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

被引：19

作者：

Pidala, Joseph ^{[1
]}

Kitko, Carrie ^{[2
]}

Lee, Stephanie J. ^{[3
]}

Carpenter, Paul ^{[3
]}

Cuvelier, Geoffrey D. E. ^{[4
]}

Holtan, Shernan ^{[5
]}

Flowers, Mary E. ^{[3
]}

Cutler, Corey ^{[6
]}

Jagasia, Madan ^{[7
]}

Gooley, Ted ^{[3
]}

Palmer, Joycelynne ^{[8
]}

Randolph, Tim ^{[3
]}

Levine, John E. ^{[9
]}

Ayuk, Francis ^{[10
]}

Dignan, Fiona ^{[11
]}

Schoemans, Helene ^{[12
,13
]}

Tkaczyk, Eric ^{[14
,15
,16
]}

Farhadfar, Nosha ^{[17
]}

Lawitschka, Anita ^{[18
,19
]}

Schultz, Kirk R. ^{[20
]}

Martin, Paul J. ^{[3
]}

Sarantopoulos, Stefanie ^{[21
]}

Inamoto, Yoshihiro ^{[22
]}

Socie, Gerard ^{[23
]}

Wolff, Daniel ^{[24
]}

Blazar, Bruce ^{[25
]}

Greinix, Hildegard ^{[26
]}

Paczesny, Sophie ^{[27
,28
]}

Pavletic, Steven ^{[29
]}

Hill, Geoffrey ^{[3
]}

机构：

[1] H Lee Moffitt Canc Ctr & Res Inst, Blood & Marrow Transplantat & Cellular Immunother, 12902 Magnolia Dr, Tampa, FL 33612 USA

[2] Vanderbilt Univ, Med Ctr, Dept Pediat, Div Pediat Hematol Oncol, Nashville, TN 37232 USA

[3] Fred Hutchinson Canc Res Ctr, Clin Res Div, 1124 Columbia St, Seattle, WA 98104 USA

[4] Univ Manitoba, Canc Care Manitoba, Winnipeg, MB, Canada

[5] Univ Minnesota, Dept Med, Med Sch, Div Hematol Oncol & Transplantat, Box 736 UMHC, Minneapolis, MN 55455 USA

[6] Dana Farber Canc Inst, Div Stem Cell Transplantat & Cellular Therapy, Boston, MA 02115 USA

[7] Vanderbilt Univ, Med Ctr, Div Hematol & Oncol, Nashville, TN USA

[8] City Hope Natl Med Ctr, Div Biostat, Dept Computat & Quantitat Med, Duarte, CA USA

[9] Icahn Sch Med Mt Sinai, Tisch Canc Inst, New York, NY 10029 USA

[10] Univ Med Ctr Hamburg Eppendorf, Dept Stem Cell Transplantat, Hamburg, Germany

[11] Manchester Univ NHS Fdn Trust, Manchester Royal Infirm, Dept Clin Haematol, Manchester, Lancs, England

[12] Katholieke Univ Leuven, Dept Hematol, Univ Hosp Leuven, Leuven, Belgium

[13] Katholieke Univ Leuven, Dept Publ Hlth, Leuven, Belgium

[14] Vanderbilt Univ, Med Ctr, Dept Vet Affairs, Nashville, TN USA

[15] Vanderbilt Univ, Med Ctr, Dept Dermatol, Nashville, TN USA

[16] Vanderbilt Univ, Med Ctr, Dept Biomed Engn, Nashville, TN USA

[17] Univ Florida, Dept Med, Div Hematol & Oncol, Gainesville, FL USA

[18] Med Univ Vienna, Stem Cell Transplantat Unit, St Anna Childrens Hosp, Vienna, Austria

[19] Childrens Canc Res Inst, Vienna, Austria

[20] BC Childrens Hosp, Pediat Hematol Oncol BMT, Vancouver, BC, Canada

[21] Duke Univ, Duke Canc Inst, Dept Med, Div Hematol Malignancies & Cellular Therapy, Durham, NC USA

[22] Natl Canc Ctr, Dept Hematopoiet Stem Cell Transplantat, Tokyo, Japan

[23] St Louis Hosp, AP HP, Hematol & Bone Marrow Transplant Dept, Paris, France

[24] Univ Hosp Regensburg, Dept Internal Med 3, Regensburg, Germany

[25] Univ Minnesota, Dept Pediat, Div Blood & Marrow Transplantat & Cellular Therap, Minneapolis, MN 55455 USA

[26] Med Univ Graz, Clin Div Hematol, Graz, Austria

[27] Med Univ South Carolina, Dept Microbiol & Immunol, Charleston, SC 29425 USA

[28] Med Univ South Carolina, Dept Pediat, Charleston, SC 29425 USA

[29] NCI, Ctr Canc Res, NIH, Bethesda, MD 20892 USA

来源：

TRANSPLANTATION AND CELLULAR THERAPY | 2021年 / 27卷 / 08期

关键词：

Chronic graft-versus-host disease; Allogeneic hematopoietic cell transplantation; Consensus; Risk assignment biomarkers; Preemptive therapy; MURINE CHRONIC GVHD; B-CELLS; RISK-FACTORS; T-CELLS; PLASMA BIOMARKERS; BRONCHIOLITIS OBLITERANS; MARROW-TRANSPLANTATION; BCR RESPONSIVENESS; PREDICTIVE-VALUE; CHILDREN;

D O I：

10.1016/j.jtct.2021.03.029

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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.

引用

页码：632 / 641

页数：10

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