Table 1.
Patient and transplant characteristics (intention-to-treat population)
| Patient characteristics | MTX group (n = 78) | Control group (n = 79) |
|---|---|---|
| Gender | ||
| Male | 42(54%) | 42(53%) |
| Female | 36(46%) | 37(47%) |
| Median age, years, (range) | 34(15–63) | 34(15–62) |
| MAGIC criteria grade | ||
| I-II | 74(95%) | 71(90%) |
| III-IV | 4(5%) | 8(10%) |
| GVHD risk category | ||
| Standard | 75(96%) | 72(91%) |
| High | 3(4%) | 7(9%) |
| Underlying malignancy | ||
| Acute myeloid leukemia | 32(41%) | 41(52%) |
| Acute lymphoid leukemia | 32(41%) | 23(29%) |
| Myelodysplastic syndrome | 11(14%) | 12(15%) |
| Other malignant disease | 3(4%) | 3(4%) |
| Graft source | ||
| Peripheral blood | 68(87%) | 62(17%) |
| Bone marrow | 10(13%) | 17 (21%) |
| Donor sourcea | ||
| Matched sibling donor | 6(8%) | 11(14%) |
| Matched unrelated donor | 4(5%) | 6(7%) |
| Haploidentical donor | 68(87%) | 62(79%) |
| GVHD prophylaxisa | ||
| CsA + MMF + MTX | 78(100%) | 79(100%) |
| Baseline organ involvement | ||
| Specific organ involved | ||
| Skin | 71(91%) | 65(82%) |
| Lower gastrointestinal tract or liver | 16(21%) | 25(31%) |
| Single or multi organ involvement | ||
| Single | 68(87%) | 69(87%) |
| Multi | 10(13%) | 10(13%) |
GVHD Graft-versus-host disease, HLA Human leukocyte antigen, MAGIC Mount Sinai Acute GVHD International Consortium, CsA Cyclosporine A, MMF Mycophenolate mofetil
aThe conditioning regimen for haploidentical donor and matched unrelated donor HSCT included cytarabine (4 g/m2/day, day –9), busulfan (3.2 mg/kg/day, intravenously days –8 to –6), cyclophosphamide (1.8 g/m2/day, days –5 to –4), semustine (250 mg/m2, day –3), and rabbit ATG (thymoglobulin; Imtix Sangstat, Lyon, France, 2.5 mg/kg/day, days –5 to –2). The conditioning regimen for matched sibling donor did not include ATG, otherwise identical to haploidentical donor and matched unrelated donor HSCT. Cyclosporine A (CsA), mycophenolate mofetil (MMF), and short-term MTX were given as GVHD prophylaxis. The dosage of methotrexate was 15 mg/m2, administered i.v. on day + 1, followed by 10 mg/m2 on days 3, 6, and 11 after haploidentical donor and matched unrelated donor HSCT( 10 mg/m2 on days 3,6,after matched sibling HSCT)