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CAR T-cell Therapy
Anakinra for Neurotoxicity Prevention in CAR-T Cell Therapy
Phase 2
Waitlist Available
Led By Matt J Frigault, MD
Research Sponsored by Marcela V. Maus, M.D.,Ph.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including specific subtypes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up infusion date to the date of disease progression or death from any cause up 100 months
Awards & highlights
Study Summary
This trial is being done to study the combination of these drugs to see if it can reduce the occurrence of Cytokine Release Syndrome (CRS) and neurologic toxicities.
Who is the study for?
This trial is for adults over 18 with relapsed or resistant large B-cell lymphoma after two prior therapies. They must have at least one measurable lesion, stable recovery from previous treatments, good organ function, and no severe allergies to study drugs. Women of childbearing age need a negative pregnancy test and agree to use contraception.Check my eligibility
What is being tested?
The study tests if anakinra can reduce side effects like Cytokine Release Syndrome (CRS) and neurologic toxicities in patients receiving axicabtagene ciloleucel for Non-Hodgkin lymphoma. It's seeing if this combination is safer than the current treatment.See study design
What are the potential side effects?
Possible side effects include nausea, headache, rapid heartbeat, shortness of breath, kidney damage, rash due to CRS; confusion from neurotoxicity; plus any typical reactions related to anakinra or axicabtagene ciloleucel.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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My large B-cell lymphoma has not responded to at least two treatments.
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I am not pregnant and agree to use birth control.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ infusion date to the date of disease progression or death from any cause up 100 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~infusion date to the date of disease progression or death from any cause up 100 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of neurotoxicity as per CTCAE v4.03 criteria
Secondary outcome measures
Duration of Response
Number of Participants with Adverse Events CTCAE version 4.03 Grade 3 or higher
Objective Response Rate
+2 moreSide effects data
From 2018 Phase 2 & 3 trial • 104 Patients • NCT0180913219%
Acute Kidney Injury
11%
Ascites
9%
Nausea
9%
Urinary tract infection
8%
Hematemesis
8%
Upper GI hemorrhage
8%
Clostridium difficile infection
6%
Hepatic failure
6%
Encephalopathy
6%
C. difficile infection
4%
Respiratory Failure
4%
Peritonitis
4%
Esophageal varices hemorrhage
4%
Tachycardia
4%
Multiple Organ Dysfunction Syndrome (MODS)
2%
Viremia
2%
Baceteremia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anakinra & Pentoxifylline & Zinc Sulfate
Methylprednisolone
Observational
Trial Design
1Treatment groups
Experimental Treatment
Group I: Anakinra and Axicabtagene CiloleucelExperimental Treatment2 Interventions
Patients who meet eligibility criteria for the study will subsequently be enrolled for treatment.
Screening
Enrollment/Leukapheresis period
Bridging therapy (if applicable)
Lymphodepleting chemotherapy period
Investigational Product (IP) treatment period
Anakinra
Axicabtagene Ciloleucel
Post treatment assessment period
Long term follow-up period
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Axicabtagene Ciloleucel
2015
Completed Phase 2
~500
Anakinra
2016
Completed Phase 4
~2240
Find a Location
Who is running the clinical trial?
Marcela V. Maus, M.D.,Ph.D.Lead Sponsor
4 Previous Clinical Trials
69 Total Patients Enrolled
Kite, A Gilead CompanyIndustry Sponsor
43 Previous Clinical Trials
3,641 Total Patients Enrolled
Matt J Frigault, MDPrincipal InvestigatorMassachusetts General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe or uncontrolled infections.I am fully active or restricted in physically strenuous activity but can do light work.I might need urgent cancer treatment soon due to a serious risk.You have a weakened immune system from birth.My side effects from previous treatments are mild or gone.My large B-cell lymphoma has not responded to at least two treatments.I have an autoimmune disease that has damaged organs or needed strong medication in the last 2 years.I have been cancer-free for 3 years, except for non-dangerous skin cancer.I have not had a heart attack or other major heart issues in the last year.I have not received a live vaccine in the last 6 weeks.I have a history of HIV or active hepatitis B or C.I am not pregnant and agree to use birth control.My kidney, liver, lung, and heart functions are all within normal ranges.I have had symptoms of a blood clot in my veins or lungs in the last 6 months.Your oxygen level is above 92% when breathing normally.I haven't had stem cell transplants, targeted therapies, genetically modified T cell therapy, or severe allergic reactions.I have cancer cells in my spinal fluid or brain, or certain brain disorders.You have at least one spot that can be measured to see how the lymphoma is responding to treatment.My blood and lymphocyte counts are within a healthy range.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Anakinra and Axicabtagene Ciloleucel
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What does Anakinra's FDA status currently entail?
"While there is some data supporting Anakinra's safety, it has not been proved effective yet and thus only received a 2."
Answered by AI
Are investigators still looking for participants in this clinical trial?
"That is correct, the online registry shows that this study is seeking participants. The posting date was October 5th 2020 and the latest update was on October 28th 2021. There are plans to enroll 20 people from 2 different hospitals or clinics."
Answered by AI
What are some of the illnesses that Anakinra has been known to help with?
"Anakinra is commonly used to treat b-cell lymphomas. It can also help with various other conditions, such as systemic juvenile idiopathic arthritis (sjia), neonatal-onset multisystem inflammatory disease (nomid), and steroids."
Answered by AI
How large is the test group for this new medication?
"Yes, the trial is recruiting participants according to the latest update on clinicaltrials.gov. The study was originally posted on October 5th 2020 and is looking for 20 individuals at 2 sites."
Answered by AI
Can you elaborate on other scientific research that has used Anakinra?
"As of now, there are 45 ongoing Anakinra studies. 7 of those active studies are Phase 3 clinical trials. The majority of the many trials for Anakinra are based in Paris, Ile-De-France; though, in total, 663 locations around the world are running these sorts of tests."
Answered by AI
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