TY - JOUR
T1 - National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease
T2 - III. The 2020 Treatment of Chronic GVHD Report
AU - DeFilipp, Zachariah
AU - Couriel, Daniel R.
AU - Lazaryan, Aleksandr
AU - Bhatt, Vijaya Raj
AU - Buxbaum, Nataliya P.
AU - Alousi, Amin M.
AU - Olivieri, Attilio
AU - Pulanic, Drazen
AU - Halter, Joerg P.
AU - Henderson, Lori A.
AU - Zeiser, Robert
AU - Gooley, Ted A.
AU - MacDonald, Kelli P.A.
AU - Wolff, Daniel
AU - Schultz, Kirk R.
AU - Paczesny, Sophie
AU - Inamoto, Yoshihiro
AU - Cutler, Corey S.
AU - Kitko, Carrie L.
AU - Pidala, Joseph A.
AU - Lee, Stephanie J.
AU - Socie, Gerard
AU - Sarantopoulos, Stefanie
AU - Pavletic, Steven Z.
AU - Martin, Paul J.
AU - Blazar, Bruce R.
AU - Greinix, Hildegard T.
N1 - Publisher Copyright:
© 2021 The American Society for Transplantation and Cellular Therapy
PY - 2021/9
Y1 - 2021/9
N2 - Positive results from recent clinical trials have significantly expanded current therapeutic options for patients with chronic graft-versus-host disease (GVHD). However, new insights into the associations between clinical characteristics of chronic GVHD, pathophysiologic mechanisms of disease, and the clinical and biological effects of novel therapeutic agents are required to allow for a more individualized approach to treatment. The current report is focused on setting research priorities and direction in the treatment of chronic GVHD. Detailed correlative scientific studies should be conducted in the context of clinical trials to evaluate associations between clinical outcomes and the biological effect of systemic therapeutics. For patients who require systemic therapy but not urgent initiation of glucocorticoids, clinical trials for initial systemic treatment of chronic GVHD should investigate novel agents as monotherapy without concurrently starting glucocorticoids, to avoid confounding biological, pathological, and clinical assessments. Clinical trials for treatment-refractory disease should specifically target patients with incomplete or suboptimal responses to most recent therapy who are early in their disease course. Close collaboration between academic medical centers, medical societies, and industry is needed to support an individualized, biology-based strategic approach to chronic GVHD therapy.
AB - Positive results from recent clinical trials have significantly expanded current therapeutic options for patients with chronic graft-versus-host disease (GVHD). However, new insights into the associations between clinical characteristics of chronic GVHD, pathophysiologic mechanisms of disease, and the clinical and biological effects of novel therapeutic agents are required to allow for a more individualized approach to treatment. The current report is focused on setting research priorities and direction in the treatment of chronic GVHD. Detailed correlative scientific studies should be conducted in the context of clinical trials to evaluate associations between clinical outcomes and the biological effect of systemic therapeutics. For patients who require systemic therapy but not urgent initiation of glucocorticoids, clinical trials for initial systemic treatment of chronic GVHD should investigate novel agents as monotherapy without concurrently starting glucocorticoids, to avoid confounding biological, pathological, and clinical assessments. Clinical trials for treatment-refractory disease should specifically target patients with incomplete or suboptimal responses to most recent therapy who are early in their disease course. Close collaboration between academic medical centers, medical societies, and industry is needed to support an individualized, biology-based strategic approach to chronic GVHD therapy.
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U2 - 10.1016/j.jtct.2021.05.004
DO - 10.1016/j.jtct.2021.05.004
M3 - Article
C2 - 34147469
AN - SCOPUS:85108517489
SN - 2666-6375
VL - 27
SP - 729
EP - 737
JO - Transplantation and Cellular Therapy
JF - Transplantation and Cellular Therapy
IS - 9
ER -