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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 days after liso-cel infusion

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 28 days after liso-cel infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 28 days after liso-cel infusion

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Absence of any grade cytokine release syndrome (CRS)

Secondary outcome measures

Adverse events (AEs)

CRS grade

Corticosteroid usage after liso-cel treatment

+4 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

Trial Design

1Treatment groups

Experimental Treatment

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

Patients receive anakinra IV (previously SC) 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 2

~1730

Bone Marrow Aspiration

2011

Completed Phase 2

~1740

Positron Emission Tomography

2008

Completed Phase 2

~2240

Computed Tomography

2017

Completed Phase 2

~2720

Bone Marrow Biopsy

2021

Completed Phase 2

~10

Anakinra

2016

Completed Phase 4

~2240

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,663 Previous Clinical Trials

40,925,880 Total Patients Enrolled

Fred Hutchinson Cancer Research CenterLead Sponsor

443 Previous Clinical Trials

148,220 Total Patients Enrolled

Fred Hutchinson Cancer CenterLead Sponsor

556 Previous Clinical Trials

1,343,243 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is enrollment being pursued for this clinical experiment?

"Affirmative, according to clinicaltrials.gov this study is still seeking participants. The initial post was created on December 27th 2021 and the most recent adjustment occurred September 19th 2022. 25 individuals are required from 1 site for the trial's completion."

Answered by AI

What pathologies is Anakinra typically prescribed to address?

"Anakinra is widely prescribed for treating b-cell lymphomas and has proven successful in helping patients with systemic juvenile idiopathic arthritis (sjia), neonatal-onset multisystem inflammatory disease (nomid), and steroids."

Answered by AI

Is this the inaugural trial of its kind?

"Since 2015, Anakinra has been extensively researched. The first clinical trial was sponsored by Kite, A Gilead Company, and completed in the same year with 307 participants. Thanks to its success, Phase 1 & 2 drug approval were granted and now there are 43 active studies involving 247 cities across 32 nations worldwide."

Answered by AI

Has the FDA sanctioned Anakinra for medicinal use?

"While Phase 2 trials do not provide efficacy data, there are some safety findings which allow us to rate Anakinra's safety a score of 2."

Answered by AI

Are there any vacancies for prospective participants in this trial?

"Yes, according to clinicaltrials.gov, this trial is actively recruiting participants as of today. The project was initially posted on December 27th 2021 and has since been amended; 25 patients are now being recruited from a single site."

Answered by AI

Are there any extant clinical trials that involve Anakinra?

"At present, there are 43 Anakinra clinical trials in progress with 8 of those active studies being conducted at Phase 3. These tests primarily reside in Paris, Ile-De-France, yet over 650 other medical locations across the world also host these treatments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04359784.

All > Toxicity