National Institutes of Health Consensus Development Project on criteria for clinical trials in chronic graft-versus-host disease: I. diagnosis and staging working group report

Alexandra H. Filipovich; Daniel Weisdorf; Steven Pavletic; Gerard Socie; John R. Wingard; Stephanie J. Lee; Paul Martin; Jason Chien; Donna Przepiorka; Daniel Couriel; Edward W. Cowen; Patricia Dinndorf; Ann Farrell; Robert Hartzman; Jean Henslee-Downey; David Jacobsohn; George McDonald; Barbara Mittleman; J. Douglas Rizzo; Michael Robinson; Mark Schubert; Kirk Schultz; Howard Shulman; Maria Turner; Georgia Vogelsang; Mary E D Flowers

doi:10.1016/j.bbmt.2005.09.004

National Institutes of Health Consensus Development Project on criteria for clinical trials in chronic graft-versus-host disease: I. diagnosis and staging working group report

Alexandra H. Filipovich, Daniel Weisdorf, Steven Pavletic, Gerard Socie, John R. Wingard, Stephanie J. Lee, Paul Martin, Jason Chien, Donna Przepiorka, Daniel Couriel, Edward W. Cowen, Patricia Dinndorf, Ann Farrell, Robert Hartzman, Jean Henslee-Downey, David Jacobsohn, George McDonald, Barbara Mittleman, J. Douglas Rizzo, Michael RobinsonMark Schubert, Kirk Schultz, Howard Shulman, Maria Turner, Georgia Vogelsang, Mary E D Flowers

Medicine - Hematology, Oncology, Transplant

Research output: Contribution to journal › Review article › peer-review

3022 Scopus citations

Abstract

This consensus document is intended to serve 3 functions. First, it standardizes the criteria for diagnosis of chronic graft-versus-host disease (GVHD). Second, it proposes a new clinical scoring system (0-3) that describes the extent and severity of chronic GVHD for each organ or site at any given time, taking functional impact into account. Third, it proposes new guidelines for global assessment of chronic GVHD severity that are based on the number of organs or sites involved and the degree of involvement in affected organs (mild, moderate, or severe). Diagnosis of chronic GVHD requires the presence of at least 1 diagnostic clinical sign of chronic GVHD (e.g., poikiloderma or esophageal web) or the presence of at least 1 distinctive manifestation (e.g., keratoconjunctivitis sicca) confirmed by pertinent biopsy or other relevant tests (e.g., Schirmer test) in the same or another organ. Furthermore, other possible diagnoses for clinical symptoms must be excluded. No time limit is set for the diagnosis of chronic GVHD. The Working Group recognized 2 main categories of GVHD, each with 2 subcategories. The acute GVHD category is defined in the absence of diagnostic or distinctive features of chronic GVHD and includes (1) classic acute GVHD occurring within 100 days after transplantation and (2) persistent, recurrent, or late acute GVHD (features of acute GVHD occurring beyond 100 days, often during withdrawal of immune suppression). The broad category of chronic GVHD includes (1) classic chronic GVHD (without features or characteristics of acute GVHD) and (2) an overlap syndrome in which diagnostic or distinctive features of chronic GVHD and acute GVHD appear together. It is currently recommended that systemic therapy be considered for patients who meet criteria for chronic GVHD of moderate to severe global severity.

Original language	English (US)
Pages (from-to)	945-956
Number of pages	12
Journal	Biology of Blood and Marrow Transplantation
Volume	11
Issue number	12
DOIs	https://doi.org/10.1016/j.bbmt.2005.09.004
State	Published - Dec 2005

Bibliographical note

Funding Information:
This project was supported by the National Institutes of Health’s (NIH’s) National Cancer Institute, Office of the Director, Cancer Therapy Evaluation Program, Intramural Research Program, and Center for Cancer Research; National Heart Lung and Blood Institute, Division of Blood Diseases and Resources; Office of Rare Diseases, NIH, Office of the Director; National Institute of Allergy and Infectious Disease, Transplantation Immunology Branch; the Health Resources and Services Administration, Division of Transplantation; and the Naval Medical Research Center, C.W. Bill Young/Department of Defense Marrow Donor Recruitment and Research Program. The authors would also like to acknowledge the following individuals and organizations that, by their participation, made this project possible: American Society for Blood and Marrow Transplantation, Center for International Bone and Marrow Transplant Research, Blood and Marrow Transplant Clinical Trials Network, Canadian Blood and Marrow Transplant Group, European Group for Blood and Marrow Transplantation, Pediatric Blood and Marrow Transplant Consortium, and the representatives of the South American transplant centers (Drs. Luis F. Bouzas and Vaneuza Funke). This project was conducted in coordination with the American Society for Clinical Oncology and the American Society of Hematology (liaisons were Dr. Michael Bishop and Jeff Coughlin). The organizers are also in debt to patients and patient and research advocacy groups, who made this process much more meaningful by their engagement. Special thanks also go to Paula Kim, who coordinated these efforts. The project group also recognizes the contributions of numerous colleagues in the field of blood and marrow transplantation, medical specialists and consultants, the pharmaceutical industry, and the NIH and US Food and Drug Administration professional staff for their intellectual input, dedication, and enthusiasm on the road to completion of these documents.

Keywords

Allogeneic hematopoietic cell transplantation
Chronic graft-versus-host disease
Consensus
Diagnosis
Staging

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Filipovich, A. H., Weisdorf, D., Pavletic, S., Socie, G., Wingard, J. R., Lee, S. J., Martin, P., Chien, J., Przepiorka, D., Couriel, D., Cowen, E. W., Dinndorf, P., Farrell, A., Hartzman, R., Henslee-Downey, J., Jacobsohn, D., McDonald, G., Mittleman, B., Rizzo, J. D., ... Flowers, M. E. D. (2005). National Institutes of Health Consensus Development Project on criteria for clinical trials in chronic graft-versus-host disease: I. diagnosis and staging working group report. Biology of Blood and Marrow Transplantation, 11(12), 945-956. https://doi.org/10.1016/j.bbmt.2005.09.004

National Institutes of Health Consensus Development Project on criteria for clinical trials in chronic graft-versus-host disease: I. diagnosis and staging working group report. / Filipovich, Alexandra H.; Weisdorf, Daniel; Pavletic, Steven et al.
In: Biology of Blood and Marrow Transplantation, Vol. 11, No. 12, 12.2005, p. 945-956.

Research output: Contribution to journal › Review article › peer-review

Filipovich, AH, Weisdorf, D, Pavletic, S, Socie, G, Wingard, JR, Lee, SJ, Martin, P, Chien, J, Przepiorka, D, Couriel, D, Cowen, EW, Dinndorf, P, Farrell, A, Hartzman, R, Henslee-Downey, J, Jacobsohn, D, McDonald, G, Mittleman, B, Rizzo, JD, Robinson, M, Schubert, M, Schultz, K, Shulman, H, Turner, M, Vogelsang, G & Flowers, MED 2005, 'National Institutes of Health Consensus Development Project on criteria for clinical trials in chronic graft-versus-host disease: I. diagnosis and staging working group report', Biology of Blood and Marrow Transplantation, vol. 11, no. 12, pp. 945-956. https://doi.org/10.1016/j.bbmt.2005.09.004

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abstract = "This consensus document is intended to serve 3 functions. First, it standardizes the criteria for diagnosis of chronic graft-versus-host disease (GVHD). Second, it proposes a new clinical scoring system (0-3) that describes the extent and severity of chronic GVHD for each organ or site at any given time, taking functional impact into account. Third, it proposes new guidelines for global assessment of chronic GVHD severity that are based on the number of organs or sites involved and the degree of involvement in affected organs (mild, moderate, or severe). Diagnosis of chronic GVHD requires the presence of at least 1 diagnostic clinical sign of chronic GVHD (e.g., poikiloderma or esophageal web) or the presence of at least 1 distinctive manifestation (e.g., keratoconjunctivitis sicca) confirmed by pertinent biopsy or other relevant tests (e.g., Schirmer test) in the same or another organ. Furthermore, other possible diagnoses for clinical symptoms must be excluded. No time limit is set for the diagnosis of chronic GVHD. The Working Group recognized 2 main categories of GVHD, each with 2 subcategories. The acute GVHD category is defined in the absence of diagnostic or distinctive features of chronic GVHD and includes (1) classic acute GVHD occurring within 100 days after transplantation and (2) persistent, recurrent, or late acute GVHD (features of acute GVHD occurring beyond 100 days, often during withdrawal of immune suppression). The broad category of chronic GVHD includes (1) classic chronic GVHD (without features or characteristics of acute GVHD) and (2) an overlap syndrome in which diagnostic or distinctive features of chronic GVHD and acute GVHD appear together. It is currently recommended that systemic therapy be considered for patients who meet criteria for chronic GVHD of moderate to severe global severity.",

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author = "Filipovich, {Alexandra H.} and Daniel Weisdorf and Steven Pavletic and Gerard Socie and Wingard, {John R.} and Lee, {Stephanie J.} and Paul Martin and Jason Chien and Donna Przepiorka and Daniel Couriel and Cowen, {Edward W.} and Patricia Dinndorf and Ann Farrell and Robert Hartzman and Jean Henslee-Downey and David Jacobsohn and George McDonald and Barbara Mittleman and Rizzo, {J. Douglas} and Michael Robinson and Mark Schubert and Kirk Schultz and Howard Shulman and Maria Turner and Georgia Vogelsang and Flowers, {Mary E D}",

note = "Funding Information: This project was supported by the National Institutes of Health{\textquoteright}s (NIH{\textquoteright}s) National Cancer Institute, Office of the Director, Cancer Therapy Evaluation Program, Intramural Research Program, and Center for Cancer Research; National Heart Lung and Blood Institute, Division of Blood Diseases and Resources; Office of Rare Diseases, NIH, Office of the Director; National Institute of Allergy and Infectious Disease, Transplantation Immunology Branch; the Health Resources and Services Administration, Division of Transplantation; and the Naval Medical Research Center, C.W. Bill Young/Department of Defense Marrow Donor Recruitment and Research Program. The authors would also like to acknowledge the following individuals and organizations that, by their participation, made this project possible: American Society for Blood and Marrow Transplantation, Center for International Bone and Marrow Transplant Research, Blood and Marrow Transplant Clinical Trials Network, Canadian Blood and Marrow Transplant Group, European Group for Blood and Marrow Transplantation, Pediatric Blood and Marrow Transplant Consortium, and the representatives of the South American transplant centers (Drs. Luis F. Bouzas and Vaneuza Funke). This project was conducted in coordination with the American Society for Clinical Oncology and the American Society of Hematology (liaisons were Dr. Michael Bishop and Jeff Coughlin). The organizers are also in debt to patients and patient and research advocacy groups, who made this process much more meaningful by their engagement. Special thanks also go to Paula Kim, who coordinated these efforts. The project group also recognizes the contributions of numerous colleagues in the field of blood and marrow transplantation, medical specialists and consultants, the pharmaceutical industry, and the NIH and US Food and Drug Administration professional staff for their intellectual input, dedication, and enthusiasm on the road to completion of these documents. ",

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National Institutes of Health Consensus Development Project on criteria for clinical trials in chronic graft-versus-host disease: I. diagnosis and staging working group report

Abstract

Bibliographical note

Keywords

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