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.

Complete Title: 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)

Trial Phase: N/A

Investigator: David Maloney

The purpose of this Managed Access Program (MAP) Treatment Plan is 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 where no overwhelming safety concerns has been identified for manufacture and release of the out of specification product.

Keywords:

Leukemia, Acute Lymphoblastic (ALL)
Lymphoma, Large B-Cell, Diffuse

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