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

PHASE2TerminatedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

October 4, 2019

Primary Completion Date

September 18, 2020

Study Completion Date

September 30, 2020

Conditions
DLBCLNeurotoxicity Syndromes
Interventions
DRUG

Defibrotide

"* Part 1: Defibrotide 2.5 mg/kg/dose or 6.25 mg/kg/dose once daily as a single dose on CAR-T Day -5, -4, and -3 before lymphodepletion, then every 6 hours daily for 8 days (CAR-T Day 0 to Day 7).~* Part 2 Recommended Phase 2 Dose: Defibrotide 6.25 mg/kg/dose once daily as a single dose on CAR-T Day -5, -4, and -3 before lymphodepletion, then every 6 hours daily for 8 days (CAR-T Day 0 to Day 7)."

Trial Locations (5)

21201

University of Maryland, Baltimore

27710

Duke University Medical Center, Durham

85054

Mayo Clinic, Phoenix

02215

Beth Israel Deaconess Medical Center, Boston

Dana Farber Cancer Institute, Boston

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY