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CAR T-cell Therapy

Anakinra for Non-Hodgkin's Lymphoma

Phase 2

Recruiting

Led By Jordan Gauthier

Research Sponsored by Fred Hutchinson Cancer Research Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to understand and provide informed consent

Subjects must be 18 years of age or older

Must not have

Major organ dysfunction: 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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 days after liso-cel infusion

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at whether anakinra can help decrease the occurrence of CRS and neurotoxicity in patients with B-cell non-Hodgkin lymphoma who are receiving CAR-T therapy.

Who is the study for?

Adults with B-cell non-Hodgkin lymphoma eligible for CAR-T therapy can join. They must understand the study, have a certain level of physical ability (Karnofsky score >= 60%), and normal kidney function. Women who can bear children need a negative pregnancy test and agree to use birth control, as do fertile men. People are excluded if they have severe liver, lung or heart problems, uncontrolled infections or require high-dose steroids.

What is being tested?

The trial is testing whether Anakinra can prevent serious side effects like CRS and neurotoxicity in patients getting CD19-targeted CAR-T cell therapy for B-cell non-Hodgkin lymphoma. It involves additional procedures like PET scans, bone marrow tests, lumbar punctures, X-rays and CT scans to monitor patient responses.

What are the potential side effects?

Anakinra may cause reactions at the injection site, headache, flu-like symptoms such as fever or muscle pain; it might also lower resistance to infections. Since it's used here to reduce other treatment side effects, monitoring will be thorough.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I understand the study and can give my consent.

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I am 18 years old or older.

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I can care for myself but may need occasional help.

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I am not pregnant and can prove it with a test taken in the last 2 weeks.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on daily steroids higher than 15 mg of prednisone or its equivalent, except for short-term high doses.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 28 days after lisocabtagene maraleucel (liso-cel) infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 28 days after lisocabtagene maraleucel (liso-cel) infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 days after lisocabtagene maraleucel (liso-cel) infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Absence of any grade cytokine release syndrome (CRS)

Secondary study objectives

Adverse events (AEs)

CRS grade

Disease response to liso-cel

+1 more

Side effects data

From 2018 Phase 2 & 3 trial • 104 Patients • NCT01809132

19%

Acute Kidney Injury

11%

Ascites

Nausea

Urinary tract infection

Hematemesis

Upper GI hemorrhage

Clostridium difficile infection

Hepatic failure

Encephalopathy

C. difficile infection

Respiratory Failure

Peritonitis

Esophageal varices hemorrhage

Tachycardia

Multiple Organ Dysfunction Syndrome (MODS)

Viremia

Baceteremia

100%

80%

60%

40%

20%

Study treatment Arm

Anakinra & Pentoxifylline & Zinc Sulfate

Methylprednisolone

Observational

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Prevention (anakinra, lisocabtagene maraleucel)Experimental Treatment8 Interventions

Patients 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lumbar Puncture

2016

Completed Phase 3

~510

Biospecimen Collection

2004

Completed Phase 3

~2020