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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: 23 Apr 2026

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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

  • 02 Apr 2026 Planned End Date changed from 27 Apr 2027 to 31 Mar 2027.
  • 17 Feb 2026 Planned End Date changed from 31 Mar 2026 to 27 Apr 2027.
  • 17 Feb 2026 Planned primary completion date changed from 31 Mar 2026 to 31 Mar 2027.

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