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Not yet recruitingNCT07919119Updated Nov 5, 2026

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

An observational study in Measurable Residual Disease and Acute Myeloid Leukemia, sponsored by Institute of Hematology & Blood Diseases Hospital, China. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Institute of Hematology & Blood Diseases Hospital, China · Observational

Updated Nov 5, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
169
Ages
18 Years and older
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Measurable Residual Disease
  • Acute Myeloid Leukemia
03

In context

Neoplasm, Residual

293 studies on the registry are indexed under Neoplasm, Residual; 137 are open to participants now.

This study's planned enrollment of 169 is above the median of 107 across 88 observational studies indexed under Neoplasm, Residual.

Browse Neoplasm, Residual studies →

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China is the lead sponsor of 410 studies on the registry; 291 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥ 18 years;
  2. Diagnosis as high-risk AML meeting at least one of the following criteria:

    1. Adverse group according to the 2022 ELN risk classification;
    2. Failure to achieve molecular remission or MRD positivity before transplantation;
  3. Receipt of hematopoietic stem cell transplantation (allo-HSCT);
  4. score ≥ 60;
  5. Written obtained from the patient or legal guardian

Exclusion criteria

Exclusion Criteria:

  1. Presence of morphological, flow cytometric, or molecular evidence of relapse at +3 months after transplantation;
  2. Concurrent diagnosis of another malignant neoplasm;
  3. Poor follow-up compliance or inability to complete NGS testing;
  4. Other conditions for which the investigator deems the subject ineligible to participate in this trial.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
169 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes

Groups and cohorts

  • 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.

    Other: NGS-MRD AML cohort

Interventions

  • OtherNGS-MRD AML cohort

    Deep NGS-MRD testing will be conducted at approximately +3 months after transplantation.

06

What researchers measure

Primary outcomes

  1. 6-month cumulative incidence of relapse

    Calculated from the date of the +3-month NGS-MRD assay until the first occurrence of AML relapse.

    Time frame: 6 months after transplantation

Secondary outcomes

  1. 1 year cumulative incidence of relapse

    Calculated from the date of transplantation until the first occurrence of AML relapse.

    Time frame: 1 year after transplantation

  2. 2 year cumulative incidence of relapse

    Calculated from the date of transplantation until the first occurrence of AML relapse.

    Time frame: 2 year after transplantation

  3. Relapse free survival

    Calculated from the date of transplantation until the relapse or death

    Time frame: 2 year after transplantation

  4. Overall survival

    Calculated from the date of transplantation until death

    Time frame: 2 year after transplantation

  5. Non-relapse mortality

    Calculated from the date of transplantation until death without relapse

    Time frame: 2 year after transplantation

  6. Time interval from NGS-MRD positivity to clinical relapse

    3-months NGS-MRD positivity to clinical relapse

    Time frame: 2 year after transplantation

07

Study locations

1 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, China
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07919119
Responsible party
Sponsor
First posted
Nov 5, 2026
Start date
Oct 19, 2026 (estimated)
Primary completion
Oct 19, 2027 (estimated)
Completion
Oct 19, 2027 (estimated)
Last update
Nov 5, 2026

Study contacts

Erlie Jiang
Contact
jiangerlie@ihcams.ac.cn
+86-15122538106
Dan Feng
Contact
fengdan@ihcams.ac.cn
+86-17863810313

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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