Managed Access Program (MAP) to provide access to CTL019 for acute lymphoblastic leukemia (ALL) or diffuse large b-cell lymphoma (DLBCL) patients with out of specification leukapheresis product and/or manufactured tisagenlecleucel out of specification for commercial release
The purpose of this Treatment Plan 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.
- Study Identifier: 831527
Recruitment StatusEnrolling By Invitation
For cancer trials contact EmergingMed: 1-855-216-0098 or PennCancerTrials@emergingmend.com