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Minitransplants With HLA-matched Donors : Comparison Between 2 GVHD Prophylaxis Regimens
Sponsor: University of Liege
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.
Official title: Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donors After Reduced-intensity Conditioning: a Phase II Randomized Study Comparing 2 GVHD Prophylaxis Regimens
Key Details
Gender
All
Age Range
16 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2011-09
Completion Date
2024-12
Last Updated
2024-05-09
Healthy Volunteers
No
Interventions
Mycophenolate mofetil
Tablets. For HLA-identical sibling donors:15 mg/kg t.i.d from day 0 to day 28. For alternative donor: 15 mg/kg, from day 0 to day 42.
Sirolimus
Tablets. 6 mg loading dose on day -3, followed by (1)-2 mg daily to a target trough level of 5 to 10 ng/mL. Full doses will be given until day 100 (sibling recipients) or 180 (alternative donor recipients). Doses will then be progressively tapered to be definitely discontinued by day 180 (sibling donors) or 365 (alternative donor recipients) in the absence of GVHD.
Locations (13)
Ziekenhuis Netwerk Antwerpen (ZNA)
Antwerp, Antwerpen, Belgium
University Hospital, Antwerp
Edegem, Antwerp, Belgium
Jules Bordet Institute
Brussels, Brabant, Belgium
AZ VUB Jette
Brussels, Brussels Region Capital, Belgium
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Brussels, Brussels Region Capital, Belgium
Queen Fabiola Children's University Hospital
Brussels, Brussels, Region Capital, Belgium
University Hospital, Gasthuisberg
Leuven, Flamish Brabant, Belgium
UZ Gent
Ghent, Flanders Ost, Belgium
Jolimont Hospital Haine Saint Paul
Haine St-Paul, Hainaut, Belgium
Cliniques Universitaires de Mont-Godinne
Yvoir, Namur, Belgium
AZ Sint-Jan AV
Bruges, West Flanders, Belgium
H.-Hart Hospital Roeselare-Menen
Roeselare, Western Flanders, Belgium
CHU Sart Tilman
Liège, Belgium