Cord Blood Transplantation With Myeloablative Conditioning and Post-transplant Cyclophosphamide (COmPACt Study) — COmPACt  

Hematological Malignancies Clinical Trial

Official title: Cord Blood Transplantation With Myeloablative Conditioning and Post-transplant Cyclophosphamide in Patients With Hematological Malignancies (The COmPACt Study)

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Cord Blood Transplantation
• Hematologic Neoplasms
• Hematological Malignancies
• Neoplasms

• NCT number: NCT03802773
• Study type: Observational
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Andrea Bacigalupo, Prof.
• Phone: 0630154180
• Email: andrea.bacigalupo@unicatt.it
• Status: Recruiting
• Start date: March 14, 2019
• Completion date: December 31, 2023