Defining and Grading Infections in Clinical Trials Involving Hematopoietic Cell Transplantation: A Report From the BMT CTN Infectious Disease Technical Committee.

Autor: Shahid Z; Department of Medicine, Infectious Disease Service, Memorial Sloan Kettering Cancer Center, New York, New York; Department of Medicine, Weill Cornell Medical College, New York, New York. Electronic address: shahidz@mskcc.org., Etra AM; Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York., Levine JE; Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, New York., Riches ML; Department of Medicine, Center for International Blood and Marrow Transplantation Research (CIBMTR), Medical College of Wisconsin, Milwaukee, Wisconsin., Baluch A; Division of Infectious Diseases, Moffitt Cancer Center, Tampa, Florida., Hill JA; Department of Medicine, University of Washington, WA and Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Wisconsin., Nakamura R; Division of Hematology and HCT, City of Hope, Duarte, California., Toor AA; Lehigh Valley Health Network, Allentown, Pennsylvania., Ustun C; Division of Hematology, Oncology and Cell Therapy, Section of Bone Marrow Transplantation and Cellular Therapy, Rush Medical College, Chicago, Illinois., Young JH; Department of Medicine, Division of Infectious Disease and International Medicine, Program in Adult Transplant Infectious Disease, University of Minnesota, Minneapolis, Minnesota., Perales MA; Department of Medicine, Weill Cornell Medical College, New York, New York; Department of Medicine, Adult Bone Marrow Transplantation Service, Memorial Sloan Kettering Cancer Center; Weill Cornell Medical College, New York, New York., Epstein DJ; Division of Infectious Diseases and Geographic Medicine, Department of Medicine, Stanford University School of Medicine, Stanford, California., Murthy HS; Division of Hematology-Oncology, Blood and Marrow Transplantation Program, Mayo Clinic, Jacksonville, Florida.
Jazyk: angličtina
Zdroj: Transplantation and cellular therapy [Transplant Cell Ther] 2024 May; Vol. 30 (5), pp. 540.e1-540.e13. Date of Electronic Publication: 2024 Mar 06.
DOI: 10.1016/j.jtct.2024.03.001
Abstrakt: The Blood and Marrow Transplant Clinical Trials Network (BMT-CTN) was established in 2001 to conduct large multi-institutional clinical trials addressing important issues towards improving the outcomes of HCT and other cellular therapies. Trials conducted by the network investigating new advances in HCT and cellular therapy not only assess efficacy but require careful capturing and severity assessment of adverse events and toxicities. Adverse infectious events in cancer clinical trials are typically graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE). However, there are limitations to this framework as it relates to HCT given the associated immunodeficiency and delayed immune reconstitution. The BMT-CTN Infection Grading System is a monitoring tool developed by the BMT CTN to capture and monitor infectious complications and differs from the CTCAE by its classification of infections based on their potential impact on morbidity and mortality for HCT recipients. Here we offer a report from the BMT CTN Infectious Disease Technical Committee regarding the rationale, development, and revising of BMT-CTN Infection Grading System and future directions as it applies to future clinical trials involving HCT and cellular therapy recipients.
(Copyright © 2024 The American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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