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A Phase IIIb Study of the Safety and Efficacy of Tisagenlecleucel Out of Specification for Commercial Release in Patients Who Are Consistent With the Label Indication

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Trial Profile

A Phase IIIb Study of the Safety and Efficacy of Tisagenlecleucel Out of Specification for Commercial Release in Patients Who Are Consistent With the Label Indication

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 29 Jan 2025

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At a glance

  • Drugs Tisagenlecleucel (Primary)
  • Indications B-cell leukaemia; B-cell lymphoma; Diffuse large B cell lymphoma; Follicular lymphoma; Non-Hodgkin's lymphoma; Precursor B-cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions; Registrational
  • Sponsors Novartis Pharmaceuticals

    • Most Recent Events

    • 24 Jan 2025 Planned End Date changed from 18 Apr 2025 to 31 Mar 2026.
    • 24 Jan 2025 Planned primary completion date changed from 18 Apr 2025 to 31 Mar 2026.
    • 30 Jan 2024 Planned End Date changed from 17 Apr 2024 to 18 Apr 2025.

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