Digital PCR Blood Tests to Watch for Leukemia Returning After Stem Cell Transplant
Tracks leftover leukemia cells with digital PCR in transplanted acute myeloid leukemia patients.
Plain-language title generated from the registry record
Registry title: Digital PCR of CHIP and MR for MRD Monitoring After Allo-HSCT in AML
Key facts
- Where
- Beijing, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults and children with acute myeloid leukemia (AML) who are having a donor stem cell transplant at the study center. They must have certain gene mutations found at diagnosis.
- Sex
- Everyone can join, women and men.
- Disease stage
- Acute myeloid leukemia (AML), tested at first diagnosis. No NPM1 mutation. No recurrent fusion genes such as AML1::ETO, CBFB::MYH11, KMT2A (MLL) rearrangements or BCR::ABL1.
- Earlier treatment
- Must be having an allogeneic hematopoietic stem cell transplant (allo-HSCT) at the investigating center.
- Biomarker or test result
- Clonal hematopoiesis (CH) and/or myelodysplasia-related (MR) gene mutations at diagnosis, for example DNMT3A, TET2, ASXL1, SRSF2, SF3B1, U2AF1, JAK2, IDH2, BCOR, EZH2, RUNX1, STAG2 or ZRSR2. Next-generation sequencing (NGS) results from diagnosis must be available.
Main reasons for not taking part
- Mutation profile that does not allow a patient-specific digital PCR (dPCR) test with a sensitivity of ≤0.1%
- No measurable molecular target to follow over time
Read by machine on 9 November 2026.
Where in China
- Peking University People's HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Peking University People's Hospital
- Trial code
- NCT07500441
- Record updated
- 30 March 2026
- Original description
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.Read full original descriptionShow less
Digital PCR-Based Detection of CHIP and MR Mutations for Minimal Residual Disease Monitoring After Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia
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 conventional methods.
Inclusion: Diagnosis of acute myeloid leukemia (AML); Undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) at the investigating center; 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; Availability of next-generation sequencing (NGS) results at initial diagnosis with accessible original reports; Negative for NPM1 mutations at initial diagnosis; 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: Patients with mutation profiles unsuitable for the design of patient-specific digital PCR (dPCR) assays achieving a sensitivity of ≤0.1%; Absence of evaluable molecular targets for longitudinal MRD monitoring.