18 and older, any sex, with DLBCL or Neurotoxicity Syndromes. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Incidence of CAR-T-associated Neurotoxicity of Any Grade, Defined by CTCAE v5.0 by CAR-T Day +30Primary· By CAR-T Day +30
The primary efficacy endpoint was the incidence of CAR-T-associated neurotoxicity of any grade defined by CTCAE v5.0 by CAR-T Day +30. The results report the estimated percentage of participants with no CAR-T-associated neurotoxicity of any grade, defined by CTCAE v5.0, which incorporated the 2 stage design.
Group
Value
95% CI
Stage 1: Defibrotide, 6.25 mg/kg/Dose
50
NA – NA
Stage 2: Defibrotide, 6.25 mg/kg/Dose
50
NA – NA
Overall: Defibrotide, 6.25 mg/kg/Dose
51
36 – 66
Incidence of CAR-T-Associated Neurotoxicity Grade 3 or Greater Defined by CTCAE v5.0 by CAR-T Day +30Secondary· By CAR-T Day +30
The secondary efficacy endpoint was the incidence of CAR-T-associated neurotoxicity Grade 3 or greater defined by CTCAE v5.0 by CAR-T Day +30. The results report the estimated percentage of participants with no CAR-T-associated neurotoxicity (Grade 3 or greater defined by CTCAE v5.0) by CAR-T Day +30.
Group
Value
95% CI
Stage 1: Defibrotide, 6.25 mg/kg/Dose
80
Stage 2: Defibrotide, 6.25 mg/kg/Dose
70
Overall: Defibrotide, 6.25 mg/kg/Dose
75
Incidence of CAR-T-Associated Neurotoxicity of Any Grade According to the ASBMT Consensus Grading System by CAR-T Day +30Secondary· By CAR-T Day +30
The secondary efficacy endpoint was the incidence of CAR-T-associated neurotoxicity of any grade according to ASBMT consensus grading system by CAR-T Day +30. The results report the estimated percentage of participants with no CAR-T-associated neurotoxicity by CAR-T Day +30 summarized descriptively by any grade according to the ASBMT consensus grading system.
Group
Value
95% CI
Stage 1: Defibrotide, 6.25 mg/kg/Dose
0
Stage 2: Defibrotide, 6.25 mg/kg/Dose
0
Overall: Defibrotide, 6.25 mg/kg/Dose
0
Incidence of CAR-T-Associated Neurotoxicity of Grade 3 or Greater According to the ASBMT Consensus Grading System by CAR-T Day +30Secondary· By CAR-T Day +30
The secondary efficacy endpoint was the incidence of CAR-T-associated neurotoxicity grade 3 or greater according to ASBMT consensus grading system by CAR-T Day +30. The results report the estimated percentage of participants with no CAR-T-associated neurotoxicity by CAR-T Day +30 summarized descriptively by grade 3 or greater according to the ASBMT consensus grading system.
Group
Value
95% CI
Stage 1: Defibrotide, 6.25 mg/kg/Dose
90
Stage 2: Defibrotide, 6.25 mg/kg/Dose
70
Overall: Defibrotide, 6.25 mg/kg/Dose
80
Incidence of Cytokine Release Syndrome (CRS) of Any Grade According to the ASBMT Consensus Grading System by CAR-T Day +30Secondary· By CAR-T Day +30
The secondary efficacy endpoint was the incidence of cytokine release syndrome (CRS) of any grade according to ASBMT consensus grading system by CAR-T Day +30. The results report the estimated percentage of participants with no CRS any grade according to ASBMT criteria and was summarized descriptively using the ASBMT consensus grading system by CAR-T Day +30.
Group
Value
95% CI
Stage 1: Defibrotide, 6.25 mg/kg/Dose
10
Stage 2: Defibrotide, 6.25 mg/kg/Dose
20
Overall: Defibrotide, 6.25 mg/kg/Dose
15
Use of High Dose Steroid By CAR-T Day +30Secondary· By CAR-T Day +30
The percentage of participants using high dose steroids was summarized descriptively. The use of high dose steroids was defined as a dose of dexamethasone of at least 7.5 mg/day or equivalent. Only the Overall Defibrotide: 6.25 mg/kg/dose group was analyzed for this outcome.
Group
Value
95% CI
Overall: Defibrotide, 6.25 mg/kg/Dose
45
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events (AEs) and Serious Adverse Events (SAEs) were recorded from the time the subject signed informed consent until the final study visit or Early Termination (ET)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Part 1: Safety Lead-In, Defibrotide 2.5 mg/kg/Dose
Serious: 4/4 (100%)
Deaths: 0/4
Phase 2: RP2D, 6.25 mg/kg/Dose
Serious: 9/21 (43%)
Deaths: 0/21
Serious adverse events (17 terms)
Reaction
System
Part 1: Safety Lead-In, De…
Phase 2: RP2D, 6.25 mg/kg/…
Cytokine release syndrome
Immune system disorders
—
—
Neurotoxicity
Nervous system disorders
—
—
Hypotension
Vascular disorders
—
—
Febrile neutropenia
Blood and lymphatic system disorders
—
—
Atrial fibrillation
Cardiac disorders
—
—
Myocardial infarction
Cardiac disorders
—
—
Small intestinal obstruction
Gastrointestinal disorders
—
—
Asthenia
General disorders
—
—
Pyrexia
General disorders
—
—
Clostridium difficile colitis
Infections and infestations
—
—
Decreased appetite
Metabolism and nutrition disorders
—
—
Tumour lysis syndrome
Metabolism and nutrition disorders
—
—
Presyncope
Nervous system disorders
—
—
Transient ischaemic attack
Nervous system disorders
—
—
Confusional state
Psychiatric disorders
—
—
Pleural effusion
Respiratory, thoracic and mediastinal disorders
—
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
Other adverse events (107 terms — click to expand)
This is a prospective, open-label, single-arm study evaluating the safety and efficacy of defibrotide for the prevention of CAR-T-associated neurotoxicity in subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) receiving Yescarta.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07070648 — Study on Predicting Response to Standard First-Line Treatment in Diffuse Large B-Cell Lymphoma (DLBCL) Patients Using ct
· recruiting
NCT06758037 — Clinical Study of HiR+X Therapy for Newly Diagnosed Elderly Patients With DLBCL Intolerant to Chemotherapy
· Phase 2
· recruiting
NCT06779435 — A Multicenter, Prospective, Real-world Study of a Regimen Containing Tucidinostat for Primary Treatment of DLBCL
· recruiting
NCT06701357 — CR-CHOP+X in Previously Untreated DEL
· Phase 2
· recruiting
NCT07335120 — A Real-world Data and Sample Compendium of Frail and/or Multiply Treated Large B-cell Lymphoma
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Jazz Pharmaceuticals
Last refreshed: 9 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03954106.