P1407: remote monitoring of car t-cell treated patients by a specialized nurse to detect and manage late complications: report of the carama program

Topic: 25. Gene therapy, cellular immunotherapy and vaccination - Clinical Background: CAR T-cells have been approved for the treatment of relapse/refractory (R/R) large B-cell lymphoma (LBCL), mantle cell lymphoma (MCL), follicular lymphoma (FL), acute lymphoblastic leukemia (ALL), and multiple myeloma (MM). Although acute toxicities of CAR T-cells are well managed during hospitalization, delayed complications (including cytopenias, infections and relapses) are more challenging to manage owing to the distance. Aims: To address this issue, we initiated a program consisting in a remote monitoring of CAR T-cell treated patients by a specialized nurse (CARAMA) to detect and manage delayed complications. Methods: Patients treated with CAR T-cells at the University Hospital of Rennes (France) were prospectively followed remotely (by phone) by a CARAMA nurse after hospital discharge. Adverse events and interventions were prospectively collected by the CARAMA nurse who called patients after hospital discharge daily until day 21, twice a week until day 28, once a week until month 2, every other week until month 3, once a month until month 6, and once every 3 months until month 12 or relapse/progression. Results: Between September 2019 and December 2022, 151 patients have been followed in the CARAMA program (113 LBCL, 11 MCL, 11 FL, 9 ALL, 7 MM). Median age was 64 years (range, 16-80). A total of 2,573 phone calls were given to the patients by the CARAMA nurse which represents a median of 15 calls/patient (range, 0-41). The CARAMA nurse: -identified complications requiring intervention including cytopenias (111 patients, 73.5%) requiring transfusions (44 patients, 29.1%) and/or growth factors (110 patients, 72.8%), and infections requiring antibiotics (37 patients, 24.5%); -was able to detect disease relapse before medical consult in 24 out of 65 patients (36.9%); -referred 75 patients (49.7%) in consult to their general practitioner (N=71), their hematologist (N=24), and/or other physicians (N=29); -requested hospitalization for 41 patients (27.2%) due to infection (48.8%), cytopenias (14.6%), disease relapse (17.1%), and/or other causes (19.5%); -organized supportive measures for 63 patients (41.7%), including physical therapy (N=38), psychological support (N=24), social worker (N=14), hypnosis (N=11), sexology consult (N=7), or dietician (N=4). A survey evaluating patients’ satisfaction (0=useless, 10=indispensable) at 3 months of the CARAMA program (N=43) showed a median score of 10/10 (range, 7-10). Summary/Conclusion: Remote monitoring of patients treated with CAR T-cells by a specialized nurse allows early detection and management of delayed complications (adverse events and/or relapse). It also saves medical time and resources. Finally, this close follow-up is reassuring for the patients and contributes to their well-being. Ours results support the development of CARAMA nurses in CAR T-cell centers. Keywords: CAR-T, Diffuse large B cell lymphoma, B cell lymphoma, Adult