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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a retrospective study of 8 patients [treated between August 2018 and March 2019], 7 patients (4 males and 3 females), aged 17−79 years were described, who developed neurotoxicity (NT) or cytokine release syndrome (CRS) following treatment with tisagenlecleucel for high grade B-cell lymphoma with secondary CNS involvement [dosages and time to reactions onsets; not all outcomes stated].
A 43-year-old woman, with diffuse large B-cell lymphoma, germinal centre B-cell like (DLBCL, GCB), received chimeric antigen receptor (CAR) T-cell course including single IV tisagenlecleucel infusion following administration of lymphodepleting chemotherapy including cyclophosphamide and fludarabine. Additionally, she was receiving concomitant maintenance with ibrutinib. Prior to this therapy,...
- Frigault MJ, et al. Tisagenlecleucel CAR T-cell therapy in secondary CNS lymphoma. Blood 134: 860-866, No. 11, 12 Sep 2019. Available from: URL: http://doi.org/10.1182/blood.2019001694 - USA