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GvHD Prophylaxis in Unrelated Donor HCT: Randomized Trial Comparing PTCY Versus ATG
Sponsor: DKMS gemeinnützige GmbH
Summary
Post-transplantation cyclophosphamide (PTCY) has become increasingly popular in the haploidentical HCT setting because it overcomes the HLA-mismatch barrier and levels GVHD risk. This advantage may also prove useful in the context of unrelated donor (UD) transplantation. GVHD prophylaxis for matched unrelated donor hematopoietic cell transplantation (alloHCT) in Europe is mainly conducted with ATG. Still, the burden of acute and chronic GVHD and especially of relapse remains high with both approaches for GVHD prevention. PTCY has not been tested against the current standard ATG for GvHD prophylaxis in large randomized trials. The goal of this trial is to compare the outcomes of PTCY and ATG for patients receiving unrelated donor PBSCT. PTCY-based prophylaxis promises to have beneficial net effects on immune reconstitution, GVHD and disease control, and thus might impact on patient survival.
Official title: Graft vs Host Disease Prophylaxis in Unrelated Donor Transplantation: a Randomized Clinical Trial Comparing PTCY vs ATG (GRAPPA)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
640
Start Date
2022-03-02
Completion Date
2026-12
Last Updated
2024-12-20
Healthy Volunteers
No
Interventions
Cyclophosphamide
50 mg/kg (AIBW) i.v. d+3, d+4 post transplant
ATG
10 mg/kg i.v. d-3, d-2, d-1 pre-transplant
Locations (23)
Uniklinik RWTH Aachen
Aachen, Germany
Univeristätsklinikum Augsburg
Augsburg, Germany
Klinikum Chemnitz gGmbH
Chemnitz, Germany
Universitätsklinikum Köln
Cologne, Germany
St.-Johannes-Hospital Dortmund
Dortmund, Germany
Universitätsklinikum Dresden
Dresden, Germany
Uniklinikum Düsseldorf
Düsseldorf, Germany
Universitätsklinikum Essen (AöR)
Essen, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Germany
Universitätsklinikum Halle (Saale)
Halle, Germany
Universitätsklinikum des Saarlandes
Homburg, Germany
Universitätsklinikum Jena
Jena, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Germany
Universitätsmedizin Mainz
Mainz, Germany
Universitätsmedizin Mannheim
Mannheim, Germany
Philipps Universität Marburg
Marburg, Germany
Universitätsklinikum Münster
Münster, Germany
Klinikum Nürnberg Nord
Nuremberg, Germany
Universitätsmedizin Rostock
Rostock, Germany
Robert-Bosch-Krankenhaus
Stuttgart, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Universitätsklinikum Würzburg
Würzburg, Germany