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
Rev. bras. hematol. hemoter
;
33(4): 283-289, 2011. ilus, tab, graf
Article
in English
| LILACS
| ID: lil-601007
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 percent) met the criteria of overlap syndrome and eight (24 percent) the classic subcategory. The overall severity of disease was moderate in 21 (62 percent) and severe in 13 (38 percent) 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 percent.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.
Full text:
Available
Index:
LILACS (Americas)
Main subject:
Consensus Development Conferences, NIH as Topic
/
Clinical Trial
/
Hematopoietic Stem Cell Transplantation
/
Graft vs Host Disease
Type of study:
Controlled clinical trial
Limits:
Humans
Country/Region as subject:
South America
/
Brazil
Language:
English
Journal:
Rev. bras. hematol. hemoter
Journal subject:
Hematology
Year:
2011
Type:
Article
/
Project document
Affiliation country:
Brazil
/
United States
Institution/Affiliation country:
Fred Hutchinson Cancer Research Center/BR
/
Hospital Amaral Carvalho/BR
/
Instituto Nacional de Câncer/BR
/
Universidade Estadual de Campinas/BR
/
Universidade Federal do Paraná/BR
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