- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Erlie Jiang
- Telefonnummer: +86-15122538106
- E-mail: jiangerlie@ihcams.ac.cn
Undersøgelse Kontakt Backup
- Navn: Dan Feng
- Telefonnummer: +86-17863810313
- E-mail: fengdan@ihcams.ac.cn
Studiesteder
-
-
Tianjin Municipality
-
Tianjin, Tianjin Municipality, Kina, 300020
- National Clinical Research Center for Blood Diseases, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
Inclusion Criteria:
-
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 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
6-month cumulative incidence of relapse
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
1 year cumulative incidence of relapse
Tidsramme: 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
Tidsramme: 2 year after transplantation
|
Calculated from the date of transplantation until the first occurrence of AML relapse. |
2 year after transplantation
|
|
Relapse free survival
Tidsramme: 2 year after transplantation
|
Calculated from the date of transplantation until the relapse or death |
2 year after transplantation
|
|
Overall survival
Tidsramme: 2 year after transplantation
|
Calculated from the date of transplantation until death |
2 year after transplantation
|
|
Non-relapse mortality
Tidsramme: 2 year after transplantation
|
Calculated from the date of transplantation until death without relapse |
2 year after transplantation
|
|
Time interval from NGS-MRD positivity to clinical relapse
Tidsramme: 2 year after transplantation
|
3-months NGS-MRD positivity to clinical relapse |
2 year after transplantation
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IIT2026119
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .