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- Klinische proef NCT07919119
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
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Contacten en locaties
Studiecontact
- Naam: Erlie Jiang
- Telefoonnummer: +86-15122538106
- E-mail: jiangerlie@ihcams.ac.cn
Studie Contact Back-up
- Naam: Dan Feng
- Telefoonnummer: +86-17863810313
- E-mail: fengdan@ihcams.ac.cn
Studie Locaties
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Tianjin Municipality
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Tianjin, Tianjin Municipality, China, 300020
- National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
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.
Beschrijving
Inclusion Criteria:
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Age ≥ 18 years;
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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;
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Receipt of allogeneic hematopoietic stem cell transplantation (allo-HSCT);
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KPS score ≥ 60;
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Written informed consent obtained from the patient or legal guardian
Exclusion Criteria:
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: COHORT
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
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. |
Deep NGS-MRD testing will be conducted at approximately +3 months after transplantation. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
6-month cumulative incidence of relapse
Tijdsspanne: 6 months after transplantation
|
Calculated from the date of the +3-month NGS-MRD assay until the first occurrence of AML relapse. |
6 months after transplantation
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
1 year cumulative incidence of relapse
Tijdsspanne: 1 year after transplantation
|
Calculated from the date of transplantation until the first occurrence of AML relapse. |
1 year after transplantation
|
|
2 year cumulative incidence of relapse
Tijdsspanne: 2 year after transplantation
|
Calculated from the date of transplantation until the first occurrence of AML relapse. |
2 year after transplantation
|
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Relapse free survival
Tijdsspanne: 2 year after transplantation
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Calculated from the date of transplantation until the relapse or death |
2 year after transplantation
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Overall survival
Tijdsspanne: 2 year after transplantation
|
Calculated from the date of transplantation until death |
2 year after transplantation
|
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Non-relapse mortality
Tijdsspanne: 2 year after transplantation
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Calculated from the date of transplantation until death without relapse |
2 year after transplantation
|
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Time interval from NGS-MRD positivity to clinical relapse
Tijdsspanne: 2 year after transplantation
|
3-months NGS-MRD positivity to clinical relapse |
2 year after transplantation
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IIT2026119
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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