Anakinra for Large B-Cell Lymphoma

Recruiting in Palo Alto (17 mi)

Overseen byPaolo Strati

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This phase II trial studies the side effects and best dose of anakinra and to see how well it works in reducing side effects (toxicity) associated with a CAR-T cell treatment called axicabtagene ciloleucel in patients with large B-cell lymphoma that has come back (relapsed) or has not responded to treatment (refractory). Anakinra is a drug typically used to treat rheumatoid arthritis but may also help in reducing CAR-T cell therapy toxicity. Giving anakinra in combination with axicabtagene ciloleucel may help control relapsed or refractory large B-cell lymphoma.

Research Team

Paolo Strati

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

My heart pumps well and I don't have fluid around it.

Absolute neutrophil count of >= 1.0 x 10^9/L

Measurable disease of >= 1.5 cm

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Exclusion Criteria

I have a history of tuberculosis but tested negative recently.

I have received treatment targeting CD19 before.

I need urgent treatment because my tumor is causing blockages or pressing on blood vessels.

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Treatment Details

Interventions

Anakinra (Interleukin-1 Receptor Antagonist)
Axicabtagene Ciloleucel (CAR T-cell Therapy)

Trial OverviewThe 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.

Participant Groups

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.

Axicabtagene Ciloleucel is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Yescarta for:

Large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy
Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy
Relapsed or refractory follicular lymphoma after two or more lines of systemic therapy

🇪🇺 Approved in European Union as Yescarta for:

Diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy
Relapsed or refractory DLBCL and primary mediastinal large B-cell lymphoma, after two or more lines of systemic therapy
Relapsed or refractory follicular lymphoma after three or more lines of systemic therapy