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®)
Categories (click each to see list of all clinical trials associated with that category): Cellular Therapy Support Service - CAR-T (ONC), Leukemia/MDS/MPD (ONC), Lymphoma/CLL (ONC)
Current Status: Open
Phase: N/A (Cancer Control)
Principal Investigator: Vose, Julie
Contact Information:
Susan Blumel, RN
402-559-9183
sblumel@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT03601442?term=NCT03601442&rank=1
Summary
The purpose is to allow access to tisagenlecleucel (CTL019) for eligible patients diagnosed with acute lymphoblastic leukemia (ALL) or large b-cell lymphomas who are unable to receive commercially manufactured product due to failure of the incoming apheresis material or outgoing product to meet the commercial specifications and where no overwhelming safety concerns has been identified for manufacture and release of the out of specification product. Program will provide access 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.