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A group of researchers from Shanghai General Hospital, Shanghai Jiao Tong University, Shanghai, China, conducted a phase II study (NCT03395860) to evaluate a novel combination of low-dose anti-thymocyte globulin (ATG) in combination with low-dose posttransplant cyclophosphamide (PTCy) in patients undergoing haploidentical peripheral blood stem cell transplantation combined with unrelated cord blood for the prevention of graft-versus-host disease (GvHD). The results of the study were published ahead of print in Bone Marrow Transplantation.
The primary endpoint of the study was the cumulative incidence (CI) of acute GvHD (time frame: 100 days after transplantation). Secondary endpoints included leukocyte engraftment, platelet engraftment, donor chimerism, relapse incidence (RI), chronic GvHD, non-relapse mortality (NRM) overall survival (OS), disease-free survival (DFS), CMV viremia and CMV-associated diseases, and EBV viremia.
Taken together, this phase II study indicates that low-dose ATG plus low-dose PTCy is a promising prophylactic regimen to prevent GvHD in the haplo setting. According to the authors, this study had several limitations, including the number of patients, the limited follow-up time, and the use of haplo-transplantation with unrelated cord blood. Further prospective trials are needed to assess the efficacy of low-dose ATG plus PTCy.
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