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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.

Publication ,  Journal Article
Pidala, J; Kitko, C; Lee, SJ; Carpenter, P; Cuvelier, GDE; Holtan, S; Flowers, ME; Cutler, C; Jagasia, M; Gooley, T; Palmer, J; Randolph, T ...
Published in: Transplant Cell Ther
August 2021

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.

Duke Scholars

Published In

Transplant Cell Ther

DOI

EISSN

2666-6367

Publication Date

August 2021

Volume

27

Issue

8

Start / End Page

632 / 641

Location

United States

Related Subject Headings

  • United States
  • National Institutes of Health (U.S.)
  • Immunology
  • Humans
  • Hematopoietic Stem Cell Transplantation
  • Graft vs Host Disease
  • Consensus
  • Chronic Disease
  • 3201 Cardiovascular medicine and haematology
  • 1103 Clinical Sciences
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Pidala, J., Kitko, C., Lee, S. J., Carpenter, P., Cuvelier, G. D. E., Holtan, 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. Transplant Cell Ther, 27(8), 632–641. https://doi.org/10.1016/j.jtct.2021.03.029
Pidala, Joseph, Carrie Kitko, Stephanie J. Lee, Paul Carpenter, Geoffrey D. E. Cuvelier, Shernan Holtan, Mary E. Flowers, 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.Transplant Cell Ther 27, no. 8 (August 2021): 632–41. https://doi.org/10.1016/j.jtct.2021.03.029.
Pidala, Joseph, 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.Transplant Cell Ther, vol. 27, no. 8, Aug. 2021, pp. 632–41. Pubmed, doi:10.1016/j.jtct.2021.03.029.
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. 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. Transplant Cell Ther. 2021 Aug;27(8):632–641.

Published In

Transplant Cell Ther

DOI

EISSN

2666-6367

Publication Date

August 2021

Volume

27

Issue

8

Start / End Page

632 / 641

Location

United States

Related Subject Headings

  • United States
  • National Institutes of Health (U.S.)
  • Immunology
  • Humans
  • Hematopoietic Stem Cell Transplantation
  • Graft vs Host Disease
  • Consensus
  • Chronic Disease
  • 3201 Cardiovascular medicine and haematology
  • 1103 Clinical Sciences