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Prospective Validation of Engraftment Syndrome Phenotypes and Outcomes After Hematopoietic Stem Cell Transplantation (ES after HSCT)

3 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

De observación

Inscripción (Estimado)

250

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Yejun Wu
  • Número de teléfono: +8618800181620
  • Correo electrónico: wyejun1999@163.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

N/A

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

Inclusion Criteria:

  1. Patients undergoing allogeneic hematopoietic stem cell transplantation at the participating center.
  2. Development of engraftment syndrome after hematopoietic stem cell transplantation, diagnosed according to predefined institutional or published clinical criteria.
  3. Availability of key clinical and laboratory data required for engraftment syndrome phenotyping, including engraftment kinetics, clinical manifestations, inflammatory markers, and organ-injury parameters.
  4. Ability to undergo prospective follow-up for post-transplant outcomes, including acute graft-versus-host disease and survival outcomes.
  5. Written informed consent provided by the patient or legally authorized representative, when required by the institutional review board or ethics committee.

Exclusion Criteria:

  1. Patients who do not develop engraftment syndrome after hematopoietic stem cell transplantation.
  2. Patients with insufficient clinical or laboratory data to confirm the diagnosis of engraftment syndrome.
  3. Patients with missing essential follow-up information for assessment of primary outcome measures.
  4. Patients who withdraw consent or decline participation in prospective follow-up.
  5. 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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
Otro: No Intervention: Observational Cohort
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to Grade II-IV Acute Graft-Versus-Host Disease
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of Grade II-IV Acute Graft-Versus-Host Disease
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Severity-Oriented Engraftment Syndrome Phenotype
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Xiao Hui Zhang

Colaboradores

Guangzhou First People's Hospital
The First Affiliated Hospital of Zhengzhou University
The Third Xiangya Hospital of Central South University
The First Hospital of Jilin University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Guangdong Provincial Hospital of Chinese Medicine, Zhuhai

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de junio de 2026

Finalización primaria (Estimado)

1 de junio de 2028

Finalización del estudio (Estimado)

1 de junio de 2029

Fechas de registro del estudio

Enviado por primera vez

3 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

3 de mayo de 2026

Publicado por primera vez (Actual)

11 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • ES-HSCT-001

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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