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Cord Blood Transplantation With Myeloablative Conditioning and Post-transplant Cyclophosphamide in Patients With Hematological Malignancies (The COmPACt Study)
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
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, RM, Italy
Start Date
March 14, 2019
Primary Completion Date
November 26, 2025
Completion Date
December 31, 2025
Last Updated
April 9, 2025
10
ESTIMATED participants
CB transplantation
PROCEDURE
Lead Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NCT02269592
NCT07122674
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06834412