ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells
- Study type
- Clinical guideline
- Study name
- ASTCT Consensus Grading
- Design
- Expert consensus statement (consensus conference supported by the American Society for Transplantation and Cellular Therapy, ASTCT)
- Sample size
- Not applicable (consensus statement; no patient numbers reported in the abstract)
- Source
- Biology of Blood and Marrow Transplantation · 2019
In plain words
Immune treatments such as CAR T cells can cause particular side effects, such as "cytokine release syndrome" and effects on the nervous system. Until now, treatment centres measured how severe these side effects were using different criteria. A group of experts in this field proposed a single, simple way to grade how severe these side effects are. The aim is for care teams in all centres to share a common language and to assess and manage these side effects more accurately.
Key guideline recommendations
- Expert consensus
New definitions and grading for cytokine release syndrome (CRS) and neurotoxicity are proposed that are objective and easy to apply and categorise the severity of these toxicities more accurately. Details of the criteria and grades are not given in the abstract and are available in the full text.
- Expert consensus
A single uniform consensus grading system for CRS and neurotoxicity associated with immune effector cell-based therapies should be used both in clinical trials and in the post-approval clinical setting.
Treatment arms and regimens
This document is a consensus statement and has no treatment regimen or intervention group. Details of the proposed grading are given in the full text.
Source of the regimen details: Abstract of the paper
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
This paper is not a clinical trial and no patients were enrolled. Its subject is the assessment and grading of toxicities specific to therapies based on activation of immune effector cells (including CAR T-cell therapy and bispecific antibody-based approaches). These therapies are in development for haematological malignancies and solid tumours. Two CAR T products have been approved in the United States and Europe for patients up to 25 years of age with relapsed or refractory B-cell acute lymphoblastic leukaemia and/or adults with large B-cell lymphoma.
Endpoints
The aim of the document is to harmonise the definitions and grading systems for cytokine release syndrome (CRS) and neurotoxicity. The proposed definitions should be objective and easy to apply and should categorise the severity of these toxicities more accurately. No clinical endpoint (survival, response, etc.) is reported in the abstract.
Safety and side effects
This paper does not report safety data from a trial. Its subject is the grading of two toxicities specific to immune effector cell-based therapies, namely cytokine release syndrome (CRS) and neurotoxicity.
Clinical significance and place in guidelines
This consensus provides a uniform grading system for CRS and neurotoxicity that applies both in clinical trials and in the post-approval clinical setting. Its use makes it easier to compare the safety of different products and to develop strategies for managing these toxicities. The abstract gives no information on the effect of this document on clinical guidelines or specific approvals; its adoption in current guidelines should be checked separately.
Limitations
The abstract describes only the aim and general framework of the consensus and does not give the exact grading criteria. The level of evidence and strength of the recommendations are also not reported in the abstract. For clinical use, the full text should be consulted. This document is based on expert consensus, not a randomised trial. Several authors declared financial relationships with manufacturers of CAR T products.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.