Actively Recruiting
Predicting Patient Relapse After Allogeneic Hematopoietic Stem Cell Transplantation Using Digital Polymerase Chain Reaction Compared to Conventional MRD
Led by Peking University People's Hospital · Updated on 2024-01-18
300
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how effective digital Polymerase Chain Reaction (dPCR) is in monitoring measurable residual disease (MRD) in patients who have undergone allogeneic hematopoietic stem cell transplantation (HSCT) for leukemia, myelodysplastic syndromes (MDS), and related blood disorders. The study aims to compare dPCR with traditional MRD monitoring methods like quantitative PCR and multicolor flow cytometry (MFC) to better predict patient relapse and survival outcomes. Participants include patients with acute leukemia, MDS, and chronic myeloid leukemia (CML). The study evaluates MRD markers such as BCR::ABL and KMT2A using dPCR and compares these results to conventional testing methods. There are no treatment interventions; instead, different diagnostic tests are performed to monitor MRD over time. Throughout the study, patients will undergo MRD monitoring by dPCR after transplantation, along with assessments using conventional MRD techniques. Researchers will measure key outcomes including the threshold of dPCR to predict conventional MRD at two years, relapse rates, overall survival, relapse-free survival, and non-relapse mortality. The study started in January 2024 and is expected to continue through December 2027.
CONDITIONS
Brief Title
Assessment of Measurable Residual Disease in Allo-HSCT Using Digital Polymerase Chain Reaction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presence of at least one fusion gene or hematological tumor-associated mutation detected at diagnosis by NGS or real-time PCR for posttransplant MRD monitoring
- Neutrophil engraftment after transplantation
- At least one MRD monitoring by digital PCR after hematopoietic stem cell transplantation
You will not qualify if you...
- Patients who relapsed or died before the first digital PCR monitoring
- Patients with only DNMT3A, TET2, and ASXL1 mutations ("DTA mutations") or only germline mutations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants undergo digital Polymerase Chain Reaction (dPCR), quantitative PCR, and multicolor Flow Cytometry (MFC) to monitor measurable residual disease after allogeneic hematopoietic stem cell transplantation.
Periodic visits for MRD monitoring over 2 years
Duration - Up to 2 years
Participants are observed for disease outcomes including hematological relapse, disease-free survival, overall survival, and non-relapse mortality.
Follow-up visits as scheduled over 2 years
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
M
Meng Lv, M.D,Ph.D
Y
Ya-zhen Qin, Ph.D
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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