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National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IIb. The 2020 Preemptive Therapy Working Group Report

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National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IIb. The 2020 Preemptive Therapy Working Group Report. / Pidala, Joseph; Kitko, Carrie; Lee, Stephanie J; Carpenter, Paul; Cuvelier, Geoffrey D E; Holtan, Shernan; Flowers, Mary E; Cutler, Corey; Jagasia, Madan; Gooley, Ted; Palmer, Joycelynne; Randolph, Tim; Levine, John E; Ayuk, Francis; Dignan, Fiona; Schoemans, Helene; Tkaczyk, Eric; Farhadfar, Nosha; Lawitschka, Anita; Schultz, Kirk R; Martin, Paul J; Sarantopoulos, Stefanie; Inamoto, Yoshihiro; Socie, Gerard; Wolff, Daniel; Blazar, Bruce; Greinix, Hildegard; Paczesny, Sophie; Pavletic, Steven; Hill, Geoffrey.

In: TRANSPL CELL THER, Vol. 27, No. 8, 08.2021, p. 632-641.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Pidala, J, Kitko, C, Lee, SJ, Carpenter, P, Cuvelier, GDE, Holtan, S, Flowers, ME, Cutler, C, Jagasia, M, Gooley, T, Palmer, J, Randolph, T, Levine, JE, Ayuk, F, Dignan, F, Schoemans, H, Tkaczyk, E, Farhadfar, N, Lawitschka, A, Schultz, KR, Martin, PJ, Sarantopoulos, S, Inamoto, Y, Socie, G, Wolff, D, Blazar, B, Greinix, H, Paczesny, S, Pavletic, S & Hill, G 2021, 'National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IIb. The 2020 Preemptive Therapy Working Group Report', TRANSPL CELL THER, vol. 27, no. 8, pp. 632-641. https://doi.org/10.1016/j.jtct.2021.03.029

APA

Pidala, J., Kitko, C., Lee, S. J., Carpenter, P., Cuvelier, G. D. E., Holtan, S., Flowers, M. E., Cutler, C., Jagasia, M., Gooley, T., Palmer, J., Randolph, T., Levine, J. E., Ayuk, F., Dignan, F., Schoemans, H., Tkaczyk, E., Farhadfar, N., Lawitschka, A., ... Hill, G. (2021). National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IIb. The 2020 Preemptive Therapy Working Group Report. TRANSPL CELL THER, 27(8), 632-641. https://doi.org/10.1016/j.jtct.2021.03.029

Vancouver

Pidala J, Kitko C, Lee SJ, Carpenter P, Cuvelier GDE, Holtan S et al. National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IIb. The 2020 Preemptive Therapy Working Group Report. TRANSPL CELL THER. 2021 Aug;27(8):632-641. https://doi.org/10.1016/j.jtct.2021.03.029

Bibtex

@article{b223ccb2a85b4c1486ec923de8fd1d7e,
title = "National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IIb. The 2020 Preemptive Therapy Working Group Report",
abstract = "Chronic graft-versus-host disease (GVHD) commonly occurs after allogeneic hematopoietic cell transplantation (HCT) despite standard prophylactic immune suppression. Intensified universal prophylaxis approaches are effective but risk possible overtreatment and may interfere with the graft-versus-malignancy immune response. Here we summarize conceptual and practical considerations regarding preemptive therapy of chronic GVHD, namely interventions applied after HCT based on evidence that the risk of developing chronic GVHD is higher than previously appreciated. This risk may be anticipated by clinical factors or risk assignment biomarkers or may be indicated by early signs and symptoms of chronic GVHD that do not fully meet National Institutes of Health diagnostic criteria. However, truly preemptive, individualized, and targeted chronic GVHD therapies currently do not exist. In this report, we (1) review current knowledge regarding clinical risk factors for chronic GVHD, (2) review what is known about chronic GVHD risk assignment biomarkers, (3) examine how chronic GVHD pathogenesis intersects with available targeted therapeutic agents, and (4) summarize considerations for preemptive therapy for chronic GVHD, emphasizing trial development, including trial design and statistical considerations. We conclude that robust risk assignment models that accurately predict chronic GVHD after HCT and early-phase preemptive therapy trials represent the most urgent priorities for advancing this novel area of research.",
author = "Joseph Pidala and Carrie Kitko and Lee, {Stephanie J} and Paul Carpenter and Cuvelier, {Geoffrey D E} and Shernan Holtan and Flowers, {Mary E} and Corey Cutler and Madan Jagasia and Ted Gooley and Joycelynne Palmer and Tim Randolph and Levine, {John E} and Francis Ayuk and Fiona Dignan and Helene Schoemans and Eric Tkaczyk and Nosha Farhadfar and Anita Lawitschka and Schultz, {Kirk R} and Martin, {Paul J} and Stefanie Sarantopoulos and Yoshihiro Inamoto and Gerard Socie and Daniel Wolff and Bruce Blazar and Hildegard Greinix and Sophie Paczesny and Steven Pavletic and Geoffrey Hill",
note = "Copyright {\textcopyright} 2021. Published by Elsevier Inc.",
year = "2021",
month = aug,
doi = "10.1016/j.jtct.2021.03.029",
language = "English",
volume = "27",
pages = "632--641",
journal = "TRANSPL CELL THER",
issn = "2666-6375",
publisher = "Elsevier BV",
number = "8",

}

RIS

TY - JOUR

T1 - National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IIb. The 2020 Preemptive Therapy Working Group Report

AU - Pidala, Joseph

AU - Kitko, Carrie

AU - Lee, Stephanie J

AU - Carpenter, Paul

AU - Cuvelier, Geoffrey D E

AU - Holtan, Shernan

AU - Flowers, Mary E

AU - Cutler, Corey

AU - Jagasia, Madan

AU - Gooley, Ted

AU - Palmer, Joycelynne

AU - Randolph, Tim

AU - Levine, John E

AU - Ayuk, Francis

AU - Dignan, Fiona

AU - Schoemans, Helene

AU - Tkaczyk, Eric

AU - Farhadfar, Nosha

AU - Lawitschka, Anita

AU - Schultz, Kirk R

AU - Martin, Paul J

AU - Sarantopoulos, Stefanie

AU - Inamoto, Yoshihiro

AU - Socie, Gerard

AU - Wolff, Daniel

AU - Blazar, Bruce

AU - Greinix, Hildegard

AU - Paczesny, Sophie

AU - Pavletic, Steven

AU - Hill, Geoffrey

N1 - Copyright © 2021. Published by Elsevier Inc.

PY - 2021/8

Y1 - 2021/8

N2 - Chronic graft-versus-host disease (GVHD) commonly occurs after allogeneic hematopoietic cell transplantation (HCT) despite standard prophylactic immune suppression. Intensified universal prophylaxis approaches are effective but risk possible overtreatment and may interfere with the graft-versus-malignancy immune response. Here we summarize conceptual and practical considerations regarding preemptive therapy of chronic GVHD, namely interventions applied after HCT based on evidence that the risk of developing chronic GVHD is higher than previously appreciated. This risk may be anticipated by clinical factors or risk assignment biomarkers or may be indicated by early signs and symptoms of chronic GVHD that do not fully meet National Institutes of Health diagnostic criteria. However, truly preemptive, individualized, and targeted chronic GVHD therapies currently do not exist. In this report, we (1) review current knowledge regarding clinical risk factors for chronic GVHD, (2) review what is known about chronic GVHD risk assignment biomarkers, (3) examine how chronic GVHD pathogenesis intersects with available targeted therapeutic agents, and (4) summarize considerations for preemptive therapy for chronic GVHD, emphasizing trial development, including trial design and statistical considerations. We conclude that robust risk assignment models that accurately predict chronic GVHD after HCT and early-phase preemptive therapy trials represent the most urgent priorities for advancing this novel area of research.

AB - Chronic graft-versus-host disease (GVHD) commonly occurs after allogeneic hematopoietic cell transplantation (HCT) despite standard prophylactic immune suppression. Intensified universal prophylaxis approaches are effective but risk possible overtreatment and may interfere with the graft-versus-malignancy immune response. Here we summarize conceptual and practical considerations regarding preemptive therapy of chronic GVHD, namely interventions applied after HCT based on evidence that the risk of developing chronic GVHD is higher than previously appreciated. This risk may be anticipated by clinical factors or risk assignment biomarkers or may be indicated by early signs and symptoms of chronic GVHD that do not fully meet National Institutes of Health diagnostic criteria. However, truly preemptive, individualized, and targeted chronic GVHD therapies currently do not exist. In this report, we (1) review current knowledge regarding clinical risk factors for chronic GVHD, (2) review what is known about chronic GVHD risk assignment biomarkers, (3) examine how chronic GVHD pathogenesis intersects with available targeted therapeutic agents, and (4) summarize considerations for preemptive therapy for chronic GVHD, emphasizing trial development, including trial design and statistical considerations. We conclude that robust risk assignment models that accurately predict chronic GVHD after HCT and early-phase preemptive therapy trials represent the most urgent priorities for advancing this novel area of research.

U2 - 10.1016/j.jtct.2021.03.029

DO - 10.1016/j.jtct.2021.03.029

M3 - SCORING: Journal article

C2 - 33836313

VL - 27

SP - 632

EP - 641

JO - TRANSPL CELL THER

JF - TRANSPL CELL THER

SN - 2666-6375

IS - 8

ER -