Recently published and ongoing prevention studies with chronic GVHD as a primary end point
| Phase . | Prevention regimen . | Primary end point/outcome . | Reference or NCT number . |
|---|---|---|---|
| Phase 3 | ATG vs no ATG with CSA/MTX | Chronic GVHD at 2 years: 32.2% (ATG) vs 68.7% (no ATG), P < .001 | 26 |
| Phase 3 | ATG vs no ATG with CNI/MTX | Freedom from systemic immunosuppression without resumption up to 12 months: 37% (ATG) vs 16% (no ATG), OR 4.25, P = .0006 | 27 |
| Phase 3 | ATG vs no ATG with Tac/MTX | Moderate-severe chronic GVHD-free survival: 48% (ATG) vs 44% (no ATG), P = .47 | 28 |
| Phase 2 | PTCy/CSA | Chronic GVHD requiring systemic treatment: 16% (95% CI, 5%-28%) | 48 |
| Phase 2 | PTCy/Tac/MMF vs bortezomib/Tac/MTX vs maraviroc/Tac/MTX | GRFS: HR 0.72, P = .04 (PTCy/Tac/MMF) vs HR 0.98, P = .92 (bortezomib/Tac/MTX) vs HR 1.10, P = .49 (maraviroc/Tac/MTX) | 49 |
| Phase 2 | Rituximab (D100, 6, 9, 12 months) post-HCT | Chronic GVHD: 48%, chronic GVHD requiring steroids: 31% | 30 |
| Phase 3 | CD34 selection vs PTCy vs Tac/MTX | CRFS: 60.2% (CD34), 60.3% (PTCy), 56.6% (Tac/MTX), P = .72 | 25 |
| Phase 1/2 | Ixazomib/Tac/Sir | Moderate/severe chronic GVHD | NCT03225417 |
| Phase 2 | Palifermin | Chronic GVHD | NCT02356159 |
| Phase 2 | Obinutuzumab | Chronic GVHD requiring steroids | NCT02867384 |
| Phase 2 | Ixazomib/CNI/MTX | Acute or chronic GVHD | NCT03082677 |
| Phase 2 | PTCy/Tac/MMF | GRFS | NCT03128359 |
| Phase 2 | PTCy/Sir/MMF | Extensive chronic GVHD | NCT03192397 |
| Phase 2 | Tocilizumab/Tac/MTX | GRFS | NCT03699631 |
| Phase 2 | Ex vivo depletion of CD45RA+ cells/Tac/MTX | GRFS | NCT03779854 |
| Phase 3 | Atorvastatin/Tac/MTX | Chronic GVHD | NCT03066466 |
| Phase 3 | PTCy/Tac/MMF vs Tac/MTX | GRFS | NCT03959241 |
| Phase . | Prevention regimen . | Primary end point/outcome . | Reference or NCT number . |
|---|---|---|---|
| Phase 3 | ATG vs no ATG with CSA/MTX | Chronic GVHD at 2 years: 32.2% (ATG) vs 68.7% (no ATG), P < .001 | 26 |
| Phase 3 | ATG vs no ATG with CNI/MTX | Freedom from systemic immunosuppression without resumption up to 12 months: 37% (ATG) vs 16% (no ATG), OR 4.25, P = .0006 | 27 |
| Phase 3 | ATG vs no ATG with Tac/MTX | Moderate-severe chronic GVHD-free survival: 48% (ATG) vs 44% (no ATG), P = .47 | 28 |
| Phase 2 | PTCy/CSA | Chronic GVHD requiring systemic treatment: 16% (95% CI, 5%-28%) | 48 |
| Phase 2 | PTCy/Tac/MMF vs bortezomib/Tac/MTX vs maraviroc/Tac/MTX | GRFS: HR 0.72, P = .04 (PTCy/Tac/MMF) vs HR 0.98, P = .92 (bortezomib/Tac/MTX) vs HR 1.10, P = .49 (maraviroc/Tac/MTX) | 49 |
| Phase 2 | Rituximab (D100, 6, 9, 12 months) post-HCT | Chronic GVHD: 48%, chronic GVHD requiring steroids: 31% | 30 |
| Phase 3 | CD34 selection vs PTCy vs Tac/MTX | CRFS: 60.2% (CD34), 60.3% (PTCy), 56.6% (Tac/MTX), P = .72 | 25 |
| Phase 1/2 | Ixazomib/Tac/Sir | Moderate/severe chronic GVHD | NCT03225417 |
| Phase 2 | Palifermin | Chronic GVHD | NCT02356159 |
| Phase 2 | Obinutuzumab | Chronic GVHD requiring steroids | NCT02867384 |
| Phase 2 | Ixazomib/CNI/MTX | Acute or chronic GVHD | NCT03082677 |
| Phase 2 | PTCy/Tac/MMF | GRFS | NCT03128359 |
| Phase 2 | PTCy/Sir/MMF | Extensive chronic GVHD | NCT03192397 |
| Phase 2 | Tocilizumab/Tac/MTX | GRFS | NCT03699631 |
| Phase 2 | Ex vivo depletion of CD45RA+ cells/Tac/MTX | GRFS | NCT03779854 |
| Phase 3 | Atorvastatin/Tac/MTX | Chronic GVHD | NCT03066466 |
| Phase 3 | PTCy/Tac/MMF vs Tac/MTX | GRFS | NCT03959241 |
CSA, cyclosporine.