: This study aims to evaluate the impact of levetiracetam (LVT) prophylaxis on the incidence and severity of immune effector cell-associated neurotoxicity syndrome (ICANS) in patients undergoing anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy for LBCL (large B-cell lymphoma). A propensity score-matched cohort of 254 patients was analyzed, comparing those receiving LVT prophylaxis (LTV-yes) with those not receiving it (LTV-no), in a 1:1 ratio. The results showed no significant difference in the occurrence of ICANS of any grade between the 2 groups (32.3% in LVT-no vs 37.1% in LVT-yes; P = .29), or in severe ICANS (grades 2-4, 15.1% vs 16.1% [P = .80]; grade 3-4, 7.9% vs 9.7% [P = .71]). The use of LVT was associated with a higher incidence of early immune effector cell-associated hematotoxicity (ICAHT), with grade 2 to 4 ICAHT occurring in 37.3% vs 63.9% (P < .001) of patients in the LVT-no and LVT-yes groups, respectively. Overall survival and progression-free survival did not differ significantly between the 2 groups (P = .337 and .670). Nonrelapse mortality rates were comparable (P = .77). These findings suggest that routine use of LVT as prophylaxis for ICANS in CAR-T therapy is not effective, and further research is needed to refine its role in selected populations or after ICANS treatment.

Galli, E., Di Blasi, R., Di Rocco, A., Cristinelli, C., Pansini, I., Bommier, C., Corrente, A., De Bernardis, I., Viscovo, M., Hohaus, S., Modoni, A., Sora', F., Chiusolo, P., Martelli, M., Sica, S., Thieblemont, C., Routine prophylaxis with levetiracetam offers no benefit in CD19 CAR-T for LBCL: a multicenter propensity-matched study, <<BLOOD ADVANCES>>, 2025; 9 (21): 5501-5509. [doi:10.1182/bloodadvances.2025017378] [https://hdl.handle.net/10807/325640]

Routine prophylaxis with levetiracetam offers no benefit in CD19 CAR-T for LBCL: a multicenter propensity-matched study

Galli, Eugenio
Primo
;
Pansini, Ilaria;Corrente, Alessandro;Viscovo, Marcello;Hohaus, Stefan;Modoni, Anna;Sora', Federica;Chiusolo, Patrizia;Sica, Simona
Ultimo
;
2025

Abstract

: This study aims to evaluate the impact of levetiracetam (LVT) prophylaxis on the incidence and severity of immune effector cell-associated neurotoxicity syndrome (ICANS) in patients undergoing anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy for LBCL (large B-cell lymphoma). A propensity score-matched cohort of 254 patients was analyzed, comparing those receiving LVT prophylaxis (LTV-yes) with those not receiving it (LTV-no), in a 1:1 ratio. The results showed no significant difference in the occurrence of ICANS of any grade between the 2 groups (32.3% in LVT-no vs 37.1% in LVT-yes; P = .29), or in severe ICANS (grades 2-4, 15.1% vs 16.1% [P = .80]; grade 3-4, 7.9% vs 9.7% [P = .71]). The use of LVT was associated with a higher incidence of early immune effector cell-associated hematotoxicity (ICAHT), with grade 2 to 4 ICAHT occurring in 37.3% vs 63.9% (P < .001) of patients in the LVT-no and LVT-yes groups, respectively. Overall survival and progression-free survival did not differ significantly between the 2 groups (P = .337 and .670). Nonrelapse mortality rates were comparable (P = .77). These findings suggest that routine use of LVT as prophylaxis for ICANS in CAR-T therapy is not effective, and further research is needed to refine its role in selected populations or after ICANS treatment.
2025
Inglese
Galli, E., Di Blasi, R., Di Rocco, A., Cristinelli, C., Pansini, I., Bommier, C., Corrente, A., De Bernardis, I., Viscovo, M., Hohaus, S., Modoni, A., Sora', F., Chiusolo, P., Martelli, M., Sica, S., Thieblemont, C., Routine prophylaxis with levetiracetam offers no benefit in CD19 CAR-T for LBCL: a multicenter propensity-matched study, <<BLOOD ADVANCES>>, 2025; 9 (21): 5501-5509. [doi:10.1182/bloodadvances.2025017378] [https://hdl.handle.net/10807/325640]
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