Summary of clinical trials for prevention approaches with low incidence of cGVHD
Approach . | Trial . | No. . | Age, y . | BM/PBSC, % . | MAC/RIC, % . | MRD/MUD/MMUD/haplo, % . | Other IS therapy . | cGVHD incidence, % . |
---|---|---|---|---|---|---|---|---|
ATG | Kroger, 201621 | 83 | 39 (18-64) | 0/100 | 100/0 | 100/0/0/0 | CSA/MTX | 32.2 (2 y) |
Chang, 202019 | 132 | 48 (40-61) | 4.5/95.5∗ | 100/0 | 100/0/0/0 | CSA/MTX/MMF | 27.9 (2 y) | |
Finke, 200920 | 103 | 40 (18-60) | 20/80 | 100/0 | 0/80/20/0∗ | CSA/MTX | 30.8 (2 y) | |
Soiffer, 201722 | 126 | 46 (18-64) | 18/75∗ | 100/0 | 0/100/0/0 | TAC/MTX | 16 (2 y) | |
Walker, 201623 | 99 | 49 (40-57) | 11/89 | 67/33 | 0/84/16/0 | CNI/MTX (or MMF)∗ | 26 (2 y) | |
CD34 selection | Devine, 201131 | 44 | 48.5 (21-59) | 0/100 | 100/0 | 100/0/0/0 | None | 19 (2 y) |
Luznik, 202239 | 114 | 51 (22-66) | 6/94 | 100/0 | 38/62/0/0 | None∗ | 8.9 (2 y) | |
Naïve T-cell depletion | Bleakley, 202232 | 138 | 37 (1-60) | 0/100 | 100/0∗ | 61/39/0/0 | TAC, TAC/MTX, TAC/MMF∗ | 7 (3 y) |
PTCy | Bolanos-Meade, 201925 | 92 | 64 (56-72) | 0/100 | 0/100 | 32/54/10/0 | TAC/MMF | 28 (1 y) |
Bolanos-Meade, 202324 | 214 | 64.2∗ | 0/100 | 0/100 | 28/68/3/0 | TAC/MMF | 21.9 (1 y) | |
Shaw, 202329 | 80 | 51.5 (18-70) | 100/0 | 50/50 | 0/0/100/0 | SIR/MMF | 20 RIC, 37.5 MAC (3 y) | |
Luznik, 202239 | 114 | 51 (20-66) | 90/10 | 100/0 | 38/62/0/0 | None | 27 (2 y) | |
Luznik, 201026 | 117 | 50 (21-66) | 100/0 | 100/0 | 67/33/0/0∗ | None | 10 (2 y) | |
Kanakry, 201430 | 92 | 49 (21-65) | 100/0 | 100/0 | 49/51/0/0∗ | None | 14 (2 y) | |
Symons, 202040 | 96 | 42 (1-65) | 100/0 | 100/0 | 0/0/0/100 | TAC/MMF | 15 (1 y) | |
Solomon, 201541 | 30 | 46 (24-60) | 0/100 | 100/0 | 0/0/0/100 | TAC/MMF | 56 (18 mo) | |
Sanz, 202042 | 22 | 41 (18-55) | 0/100 | 100/0 | 0/0/0/100 | CSA/MMF | 43 (2 y) | |
Sugita, 201943 | 50 | 36 (17-60) | 0/100 | 100/0 | 0/0/0/100 | TAC/MMF | 36 (2 y) | |
Sugita, 201943 | 77 | 58 (22-65) | 0/100 | 0/100 | 0/0/0/100 | TAC/MMF | 27 (2 y) | |
Al Malki, 202244 | 31 | 37 (21-58) | 0/100 | 0/100 | 0/0/0/100 | TAC/MMF | 35 (2 y) | |
Fuchs, 202145 | 182 | 60 (20-70) | 100/0 | 0/100 | 0/0/0/100 | TAC/MMF | 26 (2 y) |
Approach . | Trial . | No. . | Age, y . | BM/PBSC, % . | MAC/RIC, % . | MRD/MUD/MMUD/haplo, % . | Other IS therapy . | cGVHD incidence, % . |
---|---|---|---|---|---|---|---|---|
ATG | Kroger, 201621 | 83 | 39 (18-64) | 0/100 | 100/0 | 100/0/0/0 | CSA/MTX | 32.2 (2 y) |
Chang, 202019 | 132 | 48 (40-61) | 4.5/95.5∗ | 100/0 | 100/0/0/0 | CSA/MTX/MMF | 27.9 (2 y) | |
Finke, 200920 | 103 | 40 (18-60) | 20/80 | 100/0 | 0/80/20/0∗ | CSA/MTX | 30.8 (2 y) | |
Soiffer, 201722 | 126 | 46 (18-64) | 18/75∗ | 100/0 | 0/100/0/0 | TAC/MTX | 16 (2 y) | |
Walker, 201623 | 99 | 49 (40-57) | 11/89 | 67/33 | 0/84/16/0 | CNI/MTX (or MMF)∗ | 26 (2 y) | |
CD34 selection | Devine, 201131 | 44 | 48.5 (21-59) | 0/100 | 100/0 | 100/0/0/0 | None | 19 (2 y) |
Luznik, 202239 | 114 | 51 (22-66) | 6/94 | 100/0 | 38/62/0/0 | None∗ | 8.9 (2 y) | |
Naïve T-cell depletion | Bleakley, 202232 | 138 | 37 (1-60) | 0/100 | 100/0∗ | 61/39/0/0 | TAC, TAC/MTX, TAC/MMF∗ | 7 (3 y) |
PTCy | Bolanos-Meade, 201925 | 92 | 64 (56-72) | 0/100 | 0/100 | 32/54/10/0 | TAC/MMF | 28 (1 y) |
Bolanos-Meade, 202324 | 214 | 64.2∗ | 0/100 | 0/100 | 28/68/3/0 | TAC/MMF | 21.9 (1 y) | |
Shaw, 202329 | 80 | 51.5 (18-70) | 100/0 | 50/50 | 0/0/100/0 | SIR/MMF | 20 RIC, 37.5 MAC (3 y) | |
Luznik, 202239 | 114 | 51 (20-66) | 90/10 | 100/0 | 38/62/0/0 | None | 27 (2 y) | |
Luznik, 201026 | 117 | 50 (21-66) | 100/0 | 100/0 | 67/33/0/0∗ | None | 10 (2 y) | |
Kanakry, 201430 | 92 | 49 (21-65) | 100/0 | 100/0 | 49/51/0/0∗ | None | 14 (2 y) | |
Symons, 202040 | 96 | 42 (1-65) | 100/0 | 100/0 | 0/0/0/100 | TAC/MMF | 15 (1 y) | |
Solomon, 201541 | 30 | 46 (24-60) | 0/100 | 100/0 | 0/0/0/100 | TAC/MMF | 56 (18 mo) | |
Sanz, 202042 | 22 | 41 (18-55) | 0/100 | 100/0 | 0/0/0/100 | CSA/MMF | 43 (2 y) | |
Sugita, 201943 | 50 | 36 (17-60) | 0/100 | 100/0 | 0/0/0/100 | TAC/MMF | 36 (2 y) | |
Sugita, 201943 | 77 | 58 (22-65) | 0/100 | 0/100 | 0/0/0/100 | TAC/MMF | 27 (2 y) | |
Al Malki, 202244 | 31 | 37 (21-58) | 0/100 | 0/100 | 0/0/0/100 | TAC/MMF | 35 (2 y) | |
Fuchs, 202145 | 182 | 60 (20-70) | 100/0 | 0/100 | 0/0/0/100 | TAC/MMF | 26 (2 y) |
CSA, cyclosporine; MAC, myeloablative conditioning; MRD, matched related donor; MUD, matched unrelated donor; MMUD, mismatched unrelated donor; RIC, reduced-intensity conditioning.
Chang 202019: PBSC included PBSC N = 76 (57.6%) as well as bone marrow transplant (BMT) + PBSC N = 50 (37.9%). Finke 200920: N = 21 (20%) had human leukocyte antigen (HLA)-C mismatch. Soiffer 201722: N = 9 (7%) unknown graft source. Walker 2016: included CNI (either CSA or TAC) combined with MTX or MMF. Luznik 202239: reported approach/IS therapy per randomly assigned therapy, whereas N = 15 in the CD34 selection arm of the trial received TAC/MTX or other as treatment noncompliance, and N = 9 in the PTCy arm received noncompliant therapy of TAC/MTX or other. Bleakley 202232: had all myeloablative regimens, but 72% high intensity and 28% intermediate intensity; the combined report summarized different trials, which varied in the delivered pharmacologic immune suppression (included TAC alone, TAC/MTX, or TAC/MMF) alongside the naïve T-cell depletion approach. Bolanos-Meade25 2023: age reported as mean (64.2 years, ±8.5 years). Luznik 201026: 1 related donor was an HLA-identical parent. Kanakry 201430: 1 patient had a 10/10 HLA matched familial donor (grouped here with the matched sibling donor group).