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Published on: February 17, 2022
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Routine prophylaxis with levetiracetam offers no benefit in CD19 CAR-T for LBCL: a multicenter propensity-matched
Eugenio Galli1,2, Roberta Di Blasi3, Alice Di Rocco4
1Dipartimento di Scienze di Laboratorio ed Ematologiche, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
Blood Advances
|August 8, 2025
Summary
Levetiracetam (LVT) prophylaxis did not reduce Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) in large B-cell lymphoma patients receiving CAR-T therapy. LVT use was linked to increased hematotoxicity without improving survival outcomes.
Area of Science:
- Oncology
- Immunology
- Pharmacology
Background:
- CAR-T therapy, particularly anti-CD19, offers a promising treatment for large B-cell lymphoma (LBCL).
- Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) is a significant concern during CAR-T therapy, impacting patient outcomes.
- Levetiracetam (LVT) is explored as a prophylactic agent to mitigate ICANS.
Purpose of the Study:
- To evaluate the efficacy of levetiracetam (LVT) prophylaxis in preventing Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) in patients with large B-cell lymphoma (LBCL) undergoing anti-CD19 CAR-T therapy.
- To assess the impact of LVT on the incidence and severity of ICANS, as well as on other adverse events and survival outcomes.
- To determine if LVT prophylaxis is associated with improved overall survival (OS) and progression-free survival (PFS).
Main Methods:
- A propensity score-matched cohort study of 254 patients with LBCL treated with anti-CD19 CAR-T therapy.
- Comparison of patients receiving LVT prophylaxis versus those not receiving it in a 1:1 ratio.
- Analysis of ICANS incidence and severity, immune effector cell-associated hematotoxicity (ICAHT), overall survival, progression-free survival, and non-relapse mortality.
Main Results:
- No significant difference in the occurrence of any-grade ICANS (32.3% vs. 37.1%, p=0.29) or severe ICANS (grades 2-4: 15.1% vs. 16.1%, p=0.80) between LVT prophylaxis and no prophylaxis groups.
- A significantly higher incidence of grade 2-4 immune effector cell-associated hematotoxicity (ICAHT) was observed in patients receiving LVT prophylaxis (63.9%) compared to those not receiving it (37.3%, p<0.001).
- Overall survival (p=0.337), progression-free survival (p=0.670), and non-relapse mortality (p=0.77) did not differ significantly between the groups.
Conclusions:
- Routine levetiracetam prophylaxis is not effective in reducing the incidence or severity of ICANS in LBCL patients undergoing CAR-T therapy.
- LVT prophylaxis is associated with an increased risk of immune effector cell-associated hematotoxicity.
- Further research is warranted to explore the potential role of LVT in specific patient populations or for post-ICANS treatment.
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