NCT04686929

Abatacept s.c. for aGVHD Prevention in Haplo-HCT

The Efficacy and Safety of Subcutaneous Abatacept in the Prevention of Acute Graft-versus-host Disease After Haplo-identical Donor Hematopoietic Cell Transplantation

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Acute graft-versus-host disease (aGVHD) is a potentially fatal complication after allogeneic hematopoietic cell transplantation (HCT), particularly for that with a HLA-mismatched donor. Abatacept has been demonstrated as a potent drug to reduce the risk of aGVHD, but the efficacy of subcutaneous form has yet been investigated. This trial is designed to preliminarily determin the efficacy and saftey of subcutaneous abatacept in the prevention of aGVHD after haplo-identical HCT.

Conditions

• Abatacept
• Acute-graft-versus-host Disease
• Haplo-identical HCT
• Prevention

Interventions

Type	Name	Description
DRUG	Abatacept s.c.	subcutaneous abatacept: 250mg (d-1) , 125mg (d+5, +14, +21, +28, +35, +42, +49, +56) combined with CsA, MTX, MMF.

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-06-30
• Completion: 2023-12-30
• First posted: 2020-12-29
• Last updated: 2022-12-20

Locations

1 site across 1 country: China