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ACTIVE NOT RECRUITING
NCT01428973
PHASE2

Minitransplants With HLA-matched Donors : Comparison Between 2 GVHD Prophylaxis Regimens

Sponsor: University of Liege

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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