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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 is a Phase 2 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 27 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04359784
The ClinicalTrials.gov registry entry for NCT04359784 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Bone Marrow Aspiration is the first listed.
NCT04359784 reports 0 study locations.
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.
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