To address a major evidence gap in the field of graft-versus-host disease (GvHD) prophylaxis, a randomized trial was initiated to directly compare post-transplant cyclophosphamide (PTCy) and anti-thymocyte globulin (ATG) in the setting of unrelated donor peripheral blood stem cell transplantation. While PTCy has shown promise in haploidentical HCT by mitigating the effects of HLA mismatch and reducing GvHD, its role in unrelated donor transplantation remains unclear.
Current practice in Europe relies predominantly on ATG, but both prophylactic strategies carry significant risks of GvHD and relapse. This study is designed to offer high-level evidence on whether PTCy can provide superior immune reconstitution, better GvHD control and improved survival outcomes in the unrelated donor context.
The recruitment of patients is already completed, the follow-up of patients is currently ongoing and first results are to be expected at the end of 2025.
ClinicalTrials.gov identifier (NCT number): NCT05153226