National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IIa. The 2020 Clinical Implementation and Early Diagnosis Working Group Report

Carrie L. Kitko; Joseph Pidala; Hélène M. Schoemans; Anita Lawitschka; Mary E. Flowers; Edward W. Cowen; Eric Tkaczyk; Nosha Farhadfar; Sandeep Jain; Philipp Steven; Zhonghui K. Luo; Yoko Ogawa; Michael Stern; Greg A. Yanik; Geoffrey D.E. Cuvelier; Guang Shing Cheng; Shernan G. Holtan; Kirk R. Schultz; Paul J. Martin; Stephanie J. Lee; Steven Z. Pavletic; Daniel Wolff; Sophie Paczesny; Bruce R. Blazar; Stephanie Sarantopoulos; Gerard Socie; Hildegard Greinix; Corey Cutler

doi:10.1016/j.jtct.2021.03.033

National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IIa. The 2020 Clinical Implementation and Early Diagnosis Working Group Report

Carrie L. Kitko, Joseph Pidala, Hélène M. Schoemans, Anita Lawitschka, Mary E. Flowers, Edward W. Cowen, Eric Tkaczyk, Nosha Farhadfar, Sandeep Jain, Philipp Steven, Zhonghui K. Luo, Yoko Ogawa, Michael Stern, Greg A. Yanik, Geoffrey D.E. Cuvelier, Guang Shing Cheng, Shernan G. Holtan, Kirk R. Schultz, Paul J. Martin, Stephanie J. LeeSteven Z. Pavletic, Daniel Wolff, Sophie Paczesny, Bruce R. Blazar, Stephanie Sarantopoulos, Gerard Socie, Hildegard Greinix, Corey Cutler

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

32 Scopus citations

Abstract

Recognition of the earliest signs and symptoms of chronic graft-versus-host disease (GVHD) that lead to severe manifestations remains a challenge. The standardization provided by the National Institutes of Health (NIH) 2005 and 2014 consensus projects has helped improve diagnostic accuracy and severity scoring for clinical trials, but utilization of these tools in routine clinical practice is variable. Additionally, when patients meet the NIH diagnostic criteria, many already have significant morbidity and possibly irreversible organ damage. The goals of this early diagnosis project are 2-fold. First, we provide consensus recommendations regarding implementation of the current NIH diagnostic guidelines into routine transplant care, outside of clinical trials, aiming to enhance early clinical recognition of chronic GVHD. Second, we propose directions for future research efforts to enable discovery of new, early laboratory as well as clinical indicators of chronic GVHD, both globally and for highly morbid organ-specific manifestations. Identification of early features of chronic GVHD that have high positive predictive value for progression to more severe manifestations of the disease could potentially allow for future pre-emptive clinical trials.

Original language	English (US)
Pages (from-to)	545-557
Number of pages	13
Journal	Transplantation and Cellular Therapy
Volume	27
Issue number	7
DOIs	https://doi.org/10.1016/j.jtct.2021.03.033
State	Published - Jul 1 2021

Bibliographical note

Funding Information:
Financial disclosure: Funding and implementation of this Consensus Project are made possible through the support by the Intramural Program of the National Cancer Institute–Center for Cancer Research and the National Institute of Dental and Craniofacial Research, the NIH Intramural and Extramural Research Programs Institutes and Centers. E.T. work was supported in part by Career Development Award IK2 CX001785 from the U.S. Department of Veterans Affairs.

Funding Information:
Special acknowledgment goes to the Meredith Cowden GVHD Foundation, France Lymphome Espoir, NBMTLink; Anthony Nolan, National Marrow Donor Program, BMT InfoNet; and other patient advocacy groups for partnering and collaboration. Thanks go to all working groups and consensus conference participants, professional societies, US government agencies, and stakeholders in the field of hematopoietic stem cell transplantation for the generous donation of their work, time, talents, and expertise. Particular acknowledgment to the American Society of Transplantation and Cellular Therapy and European Society for Blood and Marrow Transplantation for their roles in the dissemination, education, and implementation of the concepts and best practices evolving from this project. Special thanks to the independent external peer reviewers who provided they comments and critiques to the 2020 NIH Chronic GVHD Consensus Project: Nicolaus Kr?ger, MD, Professor & Clinical Director of the Department of Stem Cell Transplantation, University of Hamburg, Hamburg, Germany, President EBMT; Ryotaro Nakamura, MD, Professor & Director of the Center for Stem Cell Transplantation City of Hope Cancer Center, Duarte, California; John DiPersio, MD, PhD, Chief, Division of Oncology; Director, Center for Gene and Cellular Immunotherapy; Deputy Director, Siteman Cancer Center, Washington University School of Medicine, St. Louis, Missouri; Mark Juckett, MD, Professor & Director of the Blood and Marrow Transplant Program, University of Wisconsin, Madison, Wisconsin; George Chen, MD, Associate Professor of Medicine, University at Buffalo, Buffalo, New York; Rafael Duarte, MD, PhD, FRCP, Head of Department of Hematology and Director of the Hematopoietic Transplant Program, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain; Franco Locatelli, MD, Professor of Pediatrics Universit? Sapienza, Roma, Head of the Department of Pediatric Hematology and Cell and Gene Therapy, IRCCS Ospedale Pediatrico Bambino Ges?, Roma, Italy; Areej El-Jawahri, MD, Associate Professor, Director of the Bone Marrow Transplant Survivorship Program, and Associate Director of the Cancer Outcomes Research and Education Program at Massachusetts General Hospital, Boston, Massachusetts; Robert Soiffer, MD, Professor, Chief of the Division of Hematologic Malignancies, Chair of the Executive Committee for Clinical Programs, Vice Chair for the Department of Medical Oncology, Chief of the Division of Hematologic Malignancies, Dana Farber Cancer Institute, Boston, Massachusetts; Daniel Weisdorf, MD, Professor of Medicine & Deputy Director of Clinical Science and Translational Science Institute; Director, Clinical and Translational Research Services, University of Minnesota, Minneapolis, Minnesota; Keith Sullivan, MD, Professor of Medicine, Hematologic Malignancies and Cellular Therapy, Duke University Medical Center, Durham, North Carolina; Catherine Lee, MD, Assistant Professor, Hematology and Hematologic Malignancies, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah; Jose Antonio Perez-Simon, MD, Professor of Hematology, University of Seville, Head of Department of Hematology, University Hospital Virgen del Rocio and Vice Director of the Biomedical Research Institute of Seville (IBIS), Seville, Spain; Doris Ponce, MD, Associate Professor of Medicine, Hematologic Oncologist, Memorial Sloan-Kettering Cancer Center, New York City, New York; Andrew Harris, MD, Pediatric Hematologist-Oncologist & Assistant Professor of Pediatrics, Pediatric BMT and Cellular Therapy Program, University of Utah/Primary Children's Hospital, Salt Lake City, Utah. Disclaimer: The opinions expressed are those of the authors and do not represent the position of the National Cancer Institute, the National Institutes of Health, or the US government. Financial disclosure: Funding and implementation of this Consensus Project are made possible through the support by the Intramural Program of the National Cancer Institute?Center for Cancer Research and the National Institute of Dental and Craniofacial Research, the NIH Intramural and Extramural Research Programs Institutes and Centers. E.T. work was supported in part by Career Development Award IK2 CX001785 from the U.S. Department of Veterans Affairs. Conflict of interest statement: J.P. has consulting and advisory board membership (Syndax, CTI Biopharma, Amgen, Regeneron) and clinical trial support (Novartis, Amgen, Takeda, Janssen, Johnson and Johnson, Pharmacyclics, Abbvie, CTI Biopharma, BMS). E.T. has received consulting fees from Incyte for cGVHD biomarker development. Y.O. has a patent in Japan (patent No. 4966019; Topical Application and Oral Intake of Tranilast for the Treatment of Chronic GVHD-Related Dye Eye Disease) and patent pending on ocular GVHD in JPO (application number JP 2017-018643, published as JPA2017-178922; application number JP2018-510646, published as WO2017/175808; and application number JP 2019-004730, published as JPA2020-111548). S.J.L. has research funding from Amgen, AstraZeneca, Incyte, Kadmon, Novartis, Pfizer, Syndax, and Takeda and is on a steering committee for Incyte. P.J.M. has served on advisory boards for Mesoblast and Rigel Pharmaceuticals Inc. and has received honoraria from Janssen. C.C. has consulting/honoraria from Incyte, Jazz, CareDx, Mesoblast, Syndax, Omeros, and Pfizer. S.P. has a patent application (US 20130115232A1 and WO 2013066369A3) on ?Methods of Detection of Graft-versus-Host Disease? licensed to Viracor-IBT laboratories. H.M.S has participated in advisory boards for Incyte, Janssen & Novartis; received speaker's fees from Novartis, Incyte, Jazz Pharmaceuticals, Takeda and the the BHS (Belgian Hematological Society); received travel grants from EBMT, CIBMTR, Celgene, Abbvie, Incyte & Gilead and research funding from Novartis and the BHS (Belgian Hematological Society). Financial disclosure: See Acknowledgments on page 553.

Publisher Copyright:
© 2021 The American Society for Transplantation and Cellular Therapy

Keywords

Allogeneic hematopoietic cell transplantation
Chronic graft-versus-host disease
Consensus
Early diagnosis

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Kitko, C. L., Pidala, J., Schoemans, H. M., Lawitschka, A., Flowers, M. E., Cowen, E. W., Tkaczyk, E., Farhadfar, N., Jain, S., Steven, P., Luo, Z. K., Ogawa, Y., Stern, M., Yanik, G. A., Cuvelier, G. D. E., Cheng, G. S., Holtan, S. G., Schultz, K. R., Martin, P. J., ... Cutler, C. (2021). National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IIa. The 2020 Clinical Implementation and Early Diagnosis Working Group Report. Transplantation and Cellular Therapy, 27(7), 545-557. https://doi.org/10.1016/j.jtct.2021.03.033

National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease : IIa. The 2020 Clinical Implementation and Early Diagnosis Working Group Report. / Kitko, Carrie L.; Pidala, Joseph; Schoemans, Hélène M. et al.

In: Transplantation and Cellular Therapy, Vol. 27, No. 7, 01.07.2021, p. 545-557.

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

Kitko, CL, Pidala, J, Schoemans, HM, Lawitschka, A, Flowers, ME, Cowen, EW, Tkaczyk, E, Farhadfar, N, Jain, S, Steven, P, Luo, ZK, Ogawa, Y, Stern, M, Yanik, GA, Cuvelier, GDE, Cheng, GS, Holtan, SG, Schultz, KR, Martin, PJ, Lee, SJ, Pavletic, SZ, Wolff, D, Paczesny, S, Blazar, BR, Sarantopoulos, S, Socie, G, Greinix, H & Cutler, C 2021, 'National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IIa. The 2020 Clinical Implementation and Early Diagnosis Working Group Report', Transplantation and Cellular Therapy, vol. 27, no. 7, pp. 545-557. https://doi.org/10.1016/j.jtct.2021.03.033

Kitko CL, Pidala J, Schoemans HM, Lawitschka A, Flowers ME, Cowen EW et al. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IIa. The 2020 Clinical Implementation and Early Diagnosis Working Group Report. Transplantation and Cellular Therapy. 2021 Jul 1;27(7):545-557. doi: 10.1016/j.jtct.2021.03.033

@article{9f4c5964261f4249aa7bbc3f352ba6e6,

title = "National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IIa. The 2020 Clinical Implementation and Early Diagnosis Working Group Report",

abstract = "Recognition of the earliest signs and symptoms of chronic graft-versus-host disease (GVHD) that lead to severe manifestations remains a challenge. The standardization provided by the National Institutes of Health (NIH) 2005 and 2014 consensus projects has helped improve diagnostic accuracy and severity scoring for clinical trials, but utilization of these tools in routine clinical practice is variable. Additionally, when patients meet the NIH diagnostic criteria, many already have significant morbidity and possibly irreversible organ damage. The goals of this early diagnosis project are 2-fold. First, we provide consensus recommendations regarding implementation of the current NIH diagnostic guidelines into routine transplant care, outside of clinical trials, aiming to enhance early clinical recognition of chronic GVHD. Second, we propose directions for future research efforts to enable discovery of new, early laboratory as well as clinical indicators of chronic GVHD, both globally and for highly morbid organ-specific manifestations. Identification of early features of chronic GVHD that have high positive predictive value for progression to more severe manifestations of the disease could potentially allow for future pre-emptive clinical trials.",

keywords = "Allogeneic hematopoietic cell transplantation, Chronic graft-versus-host disease, Consensus, Early diagnosis",

author = "Kitko, {Carrie L.} and Joseph Pidala and Schoemans, {H{\'e}l{\`e}ne M.} and Anita Lawitschka and Flowers, {Mary E.} and Cowen, {Edward W.} and Eric Tkaczyk and Nosha Farhadfar and Sandeep Jain and Philipp Steven and Luo, {Zhonghui K.} and Yoko Ogawa and Michael Stern and Yanik, {Greg A.} and Cuvelier, {Geoffrey D.E.} and Cheng, {Guang Shing} and Holtan, {Shernan G.} and Schultz, {Kirk R.} and Martin, {Paul J.} and Lee, {Stephanie J.} and Pavletic, {Steven Z.} and Daniel Wolff and Sophie Paczesny and Blazar, {Bruce R.} and Stephanie Sarantopoulos and Gerard Socie and Hildegard Greinix and Corey Cutler",

note = "Funding Information: Financial disclosure: Funding and implementation of this Consensus Project are made possible through the support by the Intramural Program of the National Cancer Institute–Center for Cancer Research and the National Institute of Dental and Craniofacial Research, the NIH Intramural and Extramural Research Programs Institutes and Centers. E.T. work was supported in part by Career Development Award IK2 CX001785 from the U.S. Department of Veterans Affairs. Funding Information: Special acknowledgment goes to the Meredith Cowden GVHD Foundation, France Lymphome Espoir, NBMTLink; Anthony Nolan, National Marrow Donor Program, BMT InfoNet; and other patient advocacy groups for partnering and collaboration. Thanks go to all working groups and consensus conference participants, professional societies, US government agencies, and stakeholders in the field of hematopoietic stem cell transplantation for the generous donation of their work, time, talents, and expertise. Particular acknowledgment to the American Society of Transplantation and Cellular Therapy and European Society for Blood and Marrow Transplantation for their roles in the dissemination, education, and implementation of the concepts and best practices evolving from this project. Special thanks to the independent external peer reviewers who provided they comments and critiques to the 2020 NIH Chronic GVHD Consensus Project: Nicolaus Kr?ger, MD, Professor & Clinical Director of the Department of Stem Cell Transplantation, University of Hamburg, Hamburg, Germany, President EBMT; Ryotaro Nakamura, MD, Professor & Director of the Center for Stem Cell Transplantation City of Hope Cancer Center, Duarte, California; John DiPersio, MD, PhD, Chief, Division of Oncology; Director, Center for Gene and Cellular Immunotherapy; Deputy Director, Siteman Cancer Center, Washington University School of Medicine, St. Louis, Missouri; Mark Juckett, MD, Professor & Director of the Blood and Marrow Transplant Program, University of Wisconsin, Madison, Wisconsin; George Chen, MD, Associate Professor of Medicine, University at Buffalo, Buffalo, New York; Rafael Duarte, MD, PhD, FRCP, Head of Department of Hematology and Director of the Hematopoietic Transplant Program, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain; Franco Locatelli, MD, Professor of Pediatrics Universit? Sapienza, Roma, Head of the Department of Pediatric Hematology and Cell and Gene Therapy, IRCCS Ospedale Pediatrico Bambino Ges?, Roma, Italy; Areej El-Jawahri, MD, Associate Professor, Director of the Bone Marrow Transplant Survivorship Program, and Associate Director of the Cancer Outcomes Research and Education Program at Massachusetts General Hospital, Boston, Massachusetts; Robert Soiffer, MD, Professor, Chief of the Division of Hematologic Malignancies, Chair of the Executive Committee for Clinical Programs, Vice Chair for the Department of Medical Oncology, Chief of the Division of Hematologic Malignancies, Dana Farber Cancer Institute, Boston, Massachusetts; Daniel Weisdorf, MD, Professor of Medicine & Deputy Director of Clinical Science and Translational Science Institute; Director, Clinical and Translational Research Services, University of Minnesota, Minneapolis, Minnesota; Keith Sullivan, MD, Professor of Medicine, Hematologic Malignancies and Cellular Therapy, Duke University Medical Center, Durham, North Carolina; Catherine Lee, MD, Assistant Professor, Hematology and Hematologic Malignancies, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah; Jose Antonio Perez-Simon, MD, Professor of Hematology, University of Seville, Head of Department of Hematology, University Hospital Virgen del Rocio and Vice Director of the Biomedical Research Institute of Seville (IBIS), Seville, Spain; Doris Ponce, MD, Associate Professor of Medicine, Hematologic Oncologist, Memorial Sloan-Kettering Cancer Center, New York City, New York; Andrew Harris, MD, Pediatric Hematologist-Oncologist & Assistant Professor of Pediatrics, Pediatric BMT and Cellular Therapy Program, University of Utah/Primary Children's Hospital, Salt Lake City, Utah. Disclaimer: The opinions expressed are those of the authors and do not represent the position of the National Cancer Institute, the National Institutes of Health, or the US government. Financial disclosure: Funding and implementation of this Consensus Project are made possible through the support by the Intramural Program of the National Cancer Institute?Center for Cancer Research and the National Institute of Dental and Craniofacial Research, the NIH Intramural and Extramural Research Programs Institutes and Centers. E.T. work was supported in part by Career Development Award IK2 CX001785 from the U.S. Department of Veterans Affairs. Conflict of interest statement: J.P. has consulting and advisory board membership (Syndax, CTI Biopharma, Amgen, Regeneron) and clinical trial support (Novartis, Amgen, Takeda, Janssen, Johnson and Johnson, Pharmacyclics, Abbvie, CTI Biopharma, BMS). E.T. has received consulting fees from Incyte for cGVHD biomarker development. Y.O. has a patent in Japan (patent No. 4966019; Topical Application and Oral Intake of Tranilast for the Treatment of Chronic GVHD-Related Dye Eye Disease) and patent pending on ocular GVHD in JPO (application number JP 2017-018643, published as JPA2017-178922; application number JP2018-510646, published as WO2017/175808; and application number JP 2019-004730, published as JPA2020-111548). S.J.L. has research funding from Amgen, AstraZeneca, Incyte, Kadmon, Novartis, Pfizer, Syndax, and Takeda and is on a steering committee for Incyte. P.J.M. has served on advisory boards for Mesoblast and Rigel Pharmaceuticals Inc. and has received honoraria from Janssen. C.C. has consulting/honoraria from Incyte, Jazz, CareDx, Mesoblast, Syndax, Omeros, and Pfizer. S.P. has a patent application (US 20130115232A1 and WO 2013066369A3) on ?Methods of Detection of Graft-versus-Host Disease? licensed to Viracor-IBT laboratories. H.M.S has participated in advisory boards for Incyte, Janssen & Novartis; received speaker's fees from Novartis, Incyte, Jazz Pharmaceuticals, Takeda and the the BHS (Belgian Hematological Society); received travel grants from EBMT, CIBMTR, Celgene, Abbvie, Incyte & Gilead and research funding from Novartis and the BHS (Belgian Hematological Society). Financial disclosure: See Acknowledgments on page 553. Publisher Copyright: {\textcopyright} 2021 The American Society for Transplantation and Cellular Therapy",

year = "2021",

month = jul,

day = "1",

doi = "10.1016/j.jtct.2021.03.033",

language = "English (US)",

volume = "27",

pages = "545--557",

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TY - JOUR

T1 - National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease

T2 - IIa. The 2020 Clinical Implementation and Early Diagnosis Working Group Report

AU - Kitko, Carrie L.

AU - Pidala, Joseph

AU - Schoemans, Hélène M.

AU - Lawitschka, Anita

AU - Flowers, Mary E.

AU - Cowen, Edward W.

AU - Tkaczyk, Eric

AU - Farhadfar, Nosha

AU - Jain, Sandeep

AU - Steven, Philipp

AU - Luo, Zhonghui K.

AU - Ogawa, Yoko

AU - Stern, Michael

AU - Yanik, Greg A.

AU - Cuvelier, Geoffrey D.E.

AU - Cheng, Guang Shing

AU - Holtan, Shernan G.

AU - Schultz, Kirk R.

AU - Martin, Paul J.

AU - Lee, Stephanie J.

AU - Pavletic, Steven Z.

AU - Wolff, Daniel

AU - Paczesny, Sophie

AU - Blazar, Bruce R.

AU - Sarantopoulos, Stephanie

AU - Socie, Gerard

AU - Greinix, Hildegard

AU - Cutler, Corey

N1 - Funding Information: Financial disclosure: Funding and implementation of this Consensus Project are made possible through the support by the Intramural Program of the National Cancer Institute–Center for Cancer Research and the National Institute of Dental and Craniofacial Research, the NIH Intramural and Extramural Research Programs Institutes and Centers. E.T. work was supported in part by Career Development Award IK2 CX001785 from the U.S. Department of Veterans Affairs. Funding Information: Special acknowledgment goes to the Meredith Cowden GVHD Foundation, France Lymphome Espoir, NBMTLink; Anthony Nolan, National Marrow Donor Program, BMT InfoNet; and other patient advocacy groups for partnering and collaboration. Thanks go to all working groups and consensus conference participants, professional societies, US government agencies, and stakeholders in the field of hematopoietic stem cell transplantation for the generous donation of their work, time, talents, and expertise. Particular acknowledgment to the American Society of Transplantation and Cellular Therapy and European Society for Blood and Marrow Transplantation for their roles in the dissemination, education, and implementation of the concepts and best practices evolving from this project. Special thanks to the independent external peer reviewers who provided they comments and critiques to the 2020 NIH Chronic GVHD Consensus Project: Nicolaus Kr?ger, MD, Professor & Clinical Director of the Department of Stem Cell Transplantation, University of Hamburg, Hamburg, Germany, President EBMT; Ryotaro Nakamura, MD, Professor & Director of the Center for Stem Cell Transplantation City of Hope Cancer Center, Duarte, California; John DiPersio, MD, PhD, Chief, Division of Oncology; Director, Center for Gene and Cellular Immunotherapy; Deputy Director, Siteman Cancer Center, Washington University School of Medicine, St. Louis, Missouri; Mark Juckett, MD, Professor & Director of the Blood and Marrow Transplant Program, University of Wisconsin, Madison, Wisconsin; George Chen, MD, Associate Professor of Medicine, University at Buffalo, Buffalo, New York; Rafael Duarte, MD, PhD, FRCP, Head of Department of Hematology and Director of the Hematopoietic Transplant Program, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, Spain; Franco Locatelli, MD, Professor of Pediatrics Universit? Sapienza, Roma, Head of the Department of Pediatric Hematology and Cell and Gene Therapy, IRCCS Ospedale Pediatrico Bambino Ges?, Roma, Italy; Areej El-Jawahri, MD, Associate Professor, Director of the Bone Marrow Transplant Survivorship Program, and Associate Director of the Cancer Outcomes Research and Education Program at Massachusetts General Hospital, Boston, Massachusetts; Robert Soiffer, MD, Professor, Chief of the Division of Hematologic Malignancies, Chair of the Executive Committee for Clinical Programs, Vice Chair for the Department of Medical Oncology, Chief of the Division of Hematologic Malignancies, Dana Farber Cancer Institute, Boston, Massachusetts; Daniel Weisdorf, MD, Professor of Medicine & Deputy Director of Clinical Science and Translational Science Institute; Director, Clinical and Translational Research Services, University of Minnesota, Minneapolis, Minnesota; Keith Sullivan, MD, Professor of Medicine, Hematologic Malignancies and Cellular Therapy, Duke University Medical Center, Durham, North Carolina; Catherine Lee, MD, Assistant Professor, Hematology and Hematologic Malignancies, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah; Jose Antonio Perez-Simon, MD, Professor of Hematology, University of Seville, Head of Department of Hematology, University Hospital Virgen del Rocio and Vice Director of the Biomedical Research Institute of Seville (IBIS), Seville, Spain; Doris Ponce, MD, Associate Professor of Medicine, Hematologic Oncologist, Memorial Sloan-Kettering Cancer Center, New York City, New York; Andrew Harris, MD, Pediatric Hematologist-Oncologist & Assistant Professor of Pediatrics, Pediatric BMT and Cellular Therapy Program, University of Utah/Primary Children's Hospital, Salt Lake City, Utah. Disclaimer: The opinions expressed are those of the authors and do not represent the position of the National Cancer Institute, the National Institutes of Health, or the US government. Financial disclosure: Funding and implementation of this Consensus Project are made possible through the support by the Intramural Program of the National Cancer Institute?Center for Cancer Research and the National Institute of Dental and Craniofacial Research, the NIH Intramural and Extramural Research Programs Institutes and Centers. E.T. work was supported in part by Career Development Award IK2 CX001785 from the U.S. Department of Veterans Affairs. Conflict of interest statement: J.P. has consulting and advisory board membership (Syndax, CTI Biopharma, Amgen, Regeneron) and clinical trial support (Novartis, Amgen, Takeda, Janssen, Johnson and Johnson, Pharmacyclics, Abbvie, CTI Biopharma, BMS). E.T. has received consulting fees from Incyte for cGVHD biomarker development. Y.O. has a patent in Japan (patent No. 4966019; Topical Application and Oral Intake of Tranilast for the Treatment of Chronic GVHD-Related Dye Eye Disease) and patent pending on ocular GVHD in JPO (application number JP 2017-018643, published as JPA2017-178922; application number JP2018-510646, published as WO2017/175808; and application number JP 2019-004730, published as JPA2020-111548). S.J.L. has research funding from Amgen, AstraZeneca, Incyte, Kadmon, Novartis, Pfizer, Syndax, and Takeda and is on a steering committee for Incyte. P.J.M. has served on advisory boards for Mesoblast and Rigel Pharmaceuticals Inc. and has received honoraria from Janssen. C.C. has consulting/honoraria from Incyte, Jazz, CareDx, Mesoblast, Syndax, Omeros, and Pfizer. S.P. has a patent application (US 20130115232A1 and WO 2013066369A3) on ?Methods of Detection of Graft-versus-Host Disease? licensed to Viracor-IBT laboratories. H.M.S has participated in advisory boards for Incyte, Janssen & Novartis; received speaker's fees from Novartis, Incyte, Jazz Pharmaceuticals, Takeda and the the BHS (Belgian Hematological Society); received travel grants from EBMT, CIBMTR, Celgene, Abbvie, Incyte & Gilead and research funding from Novartis and the BHS (Belgian Hematological Society). Financial disclosure: See Acknowledgments on page 553. Publisher Copyright: © 2021 The American Society for Transplantation and Cellular Therapy

PY - 2021/7/1

Y1 - 2021/7/1

N2 - Recognition of the earliest signs and symptoms of chronic graft-versus-host disease (GVHD) that lead to severe manifestations remains a challenge. The standardization provided by the National Institutes of Health (NIH) 2005 and 2014 consensus projects has helped improve diagnostic accuracy and severity scoring for clinical trials, but utilization of these tools in routine clinical practice is variable. Additionally, when patients meet the NIH diagnostic criteria, many already have significant morbidity and possibly irreversible organ damage. The goals of this early diagnosis project are 2-fold. First, we provide consensus recommendations regarding implementation of the current NIH diagnostic guidelines into routine transplant care, outside of clinical trials, aiming to enhance early clinical recognition of chronic GVHD. Second, we propose directions for future research efforts to enable discovery of new, early laboratory as well as clinical indicators of chronic GVHD, both globally and for highly morbid organ-specific manifestations. Identification of early features of chronic GVHD that have high positive predictive value for progression to more severe manifestations of the disease could potentially allow for future pre-emptive clinical trials.

AB - Recognition of the earliest signs and symptoms of chronic graft-versus-host disease (GVHD) that lead to severe manifestations remains a challenge. The standardization provided by the National Institutes of Health (NIH) 2005 and 2014 consensus projects has helped improve diagnostic accuracy and severity scoring for clinical trials, but utilization of these tools in routine clinical practice is variable. Additionally, when patients meet the NIH diagnostic criteria, many already have significant morbidity and possibly irreversible organ damage. The goals of this early diagnosis project are 2-fold. First, we provide consensus recommendations regarding implementation of the current NIH diagnostic guidelines into routine transplant care, outside of clinical trials, aiming to enhance early clinical recognition of chronic GVHD. Second, we propose directions for future research efforts to enable discovery of new, early laboratory as well as clinical indicators of chronic GVHD, both globally and for highly morbid organ-specific manifestations. Identification of early features of chronic GVHD that have high positive predictive value for progression to more severe manifestations of the disease could potentially allow for future pre-emptive clinical trials.

KW - Allogeneic hematopoietic cell transplantation

KW - Chronic graft-versus-host disease

KW - Consensus

KW - Early diagnosis

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UR - http://www.scopus.com/inward/citedby.url?scp=85107334809&partnerID=8YFLogxK

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DO - 10.1016/j.jtct.2021.03.033

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JO - Transplantation and Cellular Therapy

JF - Transplantation and Cellular Therapy

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ER -

National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IIa. The 2020 Clinical Implementation and Early Diagnosis Working Group Report

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