NCT06000982

Comparison of Different Dose of Post-transplantation Cyclophosphamide as Graft Versus Host Disease Prophylaxis

A Comparison Study of Reduced Dose of Post-transplantation Cyclophosphamide (PTCy 40mg/kg) Versus Standard (PTCY 50mg/kg): a Multi-center Study for Halo-identical Donor Transplantation

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Post-transplantation cyclophosphamide (PTCY) is considered as major graft versus host disease (GVHD) prophylaxis. In our previous study, the investigators demonstrated that the standard dose PTCY of 50mg/kg with tacrolimus and post-engrafted low-dose anti-thymoglobulin (ATG) achieved low incidence of acute GVHD. More recently, it has been shown that reduced dose of PTCY of 40mg/kg is considered with similar efficacy as GVHD prophylaxis, In this study, a multi-center randomized comparison is planned to evaluate the clinical outcome of GVHD prophylaxis of PTCy 40 versus 50.

Detailed description

Post-transplantation cyclophosphamide (PTCY) is considered as major graft versus host disease (GVHD) prophylaxis. In our previous study, the investigators demonstrated that the standard dose PTCY of 50mg/kg with tacrolimus and post-engrafted low-dose anti-thymoglobulin (ATG) achieved low incidence of acute GVHD. In the clinical setting, reduced dose of PTCY (40mg/kg) was used for patients over 60 or with high HCT-CI and the overall incidence of acute GVHD was similar to PTCY 50mg/kg but chronic GVHD was slightly increased. To confirmed our observation, in this study, a prospective multiple-center randomized comparison is planned to evaluate the clinical outcomes of reduced dose of PTCY (40mg/kg) versus 50mg/kg as GVHD prophylaxis.

Conditions

• GVHD

Interventions

Type	Name	Description
DRUG	PTCY	PTCY as 40mg/kg or 50mg/kg at day +3 and +4 for GVHD prophylaxis

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-10-01
• Completion: 2026-04-01
• First posted: 2023-08-21
• Last updated: 2023-08-21

Locations

2 sites across 1 country: China