Real World Evaluation of Deviation Outcomes in an Immune Effector Cell Quality Program

Introduction City of Hope (COH) was one of the first institutions to be granted Immune Effector Cell (IEC) Therapy accreditation by the Foundation for the Accreditation of Cellular Therapy, which supports our mission to provide safe, high quality patient care through expanded standardization. As part of the accreditation requirements, COH expanded established processes developed to monitor standard of care (SOC) deviations for the Hematopoietic Cell Transplantation Program to our IEC Clinical Program. As part of process improvement, we monitored our IEC Quality program to determine if there were any outcome changes as a result of deviations. Therefore, we performed a retrospective analysis of electronically submitted SOC deviations for patients treated with commercially available chimeric antigen receptor (CAR) T cell products (tisagenlecleucel or axicabtagene ciloleucel [Axi-cel]) between December 2017- March 2020 at COH. Methods During the reporting timeframe, 122 patients were planned to be treated with an IEC product. We retrieved 28 requests for SOC deviations from our electronic database for 24 of 122 patients. We analyzed for volume, trends and patient outcomes of submitted deviation requests, including trends in type of deviation, transfer to the intensive care unit (ICU), length of inpatient hospital stay and safety outcomes at 30 days post infusion. Patients who did not receive their SOC product for any reason during the reporting timeframe, or were lost to follow-up were excluded from the outcomes analysis. Results Sixteen of 24 patients were planned to be treated with SOC Axi-cel and 8 of 24 patients were planned to be treated with tisagenlecleucel; only 19 of 24 patients (10 women and 9 men) underwent infusion with their respective SOC product, 15 with Axi-cel and 4 with tisagenlecleucel. Five of 24 patients, including 1 Axi-cel and 4 tisagenlecleucel patients were excluded due to change in medical condition or infusion after the reporting timeframe. We identified elevated creatinine levels as the most common reason for SOC deviation requests for patients to be treated with tisagenlecleucel (4 of 8 patients), while deviations relating to rest days between lymphodepletion and CAR T cell infusion were the most common submitted deviations for patients planned to be treated with Axi-cel (9 of 16 patients). We also descriptively compared patients who required SOC deviations to a cohort of patients (n=98) who did not require deviations and were trea