A multicenter feasibility study of chronic graft-versus-host disease according to the National Institute of Health criteria

Abstract

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.

Translation, Cross-Cultural Adaptation, and Validation of the Lee Chronic Graft-versus-Host Disease Symptom Scale in a Brazilian Population

“…12–14 This Consortium was recently adopted by the Brazilian Bone Marrow Transplantation Society as one of the first Working Groups focused on chronic GVHD and other late effects of hematopoietic stem cell transplant, entitled Grupo de Estudos da Doença do Enxerto e Outras Complicações do TMO (GEDECO). The current multicenter study was conducted by the GEDECO at five Brazilian institutions.…”

Progress in chronic graft-versus-host disease

“…(7) These investigators translated the US prospective data forms into Portuguese and then tested their use in five Brazilian centers. To date, the study has enrolled 34 patients with chronic GvHD.…”

“…In this issue of the Revista Brasileira de Hematologica e Hemoterapia , Vigorito and colleagues describe the initial results of work by a group of Brazilian investigators to develop a platform for collaboration in clinical trials related to chronic GvHD. ( 7 ) These investigators translated the US prospective data forms into Portuguese and then tested their use in five Brazilian centers. To date, the study has enrolled 34 patients with chronic GvHD.…”