Prospective Validation of Engraftment Syndrome Phenotypes and Outcomes After Hematopoietic Stem Cell Transplantation (ES after HSCT)
3 mai 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Observationnel
Inscription (Estimé)
250
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Yejun Wu
- Numéro de téléphone: +8618800181620
- E-mail: wyejun1999@163.com
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
N/A
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Time to Grade II-IV Acute Graft-Versus-Host Disease
Délai: 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.
|
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.
|
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.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Incidence of Grade II-IV Acute Graft-Versus-Host Disease
Délai: Up to 180 days after transplantation.
|
Proportion of participants who develop grade II-IV acute graft-versus-host disease after hematopoietic stem cell transplantation.
|
Up to 180 days after transplantation.
|
|
Incidence of Chronic Graft-Versus-Host Disease
Délai: Up to 2 years after transplantation.
|
Proportion of participants who develop chronic graft-versus-host disease after hematopoietic stem cell transplantation.
|
Up to 2 years after transplantation.
|
|
Overall Survival
Délai: From transplantation to death from any cause, assessed up to 2 years after transplantation.
|
Time from hematopoietic stem cell transplantation to death from any cause.
Participants alive at the last follow-up will be censored.
|
From transplantation to death from any cause, assessed up to 2 years after transplantation.
|
|
Disease-Free Survival
Délai: From transplantation to relapse, disease progression, or death from any cause, assessed up to 2 years after transplantation.
|
Time from hematopoietic stem cell transplantation to relapse, disease progression, or death from any cause, whichever occurs first.
|
From transplantation to relapse, disease progression, or death from any cause, assessed up to 2 years after transplantation.
|
|
Cumulative Incidence of Relapse
Délai: Up to 2 years after transplantation.
|
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.
|
Up to 2 years after transplantation.
|
|
Non-Relapse Mortality
Délai: Up to 2 years after transplantation.
|
Death without prior relapse or disease progression after hematopoietic stem cell transplantation.
Relapse will be considered a competing event in competing-risk analyses.
|
Up to 2 years after transplantation.
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Severity-Oriented Engraftment Syndrome Phenotype
Délai: From transplantation to 100 days after transplantation.
|
Classification of participants into severity-oriented engraftment syndrome phenotypes based on prospectively collected engraftment kinetics, pulmonary involvement, inflammatory burden, and organ-injury markers.
|
From transplantation to 100 days after transplantation.
|
|
Association Between Engraftment Syndrome Phenotype and Grade II-IV Acute Graft-Versus-Host Disease
Délai: 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.
|
Association between severity-oriented engraftment syndrome phenotype and subsequent development of grade II-IV acute graft-versus-host disease.
|
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.
|
|
Association Between Engraftment Syndrome Phenotype and Overall Survival
Délai: Engraftment syndrome phenotype assessed up to 100 days after transplantation; overall survival assessed up to 2 years after transplantation.
|
Association between severity-oriented engraftment syndrome phenotype and overall survival after hematopoietic stem cell transplantation.
|
Engraftment syndrome phenotype assessed up to 100 days after transplantation; overall survival assessed up to 2 years after transplantation.
|
|
Association Between Engraftment Syndrome Phenotype and Disease-Free Survival
Délai: Engraftment syndrome phenotype assessed up to 100 days after transplantation; disease-free survival assessed up to 2 years after transplantation.
|
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.
|
|
Performance of an Engraftment Syndrome Risk Stratification Model
Délai: Predictors assessed up to 100 days after transplantation; outcomes assessed up to 2 years after transplantation.
|
Discrimination and calibration of a risk stratification model based on engraftment syndrome-related clinical features and laboratory parameters for predicting post-transplant outcomes.
|
Predictors assessed up to 100 days after transplantation; outcomes assessed up to 2 years after transplantation.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juin 2026
Achèvement primaire (Estimé)
1 juin 2028
Achèvement de l'étude (Estimé)
1 juin 2029
Dates d'inscription aux études
Première soumission
3 mai 2026
Première soumission répondant aux critères de contrôle qualité
3 mai 2026
Première publication (Réel)
11 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
3 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- ES-HSCT-001
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .