Digital PCR monitoring of residual AML after allogeneic stem-cell transplant in patients with clonal hematopoiesis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study creates individualized digital PCR (dPCR) assays to sensitively track patient-specific mutations in AML patients after allogeneic hematopoietic stem cell transplantation. Bone marrow samples are collected at predefined time points during the first 12 months post-transplant (baseline and months 1, 2, 3, 4.5, 6, 9, and 12) for longitudinal quantification of mutation burden. The study will analyze MRD dynamics measured by dPCR against clinical outcomes including relapse, relapse-free survival, and overall survival, and compare timing of molecular relapse detection to conventional methods. The focus is on patients with clonal hematopoiesis or myelodysplasia-related gene mutations who lack common fusion genes and NPM1 mutations, a group with limited MRD options today.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Ya-zhen Qin, Ph.D — Peking University People's Hospital
• Study coordinator: Meng Lv, M.D,Ph.D
• Email: drlvmeng@bjmu.edu.cn
• Phone: +861088324637

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.