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

3 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

250

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko
  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie dotyczy

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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.
Inny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Time to Grade II-IV Acute Graft-Versus-Host Disease
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Incidence of Grade II-IV Acute Graft-Versus-Host Disease
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Severity-Oriented Engraftment Syndrome Phenotype
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Xiao Hui Zhang

Współpracownicy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 czerwca 2028

Ukończenie studiów (Szacowany)

1 czerwca 2029

Daty rejestracji na studia

Pierwszy przesłany

3 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 maja 2026

Pierwszy wysłany (Rzeczywisty)

11 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

11 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • ES-HSCT-001

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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