Spots Global Cancer Trial Database for Minitransplants With HLA-matched Donors : Comparison Between 2 GVHD Prophylaxis Regimens
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Trial Identification
Brief Title: Minitransplants With HLA-matched Donors : Comparison Between 2 GVHD Prophylaxis Regimens
Official Title: Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donors After Reduced-intensity Conditioning: a Phase II Randomized Study Comparing 2 GVHD Prophylaxis Regimens
Study ID: NCT01428973
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ziekenhuis Netwerk Antwerpen (ZNA), Antwerpen,, Antwerpen, Belgium
University Hospital, Antwerp, Edegem, Antwerp, Belgium
Jules Bordet Institute, Brussels, Brabant, Belgium
Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Brussels,, Brussels Region Capital, Belgium
AZ VUB Jette, 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, Gent, 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, Brugge, West Flanders, Belgium
H.-Hart Hospital Roeselare-Menen, Roeselare, Western Flanders, Belgium
CHU Sart Tilman, Liège, , Belgium
Contact Details
Name: Frédéric Baron, MD; PhD
Affiliation: University of Liege
Role: PRINCIPAL_INVESTIGATOR
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