Monitoring Measurable Residual Disease Using Digital PCR to Predict Relapse After Stem Cell Transplant in Leukemia and Related Blood Disorders

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 BCRABL 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.

Assessment of Measurable Residual Disease in Allo-HSCT Using Digital Polymerase Chain Reaction