Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-19-107
Prinicipal Investigator
Mineishi, Shin
Phase
N/A
Age Group
Both
Scope
National
Secondary Protocol No.
CCTL019B2003I
Title
Managed Access Program (MAP) to provide access to CTL019, for acute lymphoblastic leukemia (ALL) or large B-cell lymphoma patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release
Objective
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 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.
Applicable Disease Sites
Leukemia, other

Other Hematopoietic
Status
Open
Participating Institutions
Hershey Medical Center