NCT07500441 Digital PCR of CHIP and MR for MRD Monitoring After Allo-HSCT in AML
| NCT ID | NCT07500441 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University People's Hospital |
| Condition | Acute Myeloid Leukemia (AML) |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-03-20 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-03-20 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Ya-zhen Qin, Ph.D
PRINCIPAL INVESTIGATOR
Peking University People's Hospital
Frequently Asked Questions
Who can join the NCT07500441 clinical trial?
This trial is open to participants of all sexes, studying Acute Myeloid Leukemia (AML). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07500441 currently recruiting?
Yes, NCT07500441 is actively recruiting participants. Contact the research team at drlvmeng@bjmu.edu.cn for enrollment information.
Where is the NCT07500441 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07500441 clinical trial?
NCT07500441 is sponsored by Peking University People's Hospital. The principal investigator is Ya-zhen Qin, Ph.D at Peking University People's Hospital. The trial plans to enroll 100 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.