drugset / Trial / NCT04432506

Anakinra for the Reduction of CAR-T Toxicity in Patients With Relapsed or Refractory Large B-cell Lymphoma

NCT04432506

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2020-07-27
Primary completion
2024-05-28
Completion
2024-05-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Anakinra Protein / enzyme biologic Subcutaneous
Subject Axicabtagene Ciloleucel Cell therapy Intravenous
Background Cyclophosphamide Other / unclassified Intravenous
Background Fludarabine Small molecule Intravenous