Kite Pharma’s (NASDAQ:KITE) ZUMA-1 study of KTE-C19 in aggressive non-Hodgkin’s lymphoma (NHL) is mandating prophylaxis with levetiracetam in an effort to prevent seizures, a source familiar with the situation said.
The latest version of the Phase I/II study’s (NCT02348216) Phase II protocol mandates that patients receive levetiracetam, a generic anti-epileptic medication originally marketed by UCB Pharma (EBR:UCB) as Keppra, the source said. The source noted the original study protocol – from when the study started in January 2015 – didn’t have the prophylaxis step, but ongoing neurotoxicity concerns sparked the company to discuss a potential prophylaxis mandate, and the protocol was subsequently amended. The source did not disclose when the amendment took place, and Kite has not disclosed this protocol amendment in its SEC files or ClinicalTrials.gov. The study’s primary completion date is March 2017. The source added, previously, patients had been given anti-seizure prophylaxis on a center-by-center basis, but the trial itself had not mandated it.