Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2024

Month: November

Request Number: A-2024-000104

Request Summary: The latest clinical trial protocols submitted to Health Canada for the following Novartis sponsored studies are requested: - Clinical Trial Application (CTA) Control Number 260736, 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. - CTA Control Number 204356, A Phase IIIB, single arm, open label, Canadian study to assess the safety and efficacy of tisagenleucel for patients with leukapheresis material that does not meet manufacturing acceptance specifications and/ or the manufactured product does not meet approved Canadian release specifications. The time period January 1, 2017 to December 31, 2023.

Disposition: Disclosed in part

Number of pages: 15

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