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Brief Title: Cord Blood Transplantation With Myeloablative Conditioning and Post-transplant Cyclophosphamide (COmPACt Study)
Official Title: Cord Blood Transplantation With Myeloablative Conditioning and Post-transplant Cyclophosphamide in Patients With Hematological Malignancies (The COmPACt Study)
Study ID: NCT03802773
Brief Summary: 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.
Detailed Description: 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, RM, Italy
Name: Patrizia Chiusolo, MD
Affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
Role: PRINCIPAL_INVESTIGATOR