse Mortality(NRM) [Time frame: 2-year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT06211166 · 2021PHA154-001