Measurable Residual DiseaseNCT07919119
Risk Stratification Value of Deep NGS-MRD Detection in Acute Myeloid Leukemia Patients After Allo-HSCT
An observational study of Measurable Residual Disease and Acute Myeloid Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
To assess the value of deep NGS-MRD detection for risk stratification in adult high-risk acute myeloid leukemia (AML) patients, in this prospective, single-center, observational cohort study following allogeneic hematopoietic stem cell transplantation (allo-HSCT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Measurable Residual Disease, Acute Myeloid Leukemia
- What is being tested?
- NGS-MRD AML cohort
- How many people
- 169 participants
- Where
- 1 siteChina
- Study dates
- 19 Oct 2026to 19 Oct 2027
- How long will I take part?
- 2 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: To assess the risk-stratifying value of deep NGS-MRD detection in high-risk acute myeloid leukemia (AML) patients following allogeneic hematopoietic stem cell transplantation (allo-HSCT), this prospective, single-center, observational cohort study plans to enroll 169 patients. Deep NGS-MRD testing will be performed at approximately +3 months after transplantation.
Who may be able to join
- Age ≥ 18 years;
- Diagnosis as high-risk AML meeting at least one of the following criteria:
- Adverse group according to the 2022 ELN risk classification;
- Failure to achieve molecular remission or MRD positivity before transplantation;
- Receipt of allogeneic hematopoietic stem cell transplantation (allo-HSCT);
- KPS score ≥ 60;
- Written informed consent obtained from the patient or legal guardian
Who cannot join
- Presence of morphological, flow cytometric, or molecular evidence of relapse at +3 months after transplantation;
- Concurrent diagnosis of another malignant neoplasm;
- Poor follow-up compliance or inability to complete NGS testing;
- Other conditions for which the investigator deems the subject ineligible to participate in this trial.
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
National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Tianjin, Tianjin Municipality, 300020
About this study
Official title: Risk Stratification Value of Deep NGS-MRD Detection in Acute Myeloid Leukemia Patients After Hematopoietic Stem Cell Transplantation
To assess the value of deep NGS-MRD detection for risk stratification in adult high-risk acute myeloid leukemia (AML) patients, in this prospective, single-center, observational cohort study following allogeneic hematopoietic stem cell transplantation (allo-HSCT). A total of 169 patients will be enrolled, and deep NGS-MRD testing will be performed at approximately +3 months after transplantation. Patients will be stratified into NGS-MRD-positive and NGS-MRD-negative groups based on test results. No investigational interventions will be administered. Follow-up analyses will evaluate the associations between NGS-MRD status and post-transplant relapse and survival.
- Being tested
- NGS-MRD AML cohort
- Medical subject headings
- Neoplasm, Residual, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NGS-MRD AML cohortOther
Deep NGS-MRD testing will be conducted at approximately +3 months after transplantation.
| Study group | Role | What they receive |
|---|---|---|
| NGS-MRD AML cohort | This prospective, single-center, observational cohort study plans to enroll 169 high-risk acute myeloid leukemia (AML) patients receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT). Deep NGS-MRD testing will be conducted at approximately +3 months after transplantation. Receives: Other: NGS-MRD AML cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month cumulative incidence of relapse
Calculated from the date of the +3-month NGS-MRD assay until the first occurrence of AML relapse.
Measured: 6 months after transplantation
Secondary outcomes (6)
1 year cumulative incidence of relapse
Calculated from the date of transplantation until the first occurrence of AML relapse.
Measured: 1 year after transplantation
2 year cumulative incidence of relapse
Calculated from the date of transplantation until the first occurrence of AML relapse.
Measured: 2 year after transplantation
Relapse free survival
Calculated from the date of transplantation until the relapse or death
Measured: 2 year after transplantation
Overall survival
Calculated from the date of transplantation until death
Measured: 2 year after transplantation
Non-relapse mortality
Calculated from the date of transplantation until death without relapse
Measured: 2 year after transplantation
Time interval from NGS-MRD positivity to clinical relapse
3-months NGS-MRD positivity to clinical relapse
Measured: 2 year after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start19 Oct 2026 (estimated)
- Primary completion19 Oct 2027 (estimated)
- Study completion19 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Measurable Residual DiseaseStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- 169 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07919119
- Sponsor's protocol ID
- IIT2026119
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratification Value of Deep NGS-MRD Detection in Acute Myeloid Leukemia Patients After Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07919119
- Acronym / sponsor ID
- IIT2026119
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 169 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 19 Oct 2026 (estimated)
- Primary completion
- 19 Oct 2027 (estimated)
- Study completion
- 19 Oct 2027 (estimated)
- First posted
- 5 Nov 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.
To assess the value of deep NGS-MRD detection for risk stratification in adult high-risk acute myeloid leukemia (AML) patients, in this prospective, single-center, observational cohort study following allogeneic hematopoietic stem cell transplantation (allo-HSCT). A total of 169 patients will be enrolled, and deep NGS-MRD testing will be performed at approximately +3 months after transplantation. Patients will be stratified into NGS-MRD-positive and NGS-MRD-negative groups based on test results. No investigational interventions will be administered. Follow-up analyses will evaluate the associations between NGS-MRD status and post-transplant relapse and survival.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NGS-MRD AML cohort | – | Other: NGS-MRD AML cohortThis prospective, single-center, observational cohort study plans to enroll 169 high-risk acute myeloid leukemia (AML) patients receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT). Deep NGS-MRD testing will be conducted at approximately +3 months after transplantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- To assess the risk-stratifying value of deep NGS-MRD detection in high-risk acute myeloid leukemia (AML) patients following allogeneic hematopoietic stem cell transplantation (allo-HSCT), this prospective, single-center, observational cohort study plans to enroll 169 patients. Deep NGS-MRD testing will be performed at approximately +3 months after transplantation.
Key inclusion criteria (7 listed)
- Age ≥ 18 years;
- Diagnosis as high-risk AML meeting at least one of the following criteria:
- Receipt of allogeneic hematopoietic stem cell transplantation (allo-HSCT);
- KPS score ≥ 60;
- Written informed consent obtained from the patient or legal guardian
Key exclusion criteria (4 listed)
- Presence of morphological, flow cytometric, or molecular evidence of relapse at +3 months after transplantation;
- Concurrent diagnosis of another malignant neoplasm;
- Poor follow-up compliance or inability to complete NGS testing;
- Other conditions for which the investigator deems the subject ineligible to participate in this trial.
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 |
|---|---|---|
| NGS-MRD AML cohortDeep NGS-MRD testing will be conducted at approximately +3 months after transplantation. | Other | NGS-MRD AML cohort |
Primary outcome
6-month cumulative incidence of relapse
Time frame: 6 months after transplantation
Calculated from the date of the +3-month NGS-MRD assay until the first occurrence of AML relapse.
6 secondary outcomes
1 year cumulative incidence of relapse
Time frame: 1 year after transplantation
2 year cumulative incidence of relapse
Time frame: 2 year after transplantation
Relapse free survival
Time frame: 2 year after transplantation
Overall survival
Time frame: 2 year after transplantation
Non-relapse mortality
Time frame: 2 year after transplantation
Time interval from NGS-MRD positivity to clinical relapse
Time frame: 2 year after 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 5 Nov 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.
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 Measurable Residual Disease and Acute Myeloid Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China 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 7 inclusion and 4 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: opening soon, as of the sponsor's last update on 5 Nov 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 Erlie Jiang (+86-15122538106, jiangerlie@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month cumulative incidence of relapse (time frame: 6 months after 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 5 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.