Anakinra for Large B-Cell Lymphoma

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byJohn Timmerman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Jonsson Comprehensive Cancer Center

Must not be taking: Immune checkpoint inhibitors

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

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

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.

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.

+6 more

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.

+15 more

Trial 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

Participant Groups

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.

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.