Antilymphocyte globulin for prevention of chronic graft-versus-host disease

Nicolaus Kröger, Carlos Solano, Christine Wolschke, Giuseppe Bandini, Francesca Patriarca, Massimo Pini, Arnon Nagler, Carmine Selleri, Antonio Risitano, Giuseppe Messina, Wolfgang Bethge, Jaime Pérez De Oteiza, Rafael Duarte, Angelo Michele Carella, Michele Cimminiello, Stefano Guidi, Jürgen Finke, Nicola Mordini, Christelle Ferra, Jorge SierraDomenico Russo, Mario Petrini, Giuseppe Milone, Fabio Benedetti, Marion Heinzelmann, Domenico Pastore, Manuel Jurado, Elisabetta Terruzzi, Franco Narni, Andreas Völp, Francis Ayuk, Tapani Ruutu, Francesca Bonifazi

Research output: Contribution to journalArticlepeer-review

Abstract

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. 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. RESULTS After 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

Original languageEnglish
Pages (from-to)43-53
Number of pages11
JournalNew England Journal of Medicine
Volume374
Issue number1
DOIs
Publication statusPublished - Jan 7 2016

ASJC Scopus subject areas

  • Medicine(all)

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