RT Journal Article
T1 Antilymphocyte Globulin for Prevention of Chronic Graft-versus-Host Disease.
A1 Kröger, Nicolaus
A1 Solano, Carlos
A1 Wolschke, Christine
A1 Bandini, Giuseppe
A1 Patriarca, Francesca
A1 Pini, Massimo
A1 Nagler, Arnon
A1 Selleri, Carmine
A1 Risitano, Antonio
A1 Messina, Giuseppe
A1 Bethge, Wolfgang
A1 Pérez de Oteiza, Jaime
A1 Duarte, Rafael
A1 Carella, Angelo Michele
A1 Cimminiello, Michele
A1 Guidi, Stefano
A1 Finke, Jürgen
A1 Mordini, Nicola
A1 Ferra, Christelle
A1 Sierra, Jorge
A1 Russo, Domenico
A1 Petrini, Mario
A1 Milone, Giuseppe
A1 Benedetti, Fabio
A1 Heinzelmann, Marion
A1 Pastore, Domenico
A1 Jurado, Manuel
A1 Terruzzi, Elisabetta
A1 Narni, Franco
A1 Völp, Andreas
A1 Ayuk, Francis
A1 Ruutu, Tapani
A1 Bonifazi, Francesca
K1 Suero antilinfocítico
K1 Enfermedad crónica
K1 Supervivencia sin enfermedad
K1 Enfermedad injerto contra huésped
K1 Humanos
K1 Inmunosupresores
K1 Modelos de riesgos proporcionales
K1 Estudios prospectivos
K1 Linfocitos t
K1 Trasplante homólogo
AB BACKGROUNDChronic 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.METHODSWe 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.RESULTSAfter a median follow-up of 24 months, the cumulative incidence of chronic GVHD was 32.2% (95% confidence interval [CI], 22.1 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).CONCLUSIONSThe 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.).
PB Massachusetts Medical Society
SN 0028-4793
YR 2016
FD 2016-01-07
LK http://hdl.handle.net/10668/2373
UL http://hdl.handle.net/10668/2373
LA en
NO Kröger N, Solano C, Wolschke C, Bandini G, Patriarca F, Pini M, et al. Antilymphocyte Globulin for Prevention of Chronic Graft-versus-Host Disease. N. Engl. J. Med.. 2016                         ; 374(1):43-53
NO Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't;
DS RISalud
RD Apr 6, 2025