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Digital PCR of CHIP and MR for MRD Monitoring After Allo-HSCT in AML

Recruitingn/aAges any - anyAllPeking University People's Hospital
NCT07500441 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This prospective observational study aims to evaluate the clinical significance of measurable residual disease (MRD) monitoring using digital PCR (dPCR) in patients with acute myeloid leukemia (AML) following allogeneic hematopoietic stem cell transplantation (allo-HSCT). The study will specifically enroll patients harboring clonal hematopoiesis (CH) and/or myelodysplasia-related (MR) gene mutations. Patient-specific dPCR assays will be established to enable highly sensitive, longitudinal quantification of mutation burden. Serial assessments will be performed at predefined time points within the first 12 months after transplantation. The study will investigate the prognostic value of dPCR-based MRD dynamics for predicting relapse, relapse-free survival, and overall survival, and will further explore its potential to enable earlier detection of molecular relapse compared with conventiona

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Diagnosis of acute myeloid leukemia (AML). 2. Undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) at the investigating center. 3. Negative for recurrent fusion genes routinely monitored in the clinical laboratory, including but not limited to AML1::ETO, CBFB::MYH11, KMT2A (MLL) rearrangements, NUP98::NSD1, NUP98::HOXA9, FUS::ERG, DEK::NUP214, SET::NUP214, PICALM::AF10, and BCR::ABL1. 4. Availability of next-generation sequencing (NGS) results at initial diagnosis with accessible original reports. 5. Negative for NPM1 mutations at initial diagnosis. 6. Presence of clonal hematopoiesis (CH) and/or myelodysplasia-related (MR) gene mutations at initial diagnosis, including but not limited to DNMT3A, TET2, ASXL1, SRSF2, SF3B1, U2AF1, JAK2, IDH2, BCOR, EZH2, RUNX1, STAG2, and ZRSR2. Exclusion Criteria: 1. Patients with mutation profiles unsuitable for the design of patient-specific digital PCR (dPCR) assays achieving a sensitivity of ≤0.1%. 2. Absence of evaluable molecular targets for longitudinal MRD monitoring.
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What it tests

  • Individualized Digital PCR (dPCR) monitoring
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Where

1 site
Peking University People's Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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