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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
640
50 mg/kg (AIBW) i.v. d+3, d+4 post transplant
10 mg/kg i.v. d-3, d-2, d-1 pre-transplant
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
...and 13 more locations
Overall survival
Time frame: from randomization
GVHD- and relapse-free survival (GRFS)
Time frame: from HCT
Overall survival
Time frame: from HCT
Relapse- and immunosuppression-free survival (RIFS)
Time frame: from HCT
Event-free survival
Time frame: 1 year
Cumulative incidence of relapse
Time frame: 1 year
Cumulative incidence of non-relapse mortality
Time frame: 1 year
Cumulative incidences of acute and chronic GVHD
Time frame: 180 days and 2 years after HCT
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