Status:
COMPLETED
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
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
Swedish Orphan Biovitrum
Conditions:
B-Cell Non-Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 lymphom...
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. Pa...
Eligibility Criteria
Inclusion
- Subjects must be 18 years of age or older
- Karnofsky performance status of \>= 60%
- Patients with B-cell non-Hodgkin lymphoma (B-NHL) and eligible for treatment with liso-cel. Patients treated with non-conforming (out-of-specification) liso-cell may remain on study.
- Negative serum pregnancy test within 2 weeks of enrollment for women of childbearing potential, defined as those who have not been surgically sterilized or who have not been free of menses for at least 1 year
- Fertile male and female subjects must be willing to use an effective contraceptive method before, during, and for at least 4 months after the last dose of anakinra
- Ability to understand and provide informed consent
Exclusion
- Subjects requiring ongoing daily corticosteroid therapy at a dose of \> 15 mg of prednisone per day (or equivalent). Pulsed corticosteroid use for disease control is acceptable
- Active autoimmune disease requiring immunosuppressive therapy is excluded unless discussed with the principal investigator (PI)
- Known hypersensitivity to Escherichia € coli-derived proteins, anakinra, or to any component of the product
- Major organ dysfunction defined as:
- Serum creatinine \> 2.5 mg/dL
- Significant hepatic dysfunction (Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \> 5x upper limit of normal; bilirubin \> 3.0 mg/dL) unless due to malignancy or Gilbert's syndrome in the opinion of the PI or designee
- Subjects with clinically significant pulmonary dysfunction, as determined by medical history and physical exam should undergo pulmonary function testing. Those with a forced expiratory volume in 1 second (FEV1) of \< 50% of predicted or diffusion capacity of the lung for carbon monoxide (DLCO) (corrected) \< 40% will be excluded
- Significant cardiovascular abnormalities as defined by any one of the following: New York Heart Association (NYHA) class III or IV congestive heart failure, clinically significant hypotension, uncontrolled symptomatic coronary artery disease, or a documented ejection fraction of \< 35%
- Uncontrolled serious and active infection
Key Trial Info
Start Date :
December 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2024
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04359784
Start Date
December 27 2021
End Date
December 23 2024
Last Update
October 23 2025
Active Locations (1)
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1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109