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

Study acronym: GRAPPA
StatusActive, Not Recruiting
PhasePhase 3
Started2022-03-02
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 9 months later Jun 2025 → Mar 31, 2026
See other at-risk trials from DKMS gemeinnützige GmbH

Amendment history

2026-08-26
Study Status v11
Primary completion pushed: 2025-06 → 2026-03-31
Completion pushed: 2026-12 → 2027-12
2024-12-18
Recruiting→Active, Not Recruiting Study Status, Study Design, Outcome Measures, Contacts/Locations v10
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-08→2025-06
Completion date2026-08→2026-12
Enrollment targetestimated 540→confirmed 640
Secondary endpoints5 to 6 entries
GVHDOverall survival Relapse- and relapseimmunosuppression-free survival (GRFSRIFS)
Primary endpoints2 entries, revised
Overall survival from HCT RelapseGVHD- and Immunosuppressionrelapse-free Survivalsurvival (RIFSGRFS) Overall survival
Study sitesdetails revised at 23 of 23 sites
2023-12-14
Study Status, Contacts/Locations v9
Study sites22→23
2023-07-12
Study Status, Contacts/Locations v8
Study sites21→22
2023-04-13
Study Status, Contacts/Locations v7
Study sites16→21
Show 6 earlier versions
2022-08-19
Study Status, Contacts/Locations v6
Study sitesdetails revised at 5 of 16 sites
2022-08-02
Completed→Recruiting Study Status, Study Design, Contacts/Locations v5
Trial statusCompleted→Recruiting
Primary completion date2022-04-05→2025-08
Completion datenot stated→2026-08
Start date2015-09-17→2022-03-02
Enrollment target281→540
Study sitesdetails revised at 16 of 16 sites
2022-07-28
Recruiting→Completed Study Status, Study Design, Contacts/Locations v4
Trial statusRecruiting→Completed
Primary completion dateestimated 2026-08→confirmed 2022-04-05
Completion date2026-08→not stated
Start date2022-03-02→2015-09-17
Enrollment targetestimated 540→confirmed 281
Study sitesdetails revised at 16 of 16 sites
2022-05-20
Study Status, Contacts/Locations v3
Study sitesdetails revised at 4 of 16 sites
2022-03-21
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-02→confirmed 2022-03-02
Study sites17→16
2022-02-17
Study Identification, Study Status, Contacts/Locations v1
Start date2022-01→2022-02
Study sites11→17
2021-12-09
Original filing
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.
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 2026-03-31 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-27