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

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Details

Item type:	Article
Journal or Publication Title:	Transplantation and Cellular Therapy
Publisher:	Elsevier
Place of Publication:	NEW YORK
Volume:	27
Number of Issue or Book Chapter:	8
Page Range:	pp. 632-641
Date:	2021
Institutions:	Medicine > Lehrstuhl für Innere Medizin III (Hämatologie und Internistische Onkologie)
Identification Number:	Value Type 10.1016/j.jtct.2021.03.029 DOI
Keywords:	MURINE CHRONIC GVHD; B-CELLS; RISK-FACTORS; T-CELLS; PLASMA BIOMARKERS; BRONCHIOLITIS OBLITERANS; MARROW-TRANSPLANTATION; BCR RESPONSIVENESS; PREDICTIVE-VALUE; CHILDREN; Chronic graft-versus-host disease; Allogeneic hematopoietic cell transplantation; Consensus; Risk assignment biomarkers; Preemptive therapy
Dewey Decimal Classification:	600 Technology > 610 Medical sciences Medicine
Status:	Published
Refereed:	Yes, this version has been refereed
Created at the University of Regensburg:	Yes
Item ID:	56760

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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 ...

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. (C) 2021 Published by Elsevier Inc. on behalf of The American Society for Transplantation and Cellular Therapy.

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Metadata last modified: 29 Feb 2024 12:37

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