RECRUITINGOBSERVATIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DIAGNOSTIC_TEST

Individualized Digital PCR (dPCR) monitoring

Bone marrow samples are collected at 0, 1, 2, 3, 4.5, 6, 9, and 12 months post-HSCT. DNA is extracted and specific CH/MR mutation burden is quantified using individualized dPCR primer/probe systems.

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China