Assessment of Measurable Residual Disease in Allo-HSCT Using Digital Polymerase Chain Reaction
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
1 other identifier
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 8, 2024
CompletedStudy Start
First participant enrolled
January 8, 2024
CompletedFirst Posted
Study publicly available on registry
January 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
ExpectedJanuary 18, 2024
January 1, 2024
2 years
January 8, 2024
January 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Threshold 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.
2-year
Secondary Outcomes (4)
Cumulative incidence of relapse (CIR)
2-year
Overall survival (OS)
2-year
Relapse-free survival (RFS)
2-year
Non-Relapse Mortality(NRM)
2-year
Study Arms (3)
Acute Leukemia
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Mixed Phenotype Acute Leukemia
MDS or MDS/MPN
Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, and other subtypes of Myelodysplastic/Myeloproliferative Neoplasm
CML
Chronic Myeloid Leukemia
Interventions
Real-time Polymerase Chain Reaction (real-time PCR)
Eligibility Criteria
Patients with hematological malignancies who underwent allo-HSCT were enrolled for MRD monitoring peri-HSCT
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Biospecimen
bone marrow
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiao-jun Huang, M.D
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 8, 2024
First Posted
January 18, 2024
Study Start
January 8, 2024
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2027
Last Updated
January 18, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share