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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 below
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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.
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My lymphoma has not affected my brain or spinal cord.
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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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My kidneys are functioning well enough, with a creatinine clearance rate of at least 45 mL/min.
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I am not pregnant and cannot become pregnant due to surgery or being postmenopausal for 2+ years.
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My lymphoma has returned or didn't respond to treatment after at least 2 treatments.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

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 more

Side effects data

From 2018 Phase 2 & 3 trial • 104 Patients • NCT01809132
19%
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

Axicabtagene Ciloleucel (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04432506 — Phase 2
B-Cell Lymphoma Research Study Groups: Treatment (cyclophosphamide, fludarabine, axi-cel, anakinra)
B-Cell Lymphoma Clinical Trial 2023: Axicabtagene Ciloleucel Highlights & Side Effects. Trial Name: NCT04432506 — Phase 2
Axicabtagene Ciloleucel (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04432506 — Phase 2

Frequently Asked Questions

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

For what purpose is Anakinra most often prescribed?

"colchicine is often treated with Anakinra. However, Anakinra can also target other conditions such as b-cell lymphomas, lung cancers, and systemic juvenile idiopathic arthritis (sjia)."

Answered by AI

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
~4 spots leftby Jan 2025