Viewing Study NCT06480630



Ignite Creation Date: 2024-07-17 @ 12:04 PM
Last Modification Date: 2024-10-26 @ 3:33 PM
Study NCT ID: NCT06480630
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-06-28
First Post: 2024-06-25

Brief Title: Effectiveness and Safety of a Single-Center Clinical Study on a CD25 Monoclonal Antibody-Containing GVHD Prophylaxis Scheme to Reduce the Incidence of Severe Acute GVHD After Umbilical Cord Blood Transplantation for Malignant Hematologic Diseases
Sponsor: Anhui Provincial Hospital
Organization: Anhui Provincial Hospital

Study Overview

Official Title: Effectiveness and Safety of a Single-Center Clinical Study on a CD25 Monoclonal Antibody-Containing GVHD Prophylaxis Scheme to Reduce the Incidence of Severe Acute GVHD After Umbilical Cord Blood Transplantation for Malignant Hematologic Diseases
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Evaluating the safety and effectiveness of a CD25 monoclonal antibody-based prophylactic acute graft-versus-host-disease aGVHD regimen following unrelated umbilical cord blood transplantation UCBT for malignant hematologic disorders in reducing severe aGVHD
Detailed Description: Acute graft-versus-host disease aGVHD is a major complication and leading cause of non-relapse mortality following allogeneic hematopoietic stem cell transplantation allo-HSCT Preliminary research findings suggest that the addition of CD25 monoclonal antibody at 3 days post unrelated umbilical cord blood transplantation UCBT has reduced the incidence of grade III-IV aGVHD compared to previous protocols In order to further explore how to improve prevention strategies of aGVHD and reduce the incidence of severe aGVHD we performed this study to evaluate the safety and effectiveness of a prophylactic GVHD regimen utilizing CD25 monoclonal antibody post-UCBT for malignant hematologic disorders aimed at reducing the incidence of severe aGVHD

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None