Design and Patient Characteristics of the Chronic Graft-versus-Host Disease Response Measures Validation Study

The Chronic GVHD Consortium

doi:10.1016/j.bbmt.2018.02.010

Design and Patient Characteristics of the Chronic Graft-versus-Host Disease Response Measures Validation Study

The Chronic GVHD Consortium

Medicine - Hematology, Oncology, Transplant

Research output: Contribution to journal › Article › peer-review

10 Scopus citations

Abstract

In 2014, the National Institutes of Health sponsored the second Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease (GVHD). The purpose was to update recommendations about key elements of chronic GVHD research, including definitions for diagnosis, severity scoring, and response measures, based on empirical data published since the first 2005 Consensus Conference. The most significant modifications were to the response assessments, based on studies demonstrating difficulty with the first consensus definitions. The Response Measures Validation Study is a multicenter, prospective cohort study of patients who are starting initial or subsequent treatments for chronic GVHD. The aim of the study is to evaluate the performance of the 2014 response measures and determine whether any other combination of assessments is superior. Clinical data, clinician assessments, patient-reported outcomes, and research samples are collected at enrollment and 3, 6, and 18 months later, and whenever another chronic GVHD systemic treatment is added. The target enrollment of 368 evaluable patients from 12 transplantation centers has been reached. This report describes the rationale, design, and methods of the Chronic GVHD Response Measures Validation Study, and invites other investigators to collaborate with the Consortium to analyze data or specimens.

Original language	English (US)
Pages (from-to)	1727-1732
Number of pages	6
Journal	Biology of Blood and Marrow Transplantation
Volume	24
Issue number	8
DOIs	https://doi.org/10.1016/j.bbmt.2018.02.010
State	Published - Aug 2018

Bibliographical note

Funding Information:
Conflict of interest statement : S.J.L. serves on advisory boards for Amgen and Incyte, and has received travel and speaking honoraria from Mallinckrodt. M.J. serves on advisory boards and as a speaker for Janssen and Mallinckrodt, and has received research funding from Janssen and Mallinckrodt. C.C. serves on advisory boards and as a consultant for Bristol-Myers Squibb and Incyte. S.S. serves on advisory boards for Gilead and Pharmacyclics and has received research funding from Gilead. M.F. serves on advisory boards and as a consultant for Pharmacyclics and has received research funding and travel and speaking honoraria from Incyte, Astellas, and Mallinckrodt. The other authors have no conflicts of interest to report.

Funding Information:
Financial disclosure: This study was funded by National Cancer Institute (CA118953).

Publisher Copyright:
© 2018 The American Society for Blood and Marrow Transplantation

Keywords

Allogeneic hematopoietic cell transplantation
Biorepository
Chronic graft-versus-host disease
Prospective longitudinal observational study
Response assessment

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10.1016/j.bbmt.2018.02.010

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6103904

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title = "Design and Patient Characteristics of the Chronic Graft-versus-Host Disease Response Measures Validation Study",

abstract = "In 2014, the National Institutes of Health sponsored the second Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease (GVHD). The purpose was to update recommendations about key elements of chronic GVHD research, including definitions for diagnosis, severity scoring, and response measures, based on empirical data published since the first 2005 Consensus Conference. The most significant modifications were to the response assessments, based on studies demonstrating difficulty with the first consensus definitions. The Response Measures Validation Study is a multicenter, prospective cohort study of patients who are starting initial or subsequent treatments for chronic GVHD. The aim of the study is to evaluate the performance of the 2014 response measures and determine whether any other combination of assessments is superior. Clinical data, clinician assessments, patient-reported outcomes, and research samples are collected at enrollment and 3, 6, and 18 months later, and whenever another chronic GVHD systemic treatment is added. The target enrollment of 368 evaluable patients from 12 transplantation centers has been reached. This report describes the rationale, design, and methods of the Chronic GVHD Response Measures Validation Study, and invites other investigators to collaborate with the Consortium to analyze data or specimens.",

keywords = "Allogeneic hematopoietic cell transplantation, Biorepository, Chronic graft-versus-host disease, Prospective longitudinal observational study, Response assessment",

author = "{The Chronic GVHD Consortium} and Lee, {Stephanie J.} and Hamilton, {Betty K.} and Joseph Pidala and Amin Alousi and Chareeni Kurukulasuriya and Lynn Onstad and Madan Jagasia and George Chen and Corey Cutler and Raewyn Broady and Mukta Arora and Sally Arai and Stefanie Sarantopoulos and Flowers, {Mary E.}",

note = "Funding Information: Conflict of interest statement : S.J.L. serves on advisory boards for Amgen and Incyte, and has received travel and speaking honoraria from Mallinckrodt. M.J. serves on advisory boards and as a speaker for Janssen and Mallinckrodt, and has received research funding from Janssen and Mallinckrodt. C.C. serves on advisory boards and as a consultant for Bristol-Myers Squibb and Incyte. S.S. serves on advisory boards for Gilead and Pharmacyclics and has received research funding from Gilead. M.F. serves on advisory boards and as a consultant for Pharmacyclics and has received research funding and travel and speaking honoraria from Incyte, Astellas, and Mallinckrodt. The other authors have no conflicts of interest to report. Funding Information: Financial disclosure: This study was funded by National Cancer Institute (CA118953). Publisher Copyright: {\textcopyright} 2018 The American Society for Blood and Marrow Transplantation",

year = "2018",

month = aug,

doi = "10.1016/j.bbmt.2018.02.010",

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volume = "24",

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AU - The Chronic GVHD Consortium

AU - Lee, Stephanie J.

AU - Hamilton, Betty K.

AU - Pidala, Joseph

AU - Alousi, Amin

AU - Kurukulasuriya, Chareeni

AU - Onstad, Lynn

AU - Jagasia, Madan

AU - Chen, George

AU - Cutler, Corey

AU - Broady, Raewyn

AU - Arora, Mukta

AU - Arai, Sally

AU - Sarantopoulos, Stefanie

AU - Flowers, Mary E.

N1 - Funding Information: Conflict of interest statement : S.J.L. serves on advisory boards for Amgen and Incyte, and has received travel and speaking honoraria from Mallinckrodt. M.J. serves on advisory boards and as a speaker for Janssen and Mallinckrodt, and has received research funding from Janssen and Mallinckrodt. C.C. serves on advisory boards and as a consultant for Bristol-Myers Squibb and Incyte. S.S. serves on advisory boards for Gilead and Pharmacyclics and has received research funding from Gilead. M.F. serves on advisory boards and as a consultant for Pharmacyclics and has received research funding and travel and speaking honoraria from Incyte, Astellas, and Mallinckrodt. The other authors have no conflicts of interest to report. Funding Information: Financial disclosure: This study was funded by National Cancer Institute (CA118953). Publisher Copyright: © 2018 The American Society for Blood and Marrow Transplantation

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AB - In 2014, the National Institutes of Health sponsored the second Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease (GVHD). The purpose was to update recommendations about key elements of chronic GVHD research, including definitions for diagnosis, severity scoring, and response measures, based on empirical data published since the first 2005 Consensus Conference. The most significant modifications were to the response assessments, based on studies demonstrating difficulty with the first consensus definitions. The Response Measures Validation Study is a multicenter, prospective cohort study of patients who are starting initial or subsequent treatments for chronic GVHD. The aim of the study is to evaluate the performance of the 2014 response measures and determine whether any other combination of assessments is superior. Clinical data, clinician assessments, patient-reported outcomes, and research samples are collected at enrollment and 3, 6, and 18 months later, and whenever another chronic GVHD systemic treatment is added. The target enrollment of 368 evaluable patients from 12 transplantation centers has been reached. This report describes the rationale, design, and methods of the Chronic GVHD Response Measures Validation Study, and invites other investigators to collaborate with the Consortium to analyze data or specimens.

KW - Allogeneic hematopoietic cell transplantation

KW - Biorepository

KW - Chronic graft-versus-host disease

KW - Prospective longitudinal observational study

KW - Response assessment

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Design and Patient Characteristics of the Chronic Graft-versus-Host Disease Response Measures Validation Study

Abstract

Bibliographical note

Keywords

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