ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells.

Biol Blood Marrow Transplant 2019 04 25;25(4):625-638. Epub 2018 Dec 25.

Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, Houston, TX. Electronic address:

Chimeric antigen receptor (CAR) T cell therapy is rapidly emerging as one of the most promising therapies for hematologic malignancies. Two CAR T products were recently approved in the United States and Europe for the treatment ofpatients up to age 25years with relapsed or refractory B cell acute lymphoblastic leukemia and/or adults with large B cell lymphoma. Many more CAR T products, as well as other immunotherapies, including various immune cell- and bi-specific antibody-based approaches that function by activation of immune effector cells, are in clinical development for both hematologic and solid tumor malignancies. These therapies are associated with unique toxicities of cytokine release syndrome (CRS) and neurologic toxicity. The assessment and grading of these toxicities vary considerably across clinical trials and across institutions, making it difficult to compare the safety of different products and hindering the ability to develop optimal strategies for management of these toxicities. Moreover, some aspects of these grading systems can be challenging to implement across centers. Therefore, in an effort to harmonize the definitions and grading systems for CRS and neurotoxicity, experts from all aspects of the field met on June 20 and 21, 2018, at a meeting supported by the American Society for Transplantation and Cellular Therapy (ASTCT; formerly American Society for Blood and Marrow Transplantation, ASBMT) in Arlington, VA. Here we report the consensus recommendations of that group and propose new definitions and grading for CRS and neurotoxicity that are objective, easy to apply, and ultimately more accurately categorize the severity of these toxicities. The goal is to provide a uniform consensus grading system for CRS and neurotoxicity associated with immune effector cell therapies, for use across clinical trials and in the postapproval clinical setting.

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.bbmt.2018.12.758DOI Listing
April 2019
63 Reads

Publication Analysis

Top Keywords

crs neurotoxicity
12
immune effector
12
car products
8
neurologic toxicity
8
american society
8
associated immune
8
effector cells
8
release syndrome
8
clinical trials
8
grading systems
8
definitions grading
8
cytokine release
8
consensus grading
8
grading
6
hindering ability
4
ability develop
4
develop optimal
4
optimal strategies
4
products hindering
4
compare safety
4

Similar Publications