Background: Chronic graft-versus-host disease (GVHD) is the leading cause of later illness and death after allogeneic hematopoietic stem-cell transplantation. We hypothesized that the inclusion of antihuman T-lymphocyte immune globulin (ATG) in a myeloablative conditioning regimen for patients with acute leukemia would result in a significant reduction in chronic GVHD 2 years after allogeneic peripheral-blood stem-cell transplantation from an HLA-identical sibling VSports手机版. .

Methods: We conducted a prospective, multicenter, open-label, randomized phase 3 study of ATG as part of a conditioning regimen. A total of 168 patients were enrolled at 27 centers. Patients were randomly assigned in a 1:1 ratio to receive ATG or not receive ATG, with stratification according to center and risk of disease. V体育安卓版.

Results: After a median follow-up of 24 months, the cumulative incidence of chronic GVHD was 32. 2% (95% confidence interval [CI], 22 V体育ios版. 1 to 46. 7) in the ATG group and 68. 7% (95% CI, 58. 4 to 80. 7) in the non-ATG group (P<0. 001). The rate of 2-year relapse-free survival was similar in the ATG group and the non-ATG group (59. 4% [95% CI, 47. 8 to 69. 2] and 64. 6% [95% CI, 50. 9 to 75. 3], respectively; P=0. 21), as was the rate of overall survival (74. 1% [95% CI, 62. 7 to 82. 5] and 77. 9% [95% CI, 66. 1 to 86. 1], respectively; P=0. 46). There were no significant between-group differences in the rates of relapse, infectious complications, acute GVHD, or adverse events. The rate of a composite end point of chronic GVHD-free and relapse-free survival at 2 years was significantly higher in the ATG group than in the non-ATG group (36. 6% vs. 16. 8%, P=0. 005). .

Conclusions: The inclusion of ATG resulted in a significantly lower rate of chronic GVHD after allogeneic transplantation than the rate without ATG. The survival rate was similar in the two groups, but the rate of a composite end point of chronic GVHD-free survival and relapse-free survival was higher with ATG. (Funded by the Neovii Biotech and the European Society for Blood and Marrow Transplantation; ClinicalTrials. gov number, NCT00678275. ) VSports最新版本. .