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NCT07919119Not yet recruiting

Risk Stratification Value of Deep NGS-MRD Detection in Acute Myeloid Leukemia Patients After Allo-HSCT

Risk Stratification Value of Deep NGS-MRD Detection in Acute Myeloid Leukemia Patients After Hematopoietic Stem Cell Transplantation

Source: ClinicalTrials.gov · Last updated 5 Nov 2026

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Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
169 (estimated)
First submitted
23 Oct 2026
Start date
19 Oct 2026
Primary completion date
19 Oct 2027
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
NCT number
NCT07919119

What you commit to

  • Study type: Observational
  • Planned participants: 169
  • From 19 Oct 2026 to the primary completion date, 19 Oct 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with high-risk acute myeloid leukemia (AML) who have had a donor stem cell transplant. Deep NGS-MRD testing is done about 3 months after transplant. No study treatment is given.

Age
18 years or older
Sex
All sexes can join.
Disease stage
High-risk AML: adverse group by the 2022 ELN risk classification, or no molecular remission or MRD positive before transplant. KPS score of 60 or more.
Earlier treatment
Must have had an allogeneic hematopoietic stem cell transplant (allo-HSCT).
Biomarker or test result
NGS-MRD (measurable residual disease) is tested about 3 months after transplant. Patients are grouped as NGS-MRD-positive or NGS-MRD-negative.

Main reasons for not taking part

  • Signs of relapse at 3 months after transplant (on morphology, flow cytometry or molecular tests)
  • Another cancer at the same time
  • Poor follow-up compliance or unable to complete NGS testing
  • Other conditions the investigator decides rule out joining

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Presence of morphological, flow cytometric, or molecular evidence of relapse at +3 months after transplantation;
  • Concurrent diagnosis of another malignant neoplasm;

Other illness

  • Other conditions for which the investigator deems the subject ineligible to participate in this trial.

Other

  • Poor follow-up compliance or inability to complete NGS testing;

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College HospitalTianjinChinaUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.