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NCT04150913 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Trial of Anakinra for the Prevention of CAR-T Cell Mediated Neurotoxicity
A Phase 2 study, sponsored by Marcela V. Maus, M.D.,Ph.D..
- Completed
- Registry status
- Phase 2
- Development phase
- 15
- Enrollment target
NCT04150913: Completed Phase 2 study, sponsored by Marcela V. Maus, M.D.,Ph.D..
NCT04150913 is a Phase 2 study that has completed, run by Marcela V. Maus, M.D.,Ph.D.. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04150913, a Phase 2 study, has completed, sponsored by Marcela V. Maus, M.D.,Ph.D..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 15 participants
- Enrollment target
Study Summary
This research study is studying the combination of anakinra and axicabtagene ciloleucel to reduce the occurrence of the side effects Cytokine Release Syndrome (CRS) and neurologic toxicities with relapsed or refractory Non-Hodgkin lymphoma (NHL). * Relapsed NHL is the condition of returned Non-Hodgkin lymphoma. * Refractory NHL is the condition of previous treatment resistant Non-Hodgkin lymphoma. * Cytokine Release Syndrome (CRS) is a group of side effect symptoms that can include nausea, headache, rapid heartbeat, shortness of breath, kidney damage, and rash. * Neurologic toxicity is nervous system disorder characterized by confusion This research study involves two drugs: * Anakinra * Axicabtagene Ciloleucel.
Primary Outcome
The incidence of grade 2+ neurotoxicity is reported below and was assessed using CTCAE (Common Terminology Criteria for Adverse Events) v4.04 criteria. Neurotoxicity is a serious side effect of cancer treatments that can impact the central and peripheral nervous systems. Neurotoxicity manifestations vary and can include confusion, obtundation, seizures, hallucinations, aphasia, ataxia, and more rarely, profound cerebral edema.
Interventions
- DRUG Anakinra
- DRUG Axicabtagene Ciloleucel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2020-10-01 |
| Est. Completion | 2024-10-31 |
| Phase | Phase 2 |
What the finished NCT04150913 record still lists
NCT04150913 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Anakinra is the first listed.
NCT04150913 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04150913 about?
NCT04150913 is a clinical study titled "A Phase 2 Trial of Anakinra for the Prevention of CAR-T Cell Mediated Neurotoxicity". This research study is studying the combination of anakinra and axicabtagene ciloleucel to reduce the occurrence of the side effects Cytokine Release Syndrome (CRS) and neurologic toxicities with relapsed or refractory Non-Hodgkin lymphoma (NHL). * Relapsed NHL is the condition of returned Non-Hodg...
What is the current status of trial NCT04150913?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2020-10-01. Estimated completion is 2024-10-31.
What interventions are being tested in trial NCT04150913?
The interventions under investigation include: Anakinra (DRUG), Axicabtagene Ciloleucel (DRUG).
Who is sponsoring clinical trial NCT04150913?
This trial is sponsored by Marcela V. Maus, M.D.,Ph.D., which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04150913's enrollment target sits among peer trials
15 1919th of 2000 higher than 60 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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