NCT04359784

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OUTLINE: Patients receive anakinra intravenously (IV) \[previously subcutaneously (SC) for some patients\] over 10-30 minutes 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.

Conditions

• B-Cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Anakinra	Given IV (previously SC)
PROCEDURE	X-Ray Imaging	Undergo x-ray
PROCEDURE	Positron Emission Tomography	Undergo PET/CT
PROCEDURE	Computed Tomography	Undergo PET/CT or CT
PROCEDURE	Bone Marrow Aspiration	Undergo BMA
PROCEDURE	Bone Marrow Biopsy	Undergo bone marrow biopsy
PROCEDURE	Lumbar Puncture	Undergo lumbar puncture
PROCEDURE	Biospecimen Collection	Undergo blood sample collection

Timeline

• Start date: 2021-12-27
• Primary completion: 2024-10-01
• Completion: 2024-12-23
• First posted: 2020-04-24
• Last updated: 2025-10-23
• Results posted: 2025-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study