Part 2: Capturing essential information on the cytokine release syndrome (CRS) and Immune Cells Associated Neurotoxicity Syndrome (ICANS).
Information on patients treated with CAR T-cells must be entered in the ProMISe database using the digital form “Cellular Therapy MED-A Form” that can be found here: https://www.ebmt.org/registry/data-collection. Patients must be registered as soon as possible after the medical decision (Read Part 1: Capturing essential information on the manufactured medicinal product).
In vivo expansion of CAR T-cells and tumor cell lysis may be associated with potential life-threatening toxicities such as CRS and ICANS that generally occur within 14 and 28 days of the CAR T infusion, respectively. Therefore, CRS and ICANS data must be captured using the Cellular Therapy MED-A Day 100 Form. In the rare cases where delayed neurological complications occur, data are captured using the Cellular Therapy MED-A 6M and Annual Follow Up Forms (i.e. 6-month or annual).
For both CRS and ICANS, the following essential information are captured: date of onset, date of resolution and highest grade in the reporting period according to the ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells (Lee et al, Biology of Blood and Marrow Transplantation, Volume 25, Issue 4, April 2019, Pages 625-638; DOI: https://doi.org/10.1016/j.bbmt.2018.12.758). Information on grading as well as calculators are also available in the ASTCT’s Practice Guideline Mobile App (downloadable from Google play and AppStore).
Rules apply to all commercial and investigational Immune Effector Cells (IEC) therapies, including CAR-T Cells.
The EBMT community thanks you for your contribution to progresses in this innovative field.