Clinical Trial Details

Primary Objective:

• To allow treatment with tisagenlecleucel (CTL019) for eligible patients diagnosed with B-cell acute lymphoblastic leukemia (ALL) or large B-cell lymphomas 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.

Secondary Objectives:
N/A

Exploratory Objectives:
N/A