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Anakinra for Large B-Cell Lymphoma
Phase 2
Recruiting
Led By John M Timmerman, MD
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Large B-cell lymphoma includes diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma
Patients with progressive or stable disease as the best response to the most recent treatment regimen or disease progression within 12 months after autologous hematopoietic stem cell transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial will study how well anakinra works to prevent a severe syndrome related to T-cell therapy in patients with B-cell lymphoma that has returned or not responded to treatment.
Who is the study for?
This trial is for adults with large B-cell lymphoma that has returned or hasn't responded to two prior treatments. They must have certain blood test levels within normal ranges, be able to make medical decisions, and not be pregnant or nursing. People with primary CNS lymphoma, certain other cancers, recent chemotherapy or stem cell transplants, untreated infections, or uncontrolled autoimmune diseases cannot join.Check my eligibility
What is being tested?
The study tests if anakinra can prevent severe brain-related side effects after CAR T-cell therapy in patients with large B-cell lymphoma. Anakinra is given alongside FDA-approved axicabtagene ciloleucel and standard drugs fludarabine and cyclophosphamide used before CAR T-cell treatment.See study design
What are the potential side effects?
Anakinra may cause reactions at the injection site, headache, nausea, diarrhea and increased risk of infection. The CAR T-cell therapy can lead to flu-like symptoms, difficulty breathing, rapid heartbeat and may affect how organs like the heart and kidneys work.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition is a type of large B-cell lymphoma.
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My cancer did not improve or got worse after my last treatment or within a year after my stem cell transplant.
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My large B-cell lymphoma has worsened after two treatments, qualifying me for axicabtagene ciloleucel.
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My kidneys are functioning well enough to clear creatinine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients who met the eligibility criteria to receive and did receive anakinra
Rate of severe chimeric antigen receptor T-cell-related encephalopathy syndrome (ICANS)
Secondary outcome measures
Duration of neurotoxicity
Incidence of adverse events (AEs)
Objective response rate (ORR)
+2 moreOther outcome measures
Changes in Electroencephalogram (EEG) that characterize ICANS: Generalized or lateralized or bilateral independent or multifocal spike
Changes in Electroencephalogram (EEG) that characterize ICANS: Slowing of EEG activity.
Changes in Electroencephalogram (EEG) that characterize ICANS: focal slowing
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Prevention (anakinra, CAR T-cell therapy)Experimental Treatment5 Interventions
Patients receive standard lymphodepleting therapy including fludarabine and cyclophosphamide on days -5 to -3, then receive axicabtagene ciloleucel CAR T-cell infusion. Patients with clinical evidence of ICANS of any grade, or CRS >= grade 3 receive anakinra SC every 6-12 hours for 12-36 doses over 9 days in the absence of unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Anakinra
2016
Completed Phase 4
~2260
Fludarabine
2012
Completed Phase 3
~1100
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Cyclophosphamide
1995
Completed Phase 3
~3770
Axicabtagene Ciloleucel
2015
Completed Phase 2
~490
Find a Location
Who is running the clinical trial?
Jonsson Comprehensive Cancer CenterLead Sponsor
360 Previous Clinical Trials
27,676 Total Patients Enrolled
John M Timmerman, MDPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- People with HIV who have very low levels of the virus in their blood can participate.I have an autoimmune disease that has caused organ damage or needed strong medication in the last 6 months.I am considered capable of making my own medical decisions.My large B-cell lymphoma has spread to my brain but did not start there.Your total bilirubin level should be less than or equal to 2.0 mg/dL.I finished my last chemotherapy less than a week ago before starting CAR T-cell therapy.My last scan was over 6 weeks ago before my CAR T-cell treatment.I haven't had a PET-CT or CT scan after my last chemotherapy before starting lympho-depleting therapy.I have an infection that needs IV treatment.I haven't had alemtuzumab in the last 6 months or clofarabine/cladribine in the last 3 months.My condition is a type of large B-cell lymphoma.It's been a short time since my last immune therapy.My cancer did not improve or got worse after my last treatment or within a year after my stem cell transplant.My large B-cell lymphoma has worsened after two treatments, qualifying me for axicabtagene ciloleucel.I have a brain tumor larger than 2 cm.I had a stem cell transplant less than 100 days before CAR T-cell therapy.You have HIV and your viral load is detectable.My cancer started as CLL and has become DLBCL.I have been diagnosed with Burkitt's lymphoma.I have received CAR T-cell therapy, but not with axicabtagene ciloleucel.I have had a stem cell transplant from a donor.My cancer is a type of lymphoma that affects the brain.Your liver enzymes (ALT/AST) are not more than 2.5 times the normal limit.I am a woman able to have children and choose not to use birth control during the study.You are allergic to proteins from E. Coli.My kidneys are functioning well enough to clear creatinine.
Research Study Groups:
This trial has the following groups:- Group 1: Prevention (anakinra, CAR T-cell therapy)
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.
By what means does this research hope to impact patients?
"The primary outcome of this clinical trial, which will be assessed over a Up to 12 months time frame is to Rate of severe chimeric antigen receptor T-cell-related encephalopathy syndrome (ICANS). Secondary outcomes include Persistent hepatotoxicity, Objective response rate (ORR), and Proportion of patients who received anakinra and develop ICAN."
Answered by AI
Are there any current openings for this type of treatment?
"That is correct. The clinical trial was first posted on 3/4/2020 and was most recently edited on 10/14/2022. The study is searching for 36 participants across 1 sites."
Answered by AI
How many people are being asked to participate in this research project?
"That is correct. The clinicaltrials.gov website says that the trial is currently open for enrollment, with the first posting on March 4th, 2020 and the most recent update being October 14th, 2022. 36 people are needed for the study taking place at 1 location."
Answered by AI
Are there long-term risks involved with using anakinra or CAR T-cell therapy?
"Since this is only a Phase 2 trial, there is not yet enough data to support the efficacy of Prevention. However, there are some safety data, which gives it a score of 2."
Answered by AI
Why is Prevention (anakinra, CAR T-cell therapy) generally prescribed?
"Prevention is a novel treatment that can be used on patients with colchicine, b-cell lymphomas, and lung cancers."
Answered by AI
Are there any other similar experiments that have been done with this drug combination?
"Out of the thousands of ongoing clinical trials, 962 are studying methods of Prevention (anakinra, CAR T-cell therapy). Of these, 171 are in Phase 3. Although most research for this area is based in Philadelphia, Pennsylvania, there are 29074 locations running similar studies."
Answered by AI
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