Minitransplants With HLA-matched Donors : Comparison Between 2 GVHD Prophylaxis Regimens
Status:
Active, not recruiting
Trial end date:
2022-09-01
Target enrollment:
Participant gender:
Summary
The present project is a multicenter phase II trail aiming at comparing which of the two
postgrafting immunosuppressive regimens proposed in this study will be best suited to prevent
graft-versus-host disease (GVDH).
The immunosuppressive regimens will consist of: Tacrolimus plus Mycophenolate Mofetil or
Tacrolimus plus Sirolimus. Before grafting patients will undergo a reduced-intensity
conditioning with Fludarabine/total body irradiation (TBI) or
Fludarabine/Busulfan/anti-thymoglobuline. Following the interim analysis of October 2014, the
protocol has been amended to allow inclusion only after Flu-TBI conditioning. The hypothesis
is that the Tacrolimus plus Sirolimus regimen will be associated with better progression-free
survival due to a lower incidence of relapse/progression.
Phase:
Phase 2
Details
Lead Sponsor:
University Hospital of Liege University of Liege
Collaborators:
AZ Delta AZ Delta Roeselare-Menen AZ Sint-Jan AV AZ-VUB Cliniques Universitaires de Mont-Godinne Cliniques universitaires Saint-Luc- Université Catholique de Louvain Hospital de Jolimont Jules Bordet Institute University Hospital, Antwerp University Hospital, Gasthuisberg University Hospital, Ghent Ziekenhuis Netwerk Antwerpen (ZNA)