Prospective Validation of Engraftment Syndrome Phenotypes and 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.

NCT Number	NCT07577375
Lead Sponsor	Xiao Hui Zhang Collaborators: Guangdong Provincial Hospital of Chinese Medicine, Zhuhai, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The First Affiliated Hospital of Zhengzhou University, The Third Xiangya Hospital of Central South University, The First Hospital of Jilin University, Guangzhou First People's Hospital
Conditions	Engraftment Syndrome, Allo-HSCT
Enrollment	250 participants
Start Date	2026-06-01
Primary Completion	2028-06-01 (estimated)
Study Completion	2029-06-01 (estimated)
Updated on ClinicalTrials.gov	2026-05-11