A Safety and Efficacy Study of Defibrotide in the Prevention of Chimeric Antigen Receptor-T-cell-associated Neurotoxicity

Inclusion Criteria

• Subject must be ≥ 18 years of age at signing of informed consent.
• Subject must be diagnosed with relapsed or refractory DLBCL (including DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma) and scheduled to receive treatment with Yescarta.
• Female subjects of childbearing potential who are sexually active and male subjects who are sexually active and have female partners of childbearing potential must agree to use a highly effective method of contraception with their partners during exposure to defibrotide and for 30 days after the last dose of defibrotide.
• Subject must be able to understand and sign written informed consent.

Exclusion Criteria

• Subject is currently receiving dialysis or expected to receive dialysis.
• Subject has used any investigational anticancer agent within 3 weeks prior to the first dose of defibrotide, or is using or plans to use any investigational agent during the study.
• Subject has previously been treated with CAR-T therapy.
• Hemodynamic instability requiring vasopressors or uncontrolled hypertension with persistent systolic blood pressure > 180.
• Subject has clinically significant active bleeding, history of intracranial bleeding, or is at risk for intracranial bleeding as determined by the Investigator.
• Subject plans to use any medication that increases the risk of bleeding.
• Subject is pregnant or lactating and does not agree to stop breastfeeding.
• Subject has a known history of hypersensitivity to defibrotide or any of the excipients.
• Subject has primary CNS lymphoma.