Recently completed trials for acute GVHD prophylaxis
| Investigational agent . | Donor type . | Study arm . | Control arm . | aGVHD (grade 3-4), % . | Relapse, % . | OS, % . | Composite end point, % . |
|---|---|---|---|---|---|---|---|
| RIC | |||||||
| PTCy (BMT CTN 1703) | MRD/MUD (8/8) | PTCy/TAC/MMF (n = 214) | TAC/MTX (n = 217) | 6.3 vs 14.7∗ | 21 vs 20 | 76.8 vs 72.6 | GRFS: 52.7 vs 34.9∗ |
| PTCy (HOVON 96) | MRD/MUD (8/8) | PTCy/CSA (n = 99) | CSA/MMF (n = 52) | 6 vs 16 | 32 vs 24 | 71 vs 65 | GRFS: 45 vs 21∗ |
| Vedolizumab | MUD (7/8 or 8/8) | Vedo/CNI/MTX or MMF (n = 168) | CNI/MTX or MMF (n = 165) | — | — | — | 85.5 vs 70.9∗ Lower intestinal aGVHD-free survival |
| Sirolimus | MUD (7/8 or 8/8) | Siro/MMF/CSA (n = 91) | CSA/MMF (n = 77) | 2 vs 8 | 19 vs 21 | 86 vs 70∗ | — |
| MAC | |||||||
| Abatacept | MUD (8/8) | Aba/CNI/MTX (n = 73) | CNI/MTX (n = 69) | 6.8 vs 14.8 | 21.5 vs 23.6 | 74.3 vs 64 | SGFS: 93.2 vs 82∗ |
| Abatacept | MUD (7/8) | Aba/CNI/MTX (n = 43) | CNI/MTX (n = 127)† | 2.3 vs 30.2∗ | 9.3 vs 21.4 | 73.6 vs 45.3∗ | SGFS: 97.7 vs 58.75∗ |
| PTCy | MUD (7/8 or 8/8) | PTCy/TAC/MMF (n = 125) | — | 4 | 25 | 80 | GRFS: 57 |
| Vedolizumab | MUD (7/8 or 8/8) | Vedo/CNI/MTX or MMF (n = 168) | CNI/MTX or MMF (n = 165) | — | — | — | 85.5 vs 70.9∗ Lower intestinal aGVHD-free survival |
| Investigational agent . | Donor type . | Study arm . | Control arm . | aGVHD (grade 3-4), % . | Relapse, % . | OS, % . | Composite end point, % . |
|---|---|---|---|---|---|---|---|
| RIC | |||||||
| PTCy (BMT CTN 1703) | MRD/MUD (8/8) | PTCy/TAC/MMF (n = 214) | TAC/MTX (n = 217) | 6.3 vs 14.7∗ | 21 vs 20 | 76.8 vs 72.6 | GRFS: 52.7 vs 34.9∗ |
| PTCy (HOVON 96) | MRD/MUD (8/8) | PTCy/CSA (n = 99) | CSA/MMF (n = 52) | 6 vs 16 | 32 vs 24 | 71 vs 65 | GRFS: 45 vs 21∗ |
| Vedolizumab | MUD (7/8 or 8/8) | Vedo/CNI/MTX or MMF (n = 168) | CNI/MTX or MMF (n = 165) | — | — | — | 85.5 vs 70.9∗ Lower intestinal aGVHD-free survival |
| Sirolimus | MUD (7/8 or 8/8) | Siro/MMF/CSA (n = 91) | CSA/MMF (n = 77) | 2 vs 8 | 19 vs 21 | 86 vs 70∗ | — |
| MAC | |||||||
| Abatacept | MUD (8/8) | Aba/CNI/MTX (n = 73) | CNI/MTX (n = 69) | 6.8 vs 14.8 | 21.5 vs 23.6 | 74.3 vs 64 | SGFS: 93.2 vs 82∗ |
| Abatacept | MUD (7/8) | Aba/CNI/MTX (n = 43) | CNI/MTX (n = 127)† | 2.3 vs 30.2∗ | 9.3 vs 21.4 | 73.6 vs 45.3∗ | SGFS: 97.7 vs 58.75∗ |
| PTCy | MUD (7/8 or 8/8) | PTCy/TAC/MMF (n = 125) | — | 4 | 25 | 80 | GRFS: 57 |
| Vedolizumab | MUD (7/8 or 8/8) | Vedo/CNI/MTX or MMF (n = 168) | CNI/MTX or MMF (n = 165) | — | — | — | 85.5 vs 70.9∗ Lower intestinal aGVHD-free survival |
Dashes denote that the results are not yet available. Aba, abatacept; BMT CTN, Blood and Marrow Transplant Clinical Trials Network; GRFS, GVHD/relapse or progression-free survival; HOVON, Dutch-Belgian Cooperative Trial Group for Hemato-Oncology; MAC, myeloablative conditioning; SGFS, severe aGVHD-free survival; Siro, sirolimus; Vedo, vedolizumab.
Statistically significant.
CIBMTR cohort.