Study on Anakinra to Prevent Severe Brain Side Effects in Patients with Recurrent or Resistant Large B-cell Lymphoma

Sponsor: Jonsson Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04205838

Provider View

This clinical trial is testing whether the drug anakinra can help prevent severe brain-related side effects in patients receiving CAR T-cell therapy for large B-cell lymphoma that has returned or not responded to treatment.

Patient Parameters

Program Overview

This study is exploring if anakinra, a medication that reduces the immune system's activity, can prevent severe brain-related side effects in patients undergoing CAR T-cell therapy for large B-cell lymphoma that has come back or not responded to previous treatments. The trial aims to see if anakinra can safely and effectively reduce these side effects, known as encephalopathy syndrome, which can occur after CAR T-cell therapy.

Description

The main goals of this study are to see if enough patients can be enrolled at one location to expand the trial to more sites and to estimate how well anakinra works in preventing severe brain-related side effects from CAR T-cell therapy. Researchers also want to understand how anakinra affects the overall effectiveness of CAR T-cell therapy and the duration of any brain-related side effects. They will also check if anakinra causes any liver problems or other side effects in patients.

Patients will receive standard treatment to prepare their body, including specific chemotherapy drugs, before getting the CAR T-cell therapy. If they show signs of brain-related side effects or severe immune reactions, they will receive anakinra injections every 6-12 hours for up to 9 days, unless they experience unacceptable side effects. After the study treatment, patients will have follow-up visits at 30, 90, and 100 days, and then at 6 months.

Eligibility Criteria

Inclusion Criteria

  • Have large B-cell lymphoma that has returned or not responded to at least two previous treatments and is eligible for a specific CAR T-cell therapy approved by the FDA.
  • Includes types like diffuse large B-cell lymphoma and others.
  • Cancer may have spread to the brain but did not start there.
  • Meet specific blood test requirements for liver and kidney function.
  • HIV-positive patients can participate if their viral load is undetectable.
  • Must be able to make medical decisions.

Exclusion Criteria

  • Receiving a different CAR T-cell therapy than the one specified.
  • Have primary brain lymphoma or certain other types of lymphoma.
  • Recent chemotherapy or radiation that does not meet study timing requirements.
  • Large brain tumors over 2 cm.
  • Recent stem cell transplant or certain other treatments.
  • Active infections requiring IV treatment.
  • History of severe autoimmune disease or allergies to specific proteins.
  • HIV-positive with detectable viral load.
  • Pregnant or breastfeeding women.
  • Women who can become pregnant must agree to use contraception during the study.

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