Despite anti-thymocyte globulin has a mainstay role in preventing GvHD (and non-relapse mortality) in CB transplantation, it also induces delayed immune recovery, increased risk of cytomegalovirus and Epstein-Barr virus reactivation, post-transplant lymphoproliferative diseases, overall accounting for increased transplant-related mortality and/or increased relapse incidence. All these findings support the use of alternative approaches for in vivo T cell depletion in the setting of CB transplantation.
Study objectives. The primary objective is to evaluate neutrophil and platelet engraftment and day +100 CD4+ cell count in patients receiving matched CB unit transplant with a myeloablative conditioning regimen and a GVHD prophylaxis including post-transplant cyclophosphamide. Secondary objective is to estimate the incidence and severity of acute and chronic GVHD. Study endpoints. Primary endpoints are hematopoietic engraftment and day +100 CD4+ cell count. Secondary endpoints are acute and chronic GVHD
Study Type
OBSERVATIONAL
Enrollment
10
Myeloablative conditioning with post-transplant cyclophosphamide in patients receiving a matched CB transplant for hematological malignancies.
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, RM, Italy
RECRUITINGhematopoietic reconstitution
number of days for neutrophil (\> 0.5x10\^9/L) and platelet (\> 20x10\^9/L) engraftment
Time frame: first post-transplant 1 day with neutrophil > 0.5x10^9/L and platelet > 20x10^9/L
immune reconstitution
number of CD4+cells at day 100
Time frame: day 100 from transplant
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