A multicenter feasibility study of chronic graft-versus-host disease according to the National Institute of Health criteria: efforts to establish a Brazil-Seattle consortium as a platform for future collaboration in clinical trials

background: new criteria for the diagnosis and classification of chronic graft-versus-host disease were developed in 2005 for the purpose of clinical trials with a consensus sponsored by the national institute of health. objectives: the aim of this study is to present the results of a multicenter pilot study performed by the brazil-seattle chronic graft-versus-host disease consortium to determine the feasibility of using these criteria in five brazilian centers. methods: the study was performed after translation of the consensus criteria into portuguese and training. a total of 34 patients with national institute of health chronic graft-versus-host disease were enrolled in the pilot study between june 2006 and may 2009. results: of the 34 patients, 26 (76%) met the criteria of overlap syndrome and eight (24%) the classic subcategory. the overall severity of disease was moderate in 21 (62%) and severe in 13 (38%) patients. the median time from transplant to onset of chronic graft-versus-host disease was 5.9 months (range: 3 - 16 months); the median time for the overlap syndrome subcategory was 5.9 months (range: 3 - 10 months) and for the classic subcategory, it was 7.3 months (range: 3 - 16 months). at a median follow up of 16.5 months (range: 4 - 39 months), overall survival was 75%. conclusions: it was feasible to use the national institute of health consensus criteria for the diagnosis and scoring of chronic graft-versus-host disease in a brazilian prospective multicenter study. more importantly, a collaborative hematopoietic cell transplantation network was established in brazil offering new opportunities for future clinical trials in chronic graft-versus-host disease and in other areas of research involving hematopoietic stem cell transplantation.