GvHD Prophylaxis in Unrelated Donor HCT: Randomized Trial Comparing PTCY Versus ATG
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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.
Eligibility
Primary outcome measure(s)
- Overall survival — from randomization
- GVHD- and relapse-free survival (GRFS) — from HCT
Trial sites (23)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05153226 on ClinicalTrials.gov ↗ ← All trials in Germany