NCT06480630

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Graft Versus Host Disease
• Malignant Hematologic Neoplasm

Interventions

Type	Name	Description
DRUG	Basiliximab	Addition of CD25 monoclonal antibody（Basiliximab） at +3 days post unrelated umbilical cord blood transplantation (UCBT)

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-06-30
• Completion: 2027-06-30
• First posted: 2024-06-28
• Last updated: 2024-06-28

Locations

1 site across 1 country: China