Measuring therapeutic response in chronic graft-versus-host disease: National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. Response Criteria Working Group report - PubMed (original) (raw)
Guideline
doi: 10.1016/j.bbmt.2006.01.008.
Paul Martin, Stephanie J Lee, Sandra Mitchell, David Jacobsohn, Edward W Cowen, Maria L Turner, Gorgun Akpek, Andrew Gilman, George McDonald, Mark Schubert, Ann Berger, Peter Bross, Jason W Chien, Daniel Couriel, J P Dunn, Jane Fall-Dickson, Ann Farrell, Mary E D Flowers, Hildegard Greinix, Steven Hirschfeld, Lynn Gerber, Stella Kim, Robert Knobler, Peter A Lachenbruch, Frederick W Miller, Barbara Mittleman, Esperanza Papadopoulos, Susan K Parsons, Donna Przepiorka, Michael Robinson, Michael Ward, Bryce Reeve, Lisa G Rider, Howard Shulman, Kirk R Schultz, Daniel Weisdorf, Georgia B Vogelsang; Response Criteria Working Group
Affiliations
- PMID: 16503494
- DOI: 10.1016/j.bbmt.2006.01.008
Free article
Guideline
Measuring therapeutic response in chronic graft-versus-host disease: National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. Response Criteria Working Group report
Steven Z Pavletic et al. Biol Blood Marrow Transplant. 2006 Mar.
Free article
Abstract
The lack of standardized criteria for quantitative measurement of therapeutic response in clinical trials poses a major obstacle for the development of new agents in chronic graft-versus-host disease (GVHD). This consensus document was developed to address several objectives for response criteria to be used in chronic GVHD-related clinical trials. The proposed measures should be practical for use both by transplantation and nontransplantation medical providers, adaptable for use in adults and in children, and focused on the most important chronic GVHD manifestations. The measures should also give preference to quantitative, rather than semiquantitative, measures; capture information regarding signs, symptoms, and function separately from each other; and use validated scales whenever possible to demonstrate improved patient outcomes and meet requirements for regulatory approval of novel agents. Based on these criteria, we propose a set of measures to be considered for use in clinical trials, and forms for data collection are provided (). Measures should be made at 3-month intervals and whenever major changes are made in treatment. Provisional definitions of complete response, partial response, and progression are proposed for each organ and for overall outcomes. The proposed response criteria are based on current expert consensus opinion and are intended to improve consistency in the conduct and reporting of chronic GVHD trials, but their use remains to be demonstrated in practice.
Similar articles
- Measuring therapeutic response in chronic graft-versus-host disease. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: IV. The 2014 Response Criteria Working Group report.
Lee SJ, Wolff D, Kitko C, Koreth J, Inamoto Y, Jagasia M, Pidala J, Olivieri A, Martin PJ, Przepiorka D, Pusic I, Dignan F, Mitchell SA, Lawitschka A, Jacobsohn D, Hall AM, Flowers ME, Schultz KR, Vogelsang G, Pavletic S. Lee SJ, et al. Biol Blood Marrow Transplant. 2015 Jun;21(6):984-99. doi: 10.1016/j.bbmt.2015.02.025. Epub 2015 Mar 19. Biol Blood Marrow Transplant. 2015. PMID: 25796139 Free PMC article. - 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 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 ME. Filipovich AH, et al. Biol Blood Marrow Transplant. 2005 Dec;11(12):945-56. doi: 10.1016/j.bbmt.2005.09.004. Biol Blood Marrow Transplant. 2005. PMID: 16338616 - National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: VI. Design of Clinical Trials Working Group report.
Martin PJ, Weisdorf D, Przepiorka D, Hirschfeld S, Farrell A, Rizzo JD, Foley R, Socie G, Carter S, Couriel D, Schultz KR, Flowers ME, Filipovich AH, Saliba R, Vogelsang GB, Pavletic SZ, Lee SJ; Design of Clinical Trials Working Group. Martin PJ, et al. Biol Blood Marrow Transplant. 2006 May;12(5):491-505. doi: 10.1016/j.bbmt.2006.03.004. Biol Blood Marrow Transplant. 2006. PMID: 16635784 - Histopathologic diagnosis of chronic graft-versus-host disease: National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: II. Pathology Working Group Report.
Shulman HM, Kleiner D, Lee SJ, Morton T, Pavletic SZ, Farmer E, Moresi JM, Greenson J, Janin A, Martin PJ, McDonald G, Flowers ME, Turner M, Atkinson J, Lefkowitch J, Washington MK, Prieto VG, Kim SK, Argenyi Z, Diwan AH, Rashid A, Hiatt K, Couriel D, Schultz K, Hymes S, Vogelsang GB. Shulman HM, et al. Biol Blood Marrow Transplant. 2006 Jan;12(1):31-47. doi: 10.1016/j.bbmt.2005.10.023. Biol Blood Marrow Transplant. 2006. PMID: 16399567 - National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. The 2014 Diagnosis and Staging Working Group report.
Jagasia MH, Greinix HT, Arora M, Williams KM, Wolff D, Cowen EW, Palmer J, Weisdorf D, Treister NS, Cheng GS, Kerr H, Stratton P, Duarte RF, McDonald GB, Inamoto Y, Vigorito A, Arai S, Datiles MB, Jacobsohn D, Heller T, Kitko CL, Mitchell SA, Martin PJ, Shulman H, Wu RS, Cutler CS, Vogelsang GB, Lee SJ, Pavletic SZ, Flowers ME. Jagasia MH, et al. Biol Blood Marrow Transplant. 2015 Mar;21(3):389-401.e1. doi: 10.1016/j.bbmt.2014.12.001. Epub 2014 Dec 18. Biol Blood Marrow Transplant. 2015. PMID: 25529383 Free PMC article.
Cited by
- Ibrutinib as a Secondary Treatment for Steroid-Refractory or Steroid-Dependent Chronic Graft-Versus-Host Disease: A Case Series of 11 Patients During the COVID-19 Era.
Mizutani Y, Ueda T, Fujita J, Fukushima K, Hosen N. Mizutani Y, et al. Cureus. 2024 Oct 14;16(10):e71474. doi: 10.7759/cureus.71474. eCollection 2024 Oct. Cureus. 2024. PMID: 39539855 Free PMC article. - Cost-Effectiveness of Extracorporeal Photopheresis in Patients With Chronic Graft-vs-Host Disease.
Peacock A, Dehle FC, Mesa Zapata OA, Gennari F, Williams MRI, Hamad N, Larsen S, Harrison SJ, Taylor C. Peacock A, et al. J Health Econ Outcomes Res. 2024 Feb 1;11(1):23-31. doi: 10.36469/001c.92028. eCollection 2024. J Health Econ Outcomes Res. 2024. PMID: 38312919 Free PMC article. - Chronic GVHD: review advances in prevention, novel endpoints, and targeted strategies.
Amanam I, Otoukesh S, Al Malki MM, Salhotra A. Amanam I, et al. Hematology Am Soc Hematol Educ Program. 2023 Dec 8;2023(1):164-170. doi: 10.1182/hematology.2023000427. Hematology Am Soc Hematol Educ Program. 2023. PMID: 38066845 Free PMC article. - Oral Manifestations of Graft vs. Host Disease: A Comprehensive Review for Best Practice in Dentistry.
Miranda M, Gianfreda F, Carlotta D, Armati S, Barlattani A, Bollero P. Miranda M, et al. Medicina (Kaunas). 2023 Nov 1;59(11):1937. doi: 10.3390/medicina59111937. Medicina (Kaunas). 2023. PMID: 38003987 Free PMC article. Review. - Perspectives on oral chronic graft-versus-host disease from immunobiology to morbid diagnoses.
Tollemar V, Garming Legert K, Sugars RV. Tollemar V, et al. Front Immunol. 2023 Jun 28;14:1151493. doi: 10.3389/fimmu.2023.1151493. eCollection 2023. Front Immunol. 2023. PMID: 37449200 Free PMC article. Review.
Publication types
MeSH terms
LinkOut - more resources
Full Text Sources
Other Literature Sources