Anakinra for Non-Hodgkin's Lymphoma

Phase-Based Progress Estimates
Fred Hutch/University of Washington Cancer Consortium, Seattle, WANon-Hodgkin's LymphomaAnakinra - Biological
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Non-Hodgkin's Lymphoma

Treatment Effectiveness

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Up to 28 days after liso-cel infusion

Day 90
Disease response to liso-cel
Day 90
Disease response to Axi-cel
Day 28
Adverse events (AEs)
CRS grade
Corticosteroid usage after liso-cel treatment
Duration of hospitalization after liso-cel treatment
Neurotoxicity grade
Rate of hospitalization after liso-cel treatment
Day 28
Absence of any grade cytokine release syndrome (CRS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Anakinra & Pentoxifylline & Zinc Sulfate
19%Acute Kidney Injury
9%Urinary tract infection
8%Upper GI hemorrhage
8%Clostridium difficile infection
6%Hepatic failure
6%C. difficile infection
4%Respiratory Failure
4%Multiple Organ Dysfunction Syndrome (MODS)
4%Esophageal varices hemorrhage
This histogram enumerates side effects from a completed 2018 Phase 2 & 3 trial (NCT01809132) in the Anakinra & Pentoxifylline & Zinc Sulfate ARM group. Side effects include: Acute Kidney Injury with 19%, Ascites with 11%, Nausea with 9%, Urinary tract infection with 9%, Upper GI hemorrhage with 8%.

Trial Design

2 Treatment Groups

Prevention (anakinra, axicabtagene ciloleucel)
1 of 2
Prevention (anakinra, lisocabtagene maraleucel)
1 of 2

Experimental Treatment

25 Total Participants · 2 Treatment Groups

Primary Treatment: Anakinra · No Placebo Group · Phase 2

Prevention (anakinra, axicabtagene ciloleucel)Experimental Group · 2 Interventions: Anakinra, Axicabtagene Ciloleucel · Intervention Types: Biological, Biological
Prevention (anakinra, lisocabtagene maraleucel)
Experimental Group · 1 Intervention: Anakinra · Intervention Types: Biological
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved
Axicabtagene ciloleucel
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 28 days after liso-cel infusion

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,149 Previous Clinical Trials
41,161,395 Total Patients Enrolled
Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
149,156 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
532 Previous Clinical Trials
1,315,326 Total Patients Enrolled
Swedish Orphan BiovitrumIndustry Sponsor
82 Previous Clinical Trials
11,560 Total Patients Enrolled
Jordan GauthierPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
3 Previous Clinical Trials
312 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 11 Total Inclusion Criteria

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Frequently Asked Questions

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

"Affirmative, according to 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies for prospective participants in this trial?

"Yes, according to, 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.