National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: IV. The 2020 Highly morbid forms report.
Allogeneic hematopoietic cell transplantation
Chronic graft-versus-host disease
Consensus
Gastrointestinal tract
Lung
Ocular
Sclerosis
Skin
Journal
Transplantation and cellular therapy
ISSN: 2666-6367
Titre abrégé: Transplant Cell Ther
Pays: United States
ID NLM: 101774629
Informations de publication
Date de publication:
10 2021
10 2021
Historique:
received:
01
06
2021
accepted:
01
06
2021
pubmed:
5
7
2021
medline:
21
10
2021
entrez:
4
7
2021
Statut:
ppublish
Résumé
Chronic graft-versus-host disease (GVHD) can be associated with significant morbidity, in part because of nonreversible fibrosis, which impacts physical functioning (eye, skin, lung manifestations) and mortality (lung, gastrointestinal manifestations). Progress in preventing severe morbidity and mortality associated with chronic GVHD is limited by a complex and incompletely understood disease biology and a lack of prognostic biomarkers. Likewise, treatment advances for highly morbid manifestations remain hindered by the absence of effective organ-specific approaches targeting "irreversible" fibrotic sequelae and difficulties in conducting clinical trials in a heterogeneous disease with small patient numbers. The purpose of this document is to identify current gaps, to outline a roadmap of research goals for highly morbid forms of chronic GVHD including advanced skin sclerosis, fasciitis, lung, ocular and gastrointestinal involvement, and to propose strategies for effective trial design. The working group made the following recommendations: (1) Phenotype chronic GVHD clinically and biologically in future cohorts, to describe the incidence, prognostic factors, mechanisms of organ damage, and clinical evolution of highly morbid conditions including long-term effects in children; (2) Conduct longitudinal multicenter studies with common definitions and research sample collections; (3) Develop new approaches for early identification and treatment of highly morbid forms of chronic GVHD, especially biologically targeted treatments, with a special focus on fibrotic changes; and (4) Establish primary endpoints for clinical trials addressing each highly morbid manifestation in relationship to the time point of intervention (early versus late). Alternative endpoints, such as lack of progression and improvement in physical functioning or quality of life, may be suitable for clinical trials in patients with highly morbid manifestations. Finally, new approaches for objective response assessment and exploration of novel trial designs for small populations are required.
Identifiants
pubmed: 34217703
pii: S2666-6367(21)00949-0
doi: 10.1016/j.jtct.2021.06.001
pmc: PMC8478861
mid: NIHMS1722009
pii:
doi:
Types de publication
Consensus Development Conference, NIH
Journal Article
Research Support, N.I.H., Intramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
817-835Subventions
Organisme : NEI NIH HHS
ID : R24 EY032440
Pays : United States
Organisme : NCI NIH HHS
ID : P30 CA008748
Pays : United States
Organisme : NEI NIH HHS
ID : R01 EY024966
Pays : United States
Organisme : NHLBI NIH HHS
ID : K08 HL145116
Pays : United States
Organisme : NEI NIH HHS
ID : R01 EY021798
Pays : United States
Organisme : NCI NIH HHS
ID : P01 CA142106
Pays : United States
Organisme : NEI NIH HHS
ID : R13 EY027189
Pays : United States
Informations de copyright
Copyright © 2021 The American Society for Transplantation and Cellular Therapy. All rights reserved.
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