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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
he 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.
Novartis will manufacture these cells despite being out of specification. This is called Individual patient Request