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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)

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Trial Profile

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)

Status: Recruiting
Phase of Trial: Clinical Phase Unknown

Latest Information Update: 09 Feb 2024

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At a glance

  • Drugs Tisagenlecleucel (Primary)
  • Indications B-cell lymphoma; Diffuse large B cell lymphoma; Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Expanded access; Therapeutic Use
  • Sponsors Novartis Pharmaceuticals

    • Most Recent Events

    • 08 Dec 2020 Interim Results (n=14 from MAP) retrospectively analysing outcomes in pediatric and young adult patients who received tisagenlecleucel via the MAP or a single-patient IND, presented at the 62nd Annual Meeting and Exposition of the American Society of Hematology
    • 06 Nov 2019 Results (n=16) released at the 61st Annual Meeting and Exposition of the American Society of Hematology.
    • 03 Aug 2018 New trial record
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