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)
Latest Information Update: 14 Dec 2021
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.