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CCTL019B2003I: 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
Study ID: STU-2018-0032
Summary
CTL019 therapy was FDa approved for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (aLL). at times, however, either the patient's apheresed cells are not sufficient to meet manufacturing criteria, or the manufactured product does not meet FDa approval specifications. in these cases, the manufactured cellular product may still be usable for patient treatment. This Managed access Program will allow physicians, along with novartis and conversation with the patient, to decide if the cells can/should still be infused. This program will provide access to CTL019 product to patients in all participating countries that have received marketing authorization and the product is commercially available until: * -all participating countries have exhausted questions regarding out of specification material * -alternative treatment options are available and/or * - Changes in the safety profile or a lack of overall efficacy of the product are evident. This is not a research study in that ongoing data will not be submitted, however our site is obligated to submit safety data on the CTL019 cellular recipient and on any pregnancy or pregnant partner should that event occur. Safety data and outcomes will be requested via release of medical information form for both pregnant participants and pregnant partners. This data may also be submitted on CiBMTR Registry if the participant has agreed to participation in that protocol.
- Cancer Related
- Yes
- Healthy Volunteers
- No
- UT Southwestern Principal Investigator
- THEODORE W LAETSCH
NOVARTIS PHARMACEUTICALS CORPORATION
Leukemia, Not Otherwise Specified; Leukemia, Other; Lymphoid Leukemia
The purpose of this Managed access Plan (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 have 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 experiences with tisagenlecleucel and the indication. it is anticipated that tisagenlecleucel may offer a therapeutic alternative for patients with r/r B-cell malignancies, which may provide greater durability of response than current salvage therapies to some patients. Tisagenlecleucel also may have the potential to provide a cell therapy alternative to patients otherwise not eligible for or unfit to undergo allogeneic SCT, as it obviates the need for matched donors.
