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CAR T-cell Therapy
Anakinra for Large B-Cell Lymphoma
Phase 2
Waitlist Available
Led By Paolo Strati
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Cardiac ejection fraction >= 50% with no evidence of pericardial effusion
Planned to receive standard of care therapy with axicabtagene ciloleucel
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year
Awards & highlights
Study Summary
This trial is testing a drug typically used to treat arthritis to see if it can help reduce side effects from a different cancer treatment.
Who is the study for?
This trial is for adults with certain types of large B-cell lymphoma that have relapsed or are refractory. They must have had at least two prior systemic therapies, adequate organ function, no CNS involvement by lymphoma, and a good performance status (able to carry out daily activities). Women must not be pregnant and participants should agree to use birth control.Check my eligibility
What is being tested?
The trial is testing the drug Anakinra's effectiveness in reducing side effects from CAR-T cell therapy (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma. It aims to determine the best dose of Anakinra and how well it works alongside standard CAR-T treatment.See study design
What are the potential side effects?
Anakinra may cause injection site reactions, headaches, nausea, increased risk of infection due to immune system suppression, allergic reactions, and potentially lower blood counts. The exact side effects when combined with axicabtagene ciloleucel will be studied.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart pumps well and I don't have fluid around it.
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I am scheduled for treatment with axicabtagene ciloleucel.
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It's been weeks since my last cancer treatment before starting axi-cel therapy.
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My lymphoma has returned or didn't respond to treatment after 2 treatments.
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My lymphoma has not affected my brain or spinal cord.
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My kidneys are functioning well enough, with a creatinine clearance rate of at least 45 mL/min.
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I am fully active or can carry out light work.
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Side effects from my previous treatments are mild or gone, except for hair loss.
Select...
My lymphoma has not affected my brain or spinal cord.
Select...
My heart pumps well and I don't have fluid around it.
Select...
I am scheduled for treatment with axicabtagene ciloleucel.
Select...
My kidneys are functioning well enough, with a creatinine clearance rate of at least 45 mL/min.
Select...
I am not pregnant and cannot become pregnant due to surgery or being postmenopausal for 2+ years.
Select...
My lymphoma has returned or didn't respond to treatment after at least 2 treatments.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of any grade cytokine release syndrome (CRS)
Secondary outcome measures
Complete response rate
Incidence of different grades and duration of both CRS and immune cell-associated neurotoxicity syndrome (ICANS)
Overall 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: Treatment (cyclophosphamide, fludarabine, axi-cel, anakinra)Experimental Treatment4 Interventions
Patients receive cyclophosphamide IV over 60 minutes and fludarabine IV over 30 minutes on days -5 to -3 in the absence of disease progression or unacceptable toxicity. Patients then receive axicabtagene ciloleucel IV over 30 minutes or less on day 0 and anakinra SC on days 0-6 in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Axicabtagene ciloleucel
FDA approved
Anakinra
FDA approved
Fludarabine
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,626 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,798,429 Total Patients Enrolled
Paolo StratiPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
71 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of tuberculosis but tested negative recently.My heart pumps well and I don't have fluid around it.I have received treatment targeting CD19 before.I need urgent treatment because my tumor is causing blockages or pressing on blood vessels.I have been cancer-free for 3 years, except for non-dangerous skin cancer or early-stage cancers.I have an infection that is not under control or needs IV drugs to manage, except for simple UTI or bacterial throat infection.I am scheduled for treatment with axicabtagene ciloleucel.I have had a serious blood clot in my leg or lung in the last 6 months.I have or had cancer cells in my brain or spinal fluid.My CLL has transformed into a more aggressive form.It's been weeks since my last cancer treatment before starting axi-cel therapy.I have a medical tube inserted, but ports like Port-a-Cath are okay.I have an autoimmune disease that has caused organ damage or needed strong medication in the last 2 years.I agree to use birth control from now until 6 months after my last anakinra injection.My lymphoma affects my heart's atrium or ventricle.I have received CAR-T cell therapy or similar treatments.I have a history of brain or nervous system disorders.My lymphoma has returned or didn't respond to treatment after 2 treatments.I have had a stem cell transplant from a donor.My lymphoma has not affected my brain or spinal cord.I haven't had a heart attack or other major heart issues in the last year.My kidneys are functioning well enough, with a creatinine clearance rate of at least 45 mL/min.I am fully active or can carry out light work.Side effects from my previous treatments are mild or gone, except for hair loss.My lymphoma has not affected my brain or spinal cord.My heart pumps well and I don't have fluid around it.I have not received a live vaccine within the last 6 weeks.I am scheduled for treatment with axicabtagene ciloleucel.My kidneys are functioning well enough, with a creatinine clearance rate of at least 45 mL/min.It's been weeks since my last cancer treatment before starting axi-cel therapy.I am not pregnant and cannot become pregnant due to surgery or being postmenopausal for 2+ years.My lymphoma has returned or didn't respond to treatment after at least 2 treatments.I had a stem cell transplant using my own cells within the last 6 weeks.Side effects from my previous treatments are mild or gone, except for hair loss.I am fully active or can carry out light work.I am not pregnant and cannot become pregnant due to surgery or being postmenopausal for 2+ years.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (cyclophosphamide, fludarabine, axi-cel, anakinra)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- 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 are some of the more serious side effects that Anakinra can cause?
"Even though there is not yet data supporting Anakinra's efficacy, there is enough information attesting to its safety to give it a score of 2."
Answered by AI
How large is the participant pool for this research?
"Sadly, this study has already collected the required number of participants and is no longer recruiting. However, there are still 2797 studies searching for patients with b-cell lymphomas and 962 studies searching for participants for Anakinra."
Answered by AI
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