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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 study of 34 patients, an approximately 76-year-old woman developed resistance to axicabtagene ciloleucel and cytokine release syndrome during treatment with axicabtagene ciloleucel for a progressive large B-cell lymphoma (LBCL), and an approximately 59-year-old man developed resistance to axicabtagene ciloleucel during treatment with axicabtagene ciloleucel for a refractory LBCL [routes, dosages and durations of treatments to reactions onsets not stated; not all outcomes stated].
Patient 1: The woman was diagnosed with LBCL at the age of 60 years. She received treatment with RCHOP regimen comprising rituximab, cyclophosphamide, doxorubicin, vincristine, prednisolone and subsequently achieved a durable complete remission. However, 16 years later (i.e. approximately at the...
- Bukhari A, et al. Rapid relapse of large B-cell lymphoma after CD19 directed CAR-T-cell therapy due to CD-19 antigen loss. American Journal of Hematology 94: E273-E275, No. 10, Oct 2019. Available from: URL: http://doi.org/10.1002/ajh.25591 - USA