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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

Must not have

Bridging chemotherapy completed < 7 days prior to CAR T-cell lymphodepleting chemotherapy

Most recent PET-CT or CT of all known disease is sites done more than 6 weeks prior to CAR T-cell infusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I finished my last chemotherapy less than a week ago before starting CAR T-cell therapy.

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My last scan was over 6 weeks ago before my CAR T-cell treatment.

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I haven't had a PET-CT or CT scan after my last chemotherapy before starting lympho-depleting therapy.

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I have an infection that needs IV treatment.

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I have a brain tumor larger than 2 cm.

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I had a stem cell transplant less than 100 days before CAR T-cell therapy.

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My cancer started as CLL and has become DLBCL.

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I have been diagnosed with Burkitt's lymphoma.

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I have received CAR T-cell therapy, but not with axicabtagene ciloleucel.

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I have had a stem cell transplant from a donor.

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My cancer is a type of lymphoma that affects the brain.

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I am a woman able to have children and choose not to use birth control during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Duration of neurotoxicity

Incidence of adverse events (AEs)

Objective response rate (ORR)

+2 more

Other study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

Cyclophosphamide

2010

Completed Phase 4

~2310

Anakinra

2016

Completed Phase 4

~1320