Acute Myeloid Leukemia (AML)NCT07500441
Digital PCR of CHIP and MR for MRD Monitoring After Allo-HSCT in AML
An observational study of Acute Myeloid Leukemia (AML), run by Peking University People's Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- What is being tested?
- Individualized Digital PCR (dPCR) monitoring
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2026to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: AML patients who underwent allo-HSCT, specifically those lacking common fusion genes and NPM1 mutations but carrying CH and/or MR gene mutations.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
About this study
Official title: 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.
Read the detailed description
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains a potentially curative treatment for patients with intermediate- and high-risk acute myeloid leukemia (AML). Post-transplant monitoring of measurable residual disease (MRD) is critical for early detection of relapse and timely clinical intervention.
This study focuses on AML patients harboring clonal hematopoiesis (CH) and/or myelodysplasia-related (MR) gene mutations (e.g., DNMT3A, TET2, ASXL1, SRSF2), who lack recurrent fusion genes and NPM1 mutations, representing a population with an unmet need for sensitive molecular MRD monitoring strategies.
For each enrolled patient, an individualized digital PCR (dPCR) assay will be developed to detect patient-specific mutations with high sensitivity. Bone marrow samples will be collected longitudinally at predefined time points (baseline [month 0], and months 1, 2, 3, 4.5, 6, 9, and 12 post-allo-HSCT).
Longitudinal dynamics of mutation burden will be analyzed to evaluate their association with clinical outcomes, including cumulative incidence of relapse (CIR) and overall survival (OS). This study aims to establish dPCR-based MRD monitoring as a precise and clinically actionable tool to guide early intervention and ultimately improve post-transplant outcomes in AML.
- Conditions
- Acute Myeloid Leukemia (AML)
- Being tested
- Individualized Digital PCR (dPCR) monitoring
- Keywords
- Measurable Residual Disease (MRD), Digital PCR (DPCR), Allogeneic Hematopoietic Stem Cell Transplantation, Clonal Hematopoiesis
- Medical subject headings
- Leukemia, Myeloid, Acute, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Digital PCR (dPCR) monitoringDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| AML post-HSCT Cohort | 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. Receives: Diagnostic Test: Individualized Digital PCR (dPCR) monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Incidence of Relapse (CIR)
CIR is defined as the time from transplantation to hematologic or extramedullary relapse
Measured: Up to 2 years post-transplantation
Secondary outcomes (2)
Overall Survival (OS)
The time from HSCT to the Death from any cause
Measured: Up to 2 years post-transplantation
Relapse-free survival (RFS)
The time from the date of HSCT to the occurrence of any of the following: Death from any cause Disease recurrence
Measured: Up to 2 years post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start20 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML)Studies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meng Lv, Peking University People's Hospital
- Investigators
- Ya-zhen Qin, Ph.D, Principal investigator, Peking University People's HospitalMeng Lv, M.D,Ph.D, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07500441
- Sponsor's protocol ID
- 2026PHB191-001
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07500441
- Acronym / sponsor ID
- 2026PHB191-001
- Conditions
- Acute Myeloid Leukemia (AML)
- Keywords
- Measurable Residual Disease (MRD), Digital PCR (DPCR), Allogeneic Hematopoietic Stem Cell Transplantation, Clonal Hematopoiesis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains a potentially curative treatment for patients with intermediate- and high-risk acute myeloid leukemia (AML). Post-transplant monitoring of measurable residual disease (MRD) is critical for early detection of relapse and timely clinical intervention.
This study focuses on AML patients harboring clonal hematopoiesis (CH) and/or myelodysplasia-related (MR) gene mutations (e.g., DNMT3A, TET2, ASXL1, SRSF2), who lack recurrent fusion genes and NPM1 mutations, representing a population with an unmet need for sensitive molecular MRD monitoring strategies.
For each enrolled patient, an individualized digital PCR (dPCR) assay will be developed to detect patient-specific mutations with high sensitivity. Bone marrow samples will be collected longitudinally at predefined time points (baseline [month 0], and months 1, 2, 3, 4.5, 6, 9, and 12 post-allo-HSCT).
Longitudinal dynamics of mutation burden will be analyzed to evaluate their association with clinical outcomes, including cumulative incidence of relapse (CIR) and overall survival (OS). This study aims to establish dPCR-based MRD monitoring as a precise and clinically actionable tool to guide early intervention and ultimately improve post-transplant outcomes in AML.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AML post-HSCT Cohort | – | Diagnostic Test: Individualized Digital PCR (dPCR) monitoringPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- AML patients who underwent allo-HSCT, specifically those lacking common fusion genes and NPM1 mutations but carrying CH and/or MR gene mutations.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized Digital PCR (dPCR) monitoringBone 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. | Diagnostic test | AML post-HSCT Cohort |
Primary outcome
Cumulative Incidence of Relapse (CIR)
Time frame: Up to 2 years post-transplantation
CIR is defined as the time from transplantation to hematologic or extramedullary relapse
2 secondary outcomes
Overall Survival (OS)
Time frame: Up to 2 years post-transplantation
Relapse-free survival (RFS)
Time frame: Up to 2 years post-transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ya-zhen Qin, Ph.D principal investigator
Peking University People's Hospital
Meng Lv, M.D,Ph.D principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia (AML), run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meng Lv, M.D,Ph.D (+861088324637, drlvmeng@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Incidence of Relapse (CIR) (time frame: Up to 2 years post-transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.