Managed Access Program (MAP) Cohort Treatment Plan CCTL019B2003I to provide access for patients with out of specification leukapheresis product and/or out of specification manufactured tisagenlecleucel (CTL019; Kymriah).
Managed Access Program (MAP) to provide access to CTL019 (Tisagenlecleucel)
What is the goal of the study?
The purpose of this Managed Access Program (MAP), which is an intermediate size patient population Expanded Access, is to allow treatment with tisagenlecleucel (CTL019) for eligible patients who meet all of the following criteria: are 1) consistent with the approved prescribing information, 2) unable to receive commercially manufactured product due to failure of the incoming apheresis material to meet acceptance specifications or final outgoing product to meet the commercial release specifications or other specification within the prescribing information, and 3) where no overwhelming safety concerns has been identified for manufacture and release of the out of specification product. The requesting treating physician submitted a request to Novartis to access tisagenlecleucel that does not meet commercial specifications, which was reviewed and approved by the medical team experienced with tisagenlecleucel and the indication.
Who can participate in the study?
Please contact the study team listed below to learn more.