Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05153226
PHASE3

GvHD Prophylaxis in Unrelated Donor HCT: Randomized Trial Comparing PTCY Versus ATG

Sponsor: DKMS gemeinnützige GmbH

View on ClinicalTrials.gov

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

DRUG

Cyclophosphamide

50 mg/kg (AIBW) i.v. d+3, d+4 post transplant

BIOLOGICAL

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