NCT05153226

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

Graft vs Host Disease Prophylaxis in Unrelated Donor Transplantation: a Randomized Clinical Trial Comparing PTCY vs ATG (GRAPPA)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 640 (actual)
• Sponsor: DKMS gemeinnützige GmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Graft Vs Host Disease
• Peripheral Blood Stem Cell Transplantation
• AML
• MDS
• MDS/MPN
• CMML

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-03-02
• Primary completion: 2025-06-01
• Completion: 2026-12-01
• First posted: 2021-12-10
• Last updated: 2024-12-20

Locations

23 sites across 1 country: Germany