Jazz JZP395-201 Ph2 Defibrotide for CRES in RR DLBCL treated with Axi-cel (Yescarta) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn more about Defibrotide and to understand if it works in preventing neurotoxicity, a potential side effect from the standard of care medicine.
What is the Condition Being Studied?
Relapsed or Refractory Diffuse Large B-cell Lymphoma

Who Can Participate in the Study?

Adults who have Relapsed or Refractory Diffuse Large B-cell Lymphoma

Age Group
Adults

What is Involved?

If you choose to join this study you will:
- Take the study drug (Defibrotide)
- Complete a physical exam
- Have a PET scan
- Have blood taken

Study Details

Full Title
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®)
Principal Investigator
Cell Therapy and Hematologic Malignancies Specialist
Protocol Number
IRB: PRO00102455
NCT: NCT03954106
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698