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Prospective, Multicenter, Open-Label, Single Arm, Phase 2 Study to Evaluate the Safety and Efficacy of Defibrotide in the Prevention of Chimeric Antigen Receptor-T-cell-associated Neurotoxicity in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma Receiving Axicabtagene Ciloleucel (Yescarta)

Trial Profile

Prospective, Multicenter, Open-Label, Single Arm, Phase 2 Study to Evaluate the Safety and Efficacy of Defibrotide in the Prevention of Chimeric Antigen Receptor-T-cell-associated Neurotoxicity in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma Receiving Axicabtagene Ciloleucel (Yescarta)

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 14 Dec 2021

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At a glance

  • Drugs Defibrotide (Primary)
  • Indications Chemotherapy-induced damage; Drug toxicity; Neurotoxicity syndrome
  • Focus Therapeutic Use
  • Sponsors Jazz Pharmaceuticals plc

Most Recent Events

  • 16 Apr 2021 Planned End Date changed from 1 May 2021 to 18 Dec 2020.
  • 16 Apr 2021 Planned primary completion date changed from 1 Apr 2021 to 14 Aug 2020.
  • 16 Apr 2021 Status changed from recruiting to discontinued as primary endpoints would be unlikely to be met based on the unplanned interim assessment on the first 20 efficacy evaluable patients.

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