Clinical trial · Observational
Digital PCR of CHIP and MR for MRD Monitoring After Allo-HSCT in AML
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Individualized Digital PCR (dPCR) monitoring | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- AML post-HSCT Cohort
- description
- Patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) who harbor clonal hematopoiesis (CH) and/or myelodysplasia-related (MR) gene mutations, and are negative for recurrent fusion genes and NPM1 mutations.
- interventionNames
- Diagnostic Test: Individualized Digital PCR (dPCR) monitoring
Primary outcomes (1)
- measure
- Cumulative Incidence of Relapse (CIR)
- timeFrame
- Up to 2 years post-transplantation
- description
- CIR is defined as the time from transplantation to hematologic or extramedullary relapse
Secondary outcomes (2)
- measure
- Overall Survival (OS)
- timeFrame
- Up to 2 years post-transplantation
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
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