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NCT04359784 · ClinicalTrials.gov registry record · Phase 2
Anakinra for the Prevention of Cytokine Release Syndrome and Neurotoxicity in Patients With B-Cell Non-Hodgkin Lymphoma Receiving CD19-Targeted CAR-T Cell Therapy
A Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 27
- Enrollment target
NCT04359784: Completed Phase 2 study, sponsored by Fred Hutchinson Cancer Center.
NCT04359784 is a Phase 2 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 27 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04359784, a Phase 2 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 27 participants
- Enrollment target
Study Summary
This phase II trial studies how well anakinra works in decreasing the occurrence of cytokine release syndrome (CRS) and damage to the nerves (neurotoxicity) in patients with B-cell non-Hodgkin lymphoma who are receiving CD-19 targeted chimeric antigen receptor T-cell (CAR-T) therapy. CAR-T cell therapy may be complicated by two potentially life-threatening side effects: CRS and neurotoxicity. Anakinra is a drug typically used to treat rheumatoid arthritis, but may also help in preventing CAR-T cell-related cytokine release syndrome and neurotoxicity.
Primary Outcome
Will assess the efficacy of anakinra in preventing the occurrence of any grade CRS using the Bayesian optimal phase 2 design. Assessed based on the ASTCT Consensus Grading for CRS and Neurotoxicity Associated with Immune Effector Cell.
Interventions
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Computed Tomography
- PROCEDURE Positron Emission Tomography
- PROCEDURE X-Ray Imaging
- BIOLOGICAL Anakinra
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2021-12-27 |
| Est. Completion | 2024-12-23 |
| Phase | Phase 2 |
What the finished NCT04359784 record still lists
NCT04359784 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 5 interventions - of which Bone Marrow Aspiration is the first listed.
NCT04359784 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04359784 about?
NCT04359784 is a clinical study titled "Anakinra for the Prevention of Cytokine Release Syndrome and Neurotoxicity in Patients With B-Cell Non-Hodgkin Lymphoma Receiving CD19-Targeted CAR-T Cell Therapy". This phase II trial studies how well anakinra works in decreasing the occurrence of cytokine release syndrome (CRS) and damage to the nerves (neurotoxicity) in patients with B-cell non-Hodgkin lymphoma who are receiving CD-19 targeted chimeric antigen receptor T-cell (CAR-T) therapy. CAR-T cell ther...
What is the current status of trial NCT04359784?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 27 participants. The study started on 2021-12-27. Estimated completion is 2024-12-23.
What interventions are being tested in trial NCT04359784?
The interventions under investigation include: Bone Marrow Aspiration (PROCEDURE), Computed Tomography (PROCEDURE), Positron Emission Tomography (PROCEDURE), X-Ray Imaging (PROCEDURE), Anakinra (BIOLOGICAL).
Who is sponsoring clinical trial NCT04359784?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04359784's enrollment target sits among peer trials
27 1697th of 2000 higher than 293 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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