Anakinra for Large B-Cell Lymphoma

Recruiting at 1 trial location

Overseen By Caspian Oliai

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Jonsson Comprehensive Cancer Center

Must not be taking: Immune checkpoint inhibitors

Disqualifiers: Primary CNS lymphoma, Burkitt's lymphoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 30

36 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well anakinra works in preventing severe chimeric antigen receptor T-cell-related encephalopathy syndrome after chimeric antigen receptor T-cell therapy in patients with large B-cell lymphoma that has come back or has not responded to treatment. Immunosuppressive therapy, such as anakinra, is used to decrease the body?s immune response, which may prevent severe chimeric antigen receptor T-cell-related encephalopathy syndrome.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, certain treatments like alemtuzumab, clofarabine, cladribine, and immune checkpoint inhibitors must have been stopped for a specific period before joining the trial.

Research Team

John Timmerman, MD

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

People with HIV who have very low levels of the virus in their blood can participate.

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.

Exclusion Criteria

I have an autoimmune disease that has caused organ damage or needed strong medication in the last 6 months.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymphodepleting Therapy

Participants receive standard lymphodepleting therapy including fludarabine and cyclophosphamide on days -5 to -3

1 week

CAR T-cell Infusion

Participants receive axicabtagene ciloleucel CAR T-cell infusion

1 day

Anakinra Treatment

Participants with clinical evidence of ICANS or CRS receive anakinra subcutaneously every 6-12 hours for 12-36 doses over 9 days

9 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 6 months

Follow-up visits at 30, 90, and 100 days, then at 6 months

Treatment Details

Interventions

• Anakinra

Trial Overview 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.

Participant Groups

Group I: Prevention (anakinra, CAR T-cell therapy) Experimental Treatment 5 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.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+