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NCT03954106 · ClinicalTrials.gov registry record · Phase 2
A Safety and Efficacy Study of Defibrotide in the Prevention of Chimeric Antigen Receptor-T-cell-associated Neurotoxicity
A Phase 2 study, sponsored by Jazz Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT03954106: Clinical Trial Phase 2 study, sponsored by Jazz Pharmaceuticals.
NCT03954106 is a Phase 2 study that was terminated before completion, run by Jazz Pharmaceuticals. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03954106, a Phase 2 study, was terminated before completion, sponsored by Jazz Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DRUG Defibrotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2019-10-04 |
| Est. Completion | 2020-09-30 |
| Phase | Phase 2 |
Why NCT03954106 stopped before completion
NCT03954106 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which Defibrotide is the first listed.
NCT03954106 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03954106 about?
NCT03954106 is a clinical study titled "A Safety and Efficacy Study of Defibrotide in the Prevention of Chimeric Antigen Receptor-T-cell-associated Neurotoxicity". 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.
What is the current status of trial NCT03954106?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2019-10-04. Estimated completion is 2020-09-30.
What interventions are being tested in trial NCT03954106?
The interventions under investigation include: Defibrotide (DRUG).
Who is sponsoring clinical trial NCT03954106?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03954106's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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