Donor Neutrophil Subsets to Predict the Risk of aGVHD

Status Active, not recruiting

Clinical Trial Summary

This is a prospective study to explore the association between donor neutrophil subsets and acute graft-vs.-host disease outcomes. Approximately 260 subjects (including 130 donors and 130 corresponding recipients) will be recruited.

Clinical Trial Description

This study was a single-center, observational, prospective cohort study. The study lasted for 3 months, from 2023.12 to 2024.3, the clinical enrollment was completed, and from 2024.3 to 2024.6, the follow-up was completed. It is planned to enroll 260 subjects, divided into 130 donors and 130 patients. No randomization or any protocol-driven treatment will be performed or provided to subjects during the course of the study. Treatment decisions and selection of treatment options are left to the discretion of the treating physician, if clinically appropriate. All recipients will be followed for aGVHD evaluation, relapse, cGVHD, leukemia relapse, disease-free survival (DFS), non-relapse mortality (NRM). aGVHD and cGVHD were graded according to published guidelines. All recipients will be monitored every month until the study is completed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06394895
Study type	Observational [Patient Registry]
Source	Nanfang Hospital, Southern Medical University
Contact
Status	Active, not recruiting
Phase
Start date	December 1, 2023
Completion date	June 10, 2024

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02241018` - MSCs Combined With CD25 Monoclonal Antibody and Calcineurin Inhibitors for Treatment of Steroid-resistant aGVHD	Phase 2/Phase 3
Completed	`NCT04539470` - Study to Evaluate the Safety and Pharmacokinetics of Efmarodocokin Alfa in Combination With Standard of Care in Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation	Phase 1
Terminated	`NCT02245412` - A Phase 2A Study of ALXN1007 in Participants With Newly Diagnosed Acute Lower Gastrointestinal Graft-Versus-Host Disease	Phase 2
Recruiting	`NCT02659657` - Prophylaxis Roles of IL-2 Treatment on GVHD After Transplantation	Phase 2
Completed	`NCT03497273` - Safety of Itacitinib in Combination With Corticosteroids for Treatment of Steroid-Naive Acute Graft-Versus-Host Disease in Japanese Subjects	Phase 1
Completed	`NCT05825833` - Infliximab Efficacy in Relation to Therapeutic Drug Monitoring and Serum TNFα Levels in Pediatric HSCT
Not yet recruiting	`NCT06294678` - Effect of Stem Cell Infusion Time on aGVHD in Patients With Hematological Malignancies	Phase 3
Not yet recruiting	`NCT06294691` - Effect of Stem Cell Infusion Time on aGVHD in Patients With Nonmalignant Hematologic Diseases	Phase 3
Recruiting	`NCT04285424` - FMT for Steroid Resistant Gut Acute GVHD	Early Phase 1
Terminated	`NCT01903473` - Donor Regulatory T Cells Infusion in Patients With Chronic Graft-versus-host Disease (GVHD)	Phase 2
Recruiting	`NCT02044185` - Clinical Implications of HMGB1 in Patients Treated With Chemotherapy or Hematopoietic Stem Cell Transplantation	N/A
Recruiting	`NCT01765634` - Mesenchymal Stem Cells for Treatment of Refractory Acute Graft-versus-host Disease	Phase 2
Terminated	`NCT00282503` - Extracorporeal Photoimmune Therapy With UVADEX for the Treatment of Acute Graft Versus-Host Disease	Phase 3
Recruiting	`NCT01521039` - Assessment of MicroRNA Expression in Acute Graft-versus-Host Disease
Terminated	`NCT03721965` - Safety and Efficacy of Itacitinib in Combination With Corticosteroids for Treatment of Graft-Versus-Host Disease in Pediatric Subjects	Phase 1/Phase 2
Not yet recruiting	`NCT04971551` - A Study of Jaktinib for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.	Phase 2
Completed	`NCT02743351` - Study of ProTmune for Allogeneic HCT in Adult Patients With Hematologic Malignancies	Phase 1/Phase 2
Terminated	`NCT05673876` - A Study to Assess the Safety and Pharmacokinetics of GDC-8264 in Combination With Standard of Care in Participants With Acute Graft-Versus-Host Disease (aGVHD)	Phase 1
Recruiting	`NCT02611180` - Dendritic Cells in Patients With Acute or Chronic Skin Graft Versus Host Disease