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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

B-Cell Non-Hodgkin Lymphoma Clinical Trial

Official title:
Phase 2 Pilot Study to Evaluate Efficacy and Safety of Anakinra to Prevent CD19-Targeted CAR-T Cell-Related Cytokine Release Syndrome (CRS) and Neurotoxicity in Patients With B Cell Lymphoma (B-NHL)

Clinical Trial 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.

Clinical Trial Description

OUTLINE: Patients receive anakinra intravenously (IV) [previously subcutaneously (SC) for some patients] daily on days 0-13 and lisocabtagene maraleucel via infusion on day 0. Patients should also undergo at screening an x-ray, positron emission tomography/computed tomography (PET/CT) or CT, bone marrow aspirate (BMA) and biopsy (if clinically indicated), and lumbar puncture (if clinically indicated), and at follow-up as clinically indicated. Patients also undergo blood sample collection on study. After completion of lisocabtagene maraleucel infusion, patients are followed up periodically for up to 90 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04359784
Study type Interventional
Source Fred Hutchinson Cancer Center
Contact Cellular Immunotherapy Patient Care Coordinator
Phone 206-606-4668
Email immunotherapy@fredhutch.org
Status Recruiting
Phase Phase 2
Start date December 27, 2021
Completion date October 3, 2024
View Details
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