- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Erlie Jiang
- Telefonnummer: +86-15122538106
- E-post: jiangerlie@ihcams.ac.cn
Studera Kontakt Backup
- Namn: Dan Feng
- Telefonnummer: +86-17863810313
- E-post: fengdan@ihcams.ac.cn
Studieorter
-
-
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
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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.
Beskrivning
Inclusion Criteria:
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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;
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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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: COHORT
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
6-month cumulative incidence of relapse
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
1 year cumulative incidence of relapse
Tidsram: 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
Tidsram: 2 year after transplantation
|
Calculated from the date of transplantation until the first occurrence of AML relapse. |
2 year after transplantation
|
|
Relapse free survival
Tidsram: 2 year after transplantation
|
Calculated from the date of transplantation until the relapse or death |
2 year after transplantation
|
|
Overall survival
Tidsram: 2 year after transplantation
|
Calculated from the date of transplantation until death |
2 year after transplantation
|
|
Non-relapse mortality
Tidsram: 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
Tidsram: 2 year after transplantation
|
3-months NGS-MRD positivity to clinical relapse |
2 year after transplantation
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IIT2026119
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