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Testing for leftover leukemia cells after stem cell transplant in acute myeloid leukemia

Checks for leftover leukemia cells in adults with acute myeloid leukemia after transplant.

Plain-language title generated from the registry record
Registry title: Risk Stratification Value of Deep NGS-MRD Detection in Acute Myeloid Leukemia Patients After Allo-HSCT

Key facts

Where
Tianjin, ChinaSee the site

Where in China

  • National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College HospitalTianjin, ChinaNo longer taking part

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Trial details

Who runs it
Institute of Hematology & Blood Diseases Hospital, China
Trial code
NCT07919119
Record updated
5 November 2026
Original description
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.Read full original descriptionShow less

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.

Inclusion: 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.

Exclusion: Presence of morphological, flow cytometric, or molecular evidence of relapse at +3 months after transplantation; Concurrent diagnosis of another malignant neoplasm; Other conditions for which the investigator deems the subject ineligible to participate in this trial; Poor follow-up compliance or inability to complete NGS testing.

ClinicalTrials.gov NCT07919119