Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) with Low-Dose Post-Transplant Cyclophosphamide for Prophylaxis of Graft-versus-Host Disease in Hematological Malignancies
Objective
The purpose of this single arm, Phase 2 study is to determine the 1-year graft versus host disease (GVHD)-Free Relapse-Free Survival (GRFS) when using low dose (25 mg/kg) of post-transplant cyclophosphamide (PTCy) in reduced intensity and non-myeloablative allogeneic stem cell transplantation. An event in this time-to-event endpoint is defined as grade III-IV acute GVHD, chronic GVHD requiring immunosuppression, disease relapse or progression, or death by any cause. We anticipate that the GRFS of allogeneic stem cell transplantation with low-dose PTCy will be superior to conventional GVHD prophylaxis.
Secondary Objectives: To determine, after transplant, 1-year overall survival, progression-free survival, day +100 cumulative incidence of grade II-IV and grade III-IV acute GVHD, 1-year cumulative incidence of chronic GVHD, donor cell engraftment, 1-year non-relapse mortality, 1-year cumulative incidence of relapse, neutrophil engraftment failure rate, cumulative incidence of documented infectious disease and evaluation of toxicities by PTCy.
