Prospective Validation of Engraftment Syndrome Phenotypes and Outcomes After Hematopoietic Stem Cell Transplantation (ES after HSCT)
3 maj 2026 uppdaterad av: Xiao Hui Zhang
A Prospective Observational Cohort Study to Validate Engraftment Syndrome Phenotypes and Their Associations With Acute Graft-Versus-Host Disease and Clinical Outcomes After Hematopoietic Stem Cell Transplantation
Engraftment syndrome (ES) is an early inflammatory complication after hematopoietic stem cell transplantation (HSCT) and has been associated with subsequent transplant-related complications and adverse clinical outcomes. However, ES is clinically heterogeneous, and its relationship with acute graft-versus-host disease (aGVHD), survival, and other post-transplant outcomes remains incompletely defined.
This prospective observational cohort study aims to validate previously identified ES-associated risk factors, severity-oriented ES phenotypes, and their associations with grade II-IV aGVHD and clinical outcomes after HSCT. Patients undergoing HSCT will be prospectively followed for the development of ES, grade II-IV aGVHD, and clinical outcomes including overall survival, disease-free survival, relapse, and non-relapse mortality. The study will evaluate whether ES phenotypes and ES-related clinical characteristics can stratify patients according to subsequent aGVHD risk and post-transplant prognosis.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Beräknad)
250
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Yejun Wu
- Telefonnummer: +8618800181620
- E-post: wyejun1999@163.com
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
N/A
Testmetod
Icke-sannolikhetsprov
Studera befolkning
The study population will include patients who develop engraftment syndrome after allogeneic hematopoietic stem cell transplantation at the participating center.
Patients will be prospectively enrolled after the diagnosis of engraftment syndrome and followed for subsequent grade II-IV acute graft-versus-host disease and post-transplant outcomes, including overall survival, disease-free survival, relapse, and non-relapse mortality.
Clinical features, laboratory parameters, engraftment kinetics, and organ-injury markers related to engraftment syndrome will be collected to validate ES phenotypes and their prognostic significance.
Beskrivning
Inclusion Criteria:
- Patients undergoing allogeneic hematopoietic stem cell transplantation at the participating center.
- Development of engraftment syndrome after hematopoietic stem cell transplantation, diagnosed according to predefined institutional or published clinical criteria.
- Availability of key clinical and laboratory data required for engraftment syndrome phenotyping, including engraftment kinetics, clinical manifestations, inflammatory markers, and organ-injury parameters.
- Ability to undergo prospective follow-up for post-transplant outcomes, including acute graft-versus-host disease and survival outcomes.
- Written informed consent provided by the patient or legally authorized representative, when required by the institutional review board or ethics committee.
Exclusion Criteria:
- Patients who do not develop engraftment syndrome after hematopoietic stem cell transplantation.
- Patients with insufficient clinical or laboratory data to confirm the diagnosis of engraftment syndrome.
- Patients with missing essential follow-up information for assessment of primary outcome measures.
- Patients who withdraw consent or decline participation in prospective follow-up.
- Patients enrolled in another study that, in the opinion of the investigators, may interfere with the observational assessment of engraftment syndrome phenotypes or post-transplant outcomes.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
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Patients With Engraftment Syndrome
Patients who develop engraftment syndrome after hematopoietic stem cell transplantation will be enrolled and prospectively followed.
Engraftment syndrome will be diagnosed according to predefined clinical criteria during the early post-transplant period.
Clinical features, laboratory parameters, transplant-related characteristics, ES phenotypes, subsequent grade II-IV acute graft-versus-host disease, and clinical outcomes will be recorded and analyzed.
|
No study-specific intervention will be administered.
Participants will receive standard clinical care after hematopoietic stem cell transplantation according to institutional practice and treating physician discretion.
The study will prospectively collect observational data on engraftment syndrome characteristics, laboratory parameters, subsequent grade II-IV acute graft-versus-host disease, and clinical outcomes.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Time to Grade II-IV Acute Graft-Versus-Host Disease
Tidsram: From hematopoietic stem cell transplantation to the first diagnosis of grade II-IV acute graft-versus-host disease, assessed up to 180 days after transplantation.
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Time from hematopoietic stem cell transplantation to the first diagnosis of grade II-IV acute graft-versus-host disease among patients with engraftment syndrome.
Acute graft-versus-host disease will be graded according to institutional standard criteria.
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From hematopoietic stem cell transplantation to the first diagnosis of grade II-IV acute graft-versus-host disease, assessed up to 180 days after transplantation.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of Grade II-IV Acute Graft-Versus-Host Disease
Tidsram: Up to 180 days after transplantation.
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Proportion of participants who develop grade II-IV acute graft-versus-host disease after hematopoietic stem cell transplantation.
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Up to 180 days after transplantation.
|
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Incidence of Chronic Graft-Versus-Host Disease
Tidsram: Up to 2 years after transplantation.
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Proportion of participants who develop chronic graft-versus-host disease after hematopoietic stem cell transplantation.
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Up to 2 years after transplantation.
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Overall Survival
Tidsram: From transplantation to death from any cause, assessed up to 2 years after transplantation.
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Time from hematopoietic stem cell transplantation to death from any cause.
Participants alive at the last follow-up will be censored.
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From transplantation to death from any cause, assessed up to 2 years after transplantation.
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Disease-Free Survival
Tidsram: From transplantation to relapse, disease progression, or death from any cause, assessed up to 2 years after transplantation.
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Time from hematopoietic stem cell transplantation to relapse, disease progression, or death from any cause, whichever occurs first.
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From transplantation to relapse, disease progression, or death from any cause, assessed up to 2 years after transplantation.
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Cumulative Incidence of Relapse
Tidsram: Up to 2 years after transplantation.
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Proportion of participants who experience relapse or disease progression after hematopoietic stem cell transplantation.
Non-relapse death will be considered a competing event in competing-risk analyses.
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Up to 2 years after transplantation.
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Non-Relapse Mortality
Tidsram: Up to 2 years after transplantation.
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Death without prior relapse or disease progression after hematopoietic stem cell transplantation.
Relapse will be considered a competing event in competing-risk analyses.
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Up to 2 years after transplantation.
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Severity-Oriented Engraftment Syndrome Phenotype
Tidsram: From transplantation to 100 days after transplantation.
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Classification of participants into severity-oriented engraftment syndrome phenotypes based on prospectively collected engraftment kinetics, pulmonary involvement, inflammatory burden, and organ-injury markers.
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From transplantation to 100 days after transplantation.
|
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Association Between Engraftment Syndrome Phenotype and Grade II-IV Acute Graft-Versus-Host Disease
Tidsram: Engraftment syndrome phenotype assessed up to 100 days after transplantation; grade II-IV acute graft-versus-host disease assessed up to 180 days after transplantation.
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Association between severity-oriented engraftment syndrome phenotype and subsequent development of grade II-IV acute graft-versus-host disease.
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Engraftment syndrome phenotype assessed up to 100 days after transplantation; grade II-IV acute graft-versus-host disease assessed up to 180 days after transplantation.
|
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Association Between Engraftment Syndrome Phenotype and Overall Survival
Tidsram: Engraftment syndrome phenotype assessed up to 100 days after transplantation; overall survival assessed up to 2 years after transplantation.
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Association between severity-oriented engraftment syndrome phenotype and overall survival after hematopoietic stem cell transplantation.
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Engraftment syndrome phenotype assessed up to 100 days after transplantation; overall survival assessed up to 2 years after transplantation.
|
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Association Between Engraftment Syndrome Phenotype and Disease-Free Survival
Tidsram: Engraftment syndrome phenotype assessed up to 100 days after transplantation; disease-free survival assessed up to 2 years after transplantation.
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Association between severity-oriented engraftment syndrome phenotype and disease-free survival after hematopoietic stem cell transplantation.
|
Engraftment syndrome phenotype assessed up to 100 days after transplantation; disease-free survival assessed up to 2 years after transplantation.
|
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Performance of an Engraftment Syndrome Risk Stratification Model
Tidsram: Predictors assessed up to 100 days after transplantation; outcomes assessed up to 2 years after transplantation.
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Discrimination and calibration of a risk stratification model based on engraftment syndrome-related clinical features and laboratory parameters for predicting post-transplant outcomes.
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Predictors assessed up to 100 days after transplantation; outcomes assessed up to 2 years after transplantation.
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Samarbetspartners och utredare
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Sponsor
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juni 2026
Primärt slutförande (Beräknad)
1 juni 2028
Avslutad studie (Beräknad)
1 juni 2029
Studieregistreringsdatum
Först inskickad
3 maj 2026
Först inskickad som uppfyllde QC-kriterierna
3 maj 2026
Första postat (Faktisk)
11 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- ES-HSCT-001
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