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B-Cell Non-Hodgkin LymphomaPhase 2NCT04359784

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 testing Anakinra, X-Ray Imaging and Positron Emission Tomography in people with B-Cell Non-Hodgkin Lymphoma, run by Fred Hutchinson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-Cell Non-Hodgkin Lymphoma
What is being tested?
Anakinra, X-Ray Imaging and Positron Emission Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
27 Dec 2021to 23 Dec 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fred Hutch/University of Washington Cancer Consortium

    Seattle, Washington, 98109

Other trials in United States

About this study

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

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.

Read the 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.

Medical subject headings
Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AnakinraBiological

    Also called Kinaret, Kineret, rIL-1ra, rIL1RN

    Given IV (previously SC)

  • X-Ray ImagingProcedure or surgery

    Also called Conventional X-Ray, Diagnostic Radiology, Medical Imaging, Radiographic Imaging

    Undergo x-ray

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, PET scan

    Undergo PET/CT

  • Computed TomographyProcedure or surgery

    Also called CAT Scan, Computed Axial Tomography, CT scan

    Undergo PET/CT or CT

  • Bone Marrow AspirationProcedure or surgery

    Undergo BMA

  • Bone Marrow BiopsyProcedure or surgery

    Undergo bone marrow biopsy

  • Lumbar PunctureProcedure or surgery

    Also called LP, spinal tap

    Undergo lumbar puncture

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection

    Undergo blood sample collection

Study groups in NCT04359784
Study groupRoleWhat they receive
Prevention (anakinra, lisocabtagene maraleucel)ExperimentalPatients receive anakinra IV (previously SC) 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, PET/CT or CT, BMA and biopsy (as clinically indicated), and lumbar puncture (as clinically indicated), and at follow-up as clinically indicated. Patients also undergo blood sample collection on study.
Receives: Biological: Anakinra; Procedure: X-Ray Imaging; Procedure: Positron Emission Tomography; Procedure: Computed Tomography; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Lumbar Puncture; Procedure: Biospecimen Collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absence of Any Grade Cytokine Release Syndrome (CRS)

    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.

    Measured: Up to 28 days after lisocabtagene maraleucel (liso-cel) infusion

Secondary outcomes (7)

  1. CRS Grade

    CRS severity was graded per American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria (Lee et al, Biol Blood Marrow Transplant, 2019) based on the presence and severity of fever, hypotension, and hypoxia: grade 1, fever ≥38°C without hypotension or hypoxia; grade 2, hypotension not requiring vasopressors and/or hypoxia requiring low-flow oxygen; grade 3, hypotension requiring a single vasopressor or hypoxia requiring high-flow oxygen; grade 4, life-threatening hypotension requiring multiple vasopressors and/or hypoxia requiring positive-pressure ventilation; grade 5, death.

    Measured: Up to 28 days after liso-cel infusion

  2. ICANS Grade

    ICANS severity was graded per American Society for Transplantation and Cellular Therapy (ASTCT) consensus criteria (Lee et al, Biol Blood Marrow Transplant, 2019): grade 1, immune effector cell-associated encephalopathy (ICE, overall score range 0-10, higher score = better condition) score 7-9, awakens spontaneously; grade 2, ICE score 3-6, awakens to voice; grade 3, ICE score 0-2, awakens only to tactile stimulus, any clinical seizure that resolves rapidly or non-convulsive seizures on EEG that resolve with intervention, focal/local oedema on neuroimaging; grade 4, ICE 0, unarousable and unable to perform ICE, unarousable or requires vigorous or repetitive tactile stimuli to arouse, stupor or coma, life-threatening prolonged seizure (>5 min); or repetitive clinical or electrical seizures without return to baseline in between, deep focal motor weakness such as hemiparesis or paraparesis, diffuse cerebral oedema on neuroimaging, decerebrate or decorticate posturing, or cranial nerve VI

    Measured: Up to 28 days after liso-cel infusion

  3. Rate of Hospitalization After Liso-cel Treatment

    Number of patients hospitalized after liso-cel treatment.

    Measured: Up to 28 days after liso-cel infusion

  4. Duration of Hospitalization After Liso-cel Treatment

    Duration of hospitalization measured in days following liso-cel administration.

    Measured: Up to 28 days after liso-cel infusion

  5. Corticosteroid Usage After Liso-cel Treatment

    Number of patients who received corticosteroids within 28 days after liso-cel infusion.

    Measured: Up to 28 days after liso-cel infusion

  6. Disease Response to Liso-cel

    Best response within approximately 90 days post liso-cel infusion will be assessed based on institutional standard using physical examination, imaging (CT or PET-CT), and if necessary, bone marrow biopsies, in patients with measurable disease prior to treatment.

    Measured: Approximately 90 days after liso-cel infusion

  7. Adverse Events (AEs)

    Grade 3 or greater AEs, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

    Measured: Up to 28 days after liso-cel infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2020
  2. Study start27 Dec 2021
  3. Primary completion1 Oct 2024
  4. Study completion23 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04359784
Sponsor's protocol ID
RG1006866
Other IDs
NCI-2020-01861, 10373
Status last verified
Oct 2025
First submitted
15 Apr 2020
Last updated
23 Oct 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anakinra, X-Ray Imaging and Positron Emission Tomography in people with B-Cell Non-Hodgkin Lymphoma, run by Fred Hutchinson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Absence of Any Grade Cytokine Release Syndrome (CRS) (time frame: Up to 28 days after lisocabtagene maraleucel (liso-cel) infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04359784.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2025.

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