NCT06108739

ATG Plus Low-dose PT-Cy for GVHD Prevention

Randomized Trial of Anti-thymocyte Globulin Plus Low-dose Post-transplant Cyclophosphamide for GVHD Prevention in Haploidentical Donor HCT

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

During the past decades, the wider application of easily available haploidentical donor hematopoietic cell transplant (haplo-HCT) has been made possible through the T cell-replete (TCR) regimens including T cell regulation with anti-thymocyte globulin (ATG)/granulocyte colony-stimulating factor (GCSF) and post-transplant cyclophosphamide (PTCy). To achieve decreased non-relapse mortality (NRM) and improved long-term outcomes in haploidentical transplant, the joint use of ATG and PTCy might effectively reduce graft versus host disease (GVHD) and mortality associated with severe forms of GVHD. Recently, investigators established a regimen using low-dose PTCy in conjunction with standard-dose ATG in order to lower the risk of GVHD without compromising engraftment and disease relapse.

Conditions

• Hematologic Malignancy

Interventions

Type	Name	Description
DRUG	Cyclophosphamid	A total of 10mg/kg ATG was administered, and two doses of 14.5 mg/kg Cy were given on days 3 and 4 post-HCT in ATG-PTCy cohort.
DRUG	ATG	A total of 10mg/kg ATG was administered.

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-10-31
• Last updated: 2025-06-03

Locations

1 site across 1 country: China