Clinical Trial

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

Study acronym: GRAPPA
Active, Not Recruiting Phase 3
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Record status
This record was last updated December 20, 2024 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2021-12-09; most recent amendment 2024-12-18.
Status change: Recruiting → Active, Not Recruiting 2024-12-18
Status change: Completed → Recruiting 2022-08-02
Status change: Recruiting → Completed 2022-07-28
Status change: Not Yet Recruiting → Recruiting 2022-03-21
Trial Details
NCT Number NCT05153226
Lead Sponsor DKMS gemeinnützige GmbH
Conditions Graft Vs Host Disease, Peripheral Blood Stem Cell Transplantation, AML, MDS, MDS/MPN, CMML
Enrollment 640 participants
Start Date 2022-03-02
Primary Completion 2025-06 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2024-12-20